Doc Faces Fraud In Pfizer Research Case
14 CommentsBy Ed Silverman // January 15th, 2010 // 8:11 am
Federal prosecutors filed a health care fraud charge against Scott Reuben, who is accused of faking research for a dozen years in published studies suggesting Vioxx and Celebrex offered benefits after surgery. Court documents indicate Reuben, an anesthesiologist, 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, the Associated Press reports.
Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield, Ma., sought and received research grants from drugmakers but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, the AP writes, citing court documents. Some of his research was not approved by an internal hospital review board and a probe later found 21 papers published in anesthesiology journals between 1996 and 2008 in which Reuben made up some or all data. Hospital officials say Reuben didn’t admit to fabrications.
The hospital asked the journals to retract the studies, some of which reported favorable results from painkillers including Pfizer’s Bextra, Celebrex and Lyrica, and Merck’s Vioxx, and his studies also claimed Wyeth’s Effexor antidepressant could be used as a painkiller, the AP writes, adding that Reuben’s attorney said last year Reuben cooperated with the hospital review and expressed regret. The lawyer didn’t return a call for comment on the federal complaint (the US Attorney statement).
Pfizer gave Reuben five research grants between 2002 and 2007, and he was a member of the company’s speakers bureau, giving talks about Pfizer drugs to colleagues, the AP notes. 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 (see here; you may have to sign in). The journal Anesthesia & Analgesia retracted 10 of Reuben’s studies last February, while the journal Anesthesiology said last year that it retracted three, the AP adds.
Justice in MI
My wife (not “into” topics pharma in general) asks the following:
Is it conceivable that no one else at the hospital know this was going on? What did the hospital make of the fact that none of this was going through their IRB while studies were getting published? Where did they imagine, or Reuben claim, the pts came from?
patrons99
Bravo to DOJ. There’s much more clinical research fraud out there. They just need to look for it. How much of the fabricated results pertained to drug safety? Many lives have been lost and continue to be lost. How much of the fabricated results went in support of expedited new drug approvals, either NDAs or sNDAs under the PDUFA? Every FDA approved drug in the marketplace today should be queried retrospectively as to whether any fraudulent research resulted in “expedited” market approvals. Was any of the pivotal study data fabricated, corrupted, fraudulent, ghost-written? The medical journals which published the “research” and the IRBs and CROs involved, should not be given a free pass.
M. Black
Is it me, or does there seem to be a common theme linking “things that will cause Pfizer monetary damage” and the recent merge with Wyeth?
M. Black
Justice: Isn’t that where the “double blind”, “quadruple blind”, “bribery” factors come into play?
Betsy
I wrote a paper 3 months ago about the behaviors of Big Pharma and was paid handsomely for that paper, but the editor of the journal chickened out of publishing it AFTER she paid me.
One of the stories I included was the above story about Scott Ruben. His fraud has been known for some time.
Amazing, isn’t it?
When you’ve done as much research as I have, one would think that I’d stop being surprised at all of Big Pharma’s misdeeds. I haven’t!
Christopher
Nowhere in Ed’s piece is there any suggestion that the sponsoring company had anything to do with Reuben’s fraud. Apparently he received research grants (from Pfizer) who supposedly did not handle or publish the data. Yet we have the usual skepticism and ‘Big Pharma’s misdeeds’ brought into the discussion. The story is about a fraudulent investigator and yet it becomes, once more, another chance to take potshots at the pharma industry.
pharmavet
Sorry, Patrons99. You’re making quite a broad assertion about the scope of clinical research fraud. I can only defend myself. I have a PhD in the biomedical sciences, and spent 28 years doing clinical research across many therapeutic areas, for both major and small companies. I will stand by every data point that I ever generated and every word that was published in support of the clinical trials under my supervision. Be careful about painting with too broad a brush.
Justice in MI
for Christopher and others–personally, I didn’t bring “big pharma” into it.
I do believe, however, that corruption begets corruption. What I would love to see is evidence that Pfizer ever questioned Reuben on where his data came from rather than rewarding him with grants and speakerships. I’m not say they were obliged to do so. But I would be happily surprised if they did.
Justice in MI
I’d also say this. It is pretty much a certainty that Pfizer’s own research people knew more about the potential benefits Reuben claimed to find than Reuben alone.
So what are the odds they didn’t at least suspect that his data were bogus? And what are the odds that, so suspecting, they didn’t let it fly anyway?
patrons99
Pharmavet: I seem to have touched a sensitive nerve. If your conscience is clear, I applaud you, sir. In your extensive career in clinical research did you ever attend investigators’ “meetings”? were you ever “rewarded” for meeting study subject enrollment targets? were you ever “rewarded” with additional studies? were you ever granted study protocol “waivers”? did you personally write or make substantive contribution to writing all of the research publications that bear your name? Is your C.V. on the internet, linking you to your “research”, and to all of the “co-authors” in your study group, and to your corporate sponsors? Where did your research subjects come from? Did they come from your clinical practice? When did your research subjects sign an informed consent? Before or after they were “pre-screened”? Who paid for the screening failures?
I wonder how Reuben’s co-authors feel about knowing he’s been indicted for health care fraud? Perhaps, they should have been a bit more discerning. It’s fair to say that Reuben has made it into the Hall of Shame. Which version of the Oath of Hippocrates did he swear to?
pharmavet
Dear Patrons99: Just FYI, but I actually ended the practice of incentivizing investigators for speedier enrollment. Honestly speaking, I didn’t do it out of altruistic motives. I did it because speedier enrollment resulted in fewer truly qualified study subjects, thus incentivization is actually a self-defeating practice, at least for me. As a Pharma Director in the 1990’s I ordered a top to bottom review of every clinical task to bring a drug to market, from first dose in humans to NDA filing. I learned that the best we could do was shave one year off the timelines, but it would take cutting corners and possibly having an unapproveable NDA as a result. In this case I was actually rewarded for NOT making any changes to the program. I can’t speak for other program directors, but the above situations taught me that speed in clinical research tends to be counterproductive
Chris
Is this guy ending up keeping his medical license?
Tombo
I know who’s not keeping their grammar license.
David Granovsky
“…the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals…His research…published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. There’s only one problem with all this:
No patients were ever enrolled in the study!”
http://repairstemcell.wordpress.com/2010/02/18/pfizer-celebrex-bextra-vioxx-clinical-trial-results-were-fake-fraud/