my column in M,M & M just out - with a fresh look at the scalded IBS drug -
For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ 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 aren¹t 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 don¹t 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.
For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ 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 aren¹t 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 don¹t 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.
