FDA sued over Provenge delay

The heated controversy over Dendreon's prostate-cancer drug Provenge has boiled over into the courtroom.

A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval of the Seattle company's genetically engineered therapy in May.

The plaintiffs say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency.

The lawsuit, filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy.

The suit doesn't skimp on harsh words for the FDA.

"There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency," the lawsuit says.

The lawsuit is the latest episode in a case that has stirred intense debate and deep emotions among patients, investors and industry observers.

Prostate-cancer patient advocates — and Dendreon investors — cheered when an FDA advisory panel made encouraging comments about Provenge in March. But two months later, the agency decided to request more data, potentially delaying the drug's launch for years.

The stock, which had rocketed to $23.58 from around $5 after the panel recommendation, sank back to single-digit levels.

The suit alleges Dr. Richard Pazdur, who heads the FDA's Office of Oncology Drug Products, sabotaged Dendreon's application in order to stake his turf as czar of all cancer-therapy approvals. The application was under review by a rival unit within the agency.

According to the suit, Pazdur placed two advisers with conflicts of interest on the review panel overseeing the drug. One of them, Dr. Howard Scher, is lead investigator in a competing cancer drug made by Novacea and is a defendant in the lawsuit.

After the majority of the FDA advisory panel gave a positive review of Provenge in March, the suit claims, Scher and other advisers embarked on a campaign to undermine the drug, writing negative letters that were later leaked to the media.

The suit claims the FDA commissioner, Andrew von Eschenbach, concerned about funding from Congress, gave in to Pazdur's demands to withhold a green light for Provenge. The lawsuit called the success of Pazdur's pressure a "coup d'état" within the FDA.

An FDA spokeswoman said she could not comment on pending litigation. A spokeswoman for Memorial Sloan-Kettering Cancer Center in New York, where Scher works, said he had no comment.

Conspiracy theories aren't necessarily the only explanation for disagreements over approving a new therapy.

Dr. Donald Kennedy, a former FDA commissioner who is editor-in-chief of the respected peer-review journal Science, said that often within the agency there are "perfectly competent people who wanted a drug to be approved and equally competent people" who don't. "You're going to have differences of opinions of that kind in a science agency all the time," he said.

Advocates of prostate-cancer patients aren't the first to sue the FDA in order to tilt the balance in favor of speedier approval. In the late 1980s, HIV-patient groups used similarly aggressive tactics and eventually succeeded in getting the agency to fast-track certain therapies.

In 2003, the Abigail Alliance for Better Access to Developmental Drugs sued seeking more availability of early-stage therapies for terminally ill cancer patients. That suit was dismissed, then reinstated, and is now being reviewed by a U.S. Court of Appeals for the District of Columbia.

Patients' push for easing controls on drugs for terminally ill patients confronts a similarly intense campaign for more strict regulation. Recent safety scandals about drugs that once received the FDA's blessing have resulted in calls for more supervision and legislation that strengthens the agency's role.

"Americans are completely torn about what policy they want," said Arthur Caplan, a prominent bioethicist at the University of Pennsylvania.

Patients with a terminal disease can have recourse to unapproved drugs if the FDA approves a request by their doctor and the company agrees to provide the medication, said Patricia Delaney, director of the Cancer Liaison Program in the FDA's Office of Special Health Issues.

Hundreds of patients get access to these experimental therapies every year, she says.

Most biotech companies, pressed for funds, produce only small batches of their therapies and therefore may restrict them to patients in their clinical trials.

"You're not going to make lots of it until you've got something that's sellable," says Delaney.

Ángel González: 206-515-5644 or agonzalez@seattletimes.com

Seattle Times researcher Gene Balk contributed to this story.