Different River

”You can never step in the same river twice.” –Heraclitus

April 7, 2005

Pfizer Withdraws Painkiller Bextra

Filed under: — Different River @ 12:33 pm

Pfizer has withdrawn the COX-2 inhibitor Bextra off the market under FDA pressure. They are also putting a “black box” warning on their older drug Celebrex, which is now the only COX-2 inhibitor left on the U.S. market, since Merck withdrew Vioxx last year under similar pressure.

The FDA is also requiring new warnings on nonspecific COX-1/2 inhibitors, more commonly known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) — the most common ones being Ibuprofen (Motrin, Advil, etc.) and Naproxen (Aleve, etc.). The public FDA statement is here.

I have my doubts that this is the right decision — that is, I’m sure all these drugs have risks, like all drugs do, but I’m not sure the risks are so severe as to justify taking them off the market completely, instead of just warning doctors to be careful to whom they prescribe them, and patients to watch for side effects. Of course, I can’t actually find out whether my doubts are valid, because the research on which these decisions are based appears not to have been published so far. (If anyone knows where I can find it, let me know!)

The fact that the information is not yet public is part of the problem. It appears that the FDA would rather have you suffer indescribable pain and be bedridden with arthritis (for example), than have you run a slight risk of a heart attack. (A risk which you might be able to mitigate with exercise, that you can’t get without athritis medicine.) Or to put it a different way, they’d rather you die of a bleeding ulcer from taking too much aspirin or ibuprofen, than die of a heart attack from taking Bextra or Vioxx. I don’t doubt that many patients, evaluating the risk-benefit trade-off with their doctors, would make the same decision. But I also don’t doubt that many would make the opposite decision, and the FDA seems to fear that — even though it’s the patients, not the FDA, who have to live with the consequences of whatever decision is made. I don’t know what the folks at the FDA actually believe, but they seem to act as if they believe that doctors and patients are too stupid to make their own decisions — and they certainly act like they believe they are able to make decisions for everybody. Not only that, but the right decision is the same one for every single patient in the country!

It is highly ironic that in this country, you have the right to make a “living will” guaranteeing yourself certain (100% chance of) death by dehydration if your health deteriorates, but if you have severe arthritis, you don’t have the right to take a 1.5% chance of death by heart attack by taking a medicine that makes you comfortable enough to get out of bed and live a somewhat normal life.

4 Responses to “Pfizer Withdraws Painkiller Bextra”

  1. Dave Schuler Says:

    One thing I wonder about in this whole discussion is the issue of risk. Are the risks of adverse reactions uniformly distributed? Are there specific risk factors? Proportional to the benefits?

    The small sample size statistics approach that I seem to be seeing more of these days also worries me since it seems to assume a kind of homogeneity that I doubt is real. The approach was developed for analyzing vats of beer after all.

  2. Personal Injury Resources Says:

    Pfizer Withdraws Painkiller Bextra
    I would like to see the trial data, too. How else can you decide how bad the risks from these Cox-2 inhibitors are?…

  3. Different River Says:

    Based on the accounts of the research I’ve seen, it doesn’t seem that this particular case involves small sample sizes. Apparently the Vioxx decision was based on a large-scale study of people taking Vioxx in the “real world.”

    My concern is the comparison base. That is, people taking aspirin (and to a lesser extent, ibuprofen and naproxen) have lower rates of heart attacks because thsoe drugs, as a side effect, protect against heart disease (while they damage the gastrointestinal tract in some patients). Vioxx (and Bextra) don’t damage the gastrointestinal tract (as much?), but they may not protect against heart disease at all. So if people taking Vioxx or Bextra have more heart attacks than people taking aspirin or ibuprofen, is that because they are taking Vioxx and Bextra, or merely because they are not taking aspirin or ibuprofen? Whether the study has answered this question depends on exactly how it was done, which is why I’d like to see it.

    And in either case, there is a legitimate case to be made that the risk/benefit trade-off should be made for each patient, not for the nation as a whole. Even if Vioxx and Bextra do slightly increase the risk of heart attacks, there may be patients for whom taking those risks is worth the benefits; for example, people with extremely severe (debilitating) arthritis, healthy hearts, and a history of stomach ulcers. There may also be ways to mitigate the heart attack risk.

  4. Different River Says:

    Kosher Trademarks, the FDA, and Electrical Safety
    Tradmark attorney Ron Coleman at Likelihood of Confusion has an excellent post on kosher certification. It’s only two paragraphs long, but it has lots of good links tying everything together. If you keep kosher, you probably know everything in those…

Leave a Reply

Powered by WordPress