Vioxx, Off-Label Promotion, and Snake Oil
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Last week Merck & Co. agreed to pay $950 million to settle government allegations that it illegally promoted Vioxx (rofecoxib). Merck voluntarily removed Vioxx from the market in 2004, but it is still resolving legal claims.

Vioxx was approved in 1999 for the treatment of pain. In 2002, the FDA added a claim for rheumatoid arthritis (RA). However, the Justice Department claims that Merck promoted Vioxx for RA prior to 2002, which would mean Merck violated the FDA's off-label promotion rules.

Never mind that the FDA later agreed that Vioxx was safe and effective for RA and this assessment was based on a Phase III clinical trial of 1,100 RA patients. Is it any wonder that Vioxx was used off-label for RA when it had been approved for acute pain, osteoarthritis, dysmenorrhea, and migraine and was also shown to work in RA? This is a clear example of evidence-based medicine--there's no snake oil being sold here.

Let's examine a hypothetical snake oil situation and see just how unlikely it is. What if Merck had promoted Vioxx for something crazy, like breast cancer?

Step 1, Merck sales representatives call on oncologists and recommend that they try Vioxx for breast cancer patients. These physicians would say, "You're kidding, right? What data do you have? What's the mechanism of action? Is this a joke? What other doctors have used it that way and can I talk to them?" To this, the Merck sales reps would have no good response.

Step 2, an oncologist makes a huge mistake and prescribes Vioxx for breast cancer anyway.

Step 3, because insurers only pay for Vioxx for the approved conditions, the pharmacist rejects the prescription and calls the prescribing doctor to report the problem. The prescription never gets filled.

In addition to these bulwarks, the general press (TV, newspapers, magazines such as Consumer Reports, and newsletters such as Berkeley Wellness Letter) and the industry press all shout that Vioxx doesn't treat breast cancer. On the Susan G. Komen website, where breast cancer victims give each other advice, the clear message would be to skip Vioxx.

Let's say that all these protections fail and a woman takes Vioxx and her breast cancer worsens, she and thousands of others could sue Merck and their doctors. Merck's liability would make $950 million look microscopic by comparison.

Now imagine that you work at Merck. Would you decide to spend limited company resources promoting Vioxx for breast cancer instead of the home run of pain? Even if you did, your boss or your boss' boss would override your decision. It would be an astonishing (and bankrupt) company to make such a bad decision.

This is why we will not return to the days of snake oil sales and why the Justice Department should focus on pursuing real criminals, not drug companies trying to help American RA patients.

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