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

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.

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abandons its outdated one-size-fits-all approach to drug regulation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: