Science News: Fraud in MedicalResearch
[This blog is by Janet Raloff, one of the most respected sciencereporters in the US in Science News, published by theAmerican Academy for the Advancement of Science. The prospecthighlighted by her story and the apparently legitimate commentsappended by other researchers is literally on the order of “Whatif everybody lies?” The worse, of course, because this dealsdirectly with the most advanced levels of current medicalresearch.
Comingon the heels of the financial meltdown, with its own version ofmultiple levels of lying and incompetence it begins to seem thatthere’s something that makes us — as humans — unable to live in acomplex, trust-based society.
Think I’ll go kayaking and look for our creekside kingfisher. . .. or see if the osprey has found his lady friend . . . bp]
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OUCH! WAY WORSE THANPLAGIARISM
Web edition : Tuesday, March 17th,2009
A little over aweek ago I wrote a two-parter on software that has uncovered hundredsof instances of apparent plagiarism in biomedical science. Copycatting someoneelse’s work is lazy at best; more likely it’s just amoral. But thecurrent issue of Anesthesiology News highlights an even moreegregious type of fraud: blatant fabrication of medical data. In two investigative news stories, Adam Marcus describes the caseagainstanesthesiologist Scott S. Reuben. This prominent Massachusetts painresearcher is accused of faking data that served as the basis for aminimum of 21 published medical studies. At least plagiarists”borrow” data that are ostensibly real and therefore might have somemedical validity. Fabricated data benefit no one but the author who islooking to bolster his reputation by fattening his portfolio ofpublished studies. Indeed, the potential for harm in seeding fake findings within themedical journals is substantial. They encourage an undue belief byclinicians that certain treatments will – or will not – helppatients. In Reuben’s case, his publications focused on the purported benefitsin prescribing non-opiate painkillers, such ascelecoxib(sold as Celebrex), a drug that inhibits cyclooxygenase-2, an enzyme that triggersan inflammatory cascade of changes in the body. His studies claimed itworked well, particularly when paired with a neuropathicpainmedicinepregabalin(sold as Lyrica). But these Pfizer drugs are not the only ones thatReuben claimed performed well in place of more powerful old-linepainkillers. Together, Reuben’s studies have served as the foundation of a fieldof medicine known as multi-modal analgesia. It recommendsadministering painkilling combos around the time of surgery, in someinstances as a form of “preemptive analgesia.” Reports Marcus: “Due to the sheer scope of the misconduct thisfield now requires major bolstering to regain the confidence ofclinicians and researchers.” He quotes Paul F. White of theUniversity of Texas Southwestern Medical Center at Dallas as saying,”We are left with a large hole in our understanding of this field [ofmulti-modal analgesia].” White is the editor of Anesthesia andAnalgesia,which had to retract 10 of Dr. Reuben’s papers. How did Reuben’s co-authors respond? At least two have apparentlycome forward and claimed that they had no knowledge they were listedas authors of the papers. If true, publishing forgery will be added tothe charges being leveled against the discredited Reuben.
Inklings of the academic misconduct, which Reuben has admitted to,came to light a year ago when the hospital he was working forperformed a routine audit of summaries for two of his studies. Marcusreports that this audit turned up no approval for the studies by thehospital’s institutional review board. “It turned out therewas not IRB approval because the data were partially or completelyfabricated,” the hospital’s chief academic officer toldAnesthesiology News. This realization ultimately triggered a wholesale audit of Reuben’swork and a slew of retractions of his oft-cited papers. Reuben is nowon “medical leave” from his job as director of acute pain serviceat BaystateMedical Center. Marcus quotes White as saying the scandal “compromises everymeta-analysis, editorial, systematic review of analgesic trials”or anything else that cited the fraudulent findings. The costs ofreviewing and undoing this fraud will just snowball in the comingmonths. People always point to peer review as the gold standard for vettingresearch – confirming that it is not only important but also solid.As the Reuben incident points out, peer review is far from perfect.Reviewers assume their colleagues won’t cheat to get their name inprint. In this case, that’s proved to be a pervasive and dangerousassumption. The big question: What change in policy could have routed thischeat’s bad deeds earlier? Now that it’s gotten a black eye from itstrust of Reuben, the medical-publishing field will have to reevaluateits policies. Of course, there’s no reason to suspect such misconduct is undulyrepresented in medicine, although the ramifications of any cheatinghere could prove especially deadly. No, cheating can happen in anyfield. Which is why chemists, physicists, environmental scientists,nutritionists and others need to also reevaluate their practices inlight of the Reuben affair.
Comments — 2 “At least plagiarists borrow data that are ostensiblyreal and therefore might have some medical validity.” – Not eventhis is true. Plagiarists also falsify data, since if they directlycopy it, it never existed in their study, and most of them make it upto differentiate themselves. And the idea that these coauthors”didn’t know” they were on those seminal papers? Would youlike to buy a bridge?
My anecdotal experience says that medical research has the highestrate of fraud in sciences, bar none. No other field of sciencerequires the same level of obsequiousness toward big shots. In noother area do big shots retaliate as viciously against those who rockthe boat. In no other area is it as costly to reproduceexperiments/studies. In no other area is there so little that iscalculable, and so many practitioners who couldn’t calculate it evenif it was. In no other area are researchers allowed to supplementtheir salary out of grants so much. (There are a number of P.I.s whopay themselves an extra bonus out of their grant money that is largerthan the salaries of anybody who works for them.)
My random walk anecdotal sample says that 3 P.I.’s out of 9 in medicalresearch have committed or commissioned fraud. Commissioning frauddelivers plausible deniability over committing it, and brings theadded benefit of an ally upon whom the commissioner of the fraud has alarge lever to force their compliance. Science fraud in medicalresearch gets people into top positions, because those people bring inthe grant money. We are talking chair of department, etcetera. Thiscircle of fraud gives many of them outsize clout in getting furthergrants, and it is the huge grants that incentivize their universitiesto ignore what they know in order to keep the NIH gravy traingoing.
And the fraud has reached its cold fingers right into the heart of thefunding mechanism at NIH. There is a regulation now that sets a”statute of limitations” on investigating scientific fraudat 6 years. In today’s world the case of the midwife toad would nothave been solved! John Toradze
Mar. 18, 2009 at 12:38pm After managing a 5-year, multi-center study of the situation,my team has concluded that fabrication rates for peer-reviewed medicalliterature dealing with pain killers range from 25.25% to 36.36%,placing them in the range of “high-rate forgery” for anyfield of study. Furthermore, approximately 42.42% of these frauds showno remorse. Ralph Dratman
Mar. 18, 2009 at 4:10am
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– Seneca the Younger(3BC-65AD)