When huge sums of money are involved you can count on companies to fudge results, shift risk to the ignorant, and go for short term gains. That’s history and if we ignore it, as we have, we face disaster.
Consider a drug company with millions, perhaps hundreds of millions, of dollars “invested” and riding on the results of a study evaluating safety and/or efficacy. What are the chances that the result will be subtly skewed towards the company’s advantage?
I don’t know but consider the FDA’s review of GlaxoSmithKline’s study on the risks of Avandia. The WSJ noted:
The scientists said that patients taking Avandia had a 27% greater chance of suffering a stroke, a 25% increased risk of suffering heart failure and a 13% greater chance of dying. Avandia increased the overall risk of experiencing heart attack, stroke, heart failure or death by 17%, the study said.
Medicare patients in the U.S. who took GlaxoSmithKline PLC’s diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, a Food and Drug Administration scientist contends in a new study.
Glaxo’s response seems to minimize the findings.
In an emailed statement, Glaxo said it was “unclear whether this study has been peer-reviewed, and until then, it would be premature to comment.” However, the company cited “inherent limitations” with retrospective studies such as Dr. Graham’s and said the limitations “can significantly impact the validity of the data.” Glaxo added that results from six clinical trials have shown that Avandia “does not increase the overall risk of heart attack, stroke or death.”
Part of the problem was that the drug company designed study was poorly done.
A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.
The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.
Medicynical Note: Money makes people do funny things. We have drugs, making billions for drug companies, that offer minimal improvement in outcomes, survival and/or patient comfort. How confident are you that drug companies with facing the loss of their investment and profits will honestly evaluate risk and efficacy? Does anyone think these companies should be deregulated? Can the “free” market sort out these subtleties? If you think so I want you to know that I have some AAA rated mortgage bonds that Bear-Stearns sold me for sale.
This seems a strong argument for objective evaluation of studies and indeed for comparison studies to determine the safest most effective drug.
Addendum July 13: It’s worse than it seemed. It appears that there was information as far back as 1999 that this drug had problems. From the NY Times:
Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.
But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.
Amazing but apparently true!