FDA Debars Doc In Pfizer Research Scandal
4 CommentsBy Ed Silverman // November 16th, 2011 // 8:06 am
Do you remember Scott Reuben? He was accused of faking research for a dozen years in published studies suggesting after-surgery benefits from Vioxx and Celebrex. Last year, he was sentenced to six months in jail plus three years supervised release after pleading guilty to fraud. 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 journals that was unwittingly published.
Now, the FDA has permanently debarring him from providing services in any capacity to a person that has an approved or pending drug product application, according to the debarment order, which was published today in The Federal Register. The agency will also not accept or review any abbreviated new drug applications submitted by or with his assistance during his period of debarment, which is forever (you can read the order here).
In the aftermath, by the way, 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. His studies also claimed Wyeth’s Effexor antidepressant could be used as a painkiller. 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 colleagues. Separately, the journal Anesthesia & Analgesia retracted 10 of Reuben’s studies, while the journal Anesthesiology retracted three studies.
Condor
Great stuff, Ed!
Interesting that of the drugs — three of them, Celebrex, Bextra and Vioxx — are in one way or another linked to one CEO: Ex-Schering-Plough CEO Fred Hassan.
He and Carrie Cox sold Pharmacia to Pfizer, and just before that transaction, had very-aggressively launched the then blockbusters Celebrex and Bextra, using the above researcher’s data.
Vioxx was technically a Merck legacy product, but Hassan busted up Schering-Plough, as he sold it to Merck.
Wonder how many times the two met. There’s a saying in drug research: “When the data looks too good to be true. . . it probably is.”
Hmmmmmm. . . how much did the executive team know?
original industry insider
He is also debarred from entering into any future Jeff Foxworthy lookalike contests.
http://www.jefffoxworthy.com/homepage.shtml
company insider
I worked for Fred and NEVER say a paper by Reuben. Pharmacia and Fred and Carrie had very good morale and we were specifically told to NOT Market Bextra in particular ways and not use certain off-label materials. THey told us to NOT do exactly what Pfizer’s management told us to do. His biggest problem appears to be building organizations and then selling them which screwed a lot of people working underneath him. However, I was never in any of these meetings were any of the illegal activity might have been discussed. But he seemed like a pretty good leader to me until he sold us. He also made sure the employees were at least a little protected from Pfizer. We were told that if Pfizer wanted us to leave in the first two years and we agreed– we were guaranteed our severance agreement that we would have received if we had never worked for Pfizer. I thought that was nice of them to set that up since they had an idea as to what might happen otherwise.
xmrk
company insider - is your post sarcastic? If not, you need to spend some time over at http://shearlingsplowed.blogspot.com/
The 2-year severance deal is one of Fred’s most widely used tools. If he comes to a company near you peddling those wares, start packing your things, a sale is in the air.