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Vioxx witness "enraged"

Maybe I'm missing something, but I was perplexed by the following account of Friday's testimony in the Humeston v. Merck trial (from the Star-Ledger weblog Ted pointed to last Thursday):

The day's dramatic highpoint came when plaintiff's witness Benedict Lucchesi, a pharmacologist, got choked up while answering a question about an internal Merck e-mail from 1997.

The e-mail, sent among Merck scientists working on Vioxx, was about how to design a clinical trial to test the safety of the painkiller, which wouldn't be approved by the FDA for another two years. The researchers were debating whether to allow people who were on a low-dose aspirin regimen to participate in the trial - a group that could skew the results because of the cardio-benefits of aspirin.

Under questioning from plaintiff's lawyer Chris Seeger, Lucchesi inferred from the e-mail that Merck's scientists recognized the potential cardiac risks of Vioxx well before it went on the market.

"When I see that, I must say I personally become enraged," Lucchesi said, apparently struggling to control his emotions. "They're putting profit before life. I know these people. I trained some of these people.

"They have to live with this."

Perhaps the email does show that Merck realized there could be a cardiac risk from Vioxx--but the fact that there might be a risk for a medication doesn't mean that the medication shouldn't be on the market; the relevant question is whether the drug's benefits outweigh those risks. It also only makes sense to me that Merck wouldn't design a test with a control group that might skew safety results because some in that group were taking another medication with offsetting benefits, which therefore might give a wrong picture of the actual risk-benefit profile of the drug you're actually testing. Unfortunately, I doubt the lay jurors are likely to ask these questions, or to understand them should Merck raise them.

I must admit I get angry when I keep hearing the "putting profit before life" boilerplate. As Ted pointed out after the Ernst verdict came down, Vioxx and other COX-2 inhibitors save lives because they do not cause the stomach problems associated with non-steroidal anti-inflammatory drugs like aspirin and ibuprofen, which take 16,500 lives per year. The question is whether the risks associated with Vioxx are worth more or less than the lives the drug saves. The Food and Drug Administration, based on the evidence then available, initially determined that the cost-benefit analysis for the drug came out in favor of letting Vioxx onto the market. Even with what we know now, that initial decision might have been the right one.

And we wouldn't have had a better picture of Vioxx's health risks if Merck had sponsored a faulty, poorly controlled test.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.