Risks and benefits – what if Merck starts selling Vioxx again?

3

Category : General, Medical Rants, Pharma

Physicians must constantly weigh risks and benefits. Every test, treatment or non-treatment carries risks and benefits.

The controversy over the Cox-2 inhibitors highlights the daily decision struggle which we face daily. Should we anticoagulate this patient – i.e., does the risk of clotting outweigh the risk of bleeding? Should we do a cardiac catheterization in this 55 yo diabetic man with a creatinine of 2.5 and new angina – i.e., does the likelihood of finding treatable coronary artery disease outweigh the risks of dye associated acute renal failure? Should we start this patient on chemotherapy? Should we do a liver biopsy?

I have yet to meet a benign medication. Some medications have more side effects; some have less; but all can cause problems. As physicians we accept these decisions as part of our jobs. We live between a rock and a hard place.

The Vioxx controversy should not surprise anyone. Even though Vioxx (and probably other Cox-2 inhibitors) increase the risk of cardiac events, does that mean that they have no benefit. Some patients (their testimony yesterday noted) have found this class of drugs miraculous. If this is the drug which bests improves your quality of life (and by a significant margin), then might you not be willing to accept a defined cardiac risk?

I often prescribe co-trimoxazole (Bactrim) for urinary tract infections. This drug can cause a serious skin reaction (Stevens-Johnson syndrome) which sometimes leads to death. Yet we continue to use this drug for its explicit benefit. Should we take this antibiotic off the market?

Aminoglycosides are useful antibiotics for serious gram negative infections – but they predictably injure the kidneys. Amiodarone is a potentially life saving antiarrythmic with serious side effects.

Merck May Resume Sales of Painkiller, Official Says

In a statement, Merck said, “If the advisory committee and the F.D.A. conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers.”

In their comments in the last two days of a three-day hearing, panel members have said they believe that all the cox-2 drugs – which include Vioxx, Celebrex and Bextra – carry heart risks. But the panel now must compare the drugs’ benefits with their risk.

Dr. Paul Seligman, a top F.D.A. official, said it was too early to determine how the agency would respond if Merck sought to resume Vioxx sales.

I have no problem with this plan. While I find it unlikely that I would use Vioxx in my patients, I support the patient’s right to use this drug with a full disclosure of its risks – for all the reasons discussed above.

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Related Posts B

  1. More on Vioxx
  2. An interesting perspective on the Vioxx damage award
  3. Continuing to consider the Vioxx withdrawal
  4. Another comment on Vioxx (now revised)
  5. The New Yorker comments on the Vioxx lawsuits

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Comments (3)

I’m an ER resident who has been reading hour website for a while….PLEASE GO BACK TO THE OLD FORMAT… This ine is really hard to read

The FDA just found that the cardiac risk seems to be a class effect (all COX II’s) — will you stop using all the drugs or go back to using Vioxx? I figure in my patients I’ll start with a non-selective NSAID and only go to a II for those without cardiac risks and WITH complications.

BladeDoc

If Cox 2 inhibitors were developed because of their supposed lower side effects profile, not because of their enhanced effectiveness, and they turn out in fact to have a higher side effect profile, what good are they? To the patient, I mean, and not to the drug industry balance sheet. Pull them from the market. Seems like a no-brainer to me.

OT: New study shows flu vaccine doesn’t reduce death in the elderly.

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