|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 06-09-2005
Drug Safety System is Broken, a Top F.D.A. Official Says
There are several articles on drug safety this week, leading off with this one.
The FDA’s current drug safety system is a bit like the World War II era French Maginot line. Lots of very intensive, expensive, time-consuming testing before a drug is allowed on the market. But once you get past drug approval, the FDA’s voluntary MedWatch system may only capture 10% of all adverse events.
Dr. Janet Woodcock, deputy commissioner of operations at the FDA, discussed this problem at an advisory board meeting at the Institute of Medicine, which the FDA has asked to review its safety procedures.
[She told the] medical advisory board on Wednesday that the nation’s drug safety system had “pretty much broken down” and that there was room for “a lot of improvement” in the government’s approach to uncovering dangers in drugs already on the market. …
“The keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient,” Dr. Woodcock said. “This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient.” [Ed: emphasis added]
The Maginot approach fails primarily for two reasons. First, there is no way to discover all of a drug’s potential side-effects before it is allowed on the market without bringing drug development to a halt. Second, doctors are too pressed for time to expect them to report any but the most serious adverse events.
This is not to say that doctors should have less discretion using medicines; perhaps half of all prescriptions in the U.S. are for “off-label” use, a practice that undoubtedly saves lives. We need to retain flexibility and initiative for physicians while systematically capturing more information on drug use and side effects.
Dr. Woodcock thinks that what the agency needs to do is to “improve systems for learning about problems with drugs on the market,” and “take advantage of electronic health records from managed-care organizations.” In other words, the pharmaceutical market is a vast repository of information that can be tapped if we just put the right automated systems in place and focus on disseminating that information to physicians and patients.
We don’t need a Maginot line to protect the public—we need modern information “warfare” against disease, where we send the right drug to the right place at exactly the right time.
The FDA has been under tremendous pressure to "get tough" on drug safety, particularly in the case of antidepressants taken by teenagers. There have been some claims that a new class of these drugs, called SSRIs, may increase suicide risk in some adolescents, and the FDA has responded by adding its most stringent warning to the drugs' labeling.
Some psychiatrists, however, contend that these risks have been exaggerated and that the FDA is doing more harm than good by frightening parents and teenagers with severe depression away from useful treatments:
The American Medical Association will consider taking a stance against a controversial Food and Drug Administration decision to add stiff warnings about antidepressant use among teens and children at its conference in Chicago this month.
Study Links NSAIDS to Increased Risk of Heart Attack
While the media have battened onto the Cox-2 painkiller Vioxx as an example of everything that is wrong with the FDA, they have largely overlooked the fact that some painkillers in common use—and commonly considered safe—may also have rare side effects that pose similar risks to Vioxx. The British Medical Journal, for instance, recently published a study finding that:
Ibuprofen and other commonly used painkillers for treating inflammation may increase the risk of heart attack…
The newer generations of anti-inflammatoriesCox-2 inhibitorsalso were associated with increased rates of first-time heart attack. Those prescribed the drugs in the preceding three months were at 21% higher risk of heart attack if taking celecoxib, and 32% increased risk if taking rofecoxib.
This finding is significant because after Vioxx and another COX-2 drug, Bextra, were withdrawn from the market, patients have shifted to the older NSAID painkillers, assuming that they posed less risk. That may yet turn out to be true. But in the interim, we shouldn’t allow rare risks to create knee-jerk reactions to medicines—old or new—that are extremely useful and safe for the vast majority of patients.
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