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Research fraud case reveals weaknesses in oversight systems, author argues

Posted by Elizabeth Cooney March 13, 2009 01:26 PM

Accusations of research fraud against a well-known Massachusetts anesthesiologist almost beggar belief.

As this Globe story reported, Dr. Scott S. Reuben, who worked at Baystate Medical Center, allegedly fabricated results in at least 21 published studies and, in some cases, even invented patients.

But weak oversight makes such a pattern possible when researchers have financial ties to the drug companies whose products they study, Alison Bass argues on her blog. She is a former Globe reporter and author of the book "Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepresssant on Trial."

"The case of Dr. Reuben, who has been apparently been faking research data for more than a decade, highlights the serious shortcomings in our current system of conducting and disseminating medical research," she writes. "It also spotlights why the much-heralded disclosure regulations recently promulgated by the state of Massachusetts are not as effective and far-reaching as state officials would have us believe."

Bass urges adoption of a national law that would require drug and medical device companies to make public all conflicts of interest.

"If Reuben's conflicts of interest had been more transparent, there's a possibility that someone in the field of pain medicine might have questioned sooner why all of his studies seemed to find positive benefits to the drugs he was studying," she writes.

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6 comments so far...
  1. In the past, Drs have had more integrity. But it is also true, in these days, that becoming a professor is almost absurd or impossible, due to many research papers to publish and the enormous amount of clinical work to do at the same time. In any circumstances that should not justify certain actions, and methods.

    Posted by Cassandra March 19, 09 06:59 PM
  1. As an academic who studies and writes about human subject protection in quality improvement activites and an anesthesiologist and ICU physician, the thesis advanced could never stop data falsification as existed at Baystate Medical Center. The falsifications were picked up serendipitously when Dr Reuben submitted a poster abstract for a presentation in his hospital's science fair that lacked documentation that he had received Institutional Review Board Approval for his study. This led to a Baystate scientific auditor checking on this study and then others the doctor had previously conducted and published.

    Thiese data falsifications are also the responsibility of other co-authoras who wrot and published papers with Dr Reuben. Many medical journals require all authors to attest separately that they had reviewed all the data and had substantively contributed to the paper. Most likely the FDA will review these matters even thought no federal research money was involved. The issues of conflicts of interest and drug company sponsorship is unlikely to be at the core of this medical Madoff style deception

    Posted by Michael Rie MD March 19, 09 09:09 PM
  1. Dear Ms. Cooney,

    Quite a story! Any chance that you organization could publish something positive every so often about healthcare, and even about some one who has received "industry funding" and is not lying, cheating, or stealing, but has done something positive with such funding? Believe it or not, there are physicians and scientists funded by industry who still play by the rules.

    Posted by some of us still care March 19, 09 09:45 PM
  1. Until the penalties far outweigh the rewards, transparency, institutional review, etc will only be partially effective. The cheater and the corporate sponsor should both face trial for fraud and the possibility of substantial financial penalties. The cheater should face fines equal to his IRS reported income during the years in question and the sponsor should be faced with suspension of all INDs as fines. Co-Investigators and co-authors should be held similarly responsible. The period of suspension would prove to be a substantial financial penalty as it would represent an expensive delay to marketing new products.

    Posted by Evan-Pannick March 20, 09 08:38 AM
  1. Academic institutions are at peril; The publish or perish demands leads to publication at any cost for promotion; How many academic professorships are based on , fraudulent data? Every insitution would have to investigate every Senior faculties papers to begin to answer; Meanwhile all promotions based on publications are suspect. Dr. in the system

    Posted by Will Gaiher March 20, 09 12:15 PM
  1. Not only is it publish or perish, in order to exist as a researcher, universities demand salary support for faculty from federally funded agencies. It is an open secret that in many institutions scientists are fabricating data in order to obtain federal funding and thus survive. Most institutes only care about the dollars that each funded grant brings in. No matter how unfortunate, the trend of fabricating data continues to rise everyday, and practically nothing is being done to stop the trend. True science is losing its integrity in the midst of this "struggle for existence"..

    Posted by Observer March 20, 09 07:34 PM
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Elizabeth Cooney is a former health reporter for the Worcester Telegram & Gazette, where she also was a business reporter and an editor. Earlier in her career, she edited medical books and journals at Little, Brown, and worked for Boston magazine.

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