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Drug Reckoning
Wall Street Journal, 3-6-06

The Journal reminds us that “an excess of caution –whether due to regulation, litigation, or fear – can itself be harmful to public health.” The Journal uses as examples two drugs — Erbitux for cancer and Tysabri for multiple sclerosis — that were either withheld or withdrawn from the market due to safety or efficacy concerns, to illustrate its argument that sometimes an excess of caution can be fatal.

Last Wednesday the FDA approved [Erbitux] for a new indication - head and neck cancer - based on data showing a whopping 20-month survival advantage over traditional chemotherapy alone. In fact, Erbitux represents the first significant advance for head and neck tumors since the 1950s.

That Erbitux worked in head and neck tumors was fairly obvious from early trial results even at the time it was first rejected for colon cancer. Dr. Mark Thornton, one of the FDA medical reviewers who finally helped push Erbitux through in 2004, tells us there was "extremely compelling" data on Erbitux for head and neck cancer as early as 2000. He adds that "it was hard to argue against providing it to patients" at the time it was first rejected. […]
The second good-news story last week concerns Tysabri, the multiple sclerosis treatment that was voluntarily withdrawn last year (read: lawsuit panic) after three patients on the drug developed a rare neurological infection. […]
Well, now several new studies reported in the New England Journal of Medicine appear to support the point that Tysabri's risks are small and its potential benefits big. Tysabri appears to cut the rate of clinical relapses by 68%, and reduce by a whopping 83% the number of new or expanding brain lesions found in MS patients.

An FDA advisory committee has recently voted to return Tysabri to market, albeit with significant safety protocols.

The Journal ultimately argues that the FDA gives too little weight to informed consent, preferring to rely on arms-length expert committees rather than allowing patients with serious or life threatening diseases to make their own decisions about what risks they are willing to tolerate. The FDA’s Acting Commissioner, Dr. Andrew von Eschenbach, appears sensitive to these concerns and has made faster approval of innovative new treatments an agency priority.

Project FDA.
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