The FDA has a mandate to make sure all drugs (prescription and OTCs) are “safe and effective.” This is the law. The only trouble is that FDA’s definition of ‘safe’ is hard to get a handle on.
The feds routinely approve drugs that have life-threatening side effects. This is completely understandable in the case of a drug that might cure a deadly cancer. It is inexcusable when it comes to a condition like arthritis, high blood pressure or diabetes.
Avandia is just the latest in a long list of FDA disappointments. The FDA has been slow to discover serious problems with medications and often drags its feet even when the warning bells are clanging.
PPA (phenylpropanolamine), for example, was a decongestant and diet aid that was found in both prescription and over-the-counter products. It was introduced in 1962. Over the years, a number of experts warned that this drug might predispose people to heart attacks and strokes. Still, it took the FDA until 2000 to ban it. Countless people suffered and died because of FDA’s delay.
There are so many other examples we don’t know where to start. The non-sedating antihistamine Seldane was introduced in 1985. Even though doctors reported that some patients suffered sudden cardiac arrest when they took Seldane in combination with certain other drugs, it took the FDA until 1998 to ask the manufacturer to take this allergy medicine off the market. The agency waited until the manufacturer had a replacement product, Allegra, ready for sale.
Vioxx got a lot of ink when its manufacturer admitted that the drug could increase the risk of heart attacks and strokes. Again the FDA was late to the show. We asked an officer of the agency why they didn’t discover this serious side effect themselves and were shocked to learn that the FDA has a very hard time detecting “common” complications such as heart attacks or strokes.
Now we are told that one of the most popular diabetes drugs (6 million people are taking it worldwide) can also increase the risk of heart attacks and premature deaths from cardiovascular causes. Avandia has been on the market since 1999. It is only because of the persistence of Steven Nissen, MD, (Chairman of the Cleveland Clinic Department of Cardiovascular Medicine) that we learned about this problem.
Dr. Nissen is a bulldog. When he suspected that there was trouble with Avandia, he tracked down studies to assess cardiovascular risks. Why didn’t the FDA figure this out itself and warn physicians sooner?
People taking Avandia should NOT stop taking their medicine. If the risk is real, problems rarely develop overnight. It is a long-term process. Nevertheless, it would be prudent to schedule an appointment with the doctor who prescribed Avandia to discuss other options for diabetes control.
We deserve safe and effective medicine, just as the law says. To get there, though, FDA will have to do a much better job designing drug studies and monitoring medications once they are approved for sale. Until the FDA really protects us, we the public will have to be more vigilant, more skeptical and slower to accept prescriptions for the newest, most popular drugs.
