Downsize DC: How the FDA Helped Kill My Dad

[shanek]

On the American Liberty Foundation's new Downsize DC website, Jim Babka has a nice, very personal, and fully sourced article on the FDA and the harm it causes:

http://www.downsizedc.org/cases/fda.shtml

My father died of cancer in April 2003. He was only 64 and in apparent good health until his cancer diagnosis. He watched his diet, got regular exercise, had no vices like alcohol, drugs, or tobacco, and lived a conservative lifestyle. He was neither depressed, nor repressed. His father had lived to 79, with a brother who lived to 83, and another who's still alive at 86. I took it for granted I'd have another 15-20 years with my Dad.

His cancer started as a renal cell carcinoma (kidney) that spread to a vein, and from there to the rest of his body. Carcinomas produce a tiny vascular system of their own that steals blood flow from the organ they inhabit. They also produce dramatically increased amounts of a substance called COX-2. Inhibiting COX-2 retards the creation of the cancer's vascular system and starves the tumor.

COX-2 also seems to play other key roles in the development of cancer cells, but no successful, cancer-specific COX-2 inhibitors are on the market. Instead, doctors rely on chemotherapy and radiation.

Alas, a COX-2 inhibiting cancer drug does exist. It started its clinical trials for FDA approval in 1999. In Phase I, the FDA concluded that the drug Endostatin (by Entremed, Inc.—NASDAQ: ENMD) has no apparent toxicity. Compare that with chemo or radiation. The drug is currently in Phase II of clinical trials. The research, much of which I studied in my father's final weeks, shows great promise, but the FDA wouldn't let my father have it.

This drug might have saved my father's life, and it almost certainly would not have killed him, but the cancer certainly did.

Endostatin won't be available for years, and the National Cancer Cooperative Group reports that 350 other new treatments are also awaiting FDA approval. Meanwhile, the American Cancer Society says 552,000 Americans will die of cancer this year alone.

Yet this kind of thing is the rule with the FDA, not the exception. Depending on which study you trust, it takes seven to ten years to get a new drug to market. Those years mean deaths. Sam Kazman of the Competitive Enterprise Institute has studied the FDA approval process and his conclusions are sobering. According to Kazman:

22,000 people died waiting for the FDA to approve streptokinase—a drug that dissolves clots in heart attack patients—and since approval has saved tens of thousands of lives.

More than 8,000 lost their lives while the FDA reviewed misoprostol—a drug that reduces gastric ulcers in arthritis victims.

A five-year delay in approving Septra—an anti-bacterial drug—cost 80,000 lives.

And there are others…

A study by Arthur D. Little, Inc. determined that a three-year delay in introducing propranolol—the first beta-blocker, used to treat angina and hypertension—resulted in 30,000 deaths.

3,500 kidney cancer victims died during the three-and-a-half years it took to approve Interleukin 2.

150,000 heart patients were victimized by FDA delays in approving an emergency blood-clotting drug called TPA.

Almost any doctor in the world will tell you that taking a baby aspirin or drinking a glass of red wine every day helps reduce the threat of heart attack. But for years the FDA imposed fines or imprisonment on aspirin makers or wineries who tried to tell you that.

The drug that caused the most deaths prior to FDA licensing was Elixir Sulfanilamide. It was poorly researched and ended up killing 107 people.

Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.

[a_unique_person]

You are mixing statistics and arguments all over the place shanek.

http://entremed.com/pipeline/endostatin/clinicaldata.cfm

This link indicates that it can help in some cases. The claim that it helped kill his father cannot be proven, as it is just as possible that it would have made no difference to this cancer. And it did not cure cancer sufferers, it reduced the sizes of the tumours in some cases. Certainly a drug that should be made available when it is fully understood, but not a 'cure' as such.

I can find you examples of drug companies pushing for drugs to be approved that turn out to be useless or no better than existing drugs. They also have an agenda, making profits, which is a conflict of interest when it comes to people's health. There has to be a watchdog. You can imagine the law suits if it lets a drug through prematurely that causes more harm than it cures, and most drugs do have side effects, and require to correct prescribing to work safely.

[shanek]

Originally posted by a_unique_person
You are mixing statistics and arguments all over the place shanek.

No, I'm not. I posted quotes from one article, in the order they appear in the article.

This link indicates that it can help in some cases. The claim that it helped kill his father cannot be proven, as it is just as possible that it would have made no difference to this cancer.

Did you even read the source material referenced in the article? Endostatin was meant to work in conjunction with other already approved treatments—and yet the FDA insisted on testing Endostatin alone, without those other treatments! Sure, Endostatin alone may have made no difference, but that isn't how he would have taken it, and that isn't how it was meant to be taken!

I can find you examples of drug companies pushing for drugs to be approved that turn out to be useless or no better than existing drugs. They also have an agenda, making profits, which is a conflict of interest when it comes to people's health.

Your usual BS rhetoric. :rolleyes:

They make profits by saving lives.

There has to be a watchdog. You can imagine the law suits if it lets a drug through prematurely that causes more harm than it cures, and most drugs do have side effects, and require to correct prescribing to work safely.

This sentence proves that you didn't even read the entirety of the article I linked to, much less the cited source material, because this point is covered in great detail.

Is it too much to ask for people to READ THE SMEGGING ARTICLES????

[chulbert]

If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.

I count far too many maybes, probablies, mights and could haves in that article to take any numbers seriously.

[RichardR]

Originally posted by chulbert
If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.Precisely. Any study needs a control. You need to compare such deaths with the number of people who would have died had there been no FDA approval process. Without that, this article is meaningless.

[a_unique_person]

Originally posted by RichardR
Precisely. Any study needs a control. You need to compare such deaths with the number of people who would have died had there been no FDA approval process. Without that, this article is meaningless.

i suppose it may appear heartless, but it is much better to be able to understand a drug properly, than to just release drugs without following a scientific process. In the long run, the scientific process will prove to be the best.

And making profits and selling drugs is a conflict of interest. Maybe you should look up also the drugs that are rejected.

[Walter Wayne]

From the article
Endostatin won't be available for years ....What is the current average turn around on the FDA. I had thought the average approval time was down to 12-13 months but I don't have the numbers here.

[RichardR]

Originally posted by a_unique_person
i suppose it may appear heartless, but it is much better to be able to understand a drug properly, than to just release drugs without following a scientific process. In the long run, the scientific process will prove to be the best.True.

Originally posted by a_unique_person
And making profits and selling drugs is a conflict of interest..Huh? That, I don't understand. How is it a conflict? And what is the purpose of making them if you can't sell them?

Originally posted by a_unique_person
Maybe you should look up also the drugs that are rejected. You would need to do that too. And estimate what deaths would have been caused if they had been released.

[a_unique_person]

Originally posted by RichardR
True.

Huh? That, I don't understand. How is it a conflict? And what is the purpose of making them if you can't sell them?

You would need to do that too. And estimate what deaths would have been caused if they had been released.

It means they will try to put drugs on the market that don't necessarily measure up. In Australia, there is a list of subsidised pharmaceutical drugs. Naturally, every manufacturer wants their drugs on that list.

Only, when drugs are tested, it turns out that many new and expensive ones don't live up to their claims. That is, having spent millions on developing a drug, their is an imperative to justify that expenditure with a profit in return.

I am not saying they should not me making money, or that they should not be making drugs, only that when it comes time to sell the drugs, there are two driving forces, one to cure people, the other to make money. A conflict comes about when one dominates the other. Naturally, the company won't be around if it doesn't make a profit, but people won't necessarily be getting the best treatment if profit overrides the need to cure people.

[Agammamon]

Thalidomide is an example of a drug rushed through the FDA approvals process because it was thought to be so useful.

[Crossbow]

I would prefer that the FDA takes the time to make sure the drug actually does what the makers claim.

Of course the makers are going to say that it works just fine because they want to make their money on it as soon as possible. There have already been far, far too many cases of manufacturers making grandiose claims about the safety of their products (e.g., cigarettes) which are just plain wrong.

Sorry, but manufacturers cannot be trusted to do a legimate evaluation of their products.

[shanek]

Originally posted by chulbert
If the delay to market introduced by the FDA "kills" people then that same delay must, in some cases, "save" people by eliminating harmful drugs.

Again, read the article! This is addressed!

If you want your position taken seriously then present both sides. Demonstrate that the estimated number of lives lost due to slow drug approval outweigh the number of lives saved by denial.

The article does exactly that! The worse drug before FDA approval took 107 lives—FDA delays routinely take more than that!

[shanek]

Originally posted by a_unique_person
It means they will try to put drugs on the market that don't necessarily measure up.

If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

[Thanz]

Originally posted by shanek


If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

I'd just like to point out the current scandal that is happening in Australia with Pan Pharmaceuticals. One story of many can be found here (http://www.nzherald.co.nz/storydisplay.cfm?storyID=3452482&thesection=news&thesubsection=general) .

Some choice snippets:Alarmed by reports of hallucinations, delirium and other reactions, described by federal parliamentary secretary for health Trish Worth as potentially life-threatening, the TGA had uncovered a scandal of fabrication and manipulation of test results and appalling quality control. The crisis had its beginnings in January, when the TGA heard disturbing reports that Travacalm, a travel sickness pill that had been used without problems for decades, was suddenly causing hallucination, blurred vision, and loss of balance.

TGA tests showed variations of up to 700 per cent in the content of ingredients in the pills, a finding confirmed later during an audit of the company's manufacturing process after Travacalm was recalled from the market.


Yes, let's trust the companies to do all the testing etc. themselves, because they wouldn't do anyhtnig slipshod to make a buck, would they?

[shanek]

Originally posted by Thanz
Yes, let's trust the companies to do all the testing etc. themselves, because they wouldn't do anyhtnig slipshod to make a buck, would they?

And here we return to the old false dichotomy that I've addressed numerous times...why do I even bother? :rolleyes:

[Thanz]

Originally posted by shanek


And here we return to the old false dichotomy that I've addressed numerous times...why do I even bother? :rolleyes:

Well, perhaps you can address this article directly on point:

http://www.caut.ca/english/bulletin/2001_nov/default.asp

A researcher was doing clinical trials of a new drug. She had some unexpected results, and wanted to warn her patients. The drug company came down on her hard, tried to sppress her findings and prevent her from warning her patients. So don't tell me its a false dicotomy - the conflict is very real.

The case of University of Toronto clinician Dr. Nancy Olivieri has been the focus of international attention since Apotex, corporate sponsor of her clinical drug trials of its drug, attempted to suppress her findings of unexpected risks. The company abruptly terminated the trials and issued warnings of legal action against Olivieri should she inform her patients at the Hospital for Sick Children of the risks, or publish her findings.

So the company threatens a doctor if she tells her patients (sick kids) about the possible risks associated with the drug. This is who you want to trust for drug approvals?

[Tmy]

The FDA doesnt own the drug. WHy not get the drug through the black market? Or from another country where its legal.

Would the guys insurance even cover an experimental drug?

Im not sure what you wantthe FDA to do. Toss evey drug out into the market? Im sure the FDA isnt dragging its feet on approval, what motive would they have to do that.

[Valmorian]

Originally posted by shanek

If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.



Not by necessity. Look at any "naturopathic" medicine supplier. They're making a profit on some products that don't DO anything.



Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

If they believe that, they're mistaken. The better job they do of LOOKING like they help people and save lives, the better their profits. The number of unproven herbal remedies out there shows this quite well.

[pgwenthold]

Originally posted by Valmorian


Not by necessity. Look at any "naturopathic" medicine supplier. They're making a profit on some products that don't DO anything.


Of c ourse, the problem is that they can claim that their product does stuff, even if it doesn't. Thus, how is the consumer to really know?

As has been stated above, that should be the role of the FDA. To make sure the product does was the manufacturer claims it does.

I'm not for the FDA saying what is good enough or not, but the FDA should certainly verify that that the product has been appropriately tested and that the claims are legitimate.

[chulbert]

Originally posted by shanek
The article does exactly that! The worse drug before FDA approval took 107 lives—FDA delays routinely take more than that!

You didn't read my post very carefully. If you want to demonstrate the FDA shouldn't exist then you need to show that lives it has cost are more than the lives it has saved. I want numbers.

How bad the drugs were before the FDA existed is irrelevant.

[daredelvis]

Originally posted by Agammamon
Thalidomide is an example of a drug rushed through the FDA approvals process because it was thought to be so useful.
Thalidomide was never approved by the FDA (until recently for chemo patients). It is an example of how the FDA works.

Pregnant mothers never took thalidomide in the U.S..
Daredelvis

[shanek]

Originally posted by Thanz
Well, perhaps you can address this article directly on point:

This "point" is just to support your false dichotomy. Government testing and testing by the company are not the only two alternatives, and I'm getting sick of people blathering on like it is no matter how many times I point out otherwise.

[shanek]

Originally posted by Tmy
Im sure the FDA isnt dragging its feet on approval, what motive would they have to do that.

The article itself gave several reasons. Why won't people just read it? :(

[shanek]

Originally posted by Valmorian
Not by necessity. Look at any "naturopathic" medicine supplier. They're making a profit on some products that don't DO anything.

If they believe that, they're mistaken. The better job they do of LOOKING like they help people and save lives, the better their profits. The number of unproven herbal remedies out there shows this quite well.

[sigh]...The problem...as I have repeatedly pointed out...is that the government have herbal and naturopathic remedies a free ride through the Dietary Supplement Health and Education Act of 1994.

[shanek]

Originally posted by chulbert
You didn't read my post very carefully. If you want to demonstrate the FDA shouldn't exist then you need to show that lives it has cost are more than the lives it has saved. I want numbers.

The article gave numbers! I have repeatedly given numbers in the past!

Here's some numbers for you: In a study covering the years 1950 to 1980, it was determined that the FDA's drug lag saved on average 33 American lives every year, but caused 2,100 to 12,000 each year to die needlessly (D.H. Geirenger, "The Safety and Efficacy of New Drug Approval," Cato Journal 5:177-201, 1985).

Those numbers good enough for ya?

How bad the drugs were before the FDA existed is irrelevant.

Strange. In another thread on the subject I was told that figures on that were vital. Make up your mind, people!

[shanek]

Originally posted by daredelvis

Thalidomide was never approved by the FDA (until recently for chemo patients). It is an example of how the FDA works.

Pregnant mothers never took thalidomide in the U.S..
Daredelvis

And yet, Congressmade the FDA become more aggressive in its testing as a result. How much sense does that make?

[davefoc]

I don't know much about this issue, but I really don't like the idea that the FDA gave a flat no to Shanek's dad.

Why not at some point through the approval cycle but before actual approval, make the drug available to people on a completely, it's your risk and your decision basis. There would be quite a bit to be gained from this. Obviously some people would die prematurely and some people would have there problems mitigated. The results of these early releases would help fine tune the relese process between too stringent and too leanient based on the results of these early users.

I liked the suggestion, Shanek, that you try to get the medicine from another country. Did you investigate this path?

[Whoracle]

"You can imagine the law suits if it lets a drug through prematurely that causes more harm than it cures, and most drugs do have side effects, and require to correct prescribing to work safely."


As much as you scream otherwise, it's a very valid point. Letting a drug that has not been proven to be safe would lead to a ton of lawsuits, which would then lead to you posting some article bitching about trial lawyers and how much they are costing us. Now I know you're all into the "invisible hand" thing thinking we can trust a corporation, but history has shown us that they have no problems cutting corners. Hell look at the auto industry. They fight tooth and nail with the government to delay or stop every safety regulation and then plaster their ads boasting how safe their cars are now forced to be.

[shanek]

Originally posted by davefoc
I don't know much about this issue, but I really don't like the idea that the FDA gave a flat no to Shanek's dad.

Clarification: It's Jim Babka's dad, not mine.

Why not at some point through the approval cycle but before actual approval, make the drug available to people on a completely, it's your risk and your decision basis.

It's supposed to be like this. It's called "compassionate use." Not that the FDA lets people take advantage of it all the time. Several months ago, I posted the story of Edie Bacon who was being refused a promising new medicine which could effectively treat her terminal cancer.

[shanek]

Originally posted by Whoracle
Hell look at the auto industry. They fight tooth and nail with the government to delay or stop every safety regulation and then plaster their ads boasting how safe their cars are now forced to be.

I have looked at the auto industry here in the past. With one exception, every single safety feature—lap/shoulder belts, anti-lock brakes, side-impact beams, all-wheel drive, traction control, on and on and on, were developed, tested, and implemented by the automobile companies absent of any government regulation whatsoever.

The only exception is air bags. The car companies were going to implement it, but the government stepped in and mandated an unsafe level of deployment force (to "protect people not wearing seatbelts," something they were never designed to do). In 1978, GM warned the government that this would lead to injuries and even death, but the regulation was made. Not only did this delay the implementation of this life-saving feature for 10 years (killing people who would have otherwise been saved by the air bags), once implemented they also started killing children and shorter adults, just as GM predicted.

The auto companies made us safer. Government killed us.

[Brooklyn Dodger]

Originally posted by Agammamon
Thalidomide is an example of a drug rushed through the FDA approvals process because it was thought to be so useful.

So Thalidomide justifies everything the FDA has ever done?

[Thanz]

Originally posted by shanek


This "point" is just to support your false dichotomy. Government testing and testing by the company are not the only two alternatives, and I'm getting sick of people blathering on like it is no matter how many times I point out otherwise.

Well, according to the article that you linked, the alternative to the FDA is to have the company do the testing, overseen perhaps by insurance companies and/or something like UL.

In order for the testing to have any credibility, it would need to be overseen by somebody. I have shown that we cannot trust companies to do it themselves. So, you either rely on insurance companies or on independent labs like UL.

Insurance companies are risk averse. They would only get involved in the area if they thought they could make money. There is no reason that an insurance company would require any testing that is less stringent or time consuming than the current regime under the FDA.

Similarly, if some outside agency were to be created, it would need funding from somewhere. Most of this funding would come from drug manufacturers. If the agency were in fact controlled by drug manufacturers, it leads to worries about the fox guarding the chicken coop,so to speak. Also, such an agency would also need its own insurance, which also drives up the cost.

I don't see anything here that convinces me that the FDA need to be done away with in favour of a private solution.

Your argument needs to be based on one of two premises: either (a) the FDA is sitting on it's butt too much, dragging out approvals for drugs that testing is complete on or (b) the FDA tests drugs too much.

If it is (a), this can be addressed within the current system. If it is (b), I think the argument relies too much on hindsight (how do you know about a drug until after comprehensive testing?) and lack of information (drugs that don't go through FDA testing at all, but might make it to market if there were no FDA requirements).

[Valmorian]

Originally posted by shanek


[sigh]...The problem...as I have repeatedly pointed out...is that the government have herbal and naturopathic remedies a free ride through the Dietary Supplement Health and Education Act of 1994.

I thought your point was that 'medications' that don't do anything would be weeded out? What does the governmental "free ride" have to do with this?

Here's a claim you made:

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.

This could be said of any medication, herbal or not. The problem is that some of those companies are quite successful selling snake oil, and the failure of their remedies to actually do anything doesn't seem to have hurt THEIR profits.

[pgwenthold]

Originally posted by Valmorian

quote: Shanek
--------------------------------------------------------------------------------

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.
--------------------------------------------------------------------------------


This could be said of any medication, herbal or not. The problem is that some of those companies are quite successful selling snake oil, and the failure of their remedies to actually do anything doesn't seem to have hurt THEIR profits.

I agree.

Actually, Shane makes a mistake here. Companies do _not_ need to do a better job of helping people and saving lives to get better profits. They only need people to _think_ they are doing a better job of helping people and saving lives.

Yes, they could make more profits by making a truly better product, or they could make a worse product and just lie to people about how good they are. It's a very difficult cognition problem for a consumer to sort out the truth from lies, and not just because the consumer is dumb, but just because it is inherently a difficult problem to evalaute in the manner that the consumer must do it.

As I said above, the role of the FDA should be to certify claims by manufacturers about what the product does. From that, I am all for letting the consumer decide if they want to use it, but they have to be able to make that decision based on accurate information. It is too easy to deceive the consumer in these cases.

[shanek]

Originally posted by Thanz
Well, according to the article that you linked, the alternative to the FDA is to have the company do the testing, overseen perhaps by insurance companies and/or something like UL.

If it's like UL, then the companies wouldn't be doing the testing!

BTW, the companies are doing all the testing now.

What's the big problem with a UL-like certification body?

I don't see anything here that convinces me that the FDA need to be done away with in favour of a private solution.

The fact that it kills dozens of times more people than it saves doesn't convince you? Then what the smeggin' H would???

[shanek]

Originally posted by Valmorian
I thought your point was that 'medications' that don't do anything would be weeded out? What does the governmental "free ride" have to do with this?

Please pay attention people...If the market IS LEFT ALONE then the tendency will be to weed the bad drugs out since there would be an enormous incentive to do so! But the DSHEA removes all such incentives!

This could be said of any medication, herbal or not. The problem is that some of those companies are quite successful selling snake oil, and the failure of their remedies to actually do anything doesn't seem to have hurt THEIR profits.

Because the government has absolved them of all financial responsiblity!!!!

How many times do I have to say the same fscking thing over and over and over again in these threads? I'm getting sick of this. There are more woo-woos among the skeptics when it comes to politics than anywhere else...

[shanek]

Originally posted by pgwenthold
Yes, they could make more profits by making a truly better product, or they could make a worse product and just lie to people about how good they are.

And how is such a lie going to be successful? You're completely ignoring the educated doctors and the medical journals and all of the fantastic amounts of information that's out there to let doctors and patients know what are good treatments and what aren't! Are you saying this would all disappear if there were no FDA? Preposterous!

[pgwenthold]

Originally posted by shanek


And how is such a lie going to be successful?


The same way that "homeopathic" treatments are successful today.



You're completely ignoring the educated doctors and the medical journals and all of the fantastic amounts of information that's out there to let doctors and patients know what are good treatments and what aren't! Are you saying this would all disappear if there were no FDA? Preposterous!

And you are ignoring reality. How many of those studies are going to be done and published if there is no FDA funding and/or requiring them?

How many homeopathic and herbal medicine companies are publishing studies of the effectiveness of their products in medical journals? By your arguments, they should be doing that in order to increase their sales. It ain't happening.

[Thanz]

Originally posted by shanek


If it's like UL, then the companies wouldn't be doing the testing!

BTW, the companies are doing all the testing now.

What's the big problem with a UL-like certification body?

If you read my post, I outlined my concerns with a company/UL/insurance based system already. Basically, I don't see what the advantages are over the FDA.

The fact that it kills dozens of times more people than it saves doesn't convince you? Then what the smeggin' H would???

How about some sort of convincing argument or evidence that a private system would be any better than the FDA??

I feel that you have simply ignored the rest of my post, which is disappointing. I'd like to know your stance on a couple of issues to help clear up your position for me.

1. Do you agree that new drug treatments should be thoroughly tested to ensure their saftey and effectiveness before being marketed to the public?

2. Do you agree that some corporations have shown a conflict of interest between ensuring they only market drugs that work and cause few side effects versus making as much money as possible?

3. Do you agree that insurance companies have no reason to accept less testing for a drug they will underwrite the risks for than under the current FDA system? If not, what are the reasons?

4. Do you think that the FDA sits on drugs too long for which testing is completed, or do you think that the FDA tests too much?

5. What reasons, if any, would a private lab have for doing less testing than under the FDA scheme?

If you are going to say that the FDA is bad and needs to be eliminated, you need to clearly state what is going to replace it (if anything) and why it would be better than the FDA. Unless, of course, you just think that drugs shouln't require testing. But I'd like to know where you stand on these questions. I would appreciate direct answers rather than insisting that you have answered it elsewhere. Thank you in advance.

[Valmorian]

Originally posted by shanek


Please pay attention people...If the market IS LEFT ALONE then the tendency will be to weed the bad drugs out since there would be an enormous incentive to do so! But the DSHEA removes all such incentives!



This is utter nonsense. "Bad Drugs" were around long before government regulations were required on them. They weren't 'weeded out' then, why should they be now? Furthermore, without an organization like the FDA, the government woud have to rely upon the industry itself to tell them what is a 'bad drug'. Doesn't sound very trustworthy to me.



Because the government has absolved them of all financial responsiblity!!!!

How many times do I have to say the same fscking thing over and over and over again in these threads? I'm getting sick of this. There are more woo-woos among the skeptics when it comes to politics than anywhere else...

You HONESTLY believe that the only reason companies who sell herbal remedies are successful is because of the lack of financial responsibility for some claims they make? What makes you think this? Are you just assuming it?

Hell, there are books on using magical spells to cure ailments. People actually make a living SELLING those books. I don't see them disappearing anytime soon, even though these spells clearly do NOTHING.

Your tendency to yell, scream, foam at the mouth (textually it looks like that) and insult those you debate with whenever someone disagrees with you politically certainly isn't lending any credence to your views, by the way.

[RandFan,Jr.]

I'm not a doctor but I play one on TV...er I fantasize playing doctor with Pamela Anderson who IS on TV.

In any event I do have several clients at UCLA including a research department and a Cancer resource center who's director specializes in debunking quack claims. When Endostatin was featured on 60 minutes a few years back it was the source of much talk especially since one of the doctors featured on the show was a doctor from UCLA.

During the past two years I think the consensus has become that the methodology of Endostatin is good but it might ultimately require a different drug. I used to update the website for the Jonsson Cancer Center (http://www.cancer.mednet.ucla.edu/). I know, wow, huh.

The fight against cancer may have gained two new weapons. Researchers announced Thursday they have discovered two new cancer-fighting proteins that may help to starve tumors. Researchers from the University of California Los Angeles (UCLA) and the Rockville, Maryland-based Human Genome Sciences discovered the two new angiogenesis inhibitors, called METH-1 and METH-2, which seem to be more potent than other similar compounds already being tested. "METH-1 is the more powerful of the two angiogenesis inhibitors and was found in laboratory studies to be 50 times as potent as one of the previously described inhibitors, called endostatin," said Dr. Judith Gasson, director of the UCLA Jonsson Cancer Center. Caveat, the last time I posted an opinion about cancer research I was chastised for my misuse of terminology and methodology.

The moral: Don't trust a computer consultant for medical or scientific information.

[Reager]

Originally posted by shanek


Please pay attention people...If the market IS LEFT ALONE then the tendency will be to weed the bad drugs out since there would be an enormous incentive to do so!

This claim is demonstrably false, wrt both drugs and foods. One example: Before 1906, market forces didn't "weed out" the companies selling rat-infested and spoiled meat, the Meat Inspection Act did that. How many lives do you think were SAVED due to the Meat Inspection Act (actually, the MIA saved the meat industry as well. After The Jungle was published, no one was buying meat. They couldn't trust the meat companies to run a clean shop)? Before the creation of the FDA, adulterated and mislabelled foods and drugs were the norm, now they are the exception. The claim that we would be better off without the FDA is laughable, and the claim that private industry can be trusted to put the health of the consumer over the desire for greater profits is equally laughable.

But the DSHEA removes all such incentives!

You'll never find me defending DSHEA, but it's unfair to pin the absurd pass given to dietary and herbal supplements on the FDA. Congress is to blame. The FDA actually proposed to INCREASE the regulation of herbal remedies and dietary supplements, to require they meet the efficacy standards for drugs. This resulted in intense lobbying from the dietary & herbal industry. In fact, Congress received more letters protesting the increased standards than on any other issue, ever. Sens. Orrin Hatch (who has financial ties to the supplement industry) and Tom Harkin (who believes that a bee pollen remedy helped cured his allergies), virtually sneaked the bill through Congress without debate.

Mike

[RandFan,Jr.]

Originally posted by mfeldman
This claim is demonstrably false, wrt both drugs and foods. One example: Before 1906, market forces didn't "weed out" the companies selling rat-infested and spoiled meat, the Meat Inspection Act did that. How many lives do you think were SAVED due to the Meat Inspection Act (actually, the MIA saved the meat industry as well. After The Jungle was published, no one was buying meat. They couldn't trust the meat companies to run a clean shop)? Before the creation of the FDA, adulterated and mislabelled foods and drugs were the norm, now they are the exception. The claim that we would be better off without the FDA is laughable, and the claim that private industry can be trusted to put the health of the consumer over the desire for greater profits is equally laughable.Hi mfeldman,

I am a huge fan of Upton Sinclair's tome. That and All Quiet on the Western Front are the two most influential books that I have read. They made me analyze some of my more conservative values. One only needs look at the thalidomide babies of the 60's to know that drug companies are willing to use humans as guinea pigs. And of what value are market forces to the person who is dead or crippled due to bad drugs?

I'm a capitalist but give me enough regulation to ensure a modicum of safety. That being said I do believe that there is too much regulation and that the process of getting drugs to patients needs to be streamlined and I think the notion of protecting a patient who is dying and in extreme pain is absurd. If such a person would like to test a drug, any drug then let him or her test it.

[shanek]

Originally posted by pgwenthold
The same way that "homeopathic" treatments are successful today.

As I've pointed out repeatedly, they only get away with this because of government protection.

And you are ignoring reality. How many of those studies are going to be done and published if there is no FDA funding and/or requiring them?

These studies are not funded or required by the FDA!!! You're the one ignoring reality.

[shanek]

Originally posted by Thanz
How about some sort of convincing argument or evidence that a private system would be any better than the FDA??

Are you denying that a private system would have incentives not to kill more people than it saves? Incentives that are not there with government?

1. Do you agree that new drug treatments should be thoroughly tested to ensure their saftey and effectiveness before being marketed to the public?

Of course.

2. Do you agree that some corporations have shown a conflict of interest between ensuring they only market drugs that work and cause few side effects versus making as much money as possible?

Again, of course, as long as there are no measures in place for holding them responsible for bad drugs getting into the market.

3. Do you agree that insurance companies have no reason to accept less testing for a drug they will underwrite the risks for than under the current FDA system?

As far as I can see.

4. Do you think that the FDA sits on drugs too long for which testing is completed, or do you think that the FDA tests too much?

The former. Not so much after it's completed, but there's way too many delays on the road to completion.

5. What reasons, if any, would a private lab have for doing less testing than under the FDA scheme?

Who said they would?

Now, some questions for you:

1. Do you agree that the evidence shows that the FDA kills more people than it saves?

2. Do you agree that pharmaceutical companies have an enormous incentive not to release drugs that kill more people than they save?

3. Do you agree that a private, UL-like body would have an incentive to get the testing done as quickly as possible, without bureaucratic delays?

4. Do you agree that said private body would be as concerned about the lives lost by drug delays as they would about deaths caused by the drug itself?

5. Do you have any evidence that the number of deaths due to taking bad drugs would increase beyond the number killed by FDA delays if the FDA were eliminated, even if nothing replaced it?

[shanek]

Originally posted by Valmorian
This is utter nonsense. "Bad Drugs" were around long before government regulations were required on them. They weren't 'weeded out' then, why should they be now? Furthermore, without an organization like the FDA, the government woud have to rely upon the industry itself to tell them what is a 'bad drug'. Doesn't sound very trustworthy to me.

Did you check the source above? The worst drug before the FDA killed only 107 people in its entire history; the FDA kills thousands every year.

According to S. David Young in The Rule of Experts, companies before the FDA advertized their safety record all the time, as well as the fact that their drugs had been approved by outside agencies.

This sounds very trustworthy to me, at least when compared to the current paradigm.

You HONESTLY believe that the only reason companies who sell herbal remedies are successful is because of the lack of financial responsibility for some claims they make? What makes you think this? Are you just assuming it?

What do you think would happen to companies making similar claims without said protection?

Hell, there are books on using magical spells to cure ailments.

I'm unaware of any magical spells killing people.

[shanek]

Originally posted by mfeldman
This claim is demonstrably false,

Odd, since I've demonstrated it to be true several times...

One example: Before 1906, market forces didn't "weed out" the companies selling rat-infested and spoiled meat, the Meat Inspection Act did that.

This is an untrue bit of myth I have debunked before on this board. This had more to do with the political lobbying efforts of large meat packers to "bring the small packers under control." Read Gabriel Kolko, The Triumph of Conservatism.

How many lives do you think were SAVED due to the Meat Inspection Act

No one, to my knowledge, has been able to provide evidence of any.

(actually, the MIA saved the meat industry as well.

No, it saved the big meat packers from competition by the small fry.

After The Jungle was published, no one was buying meat.

The Jungle was a work of FICTION!!!!

You'll never find me defending DSHEA, but it's unfair to pin the absurd pass given to dietary and herbal supplements on the FDA. Congress is to blame.

I wasn't blaming the FDA; I was providing that as a reason why the herbal and homeopathic remedies get a free ride.

[Reager]

Originally posted by shanek


Odd, since I've demonstrated it to be true several times...



Really? Where? How exactly did market forces "weed out" the companies selling tainted meat?




No one, to my knowledge, has been able to provide evidence of any.



Let's see...tainted meat=causes people to get sick and die. No more tainted meat=doesn't cause people to get sick and die. Seems pretty simple to me.


No, it saved the big meat packers from competition by the small fry.


And the fact that no one worries that the hamburgers at Winn-Dixie spoiled two month ago and were simply injected with some chemicals additives, then repackaged for sale? Was that just a coincidental benefit of the MIA and its progeny?


The Jungle was a work of FICTION!!!!

The story was fiction, but are you claiming its portrait of the meat industry was not based on reality?

Mike

[Thanz]

Shanek - thanks for answering my questions. I have some general comments, but first I'll answer your questions.

Originally posted by shanek


Are you denying that a private system would have incentives not to kill more people than it saves? Incentives that are not there with government?

Yes I am. What are these incentives that the private system has that the FDA lacks?


Now, some questions for you:

1. Do you agree that the evidence shows that the FDA kills more people than it saves?

No, I don't. I disagree with the methodology used, as it relies too much on hindsight and does not adequately state what the alternative is. The idea that "kills more than it saves" is hard to quantify, given we don't exactly know how many people the FDA saves just by being there.

2. Do you agree that pharmaceutical companies have an enormous incentive not to release drugs that kill more people than they save?

I think that your phrasing of the question is a bit skewed. No drug company will put out a drug that kills more than it saves - a 50% side effect of "death" is not something that is marketable, and shouldn't really be considered the benchmark.

Really, your question should be whether drug companies have an incentive to put out safe, effective drugs with minimal harmful side effects. And of course they do, as these will make the most money.

But make no mistake that money is the incentive, not healing people. So if some bean counter figures that the amount of money that could be made peddling a dangerous drug to desperate terminal patients would more than cover the money needed to settle the inevitable lawsuits for ill side effects, they have a big incentive to put out that drug as well. Remember the Pinto?

Also remember the article about Apotex I posted above. They threatened a doctor with a lawsuit if she told her patients (at The Hospital for Sick Children!) about possible harmful side effects from the drug she was testing.

3. Do you agree that a private, UL-like body would have an incentive to get the testing done as quickly as possible, without bureaucratic delays?

No, I disagree. Their incentive is to get it done right, not as quickly as possible.

4. Do you agree that said private body would be as concerned about the lives lost by drug delays as they would about deaths caused by the drug itself?

No, again I disagree. They would not be successfully sued for being too thorough on testing. They may be successfully sued for rushing something to market.

5. Do you have any evidence that the number of deaths due to taking bad drugs would increase beyond the number killed by FDA delays if the FDA were eliminated, even if nothing replaced it?

Unfortunately, no I don't. I don't know how to estimate this.

In general, you agree that testing is necessary, and that neither the insurance industry nor an independent lab has an incentive for less testing. I don't see where the savings, in cost or lives, happens under a private system.

[a_unique_person]

Originally posted by shanek


Odd, since I've demonstrated it to be true several times...



This is an untrue bit of myth I have debunked before on this board. This had more to do with the political lobbying efforts of large meat packers to "bring the small packers under control." Read Gabriel Kolko, The Triumph of Conservatism.



We regularly get stories of food poisoning in the newspapers. A few years ago, some children died from a rogue slaughter company that sold meat to a respected meat processing one. Both were guilty. The slaughter company for deliberately trying to flout the law, the other one for using such a company to try to boost profits.

They fly by night one, IIRC, was not convicted, as it closed as soon as it was set up, and the law only allowed the company itself to be convicted, the second, formerly reputable one was. Either way, children died and many adults were made seriously ill.

Regulations have since been tightened up.

[spoonhandler]

With reference to the original article and the specific issue raised there, I'd like to make a few points.

There is currently no treatment other than surgical removal of the tumour for renal cell carcinoma (RCC). These tumours resist chemotherapeutic and immunotherapeutic strategies and do not respond to radiotherapy.

COX-2 is just the latest in a very long list of things that RCC is known to overexpress. A number of anti-angiogenic strategies have been suggested (the hope is that by preventing the tumours from forming new blood vessels, they will be starved of nutrients/oxygen and die). So far, none of them work. Some have worked very well in mice but do not live up to expectations in human trials: one example is Endostatin.

Grabbing the first drug to hand that might inhibit something a tumour expresses a lot of is not an acceptable option for patients. I personally looked at thalidomide as a potential treatment for RCC given its anti-angiogenic properties. In mice, this drug was at best, ineffective and at worst, accelerated the growth of the tumour. I would have hated to be the one who offered it untested to patients as a potential cure only to see them die in half the time they might otherwise have had.

[shanek]

Originally posted by mfeldman
Really? Where?

Many, many places, including this very thread!

How exactly did market forces "weed out" the companies selling tainted meat?

Considering that Congressman E. D. Crumpacker of Indiana, in testimony before the House Agriculture Committee in June 1906, said that not even one of those officials "ever registered any complaint or [gave) any public information with respect to the manner of the slaughtering or preparation of meat or food products," I'd pull a Randism and say that the answer to your question is "Very well."

Let's see...tainted meat=causes people to get sick and die. No more tainted meat=doesn't cause people to get sick and die. Seems pretty simple to me.

If you think the government prevents tainted meat, you're delucing yourself. In fact, as we have discussed here several times, the last problem with tainted meat the government sat on for TWO MONTHS without telling the company! During which time they continued to unwittingly ship the bad meat!

The story was fiction, but are you claiming its portrait of the meat industry was not based on reality?

No, it wasn't. It was a political diatribe from a Socialist. A 1906 report from the Department of Agriculture's Bureau of Animal Husbandry provided a point-by-point refutation of the worst of Sinclair's "willful and deliberate misrepresentations of fact," saying that they ere "atrocious exaggeration," and "not at all characteristic." U.S. Congress, House, Committee on Agriculture, Hearings on the So-called "Beveridge Amendment" to the Agriculture Appropriation Bill, 59th Congress, 1st Session, 1906, pp. 346-350.

[shanek]

Originally posted by Thanz
Yes I am. What are these incentives that the private system has that the FDA lacks?

Oh:

1) Loss of funding
2) Loss of market support
3) Loss of support from the medical community
4) Court damages
5) Possible criminal action for negligence
6) Harm to their reputation

Whereas the FDA has no incentive at all to minimize the loss of life due to drug delays since their interest is political in nature, not medicinal. There is every incentive to delay and obstruct drugs for as long as possible lest a single drug with a bad side effect get through, but no incentive at all to make it available to people who need it.

No, I don't. I disagree with the methodology used, as it relies too much on hindsight and does not adequately state what the alternative is. The idea that "kills more than it saves" is hard to quantify, given we don't exactly know how many people the FDA saves just by being there.

"Just by being there?" Not "by preventing bad drugs from getting on the market," or "preventing Big Evil Corporations from selling bad drugs at a high profit," but just by being there???

How's a skeptic even to refute a claim like that? :rolleyes:

I think that your phrasing of the question is a bit skewed. No drug company will put out a drug that kills more than it saves - a 50% side effect of "death" is not something that is marketable, and shouldn't really be considered the benchmark.

But the claim is being made that there would be more deaths without the FDA because there'd be nothing stopping the BECs from releasing bad drugs. But since you've just admitted that no drug company will ever put out a drug that kills more people than it saves, then the number of lives saved can only go up!!!!

Really, your question should be whether drug companies have an incentive to put out safe, effective drugs with minimal harmful side effects. And of course they do, as these will make the most money.

Of course. But that question was to address the point of BECs putting out drugs that kill people without consideration for anything other than profits.

But make no mistake that money is the incentive, not healing people.

So?

Remember the Pinto?

Not only do I remember it, I've refuted it several times on this board...

Also remember the article about Apotex I posted above. They threatened a doctor with a lawsuit if she told her patients (at The Hospital for Sick Children!) about possible harmful side effects from the drug she was testing.

I fully agree that that's ridiculous. One more reason our tort system needs overhauling.

No, I disagree. Their incentive is to get it done right, not as quickly as possible.

Fair enough. I'll rephrase: "Do you agree that an independent standards body would have an incentive to approve a drug in the shortest reasonable time frame while still effectively measuring safety and efficacy?"

No, again I disagree. They would not be successfully sued for being too thorough on testing. They may be successfully sued for rushing something to market.

You don't think they could be sued for unnecessary delays?

Unfortunately, no I don't. I don't know how to estimate this.[/quote]

Then, in light of my posted figures to the contrary, my side of the claim stands as it has had the most evidence presented.

In general, you agree that testing is necessary,

Sure.

and that neither the insurance industry nor an independent lab has an incentive for less testing.

They do have an incentive to weed out unnecessary testing and unnecessary delays. They also have no reason to make companies duplicate studies just because they were done in a foreign country, as the FDA (with certain rare exceptions) does. This means the drugs would be brought to market quicker, saving lives.

Let's also not forget that someone would be legally permitted to take an unapproved drug as long as they understood that it was uncertified and agreed to the risks. People who are going to die of cancer in a year are not too concerned with long-term side effects, y'know.

[shanek]

Originally posted by a_unique_person
Regulations have since been tightened up.

Regulations which apparently weren't working before anyway. What's that definition of insanity again?

[DialecticMaterialist]

Well Shanek if the American Liberty Foundation says something bad about the FDA it MUST be true.

Seriously the FDA is a good and essential part of the system helping to preserve your rights. If the FDA approved of a drug prematurely and it killed a couple dozen or hundred people, then it'd be barked on for incompetence.

I'd rather a few people get killed from not getting a drug fast enough, then thousands dying from it arriving prematurely. Perhaps the American Liberty Foundation wishes for the return of snake oil hour?

[shanek]

Originally posted by DialecticMaterialist
I'd rather a few people get killed from not getting a drug fast enough, then thousands dying from it arriving prematurely.

The problem is, ALL of the available evidence shows that it's actually happening the other way around.

[a_unique_person]

Originally posted by shanek


Regulations which apparently weren't working before anyway. What's that definition of insanity again?

I don't get it.

You appear to be saying that we don't need regulations.

If someone does something wrong, they will get caught by the law.

Regulations are a part of the legal system.

[fsol]

Interesting story about the FDA.

http://www.newscientist.com/news/news.jsp?id=ns99993751

And another one

http://www.newscientist.com/news/news.jsp?id=ns99993781

It seems they don't always delay drugs.


I have looked at the auto industry here in the past. With one exception, every single safety feature—lap/shoulder belts, anti-lock brakes, side-impact beams, all-wheel drive, traction control, on and on and on, were developed, tested, and implemented by the automobile companies absent of any government regulation whatsoever.


I wouldn't look to the auto industry as an example to make your point.

Anti-lock brakes, all-wheel drive and traction control are not safety features. They may be marketed as such but that is not why they were developed.

As for seat belts and side-impact bars has it occured to you that they might be a response to legislation outside of the US? I'm not sure and would have to go check but it could be.

SUVs are classed as trucks? Why is that? And then there is the question of bull-bars and on and on and on...

[Skeptic]

Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.

This is a great example of the old saying, "there are three types of lies--lies, damn lies, and statistics".

Why is the number of those who die from "Bad drugs" low? Because the FDA is unnecessary? No, precisely because it DOES A GOOD JOB IN BANNING BAD DRUGS, AND QUICKLY REMOVES THE FEW BAD DRUGS THAT DO MAKE IT TO MARKET. Naturally, this means a low number of deaths from bad drugs.

Why is the number of those who die from "Good drugs" that the FDA eventually approves, during the waiting period, high? Quite apart from the fact that these numbers are HIGHLY misleading (essentially, they count EVERYBODY who died from a condition a later-approved drug helps in SOME cases as a death "due to the lack of the drug"), this shows that THE FDA DOES A GOOD JOB IN (EVENTUALLY) APPROVING DRUGS THAT DO WORK AND ARE EFFECTIVE. Naturally, once such effective drugs are approved, the number of deaths from the condition they treat is significantly lowered!

Let us take it to the two extremes, for illustration purposes.

Consider, on the one hand, an FDA where no bad drugs are ever approved, and all drugs that are approved are "miracle drugs" that (once approved) cured millions with previously-fatal conditions. This would be just about the best FDA one could imagine. Using Shanek's statistics, however, it would look really horrible: NOBODY ever dies of the drugs the FDA bans (so the number of death the "FDA prevents" is 0), while MILLIONS could have been saved if it had approved the drugs it DOES approve sooner (so the FDA is "guilty" of "killing millions" due to its "inefficiency".)

Consider now the opposite: an FDA that only approves bad and/or useless drugs. Clearly the worst possible FDA! However, on Shanek's view, things are suddenly looking up: many people would die from "bad drugs", since clearly some sort of governing body like the FDA is necessary; also, since nobody would be saved by the drugs that eventually are approved (since they are at best useless), the number of lives lost by FDA "hesitation and beurocracy" is ZERO!

In sum, Shanek's own statistics essentially prove that the FDA works very well, both in banning bad drugs, and in approving effective ones. To use these utterly misleading statistics as "proof" that the FDA is "useless" is irresponsible, not to say dangerous.

[Thanz]

shanek

I suggest you read skeptics excellent post on how the stats you rely upon are hopelessly skewed. I think that it shows your rhetoric of "kills more than it saves" to be empty.

Now, some specific responses:

Whereas the FDA has no incentive at all to minimize the loss of life due to drug delays since their interest is political in nature, not medicinal. There is every incentive to delay and obstruct drugs for as long as possible lest a single drug with a bad side effect get through, but no incentive at all to make it available to people who need it.
I think that the fact that the FDA is political does not support your view that it therefore has no incentive to save lives. It just has a different view of how to save lives - and protect the health - of people than you do. The FDA realizes that releasing a drug without understanding it is potentially more harmful than the ailment it is supposed to cure. The only way to ensure the efficacy of drugs is to test them.

Despite the factors you list, a private lab does not have the incentive to rush a drug through either. What you may see as unnecessary delay may be seen by a lab as prudent testing and research procedures, including understanding the test data once collected. I would submit that having a bad drug slip through would do infinitely more damage to the reputation and market position of a private lab than delay of a drug ever could.

"Just by being there?" Not "by preventing bad drugs from getting on the market," or "preventing Big Evil Corporations from selling bad drugs at a high profit," but just by being there???

How's a skeptic even to refute a claim like that? :rolleyes:

Well, obviously you can't refute it because it is such an airtight argument. :p

All sarcasm aside, however, "just by being there" means that drug companies know that they need to get through the FDA process, and as such, bad drugs do not get that far. The presence of the FDA stops some bad drugs, without even testing them.

But the claim is being made that there would be more deaths without the FDA because there'd be nothing stopping the BECs from releasing bad drugs. But since you've just admitted that no drug company will ever put out a drug that kills more people than it saves, then the number of lives saved can only go up!!!!
This is some real stilted logic. First, I again reference Skeptic's post on the bad math you rely on. Next, it is not that each drug has to kill more than it saves. It would be enough that the BECs release a lot of bad drugs (that do nothing, or almost nothing, to help) but kill or injure a signicant number of people.

In fact, the drugs released could be benign in the effects that they have, but if they cause people to switch from actually proven therapies, may cause the same sort of deaths you complain about with the FDA - death by lack of proper treatment.

Thanz: But make no mistake that money is the incentive, not healing people.

shanek: So?

Wasn't it you who just ragged on the FDA as their concern was "political" not "medicinal"? Why the double standard? Why do corporations get a free pass if they are pursuing dollars not medicine?

There have been several examples in this thread that show corporations caring more about the bottom line than the health of the patients they are supposedly helping. I haven't seen a concrete example of how the FDA puts politics over healing people. Even the example used by the author of the article, Endostatin, has been shown to not be as effective a drug as he makes it out to be.
Not only do I remember it, I've refuted it several times on this board...
Where? I notice you don't directly address my bean counter argument. Why?

I fully agree that that's ridiculous. One more reason our tort system needs overhauling.

It shows nothing of the sort. IIRC, they were trying to enforce some draconian contract provisions to the deteriment of patients. Nothing to do with tort. Nice try to deflect the real issue, however. What is important is not whether they could successfully sue - what is important is that they put the potential profitability of the drug ahead of the care of sick kids.

Fair enough. I'll rephrase: "Do you agree that an independent standards body would have an incentive to approve a drug in the shortest reasonable time frame while still effectively measuring safety and efficacy?"
The problem, of course, is in defining "shortest reasonable time frame". To answer your question, however, I don't see the private lab having more of an incentive to do this than the FDA.

You don't think they could be sued for unnecessary delays?

Not successfully. How do you prove "unnecessary"? Unless the body knows a drug is safe and effective, and then just sits on it for a year or something, I don't see building a case. If the delays are simply for more or better tests, or to properly analyze the data, then no way would they get successfully sued for that.

Then, in light of my posted figures to the contrary, my side of the claim stands as it has had the most evidence presented.
I refer you again to Skeptic's excellent handling of the math.

They do have an incentive to weed out unnecessary testing and unnecessary delays. They also have no reason to make companies duplicate studies just because they were done in a foreign country, as the FDA (with certain rare exceptions) does. This means the drugs would be brought to market quicker, saving lives.
If this is the real problem (duplication) lobby for changes within the FDA! You would think that drug companies, with their bucks, would already be going after this. An independent body may also want to run their own tests - to maintain their independent objectivity and prevent themselves from becoming a rubber stamp. Also, you would need to show me that in the majority of cases, the duplicate tests have the same results.

Let's also not forget that someone would be legally permitted to take an unapproved drug as long as they understood that it was uncertified and agreed to the risks. People who are going to die of cancer in a year are not too
concerned with long-term side effects, y'know.
I understand that compassionate use is part of what the FDA does already.

[shanek]

Originally posted by a_unique_person
If someone does something wrong, they will get caught by the law.

Regulations are a part of the legal system.

Only technically. In reality, regulations are anti-law. They punish everyone, regardless of whether or not they've done anything wrong.

[shanek]

Originally posted by fsol
Anti-lock brakes, all-wheel drive and traction control are not safety features.

???

I just know you can support this assertion...

As for seat belts and side-impact bars has it occured to you that they might be a response to legislation outside of the US?

Usually in those cases they just sell different cars in the different countries. Volkswagen stopped selling the beetle in the US because of mileage and emissions regulations, but continued to sell it in many other countries.

SUVs are classed as trucks? Why is that?

They're classified as "utility vehicles," the same category as trucks.

[Skeptic]

SUVs are classed as trucks? Why is that?

The reason is that, by law, passanger cars must satisfy certain efficiency standards, e.g., get at least X miles per gallon. If SUVs were classified as passanger cars, most of them would be banned.

[shanek]

The post I'm responding to is quite possible the worst example of twisted logic and blind biased reasoning I have ever witnessed in my entire life!!!

Originally posted by Skeptic
Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.

This is a great example of the old saying, "there are three types of lies--lies, damn lies, and statistics".

Why is the number of those who die from "Bad drugs" low? Because the FDA is unnecessary? No, precisely because it DOES A GOOD JOB IN BANNING BAD DRUGS, AND QUICKLY REMOVES THE FEW BAD DRUGS THAT DO MAKE IT TO MARKET. Naturally, this means a low number of deaths from bad drugs.

Hel-lo??? The Elixir Sulfanilamide incident was BEFORE THE FDA EXISTED!!!! :rolleyes:

Why is the number of those who die from "Good drugs" that the FDA eventually approves, during the waiting period, high? Quite apart from the fact that these numbers are HIGHLY misleading (essentially, they count EVERYBODY who died from a condition a later-approved drug helps in SOME cases as a death "due to the lack of the drug"),

This is a blatant lie. The numbers figure in the proportion of sufferers whose lives are saved by the drug.

Now, to the really convoluted illogic:



Provided there are no unnecessary delays, sure.

Using Shanek's statistics, however, it would look really horrible: NOBODY ever dies of the drugs the FDA bans (so the number of death the "FDA prevents" is 0), while MILLIONS could have been saved if it had approved the drugs it DOES approve sooner (so the FDA is "guilty" of "killing millions" due to its "inefficiency".)

This is bulls--t and complete intellectual dishonesty! If you were really examining my logic, you would see that the number of people killed by the FDA would be zero and the number saved would be enormous!!!!

Consider now the opposite: an FDA that only approves bad and/or useless drugs. Clearly the worst possible FDA! However, on Shanek's view, things are suddenly looking up: many people would die from "bad drugs", since clearly some sort of governing body like the FDA is necessary; also, since nobody would be saved by the drugs that eventually are approved (since they are at best useless), the number of lives lost by FDA "hesitation and beurocracy" is ZERO!

Again, total bulls--t and I am flabbergasted that you would have the lack of integrity to twist my arguments in such a fashion. Such an FDA would indeed be horrible.

But I guess it's easier to make up strawman arguments than it is to actually try and understand what someone is really saying, especially when their arguments and evidence attacks a dearly held position.

In sum, Shanek's own statistics essentially prove that the FDA works very well, both in banning bad drugs, and in approving effective ones. To use these utterly misleading statistics as "proof" that the FDA is "useless" is irresponsible, not to say dangerous. [/QUOTE]

[shanek]

Originally posted by Thanz
I suggest you read skeptics excellent post on how the stats you rely upon are hopelessly skewed.

Excellent??? That was one of the most intelectually dishonest posts I've ever seen in my life!!! And the fact that you apparently bought it floors me!

I think that the fact that the FDA is political does not support your view that it therefore has no incentive to save lives. It just has a different view of how to save lives - and protect the health - of people than you do.

No, there is a clear political division: It has a political incentive to stop deaths due to releasing bad drugs, because politically that's seen as gross negligence. On the other hand, it actually has an incentive to delay drugs because that's being cautious.

The FDA realizes that releasing a drug without understanding it is potentially more harmful than the ailment it is supposed to cure.

Again, the numbers just don't bear that out.

Despite the factors you list, a private lab does not have the incentive to rush a drug through either.

Of course it does! Private labs are answerable to the people who need the products! That's why there are no unnecessary delays in having a product UL listed.

What you may see as unnecessary delay may be seen by a lab as prudent testing and research procedures,

The delays aren't due to "prudent testing and research procedures"! They're due to the heavy drag of administrative bureaucracy!

How is completely ignoring a previous and perfectly valid study just because it was performed overseas, forcing the company to spend time and money duplicating that very study stateside, in any way, shape, or form a "prudent testing" or "research procedure"?


Well, obviously you can't refute it because it is such an airtight argument. :p

All sarcasm aside, however, "just by being there" means that drug companies know that they need to get through the FDA process, and as such, bad drugs do not get that far. The presence of the FDA stops some bad drugs, without even testing them.

Wonderful. Now all you have to do is provide evidence that this is the case.

This is some real stilted logic. First, I again reference Skeptic's post on the bad math you rely on.

It's not bad math! You've fallen prey to Skeptic's dishonesty! Elixir Sulfanilamide was released and killed the 107 people before the FDA was formed—and that's the worst case!!!!

Next, it is not that each drug has to kill more than it saves. It would be enough that the BECs release a lot of bad drugs (that do nothing, or almost nothing, to help) but kill or injure a signicant number of people.

That sounds like the same thing to me. Doing nothing, or almost nothing, means you're saving few if any lives and a "significant number" would certainly be more than that!

In fact, the drugs released could be benign in the effects that they have, but if they cause people to switch from actually proven therapies, may cause the same sort of deaths you complain about with the FDA - death by lack of proper treatment.

But in that case, the proper treatment would still be available to the person, and they, with their doctor, would have all the tools necessary to make a good judgement. With the FDA, nobody has that choice at all!!!

Why does absolutely no one want to acknowledge that aspect of it?

Wasn't it you who just ragged on the FDA as their concern was "political" not "medicinal"? Why the double standard?

What double standard? There is no double standard here! You're just getting desperate.

Why do corporations get a free pass if they are pursuing dollars not medicine?

Who said they were getting a "free pass"? Stop making stuff up!

There have been several examples in this thread that show corporations caring more about the bottom line than the health of the patients they are supposedly helping.

None of which survived scrutiny.

I haven't seen a concrete example of how the FDA puts politics over healing people.

What??? I HAVE GIVEN NUMEROUS EXAMPLES!!!! ARE YOU FSCKING BLIND????

For crying out smegging loud, HOW MANY EXAMPLES DO i HAVE TO POST????????!!!!!! :mad:

Where?

http://www.randi.org/vbulletin/showthread.php?s=&postid=1869908247#post1869908247

It was government weight and price limits that prevented them from putting in the safer gas tank that they had already received a patent for!

I notice you don't directly address my bean counter argument. Why?

Because it wasn't an argument. It was an ad hominem, with no basis in economic reality.

It shows nothing of the sort.

Yes, it does! If we didn't have a government that allowed such shenanigans in our courtroom they wouldn't dare to try it! The bad publicity alone would be enough to deter them, unless, of course, they can make the doctor face such heinous legal fees he'd rather settle than press the issue.

The problem, of course, is in defining "shortest reasonable time frame". To answer your question, however, I don't see the private lab having more of an incentive to do this than the FDA.

I have already shown why they would. You're free to refute it, but saying the same thing again proves nothing.

Not successfully. How do you prove "unnecessary"?

Unnecessary would be bureaucratic delays, forced duplication, the discarding of perfectly valid studies for nothing more than political reasons, etc. These have nothing whatsoever to do with actually determining the safety or efficacy of the drug!

I refer you again to Skeptic's excellent handling of the math.

I refer you again to my exposing of Skeptic's lie.

If this is the real problem (duplication) lobby for changes within the FDA! You would think that drug companies, with their bucks, would already be going after this.

Don't think they haven't tried. The thing is, the political pressures to make all the testing stateside outweigh the political pressures the pharmaceutical companies can put on them. It has nothing whatsoever to do with the scientific or medical benefits of the study.

An independent body may also want to run their own tests - to maintain their independent objectivity and prevent themselves from becoming a rubber stamp.

Of course, but the FDA doesn't run its own tests!!! They force the manufacturers to run and pay for the tests!

Also, you would need to show me that in the majority of cases, the duplicate tests have the same results.

But the FDA doesn't consider the other test AT ALL!!!

I understand that compassionate use is part of what the FDA does already.[/QUOTE]

Which they deny way, way too often...again, for political reasons. See my previous thread about Edie Bacon and the way people on your side tried to argue around it, saying it was obviously Johnson & Johnson's fault she couldn't get the drug (even though she was more than willing to pay a high price for it).

[fsol]

Shanek. I shall remind you what I actually said, just incase you want to quote me out of context again.

Anti-lock brakes, all-wheel drive and traction control are not safety features. They may be marketed as such but that is not why they were developed.

To try and make out that the auto industry went away, designed and developed the above as saftey features out of the goodness of their hearts is laughable to be honest.

Anti-lock brakes:

Fifty years ago there were several more additions to British automotive inventions, for example, anti-skid brakes and the first four-wheel drive technology. The British company Dunlop Ltd patented the anti-skid brakes on 30 July 1952. These brakes, which prevent locking or skidding of the wheels, were first developed for aircraft landing._


http://www.patent.gov.uk/about/press/releases/2002/291102.htm

All wheel drive: A little bit of History. http://www.panddlrc.fsnet.co.uk/tech/history4x4.htm

It would appear that all-wheel drive was introduced to road cars as a performance enhancement due to racing success.

Traction control: Though I could just say that when you have anti-lock brakes you have the necessary setup for traction control and I could argue that traction control's introduction to road cars is a result of the introduction of anti-lock brakes and so not a safety feature. I shall point you to this source about the SAAB 9000. Which again shows that traction control is a performance enhancement not a safety feature.


Saab 9000's TCS system was one of the earliest Traction Control systems applied to road cars. To Saab 9000 and other front-wheel drive cars, hard acceleration used to cause trouble to the driving wheels. Hard acceleration always causes weight transfer which lightens the front end. This reduces the traction of front wheels, thus causing wheel spin. When wheel spin occurs, the friction between wheels and ground drops considerably so that it takes longer to launch. Moreover, wheel spin also introduces instability.

http://autozine.kyul.net/technical_school/traction/tech_traction_other.htm

You can see the above link also backs up my previous link about ABS.


I just know you can support this assertion...

Apparently so.

SUVs are classed as trucks? Why is that?

Cheers Skeptic, I did know that. Another example of those humanitarian auto makers.:rolleyes:


Anyway carry on with your FDA argument.

[shanek]

Originally posted by fsol
Anti-lock brakes:

So what if they were originally developed for aircraft? They are still a safety feature voluntarily designed, researched, and implemented by private automotive companies. It's not like they could just take the airline design lock, stock, and barrel and put it in cars.

I ask you again: For what reason OTHER THAN SAFETY would they do this?

It would appear that all-wheel drive was introduced to road cars as a performance enhancement due to racing success.

Possibly so the car would handle better at greater speeds, and thus be safer?

Traction control: Though I could just say that when you have anti-lock brakes you have the necessary setup for traction control

BS. My car doesn't have anti-lock brakes, but it does have traction control, and it works wonderfully.

You're just reaching. These are all important safety features that have saved countless lives...and the government had ABSOLUTELY NOTHING TO DO WITH IT!

"Performace enhancement..." Geez...

Cheers Skeptic, I did know that. Another example of those humanitarian auto makers.:rolleyes:

It was the GOVERNMENT that classified them as such! :rolleyes: yourself!

[Skeptic]

Shanek--first of all, I was not attacking YOUR use of statistics, but that of the article you posted. Sorry for calling it "shanek's statistics"--sloopy writing on my part.

Second, let me rephrase the issue. The main flaw in the statistics you quote are that they are HYPOTHETICALS, based on the obviously flawed assumption: that the FDA will be abolished, but most of the benefits we get from its existence will remain in place.

Take the case of saying the FDA "saves at most 33 American lives every year". Why is that? Because the vast majority of drugs developed and (later) sold by drug companies are safe.

But surely, the FDA's existence is a major cause of this fact. Right now, there is no incentive for a drug company to fudge internal research that makes a drug seem safer or more efficient than it actually is--since there is an independent test at the end (FDA approval), so every cent used for a "fudged" drug will be lost when approval is denied.

If there was no such test, however, the number of questionable or "so-so" drugs given directly to the public is bound to greatly increase--and with it, the number of deaths.

Now, take the case of the "thousands of deaths caused by the FDA". The comparison is reached by looking at the amount of good the drugs the FDA eventually approved did, and extrapolating it backwards into the "waiting period", when the FDA was pondering whether to approve it or not.

The problem here is that, of course, we only know that these drugs ARE likely to be effective BECAUSE they passed a meticolous FDA approval process. So what kind of hypothetical world we are talking about here? One where the FDA does not exist, but (mysteriously), the holy ghost whispers to drug company scientists what drugs it WOULD have approved IF it did exist, and make them work only on such drugs.

In reality, of course, if there was no FDA, than the average drug on the market would be a lot LESS effective than the average drug on the market is now: there would be no independent hurdle to catch. This would mean that the number of those "saved" by the availablilty of these less-efficient drugs is going to be far smaller than it seems.

In short, the statistics are based on a world where the FDA and its approval process is abolished, but all the benefits (e.g., drug companies researching and producing drugs that are just as safe and efficient on average as they are today, when they DO have to answer to the FDA) still intact.

It doesn't work this way, and this is why these statistics are deeply misleading.

Finally, one point. I am NOT attacking drug companies when I say that a stong regulatory body is necessary in approval of such drugs. I do not imagine some sort of secret cabal of drug company executives thinking to themselves, "hooray! The FDA was abolished! Let's poison our clients for money!".

I am thinking, rather, of the USUAL human weaknesses to "improve" results and "let slide" controls and when lots of money and prestige can be had if one only SLIGHTLY pushes the results in a certain direction that one really wants, especially if one is deeply convinced that the desired result is "really" the case anyway.

This temptation is especially strong in the case of drug research and selling, for a variety of obvious reasons. So the independent controls, such as the FDA, need to be strictest there.

In sum, I am not accusing the drug companies of any conspiracy, dishonesty, or evil when I consider the FDA necessary; I am just worried that they will not always live up to the necessary standards of research and honesty in the face of great temptation. It is THAT that makes the FDA necessary!

[Hazelip]

Originally posted by shanek
The article does exactly that! The worse drug before FDA approval took 107 lives—FDA delays routinely take more than that!

Delays do not take lives, ShaneK. Your hyperbole is entertaining, but factually inaccurate. Disease takes lives.

Just because someone dies because of their disease, while a drug that may successfully treat such disease is being tested, does not mean the testing is the cause of death. The drug companies cannot even claim a drug will cure anything until it has been tested and proven to do so. So, if you cannot even claim that an unproven drug will cure, you cannot claim the same unproven drug's testing process kills.

[Hazelip]

Originally posted by shanek
I'm unaware of any magical spells killing people.

Wait a minute...

You mean to tell me that you honestly believe that delays kill people, because the drug being tested is not available for consumption, but you don't acknowledge that believing a magical spell can cure you, when it won't (the same absence of a cure), doesn't kill?

Nice double standard you have there... :rolleyes:

[fsol]

I ask you again: For what reason OTHER THAN SAFETY would they do this?

Because it makes their cars faster round a circuit than their opposition. Winning races is good publicity. Good publicity means profits. "Our race wining car has ABS, now you too can enjoy the performance benefits."

This process can be most clearly seen in the progression from Audi Quattro rally car to Audio Quattro road car. 4WD introduced as a road car because of its performance enhancing attributes. Not because it makes the car safer.

BS. My car doesn't have anti-lock brakes, but it does have traction control, and it works wonderfully.

You either misunderstand me or you know nothing about ABS and traction control other than "it works." In fact if you read the link you would have seen this...

Not only enhance braking, ABS sensors, computer and hydraulic pump also serve as the hardwares for Traction Control, Electronic Stability Control and Artificial LSD...

http://autozine.kyul.net/technical_school/traction/tech_traction_other.htm

You're just reaching. These are all important safety features that have saved countless lives...and the government had ABSOLUTELY NOTHING TO DO WITH IT!


I have shown that the development and introduction of the above features had nothing to do with safety. I cited links to back this up. What have you shown exactly, apart from a reluctance to admit you were wrong?

It was the GOVERNMENT that classified them as such! yourself!

It was the auto manufactures who went straight through the loophole that allowed SUVs to be classified that way. Now that shows a real concern for the consumers health over the auto manufacturers profits doesn't it.:rolleyes:

[shanek]

Originally posted by Skeptic
Second, let me rephrase the issue. The main flaw in the statistics you quote are that they are HYPOTHETICALS,

No, they aren't. They are actual numbers taken from the history of drugs and drug regulations.

based on the obviously flawed assumption: that the FDA will be abolished, but most of the benefits we get from its existence will remain in place.

Show where this assumption is made.

Take the case of saying the FDA "saves at most 33 American lives every year". Why is that? Because the vast majority of drugs developed and (later) sold by drug companies are safe.

I must again point out that those numbers came from the time BEFORE the FDA existed! BEFORE!!! Why do you ignore that?

But surely, the FDA's existence is a major cause of this fact.

It can't be, because THEY DIDN'T EXIST AT THE TIME!!!

Geez, am I talking to myself here?

since there is an independent test at the end (FDA approval),

Again, I must point out that the FDA does absolutely no testing whatsoever. The testing is done by the pharmaceutical companies.

If there was no such test,

And the oft-refuted false dichotomy rears its ugly head yet again...

The problem here is that, of course, we only know that these drugs ARE likely to be effective BECAUSE they passed a meticolous FDA approval process. So what kind of hypothetical world we are talking about here?

One where useless bureaucratic delays don't happen! Why do you people keep ignoring that? It's NOT a case of there being no testing—the testing would be there, but with none of the bureaucratic delays and duplication of efforts the FDA forces on the system now!

The DELAYS are what's killing people!

One where the FDA does not exist, but (mysteriously), the holy ghost whispers to drug company scientists what drugs it WOULD have approved IF it did exist, and make them work only on such drugs.

Ad hominem, exposing your blatant bias and your refusal to acknowledge the genuine alternative being offered.

[more crap that's already been addressed and refuted excised]

[shanek]

Originally posted by Hazelip
Delays do not take lives, ShaneK. Your hyperbole is entertaining, but factually inaccurate. Disease takes lives.

If you forceably prevent a sick person from getting medicine which may save their life, and they die, you are responsible for that death. End of story. Can the pathetic excuses.

[shanek]

Originally posted by Hazelip


Wait a minute...

You mean to tell me that you honestly believe that delays kill people, because the drug being tested is not available for consumption, but you don't acknowledge that believing a magical spell can cure you, when it won't (the same absence of a cure), doesn't kill?

Nice double standard you have there... :rolleyes:

What is it about the word "choice" that you people don't understand??? In the latter case, the person IS NOT FORCEABLY PREVENTED FROM RECEIVING THE CURE!!!!

Sheez...How many times are you people going to ignore these very basic and essential points?

[shanek]

Originally posted by fsol
Because it makes their cars faster round a circuit than their opposition.

And what would happen if they tried to take the corner at that speed without that technology? Hmmm??? THINK!!! They can take the corners more safely at higher speeds! IT'S A SAFETY FEATURE! Get over it!

You either misunderstand me or you know nothing about ABS and traction control other than "it works." In fact if you read the link you would have seen this...

Then explain why my Saturn has traction control but not anti-lock brakes.

I have shown that the development and introduction of the above features had nothing to do with safety.

No, you haven't. The "performance enhancement" is SAFETY RELATED. It's not the kind of performance enhancement that comes with speed, or cleaner burning engines, or cooler burning engines...it's about handling and braking and other SAFETY-RELATED issues!

Why do you have such a blatant refual to see that?

It was the auto manufactures who went straight through the loophole that allowed SUVs to be classified that way.

And who would have expected them to act any other way? You're just hand-waving here. It was the GOVERNMENT that classified them as such and the GOVERNMENT that gave them the loophole. In other words, government failed us.

I swear, the dishonesty in this thread is really getting frustrating...

[fsol]

And what would happen if they tried to take the corner at that speed without that technology? Hmmm??? THINK!!! They can take the corners more safely at higher speeds! IT'S A SAFETY FEATURE! Get over it!


ABS doesn't allow you to drive faster round corners. If you are going to argue at least know what you are talking about.

Then explain why my Saturn has traction control but not anti-lock brakes.

Umm, because Saturn decide the car would sell better that way? Traction control is newer and more "sexy" than ABS?

You clearly misunderstood my point. The point being that traction control and ABS use a lot of the same technology. ABS was developed first. The development of traction control is a result of the development of ABS. The fact that your car has one but not the other does not change this.

No, you haven't. The "performance enhancement" is SAFETY RELATED. It's not the kind of performance enhancement that comes with speed, or cleaner burning engines, or cooler burning engines...it's about handling and braking and other SAFETY-RELATED issues!

That they provide the driver with additional safety you won't hear me deny. But they weren't designed for that purpose. Why are they on road cars anyway? Marketing. "The BMW Williams F1 car has traction control, now you can have traction control on your BMW 3 series."
I think I already mentioned how the features are also marketed as safety features. They are just extras which the manufactures use to get you to buy one box with wheels over another very similar looking box on wheels. If the auto manufactures are so obssesed with customer safety why aren't these features standard on all models.

Why doesn't your Saturn have ABS or all wheel drive? Surely these selfless companies, who have spent millions developing safety features out of the goodness of their hearts, want everyone to have the benefit?


And who would have expected them to act any other way?

Yes, who indeed? Why do you think they would act this way in this case and then differently in others?

I swear, the dishonesty in this thread is really getting frustrating...

*yawn*

[shanek]

Originally posted by fsol
ABS doesn't allow you to drive faster round corners. If you are going to argue at least know what you are talking about.

You weren't talking about ABS in the quote I was responding to!!!! You were talking about all-wheel drive!!!!

How much dishonesty are you people going to make me endure?

Let me ask the lurkers here: Is anyone here convinced even for a microsecond that all-wheel drive, traction control, and ABS are not safety features?

Umm, because Saturn decide the car would sell better that way?

But according to you, ABS is necessary for traction control and was a result of that technology! So how can you have traction control without ABS, according to your earlier comments?

You clearly misunderstood my point. The point being that traction control and ABS use a lot of the same technology.

Lots of things use the same technology. So what?

That they provide the driver with additional safety you won't hear me deny.

You did exactly this when you claimed they weren't safety features! And they are being marketed as such!

They are just extras which the manufactures use to get you to buy one box with wheels over another very similar looking box on wheels.

Because people want safer cars, and the manufacturers are responding to that demand! That's been my point the whole time! I hate it when people take my point and state them back to me as if I hadn't said it, and it was their point for refutation. They usually do it with my best points, too! I guess if you can't refute it, and you can't insult it, pretend it's your point all along...

If the auto manufactures are so obssesed with customer safety why aren't these features standard on all models.

Probably because these cost money to implement, and there are people who would rather pay less for their cars than have them installed?

BTW, I never said they were "obsessed with safety." Quit lying.

Why doesn't your Saturn have ABS or all wheel drive?

Because ABS would have added thousands to the price of the car, and really isn't as much of a safety improvement to a car that already has traction control. With all-wheel-drive, there are patent issues that prevent them from implementing it. Subaru, OTOH, which is the only company not bound by these issues (since it's their patent), does in fact offer it as standard in all of its cars.



[b]Yes, who indeed? Why do you think they would act this way in this case and then differently in others?

Who says they would?

[Hazelip]

Originally posted by shanek
If you forceably prevent a sick person from getting medicine which may save their life, and they die, you are responsible for that death. End of story. Can the pathetic excuses.

Testing a drug for safe consumption isn't a pathetic excuse.

Do you ever do anything but rant?

[fsol]

I think you are going on ignore now Shanek. Three times you have groundlessly accused me of lying.

fsol "ABS doesn't allow you to drive faster round corners. If you are going to argue at least know what you are talking about."


Shanek "You weren't talking about ABS in the quote I was responding to!!!! You were talking about all-wheel drive!!!!"

Now lets see what I *was* talking about.



fsol "Anti-lock brakes:"


Shanek "So what if they were originally developed for aircraft? They are still a safety feature voluntarily designed, researched, and implemented by private automotive companies. It's not like they could just take the airline design lock, stock, and barrel and put it in cars.

I ask you again: For what reason OTHER THAN SAFETY would they do this?"


fsol "Because it makes their cars faster round a circuit than their opposition. Winning races is good publicity. Good publicity means profits. "Our race wining car has ABS, now you too can enjoy the performance benefits.""

Clearly if you follow the thread I was talking about ABS. You lie.


But according to you, ABS is necessary for traction control and was a result of that technology! So how can you have traction control without ABS, according to your earlier comments?

I don't recall saying that actually. ABS is not necessary for traction control. My original post again ...

Traction control: Though I could just say that when you have anti-lock brakes you have the necessary setup for traction control and I could argue that traction control's introduction to road cars is a result of the introduction of anti-lock brakes and so not a safety feature. I shall point you to this source about the SAAB 9000. Which again shows that traction control is a performance enhancement not a safety feature.



There is a difference between saying that something is not a "safety feature" and "the feature has some safety benefit." I have stated that the features were not originally designed as safety features for cars. I posted links to that effect. You have posted simply your own opinion and accused me of dishonesty. whilst quoting me out of context. Goodbye.

[Skeptic]

Ad hominem, exposing your blatant bias and your refusal to acknowledge the genuine alternative being offered.

(sigh...)

TRANLSATION: "Ad hominem, exposing your stupidity and pigheadedness".

Okaaaaaayyyyyyyy............

[shanek]

Originally posted by Hazelip
Testing a drug for safe consumption isn't a pathetic excuse.

WE AREN'T TALKING ABOUT TESTING!!! WHY IS NOBODY LISTENING TO ME???? :mad:

Do you ever do anything but rant?

Since everyone here is deliberately ignoring my points, I'm left with no alternative but to constantly repeat myself! How do you expect me to react?

[shanek]

Originally posted by fsol
I think you are going on ignore now Shanek.

That's probably easier than taking responsibility for your actions.

Now lets see what I *was* talking about.

Let's just use some logic here:

YOU were the one who brought up taking corners. I asked why being able to take corners at higher speeds is not a safety feature, and you respond with "ABS doesn't allow you to take corners!" But why would you assume I was talking about ABS when I was obviously referring to your other point?

You just want to get out of answering the question.

[b]I don't recall saying that actually. ABS is not necessary for traction control.[/'b]

You said that ABS was the "necessary setup" for traction control. You also said that the implementation of traction control was a result of the implementation of ABS, when it's clear you can have one without the other.

These are safety features. They were designed, implemented, and marketed by the car manufacturers as safety features for consumer autos. The fact that they may have had an earlier existence for other purposes is completely irrelevant. All technology is based on what came before it. When lasers were invented, for example, there was no thought of using them to print onto paper, or cut wood, or fight cancer. Yet, lasers are being designed, manufactured, and marketed for specifically those purposes.

But go on, ignore me. I'm sure you'll sleep better.

[shanek]

Originally posted by Skeptic
Okaaaaaayyyyyyyy............

Why do you refuse to acknowledge that the drug mentioned came before the FDA, and therefore this nullifies your entire position? Why do you refuse to show where the certain assumptions you mentioned are being made? Why do you refuse to acknowledge that the only alternative is NOT no testing at all? Why do you refuse to acknowledge that we're not talking about delays due to valid testing, but other delays due to nothing but bureaucracy?

You do none of this, you just insult your opposition by using terms like "holy ghost" to mischaracterize the actual arguments.

[Mahatma Kane Jeeves]

Originally posted by shanek
Hel-lo??? The Elixir Sulfanilamide incident was BEFORE THE FDA EXISTED!!!! :rolleyes:
Originally posted by shanek
Why do you refuse to acknowledge that the drug mentioned came before the FDA, and therefore this nullifies your entire position?
A Guide to Resources on the History of the Food and Drug Administration (http://www.fda.gov/oc/history/resourceguide/background.html)
In 1927 Congress authorized the formation of the Food, Drug, and Insecticide Administration from the regulatory wing of the Bureau of Chemistry; the name of the agency was shortened to the Food and Drug Administration in 1930. FDA left the Department of Agriculture in 1940 for the Federal Security Agency, which was created a year earlier.

The 1937 Elixir Sulfanilamide Incident (http://www.ispe.org/regulatory/histlaw3.htm)
The S.E. Massengill company decided to develop a liquid form of Sulfanilamide. Massengill’s chief chemist and pharmacist, Harold Cole Watkins, found that diethylene glycol was a good medium for the elixir Sulfanilamide. The new substance had a nice appearance and a pleasant taste. What Watkins did not realize was that diethylene glycol, which is more commonly known as antifreeze, is a deadly poison. Unfortunately, the existing law did not require any kind of pharmacological studies proving that a drug is safe, and 240 gallons of Elixir Sulfanilamide went on the market. The people who took this drug, many of them children being treated for soar throats, suffered tremendously before they eventually died. They were ill between one and three weeks, and experienced stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions. The pain was severe and unrelenting, and eventually 107 people died.
.
.
.
FDA dispatched nearly its entire force of 239 investigators to the task of tracking down the remaining unused portions of the medicine. This was a very difficult task, as pharmacies often kept very poor records of who had purchased various types of medicines. But the FDA investigators were tireless in their pursuit of the dangerous medicine, and eventually tracked down 234 gallons and 1 pint of the 240 gallons. The remaining amount had been consumed.

Massengill denied any responsibility for the tragic outcome of its quest for a liquid form of Sulfanilamide.

[a_unique_person]

Originally posted by shanek


Only technically. In reality, regulations are anti-law. They punish everyone, regardless of whether or not they've done anything wrong.

But laws are regulations. I am not allowed to kill someone, even if he has annoyed the heck out of me. I am limited in how fast I can drive. Companies have to file regular company returns, and state their financial status to their shareholders. Food handlers have to follow guidelines to ensure they don't poison people.

There are numerous stupid laws and regulations out there, for sure, but these are pretty well ignored. Why aren't they taken off the books? Eg, laws against consensual sex acts between adults. Whenever anyone is prosecuted for such laws, there is usually an uproar. They are only there because if they were repealed, idiots would protest about them being repealed, even though they know that people do it anyway and no-one gets prosecuted.

[shanek]

Originally posted by Mahatma Kane Jeeves
[snip]

Nice handwaving. Now show that the FDA was licensing at the time.

I remind everyone of the site's original claim:

The drug that caused the most deaths prior to FDA licensing was Elixir Sulfanilamide. It was poorly researched and ended up killing 107 people.[10]

Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.

The FDA did not begin licensing drugs until 1939. Try again.

[shanek]

Originally posted by a_unique_person
But laws are regulations.

Bull. All regulations are laws, but not all laws are regulations.

I am not allowed to kill someone, even if he has annoyed the heck out of me.

Murder is a crime, not a regulation. Crimes specifically target people who have performed a certain action, and the only punishment is meted out towards those people. Regulations apply to everyone, and everyone must prove compliance with regulations.

Big honking difference!

[Thanz]

Originally posted by shanek
No, there is a clear political division: It has a political incentive to stop deaths due to releasing bad drugs, because politically that's seen as gross negligence. On the other hand, it actually has an incentive to delay drugs because that's being cautious.
You imply that the delay is for the purpose of delay, and not actually being cautious. I don't have a problem with caution when it comes to determining whether a drug is both safe and effective.

Of course it does! Private labs are answerable to the people who need the products! That's why there are no unnecessary delays in having a product UL listed.
No, they are not answerable to the people who need the products, at least in terms o ftime to market. They may be answerable to the people who make the products in this regard.

They will be answerable to the public if something goes wrong, however. And it would only be worse if they pushed things through at the behest of the drug company paying them.

The delays aren't due to "prudent testing and research procedures"! They're due to the heavy drag of administrative bureaucracy!

How is completely ignoring a previous and perfectly valid study just because it was performed overseas, forcing the company to spend time and money duplicating that very study stateside, in any way, shape, or form a "prudent testing" or "research procedure"?
Well, the people who you are referenceing are not limiting themselves to these "administrative delays". They are complaining about the testing procedure itself. I'd like to see any examples of the FDA ignoring other studies, etc. if it is so common. Here is the testing procedure, from one of the articles that the "Downsize DC" people rely on: The current system causes new drugs to be approved at a very slow pace. The problem is that those with terminal diseases do not have the luxury of waiting until a promising drug is first proven "safe." What follows is a brief description of the three phases of testing the FDA requires:

Phase I trials are designed to determine the safety of a new therapy. They evaluate how a new medication should be given (orally, intravenously or by injection), how often, and at what dosage. Phase I trials generally enroll only a small number of patients. The Endostatin study was a Phase I trial.

Phase II trials provide preliminary information about how well a new medication works and generate more information about patient safety. Phase II studies usually focus on a specific type of disease (liver cancer, for example, rather than all types of cancer).

Phase III trials compare new treatments with standard ones to determine which is safer and more effective for patients. Phase III trials generally involve a large number of participants and often take place at several health centers simultaneously. Patients are randomly assigned to receive either the new therapy or the standard one.

FDA clinical study protocols mandate that new drugs like Endostatin be tested first in a Phase I "safety" study. In order for cancer patients to be eligible to participate in a clinical study using an investigational new drug, the FDA mandates that they must first fail every single conventional treatment. This virtually guarantees that terminally ill human participants in Phase I studies will derive no benefit.

Here is what the manufacturer of Endostatin (Entremed) said after the results of the Phase I trial were made public:

"It is important to understand that the primary purpose of all Phase I clinical trials is to evaluate and monitor the safety and toxicity of a drug in patients with advanced and refractory cancers. The trials are not designed to measure how effective the drug is at treating cancer, and it is expected that all patients will experience disease progression. It would be inappropriate and premature to judge the overall efficacy of any drug based on the Phase I clinical trial results."
It is clear that the LE people are complaining about the test procedure itself, not bureaucratic delays.

Again, I see no incentive on a private lab deviating from this procedure. Assuming that they want to avoid lawsuits, they would follow this procedure exactly. Any corner that gets cut will crucify them in the event of something bad happening.

It's not bad math! You've fallen prey to Skeptic's dishonesty! Elixir Sulfanilamide was released and killed the 107 people before the FDA was formed—and that's the worst case!!!!
First, you are wrong. See the post from Mahatma Kane Jeeves. Next, I don't understand why you cling to this example for dear life. It shows an example of why testing and FDA approval is important - not the opposite.

What double standard? There is no double standard here! You're just getting desperate.

Who said they were getting a "free pass"? Stop making stuff up!
They get a free pass from you because you seem to be completely ignoring the fact that the drug company is in it for the money, not the medicine. You harp on the FDA being political, but ignore the financial.

Let's put this in as clear terms as possible. According to you FDA: not medicine first=bad. Drug companies: not medicine first=so what? This is the double standard. This is the free pass.

Thanz: There have been several examples in this thread that show corporations caring more about the bottom line than the health of the patients they are supposedly helping.

shanek: None of which survived scrutiny.

This is unbelievable. How can you accuse others of intellectual dishonesty and still come out with this? Please, tell me how my examples of the huge Pan Pharmaceuticals recalls and Apotex threatening a doctor if she told sick kids the truth about the drug they were taking did not "survive scrutiny". :rolleyes:

What??? I HAVE GIVEN NUMEROUS EXAMPLES!!!! ARE YOU FSCKING BLIND????

For crying out smegging loud, HOW MANY EXAMPLES DO i HAVE TO POST????????!!!!!! :mad:
I must be blind then. I guess you are referring to your accusations that foreign studies are ignored, and that the FDA is obviously political because they don't do what you want. Instead of always asserting that you have, why not point it out (or cut and paste it)? Syaing that you have does nothing for me if I didn't see it the first time.

It was government weight and price limits that prevented them from putting in the safer gas tank that they had already received a patent for!
Source? What government weight and price limits are you talking about?

Because it wasn't an argument. It was an ad hominem, with no basis in economic reality.
BS. It is not an ad hominem, and has lots of basis in economic reality. You just don't want to address it.

Yes, it does! If we didn't have a government that allowed such shenanigans in our courtroom they wouldn't dare to try it! The bad publicity alone would be enough to deter them, unless, of course, they can make the doctor face such heinous legal fees he'd rather settle than press the issue.
Please. You know nothing about the case, and your attempts to spin what is obviously a drug company behaving in a reprehensible manner with regards to drug testing into a rant about the court system is intellectually dishonest.

I have already shown why they would. You're free to refute it, but saying the same thing again proves nothing.
It seems to prove something in your mind. Again, the threat of a lawsuit from a drug gone bad is much much higher than the threat of a lawsuit for a drug that took extra time to approve. Any risk averse organization will take the extra time, as not taking the time will be the very ground for a lawsuit.

[Skeptic]

Shanek--a few more points.

1). The argument is not about the FDA being made more efficient and less beurocratic, which is a good thing. The point is that you think the FDA need to be ELIMINATED, putting the testing of drug's efficiency and safety entirely in the hands of the drug companies.

2). Your argument that this is OK since the drug companies have no motive to cheat and put bad drugs on the market is disproved by all that we know of human history and human nature.

It is true that IN THE LONG TERM, it is probably better for drug companies to be honest and put only good drugs on the market (although spending some money on advertising and buying out critics, in practice, tends to be cheaper than actually BEING honest and caring). But, IN THE SHORT TERM, they stand to profit immediatelly by pushing a drug through testing despite problems. It is short-term, not long-term, behavior that the FDA is there to catch.

Human nature and history, however, shows clearly that humans usually, or at least often, prefer the short term, especially when the temptation to prefer it is there. For example, the life of a criminal, in the long term, is a bad one (for the vast majority of them). Yet, we lock our doors and have a police force, because we do not trust someone not to commit burgalry and murder just because in the long term it's not in their interest. If temptation is strong enough for the short term action, then people will do it--regardless of long-term consequences.

To dismantle the FDA and trust drug companies to be honest and critical of their own studies because in the long term it's better for them, is like dismantling the police based on the argument that crime isn't a problem, since in the long term it works to the criminal's detriment, or to have no testing in school since the students should know that in the long term studying is better than having a party or going to the ball game. True... but besides the point.

For some reason, you seem to believe human nature is far better than it actually is, and that in practice it will work like it should in theory. In this respect, you are like the communists--you believe unconditionally in the goodwill of companies and their executives, they, in the goodwill of the workers and their leaders. But both are unrealistic. Not because either group is evil, but simply because both are human.

There is a sad history of communism that shows what happens in real life when such trust and power is given unconditionally to ANY group of people. If there is ever a libertarian rule, it would quickly degenerate into a dictatorship that differs only in style, not in substance, from communist or theocratic dictatorships--that's what happens when ANY one group of people (the workers, the government, the clerics, the executives) are given power without checks and balances.

3). You seem to see government as the enemy, and corportations and private enterprise as a friend. This is often true, but NOT always. "The government" is NOT something totally divorced from the need of wants of the people as a whole, any more than "company executives" are. Both listen to the public, and respond to it.

You give us examples where private enterprise responded better to the will of the people than government. But sometimes, the government responds better than private enterprise.

That was the point behind the SUV example. Passanger cars must get a certain number of miles per galon. This is NOT the decision of some faceless government beurocrat ignoring the people, but the result of PUBLIC PRESSURE on government to pass some laws to protect the enviorment. It expresses, in this case, the will of (most) people for a cleaner enviorment. Trucks were excluded since, of course, you cannot force an 18-wheeler to have the fuel efficiency of a compact.

Who lost, in this case? Car and oil companies, which had to produce efficient vehicles and sell less oil. So, they used their power (as was their right) to lobby and get SUVs, for all intents and purposes family cars, as "trucks"--simply so that they will be able to circumvent this law. In short, in this case the companies used their power and a legal loophole to frustrate the will of most people for fuel-efficient cars. Obviously, in this case, they were NOT working in the interest of the public, but of their own maximized profits.

Yes, in the LONG RUN such behavior will hurt them--will make them seem even sleazier than they are now. But that doesn't stop them NOW, since, when the temptation is big enough, companies--like individuals--will think of their own short term interest first, and of anything else second, if at all.

[Mahatma Kane Jeeves]

Originally posted by shanek


Nice handwaving. Now show that the FDA was licensing at the time.

I remind everyone of the site's original claim:

The FDA did not begin licensing drugs until 1939. Try again.

Sorry, when you said (twice) that the tragedy took place "BEFORE THE FDA EXISTED!!!!," I thought you meant that it took place BEFORE THE FDA EXISTED!!!! Silly of me, I know.

[a_unique_person]

Originally posted by shanek


Bull. All regulations are laws, but not all laws are regulations.



Murder is a crime, not a regulation. Crimes specifically target people who have performed a certain action, and the only punishment is meted out towards those people. Regulations apply to everyone, and everyone must prove compliance with regulations.

Big honking difference!

So, the difference between not preparing food hygenically so that it doesn't poison anyone and murdering someone is that one is morally wrong and one isn't?

[shanek]

Originally posted by Thanz
You imply that the delay is for the purpose of delay,

I never said that. Quit lying.

and not actually being cautious.

What do these meaningless bureaucratic delays and expenses have to do with being cautious? They don't tell you anything more without the drug! They only give the appearance of being cautious because they can all say, "Look how thorough we're being! Look how much time we took examining this drug!"

It's political. Beyond that, it's meaningless and useless.

No, they are not answerable to the people who need the products, at least in terms o ftime to market.

Of course they are! If they want people to look to their label when deciding which drug to take, they are most certainly answerable to them!

They will be answerable to the public if something goes wrong, however. And it would only be worse if they pushed things through at the behest of the drug company paying them.

Well, don't you think the former would be a disincentive for the latter?

I'd like to see any examples of the FDA ignoring other studies, etc. if it is so common.

Then check out the research of Robert Goldberg, Senior Research Fellow at Brandeis University.

Here's one example:

In June 2000, the FDA had two drugs in the pipeline for approval within six months under its fast track program. But although 15 countries in Europe had already approved the drug, the FDA then had a crisis of confidence and put it on hold for more data. In the meantime, 15 people with Fabry's have died waiting for the medicine.

And later on, he says:

Academic amateurs who regard medical progress as a Trojan horse for corporate greed too often reject drugs just because others are available.

Also from the article, on a slightly different subject:

The stories of drugs that treat rare afflictions like Fabry's disease are often the most poignant, but the FDA has proven an equal-opportunity spoiler. Currently, the agency is holding up the approval of drugs to treat depression, schizophrenia, cholesterol and cancer until companies correct what are called "quality" or "safety" violations in manufacturing plants. Sounds scary until you notice that in no case has the FDA stopped companies from shipping other products from these facilities. Suddenly the hold-up looks suspiciously like rent-seeking behavior.

So, to stop one drug from shipping, they stop all the other products, too! How is that being "cautious"? How is that making us any safer?

http://online.wsj.com/article_email/0,,SB1033342193393093313,00.html

And here's another article:

What is remarkable is that while prescription-drug use has increased in the past decade, the number of adverse events as a percentage of total prescriptions has hardly budged. Drug withdrawals as a percentage of new drugs remains at about 3 percent, essentially the same ratio from decades ago.

[FDA Commissioner Alistaire] Wood ignores this safety record. Instead, he calls for companies to adhere to an impossible safety standard: "Manufacturers should behave responsibly in the promotion of new drugs for which toxicity is, by definition, currently unknown." Further, "to encourage such responsibility direct to consumer advertising should be permitted only for drugs that have undergone a monitored post marketing testing process that would include a sufficient number of patients to provide adequate confidence in their safety for widespread clinical use. This step could help prevent the excessively rapid uptake of new drugs at a rate that exceeds the capacity available to review their safety in practice."

Translation: FDA to patients: Drop dead. It's troubling enough that a proposal to link marketing to an unclear and shifting post-marketing safety standard would likely be unconstitutional and smacks of regulatory overreach. Worse, it would compromise the public health.

And, echoing a point he made in the other article:

Finally Wood questions the value of bringing another drug for the same illness to market. But if one or more drug has side effects that are dangerous to a group of patients or if some people don't respond to a particular drug, isn't that reason enough to for people to be free to have it available. Or does Dr. Wood, like [David] Kessler before him, believe that the FDA is the best arbiter of whose life is worth living or cutting short? Like his cheering section in the Public Citizen, does he have contempt for private pharmaceutical profits that blinds and biases him against the right of companies to develop and market products based on their ability to make a clinical difference in people's lives?

http://www.nationalreview.com/comment/comment-goldberg011102.shtml


Here is the testing procedure, from one of the articles that the "Downsize DC" people rely on:
It is clear that the LE people are complaining about the test procedure itself, not bureaucratic delays.

No, no, no! Again, there is a difference between saying "more efficient testing" and "no testing at all"! Why do you insist on this false dichotomy, especially after I have pointed it out more times than I care to even think about?

First, you are wrong.

No, I'm not. The FDA did not start licensing drugs until 1939.

Next, I don't understand why you cling to this example for dear life.

Cling to it? I'm just trying to get people to stop lying about it!

They get a free pass from you because you seem to be completely ignoring the fact that the drug company is in it for the money, not the medicine.

That is far from the case, liar! I've mentioned the profit motive several times! I just refute the balderdash that you and others spew that the BECs are going to kill people to get them!

You harp on the FDA being political, but ignore the financial.

The financial gives them the motivation to get it done right!!! As the article says, and as numerous points in this thread that you have ignored shows!!!

Please, tell me how my examples of the huge Pan Pharmaceuticals recalls and Apotex threatening a doctor if she told sick kids the truth about the drug they were taking did not "survive scrutiny". :rolleyes:

Because the drug company could not have gotten away with it without the backing of the government!!!! The justice system allows them to threaten others with lawsuits even when they're so clearly in the wrong! And that threat causes the other party to settle because fighting it is so expensive, and they have no way of recouping those losses even if they win!

But go on, ignore that point YET AGAIN...

Instead of always asserting that you have, why not point it out (or cut and paste it)?

Well, there are a couple of new examples in this very thread, which you have seen if you've read this far.

BS. It is not an ad hominem, and has lots of basis in economic reality.

Perhaps you could explain how?
ellectually dishonest.

It seems to prove something in your mind. Again, the threat of a lawsuit from a drug gone bad is much much higher than the threat of a lawsuit for a drug that took extra time to approve.

But at least the threat from the latter would exist! And that would be a much better situation than what it is now. There will come a point where the threat from the latter outweighs the former, and that is when they are most likely to approve the drug. As it is, with no such balancing system, it is grossly weighted to the former.

You could also have a system where people like Edie Bacon could be helped, since once you've determined that there is little to no danger of death or detrimental side effects within the first year then there would be no safety obstacle to approving the drug for people with less than a year to live—certainly a sensible measure, which is not being implemented today.

[shanek]

Originally posted by Skeptic
Shanek--a few more points.

1). The argument is not about the FDA being made more efficient and less beurocratic, which is a good thing. The point is that you think the FDA need to be ELIMINATED, putting the testing of drug's efficiency and safety entirely in the hands of the drug companies.

This is another LIE, as I've already stated several times that these are not the only two options. A UL-like certification body would not be in the hands of the drug companies!

2). Your argument that this is OK since the drug companies have no motive to cheat and put bad drugs on the market is disproved by all that we know of human history and human nature.

And yet, no one posts these proofs nor refutes the arguments to the contrary...

For some reason, you seem to believe human nature is far better than it actually is, and that in practice it will work like it should in theory.

No, I don't. The problem is you seem to believe that way—and that when these same people are put in a government and given the power to force people at the point of a gun to release safe products, that this process will in any way work without being completely corrupted!

[ad hominems deleted]

3). You seem to see government as the enemy,

A government which is made up of the same people you distrust so much...Yet, somehow, these people, who are the only ones who can use force and get away with it, are going to act in the interest of the people and for the common good, unlike the BECs, who have no such power.

That was the point behind the SUV example. Passanger cars must get a certain number of miles per galon. This is NOT the decision of some faceless government beurocrat ignoring the people, but the result of PUBLIC PRESSURE on government to pass some laws to protect the enviorment.

And the result was the SUV situation. It's just one more example of how one government "solution" just causes more problems.

Of course, the fact remains that most consumer cars get above the required mileage, and many car manufacturers are working to make the mileage even better. That same public pressure does work in the free market, which is going to act to give people what they want.

Who lost, in this case? Car and oil companies, which had to produce efficient vehicles and sell less oil.

And the consumers, who now have to pay more for a vehicle and put up with vehicles that are less safe than they should be due to the manufacturers having to lower the weight to get the mileage up. And everyone, actually, because now the economy can't create wealth quite as quickly as it could otherwise.

So, they used their power (as was their right) to lobby and get SUVs, for all intents and purposes family cars, as "trucks"--simply so that they will be able to circumvent this law.

And yet, you fail to see government as the epicenter of the problem.

The bottom line is, without government, it wouldn't have been a problem to begin with. It's just another case of government breaking your legs, handing you a crutch, and telling you you couldn't walk without them.

[shanek]

Originally posted by Mahatma Kane Jeeves
Sorry, when you said (twice) that the tragedy took place "BEFORE THE FDA EXISTED!!!!," I thought you meant that it took place BEFORE THE FDA EXISTED!!!! Silly of me, I know.

Okay, you got me, I misspoke. I should have said before the FDA licensing existed. But I thought that was obvious, given that we're talking about the licensing of drugs...Heaven forbid I expect people to use their brains...

[Thanz]

Originally posted by shanek
I never said that. Quit lying.
I said you imply. It was the implication of your statement. If you disagree, fine, but don't call me a liar - the statement is there for all to see and make their own interpretations.

What do these meaningless bureaucratic delays and expenses have to do with being cautious? They don't tell you anything more without the drug! They only give the appearance of being cautious because they can all say, "Look how thorough we're being! Look how much time we took examining this drug!"

It's political. Beyond that, it's meaningless and useless.
As I pointed out, the LE people are not talking about bureaucratice delays - they are talking about the test procedure itself and that it is not fast enough. They want to take a much more rapid approach, and see the FDA as taking too many "baby steps". I would say that baby steps not only have the appearance of being cautious, they ARE cautious.

Of course they are! If they want people to look to their label when deciding which drug to take, they are most certainly answerable to them!
Did you read the second part of the sentence? I said, at least not in terms of time to market. They are not answerable to a consumer who calls up and says - "hurry up, I want drug X. I don't care if you are not done testing it." They have no duty to provide any drug to any person until they are satisfied it is effective and safe.

Thanz: They will be answerable to the public if something goes wrong, however. And it would only be worse if they pushed things through at the behest of the drug company paying them.

shanek: Well, don't you think the former would be a disincentive for the latter?
Exactly - which is why the testing WOULD TAKE JUST AS LONG!!!

Then check out the research of Robert Goldberg, Senior Research Fellow at Brandeis University.

I will check out the links and comment later.

No, no, no! Again, there is a difference between saying "more efficient testing" and "no testing at all"! Why do you insist on this false dichotomy, especially after I have pointed it out more times than I care to even think about?
I did not say no testing at all, did I? I said that the LE people were complaining about the testing procedure itself, and that it takes too long. Which they are. I am not insisting on the false dicotomy at all, which is clear from the paragraph you omitted and failed to respond to:Thanz: Again, I see no incentive on a private lab deviating from this procedure. Assuming that they want to avoid lawsuits, they would follow this procedure exactly. Any corner that gets cut will crucify them in the event of something bad happening.
So, in simple language that I hope you will finally respond to: The LE people (whom Downsize DC rely on) say that the testing procedure is too long. Time is wasted during phase I and II. Not bureaucratic crap you harp on, they disagree with the testing itself. The testing procedure, however, takes a very cautious approach to testing and safety.

Let's say that the FDA is eliminated and some private lab steps in to oversee testing. If they follow the FDA procedures and something goes wrong, they can point to the FDA procedures they followed and explain how they are the most cautious and prudent procedures. If they take a more aggressive, faster approach, and something goes wrong, the first question asked will be why they deviated from the cautious procedures, and the plaintiff will argue that if the lab had followed the procedure, the testing would have caught the problem and they wouldn't be injured. This is a very real risk. There is no incentive for the lab to deviate from the FDA procedure.

That is far from the case, liar! I've mentioned the profit motive several times! I just refute the balderdash that you and others spew that the BECs are going to kill people to get them!
You have completely ignored the effect of the profit motive on the actions of the companies. It was the profit motive that caused Pan to fake assay results and put out a drug that varied in dosage by a huge factor (as high as 700) from pill to pill. It was the profit motive that caused Apotex to threaten the doctor if she exposed the problems with their drug. It was the profit motive that caused Ford to put out the Pinto. You do not refute anything about these points - you just ignore them.

The financial gives them the motivation to get it done right!!! As the article says, and as numerous points in this thread that you have ignored shows!!!
If that were the case, why is there a huge Pan recall? Why did Apotex threaten the doctor? You make arguments in the abstract about what the profit motive SHOULD do for these corporations. I have shown you what it ACTUALLY does, and you have failed to address the examples in any meaningful way at all.

Because the drug company could not have gotten away with it without the backing of the government!!!! The justice system allows them to threaten others with lawsuits even when they're so clearly in the wrong! And that threat causes the other party to settle because fighting it is so expensive, and they have no way of recouping those losses even if they win!

But go on, ignore that point YET AGAIN...
This is complete and utter BS and totally off point. Whether the corporation can get away with the threat DOES NOT MEAN THE CORPORATION IS ENTITLED TO MAKE THE THREAT! The point of the example is that the corporation is, as you say, so clearly wrong. The fact is that the profit motive caused them to make the threat and try to cover up the test results. Whether the threat could be carried out, or whether the court would sanction it, is 100% irrelevant to the motives of the corporation.

The point of me bringing up the example was to show how the profit motive affects the decision making of drug companies. And you have completely failed to address it. Your argument about the courts is like blaming the second amendment when someone gets shot.

Thanz: [re:Pinto and gov't regs] Source? What government weight and price limits are you talking about?

Well? Your silence on this point is deafening.

Perhaps you could explain how?
I already did, when I first brought it up. Here it is again: But make no mistake that money is the incentive, not healing people. So if some bean counter figures that the amount of money that could be made peddling a dangerous drug to desperate terminal patients would more than cover the money needed to settle the inevitable lawsuits for ill side effects, they have a big incentive to put out that drug as well.


But at least the threat from the latter would exist! And that would be a much better situation than what it is now. There will come a point where the threat from the latter outweighs the former, and that is when they are most likely to approve the drug. As it is, with no such balancing system, it is grossly weighted to the former.
I disagree - the threat of a lawsuit regarding delay of a drug for testing does not exist. It is very basic. In order for there to be a cause of action, you need a duty to the plaintiff, a breach of that duty, and resulting damages. The testing authority does not have a duty to release a drug to anyone for consumption prior to determining whether it is safe. They would have a duty to NOT release UNTIL they determine it is safe. Without a duty to release, you cannot successfully sue.

[shanek]

Here's one of the big reasons that corporations can push the "little guy" around inn courts and get away with it:

In 1895, the Supreme Court, in United States v Sparf, ruled for the first time in history that juries did not have the power to judge the law as well as the facts by upholding a lower court ruling forbidding a defense attorney telling the jury of this right. This was the result of intense pressure fron big corporations who kept trying to use the court system as their muscle (like the example Thanz brought up) but the juries kept ruling against them. "Juries also ruled against corporations in damage suits and other cases, prompting influential members of the American Bar Association to fear that jurors were becoming too hostile to their clients and too sympathetic to the poor." (Steven Barkan, Jury Nullification in Political Trials)

Restore the right of jury nullification and you take away this power of abuse by big corporations.

[shanek]

Originally posted by Thanz

I said you imply. It was the implication of your statement.

No, it wasn't, because I specifically said otherwise!!! The delays are bureaucratic in nature. No "interpretation" in necessary except by people trying to find an excuse not to argue the real point.

As I pointed out, the LE people are not talking about bureaucratice delays - they are talking about the test procedure itself and that it is not fast enough.

You don't think there's room for more efficiency in the testing without sacrificing the quality of said testing?

Did you read the second part of the sentence? I said, at least not in terms of time to market. They are not answerable to a consumer who calls up and says - "hurry up, I want drug X. I don't care if you are not done testing it."

Well, that situation would actually be made irrelevant in that case. There would be nothing stopping consumers from using the drug if they and their doctor knew and accepted the risks of taking an unproven treatment. But since patients and doctors are going to favor the proven treatments, the ones with the seal of approval, there would be the incentive to cut back on unnecessary delays while still maintaining quality testing (since the reputation of the seal of approval would be crucial).

Exactly - which is why the testing WOULD TAKE JUST AS LONG!!!

You don't know that. Without the bureaucrats mandating unnecessary duplication of tests, and other more efficient means of testing, there's no reason to believe the testing would take just as long as it does now.

I did not say no testing at all, did I? I said that the LE people were complaining about the testing procedure itself, and that it takes too long. Which they are.

Okay, I misread you. Sorry.

So, in simple language that I hope you will finally respond to: The LE people (whom Downsize DC rely on) say that the testing procedure is too long. Time is wasted during phase I and II. Not bureaucratic crap you harp on,

I only mentioned the "bureaucratic crap" in rebuttal to the idea that all of the delays were there for the sake of caution. They aren't. There's still room for more efficiency in the testing itself, and you have the testimony of many experts before you speaking to that.

Let's say that the FDA is eliminated and some private lab steps in to oversee testing. If they follow the FDA procedures and something goes wrong, they can point to the FDA procedures they followed and explain how they are the most cautious and prudent procedures. If they take a more aggressive, faster approach, and something goes wrong, the first question asked will be why they deviated from the cautious procedures, and the plaintiff will argue that if the lab had followed the procedure, the testing would have caught the problem and they wouldn't be injured.

They could argue that...But then, on the other hand, another plaintiff could come along and argue that they delays are costing lives...And we would be having the debate that the law is forbidding us to have today. The latter plaintiffs could certainly use inefficiencies in the system as their evidence, and this threat would encourage them to remove such efficiencies. As it is, no such encouragement is there with the FDA. And removing such inefficiencies would not harm their case against the former plaintiffs as the same testing would have likely yielded the same results.

You have completely ignored the effect of the profit motive on the actions of the companies.

Another lie. I've actually counted on it. The companies are going to want to demonstrate the safety of their drugs if they want the sales, and patients and doctors are going to trust a trustworthy third party more than they trust the companies themselves.

It was the profit motive that caused Apotex to threaten the doctor if she exposed the problems with their drug.

Which, as I keep pointing out to you, they wouldn't be able to do without government backing. By allowing these cases and denying juries their right of nullification, they allow the companies to run roughshod over those incapable of defending themselves.

It was the profit motive that caused Ford to put out the Pinto.

But again, without the aforementioned weight and cost restrictions, Ford could have used the other gas tank WHICH THEY ALREADY HAD PATENTED and the Pinto would have been safe. As it was, their choice was: 1) Release the Pinto with the faulty gas tank; 2) Don't release it at all; or 3) Release it with the safer gas tank but push the Pinto up into the next class of automobile. #1 was the option which gave them the biggest profits, whereas without this classification scheme it would likely have been #3.

You do not refute anything about these points - you just ignore them.

I HAVEN'T IGNORED THEM!!!! I'VE RESPONDED TO THEM SEVERAL TIMES!!!! YOU are the one who keeps ignoring the GOVERNMENT'S role in making the adverse behavior more profit-friendly!

Without jury nullification, they likely wouldn't have been able to push the doctor around—and most likely wouldn't have tried. Without automotive classification, Ford would likely have released the Pinto with a safer gas tank. These decisions don't take place in a vacuum.

This is complete and utter BS and totally off point. Whether the corporation can get away with the threat DOES NOT MEAN THE CORPORATION IS ENTITLED TO MAKE THE THREAT!

No, but if you make the laws so that someone can get away with something, do you really have such a cause to be surprised that they actually do it?

The point of me bringing up the example was to show how the profit motive affects the decision making of drug companies. And you have completely failed to address it.

Bulls--t. I've been addressing it all along. You simply do not want to hear.

Your argument about the courts is like blaming the second amendment when someone gets shot.

No, it isn't! It isn't even remotely like that! It's like blaming a law allowing someone to get away with murder when someone gets away with murder!

Well? Your silence on this point is deafening.

Silence...bah...I keep responding to it. You keep ignoring it.

I already did, when I first brought it up. Here it is again:

And, as I keep pointing out, and as you keep ignoring, there is still the incentive to avoid the lawsuits anyway—in your example, they could dell the drug just to the terminally ill patients, who will gladly choose the side effects over dying, but not sell it to others.

I disagree - the threat of a lawsuit regarding delay of a drug for testing does not exist.

Hel-lo??? I SAID it doesn't exist! That's my whole point!!! Can't you read???

[Thanz]

Originally posted by shanek
Restore the right of jury nullification and you take away this power of abuse by big corporations.

Are you actually serious with this crap? The problem with the court system is that we don't allow juries to COMPLETELY IGNORE THE LAW and punish whomever they want????

Many would argue with you and say that the exact opposite is true - too many juries already ignore the law and facts to award huge sums of money to plaintiffs who don't deserve it. In turn, these verdicts inspire more frivolous lawsuits.

If you allow juries to 100% ignore the law, do you expect MORE or LESS frivolous lawsuits?

[Thanz]

Originally posted by shanek
You don't think there's room for more efficiency in the testing without sacrificing the quality of said testing?
There may be - I don't know. That is NOT the point that LE is making - they argue that the testing is too cautious - that the FDA should not have bothered with individual testing when tests in other species showed greater therapeutic results in a combined therapy session. Which of course, tells you nothing about the safety of the individual drug - which is what they test first.

Well, that situation would actually be made irrelevant in that case. There would be nothing stopping consumers from using the drug if they and their doctor knew and accepted the risks of taking an unproven treatment. But since patients and doctors are going to favor the proven treatments, the ones with the seal of approval, there would be the incentive to cut back on unnecessary delays while still maintaining quality testing (since the reputation of the seal of approval would be crucial).
You are making some big assumptions here. How do you know whether a patient/doctor accept the risks of unproven treatment? They wouldn't even know what the specific risks are. If people are favouring "approved" remedies, what is the incentive to rush the drug? You still need to make sure it is safe. And again, the LE people argue against the test design itself, not that the FDA just gets results from tests and sits on them for months.

You don't know that. Without the bureaucrats mandating unnecessary duplication of tests, and other more efficient means of testing, there's no reason to believe the testing would take just as long as it does now.
We don't know it won't take the same amount of time, either. I haven't read the links you posted yet, but I would imagine that the number of drugs that fall into the category of "unnecessary duplication of tests" is small - less than half.

They could argue that...But then, on the other hand, another plaintiff could come along and argue that they delays are costing lives...And we would be having the debate that the law is forbidding us to have today. The latter plaintiffs could certainly use inefficiencies in the system as their evidence, and this threat would encourage them to remove such efficiencies. As it is, no such encouragement is there with the FDA. And removing such inefficiencies would not harm their case against the former plaintiffs as the same testing would have likely yielded the same results.
The problem is, thetre is no second group of plaintiffs. They do not have an argument, as I have explained. Before you get confused again, I am saying that the second group of plaintiffs (complaining of delay) do not have a case against the lab for delay. The lab owes no duty to those people, as I explained in my last post.

Another lie. I've actually counted on it. The companies are going to want to demonstrate the safety of their drugs if they want the sales, and patients and doctors are going to trust a trustworthy third party more than they trust the companies themselves.
No, what you have counted on is what you expect the profit motive to do. What you have ignored is what the profit motive has actually been shown to do.

Which, as I keep pointing out to you, they wouldn't be able to do without government backing. By allowing these cases and denying juries their right of nullification, they allow the companies to run roughshod over those incapable of defending themselves.
Again, this is missing the point entirely. See my post above regarding the jury nullification argument, which is non-sensical to say the least.

To say that Apotex has government backing to harass the doctor is disingenuous, at best. The only "government backing" it has is the same anyone has who wants to try to enforce a contract - a court system. Do you advocate the dismantling of the court system? Please. Apotex was trying to enforce a confidentiality agreement it said covered disclosure of test results to patients. The inquiry into the matter said that it didn't. That didn't stop the corporation from threatening legal action and smearing the doctor publicly.

The court system is not to blame for the corporation's actions - that blame lies solely with the corporation. The REASON they threatened was not simply because they could - the motivation was PROFIT. You have yet to address that the primary motivation here was profit. All your talk of the court sytem and costs and everything else is a huge red herring.

But again, without the aforementioned weight and cost restrictions, Ford could have used the other gas tank WHICH THEY ALREADY HAD PATENTED and the Pinto would have been safe. As it was, their choice was: 1) Release the Pinto with the faulty gas tank; 2) Don't release it at all; or 3) Release it with the safer gas tank but push the Pinto up into the next class of automobile. #1 was the option which gave them the biggest profits, whereas without this classification scheme it would likely have been #3.

But what are the regulations - I have asked you twice now. This gives me a bit more info, but what specifically are the regs? What are the effects of putting the car into the next classification? Would this have any practical effect on the car (other than not blowing up, of course) or would it just affecting the marketing and profit to Ford? What are these weight and cost restrictions you keep alluding to?

I HAVEN'T IGNORED THEM!!!! I'VE RESPONDED TO THEM SEVERAL TIMES!!!! YOU are the one who keeps ignoring the GOVERNMENT'S role in making the adverse behavior more profit-friendly!

Without jury nullification, they likely wouldn't have been able to push the doctor around—and most likely wouldn't have tried. Without automotive classification, Ford would likely have released the Pinto with a safer gas tank. These decisions don't take place in a vacuum.
On the contrary, you keep ignoring them. You still haven't addressed Pan Pharmaceuticals, or the fact that the motive for Apotex was profit. They weren't threatening the doctor just for kicks.

No, but if you make the laws so that someone can get away with something, do you really have such a cause to be surprised that they actually do it?
Ironically, you seem to be arguing here that corporations do bad things and it is the governments fault if they don't stop them. And you seem to think that this is an argument for less regulation of industry.


Thanz: Your argument about the courts is like blaming the second amendment when someone gets shot.

shanek: No, it isn't! It isn't even remotely like that! It's like blaming a law allowing someone to get away with murder when someone gets away with murder!

No, it most certainly is. You are arguing that the court system allows someone to use it to do something bad. You say - if the court didn't stop people from completely ignoring the law, the corporation couldn't make the lawsuit threat! How is this different from saying "If the second amendment didn;t allow people to carry guns, I wouldn't have gotten shot"?

Thanz: Well? Your silence on this point is deafening.

Silence...bah...I keep responding to it. You keep ignoring it.

I think you must have missed what this comment of mine was referring to, which was this quote:

Thanz: [re:Pinto and gov't regs] Source? What government weight and price limits are you talking about?

You do not keep responding to this. I still don't know exactly what regulations you refer to. This post makes it a little more clear, but I still have questions (see above). Also, no mention yet of your source.

And, as I keep pointing out, and as you keep ignoring, there is still the incentive to avoid the lawsuits anyway—in your example, they could dell the drug just to the terminally ill patients, who will gladly choose the side effects over dying, but not sell it to others.

What exactly is this incentive? To avoid the negative publicity, etc.? I assume this is what you mean. But this is exactly the kind of thing that is taken into account by the bean counter. They estimate how much it would costs to quickly and quietly settle claims and lawsuits, and balance this against the profits from the drug. If it is a huge net profit, they will release the drug and not tell people about the negative effects.

Hel-lo??? I SAID it doesn't exist! That's my whole point!!! Can't you read???
You have once again completely missed the point. I am not saying that the threat isn't there now - I am saying that the threat does not exist in the world without the FDA but with some independant lab. The threat that you rely on to speed things up does not exist in any state of affairs, no matter who is doing the testing.

[shanek]

Originally posted by Thanz
Are you actually serious with this crap? The problem with the court system is that we don't allow juries to COMPLETELY IGNORE THE LAW and punish whomever they want????

Not punish whomever they want...acquit whomever they want. Jury Nullification has been a crucial part of Trial by Jury since Magna Carta in 1215, and the 1670 trial of William Penn established that juries could not be fined for acquitting a defendant in abeiance of the law. Our founders certainly had this in mind when they penned the 6th and 7th Amendments. Throughout the 1800s, juries refused to convict abolitionists who were put on trial for violating the Fugitive Slave Act. This continued until the aforementioned case of 1895.

In the case you mentioned, a hypothetical jury, knowing they could acquit the doctor even if he was in a complete breach of contract or whatever, would almost certainly do so. They'd be hard pressed to find a jury who would sympathize with the corporation there.

Many would argue with you and say that the exact opposite is true - too many juries already ignore the law and facts to award huge sums of money to plaintiffs who don't deserve it. In turn, these verdicts inspire more frivolous lawsuits.

The opposite is the case at least in part because juries don't know they can acquit someone even if they're technically breaking the law. It wouldn't be the whole of legal reform, but it would be a huge part of it.

[shanek]

Originally posted by Thanz
You are making some big assumptions here. How do you know whether a patient/doctor accept the risks of unproven treatment? They wouldn't even know what the specific risks are.

You're just talking around the issue here. The risk is that they don't know the dangers involved!

If people are favouring "approved" remedies, what is the incentive to rush the drug?

Already answered.

You still need to make sure it is safe.

Of course, but there'd be the incentive to do so as quickly as possible.

We don't know it won't take the same amount of time, either.

So?

The problem is, thetre is no second group of plaintiffs.

There are people in that exact situation who would love to get restitution. The case of Edie Bacon mentioned in the other thread, for one. As it is, the law forbids it! So of course this group doesn't exist because they've been defined away!

They do not have an argument, as I have explained.

And as I have explained, of course they do!

Before you get confused again, I am saying that the second group of plaintiffs (complaining of delay) do not have a case against the lab for delay.

And before YOU get confused again, the lab would not be the one preventing them from getting the drug.

No, what you have counted on is what you expect the profit motive to do. What you have ignored is what the profit motive has actually been shown to do.

The profit motive has really only been shown to do this in cases where the government lets them get away with it, as I have shown.

Again, this is missing the point entirely. See my post above regarding the jury nullification argument, which is non-sensical to say the least.

All you prove with that statement is that you know nothing of the history of trial by jury or of the concept of liberty and justice.

To say that Apotex has government backing to harass the doctor is disingenuous, at best.

If the government actively prevents the doctor's attorney from informing the jury of their right of nullification, they most certainly do have the backing!

Do you advocate the dismantling of the court system? Please.

You know for a fact that I don't. Stop lying. Such a position would be inconsistent with one advocating the return of jury nullification.

Apotex was trying to enforce a confidentiality agreement it said covered disclosure of test results to patients. The inquiry into the matter said that it didn't. That didn't stop the corporation from threatening legal action and smearing the doctor publicly.

But with jury nullification, there would have been a very small likelihood that such a case would have prevailed against the doctor. Without it, the doctor is helpless.

The court system is not to blame for the corporation's actions - that blame lies solely with the corporation. The REASON they threatened was not simply because they could - the motivation was PROFIT. You have yet to address that the primary motivation here was profit. All your talk of the court sytem and costs and everything else is a huge red herring.

Bulls--t. It's all part of the picture. You're just too closed off in your deluded little world that you don't want to consider it.

But what are the regulations - I have asked you twice now. This gives me a bit more info, but what specifically are the regs?

There are regulations for classifications of vehicles based on weight and price. The government places different requirements and standards for safety, fuel economy, etc. on vehicles in the different classifications.

Would this have any practical effect on the car (other than not blowing up, of course) or would it just affecting the marketing and profit to Ford?

I don't know all of the details, but my understanding is the latter. The higher cost of legislative compliance would have made the Pinto less profitable to sell.

What are these weight and cost restrictions you keep alluding to?

IIRC, it had to be under $2000 and weigh less than 2000 pounds. It was the same limitations they released the Mustang under.


On the contrary, you keep ignoring them. You still haven't addressed Pan Pharmaceuticals, or the fact that the motive for Apotex was profit.

*Sigh* Yes, I have, you just don't want to hear it.

Ironically, you seem to be arguing here that corporations do bad things and it is the governments fault if they don't stop them.

One of the duties of government is to prevent the use of force or fraud against others. When the government removes a punishment for a crime, they are certainly responsible for future crimes committed since they removed the deterrent.

What if the government suddenly made murder legal as long as it was a white man murdering a black man? Are you saying they wouldn't be responsible for any resulting violence?

And you seem to think that this is an argument for less regulation of industry.

Less regulation, yes, but also the reinstating of proper criminal justice.

No, it most certainly is. You are arguing that the court system allows someone to use it to do something bad. You say - if the court didn't stop people from completely ignoring the law, the corporation couldn't make the lawsuit threat! How is this different from saying "If the second amendment didn;t allow people to carry guns, I wouldn't have gotten shot"?

Because guns can be used for reasons other than to commit crimes, and the 2nd Amendment does not preclude crimes against murder or armed robbery. But by removing jury nullification, they removed one of the biggest forms of checks and balances in the system.

What exactly is this incentive? To avoid the negative publicity, etc.?

And to avoid the legal costs of suing someone when they know they can't win.

But this is exactly the kind of thing that is taken into account by the bean counter. They estimate how much it would costs to quickly and quietly settle claims and lawsuits, and balance this against the profits from the drug. If it is a huge net profit, they will release the drug and not tell people about the negative effects.

Which is why the government shouldn't be making it more profitable for them to sue. It's also bogus that victims have to seek restitution in the civil, not the criminal, courts.

You have once again completely missed the point. I am not saying that the threat isn't there now - I am saying that the threat does not exist in the world without the FDA but with some independant lab. The threat that you rely on to speed things up does not exist in any state of affairs, no matter who is doing the testing.

I've already shown that to be completely bogus. In fact, the article which prompted me to start this very thread is one example. Edie Bacon is another.

[Thanz]

Originally posted by shanek


Not punish whomever they want...acquit whomever they want. Jury Nullification has been a crucial part of Trial by Jury since Magna Carta in 1215, and the 1670 trial of William Penn established that juries could not be fined for acquitting a defendant in abeiance of the law. Our founders certainly had this in mind when they penned the 6th and 7th Amendments. Throughout the 1800s, juries refused to convict abolitionists who were put on trial for violating the Fugitive Slave Act. This continued until the aforementioned case of 1895.

In the case you mentioned, a hypothetical jury, knowing they could acquit the doctor even if he was in a complete breach of contract or whatever, would almost certainly do so. They'd be hard pressed to find a jury who would sympathize with the corporation there.

Dude, you seem to be 100% confused. What the hell does criminal law and jury trials have to do with a corporation attempting to enforce a confidentiality clause in a contract? Absolutely nothing.

FYI, in Canada, where the Apotex matter took place, juries for civil trials are rare. And if a civil jury actually ignored the law, it would be appealed so fast your head would spin. I am struggling to see why you advocate a system whereby the jury is encouraged to ignore any law it chooses.

[Thanz]

I have cut out some of the "Tastes great! Less filling!" stuff to focus on the new things....

Originally posted by shanek
There are people in that exact situation who would love to get restitution. The case of Edie Bacon mentioned in the other thread, for one. As it is, the law forbids it! So of course this group doesn't exist because they've been defined away!
No, I have read the article by Mrs. Bacon and she does not have a case - and would not have a case under a private system either.

First, she is not complaining about bureaucratic delays - she is complaining about the controls that have been set up on the testing procedure. They are still testing the efficacy of the drug, and want those tests done with as much control as possible. If anomolous results come from Mrs. Bacon in the non-controlled environment, it may affect their study and require more studies, which would further delay the release of the drug to everybody. The good of the many outweighing the needs of the one.

Further, J&J does not have any duty to sell the drug to Mrs. Bacon, and the testing authority (whether it is the FDA or some private authority under a new system) does not have any duty to approve her use of that drug outside of the tests that are currently going on. Without a duty to give her the drug, there is no cause of action against either the manufacturer or the testing authority. Why don't you understand this basic principle?

And as I have explained, of course they do!
They do not have an argument, and you have not explained it. Please answer these basic questions:

1. Does the manufacturer have a DUTY to sell an unapproved drug to anyone who asks for it? If so, what is the source of this duty? Does it not go against your libertarian principles, which would demand that the corporation can do whatever it likes with its property and not be required by force to sell it to anyone?

2. Does the testing authority (assuming it is a UL type authority) have and DUTY to approve a drug for use BY ANYONE until it is reasonably satisfied of its safety and efficacy? If so, what is the source of this duty? How can they be required to approve a drug if they are not sure what, if anything, it does?

As is obvious, I say that there is no duty on the part of either party to sell the drug to Mrs. Bacon or anyone else. No duty = no cause of action = no lawsuit.

And before YOU get confused again, the lab would not be the one preventing them from getting the drug.

Then who would be? Under a private system, if it is not the manufacturer or the testing authority, who is preventing them?

The profit motive has really only been shown to do this in cases where the government lets them get away with it, as I have shown.
Not true. Pan Pharmaceuticals (still ignored by you) was caught by the government. Apotex was found to be doing bad things by the official inquiry. Neither was a case of the government letting them get away with anything.

Further, do you think that corporations will be able to "get away with" MORE bad behaviour or LESS bad behaviour once the government oversight of the FDA is abolished? How can you seriously argue that the government is to blame for letting corporations get away with stuff and in the same breath advocate less government control and supervision over corporate behaviour???

All you prove with that statement is that you know nothing of the history of trial by jury or of the concept of liberty and justice.
You really are deluded, aren't you? First of all, we are not talking about a criminal trial. We are talking about a civil action. Do you even know what jury nullification is? Why do you think that people should be allowed to argue that the jury should ignore the law in a contract dispute? If the law can be ignored in any contract dispute, why bother with contract law at all?

The concept of jury nullification has absolutely no application to what we are arguing here. We are arguing about what incentives a corporation has as a result of the profit motive. I have shown, with concrete, real world examples, that corporations have cut corners and done other bad things in the name of profits. Your response? Well, if the government allowed jury nullification (and we completely ignore the rule of law) the corporations couldn't do this! It's obviously the government's fault!

Your response assumes a couple of things: First, that what the corporations did in the first place was perfectly legal. If it was not legal, you don't need nullification - you just find against them on the law. And in the examples I have posted, what the corporation did was NOT legal - the recalls of the Pan drugs show this, as does the inquiry into the Apotex matter which concluded that the confidentiality clause relied upon by the company does not prevent the disclosure by the doctor to her patients. So in each case, the court would find against the corporation based on the law - without any need for nullification.

Next, you go on about the costs of someone like the doctor in defending such a lawsuit, and seem to think that jury nullification has any effect on these costs at all. In order to get a jury to nullify, you need to go through the entire trial and incur all those costs anyway. And as I have pointed out, in both real cases the doctor (or those affected by the recalls) have much better cases based on the LAW, not IGNORING THE LAW.

Your nullification arguments are still big, red and fishy.

If the government actively prevents the doctor's attorney from informing the jury of their right of nullification, they most certainly do have the backing!
Nullification has nothing to do with behaviour by a corporation that is not legal. If the corporation is in the wrong, they are in the wrong, and there is no need for a jury to nullify anything. And if this is the extent of government backing, your arguments are worse than disingenuous - they are outright deceitful.

You know for a fact that I don't. Stop lying. Such a position would be inconsistent with one advocating the return of jury nullification.
Come on, shanek. It was an obvious rhetorical hyperbolic statement. You are grasping at straws to call me a liar for it.

But with jury nullification, there would have been a very small likelihood that such a case would have prevailed against the doctor. Without it, the doctor is helpless.
Do you have a problem with reading comprehension skills? The inquiry found in favour of the doctor's legal arguments that the clause DID NOT prevent disclosure. The doctor was certainly NOT helpless without jury nullification, and in fact would have prevailed without it. There is no need for nullification here, and the only reason you keep bringing it up must be to distract from the fact that you still haven't addressed the motivations of the corporation.

Bulls--t. It's all part of the picture. You're just too closed off in your deluded little world that you don't want to consider it.
MY deluded little world? Please. Court costs, etc. may have been part of the reason that the corporation chose the TACTIC of threatening a lawsuit. It does not address the main behaviour, however - the desire of the corporation to bury adverse test results and prevent the disclosure of harmful side effects - even to the sick children who took the drug. The court system has nothing to do with this underlying decision, which you have still failed to address.

There are regulations for classifications of vehicles based on weight and price. The government places different requirements and standards for safety, fuel economy, etc. on vehicles in the different classifications.

Thanz: Would this have any practical effect on the car (other than not blowing up, of course) or would it just affecting the marketing and profit to Ford?

I don't know all of the details, but my understanding is the latter. The higher cost of legislative compliance would have made the Pinto less profitable to sell.

IIRC, it had to be under $2000 and weigh less than 2000 pounds. It was the same limitations they released the Mustang under.
Let me get this straight. The government sets up a vehicle classification scheme. It classifies cars according to weight and price. Ford designs a vehicle that it wants to be part of class A. The problem is, and this is known to Ford, is that the gas tank may explode under certain conditions. Ford has a safer gas tank, but doesn't want to install it as it would put the car into class B. Putting the car into class B would make the car much safer (it won't blow up) but Ford would make less money on the car.

So, what does Ford do? They have a choice between making more money, but people will inevitably get blown up by their product, or making less money, but people will not get blown up by their product. They choose to blow people up and make more money. And for this you blame the CLASSIFICATION SCHEME? Come on - they made a decision, based on profit, to blow people up. It simply doesn't matter WHY it would cost more to put a safe tank on - the fact is they decided not to, not because the government forced them to - but because they wanted more money, exploding cars be damned.

*Sigh* Yes, I have, you just don't want to hear it.
On the contrary, you have not addressed it at all and I would love to hear it. You have not addressed Pan at all, and talk of court costs and jury nullification are irrelevant to the profit motive grounding the actual bad decisions of the corporations. You argue that profit drives corporations away from these decisions. I have shown the opposite. Are you EVER going to address this?

One of the duties of government is to prevent the use of force or fraud against others. When the government removes a punishment for a crime, they are certainly responsible for future crimes committed since they removed the deterrent.

Uh, the FDA is set up to try and prevent drug companies from marketing drugs that are either unsafe, ineffective, or both. I'd say they are trying to prevent the use of fraud on others. It seems you agree that the FDA is part of the duties of government.

What if the government suddenly made murder legal as long as it was a white man murdering a black man? Are you saying they wouldn't be responsible for any resulting violence?
How is this at all relevant? The government has not removed any punishments for crime in the area of drug testing. Nice attempt at diversion, however.

Less regulation, yes, but also the reinstating of proper criminal justice.
What the heck do you mean by this? How does "proper criminal justice" need to be reinstated?

But by removing jury nullification, they removed one of the biggest forms of checks and balances in the system.
Jury nullification has nothing to do with this. As mentioned so many times, you only need jury nullification if the corporation is acting completely within it's legal rights. If you want to deny them those rights (and give them to the plaintiff, who doesn't have them) you need to get the jury to nullify.

So, tell me - what are these legal rights that the corporations have that you want to take away and give to plaintiffs, as a "check and balance"?

Which is why the government shouldn't be making it more profitable for them to sue. It's also bogus that victims have to seek restitution in the civil, not the criminal, courts.
What victims are you talking about here? How does the governement make it more profitable to sue? Why is it bogus to require people to address civil wrongs in a civil court? What crimes do you think need to be charged.

I've already shown that to be completely bogus. In fact, the article which prompted me to start this very thread is one example. Edie Bacon is another.
No, you certainly haven't. Please answer my duty questions above.

[shanek]

Originally posted by Thanz
Dude, you seem to be 100% confused. What the hell does criminal law and jury trials have to do with a corporation attempting to enforce a confidentiality clause in a contract? Absolutely nothing.

Did you even read what I wrote? The biggest reason jury nullification was denied was because corporations were having trouble doing exactly that! :rolleyes:

FYI, in Canada, where the Apotex matter took place, juries for civil trials are rare. And if a civil jury actually ignored the law, it would be appealed so fast your head would spin. I am struggling to see why you advocate a system whereby the jury is encouraged to ignore any law it chooses.

Because that's the way it was supposed to work. That's the way it worked for centuries. And that was always regarded as one of the best parts of the trial by jury system.

Answer straight: What do you think of the juries in the 1800s who refused to convict violators of the Fugitive Slave Act?

But go on, stick your head in the sand, because it's obviously something that contradicts you delusions and something you don't want to think about...

For everyone else, you might want to check out this site: http://www.fija.org/

[shanek]

Originally posted by Thanz
No, I have read the article by Mrs. Bacon and she does not have a case - and would not have a case under a private system either.

First, she is not complaining about bureaucratic delays - she is complaining about the controls that have been set up on the testing procedure. They are still testing the efficacy of the drug, and want those tests done with as much control as possible.

You're ignoring Compassionate Use again. That's supposed to be her right.

If anomolous results come from Mrs. Bacon in the non-controlled environment, it may affect their study and require more studies, which would further delay the release of the drug to everybody.

This was said in the other thread, but I don't buy it. Since she wouldn't be part of the study, her results would not weigh in one way or the other!

Why is it that, on this ONE ISSUE ALONE, people think you're supposed to consider data outside the study participants? It's not something you do in other studies!

The good of the many outweighing the needs of the one.

Spoken like a true tyrant. But this country was founded on the principle that the good of the one—the freedom of the individual—is paramount.

Further, J&J does not have any duty to sell the drug to Mrs. Bacon,

"Duty"?? The ONLY reason they didn't was because they were afraid of FDA reprisals!

and the testing authority (whether it is the FDA or some private authority under a new system) does not have any duty to approve her use of that drug outside of the tests that are currently going on.

But the private agency wouldn't have the authority to point guns at their heads and forbid her from getting the drug, even when it's supposed to be her right. The FDA does.

Without a duty to give her the drug, there is no cause of action against either the manufacturer or the testing authority. Why don't you understand this basic principle?

The problem is that she is PREVENTED BY FORCE from getting this drug! Why don't YOU understand THAT basic principle?

1. Does the manufacturer have a DUTY to sell an unapproved drug to anyone who asks for it?

The manufacturer doesn't have to sell to anyone they don't want to—but that's entirely beside the point!!! The point is that now, they're being FORCEABLY PREVENTED from doing so!

2. Does the testing authority (assuming it is a UL type authority) have and DUTY to approve a drug for use BY ANYONE until it is reasonably satisfied of its safety and efficacy?

Yes, but again, they wouldn't have the authority to FORCEABLY PREVENT the sale or use of the drug!

Why do you completely refuse to acknowledge this very imporant point?

As is obvious, I say that there is no duty on the part of either party to sell the drug to Mrs. Bacon or anyone else.

But they would sell it to here were they not FORCEABLY PREVENTED from doing so!!!

How many times do I have to say it before it sinks through that thick skull of yours?

Then who would be? Under a private system, if it is not the manufacturer or the testing authority, who is preventing them?

No one would—that's the whole point!

Further, do you think that corporations will be able to "get away with" MORE bad behaviour or LESS bad behaviour once the government oversight of the FDA is abolished?

Less, obviously, because then they would be truly responsible for their actions. No more saying, "Well, we abided by FDA rules and regulations—what more can we do?"

How can you seriously argue that the government is to blame for letting corporations get away with stuff and in the same breath advocate less government control and supervision over corporate behaviour???

I've already explained this, but your deluded mind refuses to consider it. The argument is that government shouldn't be there; the issue is what the government should be doing. It's not doing enough of what it should and too much of what it shouldn't!

First of all, we are not talking about a criminal trial. We are talking about a civil action.

So? The concept still applies.

Do you even know what jury nullification is?

Given that I posted the definition above, examples, and the historical background, the answer to that should be obvious to anyone who's actually reading my posts, and not just kneejerk-reacting to them.

Why do you think that people should be allowed to argue that the jury should ignore the law in a contract dispute?

In cases like the one you just mentioned—the company shouldn't have the power to put such a thing in the contract in the first place!

If the law can be ignored in any contract dispute, why bother with contract law at all?[/b]

Look, I'm tired of you. Research jury nullification for yourself. It was a vital part of our system until 1895.

The concept of jury nullification has absolutely no application to what we are arguing here.

Yes it does, and the fact that you keep denying it shows how deluded and biased you are.

We are arguing about what incentives a corporation has as a result of the profit motive.

But as an example, you showed a corporation using the threat of a lawsuit to get their way—a threat that wouldn't be there, or at least would be greatly diminished, with jury nullification!

It's relevant. Stop trying to weasel out of it.

I have shown, with concrete, real world examples, that corporations have cut corners and done other bad things in the name of profits.

When they can get away with it, yes. But I've always been in favor of holding corporations responsible for their actions, which includes getting rid of all the ways the government lets them get away with it, which, again, you keep blatantly ignoring.

Next, you go on about the costs of someone like the doctor in defending such a lawsuit, and seem to think that jury nullification has any effect on these costs at all.

No, that was a separate issue. Stop this dishonesty.

Come on, shanek. It was an obvious rhetorical hyperbolic statement.

Which was intended to mischaracterize my arguments. However rhetorical or hyperbolic it was, it was still dishonest and misleading.

You are grasping at straws to call me a liar for it.

The only straws I'm grasping at are the ones in your arguments.

Do you have a problem with reading comprehension skills?

You apparently do...My conclusion, as you keep ignoring, is the fact that they would have been less likely to even attempt it in the first place! It doesn't matter whether or not it actually went to trial!

[more bulls--t lies deleted]

Let me get this straight. The government sets up a vehicle classification scheme. It classifies cars according to weight and price. Ford designs a vehicle that it wants to be part of class A. The problem is, and this is known to Ford, is that the gas tank may explode under certain conditions. Ford has a safer gas tank, but doesn't want to install it as it would put the car into class B. Putting the car into class B would make the car much safer (it won't blow up) but Ford would make less money on the car.

So, what does Ford do? They have a choice between making more money, but people will inevitably get blown up by their product, or making less money, but people will not get blown up by their product. They choose to blow people up and make more money. And for this you blame the CLASSIFICATION SCHEME?

Yes, because without such a scheme they would have used the safer gas tank!

It simply doesn't matter WHY it would cost more to put a safe tank on

Oh, GIVE ME A FSCKING BREAK!!!! :rolleyes: The "why" certainly does matter when you're looking to prevent that very behavior!

I'm really getting tired of you, and of using what little spare time I have to deal with your inherent refusal to understand a single word I say.

Uh, the FDA is set up to try and prevent drug companies from marketing drugs that are either unsafe, ineffective, or both. I'd say they are trying to prevent the use of fraud on others. It seems you agree that the FDA is part of the duties of government.

The problem is, the FDA punishes everybody, not just those who commit fraud.

How is this at all relevant?

It goes back to the very thing we were discussing! But go on, stick your head in the sand...

What the heck do you mean by this? How does "proper criminal justice" need to be reinstated?

Well, for starters, the reinstatement of jury nullification, the addition of some sort of "loser pays" system, the removal of the government-sponsored monopoly on lawyers...lots of stuff.

Jury nullification has nothing to do with this. As mentioned so many times, you only need jury nullification if the corporation is acting completely within it's legal rights.

Not so! As I keep saying, and as you keep ignoring, this figures in to the decision whether or not to sue or even threaten a lawsuit in the first place!

How does the governement make it more profitable to sue?

By forbidding juries to rule against them when they're clearly in the wrong just because they acted within the letter of the law, for one.

Why is it bogus to require people to address civil wrongs in a civil court?

I never said it was! Stop lying!

I'm going to drop out of this discussion soon unless you start answering honestly. I don't need this bills--t in my life right now.

[Skeptic]

Not punish whomever they want...acquit whomever they want. Jury Nullification has been a crucial part of Trial by Jury since Magna Carta in 1215, and the 1670 trial of William Penn established that juries could not be fined for acquitting a defendant in abeiance of the law. Our founders certainly had this in mind when they penned the 6th and 7th Amendments. Throughout the 1800s, juries refused to convict abolitionists who were put on trial for violating the Fugitive Slave Act.

They also refused to convict those guilty of lynching uppity n---ers who didn't know what their place was, as many famous cases show.

Your argument is that the way to deal with corporate abuse of power (by sueing and intimidating the "small guy") is to let juries abuse THEIR power (by acquitting a guilty party to "get back" at the corporations). This is the equivalent of dealing with occassional police abuse of innocent citizens by eliminating the police and, instead, going back to the wild west "posse" system (or the deep south's lynch mob, for that matter).

Two wrongs don't make a right--and contrary to popular belief, they don't even cancel each other out. Letting juries abuse their power will not magically stop corporations from running rings around the legal system; their high-paid lawyers will simply find other tricks that take this possibility into effect. It WILL, however, let juries acquit popular or feared criminals with impunity. So you'll be back in the same place, with a even more broken legal system.

[Thanz]

shanek, I am actually quite shocked by your reply, especially after I looked at what you did not address in my last post (and at one point even called "b****hit lies". However, I do want to keep a dialogue going. For this reason I will not be posting my thoughts now in the hopes that a cooler head will prevail tomorrow. Rest assured, however, I will be replying.

Thanz

[Thanz]

shanek -

You are arguing that the government, by taking away the right of jury nullification, have handed the corporations an advantage when it comes to lawsuits. Without the threat of nullification, corporations are more likely to throw their weight around and intimidate the "little guy". If juries were allowed to nullify (and told of this) corporations would have to think twice about making these threatening moves. Is that right so far? That is how I understand your argument.

The problem with this argument here is that a jury would not have to nullify in order to find against the corporation. A jury, or judge, could find against the company in each of the examples I have posted completely within the law. Here are some snippets from my last post that you ignored that point this out:Not true. Pan Pharmaceuticals (still ignored by you) was caught by the government. Apotex was found to be doing bad things by the official inquiry. Neither was a case of the government letting them get away with anything.
Your response assumes a couple of things: First, that what the corporations did in the first place was perfectly legal. If it was not legal, you don't need nullification - you just find against them on the law. And in the examples I have posted, what the corporation did was NOT legal - the recalls of the Pan drugs show this, as does the inquiry into the Apotex matter which concluded that the confidentiality clause relied upon by the company does not prevent the disclosure by the doctor to her patients. So in each case, the court would find against the corporation based on the law - without any need for nullification.
In order to get a jury to nullify, you need to go through the entire trial and incur all those costs anyway. And as I have pointed out, in both real cases the doctor (or those affected by the recalls) have much better cases based on the LAW, not IGNORING THE LAW.
Nullification has nothing to do with behaviour by a corporation that is not legal. If the corporation is in the wrong, they are in the wrong, and there is no need for a jury to nullify anything. And if this is the extent of government backing, your arguments are worse than disingenuous - they are outright deceitful.

Therefore, your argument about nullification breaks down. Nullification does not enter into the decision making process when the corporation's position is already wrong on the law. Even if the corporation thought that it's position was correct, but could see that the other side had a viable argument, it is the viable argument that will give them the most pause, not some rare threat of nullification. There is no jury in the world that will say - "what you did was legal, but we don't like it so we won't find in your favour" when they have the perfectly viable choice of saying "what you did was not legal, based on the other side's arguments".

In each example I have posted - including Apotex and the doctor - the company would not prevail on its legal argument. Apotex did not threaten the doctor because it knew it had no fear of nullification. It threatened the doctor because it wanted to hide the results of her test, scare her into silence, and try to bully her. They knew that their confidentiality argument was shakey - but they did it anyway in the name of profits. I seriously doubt the thought of nullification and whether it exists or not ever entered their minds.

Now, turning specifically to the part of my post that you labelled "bulls--t lies" by you. Here is the first part of what you deleted:The inquiry found in favour of the doctor's legal arguments that the clause DID NOT prevent disclosure. The doctor was certainly NOT helpless without jury nullification, and in fact would have prevailed without it. There is no need for nullification here, and the only reason you keep bringing it up must be to distract from the fact that you still haven't addressed the motivations of the corporation.
Where are the "bulls--t lies" here? The only possible thing that you could label a "lie" is my conclusion as to your motive for continually raising nullification. If you disagree, fine - but you'll need a better argument as to the applicability of nullification in the examples I posted, where the corporation is already legally wrong. The rest of what I posted are the simple facts - which you have ignored and improperly labelled as "lies".

The second paragraph you deleted under this heading is this one:MY deluded little world? Please. Court costs, etc. may have been part of the reason that the corporation chose the TACTIC of threatening a lawsuit. It does not address the main behaviour, however - the desire of the corporation to bury adverse test results and prevent the disclosure of harmful side effects - even to the sick children who took the drug. The court system has nothing to do with this underlying decision, which you have still failed to address.
Where are the lies here? Where do you address the underlying decision rather than the tactic?

While we are on the topic of "bulls--t lies" I would like to return to your original post on nullification. This is what you said:In 1895, the Supreme Court, in United States v Sparf, ruled for the first time in history that juries did not have the power to judge the law as well as the facts by upholding a lower court ruling forbidding a defense attorney telling the jury of this right. This was the result of intense pressure fron big corporations who kept trying to use the court system as their muscle (like the example Thanz brought up) but the juries kept ruling against them.
The Sparf case was a murder trial, and the issue surrounded the instruction to the jury regarding murder and manslaughter. If you have ANY evidence to back up your assertion that this decision, in a murder case, was IN ANY WAY influenced (let alone "the result of") corporate pressure from big corporations I would like to see it. If you don't, your statement here is misleading at best, if not outright deceitful.

one other paragraph that you failed to address:On the contrary, you have not addressed it at all and I would love to hear it. You have not addressed Pan at all, and talk of court costs and jury nullification are irrelevant to the profit motive grounding the actual bad decisions of the corporations. You argue that profit drives corporations away from these decisions. I have shown the opposite. Are you EVER going to address this?
I am particularly interested in the bolded portion.

The Pinto

Here is the full text of may last points on the Pinto, parts of which you deleted. Come on - they made a decision, based on profit, to blow people up. It simply doesn't matter WHY it would cost more to put a safe tank on - the fact is they decided not to, not because the government forced them to - but because they wanted more money, exploding cars be damned.
You responded to my statement on why with the following Oh, GIVE ME A FSCKING BREAK!!!! The "why" certainly does matter when you're looking to prevent that very behavior!
By responding this way, you fail to address the main point - Ford decided to let people get blown up so that it could make more money. You also have not provided your source for your claims that they had a safer tank and that it's addition would have put it out of the classification. Out of the classification how? I find it hard to believe that it was a weight issue - subbing one tank for another should not make that big a difference, and the Pinto was not a big car. Therefore, I think it must have been price. Ford wanted to keep the car under a certain price (for marketing/profit reasons) and therefore cut corners on a known safety problem with severe consequences. You assert that the classification scheme is the ONLY reason they didn't put the safer tank on. I say - provide your source. I don't beleive you.

The importance of "duty" on the right to sue
You seem to have completely missed the "duty" point, and instead focussed on compassionate use and forcible prevention. First, you agree that the corporation has no duty to sell to anyone. You also say that 'compassionate use' is supposed to be Mrs. Bacon's "right". She does not have a "right" to the drug, as the corporation has no duty to sell it to her.

I know, you say that the only reason that they didn't sell her the drug is that they were prevented by the FDA. The way I read it, the corporation did not want to sell her the drug outside of the study as it may screw up the study itself - and delay approval and widespread marketing of the drug.

This situation could be the same under a private scheme, where the corporation wants the "seal of approval" as quickly as possible. The easiest way to do this is to have ALL of the data within the controlled study. The corporation could easily make the same choice - not to sell to Bacon except as part of a controlled study - and Bacon would have nothing to say about it. You have agreed that the manufacturer has no duty to sell to her, and the lab no duty to approve before it is satisfied.

Remember, your position was that the threat of lawsuits for delay would have a positive effect on the private system. But, if the people in the private system have no duty to sell the drug to anyone, or approve it on any timetable, there is no grounds for a lawsuit. None. There is no threat of a lawsuit. You cannot sue somebody for not doing something that they have no duty to do.

[shanek]

Originally posted by Skeptic
Your argument is that the way to deal with corporate abuse of power (by sueing and intimidating the "small guy") is to let juries abuse THEIR power (by acquitting a guilty party to "get back" at the corporations).

Not abuse their power&mdashlexercise their right! Jury nullification was considered a vital part of trial by jury at the time our Founders wrote the Constitution, and they most certainly had that in mind!

"It is not only [a juror's] right, but his duty... to find the verdict according to his own best understanding, judgment, and conscience, though in direct opposition to the direction of the court." —John Adams, 1771

"The jury has a right to judge both the law as well as the fact in controversy." —John Jay, the first US Chief Justice, in Georgia v. Brailsford, 1794. He was instructing the jury at the time.

"For more than six hundred years—that is, since Magna Carta, in 1215—there has been no clearer principle of English or American constitutional law, than that: in criminal cases, it is not only the right and duty of juries to judge what are the facts, what is the law, and what was the moral intent of the accused; but that it is also their right, and their primary and paramount duty, to judge the justice of the law, and to hold all laws invalid that are, in their opinion, unjust or oppressive, and all persons guiltless in violating, or resisting the execution of such laws.

"Unless such be the right and duty of jurors, it is plain that, instead of juries being a 'palladium of liberty'—a barrier against the tyranny and oppression of the government—they are really mere tools in its hands, for carrying into execution any injustice and oppression it may desire to have executed." —Lysander Spooner, 1852

"Jurors should acquit, even against the judge's instruction...if exercising their judgement with discretion and honesty they have a clear conviction that the charge of the court is wrong." —Alexander Hamilton, 1804

"In the trial of all criminal cases, the Jury shall be the Judges of Law, as well as of fact, except that the Court may pass upon the sufficiency of the evidence to sustain a conviction." —Article XXIII, Constitution of the State of Maryland

"In all criminal cases whatsoever, the jury shall have the right to determine the law and the facts." —Article I, §19, Constitution of the State of Indiana

"The jury has the power to bring a verdict in the teeth of both the law and the facts." —Justice Oliver Wendell Holmes, Horning v. District of Columbia, 1920

It's not a "posse" system, nor any other pathetic ad hominem you can sling its way. It has been highly regarded throughout the history of the trial by jury system as one of the most crucial parts of it.

[shanek]

Originally posted by Thanz
You are arguing that the government, by taking away the right of jury nullification, have handed the corporations an advantage when it comes to lawsuits. Without the threat of nullification, corporations are more likely to throw their weight around and intimidate the "little guy". If juries were allowed to nullify (and told of this) corporations would have to think twice about making these threatening moves. Is that right so far? That is how I understand your argument.

Unless those threats are of such a nature as to be just and therefore have little fear of a jury ruling against them.

To fully reform the system, other methods would have to be employed as well, such as some sort of loser pays system.

The problem with this argument here is that a jury would not have to nullify in order to find against the corporation. A jury, or judge, could find against the company in each of the examples I have posted completely within the law.

Doesn't matter. Without jury nullification, they may figure they can get past the other legal barriers.

Here are some snippets from my last post that you ignored that point this out:

I didn't ignore them; you seem to be completely unable to grasp the difference between punishment and deterrence.

It threatened the doctor because it wanted to hide the results of her test, scare her into silence, and try to bully her.

But the threat would have had no teeth if there wasn't a chance they could make good on it! Read up on the history of the 1895 case I mentioned—the effect you so steadfastly deny happened on quite a regular basis! That's why they lobbied so hard against jury nullification!

I seriously doubt the thought of nullification and whether it exists or not ever entered their minds.

Why would it? Judges don't let juries have that right anymore.

Now, turning specifically to the part of my post that you labelled "bulls--t lies" by you. Here is the first part of what you deleted:
Where are the "bulls--t lies" here? The only possible thing that you could label a "lie" is my conclusion as to your motive for continually raising nullification.

Which you had no evidence for, because it isn't true. It was a completely dishonest ad hominem.

Where are the lies here? Where do you address the underlying decision rather than the tactic?

The lie is because my argument precludes me having to address it! If the odds are in your favor, you'll still play even if you lose once in awhile! So the fact that they lost this one time does not make it a deterrent. If they think they can win more than they lose, or at least win enough to come out ahead, they'll do it!

The Sparf case was a murder trial, and the issue surrounded the instruction to the jury regarding murder and manslaughter. If you have ANY evidence to back up your assertion that this decision, in a murder case, was IN ANY WAY influenced (let alone "the result of") corporate pressure from big corporations I would like to see it.

Did you check out the links I posted?

In 1895, the Supreme Court, under pressure from large corporations, ruled in a bitter split decision that courts no longer had to inform juries they could veto an unjust law. The giant corporations had lost numerous trials pressed against labor leaders trying to organize unions. Striking was against the law at that time. "Juries also ruled against corporations in damage suits and other cases, prompting influential members of the American Bar Association to fear that jurors were becoming too hostile to their clients and too sympathetic to the poor. As the American Law Review wrote in 1892, jurors had 'developed agrarian tendencies of an alarming character'." (Barkan, 1983, emphasis added.)

http://quasar.as.utexas.edu/BillInfo/FIJA.History.html

In the 1850’s, northern juries were regularly refusing to convict abolitionists of violating the Fugitive Slave Law of 1850. After this, though, when nullification caused disgruntled workers to have freedom to strike, nullification started to seem like a bad idea to big business owners, and large corporations began to put pressure on the Supreme Court to do something about this nullification right. The result was that in 1895, the Supreme Court, in a split vote, decided that there was nothing in the Constitution requiring juries to be told about their power to judge the law as well as the facts (FIJA). Juries have the power, but do not have to be told of it (Lone). Today, no officer of the court is allowed to tell the jury of their veto power (Emal).

http://www.geocities.com/stenerin1/jury_nullification.html

(all emphases mine)

The information is out there. Not even those who argue against jury nullification doubt it. The corporations were mad about not being able to stop workers from forming unions, even though unions were illegal at the time, because jurors failed to convict the ones who tried to form them.

You argue that profit drives corporations away from these decisions. I have shown the opposite.

No, you haven't. I have been refuting that all along.

[b]By responding this way, you fail to address the main point - Ford decided to let people get blown up so that it could make more money.

But it wouldn't have been more profitable for them to do so in the first place without the government-mandated claddification schemes!

You also have not provided your source for your claims that they had a safer tank

Oh, for crying out loud—any source on this issue will tell you that!!!

How about from a page that neglects to mention the role the government played, and instead espouses your view:

In 1977, Mark Dowie of Mother Jones Magazine, using documents in the Center files, published an article reporting the dangers of the fuel tank design, and cited internal Ford Motor Company documents that proved that Ford knew of the weakness in the fuel tank before the vehicle was placed on the market but that a cost/benefit study was done which suggested that it would be "cheaper" for Ford to pay liability for burn deaths and injuries rather than modify the fuel tank to prevent the fires in the first place. Dowie showed that Ford owned a patent on a better designed gas tank at that time, but that cost and styling considerations ruled out any changes in the gas tank design of the Pinto.

http://www.autosafety.org/article.php?did=522&scid=96

(emphasis mine again)

First, you agree that the corporation has no duty to sell to anyone. You also say that 'compassionate use' is supposed to be Mrs. Bacon's "right". She does not have a "right" to the drug, as the corporation has no duty to sell it to her.

"Rights" don't apply to what we have to grant each other. They apply to what the government must allow us. So the government can't stop me from saying what I want because I have the right of free speech; that doesn't mean you have to let me use your printing press.

The fact that you don't understand this does not surprise me one iota.

The way I read it, the corporation did not want to sell her the drug outside of the study as it may screw up the study itself

The FDA would consider the study screwed up—they said that. And why would the experience of someone OUTSIDE OF THE TESTING GROUP screw up the testing?

- and delay approval

See? "Delay approval"—meaning the FDA wouldn't have considered it valid. But how is it at all scientific to consider the experience of someone completely outside of all testing groups? This is NOT good science!

This situation could be the same under a private scheme,

A private body would have a much better incentive to follow proper scientific procedures. They wouldn't consider something amounting to no more than an anecdote as "screwing up" the testing.

Remember, your position was that the threat of lawsuits for delay would have a positive effect on the private system.

Read back—that only applied when the person was FORCEABLY prevented from getting the drug, as Mrs. Bacon was. A third party could not get in the way of the sale as the FDA did in her case.

Besides, what reason would a corporation have for not selling it to her, losing a sale and taking a huge PR hit from appearing so uncaring?

[Mahatma Kane Jeeves]

Originally posted by shanek
The FDA would consider the study screwed up—they said that. And why would the experience of someone OUTSIDE OF THE TESTING GROUP screw up the testing?

See? "Delay approval"—meaning the FDA wouldn't have considered it valid. But how is it at all scientific to consider the experience of someone completely outside of all testing groups? This is NOT good science!

A private body would have a much better incentive to follow proper scientific procedures. They wouldn't consider something amounting to no more than an anecdote as "screwing up" the testing.

Read back—that only applied when the person was FORCEABLY prevented from getting the drug, as Mrs. Bacon was. A third party could not get in the way of the sale as the FDA did in her case.

Besides, what reason would a corporation have for not selling it to her, losing a sale and taking a huge PR hit from appearing so uncaring?

Reasons a company would deny "compassionate use":
CancerActionNow.org (http://www.canceractionnow.org/cu/01awhatiscu.html) - a patient advocacy group

Many drug companies for a variety of reasons refuse patient requests for compassionate use. Reasons for refusal may include:

Cost – compassionate use can be expensive
Production capacity – drugs can be expensive and time-consuming to make, and until approved, capacity to manufacture the drugs may be limited
Priorities – companies may want to use 'left-over' drugs for clinical trials in different illnesses
Lack of efficacy – there may be little evidence that the drug may be effective for the specific illness

It is important to remember that drug companies are not required to provide their unapproved drug to patients outside of a clinical trial and under no circumstances can a drug company be compelled to do so.
The FDA's policies on compassionate use (all emphasis mine):
CancerActionNow.org (http://www.canceractionnow.org/cu/01awhatiscu.html)

The FDA generally supports requests for compassionate use if the patient has exhausted standard treatment options and is ineligible for clinical trials. However, if the FDA is aware of safety issues that may foreshorten a patient’s life the FDA may refuse the patient’s application. This is a rare occurrence.
"Experimental Treatments? Unapproved but Not Always Unavailable" (http://www.fda.gov/fdac/features/2000/100_exp.html), FDA Consumer magazine, Jan-Feb 2000

As with a clinical trial, there may not be an appropriate treatment IND for an individual patient's condition, but there may be a new drug still working its way through development. If enough is known about the drug's safety, and there is some clinical evidence of effectiveness, FDA may allow a patient to become his or her own study. This so-called single-patient IND, or compassionate use IND, virtually ensures that any patient can get access to any investigational new drug.

Although FDA's requirements for a single-patient IND are relatively simple, setting up this kind of access for an individual patient is not. First of all, the company must be willing to provide the new drug to the patient. This can be expensive and time consuming for the company since, in addition to providing the drug, the company needs to track shipments of the drug, create special instructions for its use, and create a way of collecting safety data and a mechanism for tracking outcomes for each patient. Second, the patient must give informed consent, understanding that the drug is not approved and may cause side effects from mild to fatal. Third, the patient's physician must be willing to take responsibility for treating the patient and agree to collect information about the effects of the drug.

Companies sometimes say that they cannot make the drug available to a patient because FDA won't allow it, but that is rarely true. FDA only denies access when there is evidence that the risk of using the experimental drug clearly outweighs any potential benefit to the patient.

Statement by Robert J. Temple, M.D. (http://www.fda.gov/ola/2001/compassionateuse0620.html) Associate Director for Center for Drug Evaluation and Research, June 20, 2001

Commercial sponsors are not always willing to supply drug for treatment uses. A number of industry concerns about the use of experimental drugs were discussed at the June 7, 2001, ODAC meeting.

(1) There may be a limited drug supply early in drug development. The batches prepared for early drug studies are usually small; making larger amounts available is expensive and not considered reasonable until there begins to be evidence that the drug is of value.

(2) There may be competition between expanded access programs and the regulatory programs that will lead to drug approval. Competition can be either for patients entering trials or for internal company resources. The process of individualized packing and shipping of drugs for single patient use on an emergent basis can be very disruptive to departments that are organized to pack and ship drugs in a scheduled manner for clinical trials. There is significant concern that availability of all investigational drugs outside a formal protocol will decrease participation in the formal study. In fact, FDA rules allow open studies to be put on hold if they are interfering with the conduct of clinical trials

(3)The use of an investigational drug in less controlled setting, in patients with very advanced disease could lead to adverse reactions that might raise difficult to resolve but spurious safety concerns about the drug.

(4)Industry seems to learn little about a drug from single patient use. FDA expects very low response rates in patients who have received multiple previous therapies and a low rate in such patients would not damage the drug's chance for approval.

Later in the Statement (http://www.fda.gov/ola/2001/compassionateuse0620.html):

In cases where a patient cannot be enrolled in an existing protocol because of some factor that makes the patient ineligible to participate in the study, research sponsors or investigators often can make a protocol exception to treat such a patient. The data from that patient would not be part of the report of the original study. Usually such special exceptions arise in the same institutions that are conducting the original study, where investigators are familiar with the drug.

The FDA's True Policy on Experimental Drugs, Letter to the editor from Lester M. Crawford, Deputy Commissioner FDA, Wall Street Journal, 12/26/2002, pA15

...Ms. Bacon's deep concern about her lack of access to a treatment that she believes to be beneficial is understandable. The policies of the Food and Drug Administration, however, are not an obstacle to the use of experimental treatments outside clinical trials. Such use would not prompt, as Ms. Bacon appears to believe, an FDA request for additional studies.

The FDA, categorically, does not attach special significance to adverse events reported from such expanded access programs as Ms. Bacon has tried to join. We recognize that these programs involve less-controlled use of new drugs, and we assess the reported data accordingly. The development of a new medication is not slowed by side effects occurring outside clinical trials.

...So far, 67 patients have been given outside-trial access to ET-743, the drug that Ms. Bacon wants to use.

edited for spelling

[Thanz]

Originally posted by shanek
To fully reform the system, other methods would have to be employed as well, such as some sort of loser pays system.
In case you didn't know, in Ontario (where the Apotex matter occurred) we DO have a loser-pay system (usually not 100% loser pay, but the loser does pay costs to the victor in most cases). Also, civil juries are rare.

Doesn't matter. Without jury nullification, they may figure they can get past the other legal barriers.
How the hell does it not matter? What makes you think that a corporation, in the legal wrong, will think that it can overcome the legal wrong but somehow get caught by jury nullification? This makes absolutely no sense whatsoever.

Let's keep this real simple, as you seem to have problems understanding the very basics. Jury nullification was used by juries when they felt that following the law would lead to an unjust result. Correct? With me so far? It was used to nullify law that the jury felt were unjust or unfair - hanging a starving kid for stealing food, slavery, union organization, etc.

Let's take the example of union organization, which you say was illegal but juries kept nullifying. Let's change the facts a little bit and say that it was illegal for the company to take certain steps to prevent union organization (as it is now). If the company takes those steps, the union can sue and prevail in the court on the law, without the need for nullification. The corporation has nothing to fear from nullification, but they have everything to fear from the law itself.

A jury simply does not nullify when following the law would provide the just result. Why can't you understand this? Nullification is simply NOT A FACTOR when the corporation is in the wrong.

Of course, I said this in my last post, and of course, you ignored it as it shows how ridiculous your position is.

I didn't ignore them; you seem to be completely unable to grasp the difference between punishment and deterrence.
I understand the difference just fine. you don't seem to understand that nullification is not a deterrent when the corporation is in the wrong on the law. The law should be the deterrent. Nullification could only be a deterrent if the corporation could say "We are following the law here, but some ordinary people may disagree with the law, so we may be in trouble". That is not the case in the examples I posted. The corporation was wrong on the law. Nullification, even if it existed, would not be a factor. If it is not a factor, it can't be a deterrent.

Further, in civil cases, I don't agree that nullification is appropriate in any event. Why should a private party have to justify the law everytime they act in accordance with it and want to enforce it?

I'll give you a concrete example. I do work for a courier company. They have a very good track record of delivering on time, but mistakes do happen. Sometimes things get broken or lost. There are statutory provisions that have been in effect for over 100 years that limit the liability of common carriers to $2.00 per pound (the amount has changed over the years) unless a higher value is declared on the bill of lading (and extra charges paid for). The regulations are there for the efficient transportation of goods. Without them, the risks to the carriers would be much higher and shipping would cost much more for everyone.

Every once in a while, when something goes wrong, someone will sue the carrier saying that they lost their mother's pearls, broke their computer, or whatever. Inevitably, they have not declared a higher value and the mother's priceless pearls get a value of $2.00. On one side of the table you have some poor guy who lost something valuable to him, and on the other you have the BEC. If this was before a jury, they would nullify all the time. That doesn't make it right or just. Laws are made by the duly elected legislative branch of government. They should not be ignored willy-nilly. But, I digress.

But the threat would have had no teeth if there wasn't a chance they could make good on it!
There are always going to be arguments on the law. And the "teeth" can be the costs you have so frequently referred to. And in the specific case, the addition of nullification would have done absolutely nothing to change the "teeth" of the threat.

Which you had no evidence for, because it isn't true. It was a completely dishonest ad hominem.
It was a conclusion based on the evidence of your arguments. I notice you leave out the portion where I accept you may disagree. I also notice you ingore any discussion of the FACTS you have dishonestly labelled "bulls--t lies".

The lie is because my argument precludes me having to address it! If the odds are in your favor, you'll still play even if you lose once in awhile! So the fact that they lost this one time does not make it a deterrent. If they think they can win more than they lose, or at least win enough to come out ahead, they'll do it!
Your argument does not preclude you from having to address it at all. The underlying decision has to be what we are discussing. You claim that the profit motive will cause corporations to do good things with drugs. I have shown you that the profit motive causes them to make bad decisions about drugs and do underhanded things. To say that the corporation will try to get away with underhanded things if they can does not in any way address the fundamental issue of why they are doing the underhanded things - which is profit.

Do you even realize that this makes my argument, not yours? You are saying here that corporations will do bad things if they can get away with it. If new drugs do not have to be approved or tested, they can get away with selling snake oil. They could trush a drug to market before it is ready. They could lie about its effects and side effects. What is causing them to do these things? Profit.

If I said that the only reason the Columbine shootings happened was because of guns, would you agree? Would the argument that if we had banned guns, it wouldn't happen have any sway on you? Or would you look at the motivations of the individuals involved? I am asking you to look at the motivations of the corporations, and not at the means with which they use to implement those decisions.

The information is out there. Not even those who argue against jury nullification doubt it. The corporations were mad about not being able to stop workers from forming unions, even though unions were illegal at the time, because jurors failed to convict the ones who tried to form them.
Dude, your links don't have much weight with me. They are just assertions from pro-nullification activists such as yourself. They all fail to mention that the Sparf case was a murder trial - nothing to do with corporations. It may be true that corporations at the time weren't too happy about nullification. But you'll need to show me more evidence than that to convince me that corporate lobbying had an effect on the decision of the Supreme Court in a murder case.

Also, they seem to be advocating nullification only when the government is one of the parties:"FIJA" means Fully Informed Jury Amendment, Act, or Association.

As law, FlJA. would require that judges resume the practice of informing jurors of their inherent right to bring in a verdict according to conscience and their judgment as to whether the low itself is unjust or unfairly applied in any trial by jury where government is one of the parties. FIJA would also provide that defendants' motives be admissible as evidence. (emphasis mine)

Of course, in the examples I posted, the government was not one of the parties.

No, you haven't. I have been refuting that all along.
You haven't refuted it once!!!! You haven't even addressed it!!!

All your talk about the tactics that corporations employ, and whether they are supported/condoned by the government even indirectly are nothing but a smokescreen. If your argument had any validity, Apotex would not have threatened the doctor. If the profit motive always led corporations to do things that were in the public interest, the Pinto would not have been an exploding menace. The corporations would not resort to underhanded tactics, whether or not they could get away with them, if (as you claim) the profit motive would stop them from doing this.

But it wouldn't have been more profitable for them to do so in the first place without the government-mandated claddification schemes!
But this is what you have failed to provide any evidence for - the fact that it was just the classification scheme (and not pure greed) that somehow prevented the safer tank.

And even if you have proof of this assertion, why does Ford get a free pass because they can point to some regulation that lessens profit? They still made the decision to blow people up for money. The fact that a classification scheme may have been a factor IN NO WAY excuses Ford for this horrible decision.

Oh, for crying out loud—any source on this issue will tell you that!!!

How about from a page that neglects to mention the role the government played, and instead espouses your view:
Nice editing there, shanek - trying to imply that my main concern was whether they had a safer tank. You purposefully cut out the rest of my question - "and that it's addition would have put it out of the classification" - which is central to your argument. You also purposefully cut out my direct challenge to you on this, which shows exactly what I am interested in:You assert that the classification scheme is the ONLY reason they didn't put the safer tank on. I say - provide your source. I don't believe you.

I used to think that you were basically an honest chap who has different political views than I do. You careful editing behaviour on this thread has caused me to rethink my views a little bit. How about providing a source that DOES mention what you say the government's role in this was?

On compassionate use, I think that Mahatma Kane Jeeves has done an excellent job refuting your arguments. His sources show quite clearly that the FDA is not the only reason a corporation would not sell to someone like Mrs. Bacon, for reasons that would persist under a private system. Thus, the argument that the only reason J&J didn't sell to her was that they were forcibly prevented is simply incorrect.

Read back—that only applied when the person was FORCEABLY prevented from getting the drug, as Mrs. Bacon was. A third party could not get in the way of the sale as the FDA did in her case.
I suggest that YOU read back. Your original assertion was that there would be the threat of a lawsuit under a private system for delay of a drug. You seem to think that Bacon would have such a lawsuit - that is not the case. There can be no threat for dealy, as there is no duty to sell or approve the drug.

Besides, what reason would a corporation have for not selling it to her, losing a sale and taking a huge PR hit from appearing so uncaring?
I think that Mahatma Kane Jeeves' post answers this quite well.

However, instead of simply asserting that they would sell to Bacon (and others), why not try addressing the lawsuit argument? If the corporation did decide not to sell to anyone outside of the trial prior to approval, could anyone sue them for that? Of course not - you have already agreed that the company has no duty to sell it. Could Bacon sue the testing authority? No - as they don't have a duty to abide by Bacon's schedule, whatever it may be.

Edited to add: You still have not addressed Pan Pharmaceuticals. Not once. How did the profit motive prevent them from doing bad things in the drug market???

[shanek]

Originally posted by Mahatma Kane Jeeves
Reasons a company would deny "compassionate use":

Thanks for the great answers! My responses will focus on the Edie Bacon situation, the one we're currently discussing:

Cost – compassionate use can be expensive[/b]

Edie Bacon was willing to pay, so this wouldn't have been an issue.

Production capacity – drugs can be expensive and time-consuming to make, and until approved, capacity to manufacture the drugs may be limited

Bacon would not have required such a prohibitive amount of the drugs. There were drugs left over from the Boston tests, and since she was in Boston, it would have been easy for her to access them. Also, the doctors who participated in the Boston tests were available and expressed a willingness to help her.

Priorities – companies may want to use 'left-over' drugs for clinical trials in different illnesses

This is the only one that might apply here—but there's no evidence that this played into their decision.

Lack of efficacy – there may be little evidence that the drug may be effective for the specific illness

That certainly wasn't the case with ET-743.

The FDA generally supports requests for compassionate use if the patient has exhausted standard treatment options and is ineligible for clinical trials. However, if the FDA is aware of safety issues that may foreshorten a patient’s life the FDA may refuse the patient’s application. This is a rare occurrence.

Since her prognosis at the time was death within a year or two, and safety testing had already concluded that there were no deleterious effects for ET-743 in that time period, this exception obviously didn't apply either.

n cases where a patient cannot be enrolled in an existing protocol because of some factor that makes the patient ineligible to participate in the study, research sponsors or investigators often can make a protocol exception to treat such a patient. The data from that patient would not be part of the report of the original study.

Just like I said. So, why don't they seem to be practicing what they preach?

The FDA's True Policy on Experimental Drugs

Do you have a link for that? I did a Google search on the title and came up empty.

The FDA, categorically, does not attach special significance to adverse events reported from such expanded access programs as Ms. Bacon has tried to join. We recognize that these programs involve less-controlled use of new drugs, and we assess the reported data accordingly. The development of a new medication is not slowed by side effects occurring outside clinical trials.

...So far, 67 patients have been given outside-trial access to ET-743, the drug that Ms. Bacon wants to use.

Which begs the question: Why can't she get it?

[shanek]

Originally posted by Thanz
In case you didn't know, in Ontario

I've said many times before I'm unfamiliar with the Canadian system. I've been arguing on a US-specific basis (since the FDA is specific to the US). Only now do you lay it on me that this was in another country—and then accuse me of not knowing what I'm talking about!

CAN THE DISHONESTY!!!

Besides, my understanding is that medicine in Canada is regulated to a far greater degree than it is in the US. If all those regulations didn't stop it then, how are more regulations in the US going to prevent it?

Also, civil juries are rare.

Maybe if they were commonplace, like they are here, there would have been a greater threat. Only now do you bring this imprtant information to light. Pathetic.

How the hell does it not matter? What makes you think that a corporation, in the legal wrong, will think that it can overcome the legal wrong but somehow get caught by jury nullification? This makes absolutely no sense whatsoever.

It DOES make sense to anyone who actually wants to think about it for more than a nanosecond! It's harder to get through two obstacles than one! If you don't understnad that, why don't you go back to first grade for some remedial math skills?

Let's keep this real simple, as you seem to have problems understanding the very basics.

:rolleyes:

The corporation has nothing to fear from nullification, but they have everything to fear from the law itself.

You are, as you admit, arguing from a very simplitic viewpoint—and that's exactly why it's invalid! In our court system today, it's often not known exactly what is or isn't legal until you go to court and get a ruling!

Nullification is simply NOT A FACTOR when the corporation is in the wrong.

But again, the problem is that until you get a decision one way or the other in a court of law, it's often hard to tell who's in the wrong! (Legally speaking, of course, which I assume is how you meant it.)

[snip Thanz saying the exact same thing over and over and over again]

Further, in civil cases, I don't agree that nullification is appropriate in any event. Why should a private party have to justify the law everytime they act in accordance with it and want to enforce it?

Because that's the way it's supposed to work. That's the last line of defense against bad laws. The jury is supposed to determine which laws are bad or not; what you propose is making the decision before the jury does.

If this was before a jury, they would nullify all the time. That doesn't make it right or just. Laws are made by the duly elected legislative branch of government. They should not be ignored willy-nilly.

This attitude shows that you don't understand the first thing about the trial by jury system. Yes, the jury always has the option of ignoring the law if they feel that would deliver the most just result!

I also notice you ingore any discussion of the FACTS you have dishonestly labelled "bulls--t lies".

I stated exactly what they referred to. And you apparently have no answer for that except to insist that I must have been talking about something else. As I showed in my last post to you, those statements I was referring to are in no way statements of fact. They were personal insults, and you knew at the time they were untrue.

Your argument does not preclude you from having to address it at all.

All I have to do is who why it is irrelevant, which I did.

I have shown you that the profit motive causes them to make bad decisions about drugs and do underhanded things.

And I have shown you that they only do that when they think they can get away with it. That's hardly irrelevant, yet you insist that it is and that "profit" is the only motive that the BECs understand. Anyone who's ever worked at one knows that is far from the truth. Companies often sell at a loss, or donate to charities, or do other things that result in fewer profits. They do so because they know that their image and their customer satisfaction will make them longer-term profits in the future. Yet, you've insisted several times that long-term thinking is not the problem.

Do you even realize that this makes my argument, not yours?

Considering that has been my argument from the beginning, this is obviously nothing more than another pathetic attempt at hand-waving on your part.

The question is, why is it more profitable? Why is the motive there? Why is it worth the risks? These are the questions you REFUSE to acknowledge!

Dude, your links don't have much weight with me.

Well, so much for the open-minded...

They are just assertions from pro-nullification activists such as yourself.

Yep: Insult the source. Knew it was coming. You truly are the lowest of the low.

Yes, those terrible, horrible, biased people like Thomas Jefferson, John Adams, Oliver Wendell Holmes, Lysander Spooner...

Of course, in the examples I posted, the government was not one of the parties.

It doesn't have to be. Just because you found one quote that implied otherwise (from a source you admitted you disagreed with) does not invalidate the concept of nullification. But do some more quote mining; I'm sure it'll help you avoid having to think about the issue.

You haven't refuted it once!!!! You haven't even addressed it!!!

YOU FSCKING LIAR!!! YOU RESPONDED TO MY REFUTATIONS!!!! Several paragraphs in this very post are me responding to what you said about it!!!!!

:mad:

And even if you have proof of this assertion, why does Ford get a free pass because they can point to some regulation that lessens profit?

I never said they did. In fact, I have stated many times, including in this thread, that corporations should be responsible for their actions. Do you lie on purpose, or is it pathological?

I said that were it not for government interference in the first place, the profit motive would not have been there at all and the whole fiasco would not have happened.

So, I will not be answering any more of your questions. Not until you show a modicum of honesty and stop deliberately misrepresenting my position.

[Mahatma Kane Jeeves]

Originally posted by shanek
Just like I said. So, why don't they seem to be practicing what they preach?

I don't think Ms. Bacon's original editorial provides enough information to determine exactly what happened here. All we have is the company's claim (2nd hand through Ms Bacon) that the FDA wouldn't allow it.

However the process doesn't even work that way. It is the patient who gets the approval through the FDA not the company (assuming that the company is providing expanded access).

Also, the editorial makes it sound like J&J thought the FDA wouldn't allow any access at all to the drug, meanwhile other people are already getting it!

Originally posted by shanek
Do you have a link for that? I did a Google search on the title and came up empty.

No link. Library. :)

Originally posted by shanek
Which begs the question: Why can't she get it?
I have no idea. Was it the company?, the FDA? or some communication mixup between all parties? I do find it particularly telling, though, that 2 years before this incident an FDA article says "Companies sometimes say that they cannot make the drug available to a patient because FDA won't allow it, but that is rarely true. " It sounds like companies regularly scapegoat the FDA to avoid bad feelings/publicity. But as to what actually happened, I dunno.

[shanek]

Originally posted by Mahatma Kane Jeeves
I don't think Ms. Bacon's original editorial provides enough information to determine exactly what happened here.

Given the new information you brought into your earlier post, and after thinking about it awhile, I have to say I agree.

No link. Library. :)

Unfortunately, the amount of personal time I have for doing research isn't as available as it used to be.

[Thanz]

shanek - If I misrepresent your position, it is not in any way a lie or a deception. I simply post what I understand your arguments to be. If I am incorrect in my understanding of your motives or arguments, I apologize. I just call 'em as I see 'em.

Also, if I am wrong, you have shown that you are quite capable of telling me where I have it wrong. I am getting a little upset at your insistence in calling me a liar for this. When I reply to your posts, I try and include all of what I am replying to. I have only cut out some extraneous "taste great! less filling!" stuff. If that is wrong, you can point that out too.

On the other hand, you seem to chop up my arguments to respond to portions of them, when the stuff I am really arguning about gets left behind. For example, it was clear from one of my posts that I wanted to know why you said that the only reason Ford decided to not put on the safer tank was because of the classification scheme. You angrily responded by showing me a source that said they had the safer tank, which is nice as far as it goes, but doesn't address WHY it wasn't used. Which you still haven't provided.

I'll specifically address some of the stuff from your last post, then try and summarize my entire argument in the replies and at the end. I am hoping that this can get us back on track, as I think we have lost some signal in the noise.

Originally posted by shanek
I've said many times before I'm unfamiliar with the Canadian system. I've been arguing on a US-specific basis (since the FDA is specific to the US). Only now do you lay it on me that this was in another country—and then accuse me of not knowing what I'm talking about!

CAN THE DISHONESTY!!!

Besides, my understanding is that medicine in Canada is regulated to a far greater degree than it is in the US. If all those regulations didn't stop it then, how are more regulations in the US going to prevent it?

Maybe if they were commonplace, like they are here, there would have been a greater threat. Only now do you bring this imprtant information to light. Pathetic.
There is no dishonesty here. I realize that in a debate that takes place in such a disjointed fashion over several days, some things may be forgotton. However, the fact that the Apotex matter was in Canada was revealed in the very first post I made on it. The article I linked to was very clear that it was Canadian, and the portion I quoted referred to "University of Toronto clinician Dr. Nancy Olivieri". Also, if you look back to my first reply on June 4, I refer to the Canadian status of the Apotex matter AND that civil juries are rare. You even quoted and responded to this paragraph.

So, don't tell me I am being dishonest and say "Only now do you bring this imprtant information to light. Pathetic." It was never hidden, and I referred to it twice before. It is also beside the point, as I will explain later.

It DOES make sense to anyone who actually wants to think about it for more than a nanosecond! It's harder to get through two obstacles than one! If you don't understnad that, why don't you go back to first grade for some remedial math skills?
My math skills are just fine. The problem is, as I have tried to explain, there are not two obstacles. In the examples I have posted, there is only one. I will try to explain again.

Jury nullification is used when the jury disagrees with the law itself, such as slavery and anti-union laws, or when the penalty is too severe, such as death for pickpockets. In cases where jury nullification is a tool, the application of the law to the facts is not in any serious doubt. It is usually a case where the facts are very clear, and the application of the law to those facts inevitable. For example, a street urchin is brought in for picpocketing. The victim felt the kid pick his pocket, and the police caught the kid with the victim's watch in his hands. There is no doubt that the kid picked the man's pocket. However, the law says that if convicted, this kid will be hanged. The jury doesn't htink the kid deserves to be hanged, so they acquit the kid. This is a classic case of nullification and leads to the laws regarding punishment of pickpockets to be changed.

In the Apotex matter, however, the application of the law to the facts was not inevitable. It was in dispute. The inquiry found in favour of the doctor. In cases where the law is not clear, and it cannot be predicted ahead of time with any certainty, the jury will simply render a verdict on the side it feels is more just. This is not nullification. If in the pickpocket case the evidence was circumstantial and left room for reasonable doubt, a jury verdict of not guilty would not be nullification - it would be simple "reasonable doubt".

So, in a case where the application of the law to the facts is not clear, nullification simply doesn't exist. You never get to that stage, as the jury will be deciding between two different arguments within the law. Whichever way they go will be within the law, and they will determine which argument is more just. There are not 2 obstacles, there is only one - convinving the jury that your argument is correct. That is why the existence or non existence of nullification makes no difference in the examples I posted.

I have [snipped] the other stuff on nullification, in the hopes that these paragraphs make my position clear. If there is something you feel I haven't addressed and want me to, let me know. I will not, however, get into a debate (at least here) about whether nullification itself is either "Good" or "Bad". I think my position is clear that it doesn't matter when the law is uncertain.

I stated exactly what they referred to. And you apparently have no answer for that except to insist that I must have been talking about something else. As I showed in my last post to you, those statements I was referring to are in no way statements of fact. They were personal insults, and you knew at the time they were untrue.
I am not really sure I understand this response. Here are the two paragraphs that you snipped, with the statement "[more bulls--t lies deleted]" I have added some emphasis for ease of reference. The inquiry found in favour of the doctor's legal arguments that the clause DID NOT prevent disclosure. The doctor was certainly NOT helpless without jury nullification, and in fact would have prevailed without it. There is no need for nullification here, and the only reason you keep bringing it up must be to distract from the fact that you still haven't addressed the motivations of the corporation.

MY deluded little world? Please. Court costs, etc. may have been part of the reason that the corporation chose the TACTIC of threatening a lawsuit. It does not address the main behaviour, however - the desire of the corporation to bury adverse test results and prevent the disclosure of harmful side effects - even to the sick children who took the drug. The court system has nothing to do with this underlying decision, which you have still failed to address.
The bold portion in the first paragraph cannot be interpreted as a personal insult. It is a recitation of the FACTS of the Apotex matter. The italized portion is what I am assuming you have taken as a personal insult. If you were offended, I apologize. But it seemed to me that you were (and still are) making a number of arguments that do not directly address the points I am making - like some sort of argument smokescreen.

As to the second paragraph, I am at a loss to see either the bulls--t lies or the personal insult. In response to this you said that the lie is that your argument precludes you from having to address it. Obviously I disagree with that, but even if it were the case it does not make pointing out that you have failed to address an argument a "lie". All you have done is agreed that you haven't addressed it, but provided an attempt at some justifcation for your refusal to address it.

All I have to do is who why it is irrelevant, which I did.

And I have shown you that they only do that when they think they can get away with it. That's hardly irrelevant, yet you insist that it is and that "profit" is the only motive that the BECs understand. Anyone who's ever worked at one knows that is far from the truth. Companies often sell at a loss, or donate to charities, or do other things that result in fewer profits. They do so because they know that their image and their customer satisfaction will make them longer-term profits in the future. Yet, you've insisted several times that long-term thinking is not the problem.

Considering that has been my argument from the beginning, this is obviously nothing more than another pathetic attempt at hand-waving on your part.

The question is, why is it more profitable? Why is the motive there? Why is it worth the risks? These are the questions you REFUSE to acknowledge!
These paragraphs and questions go to the heart of the argument, and I will address them at the end in my summary.

Well, so much for the open-minded...

Yep: Insult the source. Knew it was coming. You truly are the lowest of the low.

Yes, those terrible, horrible, biased people like Thomas Jefferson, John Adams, Oliver Wendell Holmes, Lysander Spooner...
Again, you misrepresent what I am asking about and what sources I am "insulting". I am disputing the claim that it was corporate lobbying that led to the decision in Sparf. None of the people you quote here (Jefferson, Adams, Holmes, Spooner) said anything like that. It was clear from the part you snipped what I was interested in:They all fail to mention that the Sparf case was a murder trial - nothing to do with corporations. It may be true that corporations at the time weren't too happy about nullification. But you'll need to show me more evidence than that to convince me that corporate lobbying had an effect on the decision of the Supreme Court in a murder case.
So, I ask again, do you have any evidence that the Supreme Court of the United States based its decision in a murder trial (with the death penalty on the line) in any way on the lobbying of corporations? Any quote you have that says this from esteemed individuals like Holmes would do. A quote from Holmes espousing the greatness of nullification is not such evidence.

I do not think that I am "the lowest of the low" for not accepting that the Supreme Court let its decision in a murder case be influenced by corporate lobbying. In fact, I am defending the integrity of your highest court.

YOU FSCKING LIAR!!! YOU RESPONDED TO MY REFUTATIONS!!!! Several paragraphs in this very post are me responding to what you said about it!!!!!
When I say that you haven't refuted it, I mean that you have made no arguments on point that are convincing. In fact, your argument is that you don't have to address my points for some reason - because the government lets them get away with it. This is not a refutation - it is an attempt to steer the argument away from the central issue.

[re:Ford Pinto] I never said they did. In fact, I have stated many times, including in this thread, that corporations should be responsible for their actions. Do you lie on purpose, or is it pathological?

I said that were it not for government interference in the first place, the profit motive would not have been there at all and the whole fiasco would not have happened.
So, Ford is responsible for its actions. They could have decided to put the safe gas tank on, or to not even release the car. What I don't understand is why even mention the government regulations?

You say that without the regulations, the profit motive wouldn't have been there at all. First, you still have not provided any evidence to back up your assertion that the only reason Ford did not put the safer tank on was because of the classification scheme. I have asked you several times, still nothing.

Next, I disagree that without the regulation the profit motive would not have been there. The reason they did not put the safer tank on was it would be more expensive. More expensive = less profit. The motivation is the same with or without the classification. The classification scheme did not create the profit motive.

Your insistence on blaming the classification scheme led me to think that you were giving Ford some sort of free pass. That you felt that Ford could be excused somehow, because of the actions of the government. If that is incorrect, I apologize.

This leads into the main argument. You have asserted that the profit motive is enough incentive for drug companies to refrain from bad behaviour, such as releasing harmful drugs, or drugs that do not do what they claim, or lack of proper testing so that the true effects of the drug are really unknown.

My response has been that the behaviour we see exhibited by corporations does not bear this out. The examples I have provided are Pan Pharmaceuticals, Apotex and Ford. Your response to these examples (actually, you still have not commented on Pan) has been to point out various ways in which government action or inaction may have enabled this behaviour. Such a response, however, fails to actually address the behaviour. You state "And I have shown you that they only do that when they think they can get away with it. That's hardly irrelevant, yet you insist that it is and that "profit" is the only motive that the BECs understand."

There is a fundamental disconnect between those two sentences. First, let's address the "get away with it" aspect. Whether or not a corporation thinks it can get away with something does not excuse the behaviour. A murderer who thinks he can get away with it is still a murderer. It also doesn't address the murder itself - the person doesn't kill because he thinks he can get away with it, he kills for some other reason - money, jealousy, revenge, whatever.

Let's look at each example. Pan faked some test results, and also put out pills that varied in strength in huge amounts. It did this because to do otherwise would result in less profit. They were caught by the government, and are now being punished. There is no case of the government letting them get away with anything here. All it is is a corporation behaving badly in the name of profits.

Apotex tried to bury test results, possibly endangered the health of children and threatened a doctor with a lawsuit. The reason they did this was to protect the name and reputation of a drug they were developing, so that they could sell it for higher profits. They did not do this because of a lack of jury nullification. They did not do it because the government let them get away with anything. Again, the inquiry determined that they were in the wrong. They may have chosen tactics that they felt they could get away with, but this turned out to be false. And the choice of tactics does not do anything to address the reasoning behind the decision to employ any tactics at all: they chose to endanger the health of children to protect future profits.

I have addressed Ford above.

The logical extension to your argument would be that if the government is letting this bad behaviour happen, we need more government intervention to prevent it from happening. Yet your actual arguments (and political philosophy) seem to go against this.

I argue that without the FDA liscensing drugs, we will see more behaviour like that of Pan and Apotex, because without the rigours of testing being imposed on them they will feel that they can get away with less testing, more bad behaviour, and more profits. To take an example from this thread - if there were no testing requirements, the company may have started to market endostatin earlier. Your argument is based on the fact that they didn't do this (re: number of deaths). yet, testing has shown that the drug is NOT as effective as it was originally thought. Those who switched to endostatin may have forgone other therapies that would be more effective for them, costing lives.

It is my argument that agencies like the FDA prevent bad behavior by corporations because they cannot "get away with it" as easily as if it were not there. The profit motive is not enough to prevent this bad behaviour, as the examples have shown.

[shanek]

Originally posted by Thanz
shanek - If I misrepresent your position, it is not in any way a lie or a deception. I simply post what I understand your arguments to be. If I am incorrect in my understanding of your motives or arguments, I apologize. I just call 'em as I see 'em.

The problem is, you continue to "see 'em" how you want even after I point out the opposite!

Yes, people can get things wrong. People can misunderstand. But when you continue to misrepresent someone's position after this has been pointed out, that becomes a lie!

My math skills are just fine. The problem is, as I have tried to explain, there are not two obstacles.

Not currently, no. But again, I have been saying this all along.

In the Apotex matter, however, the application of the law to the facts was not inevitable. It was in dispute. The inquiry found in favour of the doctor. In cases where the law is not clear, and it cannot be predicted ahead of time with any certainty, the jury will simply render a verdict on the side it feels is more just. This is not nullification.

What you're ignoring that, at least in the US (which is the country the FDA is in, and hence the only country that matters to this discussion, so I reiterate the irrelevance in bringing a Canadian example into it to begin with), the judge would have made a finding of law beforehand and given that to the jury. If that finding of law showed the doctor to be within his rights, then no, it wouldn't be nullification. But if the judge had ruled the law in favor of the corporations, the jury would have to have exercised their power of nullification to acquit the doctor. Since defense lawyers are now prohibited from arguing nullification, and since judges are telling juries they do not have the right to judge the law, then unless they were unusually informed or enlightened they would not have realized that they could deliver a verdict of "not guilty" because they disagree with the law.

In other words, with nullification, they would have to persuade both the judge and the jury; without nullification, only the judge.

Now is the point clear?

The italized portion is what I am assuming you have taken as a personal insult.

It was. It was a direct and unfounded accusation that I was merely trying to distract from your arguments/

If you were offended, I apologize. But it seemed to me that you were (and still are) making a number of arguments that do not directly address the points I am making - like some sort of argument smokescreen.

Well, I really don't know how many more ways I can explain it... I don't have to refute your explanation of why the sky is green if I point out that the sky isn't green to begin with!

As to the second paragraph, I am at a loss to see either the bulls--t lies or the personal insult.

It was, again, in the direct implication that I was being evasive in not responding to your direct argument, when as I continue to point out is made entirely irrelevant by my points, which you continue to ignore!

All you have done is agreed that you haven't addressed it, but provided an attempt at some justifcation for your refusal to address it.

You really are the king og BS, aren't you? :rolleyes:

So, I ask again, do you have any evidence that the Supreme Court of the United States based its decision in a murder trial (with the death penalty on the line) in any way on the lobbying of corporations? Any quote you have that says this from esteemed individuals like Holmes would do.

Can you give me any indication that it would be worth the amount of personal time I would have to take in order to come up with such?


When I say that you haven't refuted it, I mean that you have made no arguments on point that are convincing. In fact, your argument is that you don't have to address my points for some reason

Because they are made irrelevant by my point. Let's summarize our positions:

Your position: The corporation did something evil and should be held responsible.

My position: The corporation did something evil and should be held responsible, but they were only able to do so because of actions of the government, which also should be held responsible, and the government actions that enabled the corporate actions in the first place should be abolished.

Since we both agree that corporations should be held responsible for their actions, the only possible point of contention here is whether or not the government should be, too. And obviously, you want the government to get away with it all. If you didn't, you wouldn't be disagreeing with me.

Next, I disagree that without the regulation the profit motive would not have been there. The reason they did not put the safer tank on was it would be more expensive. More expensive = less profit.

Man, you don't know the first thing about economics, do you? Companies take measures that make their products more expensive to make all the time—with increased profits.

The logical extension to your argument would be that if the government is letting this bad behaviour happen, we need more government intervention to prevent it from happening.

No, it means we need to get rid of the government intervention allowing it in the first place!

[Thanz]

Originally posted by shanek
[snip]

Now is the point clear?
No. You seem to be importing criminal procedure into a civil case. Perhaps an american lawyer could confirm that the procedure in a civil case is how you describe.

It was. It was a direct and unfounded accusation that I was merely trying to distract from your arguments.
I don't think that it was unfounded. you still haven't addressed the facts that you called lies, or even apologized for implying that they were lies.

Can you give me any indication that it would be worth the amount of personal time I would have to take in order to come up with such?
I'll take that as a "No, I can't support the statement one iota and am talking out my @ss, just like the regulations are to blame for the Pinto, which I also can't support, despite claiming that I have solidly refuted the Pinto case several times."

Because they are made irrelevant by my point. Let's summarize our positions:

Your position: The corporation did something evil and should be held responsible.

My position: The corporation did something evil and should be held responsible, but they were only able to do so because of actions of the government, which also should be held responsible, and the government actions that enabled the corporate actions in the first place should be abolished.

Since we both agree that corporations should be held responsible for their actions, the only possible point of contention here is whether or not the government should be, too. And obviously, you want the government to get away with it all. If you didn't, you wouldn't be disagreeing with me.
This is what you see my position as? You ARE either deliberately evasive or immensely stupid. I do not see you as stupid, so you must be evasive.

This whole argument started with your assertion that companies would not be selling snake oil because of the profit motive. I posted examples of where the profit motive provided incentives to bad behaviour that the corporation acted upon. The argument is not about how the wrongdoers should be punished, or whether government regulations tacitly permitted certain tactics, no matter how hard you try to make it so. The argument is about preventing the behaviour in the first place: Which does a better job - requiring testing done under the FDA, or just leaving it up to the marketplace and hope the profit motive sorts things out. I think my examples have shown the perverse incentives provided by the profit motive.

No amount of complaining about the government will change the fact that corporations do bad things to try and get higher profits. Removing the FDA will do nothing to change these incentives. Eliminating the FDA will not suddenly make corporations not do evil things - if anything, it will increase the opportunities for corporations to do evil things.

This is all very clear from my last post, which contained this:I argue that without the FDA liscensing drugs, we will see more behaviour like that of Pan and Apotex, because without the rigours of testing being imposed on them they will feel that they can get away with less testing, more bad behaviour, and more profits. To take an example from this thread - if there were no testing requirements, the company may have started to market endostatin earlier. Your argument is based on the fact that they didn't do this (re: number of deaths). yet, testing has shown that the drug is NOT as effective as it was originally thought. Those who switched to endostatin may have forgone other therapies that would be more effective for them, costing lives.

It is my argument that agencies like the FDA prevent bad behavior by corporations because they cannot "get away with it" as easily as if it were not there. The profit motive is not enough to prevent this bad behaviour, as the examples have shown.
How you can summarize this into "The corporation did something evil and should be held responsible." and claim that I am dishonest in my representations of your arguments is baffling.

Man, you don't know the first thing about economics, do you? Companies take measures that make their products more expensive to make all the time—with increased profits.
Ah, yes. Another shining example of the shanek debating style. Pick a statement out of a long section, then make a non-argument about something that wasn't even in dispute, throwing an insult in for good measure.

But, I'll play along here. I do know about economics. Are you now saying that Ford could have made more money if they put the safe tank on? But they decided to blow people up and get less money? Is this your actual friggin argument? Or are you just trying to distract from the fact that you can't provide any backup for your assertion that government regs are to blame here?

The corporation did something evil and should be held responsible, but they were only able to do so because of actions of the government,

This was quoted above as well, but I want to specifically address it here. This statement is pure BS. The actions of the government had nothing to with the evil actions of the examples I posted. Nothing. Zip. Nada. Zero.

Maybe, just maybe, you can finally address Pan Pharmaceuticals. What government action caused them to lie about assay results? To produce pills that varied as much as 700 times in dosage from pill to pill?

What government action caused Apotex to threaten a doctor with a lawsuit, attempt to smear her reputation, and endanger the health of children? To say the lack of jury nullification is the absolute worst argument I have ever seen. The FACTS, which you have ignored time and again, show that the company was wrong on the law.

We know what government action you say caused Ford to decide to blow people up - what we don't have is anything to support your assertion. You said the ONLY reason was the classification scheme. So far, you haven't provided any backup to show that it was even ONE reason.

Where is your evidence? Show me how the government CAUSES all of these things. I say the reason is simple - they think they can make more money by doing it. We are trying to prevent the bad behaviour before it hurts people. Profit doesn't do it.

[Skeptic]

Companies sometimes say that they cannot make the drug available to a patient because FDA won't allow it, but that is rarely true.

So, first the drug companies falsely scapegoat the FDA for "refusing" to let them give unapproved drugs to patients, when in reality it is they themselves who refused to treat patients with unapproved drugs for their own reasons.

Then, their lobbyists use this "evil FDA" excuse as part of an emotional appeal to try and get rid of the FDA altogether, with its annyoing insistence on independent, high-quality testing for safety and efficiency.

Gee... you mean the drug companies lied to the public???

Who would have guessed???

Not that this is any reason not to trust them to be perfectly honest with all the claims they would make about the safety and efficiency of their drugs, mind you. They won't lie just to make some money AGAIN, now would they?

[shanek]

Originally posted by Thanz
No. You seem to be importing criminal procedure into a civil case.

No, you still have a jury in a civil case. The major difference is that the standard of guilt is lower in civil cases than criminal. In a criminal case, the jury must find the defendent guilty "beyond a reasonable doubt." In a civil case, they can find a jury guilty, in many states, by the "preponderance of evidence." In NC, it's the "greater weight of the evidence;" IOW, if there's more evidence against the defendant than for him they must convict.

None of this has anything to do with jury nullification. Were jury nullification in place, they would still have the option of finding in favor of the defendant, regardless of the evidence, if they didn't think the action warranted such a response. It might be a bit dicey as far as findings of compensatory damages, since the only question there is should the defendant pay for the damages, but it certainly makes the difference as far as punitive damages are concerned.

I don't think that it was unfounded. you still haven't addressed the facts that you called lies, or even apologized for implying that they were lies.

I explained which items I was referring to, and why they were lies. And yet, you keep trying to pretend that I was referring to other sentences.

[foaming rhetoric delted]

I'll take that as a "No." :rolleyes:

This is what you see my position as? You ARE either deliberately evasive or immensely stupid. I do not see you as stupid, so you must be evasive.

That is the only logical take on your position, since if it were any other position you would not be in disagreement with me.

The argument is about preventing the behaviour in the first place: Which does a better job - requiring testing done under the FDA, or just leaving it up to the marketplace and hope the profit motive sorts things out.

How many times do I have to point out this is a false dichotomy? How many times are you going to DELIBERATELY misrepresent the options??? :mad:

Besides, WE WEREN'T TALKING ABOUT THE FDA AT THAT POINT!!! WE WERE TALKING ABOUT YOUR EXAMPLE!!!! You know, the one you claim I keep ignoring? I guess it's easier for you to keep claiming that if you pretend we were talking about something else...


Ah, yes. Another shining example of the shanek debating style. Pick a statement out of a long section, then make a non-argument about something that wasn't even in dispute, throwing an insult in for good measure.

Since that premise was blatantly false, and your entire argument was based on that, refuting the initial premise was all I needed to do.

Are you now saying that Ford could have made more money if they put the safe tank on?

Without the penalties they would incur by being over-priced, most likely. It's called a "risk/benefit" analysis. The profits they would have made from making a safer car (even if it did cost a bit more—remember that that cost would have been passed on to the consumer, and not represented a loss of profits as you so heavily imply) were nullified, so the potential profits of the cheaper gas tank even in the face of possible safety issues became greater and won out.

[more blather deleted]

[more stuff about the other example deleted]

Y'know, it just occured to me that you're demanding a lot more evidence from me about the Pinto than you've ever presented in this example...which, again, DIDN'T EVEN TAKE PLACE IN THE US!!!!!

[g]We are trying to prevent the bad behaviour before it hurts people.[/B]

Obviously aren't doing a very good job of it...

[shanek]

Originally posted by Skeptic
So, first the drug companies falsely scapegoat the FDA for "refusing" to let them give unapproved drugs to patients, when in reality it is they themselves who refused to treat patients with unapproved drugs for their own reasons.

Then, their lobbyists use this "evil FDA" excuse as part of an emotional appeal to try and get rid of the FDA altogether, with its annyoing insistence on independent, high-quality testing for safety and efficiency.

Gee... you mean the drug companies lied to the public???

Who would have guessed???

And, of course, government agencies have never, ever, ever lied...Oh, no.... :rolleyes:

[Thanz]

Originally posted by shanek
That is the only logical take on your position, since if it were any other position you would not be in disagreement with me.
Should I pull a shanek and call this a lie? No, I just think that your are deluded. It is not the only logical take on my position, as it is not my position - at least not my whole position. My position is, and has been throughout this thread, is that corporations cannot be trusted not to cut corners, market snake oil or hide adverse test results by the forces of the market alone. They need to be forced by government supervision in this area.

Thanz: The argument is about preventing the behaviour in the first place: Which does a better job - requiring testing done under the FDA, or just leaving it up to the marketplace and hope the profit motive sorts things out.

shanek: How many times do I have to point out this is a false dichotomy? How many times are you going to DELIBERATELY misrepresent the options???
No, it is not a "false dichotomy". The two options are, as I see them, FDA (or equivalent) oversight or a market based solution. The only market based solution other than simple corporate testing that has been suggested is some sort of voluntary UL type body or oversight from insurance companies.

First of all, if the UL body was voluntary, there is no one forcing any company to use it. They could bypass the system altogether and put out a drug that has severe unknown side effects, or does not work as claimed.

Second, as I have already pointed out, there are no incentives for a UL type body or insurance company to do any testing that is less rigorous or time consuming than that mandated by the FDA. Fear of lawsuits will keep the testing protocols the same, if not more cautious. There is no threat of a lawsuit for delay of a drug under any system as no one has a duty to the consumer to sell them any particular drug or to approve any particular drug for use within any time frame.

In one of the early posts in this thread, you stated:AUP: It means they will try to put drugs on the market that don't necessarily measure up.

shanek: If they do that, they will lose credibility as a drug company and doctors will be less likely to prescribe or recommend their drugs to their patients. Again, covered in the article.

Their business is helping people and saving lives. The better job they do of that, the better their profits. Don't think for a minute that they don't know that.
I have shown by my examples that corporations do not behave as you think they will behave. Sometimes, they yield to the temptation of short term profits over long term strategy. If you remove mandatory testing, you increase the temptation for these corporations and more will yield. If the market behaved in the way you assume, we would not have seen the behaviour of Pan (still ignored by you) Apotex or Ford.

Since that premise was blatantly false, and your entire argument was based on that, refuting the initial premise was all I needed to do.
First, it wasn't blatantly false. if they put the tank on, and sold at the same price, the higher cost would reduce profits. Next, the entire point was that the tank ws not put on in order to increase profits. That is the point - they blew people up for money.

Without the penalties they would incur by being over-priced, most likely. It's called a "risk/benefit" analysis. The profits they would have made from making a safer car (even if it did cost a bit more—remember that that cost would have been passed on to the consumer, and not represented a loss of profits as you so heavily imply) were nullified, so the potential profits of the cheaper gas tank even in the face of possible safety issues became greater and won out.
You have failed to produce even one scrap of evidence for this claim (that regs are the reason for the unsafe tank going on), despite claiming you have refuted the Pinto case several times and despite being asked for it several times. Unless you can back it up, I have no choice to conlcude that you are simply wrong. Whether your insistence on continuing this line of argument constitutes a lie given your lack of any evidence, I leave up to your conscience.

Y'know, it just occured to me that you're demanding a lot more evidence from me about the Pinto than you've ever presented in this example...which, again, DIDN'T EVEN TAKE PLACE IN THE US!!!!!
I am simply asking you to back up your claims on the Pinto. You haven't asked me for any other information on my examples. Also, it doesn't matter that it didn't take place in the US - it is presented as an example of bad corporate behaviour, which you argue shouldn't take place because of market forces. It is presented to show that it does take place.

[shanek]

Originally posted by Thanz
Should I pull a shanek and call this a lie? No, I just think that your are deluded. It is not the only logical take on my position, as it is not my position - at least not my whole position. My position is, and has been throughout this thread, is that corporations cannot be trusted not to cut corners, market snake oil or hide adverse test results by the forces of the market alone. They need to be forced by government supervision in this area.

But that is EXACTLY WHAT I SAID IT WAS!!!! :mad:

The difference is, I think only the wrongdoers should be punished; you think everybody should be! Guilty until proven innocent—no, strike that! You won't even give them a way to prove themselves innocent and be freed of government force!

No, it is not a "false dichotomy". The two options are, as I see them, FDA (or equivalent) oversight or a market based solution.

You specifically said "hope the profit motive sorts things out." That DOES NOT describe a UL-like solution! Nor does it describe insurance company oversight. BOTH of those would easily act as effective checks on the deleterious effects of the unfettered profit motives, especially when coupled with the ability to hold the drug companies legally responsible for any deaths caused by their product.

First of all, if the UL body was voluntary, there is no one forcing any company to use it. They could bypass the system altogether and put out a drug that has severe unknown side effects, or does not work as claimed.

And how many people would trust it? Why don't electronic manufacturers bypass the UL listing and release unsafe electronic products that electrocute people? Because manufacturers want that independent, trusted certification that says their product is safe.

Second, as I have already pointed out, there are no incentives for a UL type body or insurance company to do any testing that is less rigorous or time consuming than that mandated by the FDA.

I've refuted this so many times it's ridiculous...And yet, you come back saying the same thing over and over with no regard for that refutation.

I have shown by my examples that corporations do not behave as you think they will behave.

Not that I have refuted. And my refutations, and my counterarguments, have been completely disregarded by you.

Sometimes, they yield to the temptation of short term profits over long term strategy.

Your lie is in pretending that I ever denied this. Your lie is in pretending that my solution doesn't account for this. Your lie is in pretending that this in any way refutes my position AT ALL.

First, it wasn't blatantly false. if they put the tank on, and sold at the same price, the higher cost would reduce profits.

I've already shown why that's false. Higher cost does not necessarily lead to lower profits. You can either increase the price accordingly, in which case you just need the same number of people to buy at the higher price, or you sell it at a smaller markup, which means you need more people to buy it at that price. How do you do that? Increased demand. There is a greater demand for safe cars than for less safe cars, all other things being equal. That's why, as I have repeatedly pointed out, every single safety feature was put in voluntarily by the car manufacturers (with the exception of air bags, as I have already covered—you never did respond to that, by the way; how the only safety feature whose introduction and specification were mandated by government ended up killing people).

But, if the costs of increased regulation by having to move the vehicle up into a higher classification make the move so expensive it will not be covered by the increased demand resulting from a safer vehicle, then the move will not be made. It's as simple as that. Why you REFUSE to understand it offers no explanation other than a closed mind and a refusal to consider my argument.

I am simply asking you to back up your claims on the Pinto.

The levels of evidence you are requiring would necessitate me having to do several hours worth of research. That would take up all of my personal time for over a week! Why should I do that for someone who refuses to consider even my basic arguments? You haven't given me any reason to conclude that it would be well worth the time.

And again, I point out that you have not offered the same level of evidence for your side of the arguments.

You haven't asked me for any other information on my examples.

That's not the point. The point is, if you really felt that standard of evidence was what was required, you would have required it of the situations you mentioned and presented it here. But you easily accepted those arguments with far less evidence than you are demanding from me. This, again, is indicative of a closed mind who will not really be swayed by any level of evidence and it's not worth my time to go and do the research.

I'm sorry, but I've been burned like that here too many times. I've spent hours in the library and elsewhere gathering the information someone here said they required for proof, only to either ignore it or say it's not good enough after I presented that. I'm sick and tired of doing that. I've been burned by people like you too many times to go through it again.

Also, it doesn't matter that it didn't take place in the US

Yes, it does! We're talking about a US system under the US government with US regulations and US business practices! There are so many differences in all of these between the US and Canada that any comparison is completely invalid.

You still haven't answered one question, though: With all of the extra government controls Canada exercises over this, why didn't they prevent it? If government force is such an effective control, why didn't it control in this case?

[Thanz]

Originally posted by shanek
But that is EXACTLY WHAT I SAID IT WAS!!!! :mad:

The difference is, I think only the wrongdoers should be punished; you think everybody should be! Guilty until proven innocent—no, strike that! You won't even give them a way to prove themselves innocent and be freed of government force!
Prevention is not punishment. Requiring drug companies to actually prove that their drugs are safe and effective is not punishment.

You specifically said "hope the profit motive sorts things out." That DOES NOT describe a UL-like solution! Nor does it describe insurance company oversight. BOTH of those would easily act as effective checks on the deleterious effects of the unfettered profit motives, especially when coupled with the ability to hold the drug companies legally responsible for any deaths caused by their product.
No, UL and insurance would not be as effective as the mandatory testing of the FDA as checks, simply because they are mandatory. The ability to hold drug companies responsible already exists. It would not be different under the private system. You need to convince me that UL + insurance will be as effective a deterrent against fraud as mandatory FDA testing. I don't believe it is, and you have not shown that it would be.

And how many people would trust it? Why don't electronic manufacturers bypass the UL listing and release unsafe electronic products that electrocute people? Because manufacturers want that independent, trusted certification that says their product is safe.
Maybe they do want it. But that doesn't mean that all will get it. Also, I don't know how many people actually look at electronic devices to see if they are UL certified or not. I was unaware of them until you kept bringing it up.

I've refuted this so many times it's ridiculous...And yet, you come back saying the same thing over and over with no regard for that refutation.
But your refutation makes no sense. You only point to bureaucratic delays or duplicate testing. This does not apply to all, or even the majority, of cases.

For example, Endostatin. The complaint was about the testing design used by the FDA - phase I for safety of endostatin alone, phase II for efficacy of endostatin alone. The complaint was that endostatin was shown to be more effective in mice when used in combined therapy sessions, which were down the road for endostatin at the time. I think that it is perfectly good science to determine what Endostatin does in humans BEFORE introducing it with other drugs, and I don't see why a UL type lab or insurance company deviating from the safety based cautious test design of the FDA.

I'm all for eliminating duplicate tests and bureaucratic delays. I just don't think that you need to eliminate the FDA to do that. And I'm not convinced that they would be eliminated under a private system that would be driven by fear of lawsuits for defective drugs, not fear of lawsuits for delay of potential drugs.

Not that I have refuted. And my refutations, and my counterarguments, have been completely disregarded by you.
Well, I have disregarded your counter arguments that were crap because, well, they were crap. Jury nullification is not a counter-argument to the bad corporate behaviour we have seen. You have no evidence on the Pinto, and still haven't even addressed Pan.

Your lie is in pretending that I ever denied this. Your lie is in pretending that my solution doesn't account for this. Your lie is in pretending that this in any way refutes my position AT ALL.
Yous "solution" does NOT account for this. How are you going to PREVENT a corporation from releasing a drug that does not do what it claims?

I've already shown why that's false. Higher cost does not necessarily lead to lower profits. You can either increase the price accordingly, in which case you just need the same number of people to buy at the higher price, or you sell it at a smaller markup, which means you need more people to buy it at that price. How do you do that? Increased demand. There is a greater demand for safe cars than for less safe cars, all other things being equal. That's why, as I have repeatedly pointed out, every single safety feature was put in voluntarily by the car manufacturers (with the exception of air bags, as I have already covered—you never did respond to that, by the way; how the only safety feature whose introduction and specification were mandated by government ended up killing people).

But, if the costs of increased regulation by having to move the vehicle up into a higher classification make the move so expensive it will not be covered by the increased demand resulting from a safer vehicle, then the move will not be made. It's as simple as that. Why you REFUSE to understand it offers no explanation other than a closed mind and a refusal to consider my argument.
Your entire argument is based on the claim that the regulations would have required the Pinto to be in a different classification if the safer tank were put on. This is what I have repeatedly asked you for evidence of. Unless you completely made it up, there must be some source for it. You calim to have refuted the Pinto several times. You must have this source somewhere. It is not a question of not understanding your argument or having a closed mind, it is a question of believing your underlying assumptions of fact - which I do not. Without a shred of evidence, why should I?

Your argument also ignores the idea that if Ford could not make a safe car (that is, one that doesn't blow up) and make a profit on it, maybe they shouldn't have released the car at all. Or at least warned people that if they bought the car and were rear ended, they might blow up. But Ford didn't do that. They just released the car and let people get blown up.

Don't you see the danger for drugs here? A company may decide that they don't want to do the level of testing that is typically required for a drug. The costs would not make the drug profitable. So, they do a cursory job and sell it to people knowing that they may be harmed by it. They don't warn them of the harm, of course. They just hope that they can settle the cases quickly and quietly. The fact that you REFUSE to see this as a reasonably likely scenario, given the instances of bad corporate behaviour we have seen, just shows that you have a closed mind.

The levels of evidence you are requiring would necessitate me having to do several hours worth of research. That would take up all of my personal time for over a week! Why should I do that for someone who refuses to consider even my basic arguments? You haven't given me any reason to conclude that it would be well worth the time.
You say that it would take several hours of research. Why? All I am asking for is your source for the claim. It had to come from somewhere. Or did you just make it up? BTW, I have considered your basic arguments. I just disagree that they are good arguments.

And again, I point out that you have not offered the same level of evidence for your side of the arguments.
I don't know what level of evidence you are requiring. You haven't asked me to clarify anything. I don't think that I have made any factual claim that I haven't supported. If I have, let me know. You, however, have made FACTUAL claims that are unsupported. I am just asking you to support the facts upon which your argument is based.

That's not the point. The point is, if you really felt that standard of evidence was what was required, you would have required it of the situations you mentioned and presented it here. But you easily accepted those arguments with far less evidence than you are demanding from me. This, again, is indicative of a closed mind who will not really be swayed by any level of evidence and it's not worth my time to go and do the research.

I'm sorry, but I've been burned like that here too many times. I've spent hours in the library and elsewhere gathering the information someone here said they required for proof, only to either ignore it or say it's not good enough after I presented that. I'm sick and tired of doing that. I've been burned by people like you too many times to go through it again.
Again, I don't think that I am "one of those people". I direct your attention to the Giving USA thread. In that thread we both provided evidence to back up what we are saying. I am still waiting for your further response on that thread, but I understand if you have been busy. Again, if you are concerned with any of the facts underlying my arguments, simply ask. I think that I have provided the facts to back up my position.

Yes, it does! We're talking about a US system under the US government with US regulations and US business practices! There are so many differences in all of these between the US and Canada that any comparison is completely invalid.
I disagree. I think that the profit motive and its effect on corporate decision making is quite similar in all free market based economies. I am addressing what corporations actually do in pursuit of profits, and I think that the similarities in this area outweigh the differences. To suggest that the comparison is completely invalid is simply incorrect.

You still haven't answered one question, though: With all of the extra government controls Canada exercises over this, why didn't they prevent it? If government force is such an effective control, why didn't it control in this case?
Prevent what? Unfounded accusations and threats by a corporation? Attempts by a corporation to bully a researcher into burying her findings? What you fail to grasp is that these were attempts. The company got caught. The research was published. The patients were informed. Seems pretty good to me.

[shanek]

Originally posted by Thanz
Prevention is not punishment. Requiring drug companies to actually prove that their drugs are safe and effective is not punishment.

BS. You're forcing them to behave a certain way AT THE POINT OF A GUN. It is force, it is agression. And it costs them billions of dollars. How is it NOT punishment?

No, UL and insurance would not be as effective as the mandatory testing of the FDA as checks, simply because they are mandatory.

Uh-huh. And maybe you also feel it's time to give that Prohibition thing another try? :rolleyes:

Programs that are mandatory aren't more effective. And most of them are less effective than other preventative measures that aren't based on aggression.

The bottom line is, UL works, and works well. Insurance oversight works, and works well. The FDA doesn't—unless you consider 200,000 corpses "working well"...

The ability to hold drug companies responsible already exists. It would not be different under the private system. You need to convince me that UL + insurance will be as effective a deterrent against fraud as mandatory FDA testing. I don't believe it is, and you have not shown that it would be.

I've given you many reasons why, but you refuse to consider any of them.

Maybe they do want it. But that doesn't mean that all will get it. Also, I don't know how many people actually look at electronic devices to see if they are UL certified or not. I was unaware of them until you kept bringing it up.

Check around your house. Toasters, hair dryers, whathaveyou. Even electrical tape. You'd be hard-pressed to find even one that doesn't bear the UL label. I am not responsible for your ignorance on this matter.

But your refutation makes no sense. You only point to bureaucratic delays or duplicate testing. This does not apply to all, or even the majority, of cases.

NO IT WASN'T!!!! THAT WAS A REBUTTAL TO THE ASSERTION THAT THE DELAYS WERE FOR THE SAKE OF "CAUTION"!!!!

I'm really getting sick and tired of having to clarify myself again and again around you... Aren't you even putting a modicum of effort into understanding what I'm saying?

Well, I have disregarded your counter arguments that were crap because, well, they were crap.

You have yet to show why.

Jury nullification is not a counter-argument to the bad corporate behaviour we have seen.

I've already explained why it is, and that explanation remains unrefuted by you.

You have no evidence on the Pinto,

I've presented as much evidence as you have for your examples. To do more would require such an intense outlay of personal time and it's obvious that it would be a waste to do so, since you ignore or misrepresent even the basics of my arguments!

and still haven't even addressed Pan.

BECAUSE IT HAPPENED OUTSIDE THE COUNTRY!!!! I said from the moment you let that be known that I didn't know enough about the Canadian system to comment!!!!

But you keep latching on this and whining: "WAAAAHHH He hasn't mentioned Pan!!!!" as if it's the only way you can justify your position!

My Ed man, what do you want me to do after admitting I didn't know enough about the Canadian system to be able to comment on it or refute it???? Stop being a baby.

Yous "solution" does NOT account for this. How are you going to PREVENT a corporation from releasing a drug that does not do what it claims?


Well, obviously the FDA isn't preventing it, either. You demand 100% prevention, which isn't realistic by anyone's measures. But it all goes to your black/white way of thinking. I keep going back to those 200,000 dead bodies...

Unless you completely made it up, there must be some source for it.

Well, you simply engaged in name-calling to all the source's I've posted. It's obvious that nothing less than a reference to the exact regulations will satisfy you (and little evidence that even that would), which would be a difficult task to find even on today's laws, much less laws that were in effect 40 years ago!

Your argument also ignores the idea that if Ford could not make a safe car (that is, one that doesn't blow up) and make a profit on it, maybe they shouldn't have released the car at all. Or at least warned people that if they bought the car and were rear ended, they might blow up.[/b]

You're acting like they knew about that at the time. They knew the tank wasn't as safe as the other, but no one knew until it happened what safety problems would manifest.

Don't you see the danger for drugs here?

Not to any greater degree than it exists now, no.

The fact that you REFUSE to see this as a reasonably likely scenario, given the instances of bad corporate behaviour we have seen, just shows that you have a closed mind.

Ha! You come up with one, maybe two examples, while I show example after example of the opposite effect happening, and you say I'M the one with a closed mind??? :rolleyes:

How about the fact that only one of the drug recalls in history was FDA-mandated? All of the other recalls were VOLUNTARY and INITIATED BY THE PHARMACEUTICAL COMPANY.

How about when Merck donated over a quarter of a billion doses of Mectizan (a drug quite successful at treating onchocerciasis, aka river blindness) to over 30 million people in countries where people suffering from this disease were too poor to pay for it? And at a time when no government could figure out a solution?

How about the fact that J.D. Rockefeller, a favorite whipping boy of the anti-corporate types, engaged in charitable acts that helped result in cures for malaria, tuberculosis, and diptheria? And contributed greatly to the discovery of penicillin? And this was after he had obtained his "monopolistic empire"?

How can you reconcile all of these facts and more with your assertion that, given half a chance, corporations will kill anyone for a buck?

[Thanz]

Okay, shanek, this has really gotten stupid. I don't think that anything more can be gained from us shouting at each other. I feel as though we are both beating our heads against a wall, and neither of us can understand why the other just doesn't understand. I, for one, feel as though we are going in circles and I hope that we can just agree to disagree on this issue and move on.

I hope that our experience on this thread will not hamper our ability to have reasonable, intelligent discussions on other threads.

If you are interested in discussing jury nullification in general, there is a thread that you may not have seen in banter called Jury Question (http://www.randi.org/vbulletin/showthread.php?threadid=21146) that may interest you.

I am still interested in continuing our discussion on charitable donations. I know that you have been busy, and if I am reading between the lines correctly you have other issues going on in your life that obviously are more important than an internet message board. But just so I know, do you intend to continue that other thread or are you just too busy/not interested enough?

[shanek]

Originally posted by Thanz
Okay, shanek, this has really gotten stupid. I don't think that anything more can be gained from us shouting at each other. I feel as though we are both beating our heads against a wall, and neither of us can understand why the other just doesn't understand. I, for one, feel as though we are going in circles and I hope that we can just agree to disagree on this issue and move on.

Fine with me.



Of course not. I don't hold grudges, and I don't get personal.

[b]If you are interested in discussing jury nullification in general, there is a thread that you may not have seen in banter called Jury Question (http://www.randi.org/vbulletin/showthread.php?threadid=21146) that may interest you.

I'll check it out! Thanks.

I am still interested in continuing our discussion on charitable donations. I know that you have been busy, and if I am reading between the lines correctly you have other issues going on in your life that obviously are more important than an internet message board. But just so I know, do you intend to continue that other thread or are you just too busy/not interested enough?

I bumped that thread the other day; maybe you missed it. Yes, I'm going to continue it on down the road, but right now the personal time just isn't there.