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F.D.A. Restricts Access to Cancer Drug, Citing Ineffectiveness
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Roman Bystrianyk
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Joined: 02 May 2005
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PostPosted: Sun Jun 19, 2005 9:06 pm    Post subject: F.D.A. Restricts Access to Cancer Drug, Citing Ineffectiveness Reply with quote

ANDREW POLLACK, "F.D.A. Restricts Access to Cancer Drug, Citing
Ineffectiveness", New York Times, June 18, 2005,
Link: http://www.nytimes.com/2005/06/18/business/18drug.html

The Food and Drug Administration stopped just short of withdrawing the
lung cancer pill Iressa from the market yesterday, restricting access
to the drug to existing or previous users and to patients in clinical

The action follows the failure of the drug, developed by AstraZeneca,
to prolong lives in two clinical trials.

This is the first time the F.D.A. has restricted use of a cancer drug
that had received so-called accelerated approval. Such approval allows
drugs for serious diseases to reach the market quickly based on only
partial evidence of effectiveness, providing the benefit of the drug is
later confirmed by clinical trials.

Patient advocacy groups say the program speeds desperately needed drugs
to patients. But some critics have said the program can allow
ineffective or risky drugs on the market.

Representative Edward J. Markey, a Massachusetts Democrat, recently
issued a report stating that drug companies often do not do the
promised follow-up studies. Questions were also raised when the
multiple sclerosis drug Tysabri, which received accelerated approval
last November, was withdrawn from the market three months afterward
when it was linked to deadly brain infections.

Iressa was approved in 2003 based on a small trial showing that it
shrank tumors in about 10 percent of patients who had run out of other
therapy options. There were some examples of near miraculous
improvements. But subsequent larger trials showed it did not prolong
lives in the lung cancer population as a whole.

Yesterday's decision appears to be an attempt at compromise. "One of
the issues that we were very concerned about was not disrupting the
supply of the drug for individual patients," Dr. Richard Pazdur, the
head of the F.D.A. cancer drug office, said in an interview.

Patients who are now using the drug and benefiting from it, or who have
previously used it and benefited, will be able to get the drug
indefinitely. Starting in September, though, they will have to obtain
it from a single designated mail-order pharmacy and will have to
document their eligibility, AstraZeneca said.

The only new users will be participants in clinical trials.

AstraZeneca said there are about 4,000 users left in the United States.
Many patients who would have gotten Iressa are now getting Tarceva, a
similar drug developed by OSI Pharmaceuticals and Genentech. The
availability of Tarceva, which did improve survival in a clinical
trial, made it easier for the F.D.A. to limit access to Iressa.

Still, some patient groups expressed dismay about the decision.

"What about a new patient who has washed out of all other options?"
asked Laurie Fenton, president of the Lung Cancer Alliance. "Why should
Iressa not be made available to them?"

Steven Walker, adviser to the Abigail Alliance for Better Access to
Developmental Drugs, said effectively removing Iressa was "entirely
unnecessary" because doctors were already using Tarceva before Iressa.
"It appears the F.D.A. is waging war on cancer patients instead of on
cancer," he said.

Dr. Paul Bunn, a lung cancer specialist at the University of Colorado,
said there were a small number of patients who could not tolerate
Tarceva but can use Iressa.

But Dr. Sidney M. Wolfe of Public Citizen said the F.D.A. should have
revoked the approval completely and allowed the existing users to go
into clinical trials.

"This is an abuse of the worst kind" of the accelerated approval
program, he said. Public Citizen had petitioned F.D.A. to remove Iressa
from the market, saying it was ineffective and posed safety risks.
AstraZeneca maintains the drug is safe.

AstraZeneca is continuing with another clinical trial, with results
expected in early 2007. If successful, use of Iressa might be expanded

There is also evidence that Iressa works best in Asians, nonsmokers,
and people whose tumors have particular mutations. If such observations
are verified, the drug may be approved for particular groups.

"The science just needs to catch up in order for Iressa to have another
chapter," said Mary Lynn Carver, a spokeswoman for AstraZeneca.
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