Dr. Aubrey Blumsohn was stunned, he said: Research results were submitted to a scientific meeting under his name, yet the British bone specialist insists he not only hadn't written or reviewed the report, he wasn't sure it was accurate. The incident turned into a public feud when Blumsohn charged that the U.S. drug company paying for the study rebuffed his attempts to analyze the data. It's the latest in a string of controversies about pharmaceutical industry control of medical research, from hidden antidepressant risks to the undercounting of heart attacks in a critical study of the painkiller Vioxx.
Whoever PAYS for medical research, and not necessarily the scientists who do the work controls what doctors and the public learn about its outcome. Scientific journals, including one that published some of the reports Blumsohn now questions, are grappling anew with how to ensure that they print complete results.
Why has it taken so long to police themselves? Simple. The pharmaceutical industry provides approximately 70 percent of the financing for studies of medications in the United States and therein is the problem. In a nutshell, 70 percent of all studies are conflicts of interest, slanted to maximize sales, if not outright inaccurate and could cost the patient severe to life-threatening side-effects if not life itself.
Questions about flawed research started making headlines in 2004, when a Food and Drug Administration re-analysis of industry antidepressant studies concluded those drugs sometimes increase the risk of suicide in children. Next, Merck & Co. pulled its arthritis drug Vioxx off the market, after downplayed research came to light, and showed long-term use doubled the risk of heart attacks. Critics say the risk was downplayed to keep the money-making drug on the market, irregardless of the dangers involved. Last December, the New England Journal of Medicine revealed that it had published a 2000 Merck study that failed to disclose some heart attacks, making the drug appear less risky than later determined.
Dr. Blumsohn, in a Capitol Hill visit recently arranged by the watchdog Government Accountability Project, is raising questions of more subtle influence.
Procter &Gamble hired Blumsohn’s lab at Sheffield University in the UK, to analyze samples from thousands of women who used its osteoporosis drug Actonel. The goal: to determine what rate of bone renewal gives the most protection against fractures. E-mails that Blumsohn provided to The Associated Press suggests pretty clearly that P&G denied him access to the patient data until months AFTER results had been submitted fraudulently in his name to the bone society. Blumsohn finally got a brief look in July 2003, only to conclude that about 40% of the data was missing, skewing the results completely. "We've allowed the basic rules of science to be flouted without a murmur from anyone," contends Blumsohn, who met recently with Grassley's staff and drug regulators in Washington.
P&G spokesman Tom Millikin said Blumsohn "was provided full and unfiltered access to all of the data that was relevant to the work he performed." The key word here is “relevant” and that relevancy was determined by P & G and in its own interest to squash any data that might harm sales.
Blumsohn counters that he presented only data he could confirm. "Access to data means you've got the numbers, and ALL the numbers. They redefined 'access to data' meaning a company statistician would give you some tables," Blumsohn said. "These companies are using scientists, university scientists, to give their research a veneer of university respectability and credibility." And, they are costing lives as they revamp, rewrite, restructure, fudge, downplay, outright lie about the research…whatever you want to call it, it stinks.
Dr. Blumsohn’s case made headlines in Great Britain, and was raised in Parliament last December after the university suspended him. Blumsohn said his suspension was for speaking to the press, letting the cat out of the bag so to speak. University reports at the time quoted the university as saying it had encouraged him to raise his concerns using proper channels, which is their way of slapping his hands for not “conforming” to the “don’t ask, don’t tell” protocol prevalent at Sheffield University. At Sheffield, if you don’t let the “money talk” you are ”forced to walk” or there is a snarky attempt to buy you off or destroy your career.
Dr. Blumsohn refused to die so easily and he refused to be bought off.
NOTE: A recent survey, published in the New England Journal of Medicine of 122 universities' standards for drug-company research found only 17 percent reported disputes over control of or access to data. They also reported widespread disagreement over whether the companies that pay for research should even be allowed to help write the results for publication, or insert their own interpretation of those results.
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