Big Pharma's Hold on Drug Research Hides the Truth
Drug companies' close involvement in trials of their own products means we can't trust the results, an investigation shows.
A Washington Post investigation published yesterday suggests that Big Pharma's growing influence over research on new medications leads to the FDA approving dangerous drugs. According to journalist Peter Whoriskey, controversies in the past decade over highly profitable “blockbuster” drugs like Vioxx, Avandia and Celebrex have prompted investigations into whether the drug industry’s company-funded research deliberately misleads the public and the government about risks.
Avandia, a drug developed by GlaxoSmithKline to treat diabetes, for example, was approved after researchers published an article in 2006 in the New England Journal of Medicine, which Whoriskey calls "arguably the most prestigious medical journal in the world." GlaxoSmithKline became the subject of a Senate investigation when the article was found to have masked the dangers of the drug, using tactics such as publishing incomplete trial data or not publishing overly negative trials. Avandia was estimated by the FDA to have been associated with 83,000 heart attacks and deaths before it was pulled. The Washington Post reviewed all the articles on original studies of new drugs that were published in the New England Journal of Medicine over a year-long period ending this August. Of the 73 articles, 60 were found to be funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who'd previously accepted compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.
But do we know whether financial incentives lead to bias? In an analysis by Justin Bekelman, a professor at University of Pennsylvania, the odds of coming to a favorable conclusion were found to be 3.6 times greater in research sponsored by the industry than in research sponsored by the government or nonprofit groups. And the drug industry now funds a larger share of research than ever. “It used to be that drug companies would hand their new drug over to an academic center to have it tested, and then they sat back and waited,” says Marcia Angell, who worked at NEJM for over 20 years and retired as editor-in-chief in 2000. “Now they’re intimately involved in every step along the way, and they treat academic researchers more like hired hands.”
So what can be done to protect us from drug companies who only have eyes for profits, not patient welfare? Whoriskey suggests an increased need for transparency about industry-sponsored drug trials. Such transparency wouldn't eliminate all of the drug companies' tricks—like designing research that gives only positive views of their products, or hiring researchers they know to be partial to a drug. But it would allow independent researchers to analyze the data from trials and draw their own conclusions. “If you have the privilege of selling a drug, in return should come the responsibility to share everything you know about the drug,” says Harlan Krumholz, a professor of medicine at Yale and a leading advocate of data access. “This is not about doing gotcha with industry. It’s about how to restore trust.”