[fmichael]

My dear Dubious -

In no way did I intend to bring you into this thread in a bad light. If anything I was throwing out an invitation to come out and play on the issue of meta-studies in general, and in particular their effect in spreading the contagion from a single inflected study, through the body of literature as a whole, to fully utilize the metaphor.

And I didn't for a second mean to suggest that there was a huge problem with unethical medical researchers. I have little doubt that the overall level of fraud, including oppression in all facets of an individual’s economic relationships is greater for attorneys than medical researchers. But the thing is, the medical research system isn't built with a lot of firewalls to contain the effect of a given fraud, whereas the legal system way too much practice in that area.

On the issue of assuming the existence of bad apples in the medical research profession beyond Reuban, I only know a few things, first that the general health of study participants has this funny way of being significantly better than the population at large. A cynic might say this was to minimize the occurrence of reportable adverse effects. For another academic physicians may not always be paid on a par with their counterparts (although their have been some noticeable exceptions of late) in private practice. And there is Big Pharma with all of its walk around money and the (and I stress) reputation to be willing to do about anything to advance its economic interests. Where the academic researchers as a whole stand as a pillar of legitimate strength, keeping tabs on all aspects of medicine and the medical system, this could be the equivalent of an intelligence agency wanting to turn an employee in the other guy's ministry.

And even if Rueban the man is (as to be fervently hoped) an irreproducible result, the damages may very well extend to those studies that incorporated the "n" of his test results. And if in turn the FDA and its advisory panel relied on the meta-analysis or an article of Reuban in approving that drug, what happens then? Same answer if it only relied upon the meta-study?

That's all I was talking about, firewalls. Apologize again for posting in an unskillful fashion, where my intentions must have been unclear.

Mike

[fmichael]

Bumping up where where first line of prior post was completely incomprehensable. Sorry.

[Sandel]

Hi.. Here is an other artical about the fraud, the end of it lists the 21 papers in question.

http://scienceblogs.com/authority/20...ud_in_anes.php

This is such a huge step back for us in the research field. And pretty scarry for those going through post op.. I thought the studies were a tad over stated (having been on lyrica) it takes time to build up and is a generalised nerve type pain reliever like gabipentin.. would you request a high dose of gab after knee surgery? not me plug me in to make pain go away before you invite RSD...

Also Pfizer took over for another company that was being fradulant about gabipentin's off label uses, can't remember name begins with W I think.
be well,
Sandra

[angelrsd]

this is huge blow to all of the anesthesia community as alot of this research was applied to back surgery and us and most post op care and pre op.. this shows that money from these drug companies need to be elevated more carefully period. us as the public take the repercoutions not the doctors most times .

that is my input sorry for the spelling issues

carrie

[Mslday]

Peer review, as it stands now, is not equipped to catch fraud. Reviewers necessarily start their work assuming that the actual data presented in the paper is real and accurate. There's no way they can reasonably be expected to do anything else. Any pre-publication attempt to catch fraud would require physically replicating some of the study, and that's expensive and time consuming.

As a result, it's not all that difficult to get a fraudulent paper through peer review. Fraud detection usually happens later, and for different reasons.

Some food for thought...How can we move forward as patients and trust the medical decisions made for us when they are based on this type of research? I for one have been through a huge domino effect of health problems caused by very well intentioned doctors who have based their decisions on this type of evidence based research. Good intentions do not make good medicine.

MsL

[mrsD]

Originally Posted by Sandel

Hi.. Here is an other artical about the fraud, the end of it lists the 21 papers in question.

http://scienceblogs.com/authority/20...ud_in_anes.php

This is such a huge step back for us in the research field. And pretty scarry for those going through post op.. I thought the studies were a tad over stated (having been on lyrica) it takes time to build up and is a generalised nerve type pain reliever like gabipentin.. would you request a high dose of gab after knee surgery? not me plug me in to make pain go away before you invite RSD...

Also Pfizer took over for another company that was being fradulant about gabipentin's off label uses, can't remember name begins with W I think.
be well,
Sandra

Warner Lambert, which had merged with ParkeDavis. 430,000,000 dollar fine for improper promotion of Neurontin and experimentation on patients without "peer reviewed" FDA studies.
more here:
http://www.fda.gov/fdac/features/2004/404_wl.html

The numbers have gone up since that fine...and so have the profits.
Lilly has agreed to a 1.3 BILLION dollar fine for misrepresenting Zyprexa.
The uproar about this is a record settlement. But Lilly made 39 billion with their scams so what is 1.3 billion? It appears that drug companies have learned that the FDA is not a great watchdog, and since the majority of funding to the FDA comes from THEM, they can really do what they want. If they accrue enough profits from dishonest means, they can pay off the lawyers, damaged patients and government fines and still have plenty of money left over.

[Mslday]

This is absolutely outrageous!!!

The fact that doctors still insist on prescribing this medication for RSD is a crime.

Thankfully I did not stay on Nurontin, gabapentin or celebrex. This just confirms for me the importance of listening to my own body no matter what my doctor says about recent studies, I know best about how my body responds to these medications. I'm tired of being used as an experiment for the benefit of corporate profit.

But not all is lost here for RSD patients who have to have another surgery. I did not take any of these drugs post surgery last fall. There are other ways to manage the pain and potential spread of rsd as I have posted about in other threads.

MsL

[fmichael]

At least they finally have senior nominees for FDA positions who - remarkably enough - do not appear beholdend to industry. From a lengthy editorial posted online Saturday by the New England Journal of Medicine:

Published at www.nejm.org March 14, 2009 (10.1056/NEJMp0810755)

A To-Do List for the New FDA Commissioner

Susan Okie, M.D.

A week before President Barack Obama's inauguration, the departing commissioner of the Food and Drug Administration (FDA), oncologist Andrew von Eschenbach, compared the agency he has led for the past 3 years to a person with cancer. Responding to a new report critical of the FDA, von Eschenbach said, "It is a great shock and surprise when someone says you have cancer. . . . The truth of the matter is that the process has been going on for a long time before it becomes apparent."

Von Eschenbach's metaphor, although startling, was apt: the new commissioner of the FDA will take over an agency with serious systemic problems that urgently need to be addressed. . . .

* * *

Dr. Margaret Hamburg, President Barack Obama's nominee for commissioner of the Food and Drug Administration (FDA), is an experienced public servant who has excelled in various jobs in the federal government and the nonprofit sector. But it was her 6 years as New York City health commissioner during the 1990s that presented the greatest challenges to her leadership, political skills, and ability to make tough public health decisions. Friends and colleagues say the New York health department was Hamburg's crucible — and that her tenure there provided ideal training for the FDA post. . . .

http://content.nejm.org/cgi/content/...0755?query=TOC

I commend the full editorial to anyone who's remotely interested. It's really quite sweeping.

Mike

[Sandel]

Originally Posted by Mslday

This is absolutely outrageous!!!

The fact that doctors still insist on prescribing this medication for RSD is a crime.

Thankfully I did not stay on Nurontin, gabapentin or celebrex. This just confirms for me the importance of listening to my own body no matter what my doctor says about recent studies, I know best about how my body responds to these medications. I'm tired of being used as an experiment for the benefit of corporate profit.

But not all is lost here for RSD patients who have to have another surgery. I did not take any of these drugs post surgery last fall. There are other ways to manage the pain and potential spread of rsd as I have posted about in other threads.

MsL

Both Gabipentin and Lyrica do have their uses in controlling RSD pain to a certain extent, the problem is that the drug company's get greedy and want more off label uses to be claimed to be of use as well.. In the case of Gabipentin they claimed it helped with other conditions like glaucouma as well and people went blind!
Now for the sake of some continuing grant money this doctor fakes the results of these studies, putting the lives of future participants in jepordy (as we know continuing the pain cycle leads to RSD) This is absolutly criminal!

[fmichael]

Sandel -

Points well taken indeed. Please check out the thread I just posted, "Neurontin: an effective response to 'wind-up' related to intensity of sensitization," at http://neurotalk.psychcentral.com/thread81296.html

Mike