Drug Research: What Are Patients Supposed to Believe?

By Christine Miller, HealthCentral's Patient Expert

Eighteen months ago, Merck & Co. withdrew its painkiller Vioxx from the market, stating that research data showed that patients who took Vioxx for 18 months had an increased risk of heart attacks. Since then, more than 11,500 law suits have been filed against the drug manufacturer by people who claim to have had heart attacks as a result of taking the drug.

Now Merck has made the news again this week with the revelation that data from a one-year follow-up study suggests that the cardiovascular risks associated with Vioxx begin after four months instead 18 months. Merck also released data last week showing that the risks of taking Vioxx continued for one year after patients discontinued use. The company has stated, however, that the data “do not establish that the risk for Vioxx starts earlier than had been previously reported.” Although the number of cardiovascular events at four months was not statistically significant, the data does show an increasing trend from the four-month point.

My first wonder is what effect this information will have on all of the pending lawsuits in the courts. But it also leads me back to a question I’ve been asking myself and my doctors for years. What are my medications doing to me in the long term? Are they safe? I’ve never taken Vioxx, but I have been on various medications for my JRA since 1978, some for years at a time. I have taken Celebrex for more than five years, 400mg a day, even after it too was being reviewed for withdrawal from the market. At the time, I had asked my doctor about the potential risks of developing heart problems. But she assured me that since I was in my 20’s, I had nothing to worry about. Somehow, her response didn’t really comfort me.

It is difficult for patients to really know all of the potential risks and side effects of these drugs. Studies often contradict each other, and it is often difficult to know what the potential holes and biases are in the data. The cynical side of me thinks that drug companies selectively study their drugs, minimizing the potentially bad data in order to get drugs approved and on the market in order to reap the returns of their expensive research and development investments. I also worry about drugs after they have been approved, if enough attention and research are paid to them to make sure they are safe over the long term. I don’t know enough about the FDA approval process to make real suggestions. But I do hope that enough people care about the issue to force more transparency and some real change in the drug industry.

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