A year after approval of the Provenge prostate-cancer vaccine was delayed by the FDA, a determined group of prostate-cancer patients - and some investors, too - plan to stage a series of nationwide protests that will include the largest annual gathering of oncologists, two organizers tell us. The events are planned by a non-profit called [...]

At the heart of the controversy over the Provenge prostate-cancer vaccine, which an FDA panel last year recommended before the agency delayed approval, are allegations of undisclosed conflicts of interest involving two of those panel members. They quietly wrote FDA officials to urge a go-slow approach and their actions have since drawn derision and fury [...]

The ongoing controversy over the Provenge prostate cancer vaccine is now one year old, and some of the prostate cancer patients and investors in Dendreon, which is developing the vaccine, are commemorating the saga by taking out full-page newspapers ads. The missives, which are sponsored by Care To Live, a non-profit that has filed a [...]

This is a rare bit of hopeful news for the many agitated prostate cancer patients and Dendreon investors, who have been angry at the FDA after the agency ignored a recommendation last spring from its own advisory panel to approve the vaccine.
The FDA has approved an amended trial design of a late-stage study, which [...]

How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour [...]

One month after a non-profit group accused the FDA of violating the Freedom of Information Act by failing to provide documents, the agency has forked over paperwork indicating FDA commish Andy von Eschenbach did hear from two panel members who last year urged him not to approve the Provenge prostate-cancer vaccine.
The non-profit, Care To Live, [...]

In the latest setback to a vociferous non-profit group that is battling the FDA over the Provenge prostate-cancer vaccine, the group’s lawyer was just sanctioned for his behavior. In an 8-page ruling, US District Court Judge Greg Frost chided Kerry Donahue, who represents Care To Live, for “unreasonable conduct” and ordered him to pay $6,000 [...]

The battle among prostate-cancer patients and investors to have the FDA approve Dendreon’s Provenge suffered a setback yesterday when a congressional committee declined to hold a hearing into the agency’s handling of the controversial vaccine. Today, however, the drugmaker released some news that it hopes will convince regulators that their decision to delay approval should [...]

In another blow to an ad hoc group of prostate-cancer patients and stock investors, the House Energy & Commerce Committee has decided not to hold a hearing into the controversy over the FDA’s handling of Dendreon’s Provenge vaccine. In a letter sent earlier today to four congressmen who had requested a hearing on behalf of [...]

It had to happen sooner or later. Prostate-cancer patients have filed lawsuits and furiously lobbied their congressional reps to investigate FDA review of Dendreon’s Provenge vaccine. Now, several doctors, who have already been actively involved in the battle, have formed a new ad-hoc group in hopes of finding another way to generate attention to the [...]