WSJ takes another shot at the FDA approval process ...
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Erbitux for Americans Too
Who says the Swiss are cautious and boring? On Monday they moved decisively out of the neutral column on Erbitux, becoming the first nation on earth to approve the sale and marketing of the revolutionary new cancer drug.
Expectations are that the United States and European Union will soon follow, or else watch as cancer refugees descend on Zurich and Geneva for what is obviously a safe and effective treatment. This is vindication for those who promoted the drug at and outside of ImClone, only to see its potential trampled in the media rush to condemn the stock sales of Martha Stewart and Sam Waksal. But any satisfaction is certainly tinged by the knowledge that the U.S. Food and Drug Administration passed up an opportunity to approve Erbitux nearly two years ago, and that tens of thousands of colorectal cancer victims have since died needlessly premature deaths.
Erbitux isn't a miracle cure for most patients. But it will improve and extend many lives. Consider this back-of-the-envelope calculation. The American Cancer Society predicts about 57,000 Americans (or 156 per day) will die from colorectal cancer this year. Studies suggest that more than 20% of them would have responded dramatically to Erbitux in combination with chemo (a greater than 50% reduction in tumor size), while for many others the disease would have at least stabilized. "Conceivably, as many as 100 people died today that wouldn't have if they had been able to obtain Erbitux," says Steve Walker of the Abigail Alliance for Better Access to Developmental Drugs.
Unfortunately, those kind of numbers haven't counted for much at the FDA, which sent Erbitux back into clinical trials because of minor quibbles (ImClone has since been vindicated) with the efficacy data. We expect the agency to get it right this time around, of course, but it seems in no particular hurry to beat its February deadline for a ruling. Hey, we're not talking about laboratory rats here! Commissioner Mark McClellan needs to remind his bureaucrats that every day of delay has real human costs.
Updated December 3, 2003 |
