Its hard not to think of pharmaceutical conspiracies when... [Archive]

Wolfman

20th November 2009, 11:20 PM

...I often hear people talking about the 'great conspiracies' between multinational pharmaceuticals to keep prices of medications high, and all that goes with that...you know, stuff like making people take medications they don't need, or that are harmful (think immunization shots); or hiding discoveries that would cure the conditions their drugs treat (like the colloidal silver nonsense).

Now, I'm not supporting the majority of such theories; but I do think it is obvious that the pharmaceuticals industry in the US has very deep financial relationships with the US gov't...and that they will engage in unethical or even illegal activities in order to increase their profits (there have been plenty of cases of information about potential harmful side effects of drugs that are covered up in order to sell them). And the whole thing of paying doctors to sell their drugs (thereby encouraging doctors to prescribe medications that patients don't need, or that are more expensive than another equally effective treatment).

But today, I read this article (http://www.theglobeandmail.com/news/national/researchers-labour-of-love-leads-to-breakthrough-in-treating-ms/article1372414/) about a potential treatment for Multiple Sclerosis. It postulates an entirely different cause for MS than the standard theories; but it actually seems to be based on very sound science, with significant evidence to support it. Operations have been performed that have had far, far better results than any current MS treatment (in fact, in some cases this appears to cure MS altogether, while all current treatments serve merely to alleviate symptoms).

The article is very interesting reading, and I'd love to hear from those with stronger medical backgrounds comment on this, and particularly about the quality of research and the evidence to support this new idea.

However, one thing that struck -- and concerned -- me when I read this article was the following quote:
The U.S. society goes further, discouraging patients from getting tested or seeking surgical treatment. Rather, it continues to promote drug treatments used to alleviate symptoms, which include corticosteroids, chemotherapy agents and pain medication.Now, I understand the need for caution; and certainly, I myself have often told friends that they should stick with established, proven treatments rather than pursuing unproven or questionable claims.

But at least based on the info in this article, this is a theory and a treatment with very solid science behind it, and with plenty of evidence that, at the very least, deserves very serious study. Yet in the U.S., they are instead advising people to even stay away from getting tested, and seem to indicate no real interest or desire to study this further. After all, if they were planning to study this...wouldn't they be actively looking for people who wanted to volunteer to be a part of such a study, rather than telling them, effectively, "Stay away from this cure, and instead just keep taking your medications that will simply alleviate your symptoms."

Certainly, elsewhere in the world, doctors seem to be taking this very seriously...they may not be ready to say, "This is the answer", but they're certainly saying it deserves very serious study.

And I can't help but feel that -- if the information in this article is correct (which I'm hoping others can help verify), it really does sound like a case of Big Pharmaceutical doing their very best to hang on to an audience that is dependent on their medications, and keep them away from a treatment that could, in fact, make their medications practically worthless.

Comments?

PingOfPong

20th November 2009, 11:58 PM

But at least based on the info in this article, this is a theory and a treatment with very solid science behind it, and with plenty of evidence that, at the very least, deserves very serious study. Yet in the U.S., they are instead advising people to even stay away from getting tested, and seem to indicate no real interest or desire to study this further. After all, if they were planning to study this...wouldn't they be actively looking for people who wanted to volunteer to be a part of such a study, rather than telling them, effectively, "Stay away from this cure, and instead just keep taking your medications that will simply alleviate your symptoms."

The article said that researchers in Buffalo are recruiting 1700 MS sufferers for testing. That sounds like some serious medical research to me.

Are you insinuating somewhere here that the American MS society is advising people away from the Zamboni treatment in order to bolster drug sales? That's the only conspiracy theory that I can draw from this.

Wolfman

21st November 2009, 12:23 AM

Are you insinuating somewhere here that the American MS society is advising people away from the Zamboni treatment in order to bolster drug sales? That's the only conspiracy theory that I can draw from this.I'm stating that this would be a very valid suspicion. Not to 'bolster' drug sales, as such, but rather to ensure that drug sales continue.

I'm not saying there is such a conspiracy...just that the article, and the way this particular segment was worded, certainly raised that question in my mind. Would be curious to know of the American MS Society's links to such drug companies...ie. do they receive significant financial support from them? Are people from pharmaceutical companies on their Board of Directors, or have other influence on policy? There were, after all, all sorts of 'health organizations' that were set up (or influenced) by the tobacco industry to pump out false information, produce propaganda in the guise of 'research', and encourage people that smoking was really 'not that dangerous'.

And there can really be no doubt at all that if this new treatment proves valid, the drug companies that make the current MS drugs will be looking at a huge hit to their revenues. They cannot be looking at this and saying, "Oh, goody."

The response of the American MS Society just seems to stand in such stark contrast to everyone else's responses. It seems -- and again, I'm basing this only on the article in question -- to rather actively advocate against this new theory, to the point of even telling people not to bother even getting tested (which would not harm them in any way whatsoever). It is hard to believe that sincere interest in determining the validity of a potentially life-changing treatment would be demonstrated by telling everyone with MS not to even get tested to see if the iron levels in their systems match the patterns of other MS patients.

How does sincere scientific desire to determine if this new theory is valid supported by telling those with the disease to avoid testing? And where is the interest in a potential cure, compared with keeping people on a life-long treatment of drugs that, at best, only alleviate symptoms?

Again...I am basing all of this only on the info in the article here. I'm quite certain that others will be able to give a lot more information about this, and it could well be that some of the information in the article gives an inaccurate picture of what's actually happening.

My point is simply that, the way this particular article is written, its pretty hard not to read it and think 'that's mighty suspicious'.

P.S. -- I posted this here, rather than the conspiracy forum, specifically because I'm more looking for knowledgeable commentary on the whole thing, as opposed to paranoid fantasies.

fls

21st November 2009, 03:31 AM

Myriad

21st November 2009, 05:24 AM

Why are the MS societies promoting caution?

The U.S. society goes further, discouraging patients from getting tested or seeking surgical treatment. Rather, it continues to promote drug treatments used to alleviate symptoms, which include corticosteroids, chemotherapy agents and pain medication.

I think the answer lies in the ensuing paragraph:

Many people with multiple sclerosis, though, are impatient for results. Chatter about CCSVI is frequent in online MS support groups, and patients are scrambling to be part of the research, particularly when they hear the testimonials.

...when viewed in the context of the nature of MS:

- MS occurs as a series of attacks, with periods of remission (not sure if that's the correct term) in between.

- MS is a progressive disease. The current treatment is to ward off attacks and to limit the severity of attacks when they do occur. Attacks, especially severe ones, permanently worsen the patient's baseline condition.

- The drugs used to ward off attacks and limit their severity when they occur do have undesirable side effects.

Put those three facts together and you have a recipe for disaster if an unproven treatment (even one that works well in some but not in all MS patients) is overhyped. If the surgery is not available to everyone immediately, or if it doesn't work as hoped, or if it doesn't work on everyone, you could have large numbers of patients refusing their troublesome medications in expectation of having been or soon being cured by surgery, thinking they are cured until their next attack, and having severe attacks with permanent consequences.

The current treatments for MS work very well in slowing the progressive course of the disease to a relative crawl. For most patients there is plenty of time for studies to be completed, to sort out the risks, benefits, and limitations of the Zamboni treatment. But not if patients en masse abandon their current therapies prematurely.

Respectfully,
Myriad

ETA: Here's a simpler way to put it. The recommendation to continue to "promote drug treatments used to alleviate symptoms" might make more sense when one realizes that the chief "symptom" being alleviated is permanent progressive nerve damage.

Modified

21st November 2009, 05:35 AM

Wolfman

21st November 2009, 05:41 AM

Dancing David

21st November 2009, 06:00 AM

Myriad

21st November 2009, 06:02 AM

Here's the (U.S.) National MS Society's explanation, for what it's worth. From http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2206.

Q: I have MS. Should I be tested for signs of CCSVI?
A: No, unless you are involved in a research study exploring this phenomenon, since at this time there is no proven therapy to resolve any abnormalities that might be observed, and it is still not clear whether relieving venous obstructions would be beneficial.

Sounds like a boilerplate cautious reaction to initial news of a claimed breakthrough. Apparently treating venous obstruction surgically is not a standard surgical measure but rather is itself experimental. If the procedure does prove beneficial, this will be quickly overtaken by events.

Respectfully,
Myriad

fls

21st November 2009, 06:04 AM

The article talks about a person with 60 and 80% blockages in his jugular veins. In the absence of MS symptoms (or any symptoms), wouldn't this still be something that would be treated surgically? I know that when blockages in the arteries feeding the brain get to around 60% they start considering surgery. Is it different for veins?

Yes it is different for veins. Surgery would not normally be indicated simply for the presence of a venous stenosis.

Linda

fls

21st November 2009, 06:13 AM

Myriad,

In regard to A) abandoning current treatment and/or B) rushing into surgical treatment, I would agree.

But in regard to simply getting tested? I guess that's where my difficulty lays...since one of the key steps in determining the validity of Zamboni's claims is to determine if there are indeed differences in iron levels between those with MS, and those without.

However, arbitrary testing of a hodge-podge of patients who may or may not have MS will not help in that determination. It will simply cause anxiety or stress or false reassurance as well as wasting resources, while contributing little to our knowledge about MS. Surely it is reasonable to suggest that we can do better than that?

Also, it should be pointed out that the testing referred to is not the testing of iron levels, which is at least cheap, but rather specialized MRI or US scans.

Testing neither requires abandoning current treatments, nor does it require surgery. It is the strong advice against testing which bothered me.

As PingOfPong pointed out, researchers are looking for 1700 MS sufferers for testing. How does that ballance with the American MS Association telling people, "Don't get tested"?

It's one thing to participate in a study where there is at least a chance that useful conclusions can be drawn from the data, and another thing to gather information which cannot be placed into context and from which no conclusions can be drawn.

Linda

ARubberChickenWithAPulley

21st November 2009, 06:00 PM

But in regard to simply getting tested? I guess that's where my difficulty lays...since one of the key steps in determining the validity of Zamboni's claims is to determine if there are indeed differences in iron levels between those with MS, and those without.

Testing neither requires abandoning current treatments, nor does it require surgery. It is the strong advice against testing which bothered me.

But testing does cost money. An MRI in the U.S. can be expensive (average is around $1500, and brain scans are on the higher end of the spectrum). I'd imagine few if any insurance companies would pay for it either for this purpose -- which means the patient would likely pay out of pocket.

And let's say a patient does get tested -- what's the point? I'd imagine few organizations are at the point where they'd recommend the surgery, since the whole thing is relatively unproven. So the end result of the test is that the patient would have paid a thousand bucks (or more) to know if they have a condition that may or may not be related to MS, for which they may or may not be able to pay (probably an even more substantial sum) to have surgery to cure (again, doubtful any insurance company would cover it. This is the very definition of experimental).

It makes sense to me that, at this point, they would not recommend for people to get tested. You might disagree with that, but I think the above reasoning is far more likely than a conspiracy between these groups and big pharma.

Eos of the Eons

21st November 2009, 07:26 PM

All of the MS societies I know of are non-profit, and none get donations from drug companies, maybe personally from some employees like they would from grocery store or auto company or any other company employees. MS societies don't conduct research themselves and wouldn't get grants. Nurses are often employed to see patients, while the other staff conduct support groups and give out information on where financial support can be accessed while they suffer the effects of the disease.

Plaques in the brain, and other symptoms prove the nervous system is involved. Veins??? Iron is bound in hemoglobin in a way contradictory to what zamboni is suggesting.

The mainstay of science is to replicate findings. If veins were blocked, then don't varicose veins result, not MS? I'm sure other researchers would refute these claims competently. Other vein blockage problems and their treatments don't stack up to his claims.

This guy sounds like other hacks out there that come up with crazy hypotheses and then go to the public instead of publishing their results where peers can review and attempt to replicate and substantiate it.

Jumbled within his claims are other hack claims about things like vitamin D. If it were that simple, then supplementation would reveal results, but people aren't being cured by vitamin D (overdoses of vitamin D can also cause painful kidney stones).

There is myelin loss on nerve cells, so how is that and how it affects the cerebellum explained by venous problems?

Also, closely related are ALD and ALS.

Wolfman

21st November 2009, 07:59 PM

This guy sounds like other hacks out there that come up with crazy hypotheses and then go to the public instead of publishing their results where peers can review and attempt to replicate and substantiate it.
Thanks for the responses everyone...appreciated :-)

However, Eos...I'd point out that, in contrast to most "hack claims", this one is in fact being taken very seriously by the medical community, with medical groups in a number of nations planning to test his theories further. They don't seem to consider his claims to either be "crazy", or without merit.
There is myelin loss on nerve cells, so how is that and how it affects the cerebellum explained by venous problems?You did read the article before responding, yes? Because it addressed this question directly:
He hypothesized that iron was damaging the blood vessels and allowing the heavy metal, along with other unwelcome cells, to cross the crucial brain-blood barrier. (The barrier keeps blood and cerebrospinal fluid separate. In MS, immune cells cross the blood-brain barrier, where they destroy myelin, a crucial sheathing on nerves.)
I appreciate everyone's comments. I agree 100% that more study needs to be done before people go rushing to have surgical intervention.

But given how seriously many in the medical profession seem to be taking this, I find apparently full-out rejection or condemnation of him puzzling, too. I have a hard time believing that researchers and medical professionals would be taking his claims seriously enough to engage in large-scale studies in several different countries if it was "just another hack" claiming a miracle cure.

Professionals who have far more understanding of this than I do are, apparently, taking his claims seriously, and undertaking to examine them much more closely to determine their validity. To me, this is an indication that there is, in fact, at least some substance to his claims, enough that it does deserve serious consideration.

And it is for that reason that I found calls not to even seek testing to be questionable; given some of the arguments here, I have amended my opinion in that regard. Particularly Myriad's clarification that the American MS Society actually says not to seek testing except as part of a formal research study. Which seems far more reasonable to me than simply "You should not get tested."

But equating this with other quack theories? I dunno. There are an awful lot of very knowledgeable medical professionals who seem to be taking his theory quite seriously.

technoextreme

21st November 2009, 08:18 PM

Emperor_Gestahl

21st November 2009, 11:18 PM

I can't comment on the Iron theory because I have several levels of confirmation bias in this area. I can add though that being nonprofit does not make an organization above conflicts of interest, especially in cases where the continued existence of the organization is dependent on the continued existence of a specific disease or condition.

fls

22nd November 2009, 04:52 AM

Thanks for the responses everyone...appreciated :-)

However, Eos...I'd point out that, in contrast to most "hack claims", this one is in fact being taken very seriously by the medical community, with medical groups in a number of nations planning to test his theories further.

Where are you getting the idea that this is being taken very seriously by the medical community or that medical groups in a number of nations are planning to test his theories further? The only study mentioned is one out of Buffalo which will look at diagnostic imaging (not surgery). Recruiting enough patients will necessarily involve physician involvement in other centres, but agreeing to supervise patients undertaking a diagnostic imaging study is not the same as taking the idea very seriously. A single study involving a handful of doctors which is designed to test whether or not there is even anything there other than selection bias is hardly enough to start recommending that people rush out to participate in the latest MS woo (and MS is perfect for generating woo therapies, since as has been pointed out already, MS comes and goes on its own, and many people measure its presence through subjective evaluations).

If this claim was taken seriously by the medical community, you'd see many physicians start to offer this treatment with referrals to these physicians from neurologists. Instead, what you are seeing is a handful of researchers willing to address the validity of his images and the vast majority of professionals ignoring his main claim.

Linda

Eos of the Eons

22nd November 2009, 05:20 AM

I thought I saw the article end and then comments start. He's playing with his wife, but seems to have forgotten that the disease waxes and wanes. Almost anything can seem to help for a while until a person experiences symptoms again.

My points also stand. We have a bunch of deluded DAN doctors trying to cure autism by giving people a treatment for heavy metal poisoning. Heavy metal poisoning doesn't cause autism though, any more than his claims abut iron causes MS. He doesn't seem to understand how to check his hypothesis against reality.

The plaques in the brain are not iron.

If peoples veins were blocked, then they they were misdiagnosed. He hasn't shown a re-myelination of nerves, and other evidence is lacking.

It's good if others do research, it's the only way to prove or disprove what this guy is claiming.

Eos of the Eons

22nd November 2009, 05:21 AM

fls

22nd November 2009, 05:30 AM

The MS societies don't do research.

Many of these disease-specific charities offer grants/funds for research - it's an important source of non-Big-Pharma research dollars.

Here's the first example that popped up on a quick google search:
http://www.nationalmssociety.org/for-professionals/researchers/get-funding/collaborative-ms-centers/index.aspx

Linda

icerat

22nd November 2009, 05:44 AM

Eos of the Eons

22nd November 2009, 06:45 AM

Many of these disease-specific charities offer grants/funds for research - it's an important source of non-Big-Pharma research dollars.

Here's the first example that popped up on a quick google search:
http://www.nationalmssociety.org/for-professionals/researchers/get-funding/collaborative-ms-centers/index.aspx

Linda

Yes, they can raise funds for research, but most don't. They don't do the research. And the fine ladies I know at the MS Society here would be more than happy to close their doors and work elsewhere if all MS suddenly got cured.

fls

22nd November 2009, 06:48 AM

My feeling is that the MS society is just being cautious, particularly given the costs involved.

What I find more revealing is the responses on this forum.

We have Professor of Medicine, with a pretty respectable number of relevant peer-reviewed publications in the field (http://scholar.google.se/scholar?q=Paolo+Zamboni&hl=en&btnG=Search&as_sdt=2001),

These are studies on peripheral venous disease, not studies on MS, which makes these studies not relevant. Now why would you consider them relevant?

at a respected University who has undertaken a study (and 65 people is not "small" in the context of pilot studies like this) with extremely promising results

The intervention study was without controls, in patients who were diagnosed specifically as having a disease which waxes and wanes, with subjectively measured outcomes (the extent of which is highly amenable to expectation). Rather than "extremely promising", the results were exactly what you'd expect if the intervention had no effect. That is you'd expect a substantial portion, if not all, of the people to have a waning of their disease, even if there had been no intervention. And you would expect most of them to report subjective improvements in any symptoms, simply on the basis of well-known cognitive biases resulting from participating in an amazing new experimental treatment provided by a committed and enthusiastic proponent.

and on JREF he's virtually being labelled a quack. :confused:

I'd wonder more about the agenda of some folk here than the MS society! :cool:

Why on earth would you have to "wonder"? I've always made it clear that my interest is in the use of scientific methods and evidence-based recommendations in medicine. It hardly makes sense to label it a "conspiracy" when it is discovered that most physicians and organizations dedicated to specific diseases have a similar interest.

Linda

Eos of the Eons

22nd November 2009, 06:50 AM

technoextreme

22nd November 2009, 07:17 AM

We have Professor of Medicine, with a pretty respectable number of relevant peer-reviewed publications in the field (http://scholar.google.se/scholar?q=Paolo+Zamboni&hl=en&btnG=Search&as_sdt=2001), at a respected University who has undertaken a study (and 65 people is not "small" in the context of pilot studies like this) with extremely promising results and on JREF he's virtually being labelled a quack. :confused:

*Claps* Congratulations you have just won the award for fitting the most logical fallacies in a single sentence. I could write a paragraph on how that means absolutely nothing. I've seen peer reviewed papers completely decimated that were written in Nature. I've seen peer reviewed papers that somehow screwed up the structure of the molecule that they were actually studying. Professors at prestigious universities either do go quacky or just screw up. Rustum Roy is one such example and a faculty member at my university screwed up research involving intercalation of Lithium which if he was correct would have been bigger than sliced bread. Perhaps quackery wasn't the best word. Crap.

Moochie

22nd November 2009, 09:20 AM

A researcher is promoting a treatment based on observations made in the absence of controls, and by extrapolating from ideas without establishing the hypothetical or theoretical soundness to those ideas in the first place. What you have is a physician operating in the same manner as homeopaths and every other SCAM proponent, yet for some reason, those who caution against using a treatment whose effectiveness beyond placebo has not yet been established must be part of a conspiracy?

Linda

Also, there are a few interesting comments accompanying the article. I think it very wise to be cautious. First, it must be rigorously established that there is anything to this beyond anecdotes. It appears that this is relatively new -- let some accredited people get behind it and determine what is and isn't true, before raising people's hopes needlessly. I remain hopeful that the guy's onto something, but would prefer to see some reliable evidence before commenting further.

ETA: I understand that MS sometimes goes into permanent remission, but perhaps someone more knowledgeable could clarify this for us.

ETA #2: Given that this field of study isn't new:

The idea that MS may involve a problem in blood circulation was an early idea that was eventually dismissed as more research suggested that immune-system attacks and inflammation played a pivotal role in the damage to nervous system tissues. A few recent studies have posed the idea that lower blood flow in the brain might contribute to nervous system damage.

It seems to me that Zamboni may be looking for a question to his unverified answer.

M.

icerat

22nd November 2009, 10:41 AM

These are studies on peripheral venous disease, not studies on MS, which makes these studies not relevant. Now why would you consider them relevant?

Ummm, geee, maybe because his theory link peripheral venous disease and MS? Would you be happier if he was an MS expert with no knowledge on peripheral venous disease? It's not unusual for breakthroughs, if this is one - and clearly more research needs to be done to determine that - to come from people who are experts in related fields but not the specific issue.

The intervention study was without controls, in patients who were diagnosed specifically as having a disease which waxes and wanes, with subjectively measured outcomes (the extent of which is highly amenable to expectation).

Number of brain lesions is "subjectively measured"? According to the news article that was one metric they looked at.

Rather than "extremely promising", the results were exactly what you'd expect if the intervention had no effect. That is you'd expect a substantial portion, if not all, of the people to have a waning of their disease, even if there had been no intervention.

I'm by no means an MS expert, is it normal for 73% of sufferers to have no symptoms for 2 years, after suffering attacks regularly before that? I know there's a relapse and remission pattern, but 73% for over 2 years seem fairly large numbers to me - the news article calls it "dramatic".

Furthermore, I'd be extremely surprised if a Professor of Medicine with a substantial publishing history is not aware of something as obvious as this and it isn't at least addressed in any final publication.

And you would expect most of them to report subjective improvements in any symptoms, simply on the basis of well-known cognitive biases resulting from participating in an amazing new experimental treatment provided by a committed and enthusiastic proponent.

None of which makes him a quack or his hypothesis wrong. It just means there's stuff that needs to be controlled for in further research. Incidentally, since you appear to know there was no controls, which isn't mentioned in the news article, I gather you have a copy of the study?

Why on earth would you have to "wonder"? I've always made it clear that my interest is in the use of scientific methods and evidence-based recommendations in medicine. It hardly makes sense to label it a "conspiracy" when it is discovered that most physicians and organizations dedicated to specific diseases have a similar interest.

I didn't label it a conspiracy, quite the contrary I said I think the MS society is being sensibly prudent. My comment is regard to promising research being dismissed on JREF rather than taken for what it is - promising research that deserves further investigation. So far what we're seeing is science in action. A theory, a plausible mechanism, a small study to see if it's worth looking at further, and if further studies (and funding!!!) are justified.

Heck, just the finding 90% of MS sufferer tested had these blockages compared to none without MS is pretty staggering. To just simply dismiss findings like that is the antithesis of good science. It deserves further investigation.

Now, if you can provide me with some evidence that decreases in brain lesions and no symptoms in three quarters of patients for over 2 years is "normal" in MS progression, then that's fine, you've a reasonable basis for skepticality. I'd also be interested in a theory of why you appear so sure the blockages have nothing to do with MS, given their apparent prevalence.

ETA: Oh look, Professor Zamboni does appear to know about the importance of matched controls (http://www.ncbi.nlm.nih.gov/pubmed/18045150?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_SingleItemSupl.Pubmed_Discovery_RA&linkpos=5&log$=relatedarticles&logdbfrom=pubmed).

icerat

22nd November 2009, 10:46 AM

*Claps* Congratulations you have just won the award for fitting the most logical fallacies in a single sentence. I could write a paragraph on how that means absolutely nothing. I've seen peer reviewed papers completely decimated that were written in Nature. I've seen peer reviewed papers that somehow screwed up the structure of the molecule that they were actually studying. Professors at prestigious universities either do go quacky or just screw up. Rustum Roy is one such example and a faculty member at my university screwed up research involving intercalation of Lithium which if he was correct would have been bigger than sliced bread. Perhaps quackery wasn't the best word. Crap.

Oh good grief. And I've seen peer-reviewed papers published *with* controls that ended up being bogus too.

There is no logical fallacy at all in concluding that someone with a good publication history is probably a reasonably good scientist.

If you want to follow your kind of logic, then the (il)logical conclusion of your little rant is that all peer-reviewed research should be dismissed because some of it is crap.

Or should only the stuff you happen to disagree with for some reason be dismissed?

So far we have ZERO evidence at all to suggest this guy is a quack, and plenty of evidence to suggest he is not.

icerat

22nd November 2009, 12:12 PM

Found a list of relevant studies -

http://csvi-ms.net/en/content/publications-venous-multiple-sclerosis

#6 reports on some of the clinical results, probablity of relapse decreased 4-fold following treatment compared to the same population the previous year.

The more I'm reading of the actual theory and research, the more exciting this looks. Check out the unofficial minutes of the Bologna conference. If this pans out as true it may effect understanding of many neurological disorders.

fls

22nd November 2009, 12:31 PM

Ummm, geee, maybe because his theory link peripheral venous disease and MS? Would you be happier if he was an MS expert with no knowledge on peripheral venous disease? It's not unusual for breakthroughs, if this is one - and clearly more research needs to be done to determine that - to come from people who are experts in related fields but not the specific issue.

Peripheral venous hemodynamics and physiology are different from those processes within the central nervous system. It is not a trivial matter to lack familiarity with a disease whose diagnosis is complicated and unreliable when reliable and valid measurement is crucial. Evidence-based evaluations of diagnostic tests and of therapies involve a specific set of skills.

Number of brain lesions is "subjectively measured"? According to the news article that was one metric they looked at.

Most radiographic readings are performed blinded in studies, because there is a subjective component. However, this is not a good measure anyway.

I'm by no means an MS expert, is it normal for 73% of sufferers to have no symptoms for 2 years, after suffering attacks regularly before that? I know there's a relapse and remission pattern, but 73% for over 2 years seem fairly large numbers to me - the news article calls it "dramatic".

It is normal for people who have relapsing-remitting MS (note that 50% of the subjects did not have attacks in the two years prior to the surgery). And again, how would a reporter know whether or not that is the result which actually occurred and whether it would be characterized as dramatic? They are simply repeating what they were told. And they were not told anything about the 55 patients who also underwent surgery that the researchers chose not to mention.

Furthermore, I'd be extremely surprised if a Professor of Medicine with a substantial publishing history is not aware of something as obvious as this and it isn't at least addressed in any final publication.

This is the part where familiarity with Multiple Sclerosis would come in handy. :)

None of which makes him a quack or his hypothesis wrong. It just means there's stuff that needs to be controlled for in further research. Incidentally, since you appear to know there was no controls, which isn't mentioned in the news article, I gather you have a copy of the study?

It simply makes the information too unreliable to recommend its use outside the setting of a clinical study, which is all that is being said.

The study is in press, but the results are reported upon here (http://www.facebook.com/note.php?note_id=130978702210).

I didn't label it a conspiracy,

Right, Wolfman labelled it a conspiracy. Then you "wondered" why I would challenge him on that.

quite the contrary I said I think the MS society is being sensibly prudent. My comment is regard to promising research being dismissed on JREF rather than taken for what it is - promising research that deserves further investigation. So far what we're seeing is science in action. A theory, a plausible mechanism, a small study to see if it's worth looking at further, and if further studies (and funding!!!) are justified.

Did anyone say otherwise?

Heck, just the finding 90% of MS sufferer tested had these blockages compared to none without MS is pretty staggering. To just simply dismiss findings like that is the antithesis of good science. It deserves further investigation.

Now, if you can provide me with some evidence that decreases in brain lesions and no symptoms in three quarters of patients for over 2 years is "normal" in MS progression, then that's fine, you've a reasonable basis for skepticality.

So if I presume, from your request, that you did not have this information beforehand, what you are saying is that you chose to characterize these findings as "staggering" and "dramatic" without having any idea as to whether they are?

I'd also be interested in a theory of why you appear so sure the blockages have nothing to do with MS, given their apparent prevalence.

I'm not sure the blockages have nothing to do with MS. But in another paper Zamboni mentions that he had 1430 measures from doppler ultrasound. That's a pretty hefty denominator for a numerator of 5.

Linda

icerat

22nd November 2009, 01:12 PM

Peripheral venous hemodynamics and physiology are different from those processes within the central nervous system. It is not a trivial matter to lack familiarity with a disease whose diagnosis is complicated and unreliable when reliable and valid measurement is crucial. Evidence-based evaluations of diagnostic tests and of therapies involve a specific set of skills.

All of which seem to have been well addressed in their research

This is the part where familiarity with Multiple Sclerosis would come in handy. :)

It appears he has been studying it for years, and has numerous associates working in the field as well. This is the part I'm querying - the assumption for no apparent reason, that this guy is some quack who hasn't addressed such potential weaknesses.

It seems to be to me entirely unjustified and unfounded.

It simply makes the information too unreliable to recommend its use outside the setting of a clinical study, which is all that is being said.

I mostly agree, but given what appears to be pretty solid theory behind the treatment as well as other supporting evidence, it's pretty clear why sufferers would be keen to get in line.

The study is in press, but the results are reported upon here (http://www.facebook.com/note.php?note_id=130978702210).

And nowhere there is there any indication at all that the researchers did not compare with some control group. Yet you apparently dismissed the study assuming they had not. On what basis?

Right, Wolfman labelled it a conspiracy. Then you "wondered" why I would challenge him on that.

No, not at all. What I challenge you on is things like assuming it was a poorly designed study (it appears to be farily rigourous for an initial study), stating that the findings are what you'd expect if the intervention had no effect (which seems to be false, I suspect you just made that up).

My earlier comments weren't so much directed at you as the likes of Eons who stated the researcher was simply "playing with his wife" and forgotten things like MS "waxes and wanes" and technoextreme calling it "quakary" when in reality there seems to have been some pretty solid science going in to this for years.

Did anyone say otherwise?

Yes, scrollback and see Eons and technoextreme's comments

So if I presume, from your request, that you did not have this information beforehand, what you are saying is that you chose to characterize these findings as "staggering" and "dramatic" without having any idea as to whether they are?

No, I was asking about the one particular intervention study. The study about blockage prevelance was a different one.

I'm not sure the blockages have nothing to do with MS. But in another paper Zamboni mentions that he had 1430 measures from doppler ultrasound. That's a pretty hefty denominator for a numerator of 5.

Given the blockages occur in MS patients but not in normal patients, a finding replicated elsewhere, it seems unlikely the have nothing to do with MS.

Your scan comments are outside my knowledge area, however I did notice that apparently the scan technology and expertise they're using is relatively new and not readily available in the US.

This may of course contribute to the "conspiracy theory" - all my US republican friends constantly tell me the US has the best medical systems in the world and everyone travels there for treatement ... we can't very well have these pesky Europeans having a treatment with technology too advance for the US, can we? :D

(Just to make sure nobody takes that the wrong way, I *am* just joking... mostly ... ;))

technoextreme

22nd November 2009, 01:41 PM

There is no logical fallacy at all in concluding that someone with a good publication history is probably a reasonably good scientist.

Argument from authority.
If you want to follow your kind of logic, then the (il)logical conclusion of your little rant is that all peer-reviewed research should be dismissed because some of it is crap.

No. I'm saying READ THE DAM PAPERS AND IF YOU CAN NOT UNDERSTAND THEM THEN DO NOT MAKE ANY CONCLUSIONS. DO NOT BASE ANY ASSUMPTIONS OFF OF PUBLICATION HISTORY. DO NOT BASE MERIT OFF OF FAME.

icerat

22nd November 2009, 02:21 PM

Have you read the papers technoextreme?

My point is that I get the feeling YOU are making conclusions without having read them.

I've read quite a few of them now, and I understand enough to see it's worth taking seriously and also enough to see that other experts in the field are taking it seriously.

On what basis do you dismiss it?

icerat

22nd November 2009, 02:23 PM

Linda, I just reread your earlier post -

A researcher is promoting a treatment based on observations made in the absence of controls, and by extrapolating from ideas without establishing the hypothetical or theoretical soundness to those ideas in the first place.

On what basis did you make these statements? The researchers seem to have spent some years establishing sound hypotheses and theories to support the treatment and have undertaken studies with controls.

fls

22nd November 2009, 03:11 PM

All of which seem to have been well addressed in their research

Well, no, it's not. For example, when studying the reliability and validity of diagnostic criteria, you have to apply those criteria to a different population from which you developed your criteria. In his report on the US findings, he applied his criteria to the same population.

It appears he has been studying it for years, and has numerous associates working in the field as well. This is the part I'm querying - the assumption for no apparent reason, that this guy is some quack who hasn't addressed such potential weaknesses.

It seems to be to me entirely unjustified and unfounded.

Well, if he has been studying it for years, why has he proceeded without doing the kind of study that is necessary to show whether or not the treatment is effective?

I mostly agree, but given what appears to be pretty solid theory behind the treatment

The theory behind the treatment is not solid. There are plausible components to the idea, but many steps in establishing the idea are still missing, and it fails to explain some of the other information on MS (such as why other therapies have demonstrable effectiveness).

as well as other supporting evidence, it's pretty clear why sufferers would be keen to get in line.

And nowhere there is there any indication at all that the researchers did not compare with some control group. Yet you apparently dismissed the study assuming they had not. On what basis?

Are you serious? No control group is ever mentioned, the results are not reported as a comparison to a control group, the type of study (open-label, progressive) is the kind of study which does not have an untreated control group, no mention is made of randomization or blinding (two necessary components to the use of a control group), yet it is unreasonable for me to think that they don't have a control group?

No, not at all. What I challenge you on is things like assuming it was a poorly designed study (it appears to be farily rigourous for an initial study),

What are the criteria for 'rigour' in a clinical trial?

stating that the findings are what you'd expect if the intervention had no effect (which seems to be false, I suspect you just made that up).

I used the results from controls groups for clinical trials of other interventions for multiple sclerosis.

My earlier comments weren't so much directed at you as the likes of Eons who stated the researcher was simply "playing with his wife" and forgotten things like MS "waxes and wanes" and technoextreme calling it "quakary" when in reality there seems to have been some pretty solid science going in to this for years.

Well, some people like to rant a bit. :)

No, I was asking about the one particular intervention study. The study about blockage prevelance was a different one.

Here's an example:

http://content.nejm.org/cgi/content/full/354/9/899?ck=nck#T1

In a patient population with substantially worse disease than in Zamboni's group (for example, only 1 percent of patients in this group had no relapses in the prior year, compared to 50 percent in Zamboni's), 46 percent had no relapses in the following two years and the number of active lesions dropped from 49 percent to 28 percent.

Given the blockages occur in MS patients but not in normal patients, a finding replicated elsewhere, it seems unlikely the have nothing to do with MS.

You have to consider that the researchers had the choice of many different abnormal parameters and picked a handful as related to MS. This needs more work to show that it is a reliable and valid association. Even then, you are left with the problem of correlation not meaning causation.

Linda

fls

22nd November 2009, 03:18 PM

Linda, I just reread your earlier post -

On what basis did you make these statements?

On the basis that they studied a clinical intervention without controls and that haven't established anything beyond a temporary association of some imaging abnormalities with the presence of MS.

The researchers seem to have spent some years establishing sound hypotheses and theories to support the treatment

They have established that there is some plausibility to their ideas, which is an important step to get others interested in those ideas in order to test them, but they haven't established any causal connection, not have they established whether intervention is effective.

and have undertaken studies with controls.

I have been unable to find a reference to a controlled trial. Did you find some?

Linda

icerat

22nd November 2009, 03:52 PM

To address a few points ....

Well, if he has been studying it for years, why has he proceeded without doing the kind of study that is necessary to show whether or not the treatment is effective?

From what I've read, that's exactly what's happening (http://www.buffalo.edu/research/article.html?id=105620009). You can't have it both ways, claim they should have spent time on developing theoretical grounding, and when I point out they have claim they should have proceeded to more rigourous clinical trials!

The theory behind the treatment is not solid. There are plausible components to the idea, but many steps in establishing the idea are still missing, and it fails to explain some of the other information on MS (such as why other therapies have demonstrable effectiveness).

All perfectly normal for the early stages of investigating a potential new theory (depending on how you define "solid"). None of them are grounds for dismissing it.

Are you serious? No control group is ever mentioned ...

My point is *we don't know* what the researchers say about all this. I'm pretty certain the researchers no full well a larger study with a well matched control group is needed. It w

http://content.nejm.org/cgi/content/full/354/9/899?ck=nck#T1

In a patient population with substantially worse disease than in Zamboni's group (for example, only 1 percent of patients in this group had no relapses in the prior year, compared to 50 percent in Zamboni's), 46 percent had no relapses in the following two years and the number of active lesions dropped from 49 percent to 28 percent.

Zamboni's 50% figure is for "acute attacks". I'm guessing there is such a thing as "non-acute" attacks? Did both studies use the same criteria?

Either way, the data you provided does not support your assertion that a 74% 2yr no-relapse rate is to be expected.

You have to consider that the researchers had the choice of many different abnormal parameters and picked a handful as related to MS. This needs more work to show that it is a reliable and valid association. Even then, you are left with the problem of correlation not meaning causation.

Yes, and again perfectly normal in the initial phases of testing a new theory, and no reason for immediate (and in some cases above, violently agressive) dismissal.

BTW, this reference (http://news.sympatico.ctv.ca/Canada/ContentPosting_WFIVE?newsitemid=CTVNews%2F20091120 %2FW5_QandA_091121&feedname=CTV-W5_V3&show=False&number=0&showbyline=True&subtitle=&detect=&abc=abc&date=True) says this treatment in the US costs $80,000. If I had MS in the US, I think I'd hold off for a little more evidence!

Dancing David

22nd November 2009, 04:17 PM

Linda, I just reread your earlier post -

On what basis did you make these statements? The researchers seem to have spent some years establishing sound hypotheses and theories to support the treatment and have undertaken studies with controls.

Where is the control group? Which paper, I would read it gladly.

Zeuzzz

22nd November 2009, 04:24 PM

Of course there are conspiracies in things like this when there is money, profit, greed and business involved. Not so sure about this particular case though tbh.

The science speaks for itself, however. Sometimes funding and monetary motives are certainly capable of scewing results of science. Over time however this bad science get found out. A lot of pharmaceutical companies (including really big ones like Pfizer, Glaxo, etc) have had many court cases rule against them for selling drugs for reasons they have not been scientifically approved for. And some cases even of academic fraud into research of some drugs. However the positives of the research done and work the drug companies do far outweigh the negative and occasional scandals. But to pretend that they dont exist is just stuppid. And to label people quacks for coming up with new original treatments that contradict previous studies is equally ridiculous, if the science is sound.

Corporations are corporations. They have to make money to stay alive. This is their sole motive. And they use science as a tool to do this.

Over time science always finds out any errors or bias that has infiltrated research as independant studies are done. So its really not a very fruitful way to make profit and so is not as common as some people think. But it does happen as numerous previous examples can show (Pregabalin, Rosiglitazone, Bextra, Geodon, Propoxyphene, Aprotinin, Zicam, Hydroxycut, Benzamidenafil, etc, etc, etc) All of which supposedly passed all the scientific safety tests first, but then failed them later after they had been sold to the general population, some resulting in many deaths.

icerat

22nd November 2009, 04:33 PM

Eos of the Eons

22nd November 2009, 05:13 PM

fls

22nd November 2009, 05:25 PM

To address a few points ....

From what I've read, that's exactly what's happening (http://www.buffalo.edu/research/article.html?id=105620009). You can't have it both ways, claim they should have spent time on developing theoretical grounding, and when I point out they have claim they should have proceeded to more rigourous clinical trials!

I would be happy if they had done one or the other, instead they have done neither. He could have done a controlled clinical trial using the 120 people he has treated. There really isn't any excuse for not having done so.

All perfectly normal for the early stages of investigating a potential new theory (depending on how you define "solid"). None of them are grounds for dismissing it.

Again. It's not being dismissed. People are merely pointing out that there is no point to assuming results on studies which have not yet been done.

My point is *we don't know* what the researchers say about all this. I'm pretty certain the researchers no full well a larger study with a well matched control group is needed.

I bet they do. Which starts to make it almost suspicious that they have failed to do so. And we do know that they didn't have a control group. In every other study where a control group is present, they make mention of that aspect. As an established researcher, Zamboni would recognize that it is a crucial piece of information for his audience, so to describe it as an uncontrolled study, when it was actually controlled, would be bizarre, unless he's hiding something.

Zamboni's 50% figure is for "acute attacks". I'm guessing there is such a thing as "non-acute" attacks? Did both studies use the same criteria?

They would both be acute attacks.

Either way, the data you provided does not support your assertion that a 74% 2yr no-relapse rate is to be expected.

Yes, I was being generous. An even higher no-relapse rate could reasonably be expected based on the baseline difference. Which means that we should actually wonder whether his treatment made things worse.

Yes, and again perfectly normal in the initial phases of testing a new theory, and no reason for immediate (and in some cases above, violently agressive) dismissal.

I don't have a problem with people investigating leads. I have a problem with those who suggest that it requires a "conspiracy" or an "agenda" when we fail to recommend whole-hearted adoption of quite tenuous leads.

Linda

icerat

22nd November 2009, 06:19 PM

I would be happy if they had done one or the other, instead they have done neither. He could have done a controlled clinical trial using the 120 people he has treated. There really isn't any excuse for not having done so.

Very few preliminary investigations involve controlled clinical trials as the first step. If nothing else you need to establish protocols for what you want to test.

I bet they do. Which starts to make it almost suspicious that they have failed to do so.

Again, very few initial investigations are controlled clinical trials.

And we do know that they didn't have a control group. In every other study where a control group is present, they make mention of that aspect. As an established researcher, Zamboni would recognize that it is a crucial piece of information for his audience, so to describe it as an uncontrolled study, when it was actually controlled, would be bizarre, unless he's hiding something.

I think I, you, or likely both, have gotten confused in which studies were actually talking about. I've been referring to different studies these guys have done, not just the one currently in publication. Without going back through all the posts I suspect the confusion is my fault, my apologies.

My point is that if the current study has no controls, I've no doubt the investigators are aware of that as a weakness and quite possibly even say so in the publication.

They would both be acute attacks.

Why do you say that?

Yes, I was being generous. An even higher no-relapse rate could reasonably be expected based on the baseline difference.

evidence?

I don't have a problem with people investigating leads. I have a problem with those who suggest that it requires a "conspiracy" or an "agenda" when we fail to recommend whole-hearted adoption of quite tenuous leads.

Well there we are in agreement. Again, my issue is with the agressive dismissal of a new hypothesis for no apparent or for unjustified reasons - such as complaining that an early study isn't up to gold standard, when that's really quite normal. It seemed to me there's been some pretty unfair attacks on what seem to be some decent scientists. You've not been the worst of it by any means, but even claiming it's "suspicious" that such an early study didn't have clinical controls is overly harsh.

fls

22nd November 2009, 06:43 PM

Very few preliminary investigations involve controlled clinical trials as the first step. If nothing else you need to establish protocols for what you want to test.

I agree. But obviously he is long past the establishment of protocols as he has been performing this procedure, without evidence as to its efficacy, for several years now. It's one thing to pretend that you are establishing a hypothetical basis before you start offering untested treatments, but once you start invasive treatments and testing, you are under an obligation to gather some sort of reliable data. Otherwise, all you are doing is profiteering.

Again, very few initial investigations are controlled clinical trials.

A case series of a dozen patients would be typical. To carry on for years as though you are still in "initial investigations" strains credibility. Because the thing is, it would have been easy peasy to turn those 120 patients into a controlled trial.

My point is that if the current study has no controls, I've no doubt the investigators are aware of that as a weakness and quite possibly even say so in the publication.

That doesn't make it okay. It merely highlights their irresponsibility.

Why do you say that?

Because of the description in both and because there isn't really anything else they could be referring to when it comes to MS.

evidence?

I provided you with the information. If you start with a population with such unremitting disease that only 1 percent were free of relapse in the prior year, yet without any treatment 46 percent of them remain relapse free in the following two years, then a population with such mild disease that 50 percent were free of relapse to start with, you'd expect almost none of them to relapse in the next two years. That 27% of them relapsed should make you wonder whether you made things worse. It certainly shouldn't be taken to mean that you made things better.

You've not been the worst of it by any means, but even claiming it's "suspicious" that such an early study didn't have clinical controls is overly harsh.

I've actually been generous. It's one thing to perform a small case series without good evidence. But to carry on for years, with well over a hundred patients, is inexcusable in a physician who is sincere about acting ethically.

Linda

Skeptic Ginger

22nd November 2009, 08:25 PM

An acquaintance of mine was head of research for a major pharmaceutical company. He told me a favourite trick was to fund 20 studies (or however many were needed) and then publish the one they want with the appropriate finding at p<0.05 :covereyes:

With the increasing need to pre-register studies this will hopefully eventually disappear, but I suspect the increasing number of journals might make it moot. :(

Re the original question and conspiracies. the MS Society fact sheet on the topic (lost the URL sorry) explictly states that they'd be interested in funding in quality research proposals on this theory.

Dancing David - check out all the studies in the link earlier. The current study in partnership with Buffalo seems to be the first large scale controlled study of the intervention, but there were earlier ones looking at different aspects of the theory.As for your 'insider tip' :rolleyes: from your friend at the pharmaceutical company, this is nothing new and it can hardly be described as 'a favorite trick'. It is widely known that some pharmaceutical companies suppress negative findings of studies they fund. When found out the companies are openly criticized, and the scientific and medical communities do not typically rely only on drug company funded reports to evaluate pharmaceuticals and other medical interventions. We aren't stupid, nor is every pharmaceutical company corrupt.

This is what is posted on the National MS Society webpage on Oct 06, 2009 - Research into Blood Flow in the Brain and Venous Insufficiency, or CCSVI, in MS (http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2206)Many questions remain about how and when this phenomenon might play a role in nervous system damage seen in MS, and at the present time there is insufficient evidence to suggest that this phenomenon is the cause of MS.(Maybe someone has already posted this link, I haven't had time to read the whole thread.)

The links you cite appear to be the typical woo sites we see very often that prey on hope and sell unproven interventions to desperate people. Lots of red flags on the OP links IMO.

Emperor_Gestahl

22nd November 2009, 11:19 PM

A lot of pharmaceutical companies (including really big ones like Pfizer, Glaxo, etc) have had many court cases rule against them for selling drugs for reasons they have not been scientifically approved for.

How many times did they not get caught? How many times did someone keep their mouth shut? You seem to suggest that we've been competent enough to catch every piece of bad science done by these companies but you cannot possibly know that.

Oops confirmation bias (edit: Mine, I mean), the bias you're most likely to have when you're right.. But not vice versa, damn!

icerat

23rd November 2009, 04:00 AM

As for your 'insider tip' :rolleyes: from your friend at the pharmaceutical company, this is nothing new and it can hardly be described as 'a favorite trick'. It is widely known that some pharmaceutical companies suppress negative findings of studies they fund. When found out the companies are openly criticized, and the scientific and medical communities do not typically rely only on drug company funded reports to evaluate pharmaceuticals and other medical interventions. We aren't stupid, nor is every pharmaceutical company corrupt.

(1) Never said you were. (2) Who was funding studies wasn't always so clear in the past (3) My friend retired many years ago and I don't appreciate the implication of your eye rolling smiley.

This is what is posted on the National MS Society webpage on Oct 06, 2009 - Research into Blood Flow in the Brain and Venous Insufficiency, or CCSVI, in MS (http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2206)(Maybe someone has already posted this link, I haven't had time to read the whole thread.)

Yes it's been linked to. It's one of the "woo sites" I referenced :rolleyes:

The links you cite appear to be the typical woo sites we see very often that prey on hope and sell unproven interventions to desperate people. Lots of red flags on the OP links IMO.

What I provided linksto was a list of relevant studies, which mostly appeared to be in well regarded peer-reviewed journals. I was not aware that Neurology, American Journal of Neuroradiology, The Journal of the Royal Society of Medicine etc were considered "woo sites".

icerat

23rd November 2009, 04:08 AM

I agree. But obviously he is long past the establishment of protocols as he has been performing this procedure, without evidence as to its efficacy, for several years now. It's one thing to pretend that you are establishing a hypothetical basis before you start offering untested treatments, but once you start invasive treatments and testing, you are under an obligation to gather some sort of reliable data. Otherwise, all you are doing is profiteering.

Profiteering? From whom? The italian health system is public and there's no indication at all patients were paying for this intervention. Theres also plenty of evidence they were gathering data.

Quite frankly I find your continued unfounded accusations against what are clearly reputable scientists quite offensive.

Because of the description in both and because there isn't really anything else they could be referring to when it comes to MS.

Seems you're making further assumptions. So there are only "acute" relapses?

I provided you with the information.

I find it ... interesting ... that you regularly dismiss any study not done to the utmost level of scientific pedanticism, yet when you want to support an assertion its' perfectly OK to us completely different data, make assumptions, and extrapolate, without direct supporting evidence. :rolleyes:

fls

23rd November 2009, 04:53 AM

Profiteering? From whom? The italian health system is public and there's no indication at all patients were paying for this intervention. Theres also plenty of evidence they were gathering data.

I suppose there could be monetary profit as well - there are all sorts of people providing the sorts of services which are remunerated, in this endeavour. But he also gains in terms of notoriety, for example.

Quite frankly I find your continued unfounded accusations against what are clearly reputable scientists quite offensive.

Interesting. The code of medical ethics states that it is unethical to ask human subjects to participate in research which lacks scientific merit - specifically research whose methodology is inadequate to allow for an advancement of knowledge, which includes clinical studies whose results cannot be distinguished from no treatment.

Seems you're making further assumptions.

I am using my knowledge and experience with MS to understand what they have described.

So there are only "acute" relapses?

That's what it means to have relapsing-remitting MS.

I find it ... interesting ... that you regularly dismiss any study not done to the utmost level of scientific pedanticism,

Now that is a very woo technique - to pretend that something so simple and basic as a control group is merely "scientific pedanticism". How are we supposed to consider it non-woo to support his work when you choose to support it with woo arguments?

yet when you want to support an assertion its' perfectly OK to us completely different data, make assumptions, and extrapolate, without direct supporting evidence. :rolleyes:

If we want to have some indication of what might happen in an MS control group, how is it not relevant to look at what has happened in other MS control groups? In particular, if Zamboni's conclusions depend upon only one particular result (i.e. controls not showing improvement), does it not make sense to see whether this ever happens before going along with his assumption that it does? I'm not saying that we can tell for sure just what would have happened with his population of MS patients had he not performed the procedure. I'm saying that we clearly cannot assume one particular outcome when the evidence shows that other outcomes would more reasonably be expected. And since we cannot draw any scientific merit from his study unless we can assume that one particular outcome, this means that his study fails to fulfill the requirements of ethical research on human subjects.

Linda

Dancing David

23rd November 2009, 04:55 AM

So Icerat, I take it you are not going to tell me which study was controlled but just wave your arm and say 'somewhere in there'.

When you show the data, then we can look at the protocols and say what possible meaning it has.

I am not saying that there is not possible benefit, i am saying that this would fall into the category of 'possibly interesting but needing greater follow up'.

Dancing David

23rd November 2009, 04:59 AM

Quite frankly I find your continued unfounded accusations against what are clearly reputable scientists quite offensive.

My my, maybe you shouldn't partcipate in threads in SMT at the JREF, this is what we do, we discuss the protocols, you are veering into politics and spin here. I say this because you seem to be taking critiques personally by the tone of your post.

these are the standard critiques and arguments, it is part and parcel of evaluating claims.

there is only vague, tentative, speculative and unbounded research at this point. FLS has discussed the possible reasons and sources of error and what would need to be done to tighten up the data.

don't take it personally.

fls

23rd November 2009, 05:49 AM

Quite frankly I find your continued unfounded accusations against what are clearly reputable scientists quite offensive.

There is something else that needs to be said in regards to the intervention study. Because I actually hope that you are right. If his study was performed with controls, then I don't have to wonder what ethics committee would approve a study involving an invasive intervention while failing to ensure that the results could have any scientific merit. I don't have to wonder why it didn't occur to someone who realizes the importance of controls to include controls in this study. I don't have to wonder why his colleagues who were aware of the study didn't intervene on behalf of the patients.

Because, if it isn't true that in his naiveté he failed for account for the natural course of MS, that his 'study' simply represents a case series report on an intervention he took it upon himself to offer thereby (mistakenly)foregoing any need for ethics committee approval, then what he has done instead is to deliberately withhold information that would allow other physicians to implement his treatment. And that is even worse, because it would have to be deliberate deception. Knowing that physicians act upon reliable information, and that comparison with a control group would change his study from unreliable information to more reliable information, to fail to include that information if it was present would mean that he intended to prevent other physicians from acting upon this information by offering this intervention to those who could benefit.

Linda

icerat

23rd November 2009, 09:03 AM

I suppose there could be monetary profit as well - there are all sorts of people providing the sorts of services which are remunerated, in this endeavour. But he also gains in terms of notoriety, for example.

So wou're saying is your accusations are simply guessing

Interesting. The code of medical ethics states that it is unethical to ask human subjects to participate in research which lacks scientific merit - specifically research whose methodology is inadequate to allow for an advancement of knowledge, which includes clinical studies whose results cannot be distinguished from no treatment.

So have you read all the studies and protocols?

No?

So you're guessing about this too

I am using my knowledge and experience with MS to understand what they have described.

But you don't know for sure the categorisation criteria, so you're guessing, again.

Now that is a very woo technique - to pretend that something so simple and basic as a control group is merely "scientific pedanticism". How are we supposed to consider it non-woo to support his work when you choose to support it with woo arguments?

Have you read all the studies and protocols? No? Guessing again.

If we want to have some indication of what might happen in an MS control group, how is it not relevant to look at what has happened in other MS control groups? In particular, if Zamboni's conclusions depend upon only one particular result (i.e. controls not showing improvement), does it not make sense to see whether this ever happens before going along with his assumption that it does?

Have you read all the studies and protocols? No? Guessing again.

I'm not saying that we can tell for sure just what would have happened with his population of MS patients had he not performed the procedure. I'm saying that we clearly cannot assume one particular outcome when the evidence shows that other outcomes would more reasonably be expected. And since we cannot draw any scientific merit from his study unless we can assume that one particular outcome, this means that his study fails to fulfill the requirements of ethical research on human subjects.

Have you read all the studies and protocols? No? Guessing again.

That's my issue here - and I won't bother replying to the other comments which rehash pretty much the same stuff - folk are simply making assumptions and guesses based on limited information, and using these assumptions and guesses to draw conclusions which may or may not be valid, and in the process attacking the integrity of people involved.

That's not science.

I haven't read all the studies, and neither has nobody else here (some aren't even published yet). I don't know the researchers involved, and neither does anybody else here (it seems).

No firm conclusions can be drawn from any of the information we actually have, yet some people are hypocritically attacking scientists for supposedly doing exactly what they doing, asserting firm conclusions on the basis of little or unreliable evidence - when all the accusers are really doing is just guessing.

Seriously, read the thread. A newspaper report (a notoriously unreliable source) of an as yet unpublished study. Starting from as little information as that these researchers at top institutions have been accused of being quacks, profiteering, unethical behaviour and more.

You should be ashamed of yourselves.

fls

23rd November 2009, 09:44 AM

So wou're saying is your accusations are simply guessing

Huh? I'm referring to his receipt of international attention because of his ideas. Are you trying to claim that he has not become better known because of this work?

So have you read all the studies and protocols?

No?

So you're guessing about this too

He provides a description of the study and the results. I do not have to 'guess' as to what he did. The other studies and protocols I have read do not involve invasive interventions on human subjects, so they are not relevant to this particular issue.

But you don't know for sure the categorisation criteria, so you're guessing, again.

No, I'm saying that the information given is sufficient to indicate the categorization criteria.

Have you read all the studies and protocols? No? Guessing again.

I realize that you are using a rhetorical technique, but don't you feel a little silly that it's application is wholly irrelevant to this particular criticism?

Have you read all the studies and protocols? No? Guessing again.

I realize that you are willing to pretend that Zamboni intended to deliberately deceive us when he described his study and the results, but is this really a reasonable assumption for you to make?

Have you read all the studies and protocols? No? Guessing again.

I have read many studies on relapsing-remitting MS and the control groups quite consistently show improvement. If you are trying to claim that a substantial number do not, then please provide references to those studies.

That's my issue here - and I won't bother replying to the other comments which rehash pretty much the same stuff - folk are simply making assumptions and guesses based on limited information, and using these assumptions and guesses to draw conclusions which may or may not be valid, and in the process attacking the integrity of people involved.

I would like to point out that if, as you claim, the available information is so sparse that we cannot trust that Zamboni has accurately described what he did, that means that the available information is also too sparse to support those very practices which you and Wolfman chose to defend - testing for imaging abnormalities and implementing additional research studies.

That's not science.

I haven't read all the studies, and neither has nobody else here (some aren't even published yet). I don't know the researchers involved, and neither does anybody else here (it seems).

No firm conclusions can be drawn from any of the information we actually have, yet some people are hypocritically attacking scientists for supposedly doing exactly what they doing, asserting firm conclusions on the basis of little or unreliable evidence - when all the accusers are really doing is just guessing.

Seriously, read the thread. A newspaper report (a notoriously unreliable source) of an as yet unpublished study. Starting from as little information as that these researchers at top institutions have been accused of being quacks, profiteering, unethical behaviour and more.

You should be ashamed of yourselves.

I didn't link to a newspaper report. I linked to the information that Zamboni himself put out. Now you seem to be claiming that what he says is a lie, or at least seriously inaccurate. And I'm supposed to be ashamed for giving him the benefit of the doubt and taking what he says at face value?

Linda

icerat

23rd November 2009, 10:12 AM

:eye-poppiHuh? I'm referring to his receipt of international attention because of his ideas. Are you trying to claim that he has not become better known because of this work?

I'm claiming it's stretch to call that "profiteering". A friend of mine was the key researcher behind the first HPV vaccine. He became better known, and in the paper a lot, as a result of his work. Calling it "profiteering" is offensive.

He provides a description of the study and the results. I do not have to 'guess' as to what he did. The other studies and protocols I have read do not involve invasive interventions on human subjects, so they are not relevant to this particular issue.

A flippin facebook page! The only link to Zamboni's work you've provided was asummary on a facebook page! (http://forums.randi.org/showpost.php?p=5337030&postcount=30):eye-poppi

That's the only link you've given. Do you seriously believe a note on a facebook page is as extensive as a published study?

No, I'm saying that the information given is sufficient to indicate the categorization criteria.

I have read many studies on relapsing-remitting MS and the control groups quite consistently show improvement. If you are trying to claim that a substantial number do not, then please provide references to those studies.

Now who is up to the rhetorical tricks? I in no way stated or claimed what you are saying. *YOU* claimed a 74% no-relapse rate over 2 years was normal, and you still have not supplied any clear evidence to support it - you've merely hypothesised it based on a different study which had a significantly lower control relapse rate, assumed that classification criteria are the same, and backed up that assumption with little more than a "trust me".:boggled:

fls

23rd November 2009, 10:36 AM

:eye-poppi

I'm claiming it's stretch to call that "profiteering". A friend of mine was the key researcher behind the first HPV vaccine. He became better known, and in the paper a lot, as a result of his work. Calling it "profiteering" is offensive.

I didn't refer to what your friend did as profiteering, since he was clearly offering something of benefit.

A flippin facebook page! The only link to Zamboni's work you've provided was asummary on a facebook page! (http://forums.randi.org/showpost.php?p=5337030&postcount=30):eye-poppi

That's the only link you've given. Do you seriously believe a note on a facebook page is as extensive as a published study?

Of course not. The information is a summary report which includes Zamboni's report on the results of his study. That report is duplicated on several sites. It was particularly readable on the facebook site (which is why I chose that one), but the contents of the report do not change based on where it is posted. Regardless of where the summary is posted, do you think Zamboni is lying in that report or do you think it can be taken at face value?

Now who is up to the rhetorical tricks? I in no way stated or claimed what you are saying.

Then what were you trying to claim?

*YOU* claimed a 74% no-relapse rate over 2 years was normal,

No I didn't. I claimed that you cannot pretend to know what would happen in an untreated control group, and I provided an example where what happened in the one year prior was staggeringly different from what happened in the two years subsequent to enrollment in the study. This is a consistent finding in MS studies. I chose that particular reference mostly because full text was available so you wouldn't have to "trust me".

and you still have not supplied any clear evidence to support it - you've merely hypothesised it based on a different study which had a significantly lower control relapse rate, assumed that classification criteria are the same, and backed up that assumption with little more than a "trust me".:boggled:

Yet it seems perfectly reasonable to you to make the claim that the course subsequent to enrollment will be equal to the course prior to enrollment when the available evidence contradicts that assumption?

Linda

icerat

23rd November 2009, 10:56 AM

I didn't refer to what your friend did as profiteering, since he was clearly offering something of benefit.

And so may Zamboni.

Regardless of where the summary is posted, do you think Zamboni is lying in that report or do you think it can be taken at face value?

I think it can be taken for what it is - a brief summary that does not include the same information as in a published study.

No I didn't. I claimed that you cannot pretend to know what would happen in an untreated control group

You explicitly stated - (http://forums.randi.org/showpost.php?p=5336206&postcount=23)

the results were exactly what you'd expect if the intervention had no effect

I asked in response - (http://forums.randi.org/showpost.php?p=5336810&postcount=27)

I'm by no means an MS expert, is it normal for 73% of sufferers to have no symptoms for 2 years, after suffering attacks regularly before that? I know there's a relapse and remission pattern, but 73% for over 2 years seem fairly large numbers to me

You responded (http://forums.randi.org/showpost.php?p=5337394&postcount=35) by citing a study with a 46% no-relapse rate that *maybe* had a tougher criteria, and asked us to just accept your assumption that the criteria was tougher and accept your assumption that this meant a 73% no-relapse rate was "normal".

And you're criticising other people for poor science?

Yet it seems perfectly reasonable to you to make the claim that the course subsequent to enrollment will be equal to the course prior to enrollment when the available evidence contradicts that assumption?

I never made any such claim.

fls

23rd November 2009, 11:13 AM

I think it can be taken for what it is - a brief summary that does not include the same information as in a published study.

But do you think it is reasonable to think that Zamboni is representing or misrepresenting the information that is in the published study?

You responded[/url] by citing a study with a 46% relapse rate that *maybe* had a tougher criteria, and asked us to just accept your assumption that the criteria was tougher and accept your assumption that this meant a 73% no-relapse rate was "normal".

I'm not asking you to assume anything. I'm pointing out that a lower relapse rate subsequent to enrollment is what is found in other studies, and I provided a reference to an example. I agree that you cannot use that information to figure out exactly what rate to expect, but it certainly allows you to realize that the results that Zamboni reported would be expected without any intervention. At the least, it highlights the point I have been making all along. If you cannot tell what would have happened if Zamboni's patients had not received any intervention, then no conclusions can be drawn from information gathered in the absence of a control group.

Linda

icerat

23rd November 2009, 12:33 PM

But do you think it is reasonable to think that Zamboni is representing or misrepresenting the information that is in the published study?

I think it's unreasonable to assume there is not more discussion and clarification in the published paper than in a brief facebook synopsis. Much of what you have claimed is little more than assumptions that may or may not be based in fact, or fair.

I'm not asking you to assume anything. I'm pointing out that a lower relapse rate subsequent to enrollment is what is found in other studies, and I provided a reference to an example. I agree that you cannot use that information to figure out exactly what rate to expect, but it certainly allows you to realize that the results that Zamboni reported would be expected without any intervention.

It allows no such thing. What you're doing is little more than guessing.

At the least, it highlights the point I have been making all along. If you cannot tell what would have happened if Zamboni's patients had not received any intervention, then no conclusions can be drawn from information gathered in the absence of a control group.

That depends what you mean by "conclusions". You can make some preliminary observations and preliminary conclusions pending further study. Until the paper is published we have no idea what Zamboni et.al have to say about the (assumed) absence of a control group. Who knows, they perhaps compared with population data from another study, as you did, but (hopefully) with more info on matching.

fls

23rd November 2009, 02:43 PM

I think it's unreasonable to assume there is not more discussion and clarification in the published paper than in a brief facebook synopsis. Much of what you have claimed is little more than assumptions that may or may not be based in fact, or fair.

The only assumption I am making is that Zamboni didn't misrepresent his own study. Why do you think that this is an unreasonable assumption?

It allows no such thing. What you're doing is little more than guessing.

If my use of relevant evidence is "guessing", then what do you call Zamboni's use of no evidence at all, and why is that somehow defensible?

That depends what you mean by "conclusions". You can make some preliminary observations and preliminary conclusions pending further study. Until the paper is published we have no idea what Zamboni et.al have to say about the (assumed) absence of a control group. Who knows, they perhaps compared with population data from another study, as you did, but (hopefully) with more info on matching.

It doesn't matter. We already know that those sorts of comparisons are unreliable. Otherwise, we'd be able to do away with randomized, placebo-controlled, double-blind studies. Besides which, he specifically mentions comparisons with pre-enrollment measures - not population data, not control group data, not matched group data. Why do you persist in assuming that he is misrepresenting his own study?

Linda

icerat

24th November 2009, 02:43 AM

Why do you persist in the bizarre belief a brief synopsis on a Facebook page is the equivalent to a full published paper?

All I'm saying is to wait and see what the paper actually says instead of making assumptions. For all you know the authors may make the exact same criticisms of their work as you do. That wouldn't be unusual in the discussion of a self-described preliminary study.

Dancing David

24th November 2009, 03:57 AM

icerat

24th November 2009, 04:27 AM

that study didn't even involve treatment, the controls were multiple matched groups, not "psuedo groups", and double-blinding isn't even an applicable concept in this study.

but heck, we already know actually reading stuff is apparently completely unnecessary for the sake of offering criticism :rolleyes:

EverLastingGodStopper

24th November 2009, 04:34 AM

Well, maybe if the citation was an actual quote of the America MS Association?

ETA:
I would assume the acticle is in reference to the MSAA (http://www.msassociation.org/)

Here is the search for surgery (http://www.msassociation.org/searchpro/index.asp?q=surgery) which is a null error
Here is the search for Zamboni (http://www.msassociation.org/searchpro/index.asp?q=zamboni)

Now there is also the National MS Society (http://www.nationalmssociety.org/index.aspx)
which has this link for zamboni (http://www.nationalmssociety.org/search-results/index.aspx?pageindex=0&pagesize=20&keywords=zamboni&x=24&y=13)

Which links to the article here:
http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2206

And in fcat the article itself does not suggest anything other than what FLS said, small study, uncontrolled, tentative results , needs further study.

No conspiracy to promote medications at all.

Thanks for posting this. One of my dearest, closest friends has MS and suffers greatly as a result. It's very promising to hear of new treatment. But one of my other dearest, closest friends works at the MSAA. The MSAA is a service group. They help people with MS. They have programs and outreach and education. They are not some drug company shills, and I seriously doubt they get any funding from any drug company.

I forwarded a link to this thread to both of them. I'm seeing my friend with MS today; I'll probably see her before she gets my email. She'll be glad to hear that there are new, promising developments in the field. Maybe one day she can be helped.

I'm seeing my other friend this weekend, but he'll get the email today. Whatever he may have to say about people who accuse the MSAA of conspiracy with drug companies will probably be Rule 10'd out.

fls

24th November 2009, 06:59 AM

Why do you persist in the bizarre belief a brief synopsis on a Facebook page is the equivalent to a full published paper?

If it bugs you to read something on Facebook, then use this link instead.

http://www.fondazionehilarescere.org/cst/eng/090908/1_CSTgenerale_8sett09_eng.doc

I have not said that a summary contains the same information as a full published paper. I have said that unless you have some reason to think that the author of the summary intends to be deliberately deceptive, it is reasonable to think that a summary will be representative. This means that if the author describes the study as one without controls in which comparisons were made between the status of the patients pre-intervention to their status post-intervention, that what was actually performed was a study without controls in which comparisons were made between the status of the patients pre and post-intervention.

I also said that I read published descriptions of this same patient population and of the intervention. Those published descriptions (consistent with the summary) clearly describe an intervention performed on all patients who underwent US without any patients designated as controls.

For example, a paper you made reference to earlier:
http://www.fondazionehilarescere.org/pdf/CX.PDF

All I'm saying is to wait and see what the paper actually says instead of making assumptions. For all you know the authors may make the exact same criticisms of their work as you do. That wouldn't be unusual in the discussion of a self-described preliminary study.

How would that help? Noting that their study used methodology that does not allow them to distinguish the effects from no treatment does not magically summon a control group for them.

Linda

fls

24th November 2009, 07:44 AM

Well this is the paper cited in the article, but not the sort of paper anything other than sugegstive
http://www.ncbi.nlm.nih.gov/pubmed/19060024

You will note that there are lacking (as one might find in a preliminary study, but a poorly designed one) no real control groups, there are psuedo groups that pose as a sort of control, but they are not assigned in a double blind.

There is no measure of pre treatment MS symptomolgy and no post treatment symptomology.

So 'slightly suggestive' but not really much.

This study is about establishing the reliability/validity of the imaging abnormalities they chose to associate with MS. The control group in these kinds of studies are the kind that they describe - people without disease or with unrelated problems, people with related problems, people who are undergoing the gold-standard test for unrelated reasons.

It is important, once you think you have selected which abnormalities can be associated with MS, to then apply those choices to a new population of MS patients, in order to determine how well your selections perform when it comes to sensitivity/specificity, etc. They did not do this, so you cannot determine sensitivity or specificity from this study. Also, they did not apply the gold-standard test to all the participants, which also hampers your ability to determine whether these associations are reliable and valid.

It's a reasonable preliminary study, but not one you could use to justify testing outside of the context of "needs more study".

Linda

fls

24th November 2009, 07:51 AM

double-blinding isn't even an applicable concept in this study.

That is incorrect. Blinding is critical to establishing that these are reliable and valid associations. Why did you think that they mentioned blinded ultrasound interpretations if blinding wasn't an applicable concept?

Linda

icerat

24th November 2009, 01:11 PM

That is incorrect. Blinding is critical to establishing that these are reliable and valid associations. Why did you think that they mentioned blinded ultrasound interpretations if blinding wasn't an applicable concept?

Linda

I'm pretty certain you know the difference between single blind and double blind, so I can only assume you're being argumentative for the sake of it.

fls

24th November 2009, 01:18 PM

I'm pretty certain you know the difference between single blind and double blind, so I can only assume you're being argumentative for the sake of it.

Yes, I know the difference. Double-blinding is also applicable to the situation.

Linda

icerat

24th November 2009, 02:08 PM

Do explain

Dancing David

24th November 2009, 02:21 PM

This study is about establishing the reliability/validity of the imaging abnormalities they chose to associate with MS. The control group in these kinds of studies are the kind that they describe - people without disease or with unrelated problems, people with related problems, people who are undergoing the gold-standard test for unrelated reasons.

It is important, once you think you have selected which abnormalities can be associated with MS, to then apply those choices to a new population of MS patients, in order to determine how well your selections perform when it comes to sensitivity/specificity, etc. They did not do this, so you cannot determine sensitivity or specificity from this study. Also, they did not apply the gold-standard test to all the participants, which also hampers your ability to determine whether these associations are reliable and valid.

It's a reasonable preliminary study, but not one you could use to justify testing outside of the context of "needs more study".

Linda

:cool:

I kinf of wondered, since it seemed to focus on the imaging.

fls

24th November 2009, 04:44 PM

Do explain

What do you think it means to say that a study is double-blind?

(ETA: This isn't a trick question, I'm just asking for your understanding of what it means, because it can mean a bunch of different things.)

Linda

icerat

25th November 2009, 04:38 AM

fls

25th November 2009, 07:32 AM

i'm interpreting it as blinding of both the subjects and researchers, which would seem to be the use Dancing David was referring to since (for some reason) he thought it was a treatment study.

In this kind of study, blinding of the subjects provides no benefit I can see - indeed I'm not even sure exactly what it would entail -blinded against what?

Blinding against knowing what result is looked for on the test. Now, in this case, even though it is not specifically mentioned, the subjects are effectively blinded because the test is too complicated for them to know what result is looked for, except for a few effort-related measures. The technicians may have foiled that blinding if they explained what they were doing during the procedure, so the study would have been improved if it had explicitly stated what measures where taken to ensure that the subjects remained blinded. Ultimately though, this issue is likely minor compared to the lack of blinding in the researchers.

Blinding of the researchers is important, and that occurred.

Those reading the US images were blinded, but those doing the venography were not blinded. And more importantly, the selection of which specific parameters would be used to identify the venous insufficiency was done with knowledge of which abnormalities had been found in MS patients and which had not.

Linda

icerat

25th November 2009, 09:37 AM

Blinding against knowing what result is looked for on the test. Now, in this case, even though it is not specifically mentioned, the subjects are effectively blinded because the test is too complicated for them to know what result is looked for, except for a few effort-related measures.

That was my perspective, glad we agree.

The technicians may have foiled that blinding if they explained what they were doing during the procedure, so the study would have been improved if it had explicitly stated what measures where taken to ensure that the subjects remained blinded.

I doubt it, I can't see any plausible situation where this may have changed the imaging results.

Those reading the US images were blinded, but those doing the venography were not blinded.

Again, minor, I don't see how this would have signficiantly changed the results.

And more importantly, the selection of which specific parameters would be used to identify the venous insufficiency was done with knowledge of which abnormalities had been found in MS patients and which had not.

That's a reasonable criticism. I didn't read the paper closely enough to know that was the case. Even so it's a relatively minor criticism. Still it's one that would need to be addressed if there was any cause for concern it affected the outcome.

Dancing David

25th November 2009, 09:40 AM

My main complaint was that there was not an assesment of the MS symptoms and history and a random assigned no intervention group. Which would not have mattered given the atcual focus of the study.

icerat

25th November 2009, 10:28 AM

My main complaint was that there was not an assesment of the MS symptoms and history and a random assigned no intervention group. Which would not have mattered given the atcual focus of the study.

Which was my main complaint - you clearly hadn't read the study at all yet jumped on the bandwagon to criticise it. There was no intervention in the paper under question - it's a bit ridiculous to demand they randomly assign people to a no intervention group when there isn't even an intervention group!

The issue of a non-intervention control group was to do with another study altogether, where it's a valid criticism but, in my opinion a minor one for a preliminary study, particularly if other studies already give you a decent idea what the no-intervention relapse rate should be.

fls

25th November 2009, 12:15 PM

I doubt it, I can't see any plausible situation where this may have changed the imaging results.

Some of the measurements are sensitive to the effects of breathing and compliance with breath-holding and other instructions.

Again, minor, I don't see how this would have signficiantly changed the results.

Interpretations of various imaging modalities, including US and venography, have a substantial subjective component, such that evaluations of reliability and validity are usually done blinded.

That's a reasonable criticism. I didn't read the paper closely enough to know that was the case. Even so it's a relatively minor criticism. Still it's one that would need to be addressed if there was any cause for concern it affected the outcome.

I think the criticism will be dealt with by different researchers repeating the studies on different populations.

Linda

icerat

25th November 2009, 04:16 PM

Some of the measurements are sensitive to the effects of breathing and compliance with breath-holding and other instructions.

Only would have been an issue if the technicians also new which group the subject belonged to, which is unlikely. Even then it's of doubtful significance. Yes it's a marginally "better" study with this ensured, but it doesn't make the study worthless without it.

Interpretations of various imaging modalities, including US and venography, have a substantial subjective component, such that evaluations of reliability and validity are usually done blinded.

interpretations were blinded

I think the criticism will be dealt with by different researchers repeating the studies on different populations.

Which is pretty much the whole point of publication! I doubt there's a study published that one couldn't find something to improve.

My point remains that your's and other's assaults on the researchers character was entirely unfair and uncalled for.

fls

25th November 2009, 06:15 PM

Only would have been an issue if the technicians also new which group the subject belonged to, which is unlikely.

It goes something like this:

Subject: So what are you looking for?
Technician: We're looking for blood flow when you take a deep breath in.

The subject knows that her/his test may be abnormal (the purpose of the study (assuming she/he provided informed consent)), which subconsciously (or deliberately, I suppose) alters his effort.

Even then it's of doubtful significance. Yes it's a marginally "better" study with this ensured, but it doesn't make the study worthless without it.

I agree. Like I said earlier, this issue is likely minor.

interpretations were blinded

No. The US interpretations were blinded, but the venography was done knowing the patient's diagnosis.

Which is pretty much the whole point of publication! I doubt there's a study published that one couldn't find something to improve.

Oh sure. As I said earlier, though, one can't proceed as though one already knows what those additional studies will show. Sure, "if this study is replicable, it may indicate some abnormalities associated with MS" is enough to say, "let's replicate this study". But it's not enough to say, "why isn't everyone acting as though this study has been replicated?"

My point remains that your's and other's assaults on the researchers character was entirely unfair and uncalled for.

I can only speak for my own comments. All I have done is point out that offering treatments without reasonable expectation of effectiveness, failing to obtain that evidence of effectiveness when it would have been easy to do so, and asking patients to participate in medical research whose methodology precludes the advancement of scientific knowledge is not considered ethical behaviour. When it occurs in those we find easy to identify as quacks - homeopaths or the DAN doctors - we seem to have no problem condemning it.

Linda

fls

25th November 2009, 06:22 PM

The issue of a non-intervention control group was to do with another study altogether, where it's a valid criticism but, in my opinion a minor one for a preliminary study, particularly if other studies already give you a decent idea what the no-intervention relapse rate should be.

So what was the point of attacking and berating me for bringing up that exact same point? And since other studies give you a decent idea that the no-intervention relapse rate is substantially lower than the pre-intervention relapse rate, how is it a minor criticism to discover that this intervention fails to show this substantial decrease?

Linda

mike3

25th November 2009, 07:41 PM

But testing does cost money. An MRI in the U.S. can be expensive (average is around $1500, and brain scans are on the higher end of the spectrum). I'd imagine few if any insurance companies would pay for it either for this purpose -- which means the patient would likely pay out of pocket.

And let's say a patient does get tested -- what's the point? I'd imagine few organizations are at the point where they'd recommend the surgery, since the whole thing is relatively unproven. So the end result of the test is that the patient would have paid a thousand bucks (or more) to know if they have a condition that may or may not be related to MS, for which they may or may not be able to pay (probably an even more substantial sum) to have surgery to cure (again, doubtful any insurance company would cover it. This is the very definition of experimental).

It makes sense to me that, at this point, they would not recommend for people to get tested. You might disagree with that, but I think the above reasoning is far more likely than a conspiracy between these groups and big pharma.

So then how could the efficacy of this treatment be scientifically confirmed or refuted so the benefits could be reaped (if confirmed), or effort directed somewhere else (if refuted)?

Ivor the Engineer

26th November 2009, 02:17 AM

So what was the point of attacking and berating me for bringing up that exact same point?

<snip>

Perhaps you just have that kind of face?

I'd suggest a cute dog Avatar, but it doesn't seem to help me.

icerat

26th November 2009, 04:27 AM

So what was the point of attacking and berating me for bringing up that exact same point?

My "berating" was in regard to the vicious personal attacks on the researchers from you and others.

And since other studies give you a decent idea that the no-intervention relapse rate is substantially lower than the pre-intervention relapse rate, how is it a minor criticism to discover that this intervention fails to show this substantial decrease?

That has not been shown at all. You claimed this but when I asked for evidence you provided a study which did not support your claim, indeed to the contrary. The non-relapse rate in the Zamboni study was significantly higher than in the study you cited. You (unscientifically) claimed this didn't matter since your "supporting" study used a stricter standard. Until the Zamboni study is published we don't know what they have to say about the expected no-relapse rate.

fls

26th November 2009, 05:21 AM

So then how could the efficacy of this treatment be scientifically confirmed or refuted so the benefits could be reaped (if confirmed), or effort directed somewhere else (if refuted)?

After they have performed the venogram, but before they perform a venoplasty or place a stent, they randomly pick whether that patient receives any further intervention (keeping the patient blind to this decision). Any further follow-up is performed under the assumption that the patient received the intervention. At this point, they would have roughly 60 patients who had received the intervention and 60 who had not, so it would be possible to confirm or refute whether those who received the intervention had better outcomes.

Linda

fls

26th November 2009, 05:49 AM

My "berating" was in regard to the vicious personal attacks on the researchers from you and others.

You also berated me for using information from other studies. In fact, you called the practice, "poor science", "just guessing", and "little more than a 'trust me'". And you said I should be ashamed of myself for making this suggestion.

However, how is it a vicious personal attack to point out that he is not following ethical guidelines for medical research and for medical care? It seems perfectly acceptable to bring up these issues when we are talking about those people we think are quacks, but it's a topic which is so completely off-limits when talking about physicians that to do so is a vicious personal attack? And you haven't even addressed this criticism. Why is that? Why is it okay to take steps to avoid taking advantage of vulnerable subjects in one set of patients, but seemingly not okay to suggest we do the same in another?

That has not been shown at all. You claimed this but when I asked for evidence you provided a study which did not support your claim, indeed to the contrary. The non-relapse rate in the Zamboni study was significantly higher than in the study you cited. You (unscientifically) claimed this didn't matter since your "supporting" study used a stricter standard.

I didn't say that the other studies used a stricter standard. I said nothing of the kind. That was something you made up.

The effect size in other studies, such as the one I referenced, is on the order of 1.00 (the exact effect size in the one I referenced is 1.451). Applying a similar effect size to Zamboni's study - a practice which you blithely suggested was an acceptable practice in your response to Dancing David - means that we'd expect the relapse rate to change from 50 percent to less than 10 percent (less than 1 percent if equivalent to the study I referenced). This suggests that the expected relapse rate is much lower than what was actually observed. Now, I'm not going to claim that we know for sure what the relapse rate would have been, but I most certainly wouldn't be comfortable assuming that I made it better, when the studies contradict that assumption.

Until the Zamboni study is published we don't know what they have to say about the expected no-relapse rate.

It doesn't matter what Zamboni has to say about the expected no-relapse rate because he doesn't know what to expect either. All he has available to him is the same information that I used to make an estimate, because he didn't collect that information on his own subjects.

Linda

Ivor the Engineer

26th November 2009, 06:29 AM

<snip>

However, how is it a vicious personal attack to point out that he is not following ethical guidelines for medical research and for medical care? It seems perfectly acceptable to bring up these issues when we are talking about those people we think are quacks, but it's a topic which is so completely off-limits when talking about physicians that to do so is a vicious personal attack?

<snip>

Given all the crap I've taken from you and others for daring to criticise physicians on such issues, that's really priceless.

Dancing David

26th November 2009, 07:45 AM

Which was my main complaint - you clearly hadn't read the study at all yet jumped on the bandwagon to criticise it.

In case you didn't notice, I don't recall saying much more than I said. I did not criticize it, and certainly did not mean to degrade it. As I said before you are taking this way too personally.

I may and did not read it as carefully as I could have.

But you can take your bandwagaon and make a parade.

save the spin and keep it to your self.

I did not jump on the bandwagon, I offered my not very good opinion.

There was no intervention in the paper under question - it's a bit ridiculous to demand they randomly assign people to a no intervention group when there isn't even an intervention group!

The issue of a non-intervention control group was to do with another study altogether, where it's a valid criticism but, in my opinion a minor one for a preliminary study, particularly if other studies already give you a decent idea what the no-intervention relapse rate should be.

Sure, but I was confused as well and you are all het up with your ego. If you back down, I will not taunt you for being so emotional and overwrought.

I am admitting that I did not understand the purpose of the study and that is still true.

ETA: Well now that Ivor has arrived to just dump vitriol, I shall probably comment no further, Later Icerat, I did read your posts and appreciate them.

icerat

26th November 2009, 07:48 AM

You also berated me for using information from other studies. In fact, you called the practice, "poor science", "just guessing", and "little more than a 'trust me'". And you said I should be ashamed of myself for making this suggestion.

Oh please. You took a different study with what you yourself said was a different population that had a relapse rate double that of the intervention under a question, and offered it as evidence that -

the results were exactly what you'd expect if the intervention had no effect.

That's YOUR bolding.

However, how is it a vicious personal attack to point out that he is not following ethical guidelines for medical research and for medical care?

It's a vicious attack when you have no idea if it is true or not. Your simply assuming that certain things weren't done because it's not mentioned in a summary on a facebook page!

It seems perfectly acceptable to bring up these issues when we are talking about those people we think are quacks, but it's a topic which is so completely off-limits when talking about physicians that to do so is a vicious personal attack?

No, I think it's wrong to do it with quacks as well. Attack them based on the evidence, not based on your guesswork and assumptions.

I didn't say that the other studies used a stricter standard. I said nothing of the kind. That was something you made up.

Poorly worded, my apologies. The other study has a group was of with worse MS. I meant "stricter standard" in terms of who was included in the sample.

The effect size in other studies, such as the one I referenced, is on the order of 1.00 (the exact effect size in the one I referenced is 1.451). Applying a similar effect size to Zamboni's study - a practice which you blithely suggested was an acceptable practice in your response to Dancing David - means that we'd expect the relapse rate to change from 50 percent to less than 10 percent (less than 1 percent if equivalent to the study I referenced).

It's acceptable if you're dealing with matched populations. You here are not, and you're also assuming the researchers are not.

This suggests that the expected relapse rate is much lower than what was actually observed. Now, I'm not going to claim that we know for sure what the relapse rate would have been, but I most certainly wouldn't be comfortable assuming that I made it better, when the studies contradict that assumption.

It doesn't matter what Zamboni has to say about the expected no-relapse rate because he doesn't know what to expect either. All he has available to him is the same information that I used to make an estimate, because he didn't collect that information on his own subjects.

Or instead of all these "suggests" and "assumptions" we could just wait and see what the researchers actually wrote! It may be they didn't talk about the expected relapse rate at all - in which case I'll be as critical as you. It may be they have a well matched population from another study that you don't know about, in which case it's reasonable to make some preliminary conclusions from what is self-described as a preliminary study.

The difference is I'll wait and see what the paper actually says before leaping in and declaring it invalid, calling them quacks, unethical etc etc etc

icerat

26th November 2009, 07:53 AM

Sure, but I was confused as well and you are all het up with your ego. If you back down, I will not taunt you for being so emotional and overwrought.

I am admitting that I did not understand the purpose of the study and that is still true.

I'm not sure what my ego has got to do with it, but kudos to you for admitting you erred. I'd suggest a certain other poster on this thread knows full well she has erred too but doesn't have the gumption to admit it.

fls

26th November 2009, 06:45 PM

Oh please. You took a different study with what you yourself said was a different population that had a relapse rate double that of the intervention under a question, and offered it as evidence that -

Originally Posted by fls
the results were exactly what you'd expect if the intervention had no effect.

That's YOUR bolding.

All "other studies" will involve a different population. And all "other studies" will vary with respect to baseline rate. Your suggestion that the use of "other studies" is acceptable is no different from what I suggested.

It's a vicious attack when you have no idea if it is true or not.

It is true that I have no idea whether or not Zamboni and the other researchers have grossly misrepresented their work. However, gross misrepresention isn't exactly ethical, either.

Your simply assuming that certain things weren't done because it's not mentioned in a summary on a facebook page!

Since reference has been made to several documents, including published research and an academic publication which happened to be reproduced in several places (including a facebook page), who exactly do you think you are fooling by characterizing this information as a summary on a facebook page?

No, I think it's wrong to do it with quacks as well. Attack them based on the evidence, not based on your guesswork and assumptions.

Why does published research and summaries presented by researchers not count as 'evidence' to you?

Poorly worded, my apologies. The other study has a group was of with worse MS. I meant "stricter standard" in terms of who was included in the sample.

Yes. At least half of Zamboni's patient population would not have fulfilled the inclusion criteria for the other study. Most researchers will choose a study population so that the expected outcomes will be numerous enough to show a difference. Choosing subjects who have had relapses in the prior year is one way to increase the number of expected relapses in the period following the intervention.

It's acceptable if you're dealing with matched populations. You here are not, and you're also assuming the researchers are not.

Well, read anything out there on MS and you will see that it isn't possible to match populations with that degree of accuracy because there is far too much variation when it comes to prognosis - especially for relapsing-remitting MS.

Or instead of all these "suggests" and "assumptions" we could just wait and see what the researchers actually wrote! It may be they didn't talk about the expected relapse rate at all - in which case I'll be as critical as you. It may be they have a well matched population from another study that you don't know about, in which case it's reasonable to make some preliminary conclusions from what is self-described as a preliminary study.

The difference is I'll wait and see what the paper actually says before leaping in and declaring it invalid, calling them quacks, unethical etc etc etc

Well, we may discover that they have so grossly misrepresented what they did, including what they have already published, that there is some validity to their study. Some people might consider gross misrepresentation unethical, though.

Linda

Thunder

26th November 2009, 08:57 PM

i know for a fact that pharmaceutical companies do indeed bribe doctors into prescribing only their medications.

fls

27th November 2009, 03:47 AM

i know for a fact that pharmaceutical companies do indeed bribe doctors into prescribing only their medications.

Bribery under these circumstances is a crime and also is professional misconduct. I'm not sure exactly how to go about reporting this sort of crime to law enforcement, but you should contact the professional association responsible for licensing and maintaining physician practice in the area where the physician(s) practice. In the US, this will be the state board of medical practice, in Canada, it will be the provincial college of physicians and surgeons.

Linda

Eos of the Eons

27th November 2009, 05:28 AM

i know for a fact that pharmaceutical companies do indeed bribe doctors into prescribing only their medications.

A doctor will see reps to hear about new meds, and might get a pen, scratch pad or free samples, but they then weigh that information against tried and true meds. I've never seen a doctor get monetary rewards for prescribing a med. Prescriptions are tracked in databases at the pharmacy, and a doctor can get in trouble for over prescribing oxycontin or something, but most patients have to get several doctors to prescribe and several pharmacies to dispense before they are allowed too many meds. Most insurance companies will also step in and not allow patients more than a certain amount of meds to be covered at a time as well.

I'd like to see your evidence of this bribing.

Ivor the Engineer

27th November 2009, 05:47 AM

Eos of the Eons

27th November 2009, 07:04 AM

And I don't care what the doc prescribes, I always get the generic brand, which is always cheaper. I think pharmacists only track what patients get, so drug companies wouldn't know, nor do they get lists from the pharmacists to know, what individual doctors are prescribing.

Ivor the Engineer

27th November 2009, 07:07 AM

Deleted becuase Eos had to go and correct her typo.:(

Eos of the Eons

27th November 2009, 07:26 AM

Deleted becuase Eos had to go and correct her typo.:(
Freudian slip. Wishing I WAS drunk.

icerat

27th November 2009, 02:50 PM

i know for a fact that pharmaceutical companies do indeed bribe doctors into prescribing only their medications.

Any evidence for this?

I think your misconstruing successful marketing as "bribing". Pharmaceutical companies market their products and services to the medical community. Doctors are influenced by this. Doctors cannot possibly be aware of every available option, so they make decisions based on their knowledge and experience - knowledge and experience that is influenced by marketing ... just like the rest of us.

Skeptic Ginger

29th November 2009, 01:23 PM

(1) Never said you were. (2) Who was funding studies wasn't always so clear in the past (3) My friend retired many years ago and I don't appreciate the implication of your eye rolling smiley.(3) What implication would that be?

The implication of my smiley face was that the medical and scientific communities are not dupes or idiots as is implied by the way you pointed out your inside access to info that research can be biased in profit motivated research. It doesn't take an insider whistle blower to figure out how to interpret potentially biased research.

(2)One doesn't rely on any single study. One looks at the body of research. One looks for replicated results, reputable sources, and so on. If you think the medical community doesn't know how to evaluate the research of any particular medical intervention, that doesn't say much for your knowledge of the medical community.

(1) Your comment implied the medical/scientific community needs a whistle blower to evaluate research bias. I realize this broad implication I am assigning to such a trivially noted comment may seem out of proportion to your actual comment. It is. The reason for my reply was larger than your single comment.

There is a general lack of understanding in a small but significant group of people about how the scientific and medical communities evaluate scientific knowledge. That small group of people act as if convinced the scientific and medical communities are incapable of recognizing research bias while the small group of people can see the bias. The years of education and experience the scientific and medical communities have are ignored by the small group of people who believe a fantasy that they have secret knowledge the educated and experienced people do not have.

You appear by your comments, "An acquaintance of mine was head of research for a major pharmaceutical company. He told me a favourite trick was to fund 20 studies (or however many were needed) and then publish the one they want with the appropriate finding at p<0.05", and, "Who was funding studies wasn't always so clear in the past", to be in that group of people who are oblivious to the role education and experience plays in providing scientists and medical professionals the skills they need to evaluate medical research. I may be stretching the evidence here to draw my conclusions, but I think not.

Yes it's been linked to. It's one of the "woo sites" I referenced :rolleyes:You lost me here. My link to the MS society comment on the CCSVI you have been discussing is a "woo site"? I don't think so. I found it via a web search looking for independent corroborating (or not) sources of the information you provided.

What I provided linksto was a list of relevant studies, which mostly appeared to be in well regarded peer-reviewed journals. I was not aware that Neurology, American Journal of Neuroradiology, The Journal of the Royal Society of Medicine etc were considered "woo sites".All I did was point to a comment I felt likely reflected the current status of the research as a whole on this etiology of MS.

Antiquehunter

5th April 2010, 04:23 AM

Bumpity bump.

This is getting a lot of media attention in Canada for some reason. A friend of mine who is a sufferer (and perhaps is more biased to hoping there is truth to all this than I am) is already convinced that this Zamboni treatment is the bees-knees. (I thought a Zamboni treatment had something to do with dressing the ice at a hockey game).

I must admit that as an amateur and outsider to the medical profession, by baloney detector does start beeping loudly whenever I hear of a medical practitioner going for press releases and media rather than tried & tested peer-review.

Is anyone else tracking this story actively, and any indiciations as to the veracity / quakery of the 'Zamboni' treatment for MS???

-AH.

fls

5th April 2010, 06:23 AM

Is anyone else tracking this story actively, and any indiciations as to the veracity / quakery of the 'Zamboni' treatment for MS???

-AH.

I'm not actively tracking it (there really won't be new information until a controlled trial has been completed), but there was an article in my local paper a few weeks ago about it. It basically said the same sorts of things that have already been said - researchers in Italy think it is beneficial, recruiting is ongoing for a clinical trial, some doctors and patients don't want to wait and are going ahead with the proceedure anyway.

I still can't find any indication that a controlled trial has been planned (nothing on the CCSVI website and nothing on a search at Clinical Trials), only mention of an open-label clinical trial, which is essentially useless for this purpose.

Linda

Eos of the Eons

5th April 2010, 07:04 AM

It's a lot like quack treatments for autism. MS waxes and wanes, so catch it while the patient is improving in any way and attribute it to this next new fad treatment. They are marketing it directly to the public instead of going through proper channels, and that is about the biggest red flag out there with this type of thing. Let's just hope it does not do more harm than nothing.

Skeptic Ginger

5th April 2010, 10:24 AM

A doctor will see reps to hear about new meds, and might get a pen, scratch pad or free samples, but they then weigh that information against tried and true meds. I've never seen a doctor get monetary rewards for prescribing a med. Prescriptions are tracked in databases at the pharmacy, and a doctor can get in trouble for over prescribing oxycontin or something, but most patients have to get several doctors to prescribe and several pharmacies to dispense before they are allowed too many meds. Most insurance companies will also step in and not allow patients more than a certain amount of meds to be covered at a time as well.

I'd like to see your evidence of this bribing.To add to what you are saying and what I posted above (since it was a while ago), drug companies have a number of means of promoting their products like free dinner or continuing ed credits for attending a seminar where they present scientific information on their drugs. Some companies have, in the past, done more than one unethical thing in these presentations such as offering a free week's vacation and not just a dinner, or having an expert present the data implying the expert had done the study when they had not, or not publishing the negative results they got.

These 'pushing the envelope' practices are common among many corporations and that is unfortunate. Rarely they go so far as to be more criminal than not (like Enron). But for the most part the practices are not tolerated when uncovered, and they are not something the nursing or medical professions condone or ignore or as a whole are part of (clearly individuals have been guilty of taking part).

If one is going to a medical provider who isn't evaluating drugs and other treatments based on many sources of scientific information, that isn't likely a very good health care provider regardless of whether they are being influenced by a drug company or not.