Jewish Journal


January 20, 2005

Where Have All the ‘Safe’ Drugs Gone?



In the fall, my Vioxx patients fled to Celebrex. The other day they fled to Aleve. Now they don't know what to do.

Now that it was discovered that patients taking naproxen (Aleve) for three years had a 50 percent increased risk of heart disease, my patients want to know if any arthritis drug is safe.

I tell them that all these drugs are probably safe -- if taken for the right reasons and if judiciously prescribed.

I tell them that the increased risk of heart disease is due to taking these drugs at high doses over a prolonged period of time. In the case of Celebrex, an enzyme is diminished that prevents clotting. And clotting is associated with heart attacks.

In the case of Aleve (and perhaps all the non-steroidal anti-inflammatory drugs), prolonged use can lead to fluid retention and elevated blood pressure, a risk factor to the heart.

A significant issue here is how well the Food and Drug Administration (FDA) patrols drug-safety issues, both before and after a drug is launched. There are certain life-saving drugs that need to be rushed to market, AIDS drugs being an example -- but in many situations the "new" advantage may be marginal or even non-existent.

An even larger issue is the way drug companies inflate the balloon of expectations, which can then be popped when a significant side effect is found. If the supposed ability of Celebrex to protect the stomach hadn't been so overstated, then the 20 million-plus who take Celebrex might not feel as betrayed now that the potential risk of heart disease has been found.

The largest issue of all is how poorly we physicians keep track of what we prescribe. Why should the latest and greatest new pill take the place of the tried-and-true? It shouldn't. Why should we always rush to take medicines for aches that might do just as well with weight loss and physical therapy? We shouldn't.

Doctors and patients alike are plied by ads of healthy people who only seem to be smiling because of pill X. It is time for doctors to take a harder look at what we prescribe and why. Doctors shouldn't rely on drug-company education -- it is naturally tilted in the direction of a particular drug. Why should we expect balanced information from a source that has a vested interest in making sure its drug succeeds?

Prescribing drugs is a cost/benefit analysis -- weighing the risks and benefits of the medication, vs. the alternatives (how well the patient would do without it). Perhaps we haven't followed this model carefully enough, but we shouldn't swing from drug dependency to drug panic.

If Celebrex is found to be a greater risk to the heart than it is beneficial to the stomach, we doctors simply need to factor that information into which drugs we prescribe, as the FDA factors it into which drugs are on the market.

In the case of Aleve, which is available over-the-counter, the problem is tied to unregulated use of a drug without a physician's guidance. This can easily lead to overuse, and if heart attack or stroke is a significant risk, the FDA will have to rethink whether to allow this valuable drug to be available without a prescription.

It isn't so much a particular drug that is dangerous as the process of ramping up expectations and overusing a drug, ignoring the risks -- and, in the end, being consumed by them.


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