The Food and Drug Administration wouldn't approve a drug without strong evidence of its safety, would it? No. It wouldn't. And once a drug is approved, the FDA tracks it to make sure, doesn't it? Well, sort of.
Today the FDA was on the hot seat on the Hill over one of those sort-ofs--the diabetes drug Avandia, which is in the middle of an imbroglio over safety concerns eight years after coming to market. Rep. Henry Waxman, a Democrat from California, called the hearings because he believes the FDA should have the will, the funding, and the power to closely monitor drugs not just before but after they reach the public. That authority should include ordering pharmaceutical companies to conduct large-scale safety studies. To Waxman, Avandia was a case in point. In his view, “The FDA dropped the ball.”
The truth is that every drug, from an over-the-counter heartburn remedy to the latest blood-pressure medication, carries risks. The challenge when evaluating a drug, as FDA Commissioner Andrew von Eschenbach noted today, is to find these risks, measure them, and decide whether they outweigh the drug’s benefits. But after the FDA makes that determination and the number of people put on the drug over the years dwarfs the number in the original clinical trials, problems may pop up or loom larger than originally believed. That’s what happened with Baycol, a statin taken off the market in 2001 after more than 30 patient deaths. It happened recently with drug-coated stents, which were found to slightly raise the risk of fatal blood clots after several years.
Someone on a medication that suddenly comes under a cloud must be horribly confused. I’m grateful I don’t have to deal personally, as millions of people with type 2 diabetes do, with the still-escalating controversy over Avandia, GlaxoSmithKline drug that helps keep blood sugar under control. I’d feel buffeted by claims and counterclaims that hardly anybody can be expected to follow, let alone understand. That’s why we posted a consumer Q&A shortly after a study in the New England Journal of Medicine[hyperlink: http://www.nejm.org] showed a 43 percent higher risk of heart attack for those taking Avandia compared with those not taking the drug. The FDA posted a consumer alert as well.
Yesterday another stat-heavy analysis, this one funded by Glaxo, appeared in the New England Journal. Using preliminary data from a six-year study that won’t be completed for more than another two years, the company stated that the findings were “reassuring” because there were few heart attacks and cardiovascular deaths, and the numbers were comparable with those for non-Avandia patients in the study. The study termed these findings “inconclusive,” however. It also identified a sharply higher risk of heart failure. Demonstrating the stakes and high public profile of the debate, three editorials accompanied the study, and all sounded strong notes of caution. The results “do not provide any assurance of the safety of treatment,” said one.
The advice in the U.S. News Q&A still holds. We don’t want anybody stopping a drug without talking with a doctor. Whipsawing consumers from headline to headline may make some people feel like reaching for a headache tablet. But as another of the New England Journal’s editorials observed, “In this age of freely available information, drugs cannot easily be parsed into ‘safe’ and ‘unsafe’ categories.” That’s a reality we’ll have to live with. As will the FDA.