The Official Medtipster Blog

www.Medtipster.com Source: The Boston Globe – Christoph Westphal, 6/28/2010

If we focus too much on side effects, we might forfeit important new medications

WHEN IT comes to prescription drugs, patients expect benefits but appear intolerant of risks. What would happen in a world that accepts no risks in its pharmaceuticals? We would have very empty medicine cabinets.

Every June, 200 biotech and pharmaceutical CEOs gather in Boston. This year, the deputy commissioner of the Food and Drug Administration spoke to the group on the evolving risk-benefit analysis regarding prescription drugs. Much of the ensuing dialogue with the CEOs centered on society’s changing views of drug benefits and risks.

The first “wonder drug,” aspirin, was synthesized by Bayer in 1897 and marketed in 1899. This extremely rapid path from initial experiments to market is impossible to imagine in today’s world. Now, aspirin has some wonderful properties – it reduces inflammation, prevents blood from clotting, lowers fever, and lessens pain. Millions of Americans take aspirin every year, without a doctor’s prescription. However, side effects kill roughly 10 out of 100,000 men taking aspirin. In fact, it is possible that aspirin would not be approved today by the FDA, so dramatic is the shift in society’s risk-benefit views regarding pharmaceutical products.

That shift spelled the doom a few years ago of another drug with significant benefit, but some risk, namely Vioxx. Merck had shown beneficial effects of Vioxx in severe arthritis in thousands of patients, and the drug was approved. After Vioxx reached the market, however, the risk of death from heart attack, estimated by independent academics to be on the order of 20 to 30 out of 100,000 patients taking the drug, led Merck to remove Vioxx from the market. There are likely patients with severe arthritis who would accept the risk of side effects, in order to benefit from this effective medicine. But these patients no longer are able to make their own risk-benefit calculations. Instead, society has determined on their behalf that this therapeutic option should no longer be available to them.

How dangerous, in comparison to taking aspirin or Vioxx, is driving a car? According to the National Safety Council, the risk of dying in a car accident during one year is about 155 out of 100,000. The death rate of car usage actually appears a good deal higher than the likelihood of death caused by taking Vioxx or aspirin. Nevertheless, no one is arguing that cars should be taken off the market. Instead, society has decided that the benefits of cars outweigh their risks.

As society has shifted to a view that medications should have virtually no risks, the inevitable effect has been to reduce the flow of important new drugs. It is certainly fair to rigorously test any new medication prior to approval. In addition, any new drugs should be monitored for safety and efficacy after they have reached the market.

But society must be careful to weigh the benefits of effective new drugs for diseases that until now have been poorly treated, versus the added risks of the new medications. If we focus too much on the risks of drugs, and do not balance those risks against the benefits, fewer drugs will be approved and reach patients in need. That is a risk in and of itself.

On your next drive, remember that it may be riskier to get in your car than to take the drug Vioxx, which was shown to be highly beneficial to patients with severe arthritis, but has been removed from the market.