Clear Thinking About Vioxx

The risk is not what you think.

David Henderson & Charles Hooper | January 3, 2005

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Two final pieces of evidence come from the behavior of the FDA itself. First, the FDA is exceptionally conservative. It is acutely aware that of the two ways it can fail, approving a bad drug is significantly worse for its employees than failing to approve a good drug. Approving a bad drug may kill or otherwise harm patients, and an investigation of the approval process will lead to finger pointing. As one former FDA employee, Henry Miller, put it, "This kind of mistake is highly visible and has immediate consequences—the media pounces, the public denounces, and Congress pronounces." Given this, it seems highly unlikely that the FDA suspected any serious cardiovascular problems with Vioxx, even after it studied the VIGOR results.

The second piece of evidence is the current behavior of the FDA. No one likes to be accused of screwing up, especially if the accusation is false. If Merck had withheld important information about Vioxx from the FDA, then officials in the FDA would now have a strong incentive to lay the blame on Merck. But they aren't doing so. And it's presumably because they can't, because they were fully informed and saw the risks as being fairly small.

Why does this matter to anyone other than Vioxx patients, Merck stockholders, and trial lawyers? For two main reasons. First is the issue of simple justice. Merck is one of the most cautious and benevolent drug companies in the business. Merck has a long history of innovative discoveries that have improved human health around the world. In a huge breakthrough in 1989, Merck researchers determined the three-dimensional structure of HIV protease at a time when AIDS was much scarier. They could have used this tremendous competitive advantage, but they chose to make it publicly available. Every day that this information was withheld, they reasoned, was one more day for the AIDS epidemic to spread.

The second reason for caring about the Vioxx case is the issue of long-term consequences. The FDA already has incentives to turn down drugs that are beneficial if they have reason to expect any negative side effects. And the greatest scandal of all, even if people's worst fears about Vioxx are true, is not Vioxx but the dozens of new drugs that will never be developed because the cost of clearing the FDA's superconservative hurdles make those drugs not worth developing. One of the authors of this article already informs drug companies that some of the medicines they are developing don't make economic sense. Add a few years and a few hundred million dollars to the development timeline and the economics become that much worse. Emory University economist Paul Rubin reports an estimate that FDA regulation saves between 500 and 1,000 injuries (not deaths) per year but costs between 2,100 and 12,000 lives annually. That's not a good tradeoff. The last thing we need is further hurdles to new drug development.