Monday, December 20, 2004

Is Celebrex next?

Medpundit thinks that the knives are out for Celebrex. I think she's probably right. Just last week, a patient's spouse told me darkly that his wife had suffered a heart attack and a stroke while taking Celebrex. The connection seemed obvious to him. Why were they seeing me? The spouse had apparently taken it upon himself to increase the patient's tricyclic, which someone had prescribed for sleep, until it had reached toxic levels. The patient was floridly delirious, hallucinating, agitated, uncontrollable. I told the spouse that the tricyclic was far more risky than Celebrex for the patient's heart. The spouse was most unhappy to hear this. I don't think I convinced him at all. (I can't imagine that the FDA would approve meds like the tricyclics if they were introduced today.)

If Celebrex goes, it will complicate pain management for most of my patients with chronic pain. This is a huge issue in Oregon, where medical licenses are revoked when doctors treat pain inadequately. My orthopedist friends tell me that their phones have not stopped ringing since Vioxx was pulled. Patients are terribly concerned. Derek Lowe, also cited by Medpundit, has offered some perspective in his post,"Safe, and other four letter words."
"Safe" is a word that means different things to different people at different times, which is something you'd think any adult would be able to understand. The only definition that everyone would recognize, at least in part, is "presenting no risk of any kind to anyone." That'll stand as a good trial-lawyer definition, at any rate.

And by that one, not one single drug sold today is safe. Of course they aren't. These compounds do things to your body - that's why you take them - and that's inherently risky...

The drug industry, the FDA, physicians and most patients recognize that safety standards vary depending on the severity of the disease. Toxic drug profiles are tolerated in oncology, for example, that would have stopped development of compounds in almost other area. And the standards go up as additional drugs enter a market - yes, I'm talking about those evil profit-spinning me-toos. One of the best ways to differentiate a new drug in a category is through a better safety profile.

So when someone asks, "Is drug X safe?", they're really asking a whole list of questions. What are the risks of taking the compound? That is, how severe are the side effects, and how often do they occur? How do those stack up against the benefits of the drug? Then you ask the same set of questions in each patient population for which you have distinguishable answers...

The COX-2 inhibitors look much better (in a risk-reward calculation) in the patients who cannot tolerate other anti-inflammatory drugs because of gastrointestinal problems. Vioxx itself also looks a lot more reasonable in patients who are not in the higher-risk cardiovascular categories. But it (and the others in its class) have been marketed and prescribed to all kinds of people, and the fallout is just starting...

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