Protesters demand new cancer drugs
Activists claim the agency is dragging its feet on approving Dendreon's Provenge and other drugs that might extend lives.
Seattle Times business reporter
ROCKVILLE, Md. — Rallying in front of the U.S Food and Drug Administration Tuesday to denounce what they call the agency's slow pace in approving cancer drugs, a group of about 80 protesters had the well-rehearsed rhythm of anti-war marchers.
"Who should get out of the way?" health-care activist Frank Burroughs asked those packed on the sidewalk in front of the agency's Rockville, Md., headquarters. "The FDA," they responded in unison.
Pointing at the massive glass-and-steel building, Burroughs addressed an invisible Andrew von Eschenbach, the agency's commissioner. "Dr. von Eschenbach — tear down this wall."
Along with cancer patients and their supporters, the group included people like Arnie Mass, a retired broker from Chicago who invested in Seattle-based Dendreon, developer of the prostate-cancer drug Provenge. The controversial therapy, whose approval was delayed last spring when the FDA requested more data, was the focus of Tuesday's demonstration.
"The FDA is not about safety, it's about whose ox is gored," Mass said.
Protestors also carried signs calling for the approval for other cancer drugs, such as Genasense, by Genta.
The demonstration, which drew considerable media coverage, underscores how activism in favor of innovative therapies is again on the rise.
Activists say the FDA should speed up approval of drugs designed for terminally ill patients, who are willing to take bigger risks in the hope of survival. This comes at a time when the agency is saddled with criticism for doing exactly the opposite — hurriedly approving drugs like Merck's Vioxx that turned out to cause problems.
Provenge supporters previously staged rallies in Chicago and the U.S Capitol. But a patient demonstration in front of the nation's top regulator of pharmaceuticals is a "pretty rare event," said FDA spokeswoman Karen Riley.
The last one FDA patient representatives remember was nine years ago and was related to HIV treatments, she said.
The FDA is unlikely to budge in response Tuesday's complaints, said Shobita Parthasaraty, an expert on the politics of biotechnology at the University of Michigan.
"There's enough pressure on the other side that says that the FDA has been approving drugs too fast. That's the prevailing wisdom right now," she said.
But activists say medicines for terminally ill patients deserve their own, faster track. "There's a difference between someone who has a terminal disease and someone who is in need of another toe-fungus cream or another medicine for headache," Burroughs said.
Burroughs, who founded the Abigail Alliance for Better Access to Developmental Drugs after cancer killed his daughter, is at the forefront of the recent rise in activism.
He said he took the FDA to court after two years of pleading with it to speed up approval of experimental therapies.
Federal courts have twice turned down the argument, which asserts terminally ill patients have the right to use unapproved but potentially life-saving drugs. the
The alliance hopes to take it all the way to the Supreme Court and is also lobbying Congress.
The legal fight has "helped elevate the issue in the media," Burroughs said. "We feel that the FDA has gone too far in playing doctor."
Provenge fans, many of them organized through the Internet, bought a $24,000 ad in The Washington Post and sued the FDA, calling it dysfunctional and politically driven.
"There's definitely a political and palace struggle within the FDA," said Kerry Donahue, an Ohio lawyer who filed the Provenge lawsuit.
The lawsuit accuses Dr. Richard Pazdur, who heads the FDA's Office of Oncology Drug Products, of sabotaging Provenge's path toward approval to protect his turf at the agency.
Several protesters carried signs calling for Pazdur's dismissal.
The FDA wouldn't comment on the lawsuit. Spokeswoman Riley said the agency's request for more data on Provenge was part of the approval process.
Richard Klein, a director in the FDA's Office of Special Health Issues, said patients already can get access to experimental drugs, if the manufacturer wishes. If a company consents to provide a desperately ill patient with an experimental drug, the FDA can approve it within a few hours.
Companies can also create expanded access programs to distribute some of their experimental drugs to patients.
But activists say companies have no incentive to do so, as it makes more sense for them to use the limited quantities they produce in clinical trials. Klein said, however, that expanded access is a way to get the drug known in the marketplace before its official launch.
Investors to the rescue
The latest wave of patient activism is different in harnessing the support, and leadership, of disgruntled individual investors.
In the case of Provenge, many of them became familiar with drug through Internet message boards, and brimmed with optimism after an FDA advisory panel recommended the drug for approval.
When the agency later requested more data instead, the stock crashed. Some investors blamed the company for not clearly communicating expectations about what was going to happen with the drug; others blamed the FDA.
Dendreon shares closed at $8.13 Tuesday, down 10 cents, or 1.2 percent, near the low end of their 52-week range of $25.25 to $3.57.
Those who still believe in Provenge made up a significant portion of the demonstrators Tuesday. Mass, the retired broker, said he also attended the first pro-Provenge rally in Chicago in June.
Mike Bauman, another person who became familiar with Dendreon through investment message boards, became an activist among patient-support groups in Hudson, Ohio.
He sees no contradiction between his financial interest and support for cancer patients.
"If everybody pulls out, [the companies] don't get funding. They only get funding from investors," Bauman said.
Tom Souza, 64, a prostate-cancer patient from Stow, Ohio who attended the rally, said he learned about Provenge from Bauman.
He was diagnosed two years ago and counts on access to new therapies to extend his survival.
"I want to be able to see my grandchildren get married," he said.
Ángel González: 206-515-5644 or email@example.com
Copyright © 2007 The Seattle Times Company
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