Friday, July 02, 2010

Bitter Medicine

David Lazarus, business columnist for the Los Angeles Times and himself a diabetic (Type 1), examined the brewing storm swirling around the glucose-lowering drug Avandia. The Food and Drug Administration has known since 2000 that the drug has a dangerous side effect: it increases the risk for heart attacks and strokes in some of its users. Nevertheless, the drug has remained on the market because it is effective in what it does. Once again, the FDA is engaged in a very tricky balancing act. Mr. Lazarus asks the right question about this balancing: When does the risk outweigh the benefit?

"You can improve safety by keeping drugs off the market for more testing," said William Comanor, director of UCLA's Research Program in Pharmaceutical Economics and Policy. "But then you're not helping people who might benefit from that drug.

"It's a balance," he said. "You don't want to bring out a drug too soon, but you don't want to be too late. Where the middle ground is, I don't think anyone can say for sure."

As someone with Type 1 diabetes (who hasn't taken Avandia), I find that deeply troublesome — as should anyone who relies on prescription drugs to either make them or keep them well. By the time a medicine reaches consumers, it would be nice to think we know everything it can do to you, good and bad.

Troublesome, indeed. I think an argument can be made that the FDA waited too long before pulling Vioxx, a pain reliever, for some of the same side effects. And like Vioxx, there are other, safer drugs on the markets for the targeted consumers than Avandia. Still, Avandia does represent an advance in the fight against diabetes, a disease that is increasingly ravaging Americans. What can the FDA do? Handcuff researchers until they prove beyond a reasonable doubt that any given drug is absolutely risk free?

Surely not, but the FDA could do more to protect consumers from the unnecessary risks, and Mr. Lazarus suggests some ways that protection can be offered.

What drugs like Vioxx and Avandia highlight is that when dangerous side effects become known — or at the very least strongly suspected — it's important for regulators to step in quickly with a second look.

That means an immediate moratorium on sales as soon as a credible study raises questions about safety. It means additional research by the manufacturer to address the new concerns.

If a drug becomes unavailable for a matter of months or even years, so be it. In most cases, there will be other drugs to address people's medical needs. Avandia isn't the only drug that helps people with Type 2 diabetes lower their glucose levels. Vioxx wasn't the only pain reliever.

That would certainly be a good start. Pharmaceutical companies just might be a bit more thorough and careful the first time around rather than face a massive recall of their product. Doctors might then feel a little more comfortable prescribing new drugs knowing that all potential side effects have been carefully examined. Yes, it will cost the drug companies some money, but knowing that their products are as safe as they can make them just might save them litigation costs in the future.

My question is simply this: why hasn't the FDA already taken such an approach?



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