FDA

A Miracle Drug Cured Ed Levitt of Stage IV Lung Cancer. Then the FDA Withdrew it From the Market.

The FDA must adapt to the new age of personalized medicine.

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I have a new video out today (click above) that I made for the Manhattan Institute, which tells the story of Ed Levitt, who in 2004 was diagnosed with terminal lung cancer. Unable to get out of bed and covered in tumors from head to toe, Levitt's doctors advised him to start making funeral arrangements.

Levitt's nurse suggested he try a new experimental drug called Iressa that could make his radiation treatments more effective. The goal was strictly palliative; Levitt was told that his best hope was that the radiation augmented with Iressa could save him from spending his final days in sheer agony.

A few weeks later, all signs of Ed Levitt's cancer had disappeared. Nine years later, he's still in almost perfect health. It turns out that Iressa effectively eliminated Levitt's cancer because has a genetic mutation affecting what's called the epidermal growth factor receptor in his cells. The following year, the FDA withdrew Iressa from the market. Those who were already taking it, like Levitt, could continue, but no new patients could start.

Ed Levitt and his wife Linda |||

The FDA's decision to take Iressa of the market is indicative of how the agency is out of touch with the emerging paradigm of personalized medicine. The FDA's method of conducting clinical trials is designed to identify drugs that work for the typical or average patient, "but you're not wholesale, and neither am I," says Peter Huber, a senior fellow at the Manhattan Institute, and the author of The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. The war on cancer, Huber argues, will be won using cocktails of drugs tailored to the unique biology of each patient and his or her variant of the disease. Only if the FDA abandons its outdated one-size-fits-all approach to drug regulation will there be more patients like Ed Levitt.

For more on how the new era of personalized medicine threatens the FDA's command and control approach to drug regulation, read Nick Gillespie and Ron Bailey on the agency's recent efforts to get the genetic testing company 23andme to stop selling its genotype screening test.

For more on how the FDA keeps life-saving treatments out of the hands of patients, watch Nick Gillespie's Reason TV interview with Peter Huber: