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The Boston Globe has reported that an anesthesiologist at Baystate Medical Center in Springfield, Mass. allegedly fabricated studies on post-surgery pain management.
“The investigation uncovered 21 published papers over 13 years…”
Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia, stated that, if the allegations are proven to be true, the case will be “the largest research fraud in anesthesia.”
Some of the drugs involved, Celebrex, Lyrica, and Neurontin, are made by Pfizer and it was learned that the company had given the doctor five research grants, and he was also one of their registered speakers. However, a Pfizer spokesperson stated that the company is, “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”
The doctor is currently on leave.
To read the full story, copy and paste the link below.
www.boston.com/news/health/articles/2009/03/11/doctor_accused_of_faking_studies/ - Liz Kowalczyk, Globe Staff / March 11, 2009
Saturday, March 14, 2009
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“Baystate Medical Center in Springfield, Mass., began investigating Reuben's findings last May after its chief academic officer, Hal Jenson discovered during a routine audit that Reuben had not received approval from the hospital's review board to conduct two of his studies. Reuben 'violated the trust of Baystate, the community and science,' Jenson says. The story of the investigation was first reported by Anesthesiology News late last month.”
ReplyDeleteHowever many others share culpability for these misdeeds, as stated here:
“In hindsight, Anesthesia & Analgesia editors Shafer and White admit that it should have been a ‘red flag’ that Reuben's studies were consistently favorable to the drugs he studied. White, who has also received drug company educational grants, says that such funding comes with ‘subtle pressure’ to give the companies the results they want. For now, at least, neither the drug companies nor Reuben's co-authors are officially sharing in the blame, but that's expected to change. ‘There's a lot of responsibility to pass around,’ White says, ‘It's all being focused on Scott Reuben, but the reality is there are many other responsible parties."
Click on the "Good Guy" link above to read Dr. Jenson's bio. Kudos to Dr. Jenson for reporting the errors.
ReplyDeleteI doubt that Dr. Jenson conducted the routine audit himself (although I could be wrong), so there are probably other responsible parties who deserve credit as well for discovering this travesty. Look here:
http://academics.bhs.org/Research/ClinicalTrials/index.html
I'm still confused about what this story is about--perhaps that's the nature of the story at this point.
ReplyDeleteIs this one guy on the take?--as some seem to suggest.
Is he taking the fall (perhaps unwillingly) for others?
Pfizer's spokesperson was quick to point out that Dr. Reubens studies were not used for FDA approval; however how important were Dr. Reubens studies for promoting off label use of Pfizer products.
ReplyDeleteRight. Certainly it would have been serious enough if they were part of an NDA. But their use for promo is not far behind if Pfizer was aware they were "questionable."
ReplyDeleteThe American Society of Regional Anesthesia & Pain Medicine held its 27th Annual Spring Meetings & Workshops (2002) in Chicago, Illinois. Reuben presented five abstracts at the meeting. Take a look at the abstract titled “Efficacy of the Perioperative Administration of Venlafaxine XR in the Prevention of Postmastectomy Pain Syndrome.” Use the search term PD-17 to find the abstract in the pdf:
ReplyDeletehttp://www.asra.com/meetings/2002spring/abstracts.pdf
According to the financial disclosure section, Reuben and his coauthors each had a financial relationship with Wyeth, the manufacturer of the study drug. The company may have provided the medication for the study. Note that one of the authors worked at another hospital.
Gardiner Harris reported in the NY Times (March 10, 2009) that, “Drug companies routinely hire community physicians to conduct studies of already-approved medicines. In some cases, prosecutors have charged companies with underwriting studies of little scientific merit in hopes of persuading doctors to prescribe the medicines more often.” This is what James brought up previously in this thread. I would add that if the study is positive, the results could be used to support a new FDA-approved indication for the drug.
It is not clear if Wyeth provided any support for this study. Though Wyeth was talking about the use of venlafaxine in postmastectomy pain syndrome, here:
http://www.atypon-link.com/PPI/doi/abs/10.1592/phco.24.6.621.34748
To date, Effexor XR has not been approved by the FDA for post-surgical pain.
Finally, I wonder if this was one of the studies mentioned in the news reports that had not been approved by the Institutional Review Board. This is important because the IRB serves to protect the rights and welfare of research subjects.
A physician writes about Scott S. Reuben's deleterious impact on healthcare and the systems that allowed it to happen (Insomniac will take you to the full write-up.)
ReplyDeleteTo Insomniac thanks for the link. The actions of Reubens and Madoff, while despicable, probably represent only a minute fraction of the corruption in our profit obsessed society.
ReplyDeleteIn addition, I previously posted this link to a Rolling Stone article on Zyprexa and I felt it was relevant to the Reubens/Pfizer connection.
http://www.rollingstone.com/politics/story/25569107/bitter_pill/1
Thank you for the link, James.
ReplyDeleteArnold Relman discusses this topic in "Medical professionalism in a commercialized health care market." (Insomniac links to the paper.)
The commentary written by Dr. Kate Scannell--referred to in this thread--is titled "If Bernard Madoff were a doctor" and can be found at InsideBayArea.com.
ReplyDeleteDear Insomnia,
ReplyDeleteThank you for the link. I agree with Dr. Scannell’s comparison of Madhoff’s misdeeds with those of Scott Reuben’s, two individuals who are helping to bring medicine and finance to their knees.
Sadly, my family and friends are beginning to wonder who we can trust.
It is likely that someday even Bernie and the anesthesiologist will be depending on healthcare to make them well. When that day comes they will be hoping and praying they get the best medicine money can buy. They will probably even be willing to give away all their money to get it.
Sleepless, would you happen to be writing from Seattle? (Insomniac links to information on selecting a doctor.)
ReplyDeleteI wonder how Bernie and the anesthesiologist sleep at night.
Yes, and it’s time for some magic.
ReplyDelete