Note: To see a compiled list of Scher's conflicts of interest,
many of which he denied, see
http://www.fileupyours.com/files/104862/Scher%2520COI-3.pdf
p.

FDA Delay In Cancer Therapy Is Attacked

By Rob Stein
Washington Post Staff Writer
Friday, July 6, 2007; A01

Oncologists do not usually need bodyguards when they present
scientific data at a medical symposium.

But when Howard I. Scher of the Memorial Sloan-Kettering Cancer
Center and Maha Hussain of the University of Michigan spoke at
the recent meeting of the American Society of Clinical Oncology,
they were in fear for their safety.

The two doctors have been at the center of an unusually bitter
debate over an experimental therapy for prostate cancer, ever
since they helped persuade the Food and Drug Administration to
delay approving it, enraging both patients and investors. The
first-of-its-kind therapy, called Provenge, is a "vaccine"
designed to extend the lives of patients with advanced prostate
cancer by stimulating their immune systems.

The debate over Provenge illustrates the highly charged
atmosphere that often surrounds new treatments as the desperation
of deathly ill patients increasingly converges with the
high-stakes intensity of biotech investing in the anything-goes
forum of the Internet. The result in this case has been anonymous
threats, accusations of conflicts of interest, Capitol Hill
protests, congressional lobbying and vitriolic postings on blogs,
Web sites and MySpace pages.

"This case may be different and all the more controversial
because it's at the intersection of patient advocacy and the
nervous world of biotech investors," said Daniel P. Carpenter,
who studies the politics of health care at Harvard University.
"It makes for a much more volatile politics."

A panel of experts recommended in March that the FDA approve
Provenge. But in May, the agency instead asked for more evidence
that the vaccine works after specialists, including Scher and
Hussain, questioned its effectiveness.

Scher and Hussain told the FDA that Dendreon Corp., the small
Seattle biotech company that developed Provenge, submitted a
study to win approval for the drug that was so small that the
apparent benefit it showed could have been the result of chance.

The FDA's surprise decision unleashed a spasm of criticism by
prostate-cancer patients, advocacy groups and investors in
Dendreon.

After the price of Dendreon's stock quadrupled and then
plummeted, irate investors wrote hundreds of letters to the FDA
and Congress, posted blistering critiques in Internet chat rooms,
and created Web sites and MySpace pages denouncing the FDA,
Hussain and Scher. They alleged various motives for the decision,
including internecine rivalries within the FDA and pressure from
larger rival drug companies.

"Why else would they object?" said Ray Vestal, a Huntsville,
Ala., investor. His "Approve Provenge Now" MySpace page asks,
"Hey, Hey, FDA, How Many Dads Did You Kill Today?" as images of
Hussain and Scher flash across a backdrop of crooked crosses and
Mozart's "Requiem" plays. "Perhaps there's something else behind
the scenes," he said.

Patients and advocacy groups, meanwhile, borrowing strategies
from AIDS activists and breast-cancer advocates, mounted an
orchestrated lobbying effort. They launched their own
letter-writing campaign and Web sites, staged a Capitol Hill
rally June 4, and demanded and got a meeting with FDA
Commissioner Andrew C. von Eschenbach the same day. They began
lobbying to amend FDA legislation moving through Congress to
allow easier access to experimental treatments.

"The prostate-cancer community has probably been awakened for the
first time. We're clearly upset about what has happened," said
Thomas A. Farrington of the Prostate Health Education Network,
which created the ProvengeNow.org Web site. "The true victims are
the prostate-cancer patients whose lives could be saved. We're
talking about terminally ill men, many of whom have no other
options."

Scher and Hussain, meanwhile, began receiving anonymous e-mails,
phone calls and letters attacking and sometimes threatening them.

"We have been harassed and trashed for giving our opinion in an
area of our expertise," Hussain said. "It's been a nightmare, to
say the least."

The pair requested and received extra security at the cancer
meeting in Chicago after they heard that Provenge supporters were
planning a protest June 3.

"This was concerning, especially since I was scheduled for a
podium presentation that day," said Hussain, who has wondered
whether to continue as an FDA adviser.

"When this sort of thing interferes with my patients and/or
family, I might have to say 'sorry' and pull out," she said.
"Right now, I believe I have an obligation to my patients to stay
and continue to do the right thing, no matter how difficult it
might be."

A handful of protesters did try to enter the meeting, but they
left peacefully after being turned away by guards.

Farrington and other patient advocates, and several vocal
investors, including Vestal, dispute Hussain and Scher's
arguments but deny any involvement in the threats.

"I don't believe terminally ill men are getting up off their beds
to threaten anyone," Farrington said.

Dendreon CEO Mitchell Gold said that the company has not
orchestrated or financed any of the efforts by patients or
investors. He also condemned the attacks.

"We don't condone those kinds of threats," he said. "But we
morally support what the patients and advocates are going through
and their desire to live longer and better lives."

The FDA said the agency continues to work with the company as it
completes more research on Provenge.

"Additional scientific data is required before a definitive
decision can be made," spokeswoman Kristine B. Mejia wrote in an
e-mail.

The campaign for Provenge has been seized on by other groups who
want to make it easier for patients to get experimental
therapies.

"It's certainly glaring proof of what we've been talking about
and the need for change," said Frank Burroughs of the Abigail
Alliance, which is suing the FDA in federal court. "What we're
saying is that when you have a drug like Provenge, you should let
people have access to it who have run out of options."

But that argument worries those who say the FDA needs to be more
vigilant, not less, about ensuring the safety and effectiveness
of new treatments in order to avoid another Vioxx debacle.

"I certainly understand the desperation that patients feel," said
Nancy Davenport-Ennis of the National Patient Advocate
Foundation. "But at the end of the day, our society is protected
through the system that we have and the process that assures us
that when a drug is approved by the FDA, adequate testing has
been completed to assure safety and efficacy."

The Provenge controversy comes amid revelations that a widely
used diabetes drug, Avandia, may increase the risk of heart
attacks. That triggered a similarly intense debate, including
angry criticism of cardiologist Steven Nissen of the Cleveland
Clinic, who sounded the alarm about the drug.

The stakes can be especially high for small biotech companies,
because their future is often riding on a handful of products --
and sometimes just one. At the same time, patient groups are
vying more for scarce research dollars, experts say.

"Something has changed," said Marie Hojnacki, who studies patient
advocate groups at Penn State University. "It's become an
increasingly competitive atmosphere, and both patient advocacy
groups and others, including pharmaceutical companies, are doing
what they feel like they need to do, which means being very
aggressive about getting what they want."