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Keep This Straight

Soon we will begin to see outrage over all the pending law suits against Merck regarding its recently recalled drug Vioxx. We will begin to see columnists railing against the onslaught of ads for lawyers willing to take on your case. The assault on Merck will be cited as one more reason for capping punitive damages.

So before all of that really takes off, take a moment to get this straight in your mind: Merck didn't just "ask for it"; it advertised for it.

From an article at :

Vioxx and other drugs in its class were initially developed as alternatives to pain relievers that caused internal bleeding in some patients.

and

The painkiller rofecoxib, sold under the name Vioxx by New Jersey-based manufacturer Merck, was pulled from the market in September 2004. The decision was made after a study of Vioxx's effect on colorectal cancer revealed that it increased patients' risk of heart attacks.

There were questions about Vioxx from the beginning. From an article by James Surowiecki in the current New Yorker:

Questions about Vioxx’s potential risks have been common since its introduction, six years ago, especially after a 2000 trial suggested that the drug increased the risk of heart disease. Merck did not hide these data, and beginning in 2002 the drug’s label included a warning about the possible cardiovascular risks.

But see, this was a risk-benefit question. The whole reason for the introduction of the drug was because there is a group of people who have a genuine medical need for it. From Surowiecki:

The simple fact that Vioxx might have risks wasn’t reason to recall it, since the drug also had an important benefit: it was less likely to cause the internal bleeding that aspirin and ibuprofen cause, and that kills thousands of people a year.

Okay, that's cool. But wait... Surowiecki again:

It would be one thing if Merck had marketed Vioxx only to people who really needed it -- people who couldn’t take ibuprofen or aspirin safely. Instead, the company marketed it aggressively to everyone, so that some twenty million Americans had Vioxx prescriptions.

In 2000, Merck spent $161 million marketing Vioxx on television. ("More prescription drug ads on TV", February 21, 2002 issue of Harvard University Gazette.)

From :

[A] group led by Randall Stafford of Stanford University's Prevention Research Centre in Palo Alto, California, found that many patients taking Vioxx did not even need the drug.... [B]y studying two federal surveys, Stafford and his colleagues found that almost two-thirds of new prescriptions written between 1999 and 2002 went to patients who were not at risk of internal bleeding. By 2002 only 39% of patients receiving the class of drugs that includes Vioxx actually needed that type, rather than earlier types of painkiller.

Okay, so the question juries are going to be asking Merck is: "Thanks for developing this drug that was a real benefit for a certain group of patients and everything, but why did you so aggressively market this same drug to the population at large, people for whom the risks of the drug, according to studies way back in 2000, clearly outweighed its benefits?"

Sounds like a perfectly reasonable question to me.

Read Surowiecki's commentary on all this here. It's compact and it's smart.

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