Fraud Doc Must Repay $296K To Pfizer
16 CommentsBy Ed Silverman // January 19th, 2010 // 8:07 am
Scott Reuben is on the hook for nearly $300,000 for faking research he conducted on various meds. The former chief of acute pain at Baystate Medical Center in Springfield, Ma., sought and received research grants from Pfizer and other drugmakers but never performed the studies. He fabricated patient data and submitted info to anesthesiology journals that unwittingly published it. Reuben must also pay $16,000 in restitution to Wyeth, which is now owned by Pfizer, and $49,375 to Merck (see documents here).
You may recall that, last week, federal prosecutors filed a health care fraud charge against Reuben, who is accused of faking research for a dozen years in published studies suggesting Vioxx and Celebrex offered benefits after surgery. Reuben agreed to plead guilty in exchange for a recommendation of a more lenient jail sentence of up to 10 years, a $250,000 fine and forfeiture of assets worth at least $50,000 received for the research (here’s the background).
Pfizer gave Reuben five research grants between 2002 and 2007, and he was a member of its speakers bureau, giving talks about Pfizer drugs to other docs. The drugmaker said it wasn’t involved in the conduct of Reuben’s studies or in interpretatng or publishing results. The investigation was first reported by the trade publication, Anesthesiology News. The journal Anesthesia & Analgesia retracted 10 of Reuben’s studies last year, while the journal Anesthesiology said it retracted three. The restitution was first reported in The Day.
patrons99
DOJ needed just to either “follow the money” or “follow the body count” and see where it leaded. Did any of Reuben’s research subjects end up in the morgue? Perhaps, a plea bargain was premature.
patrons99
Generally speaking, it occurs to me (a non-attorney), that there are two large categories of clinical research fraud: that which enriches the investigator and endangers the research subjects, and that which enriches the investigator and results in injury (hospitalization or death). As for Reuben, neither type may apply, if indeed, his research subjects were all fabricated. What did the drug company know and when did they know it? What did the IRB know and when did they know it? Was a CRO involved? Was there no oversight? Was value transferred from the drug company to the medical center? What was the quid pro quo? expedited enrollment? referral of research subjects? additional “research” studies? What about all of the deaths worldwide (>200,000) in patients exposed to Vioxx and Celebrex that were not involved in research studies? This is not an insignificant number.
pharmavet
Based on typical timelines it will take FDA about five years to debar Rueben. I can guarantee, however that he has already been blacklisted by industry. I expect that he will never receive another dime from Pharma, as it should be.
patrons99
How did the investigation begin? Was there a whistleblower? What “various meds” and “other drugmakers” were involved? Quite often, there are multiple studies conducted simultaneously by a single investigator for multiple drugmakers. Some would argue that high-enrollers of multiple studies for multiple drugmakers are rarely agressively prosecuted for fraud because the number of marketed drugs involved is too high and the number of retractions of “research” publications would be too great. This is especially true when the research studies are in support of an NDA or an sNDA. To get around this “problem”, when an NDA or sNDA is directly involved, FDA simply eliminates (posthoc) the compromised study subjects (research site) from the pivotal study database, so as not to delay expedited market approvals under the PDUFA. I suspect that this kind of fraud is already “budgeted” for (anticipated), as a cost of doing business. Damage control is invariably effective under the PDUFA.
Chris
Debarring is not the same as losing his medical license. Doesn’t the AMA have an ethics rule?
pharmavet
Chris, I’ve attached a link to the Massachusetts Board of Registration in Medicine as to the criteria for losing one’s medical license following a complaint with the Board. Based on this, Dr. Reuben’s behavior would not rise to the level of suspension or revocation. If you want a recent example of a qualifying act, look up the case of Dr. David Arndt, who is a Mass. orthopedic surgeon and drug addict, who lost his license when he left a patient on the operating table in the middle of spinal surgery while he went to the bank to cash a check. Not only that, lacking the proper instrumentation, he sawed off the business end of a screwdriver and implanted it in place of the appropriate rod. That’s the level of misbehavior that will get your license whacked, at least in Massachusetts.
http://www.massmedboard.org/consumer/consumer_faq.shtm#19
patrons99
pharmavet: can we agree that it’s a very pathetic state of affairs when a criminal fraud indictment and prison sentence “does not rise to the level of suspension or revocation”, whether in Massachusetts or in any state? As far as FDA is concerned, Reuben could, at least in principle, continue to do “research” studies for another 5 years, prior to debarment, even if only in a jail cell. There’s something very wrong with that picture.
Robert
I didn’t know Jeff Foxworthy was a doctor.
patrons99
I wonder if DOJ tried to “flip” Reuben. Does anyone seriously believe he was acting alone? Yes, Robert, the resemblance to Foxworthy is uncanny.
Anne PME
pharmavet, the reason that Dr. David Arndt probably lost his license is that the news media published a story about it so the board had to do something before a negative story was written about them.
There is a physician in MASS who has had six medical board complaints filed against him, including a complaint alleging Medicare fraud. Nothing happened to the physician in question. The physician is still practicing and still double dipping. There is another physician who had a MASS license but was practicing in another state as the MD of an HMO. On learning about the medical license issue, the MASS board did nothing. The physician received a prestigious appointment.
Loose Fat Stomach
If he commits that mistake, he must be responsible enough for the consequences.
It’s very alarming! Med. Dept. should give examples to this kind of people, if proven guilty of course.
pharmavet
Patrons, I apologize for the felony oversight. Rueben’s license is toast in Mass. I might consider the possibility of co-conspirators, however. Based on the resemblance to Foxworthy, we might finger Larry the Cable Guy, Bill Engvald, or especially Greg Giraldo (he looks particularly nasty).
patrons99
Just give them all cigars and they could pass for pharma CEO’s. Life has been good to them.
pharmavet
I have to admit that even being a Pharma guy, I’m continually amazed at the level of vitriol and vernom leveled against an industry that has helped change the course of human suffering for the better. You would think we were Big Tobacco.
Justice in MI
Vet–The latest Harris poll was cited on another thread, so pharma is definitely doing better than big tobacco, although not by a huge amount.
How do you understand the “vitriol and venom,” reflected in such polls, and not just by folks here and there? Genuine question.
harry
This is hilarious. The doc ends up paying the pharmaceutical companies. It is obvious the companies were involved.
This prompted me to look up those prosecuting these pharma cases and their connections.
The Senate Judiciary Committee today released its questionnaire on Carmen Ortiz (Adelphi University, George Washington University Law School), nominated to replace Michael J. Sullivan as U.S. Attorney in Massachusetts. Sullivan resigned April 19 ‘09 to join The Ashcroft Group.
THE ASHCROFT group as in John Ashcroft.
Carmen Ortiz is the new Mass Attorney General.