Doc Pleads Guilty In Pfizer Fraud Case
21 CommentsBy Ed Silverman // February 23rd, 2010 // 7:41 am
Scott Reuben, who was accused of faking research for a dozen years in published studies that suggested after-surgery benefits from Vioxx and Celebrex, pleaded guilty yesterday to one count of federal health care fraud. The 51-year-old anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty, the Associated Press reports.
Prosecutors alleged the former chief of acute pain at Baystate Medical Center received grants from various drugmakers but never performed the studies, fabricated patient data and submitted info to anesthesiology journals that was unwittingly published. Later, an investigation found 21 papers published in journals between 1996 and 2008 in which Reuben made up some or all of the data (background here and here).
The hospital asked the journals to retract the studies, some of which reported favorable results for Pfizer’s Bextra, Celebrex and Lyrica, and Merck’s Vioxx. The studies also claimed Wyeth’s antidepressant Effexor could be used as a painkiller. Reuben faces up to 10 years in prison, plus three years of supervised release and a $250,000 fine.
Reuben’s attorneys say he suffered from biopolar disorder that was only accurately diagnosed in 2008, and he had no financial motive. “His alternating periods of mania and depression fueled his misconduct and adversely affected his ability to halt his wrongful behaviors in the area of research,” they said. Hmm…imagine if he had doctored Abilify data?
patrons99
Just another rogue doc, acting alone, with “temporary” insanity. I think this one qualifies for the rogue’s gallery…the Hall of Shame.
Lisa Van Syckel
Ahhhhh,.. Good Ole Prozac Defense, how original.
AnneS
“The 51-year-old anesthesiologist will have to repay $361,932 in research grants ”
So he has to repay Pfizer? Doesn’t seem like Pfizer is being punished at all in this matter. Shouldn’t they, since they’re responsible for studies published about their products too?
SteveM
The only thing that will deter white collar criminals is jail time.
Reuben belongs in the can. Then someone should write an article on how he’s doing in the slammer for JAMA.
RockDoc
Why should Pfizer be punished? It had no idea that Rueben was engaged in research fraud. If you knew anything about how investigator studies are funded and conducted you would know that Pfizer had no input into the conduct of the studies and no ownership of the data. Pfizer got ripped off and damaged by Reuben’s fraud.
Ed, I don’t know how useful it is for your blog and its readers to have the same Kool-Aid drinking pharma-bashers repeating the same tired mantra in their posts regardless of the content of your blogs. Just my opinion.
Christopher
RockDoc said it - I thought it. This was covered very well the first time Ed raised this subject. Pfizer had no knowledge that Reuben’s data were false. Why on earth should they be punished?
patrons99
Why did it take a dozen years to unearth this fraud? Does anyone seriously believe that Reuben acted alone? He must have been Superman!Inspector Clouseau might have done better. There had to be accomplices.
What about the IRB? What about the medical center? What about the clinical research coordinators and study monitors? Where did the study subjects come from? Did pharma have no responsibility for oversight of these studies? Did anyone have responsibility for oversight of these studies? Was FDA involved? Were ADEs (or lack thereof) fabricated? Let’s not forget that he “studied” Vioxx, amongst other drugs.
How many of those 21 papers “unwittingly” published in “prestigious” medical journals have been retracted? Who actually wrote these research publications? How does one doctor get away with more than a decade of “fabricated” clinical research?
Hopefully, he will receive “treatment” for his psychiatric condition while incarcerated. Perhaps there’s a market opportunity here.
JaT
Wouldn’t it then make sense for a huge pharmaceutical company to have this sort of thing avoided by not relying on only one person’s data? Come on. If Pfizer was only going by this wrong information was it because they didn’t want conflicting opinions?
Condor
Ding!
JaT — exactly!
Namaste
Christopher
JaT - it would make sense but there is nothing I can see to suggest that Pfizer, Merck or Wyeth did rely on one person’s data. With drugs like these there would have been multiple studies underway at any one time. Ed’s earlier post on this (Jan?) reported there was no involvement of Pfizer in study conduct, data interpretation or publication which seems to support the decision to have Reuben repay the research grants. No doubt his findings were welcome - hence his inclusion on speaker panels etc - but that doesn’t mean he and his data were Pfizer’s only source of positive studies.
JaT
I’m sure his reports also contributed to amassing a not so small fortune. So they get paid back after they took advantage of his findings?
Somehow Oliver North comes to mind.
Christopher
I’m sure his reports helped to amass a very significant fortune. But Pfizer was paid back because he conducted fraud and did not deliver what the funding was provided to support.
They took advantage of his data (not findings because he made them up) presumably because they could, not knowing they were dodgy.
I wouldn’t know how to isolate the sales value of his false data vis a vis that of other investigators and how that might translate into a refund.
Anyway, I think Reuben doesn’t justify more airtime - from me anyway - a crook is a crook regardless.
JaT
I’m just saying that it has the appearance of profiting handsomely for passing the buck.
How on earth can we have safe medications if drug makers don’t take responsibility for their products?
pharmavet
One of my least favorite jobs was being responsible for “investigor-initiated studies” when I was a medical monitor. Because these are unmonitored studies, my hard and fast rule was NEVER to give a single investigator enough money or patients so that he or she could publish a paper in a reputable journal. The idea was basically to throw a few dollars their way so that they wouldn’t be bothering me incessantly with phone calls asking for money. These grants were generally in the range of $10,000-15,000 tops. I never gave anyone near the kind of money that Rueben got.
2nd baseman
“tossing $10-15000 their way to keep them from bothering” pharmavet. I often wondered where some of the money-grubbers were coming up with these ‘grants’! Ethical pharmas don’t need any pharmavets working for them!…..Patrons99 has his finger on the pulse….any Clinical Research Associate worthy of the name would have tagged this guy. If not, his employer is responsible. SB
pharmavet
To clarify, 2nd baseman. First of all CRA’s would not be able to “tag” Rueben or any of these other guys because they are not in the loop, as these are unmonitored studies, if you bother to read my post carefully. The grants themselves are a pittance, and actually a lot cheaper than paying them as consultants. Basically the money helps to keep these guys in the stable in case we need them as future speakers or KOL’S. I agree that 90% of these guys are worthless, but the other 10% are highly sought ofter experts, and if we don’t pay to keep them in the bullpen another company will. That’s simply how the game is played, like it or not. Based on your ignorance about CRA’S, it is doubtful that you know anything about this industry or how it operates.
patrons99
These “unmonitored studies” involved human subjects. How can anyone justify performing research studies on humans which are completely unmonitored? What about the informed consent? Who controlled access to the clinical source documents? Was there no IRB? Where was the IRB located? Did the IRB ever pay a visit to the medical center over the last 12 years?
CRA’s can be whistle-blowers. So can study monitors. So can RN’s and MA’s. So can the front office help. So can the billing office. Anyone with a conscience and moral compass can rise to the occasion and blow the whistle. Someone should have, much earlier. 12 years of fraudulent research. It’s both an outrage and sign of the times, plain and simple.
Pharma has shown a trend toward outsourcing clinical research to CROS’s to insulate themselves from liability, by leaving the “conduct and control” of the enterprise to the CRO.
pharmavet
Patrons, the outsourcing of the study monitoring to CRO’s does not release the sponsor from liability. In fact, when a new CRO is brought on board by the sponsor, one of the first documents to be executed is a Letter of Indemnification which indemnifies the CRO against legal liability. The sponsor is ultimately responsible for all aspects of the study conduct. Non-monitored studies does not mean unreviewed. They must be IRB approved, and the data are regularly sent back to the company for review. Apparently in the case of Reuben this process broke down. Because these studies fund so few subject enrollments, it is simply not cost-effective for the sponsor to send a CRA to these sites. If that were done, study costs would rise, and consumers would ultimately pay the penalty in terms of higher drug costs, which we would all like to avoid.
2nd baseman
“Non-monitored studies does not mean unreviewed”, to quote pharmavet. He/she overlooks the fact that CRAs are commissioned, at least by Pharmas who care about how their money is spent, to review minor ‘granted’ studies the same as they would an FDA regulated, pre-market Phase I, II, or III, hence, reviewed, as the above quote suggests.I think that pharmavet is perhaps unaware that the major Pharmas have (had?) field CRAs available in specific geographical areas for years.SB
pharmavet
SB: If I had a geographically proximate CRA who had some extra time on their hands, I might send them to an unmonitored study sight to pick up data and send it back to me. If the CRA can be there and back home on the same day and not spend company money on hotel and meals I might authorize it, especially since other than the CRA’s salary, I don’t pay for same-day meal-related expenses (they cannot be considered as a business expense by the IRS, so we don’t reimburse the CRA for them)
sadnessaddiction
Antidepressant advertising is directly targeted at manipulating normal healthy women to want to be medicated. Women must stand up to big pharma’s bullying them to over-medicate with antidepressants washing out their emotions & personalities and interfering being mothers, sisters, brothers, daughters, partners and lovers.. Women are targeted for antidepressants by big Pharma in the same way that tobacco companies targeted us 70 years ago. Drug companies are so effective at selling unhappiness to women that women take more than twice as many antidepressants as men. Like effexor Wyeth/Pfizer plans on using modern marketing techniques and direct payments to doctors to have Pristiq over prescribed instead of used based on evidence based diagnosis. http://sadnessaddiction.blogspot.com/