• Drug safety: Waking the watchdogs Drug safety: Waking the watchdogs By St. Louis Post-Dispatch – February 23, 2005 Pharmaceutical companies conduct detailed testing to get their products approved for market. But they cannot be ordered to perform more tests
• Drug safety: Waking the watchdogs
Drug safety: Waking the watchdogs
By St. Louis Post-Dispatch – February 23, 2005
Pharmaceutical companies conduct detailed testing to get their products approved for market.
But they cannot be ordered to perform more tests if questions arise about a drug that has been approved. Nor can the federal government legally conduct those tests itself. No one is well-served by a system that puts regulators in the uncomfortable position of answering “We don’t know” when asked about the safety of drugs on the market.
Creation of an advisory panel to focus on the safety of drugs already on the market, which the U.S. Food and Drug Administration announced last week, will improve the untenable status quo, but only marginally. The panel isn’t independent of the FDA. But it won’t be composed of the same people who approved the drug and whose reputations – as well as those of the drugs’ makers – rest on not having approved a dangerous medication.
Even so, the new panel won’t be a success unless Congress gives it two things: money and the legal authority to do the job.
Performing large-scale drug safety reviews often involves culling millions of patient records. It’s an expensive undertaking. But the FDA is short of cash. More accurately, it’s short of taxpayers’ cash.
A 1992 law pushed by the Clinton administration allowed drug companies to make contributions to the FDA, but only to give so-called fast-track approval to new drugs. But as the amount of drug company money increased, the amount of federal tax money earmarked for drug reviews dropped. Virtually all federal drug reviews now are paid for by drug companies. If Congress wants more objective data in order to protect public health – as it should – Congress must be willing to pay for it.
Congress also should change the law to allow the FDA to require additional testing and to mandate recalls. Nearly a dozen drugs have been withdrawn from the market – virtually all of them by their makers, not the FDA – since 1997.
The problem with those drugs isn’t that they can cause harm; all prescription drugs carry risks. The question is whether the risks outweigh the benefits. One good example is the class of arthritis drugs called COX-2 inhibitors, which include Celebrex and Vioxx. The chief benefit of COX-2 inhibitors was that they were considered less likely to cause ulcers and other stomach problems. But because the drugs were advertised heavily in mass-market publications and on television, many people who didn’t need them asked their doctors for these drugs anyway. As many as two-thirds of the people taking COX-2 inhibitors at the height of their popularity had none of the problems for which the drugs were intended. An FDA advisory panel last week recommended that COX-2 inhibitors stay on the market, but the drugs’ blockbuster popularity is unlikely to return.
The best people to weigh the risks and benefits of drugs are doctors, but even they aren’t infallible. There are real questions about whether doctors can weigh risks and benefits adequately under the current system. All too often, the risks are hidden by drug companies that finance the studies of their own drugs.
That was the case with certain antidepressants that were being used to treat adolescents. Drug company studies, including some shared with but not released by the FDA, showed they carried a slightly greater risk of suicide. In fact, the drugs didn’t work well for adolescents. But doctors never knew about the studies because they weren’t published.
No big pharmaceutical company, having invested hundreds of millions of dollars in a product, is likely to seek out problems with its drugs. That’s a job for drug regulators. The United States needs a drug safety system whose vigilance doesn’t end when medicine makes it to market. We need a system that is actively checking the safety of drugs already on the market, a system that has enough legal authority to demand answers to tough questions and is nimble enough to reanalyze data when new questions arise.
After last week, we are marginally closer. But we still have a long way to go.
