For many patients suffering from Irritable Bowel Syndrome (IBS) with severe constipation, Novartis’ Zelnorm was a miracle treatment. But the current focus on negative aspects of the drug has placed an unfortunate cloud over its use.
What happened? A total of 29 placebo-controlled, 1-3 month trials of more than 11,600 patients receiving Zelnorm showed a slight increase in the risk of cardiovascular events—angina, heart attacks and strokes—over placebo (0.1% versus 0.01%).
But these studies—for the most part—involved patients in higher risk groups than those for whom myself and others would prescribe it, and for some also a longer use of the drug. Plus, many physicians were already aware of this potential problem, which was why we gave the drug
mainly to younger people with lower risk for cardiovascular events.
The Food and Drug Administration acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the US. This is certainly a responsible and cautious reaction. So why aren’t the FDA and Novartis being praised for their actions on behalf of drug safety?
The answer is that we currently live in an unhealthy climate of drug company bashing where every newly demonstrated risk is an opportunity for a new round of criticism. Those who engage in this habit tend to justify it as a way to protect society, though there is certainly a tradeoff—excess caution and fear of attack is certainly not conducive to research and development, so don’t be surprised if drug discoveries continue to decline.
It makes sense to keep Zelnorm in reserve for those in lower risk groups who really need it. It also makes sense to not inflame the news of its slight increased risk of heart disease and stroke and use it as a pulpit to start criticizing everyone in sight.
Marc Siegel, MD, is an internist and associate professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear.
From the May 01, 2007 Issue of MM+M - Medical Marketing and Media
