Americans should not buy Foreign Meds but its ok for Drug Companies

[SteveGrenard]

Heparin, marketed but not made by Baxter in the U.S., and which was imported from overseas has caused at least 4 U.S. deaths due to severe allergic reactions and similar reactions in some 350 other recepients.

The first reference below (www.fool.com) points out that while the FDA is trying to prevent Americans from buying their medications from Canada because they are not inspected by them, it seems that the Agency allows U.S. drug companies to go even further afield than our close neighbor to the north in order to do so ….a fascinating irony if there ever was one ....



http://www.fool.com/investing/dividends-income/2008/02/21/a-bit-of-irony-from-the-fda.aspx


Baxter recalled thousands of vials of the blood thinner and halted production earlier this month after it was linked to four deaths and hundreds of allergic reactions. FDA officials said Monday the Chinese plant was not inspected because it was confused with a different company with a similar name. The agency has sent inspectors to China to determine if the factory is the source of the problems.

With more at:

http://www.forbes.com/markets/feeds/afx/2008/02/21/afx4683573.html


Here’s a good wrap-up of the magnitude (numbers/stats) of the problem:

http://www.bendweekly.com/Opinion/Editorials/13660.html


Plus another by the WSJ that sheds different light on this matter:

http://blogs.wsj.com/health/2008/02/22/heparin-imbroglio-update-congress-baxter-importation/?mod=googlenews_wsj

After thought:

And this week the U.S. Supreme Court decided that medical device makers are not liable to
lawsuits for injuries or deaths that were caused by their products if they were approved by the FDA. Drugs may not be far behind according to some:

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/20/AR2008022001140.html?hpid=sec-tech

Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin.

http://www.nytimes.com/2008/02/21/washington/21device.html?ref=technology

[Skeptic Ginger]

Regardless of the location of the manufacturing plant drugs licensed for use in the US are actually tested (lots are sampled) by the FDA and the factories inspected. Location of the factory is not the relevant difference, lots of drugs are manufactured outside the US. The difference is the licensing process.

On that note however, drugs from any number of countries, Canada for example, have their own system of monitoring safety. Claims drugs from Canada are unsafe is strictly political maneuvering with powerful drug lobbies getting their way.

One could argue it is an unfair competition to have one approval system that was more cumbersome and expensive, which the drug companies claim the US FDA approval is, and other drugs for sale that were cheaper to produce under other counties' approval systems. On the other hand, there is also the problem of drug company price controls they don't want drugs they sell more cheaply to Canada to be accessible to the market in the US where they sell the same drug for more.

Then of course there's the extortion the companies are threatening Canada with by asserting if Canada resales the drugs to US citizens, the companies will limit supplies giving Canadians the choice of not having enough for themselves if they let American's buy the drugs.

Very complicated these things. One cannot come up with simple answers without looking at the range of issues. It is tempting to oversimplify the problem, but you cannot.

[WildCat]

The problem is that other countries regulate the price of drugs, with the threat that they'll simply make them themselves (violating the patents) if the drug companies don't go along. So US customers end up subsidizing foreign drug buyers.

The drug companies are damned if they do, damned if they don't in this case.

[Skeptic Ginger]

Wildcat, that is naive.

[WildCat]

Wildcat, that is naive.
How so?

[Skeptic Ginger]

Your version of how prices are negotiated in Canada, for an example of a foreign country, is not correct at all. Canada negotiated the prices they have because the market forces were in play. In the US, drug company lobbying has thwarted those forces.

For example, Bush included a restriction of price negotiations in the prescription drug bill. Yet the public health gets cheaper vaccines because of their competitive buying power and has for years. And hospitals here join forces and use their collective buying power to get cheaper prices. Insurance companies do the same. About the only one left out of the negotiations are the individuals and Bush made sure individuals didn't get any buying power when they could have with the drug bill.

It isn't that Canada regulates anything, it's that they are a big customer and as such negotiate for a good deal.

[SteveGrenard]

Regardless of the location of the manufacturing plant drugs licensed for use in the US are actually tested (lots are sampled) by the FDA and the factories inspected. Location of the factory is not the relevant difference, lots of drugs are manufactured outside the US. The difference is the licensing process.



In an ideal world which this definitely isn’t. You are being naïve if you think all drug plants overseas are inspected, more naïve if you think they are unannounced inspections. We are all naïve if we think all drugs imported into the US from foreign sources are batch tested for anything other than perhaps the active ingredient’s potency. And even if every possible contaminant was tested for, which it isn’t, the drug companies would have to rely on the batch or lot number integrity which it cannot.
The FDA is so short-staffed and underfunded, the Government Accountability Office reported last month, that it would need 13 years to inspect every foreign drug plant that ships products into this country. Its record in China is even worse.

That country has more than 700 plants approved to ship drugs to the U.S. Between 2002 and 2007, the FDA inspected just 88 of them. At that rate, it would need 40 years to inspect every Chinese plant now shipping drugs into this country.

The drug safety agency conducts no unannounced plant visits overseas. Even when it does visit, inspectors have no independent translators. Obviously, the agency's lack of language skills played a role in this tragedy. But so did the FDA's faulty databases; the agency has conflicting information about the number of foreign plants shipping into the United States in two databases it maintains.

http://www.bendweekly.com/Opinion/Editorials/13660.html



Skepticgirl: On that note however, drugs from any number of countries, Canada for example, have their own system of monitoring safety. Claims drugs from Canada are unsafe is strictly political maneuvering with powerful drug lobbies getting their way.

I agree. Many of the drugs we can buy from Canada come from the U.S. anyway and are no less safe or more safe than the ones we can buy here. The safety issue is a scare tactic and is protectionist of drug company price structures which are, as you say, higher in the U.S. for individual consumers.

One could argue it is an unfair competition to have one approval system that was more cumbersome and expensive, which the drug companies claim the US FDA approval is, and other drugs for sale that were cheaper to produce under other counties' approval systems. On the other hand, there is also the problem of drug company price controls they don't want drugs they sell more cheaply to Canada to be accessible to the market in the US where they sell the same drug for more.

That's the ridiculous irony of the current heparin recall ....it was sourced overseas in a pig guts rendering plant which was never inspected by the FDA. According to Congressional critics the FDA is not REQUIRED to inspect such plants even though it does so on a limited basis. Congress now is screaming to make it madatory. If they do they will have to give the agency the funds and manpower to do this properly.

[SteveGrenard]

There is more news on the heparin recall including its expansion. The NY Times ran an interesting follow-up article today on the manufacture of heparin from raw materials overseas which again underscores the fact that while Americans are told not to buy or use medications from overseas ... heck, they're good enough for Canadians but not us is what it really sounds like, the joke is we are already being given foreign medications from questionnable sources only re-packaged by American companies to look like they're made in the USA. I have looked at some of the heparin vials which are subject to the recall and not one of them indicated they contained the active ingredient from overseas. Cookies, sardines, even produce ...you name it, carry such labeling but not meds.


The FDA emphasized that it had yet to identify the root cause of the
problem, and that it had not concluded that the Chinese plant was
responsible. The agency also said it was investigating 2 Chinese
wholesalers, also called consolidators, that supplied crude heparin
to the Chinese plant, Changzhou SPL, as well as those that sold raw
ingredients to the consolidators.

The New York Times reported Thursday [28 Feb 2008] that at least one
of the consolidators received supplies from small, unregulated family
workshops that scraped mucous membrane from pig intestines and cooked
it, eventually producing a dry substance known as crude heparin.

The FDA admitted this month [February 2008] that it had violated its
own policy by failing to inspect SPL, located west of Shanghai,
before the factory began shipping the heparin ingredient to Baxter in
2004. China's drug agency also did not inspect the plant. Last week
[18-24 Feb 2008], the FDA sent inspectors to the plant.

Date: Fri 29 Feb 2008
Source: The New York Times [edited]

Complete article at:

http://www.nytimes.com/2008/02/29/us/29heparin.html?em&ex=1204434000&en=16faab828e4f9ebf&ei=5087

[Skeptic Ginger]

I am not naive about foreign drug company inspections. You are naive if you think the US manufacturing sites are adequately inspected. I merely said the difference was being subject to licensing in the US, not where the manufacturing plant was located. It would appear the plants in China were subject to US inspection but that it did not occur.

No surprise there. The last 7 years the Bush admin has allowed most government regulators to suffer from budget cuts and lack of replacement personnel.

Here was the warning in 2001: Bush Is Putting Team in Place for a Full-Bore Assault on Regulation (http://query.nytimes.com/gst/fullpage.html?res=9C05EFD7123DF930A15756C0A9679C8B 63&sec=&spon=&pagewanted=all)Across an array of federal agencies, the Bush administration has begun to make good on its commitment of broad deregulation, promoting a policy transformation long sought by the business community and opposed by consumer, labor and environmental organizations....

...last week in the proposal for a relaxation of regulations to encourage energy development, the scaffolding of a new regulatory framework is taking shape.

It would affect antitrust enforcement, telecommunications, workplace rules, consumer protections, financial services and even how the military and other agencies buy goods and services from the private sector.

For instance, Mary Sheila Gall, the official selected to head the Consumer Product Safety Commission, has a decade-long track record at the agency of voting against proposed safety rules because she has often said that injuries are caused not by faulty product designs but by negligent consumers. Her record has attracted widespread support from many manufacturers and strong criticism from Consumers Union and other similar groups.

She has criticized the agency for promoting ''a federal nanny state.'' Safety experts and industry executives predict that after she takes over, a number of proposals under consideration, like one requiring flame-resistant treatment of upholstered furniture and another regulating baby bath seats, will be dropped.


Not sure about this source but this opinion piece is accurate.
Editorial: Wake-up call to fix U.S. food safety system; Published: Sunday, February 24, 2008 (http://www.burlingtonfreepress.com/apps/pbcs.dll/article?AID=/20080224/OPINION/802240314/1006/NEWS05)The record recall of frozen beef announced last week represents yet another stunning failure of our federal regulatory system to ensure the minimum standard of health and safety for Americans. ...

The breakdown in food safety is hardly an isolated event when it comes to the federal government's performance in ensuring public safety in the marketplace. Remember the recall of spinach, pet food and fish just in the last year? The lapse came under the watch of the Bush administration, which has starved regulatory agencies of resources and packed key positions with industry sympathizers.

[SteveGrenard]

What does the lack of adequate or any inspections of domestic plants have to do with the same thing for overseas medication mfg facilities? Both are bad. You started out by saying overseas facilities of American meds imported into the U.S. by American drug companies are subject to inspection by the US FDA. Apparently not. They may be subject to such inspections but clearly this is not happening. I merely pointed out that not only in this heparin case but in many others (40 years worth of inspections needed at current rate) such inspections are not taking place. And in China, even if they take place, they are hobbled by the lack of unbiased translators obtained locally and who are on the payroll of the local purveyor. It's a farce. And the irony is that American consumers are then told not to buy their meds from Canada because they may not be safe.

We both agree Bushco really dropped the ball on this one. I have friends in the FDA that are extremely frustrated by this, good people who want to see their mandate, their job done but can't because they don't have the budget to do so. Just one more price we're paying for
everything else that's assaulted our economy.

[Skeptic Ginger]

Steve, the drug companies are mostly international. There are manufacturing plants all over the world. What makes you think most drugs are made here? Or what makes you think the plants here don't have their share of problems? I get 2-3 FDA notices a day in emails on problems with prescription meds. Go to the FDA MedWatch site (http://www.fda.gov/medwatch/index.html) and take a look.

I'm saying the difference in a person buying drugs in or from another country is those drugs are not licensed or overseen at all by the FDA. That is what the FDA says is the reason they don't want drugs from other countries used here. It isn't because the manufacturer is in another country.

When we had that severe flu vaccine shortage a few years back, I could not get flu vaccine from Canada, yet the Aventis plant the vaccine was made in was actually in Michigan!

All of our drugs are manufactured all over the world and some of the ingredients are made internationally even if the drug is actually made here. This is nothing new.

Whether or not the FDA does a good job is another story. They don't and they've gotten worse under Bush's policy of not regulating business by ignoring laws passed by Congress and simply not enforcing those laws by neglecting these regulating agencies.

It isn't where the drugs are manufactured that is the problem, with the exception maybe of China. Hard to say if that is just our news media and the 'echo story formula' (meaning if one story comes out, anything in the same vein makes the news when it might not have otherwise) or whether China really is a lot worse than the rest of the world.

[Beerina]

The reason the government doesn't want Americans to import isn't the safety issue. That's a fraudulent cover story.

The real reason is that reducing profit to drug companies slows drug research, which causes more misery and death in the long run. Canada, Europe, and other socialized places mandating cheaper prices slow such research, and thus end up causing more misery and death than would happen with more expensive drugs.

Yes, even if you count those who "cannot afford it".

In this manner does humanity ride to Hell in a handbasket, to the applause of 98% of the population.

[The Kilted Yaksman]

Maybe if the pharmaceutical industry would spend more on R&D than it does on advertising the R&D process would be faster.
http://www.sciencedaily.com/releases/2008/01/080105140107.htm

[Cuddles]

What does the lack of adequate or any inspections of domestic plants have to do with the same thing for overseas medication mfg facilities? Both are bad.

Exactly. So why did you start a thread complaining about drugs being imported from overseas, since the problem is nothing to do with drugs being imported from overseas? The problem is the lack of inspections in both foreign and domestic plants. The fact that this particular problem was in a foreign one is irrelevant.

[SteveGrenard]

skepticnurse wrote: {quote]Steve, the drug companies are mostly international. There are manufacturing plants all over the world. What makes you think most drugs are made here? Or what makes you think the plants here don't have their share of problems? I get 2-3 FDA notices a day in emails on problems with prescription meds. Go to the FDA MedWatch site and take a look.[/quote]

Nothing makes me think that because I know many drugs and/or their active ingreients are made overseas. I don't know how many and I suggest you don't either. I wonder why that is? Could it be they don't want anyone to know. But ALL being made here is what Americans are lead to believe when they are told not to buy meds or import them from overseas. Also: once again, look at the labeling on virtually any drug and you will not see country of origin on the label as you would for foodstuffs or produce. If anything you'll see the address of the mfg's offices in the U..S. leading folks to believe the drugs are U.S. made and sourced. A belief which may or may not be true.

Thank you for confirming the irony meant to be expressed in the title of this thread.

Of the meds and vaccines made in the U.S. and I would think operations here would at least be inspected and regulated a bit better than facilities overseas, especially when inspections are not done or if they are performed in the absence of an unbiased translator
in countries where that is necessary.

The problem with drug plant mfg inspections may not be solely due to budgetary cut-backs. I
am certain that the drug companies self-pay all the costs for such inspections and this cost per se does not come out of the public purse.

[Skeptic Ginger]

The reason the government doesn't want Americans to import isn't the safety issue. That's a fraudulent cover story.

The real reason is that reducing profit to drug companies slows drug research, which causes more misery and death in the long run. Canada, Europe, and other socialized places mandating cheaper prices slow such research, and thus end up causing more misery and death than would happen with more expensive drugs.

Yes, even if you count those who "cannot afford it".

In this manner does humanity ride to Hell in a handbasket, to the applause of 98% of the population.This is a gross oversimplification of the actual issues involved.

Overall, the FDA has been a good thing.
Bush has weakened the agency.
There is a factor of safety involved, that's what the point of licensing drugs is all about.
There is a factor of which countries' FDAs are overkill, underkill, or just right.
There is political motivation to not allow Canadian and European drugs on the US market.
There is the issue that the FDA has rules to follow and sometimes they are not suited to the situation that arises.
Hospitals get cheaper drugs, the CDC gets cheaper vaccines, countries with national health systems and even some insurers all get cheaper drugs because they have used their weighty customer purchasing power to negotiate lower prices.
Some market forces have been good some bad (I've discussed these in other threads)

The point of all this is it is naive to think only simplistic events, good guys, bad guys and so on underlie these complex issues.

[Skeptic Ginger]

Nothing makes me think that because I know many drugs and/or their active ingreients are made overseas. I don't know how many and I suggest you don't either. I wonder why that is? Could it be they don't want anyone to know. But ALL being made here is what Americans are lead to believe when they are told not to buy meds or import them from overseas. Also: once again, look at the labeling on virtually any drug and you will not see country of origin on the label as you would for foodstuffs or produce. If anything you'll see the address of the mfg's offices in the U..S. leading folks to believe the drugs are U.S. made and sourced. A belief which may or may not be true.

Thank you for confirming the irony meant to be expressed in the title of this thread.

Of the meds and vaccines made in the U.S. and I would think operations here would at least be inspected and regulated a bit better than facilities overseas, especially when inspections are not done or if they are performed in the absence of an unbiased translator
in countries where that is necessary.

The problem with drug plant mfg inspections may not be solely due to budgetary cut-backs. I
am certain that the drug companies self-pay all the costs for such inspections and this cost per se does not come out of the public purse.There are some reasons drug companies don't want attention called to the fact they have manufacturing plants world-wide, but it is hardly a secret and hard to find information. Just go to the website of any manufacturer and look.

And, excuse me, but I do know. I buy drugs from distributors and manufacturers. My practice purchases thousands of dollars worth of vaccines and other meds every year. I also have had many occasions to contact drug manufacturers. They don't even all have their primary headquarters here.

I don't know the percentage of drugs made in and out of the country but I believe the majority of companies are international.

Pfizer Company Fact Sheet (http://www.pfizer.com/about/leadership_and_structure/company_fact_sheet.jsp)Pfizer Locations: Corporate Headquarters:
New York, NY (USA)

Research & Development:
Groton and New London, Connecticut
Sandwich, England
La Jolla, California
St. Louis, Missouri
Cambridge, Massachusetts
Rinat, South San Francisco, California

About Merck (http://www.merck.com/about/)Merck & Co., Inc. is a global research-driven pharmaceutical company

Sanofi Aventis (http://www.sanofi-aventis.us/live/us/en/layout.jsp?scat=0F61A954-E5D2-4342-BB93-6E6392AB61C1)With 2006 pro forma combined net sales of 28.4 billion euros and an estimated 100,000 employees worldwide, sanofi-aventis is one of the world’s largest pharmaceutical companies. Global headquarters are located in Paris, France and U.S. headquarters are in Bridgewater, NJ.

Bristol-Myers Squibb international websites (http://www.bms.com/aboutbms/web_sites/content/data/intern.html)Our employees work in offices, research and development labs, manufacturing plants and distribution facilities located in almost every country around the world.

[Skeptic Ginger]

Maybe if the pharmaceutical industry would spend more on R&D than it does on advertising the R&D process would be faster.
http://www.sciencedaily.com/releases/2008/01/080105140107.htm
Another one of those market forces that prevent us from getting the best product at the best price. Instead we get the best marketing.

[SteveGrenard]

The average prescription or OTC consumer is not going to check pharma websites to see where a drug was made, even if that information were located there next to the drug in question which, as a rule, it isn't The fact that you buy large quantities and are in the business opens up other avenues of information to you. Most Rx drugs are removed from mfg packagaing and placed in Rx jars with labeling for the patient including pt. name, doctor, dose, instructions, etc. but not country of origin. For sure we get el supremo marketing including prime time TV ads and ads in slick consumer magazines.

Some news....

In the meantime the FDA announced today at a conference they have identified a heparin like contaminant in the recalled heparin that analyzes like heparin, probably
on mass spec, so it is impossible to see on routine assays.The contaminant was found in the finished product and in the active pharmaceutical raw ingredient.

China was a major source of the raw ingredient but Baxter heparin was also processed in Wisconsin. Since some source material comes from Wisconsin. it was impossible to tell, at this point, if the contaminant was added in China or the U.S.

The name of the contaminant was not released when I heard about this today.
I checked and as of a few moments ago there was nothing yet on the FDA website about this news, at least that I could find. Maybe later.

[Skeptic Ginger]

The average prescription or OTC consumer is not going to check pharma websites to see where a drug was made, even if that information were located there next to the drug in question which, as a rule, it isn't The fact that you buy large quantities and are in the business opens up other avenues of information to you. Most Rx drugs are removed from mfg packagaing and placed in Rx jars with labeling for the patient including pt. name, doctor, dose, instructions, etc. but not country of origin. For sure we get el supremo marketing including prime time TV ads and ads in slick consumer magazines.
....I don't get the point of this comment.

[Skeptic Ginger]

From the Yahoo News article:Baxter, which had provided about half the nation's supply, halted production last month after its brand was linked to hundreds of reports of allergic-style reactions, including vomiting, nausea and difficulty breathing. Baxter purchases bulk heparin from Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory and buys additional crude heparin from other Chinese suppliers.

Baxter said it found the contaminant in samples of the ingredient from the China plant, Changzhou SPL, and in samples processed at the Wisconsin factory that came from Chinese-made crude heparin.

"These results suggest that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter," the company said.

The vast majority of the world's heparin comes from Chinese ingredients, Baxter officials noted.

...FDA inspectors last week found quality-control problems at the Changzhou factory, a facility the agency had never before inspected — in violation of its own rules — because of a mix-up with the company's name.So it would seem that a) vast majority of the world's heparin comes from Chinese ingredients; b) Baxter purchases bulk heparin from Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory and buys additional crude heparin from other Chinese suppliers; and c) FDA inspectors last week found quality-control problems at the Changzhou factory, a facility the agency had never before inspected — in violation of its own rules.

So international drug manufacturing in part or whole is common and the FDA is supposed to inspect foreign plants.

[SteveGrenard]

While I agree 100% that foreign drug sources should be inspected by the FDA and they can do better, new evidence announced today lays this debacle smack dab at the feet of unscrupulous Chinese businessmen and middlmen. Who are these middlemen and are any of them members of this forum?


The substance, hypersulfated chondroitin sulfate, mimics the blood thinner in standard safety tests and may have been deliberately substituted to boost middlemen's profits.

By Ricardo Alonso-Zaldivar, Los Angeles Times Staff Writer

March 20, 2008

WASHINGTON -- A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday.

http://www.latimes.com/news/printedition/asection/la-na-fda20mar20,1,4695849.story


We don't even know how many recipients of this contaminated heparin have suffered or even died as a result of these sorts of business practices. Many are calling for an all out boycott of Chinese products and while some have been open minded about this, it is becoming increasingly difficult to remain that way. We can continue to be apologists for our lack of inspections but the cause of the problem in this case was so devious that a routine overseas plant inspection probably would not have helped. After all it is a simple matter to take some of this Chinese heparin and subject it to a mass spec analysis in the U.S. and still not find the contaminant.

[Skeptic Ginger]

Did you miss this story, Steve?

FDA to open offices in China (http://www.upi.com/NewsTrack/Science/2008/03/14/fda_to_open_offices_in_china/7634/)The FDA said it plans to open eight permanent offices at U.S. diplomatic posts in China in the next 18 months, pending authorization from the Chinese government. Along with placing FDA staff in the positions, the agency said it will hire five local Chinese nationals to work with staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Dr. Murray M. Lumpkin, deputy commissioner for FDA's international programs, said in a statement.I also read that the Chinese government was being very cooperative in the heparin investigation.

[The Man]

How do you know where your drugs are produced or the constituent elements that produce said drug? When I had Lyme’s disease, I had to inject heparin both before and after I administered the IV antibiotics. I never gave much concern as to where that heparin was produced, but that was 20 years ago. Today I must inject a biological protein or tumor necrosis factor inhibitor on a weekly basis or my psoriatic arthritis would prevent me form doing the very physical aspects of my job. Although any pharmaceutical may be produced in any country it is the traceability and regulation of production quality standards that makes any drug reliable. Deregulation and lack of production quality controls makes the supplement industry less dependable then the pharmaceutical industry. Even with the blatant advertisement of possible side effects on TV, you may have more reason to be concerned about some unregulated supplement, from who knows where, then from any pharmacological element where the risks (unfortunately, not all risks, as we see on this thread) are, hopefully (and by regulation), explicitly defined

[SteveGrenard]

Did you miss this story, Steve?

No. I didn't. I wish them well and hope they achieve results.


FDA to open offices in China (http://www.upi.com/NewsTrack/Science/2008/03/14/fda_to_open_offices_in_china/7634/)I also read that the Chinese government was being very cooperative in the heparin investigation.

I am not blaming the government anymore than I blame the US Government for the acts of criminals in the U.S. Corruption is so ingrained in China any government efforts to stem the problem may never help. It might be a hopeless task. We can criticize the Chinese government for its excesses in Tibet but we cannot blame them for the criminal organizations that run drug counterfeiting rings.

So unless or until government muckrakers in China achieve their goal my suggestion is to stay away from any drug sourced there. OOps, wait a minute. We can never know where the stuff we swallow comes from. I believe that was the thesis of this thread.

In case you missed the NY Times on this:


"A child could tell you it's counterfeiting," said Dr. Jawed Fareed,
a professor of pathology and pharmacology at Loyola University
Chicago, who has been studying batches of heparin since the problems
with the drug were discovered.

Dr. Fareed said he was conducting his own investigation because he
was concerned that the quality problems with heparin were far more
widespread than acknowledged. "Of 7 or 8 batches I have, 6 are
contaminated," said Dr. Fareed. "And these were used by doctors at
Loyola University Medical Center."

To which Dr Fareed added:


"This is a deliberate act of chemically manipulating a heparin-like
substance and mixing it with heparin to increase the yield," he
added. But some batches of heparin containing the contaminant did not
elicit adverse reactions, casting uncertainty on their root cause,
Dr. Fareed said.

[Byline: Jake Hooker and Walt Bogdanich]


http://www.nytimes.com/2008/03/19/world/asia/19heparin.html?_r=1&ref=worldbusiness&oref=slogin

And you, skepticnurse, are fully aware that of all the people who may've died from some sort of thromboembolic event in the last year or perhaps for longer, we have no way of knowing if the heparin they were given was any good in the first place and never will. We simply bury the
evidence.

[SteveGrenard]

How do you know where your drugs are produced or the constituent elements that produce said drug?

You don't. Drug companies can buy their ingredients from anywhere and there is no
information given to patients about this. Ironically the U.S. does not want patients
buying drugs from overseas but apparently it is okay for drug companies to do so and
then conceal this fact ... or, rather, simply not release it.

Although any pharmaceutical may be produced in any country it is the traceability and regulation of production quality standards that makes any drug reliable.

You would think so. I would think so. We all would hope so but when events like this keep coming up it appears that your faith in the system is not enough. In this case the heparin
was tainted with a drug that during ordinary assay appears as if it is something else. The
Chinese did this last year with wheat gluten "diluted" with scrap melanine, a plastic, that
over 40 dog food companies unknowingly caused dog owners in the U.S. to feed and
subsequently injure or kill their pets. The motive in both cases, the heparin and the wheat gluten, was greed.

Deregulation and lack of production quality controls makes the supplement industry less dependable then the pharmaceutical industry. Even with the blatant advertisement of possible side effects on TV, you may have more reason to be concerned about some unregulated supplement, from who knows where, then from any pharmacological element where the risks (unfortunately, not all risks, as we see on this thread) are, hopefully (and by regulation), explicitly defined

You are absolutely correct. But apparently your concerns re the unregulated supplements industry also extend to what we thought or believed was the more tightly regulated "ethical" pharmaceutical industry.

Reform is necessary. Not only must better methods of batch assaying be conducted, foreign sources of ingredients, active or otherwise, should be placed on labeling. As I stated above we cannot buy a bannana or an orange without a sticker indicating its
origin, how come such rules concerning foods don't extend to the drugs we swallow?

[The Man]

Reform is necessary. Not only must better methods of batch assaying be conducted, foreign sources of ingredients, active or otherwise, should be placed on labeling. As I stated above we cannot buy a bannana or an orange without a sticker indicating its
origin, how come such rules concerning foods don't extend to the drugs we swallow?

You will get no augment from me on that regard, other then to deter this remark.


“it appears that your faith in the system is not enough.”


It is the system it self that must be adequate and constantly improving, that is the only system I would have faith in. As for now I have no viable alternative and I understand the risk I undertake each time I inject.

[Skeptic Ginger]

Steve, don't stretch my point into a straw man. I said US drugs were made all over the world and the difference was FDA approval, not the location of the manufacturing plant. You continue to blame the location when it is lack of FDA oversight, not the factory location. If you don't think American companies are subject to fraud, then I suggest you read about Enron and Tyco.

And you make the claim, Corruption is so ingrained in China any government efforts to stem the problem may never help. That is the perception we get from the news, that doesn't make it true. And right now our own government is involved in corruption big time in Iraq. We just are not as immune from corruption as you think, nor is China likely to be as bad as you think.

There have been many problems with drugs from lots of manufacturers. China is not unique. But it is currently a problem and fraud may indeed turn out to be greater there. But it is wrong to draw conclusions from the misrepresentative sample one gets from reading the news or from learning about individual incidents.

[Architect]

Can I just observe, with typicaly European ire, that you apparently lump everything outside of North America as "all over the world" and tar it with the same brush as the China case. None of you are presumably suggesting that the testing regimes in Europe, in particular the UK/France/Germany, are in any way less onerous or appropriate than that used in your own countries......are you?

[Skeptic Ginger]

Can I just observe, with typicaly European ire, that you apparently lump everything outside of North America as "all over the world" and tar it with the same brush as the China case. None of you are presumably suggesting that the testing regimes in Europe, in particular the UK/France/Germany, are in any way less onerous or appropriate than that used in your own countries......are you?Don't paint me with Steve's brush. It is the wrong color paint.

Actually, the US's approval process is a tad more stringent than Europe's or Canada's. There have been complaints by some drug manufacturers that getting FDA approval was more costly in terms of required research and documentation and prevents them from seeking approval for their products.

Personally, I'd have no qualms about using any drug approved by any modern country.

[Architect]

We're in the same ball park. I'm just wary after Jerome De GNome's bizarre current claims that the UK and Canadian systems aren't broadly equivalent in terms of clinical standards and outcomes to those in the US. He clearly thinks we're all still living in reed thatched clay huts over here.

[SteveGrenard]

First of all heparin per se is far from being a new drug requiring FDA approval as are many other old standby's. So this is a misrepresentation where FDA "approval" is concerned. The huge amounts of money that the FDA causes drug ompanies to spend on approvals is for new drugs or new indications for old drugs, not existing drugswith existing indications This is a clear case of drug counterfeiting per Dr. Fareed and many tend to agree.

Secondly whether the U.S. or U.S. persons are involved in corruption in a war zone such as Iraq is clearly off topic. I cannot imagine a more different set of circumstance.

[Skeptic Ginger]

Steve, please don't tell me you don't know how the FDA works. Surely you have some idea how drug manufacturing sites are inspected? Do you think the 8 FDA offices planned for China are expecting a rash of new drug submissions to come flooding in?

[Bluefire]

http://www.youtube.com/watch?v=D6Zoexl23lY

[Skeptic Ginger]

Interesting video. She gets a bit carried away ranting my body my rights. Prescription drugs are controlled. That's the way it goes.

And there have been many cases of counterfit pills coming from web purchases.

She also said it wasn't a controlled drug then in the end of the video controlled drugs were all the web pages listed for sale. I wonder just what drugs are really getting stopped.

But the profit motive is pretty well established and Bush added to that corporate protectionism during his term in office.

Anyway, interesting rant.

[SteveGrenard]

Steve, please don't tell me you don't know how the FDA works.

more than you know. Let me try and explain this. In the case of a drug such as heparin which has been approved for a long time the FDA concentrates on standards known as
GMP or Good Manufacturing Practices which is well they should. In this case the heparin
was not the good old fashioned heparin we all know and love but a counterfeit version. The FDA relies on a system of checks and balances dictated by GMP. They are on a paper chase
or audit very much like the IRS might do in a financial investigation. They do not expect the drug in question, in this case heparin, to have been altered by the presence of another, cheaper substance that assays (by the usual methods) identically to that of the real thing. But as this event, the melanine incident and the antifreeze in mouthwash and toothpaste incidents have taught us we can no longer rely on GMP alone to insure the purity, efficacy and safety of such products coming from China. Does that make sense to you?


Surely you have some idea how drug manufacturing sites are inspected?

Surely I do. If the FDA walks into a plant in Pennsylvania & they see violations, then they
issue warnings, stop work orders and use other means to correct them. They, the FDA, might do the same in China (but they can't since they have no jurisdiction) but again they do not expect the Pennsylvania plant to be falsifying their data or using devious means to dilute the drug to increase profit margins. This is exactly what has been and is happening in China. I am sure they realize this by now. The FDA can, in China, only issue embargoes on drugs destined for the U.S. So the Chinese plant can continue in business and ship elsewhere.

I mention the Pennsylavnia example because I am intimately familiar with an FDA action which shut down a plant there which made vaccines and anti snake venom on the basis of GMP violations. The company corrected the violations but decided anyway to sell off their vaccine biz and they stopped production of anti snake venom altogether.

Do you think the 8 FDA offices planned for China are expecting a rash of new drug submissions to come flooding in?

I expect that this effort will tighten up appreciably the possibilities for counterfeting. One can hope. In the years ahead they may have their hands full with applications for facilities manufacturing new drugs, even if they are not involved in the approval and clinical testing of the new drugs.

The approval of novel molecules, or new drugs or new indications for old drugs involves another set of rules or imperatives embodied in what is called GCP or Good Clinical Practices. GCP does not impact on GMP except perhaps in the manufacture of blood and blood products, tissues for transplant, vaccines and antivenom which involves clinical practices. This is why the FDA has a separate biologicals division, CBER, to deal with this specialized area. See:

http://en.wikipedia.org/wiki/Center_for_Biologics_Evaluation_and_Research

I hope this helps. It is sad this FDA effort won't legally be able to help other countries destined to receive poorly mfg Chinese drugs, knock-offs or counterfeits unless the Chinese government steps up to support the FDA actions. It remains to be seen.

[SteveGrenard]

As predicted above news reports today indicate that counterfeit Chinese heparin has been recalled in Germany, Japan, France, Italy and Denmark. Along with the U.S. this is probably just the tip of the iceberg when it comes to Chinese pharma malfeasance risking the lives of millions of people. The FDA by itself cannot prevent this from happening. The ball is in their, meaning China's court, once again.

[SteveGrenard]

More on the irony from the OP:

http://www.latimes.com/news/opinion/editorials/la-ed-heparin25mar25,0,7059874.story


More on fiasco from bloggers:

http://www.bloggernews.net/114738



On FDA inspections there was this snippet:

The most common problems uncovered by FDA inspections of 67 facilities included inadequate restroom sanitation, litter piles and indoor condensation posing a risk of food contamination by microorganisms. Inspectors also found buildings vulnerable to rodent infestation and workers with uncovered hair and poor hygiene.

http://blog.washingtonpost.com/thecheckout/2008/03/post_17.html?nav=rss_blog


All of which is well and good for an OSHA and food safety inspection but a waste of time when more important issues prevail such as assays of the products being produced.

[Skeptic Ginger]

So how does this differ from the recent Dioxin in the buffalo milk tainting all the Italian mozzarella (http://www.guardian.co.uk/environment/2008/mar/28/food.italy)?

[CFLarsen]

So how does this differ from the recent Dioxin in the buffalo milk tainting all the Italian mozzarella (http://www.guardian.co.uk/environment/2008/mar/28/food.italy)?

Where do you read that all Italian mozzarella has been tainted by dioxin?

Italy disclosed last week that high levels of dioxins - mostly poisonous chemical byproducts of the manufacture of herbicides and bactericides - were found in the milk of 66 herds of buffalo around Naples.
...
But he confirmed that 83 of 1,900 buffalo dairy farms had been affected by the findings.

Nor is all mozzarella made from buffalo milk:

mozzarella di latte di bufala made from unpasteurized water buffalo's milk; mozzarella di bufala campana made only from Campania's buffalo milk; mozzarella fior di latte made from fresh pasteurized or unpasteurized cow's milk; and mozzarella made from mixtures, sometimes smoked, and those stored in preservatives.
Source (http://en.wikipedia.org/wiki/Mozzarella)

It's one thing that you don't know what you are talking about, but at least read your own sources.

[SteveGrenard]

So how does this differ from the recent Dioxin in the buffalo milk tainting all the Italian mozzarella (http://www.guardian.co.uk/environment/2008/mar/28/food.italy)?

I agree w/ Claus not "all" mozzarella is involved. But an even bigger difference in this case is that Italian cheesmakers did not contaminate their product in order to boost profits. In addition it would seem that reports indicate the Italian government and European Commission moved swiftly and decisively on this matter. Nor was all heparin involved in the primary matter under discussion although a lot of it was, involving the U.S. and a growing list of countries where it has shown up.


The Italian government says it is ready to withdraw from sale the mozzarella cheese linked to dioxin contamination. Italy's health ministry said the affected cheese came from 25 producers in the Campania region near Naples, where buffalo mozzarella is made.


http://news.bbc.co.uk/2/hi/europe/7318391.stm


See also:

http://news.monstersandcritics.com/health/news/article_1397315.php/EU_gives_Italian_mozzarella_the_all_clear

It would be nice if this sort of rapid response and clearing of a problem would occur with products found to be contaminated when made elsewhere.

[Skeptic Ginger]

Claus, you could chose to have a polite discussion instead of following your obsession with pedantic matters. You really might find it more interesting and certainly more productive. Besides, you aren't always correct in your obsession.

Try thinking about the point of the post or the gist of the discussion.

Or you could preface your posts with "pedantic quibble". People respond to that.

Yes, yes, shame on me for those pedantic errors.

Move on.

[Skeptic Ginger]

In the US, we have failed to enact the same safeguards against BSE as did Europe and Canada. We were slower to adopt the feed ingredient ban and less complete when we did adopt it.

http://cidrapbusiness.org/cidrap/content/other/bse/news/jul1307feedban.html

[CFLarsen]

Claus, you could chose to have a polite discussion instead of following your obsession with pedantic matters. You really might find it more interesting and certainly more productive. Besides, you aren't always correct in your obsession.

Try thinking about the point of the post or the gist of the discussion.

Or you could preface your posts with "pedantic quibble". People respond to that.

Yes, yes, shame on me for those pedantic errors.

Move on.

Instead of trying to blame others for your errors, try to admit that you were wrong. Then, you can move on with a clear conscience.

Nobody will criticize you if you do.

[Skeptic Ginger]

You can criticize all you want. How you get "blaming others" out of "Yes, yes, shame on me for those pedantic errors" however is another error you need to add to your list.

[CFLarsen]

You can criticize all you want. How you get "blaming others" out of "Yes, yes, shame on me for those pedantic errors" however is another error you need to add to your list.

Just admit your mistakes, and stop blaming others for them.

[rwguinn]

The problem is that other countries regulate the price of drugs, with the threat that they'll simply make them themselves (violating the patents) if the drug companies don't go along. So US customers end up subsidizing foreign drug buyers.

The drug companies are damned if they do, damned if they don't in this case.

Wildcat, that is naive.
Wildcat is correct.
In the US, drug companies are allowed to recover their R&D costs throiugh charging more for the products.
In most foreign countries, including Canada, those costs are not allowed to be passed on--even on imports.
That is why the same drug, with the same formulation, by the same company, are usually more expensive in the US--we pay the R&D costs, subsidizing the rest of the world.

[Skeptic Ginger]

Wildcat is correct.
In the US, drug companies are allowed to recover their R&D costs throiugh charging more for the products.
In most foreign countries, including Canada, those costs are not allowed to be passed on--even on imports.
That is why the same drug, with the same formulation, by the same company, are usually more expensive in the US--we pay the R&D costs, subsidizing the rest of the world.Just how would these Canadian pharmacies be passing any drug costs on when they have national health insurance? The government is not a middle man, the government is the customer.

In the US, hospitals and the CDC pool their purchasing power and collectively negotiate drug prices. Large insurance companies do the same.

In a few cases third world countries threaten to break patent agreements. This has been a particularly sensitive problem with HIV drugs. But countries that break patent agreements risk international sanctions and they are well aware of this. Some agreements have been negotiated, again, especially with HIV drugs because the poor countries suffering many HIV cases have garnered empathy from countries that might enforce sanctions for breaking patent agreements.

The reason drug companies are charging more for drugs in the US is because individuals do not have the customer negotiating power that a large buyer would have.

For example, when I buy Tubersol, 50 tests/vial as an independent provider in the US, I pay ~$100.00 per vial. The hospital my employee health colleagues work for pay ~$10.oo for that very same vial, same company, same size vial. The same is true for vaccines I buy for my practice. Both the hospitals and the public health pay a fraction of what the drug company charges me.

The other matter is I can only buy drugs approved in the US. Canada can approve drugs manufactured by competitors in Europe if they choose to do so. That means there are different competitors competing against the US drug companies when Canada buys its pharmaceuticals. The same is true in Europe.

The point is you are both oversimplifying the economics and doing so without adequate knowledge of the actual factors involved in drug pricing.

Do the US drug companies make excessive profits? Yes, I think so. Especially given I pay a lot more for my wholesale supplies than my competitors in the occupational health businesses that are associated with the hospitals do. And individuals get the worst end of the deal.

But the forces at work are complex and most certainly are not because countries just threaten to ignore patents. That would be a 2-way street and international trade agreements just don't allow countries to operate that way.

And it is somewhat of a myth that the US subsidizes R&D. What we subsidize are excessive profits. All R&D in the pharmaceutical industry is not taking place exclusively in the US. People who are against national health insurance are spreading that particualr propaganda and many of them are the same people making those excessive profits. The for profit health care system is not responsible for all the health care innovation in the world, not by a long shot.

[Skeptic Ginger]

... But an even bigger difference in this case is that Italian cheesmakers did not contaminate their product in order to boost profits. In addition it would seem that reports indicate the Italian government and European Commission moved swiftly and decisively on this matter. ...
It would be nice if this sort of rapid response and clearing of a problem would occur with products found to be contaminated when made elsewhere.My issue with your OP remains that one can find similar corrupt actions around the world including in Western nations. You didn't like my first example, claiming this or that was different. So, here's another where in this case someone purposefully sold or intended to sell an adulterated product which ended up being harmful.

Mafia blamed for 70 million litres of tainted Italian wine: report (http://news.yahoo.com/s/afp/20080404/hl_afp/italyhealthfoodwinecrime_080404182422) ROME (AFP) - Italy produced and sold at least 70 million litres of cheap wine containing acid, manure and fertiliser, Italian weekly L'Espresso said on Friday, largely blaming organised crime in the south.

It said bottles sold at less than two euros (around three dollars) a litre contained very little wine, and a potentially deadly concoction of water and chemical substances, including hydrochloric acid....

...20 companies, eight of which are in the north of Italy, were currently being investigated....

In a statement Agriculture Minister Paolo De Castro described the Italian wine industry as dynamic and healthy, insisting that habitual wrongdoers known to the police "would not ruin the image of an entire economic sector".

Nonetheless, on Friday, the European Commission's spokeswoman on health Nina Papadoulaki asked Italian authorities for an explanation on the matter.

L'Espresso's findings come as the government is investigating 13 producers of the upmarket Tuscan wine Brunello di Montalcino for using unauthorised grapes. It has since confiscated bottles from four of the producers....


In addition, there is now evidence that the dioxin contaminants in the cheese was also the result of purposeful criminal activity.

See post #39:So how does this differ from the recent Dioxin in the buffalo milk tainting all the Italian mozzarella (http://www.guardian.co.uk/environment/2008/mar/28/food.italy)? [And for Claus' sake, "all" in that post is figurative as in "all that..." which does not mean 'all' literally but rather, 'all that', as in all that stuff being referred to, not all the Mozerella in the country. No further pedantic and irrelevant discussion of the matter will be replied to.]




The new scandal comes two weeks after Italy was forced to withdraw mozzarella from the market when raised dioxin levels were found in the soft buffalo milk cheese.

Scientists linked the case to thousands of tonnes of rubbish which has accumulated in the Naples area, again partly because of mafia activities.



And from the comments in this article about the EU being concerned about the Italian government's response, this seems to contradict your claim that China didn't crack down sufficiently where as Italy did.

There are a lot of bad things and bad people and corrupt and inefficient or incompetent government members in this world. And indeed some things might be severe in one country while only a minor problem on the scale of things in another. I just think it is not an accurate picture of China when you single out a couple of serious but not unique in the world incidents and claim China fits the stereotype image we seem to have from the media of allowing criminals to profit at the expense of the population. The issues behind such events are more complex than just a simple claim the Chinese government allows this sort of thing and doesn't care.

[SteveGrenard]

Thank you for your findings as cited above. As a fan of two wrongs don't make a right I will not deign to argue with you that problems exist everywhere with tainted food, less so with counterfeit and tainted medications save for China and perhaps elsewhere in Asia where this business is poorly to non-existently regulated.

The Chinese government as has the entire world been well aware of the problems with counterfeit and tainted drugs for quite some time. It would be hard not to think they allow this to continue when they are so ruthlessly efficient in using their muscle to arrest and/or kill demonstrators either at home in Bejing or in bordering territories, e.g. Tibet.

The tactic of defenders of China also like to point out that the guilt belongs on the victims, e.g. importers and re-sellers of the tainted drugs. I needn't remind you that this is a nefarious tactic of defense attorneys who try and put the victims or plaintiffs on trial in order to spare their defendents any guilt. I don't think most reasonable people buy into this but it is very clever and often works in court, even blaming rape victims instead of rapists for the crime.

To get this back on topic, the FDA has reported in the last day or so that they now have 103 reports of deaths in patients who received heparin in the months covered by
the discovery of the problem. Since thousands of people receive heparin, many of them critically ill and many who die from thromboembolic phenomena, we will probably never know the extent of damage that the tainted Chinese heparin has caused American patients. For myself, I will not be so politically correct as to ignore this when it comes to other medications of Chinese origin and I suspect that neither will a lot of others. It remains to be seen what, if anything, the Chinese government and the FDA initiatives in China accomplish to prevent this from ever happening again.

As someone who neither drinks crappy wine or eats imported mozzarella cheese the issues you bring up, while important to some, pale in comparison to the problem of counterfeit medications.

[Skeptic Ginger]

I didn't say two wrongs made a right. I said, "You are naive if you think the US manufacturing sites are adequately inspected. I merely said the difference was being subject to licensing in the US, not where the manufacturing plant was located. It would appear the plants in China were subject to US inspection but that it did not occur."

And I said it because you implied there was some correlation in location of drug manufacturing and drugs for sale within or outside the US. I said the difference was drugs sold within the US meet the US FDA approval process, not that they are manufactured within the US borders.

Of course counterfeit meds are bad. Were you aware some US pharmacists have been convicted of selling counterfeit drugs?

Washington Post; Date: 18th October 2003; U.S. Prescription Drug System Under Attack Multibillion-Dollar Shadow Market Is Growing Stronger (http://www.biopsychiatry.com/misc/prescription.html)The illegal operators exploit gaps in state and federal regulations to corrupt this system, creating a wide-open drug bazaar that endangers public health. A yearlong investigation by The Washington Post has found:

* Networks of middlemen, felons and other opportunists operating out of storefronts and garages fraudulently obtain deeply discounted medicines intended for nursing homes and hospices. The medicines are stored in U-Hauls and car trunks in blazing heat, manhandled, stuffed in plastic sandwich bags and traded in a daisy chain of transactions with no purpose except to enrich the traders. Those drugs are ultimately sold to unwitting patients.

* Counterfeiters using pill-punching machines and special inks produce near-perfect copies of the most popular and expensive drugs. They pass undetected through wholesalers to the shelves of retail pharmacies.

* Pharmaceutical peddlers take advantage of lax regulations to move millions of prescription drugs into the United States from Canada, Mexico and elsewhere. Overwhelmed customs workers inspect less than 1 percent of an estimated 2 million packages containing medicine shipped into the country each year. Virtually all of those shipments are illegal, yet the Food and Drug Administration fails to enforce its own import regulations, saying it lacks the resources to intercept the illegal packages.

* Rogue medical merchants set up Internet pharmacies that serve as pipelines for narcotics, selling to drug abusers and other buyers who never see doctors or undergo tests. The sellers move tens of millions of doses of hydrocodone, Xanax, Valium, Ritalin, OxyContin and other controlled substances. Scores of customers have become addicted, overdosed or died.

These illegal pharmaceutical sales have rapidly multiplied, with little public attention.

[SteveGrenard]

And the source of counterfeit drugs? China and elsewhere in Asia. Well documented,by Interpol and other law enforcement agencies.

On the question of FDA inspections for overseas manufacture of drugs do you know what
legal authority the FDA has over the sites inspected? If they are guilty of GMP violations what can the FDA do? In Amerrica they can shut down the plant, call for improvements and recall products. What can the FDA do about fake heparin being mader in China? Prohibit its import into the U.S. if they can find it or if incidents occur as happened in this case. If anything was found amiss in the fcoreign made product the FDA could do little other than to recommend changes. They have no legal authority over the non-US parts of this complex manufacturing process. On the other hand, here in country, they could go in and shut down a facility in violation. Get a court order and padlock it if necessary.

All this does not stop felons, criminals, from counterfeiting drugs, designing them to assay and look like the genuine article. Like it or not, China is the home to the deliberate counterfeting of most of medications referred to in your reference.



I don't doubt that inspections often did not occur because the FDA has neither the resources, manpower or budget to conduct them.

I am extremely familiar with the manufacture of pit viper antivenom for U.S. snakebite. It is made from venom collected by U.S. snakes in America, the venom is then shipped to Australia or Wales where it is injected into sheep, the antibody containing serum from the sheep is then withdrawnsent to England where it is purified, freeze dried or lypholized and packaged for
export to the United States. This product at some points in its development involved three different countries, all of which were inspected by the FDA and found in compliance at all levels. On the other hand the FDA inspected a plant in the U.S., in Pennsylvania, where a competing product was made and found it to be in substantial violation of GMP compliance. This plant was shut down, the product was withdrawn by the company and the facility sold off to another pharma company to make vaccines.

[Skeptic Ginger]

Do you have a source that says the counterfeit drugs are being made in China? I have not seen that anywhere.

[SteveGrenard]

I recall seeing it on a newshow such as Nightline. I will try and find you some refs.

[SteveGrenard]

Do you have a source that says the counterfeit drugs are being made in China? I have not seen that anywhere.

Yes, check this one out:

http://usinfo.state.gov/eap/Archive/2005/May/20-45620.html

Yes I am aware that licensed U.S. pharmacists have been arrested, convicted and
even jailed for knowingly trafficking in counterfeit drugs ...er, origin, China. You can find
cases on Google by searching "origin counterfeit drugs China".

Give someone who is a crook a way to make an easy buck or bigger profit and they'll take it even if it means hurting people, in this case, patients. Such pharamcists are among the lowest form of life after the Chinese counterfeiters themselves.

[Skeptic Ginger]

Thank you for the opportunity to testify about FDA’s efforts regarding counterfeit prescription drugs... (http://www.fda.gov/ola/2005/counterfeit1101.html)FDA cannot, however, offer the same assurance to the public about the safety and quality of drugs purchased from sources that are outside the U.S. regulatory system. My testimony today will focus on FDA’s efforts to further secure the safety of our nation’s drug supply. ...

Although FDA believes domestic counterfeiting is not widespread, the Agency has witnessed an increase in counterfeiting activities and a more sophisticated ability to introduce finished dosage counterfeits into legitimate drug distribution channels. Illicit wholesale drug diverters provide the window through which most counterfeit drugs have historically entered legitimate distribution channels. ...

While the rate of counterfeiting in the U.S. is difficult to estimate, on a global scale, counterfeiting is a widespread problem and affects both developing and developed countries. The World Health Organization (WHO) has reported that up to 25 percent
of medicines consumed in poor countries are counterfeit or substandard. It has been reported that up to 50 percent of drugs for sale in some countries are counterfeit. Counterfeit drugs are most prevalent in developing countries. ...

In one instance, over two million unapproved and potentially unsafe and ineffective Ovulen-21 birth control tablets from Panama were distributed throughout the U.S. ...

On August 21, 2005, the U.S. Attorney’s Office for the Western District of Missouri issued a press release announcing that three businesses and eleven individuals were indicted for their involvement in a $42 million dollar conspiracy to sell counterfeit, smuggled and misbranded Lipitor and other drugs and for participating in a conspiracy to sell stolen drugs. As part of this investigation, FDA initiated a recall of more than 18 million Lipitor tablets, which ranks as one of the largest recalls in the history of criminal investigations of counterfeit medications.

Participants in this scheme conspired to purchase and sell counterfeit, misbranded and illegally imported drugs. Foreign versions of Lipitor and Celebrex were smuggled into the U.S. from South America and re-sold after being re-packaged to conceal the true origin of the drugs. Counterfeit Lipitor also was manufactured in South America and then smuggled into the U.S. where it was co-mingled with the genuine foreign Lipitor and sold in the U.S. In addition, participants conspired to buy, sell and traffic almost eight million dollars worth of stolen Glaxo Smith Kline and Roche drugs, using fake pedigrees to launder the drugs and thereby concealing that they were stolen. There also were charges related to the sale of counterfeit Procrit, as well as counterfeit and misbranded Serostim and Neupogen. Procrit is an injectable drug used in the treatment of anemia and Neupogen is an injectable drug used by cancer patients to stimulate the production of white blood cells in order to decrease the incidence of infections....

On September 12, 2005, the U.S. Attorney’s Office for the Southern District of Texas announced the indictment and arrest of an individual from the state of Washington for his alleged involvement in the importation from China and subsequent distribution of counterfeit drugs, including Viagra and Cialis. This joint OCI and U.S. Immigration and Customs Enforcement (ICE) investigation was significant in that it also involved the direct assistance of OCI and ICE in China to determine the source of the counterfeits. As a result of this collaborative effort, Chinese authorities arrested 11 individuals who will be prosecuted by the Chinese government for their involvement in manufacturing and distributing counterfeit Viagra, Cialis, and Lipitor. In addition to the arrests, Chinese officials recovered 600,000 counterfeit Viagra labels and packaging, 440,000 counterfeit Viagra and Cialis tablets, and 260 kilograms of raw materials used to manufacture counterfeit drugs....

In October of this year, the U.S. Attorney’s Office for the Southern District of Florida issued press releases following the sentencing of two individuals involved in drug diversion and counterfeiting. One individual was sentenced to 30 months in jail for counterfeiting Zyprexa and Risperdal prescription labels and selling them to various individuals. In a related investigation, a second individual was sentenced to 24 months in jail for the illegal wholesale distribution of prescription drugs and possession with the intent to distribute controlled substances....

In the summer of 2004 and again in the spring of 2005, OCI received Voluntary Suspect Counterfeit Drug notifications from the drug manufacturers of Zocor, Carisoprodol, Lipitor, Viagra, and Evista. Counterfeit versions of these drugs were being sold to U.S. consumers from Mexican pharmacies along the U.S. border. The analysis of all these drugs showed they either contained little or no active ingredients....

In pleading guilty, the defendant admitted that he conspired with a manufacturer in Beijing to import thousands of counterfeit Viagra tablets into the U.S., which he would then resell. The defendant was sentenced, on March 25, 2005, to 18 months in prison, followed by 3 years probation and was fined $6000....

n January of this year, a southern California man pled guilty to importing counterfeit Viagra from China and manufacturing 700,000 counterfeit Viagra tablets at a lab in the U.S. An accomplice was convicted of similar charges in September 2004. The total value of the counterfeit Viagra in this case is more than $5.65 million....

The drugs distributed included a variety of products counterfeited in Mexico, smuggled into the U.S. and sent throughout the country. Some of the ingredients for the drugs were shipped from India and China. In other instances, unapproved and counterfeit drugs made in India and Pakistan entered the U.S. via the Bahamas. At least 14 other individuals also are being prosecuted in California or Florida as part of this international conspiracy....


So it would seem that a number of countries are locations for counterfeiting, China has been involved in enforcement, and plenty of US citizens are willing to do bad things to make a buck.

[Skeptic Ginger]

Could you restate your position or reason for appearing to single out China here?

[SteveGrenard]

Could you restate your position or reason for appearing to single out China here?

It was and remains the source of counterfeit heparin imported into the United States, a counterfeit that was cleverly concocted and resulted in an unknown number of deaths,
reported now at 103. It was the source of toothpaste and mouthwash that resulted in deaths in Panama. The toothpaste was a particularly nefarious operation, using antifreeze as the sweetner instead of glycerin, and packaged to appeal
to children, many of whom died. After the childrens deaths in Panama the U.S. managed to intercept shipments here before any child died.

I do not doubt other countries stamp out counterfeit pills, particularly popular ones that sell at a premium such as Viagra, which
besides
being used for the non critical disorder of ED is also prescribed for pulmonary hypertension. I just appear to be singling out China because they are a major player in many high profile incidents and if you read the report on the State Department website I cited above you would see that.

[Skeptic Ginger]

What makes you think I didn't read it?

I'd say your position is somewhat softened from the first few posts suggesting the problem was the US pharmaceutical companies buying ingredients from Chinese suppliers given that country's government did little to enforce product quality and company honesty.

[SteveGrenard]

What makes you think I didn't read it?

I'd say your position is somewhat softened from the first few posts suggesting the problem was the US pharmaceutical companies buying ingredients from Chinese suppliers given that country's government did little to enforce product quality and company honesty.

So be it ... somewhat softened. While I agree there are middlemen and pharmacy purveyors who knowingly traffic in counterfeit meds there are others who do not. There is also the layer represented by the end users of such meds -- the patients. I don't reasonably expect either Baxter, for example or the patients who ended up getting their crappy fake Chinese heparin to whip out a state of the art desorption mass spectrometer and check every drug they distribute, retail or administer or voluntarily swallow when they've been doing so for most of their lives. That is until China, and yes other nations home to counterfeit operations, have come into being.

So blame the victims .... that nefarious defense tactic that works so well in rape cases.

[SteveGrenard]

Here's more news unfolding on the Chinese heparin scandal:

April 15, 2008: 05:02 PM EST


(Updates with additional SPL comment in fifth paragraph.)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The top U.S. Food and Drug Administration official told a Senate panel Tuesday he believes batches of Baxter International's (BAX) blood thinner heparin sourced from China were likely tainted for economic reasons.
Last month the FDA said some of the heparin contained oversulfated chondroitin sulfate, an altered version of chondroitin sulfate that's used as a dietary supplement and is typically made from animal cartilage.

"It was apparently done, we suspect, by virtue of economic fraud," said Andrew von Eschenbach, FDA commissioner before the Senate Appropriations Committee's agriculture subcommittee hearing on the agency's fiscal 2009 budget.

http://money.cnn.com/news/newsfeeds/articles/djf500/200804151702DOWJONESDJONLINE000731_FORTUNE5.htm

I am sorry, I thought you didn't read it because you asked me to provide a reference to China's role in drug counterfeiting, this review did that but you seemed to be unimpressed with my response to your question. No problem. I am glad you read it.

[SteveGrenard]

Here's an update on the FDA getting inspections in China:

http://ap.google.com/article/ALeqM5jbComwdCp5Vt0SqZwgtFD0z-MMMAD90RKLT82

WASHINGTON (AP) — Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday.

The Food and Drug Administration wants to establish foreign offices in three Chinese locations — Beijing, Shanghai and Guangzhou. Thirteen employees would be assigned to work there.

Leavitt said Chinese health officials support the concept of an FDA presence, but the Ministry of Foreign Affairs has yet to give its formal approval. Once it does, the ministry will begin the process of approving diplomatic visas.

"Bureaucracies in their country and in ours never move fast enough for me," Leavitt said. Still, he said he believed that approval for the offices would happen soon.