Fraud Case Rocks Anesthesiology Community
 

For those who have followed Scott S. Reuben, work. This is very shameful!

http://www.anesthesiologynews.com/in...ticle_id=12634


MsL

OMG is all i have to say !!!!!

It's worse than shameful. It calls into question the very essence of peer reviewed publications, suggesting that a good name alone will get you published. (One can only hope that it was the editors, ratherr than the reviewers who were taken in by this fraud. God help us if articles are commonly sent out for review in an "un-blinded" fashion.) This from a follow up article to the one above:

ANESTHOLOGY NEWS, ISSUE: 3/2009 | VOLUME: 35:3

Routine Audit Uncovered Reuben Fraud

Paul F. White, PhD, MD, the Margaret Milam McDermott distinguished chair in anesthesiology at the University of Texas Southwestern Medical Center in Dallas, called the Reuben case “unprecedented in our specialty.” Dr. White, an editor of Anesthesia and Analgesia, said that given the retracted (and likely-to-be withdrawn) papers and those that are unsullied by the affair, practitioners of multimodal analgesia are now confronted with several significant problems.

* * *

Because of the layered nature of scientific research and publishing, the scandal “compromises every meta-analysis, editorial, systematic review of analgesic trials”—as well as every lecture and continuing education course—that cited the fraudulent findings, added Dr. White, a member of the editorial board of Anesthesiology News. “Clearly, it’s time get back to the hard work of conducting clinical analgesic studies to address important issues in perioperative pain management and patient outcomes.”

http://www.anesthesiologynews.com/in...ticle_id=12641

Think of this guy as the Bernie Madoff of academic medical publishing.

And tragically for us, Dr. Reuben was the co-author of a number of articles on RSD & Surgery that may be withdrawn, even though the work on continuous regional anesthisia - from which a number of us have benefited - has been replicated in other studues and the contributions of his coauthors have not been called into question.

Mike

Baystate Medical pain clinic is my second home. I've been been going there since 1999. Thank God I only saw this Dr. once. Its scary to think what harm he has caused. What even scares me more is that the doc that did my hip replacement which led to the RSD, his name is on one of those publications. The pain clinic at Baystate is a great clinic. There are many very caring nurses and Drs. that have helped me through this nightmare. I pray that the other docs are not like him and he is let go right away. This clinic helps alot of people with RSD and its a shame he has most likley ruined Baystates reputation and all the hard work they do everyday.

Sue K

Sue -

I am so sorry. Of course all of the stories have emphasised that none of Dr. Reuban's coauthors were involved in the fraud, for whatever that's worth.

And now in this morning's New York Times, Reuban's lawyer states that Baystate officials “were aware of extenuating circumstances,” whatever that means. The paper then suggests that Reuban may have been beholden to Pfizer with respect to a group of studies (from 2002 -2007) that had nothing to do with his work on continuous regional anesthesia. Yet his clinic is clearly stating that he fabricated his results (but not that of his coauthors) in even two of the CRPS studies. Here's three sentence lead-in to the N.Y. Times story:

March 11, 2009

Doctor Admits Pain Studies Were Frauds, Hospital Says

By GARDINER HARRIS

In what may be among the longest-running and widest-ranging cases of academic fraud, one of the most prolific researchers in anesthesiology has admitted that he fabricated much of the data underlying his research, said a spokeswoman for the hospital where he works.

The researcher, Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., who practiced at Baystate Medical Center, never conducted the clinical trials that he wrote about in 21 journal articles dating from at least 1996, said Jane Albert, a spokeswoman for Baystate Health.

The reliability of dozens more articles he wrote is uncertain, and the common practice — supported by his studies — of giving patients aspirinlike drugs and neuropathic pain medicines after surgery instead of narcotics is now being questioned. . . . [Emphasis added.]

http://www.nytimes.com/2009/03/11/he...0reuben&st=cse

Mike

Hi Mike,

A better word to describe this is "Shocking" and even worse the insidious role that Pfizer has played in this to have their drugs prescribed to pain patients. In light of the fact that this research is a complete lie, it brings into question the use of these drugs for rsd patients.

I was put on Lyrica, it did nothing for my pain and made me very fat and depressed. I still have my celebrex prescription sitting on the shelf, never took that one after reading all the side effects on the product brochure.

This has caused great harm to many patients and it criminal. :mad:

MsL

Neurontin Law Suits
 

A BIT OFF THE SUBJECT PERHAPS, BUT THIS IS BY NO MEANS THE ONLY EXAMPLE OF PFIZER MISLEADING CONSUMERS, THUS PUTTING THEIR SAFETY AT RISK. THERE HAVE BEEN NUMEROUS LAW SUITS SURROUNDING THE MARKETING OF NEURONTIN FOR CHRONIC PAIN (AMONG OTHER THINGS) WITHOUT CONDUCTING TESTS TO SUBSTANTIATE ITS USE FOR THE VARIOUS OFF-LABEL APPLICATIONS THAT PFIZER WAS PROMOTING. FROM WHAT I UNDERSTAND, IT IS O.K. TO USE DRUGS FOR OFF-LABEL USES, BUT IT IS ILLEGAL FOR DRUG MANUFACTURERS TO PROMOTE ITS USE WITHOUT SUFFICIENT STUDIES. YOU MIGHT JUST WANT TO GOOGLE NEURONTIN LAWSUITS.

[Neurontin is a prescription drug manufactured by Pfizer used to treat post-herpetic neuralgia (PHN) and partial seizures in adults and children. For years, Pfizer intentionally and misleadingly promoted the drug for a number of uses for which it had not been approved (called off-label usage) .

Marketing a drug for unapproved uses is illegal - defying FDA regulatory and statutory procedures. In so doing, Pfizer knowingly put patients at risk for harm . Moreover, the company was well aware that Neurontin showed no efficacy for the uses it encouraged. The company is currently embroiled in numerous product liability and personal injury Neurontin lawsuits.]

I agree with MsL, there are big problems ahead. First, let me repeat something from one of the Anesthesia News stories that was posted yesterday:

Because of the layered nature of scientific research and publishing, the scandal “compromises every meta-analysis, editorial, systematic review of analgesic trials”—as well as every lecture and continuing education course—that cited the fraudulent findings, added Dr. White, a member of the editorial board of Anesthesiology News. “Clearly, it’s time get back to the hard work of conducting clinical analgesic studies to address important issues in perioperative pain management and patient outcomes.”

Sort of reminds you of credit default swaps, doesn't it? http://topics.nytimes.com/topics/ref...aps/index.html

Everything all ties together like that. Now, just like the ask about how many more Madoffs there are out there, we wonder how many more Reubans Big Pharma has bequeathed unto us.

So Dubious, you still in favor of "meta-analysis."

And just why the FDA hasn't at any time in the last 50 years attempted to regulate the financial and disclosure issues surrounding the pharmaceutical/researcher relationship - beyond the relatively recent requirement that was imposed not by the FDA, but by the medical journals (NEJM I believe forced the hand of everyone else) to voluntarily state whether the author has any "conflicting interests" in the study - is beyond me.

Mike

Anyone want to take a guess as to how many drugs this could ultimately put in question?

And isn't funny how they (apparently) can't reach an agreement as to who will be the next FDA Commissioner? I'm guessing that it boils down to a power play involving political money, with emphasis on the Mid-Atlantic region. But a guess is all it is.

Mike,

Why are you dragging me into this thread in a negative light? I didn't even post on it till now.

Did I say something to **** you off?

I think his pertinent papers should be recalled if in fact the accusations are correct. I see "junk science" literature all day long and I am here to tell you that there are researchers who have an agenda and get useless ****printed. People are people; less than perfect, so scoundrels exists in all professions. And you can't tell me the "Bar" is white as snow....can you councilor?

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

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

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

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

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

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.

This is absolutely outrageous!!! :mad::mad::mad:

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

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

FDA update
 

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

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!

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