I received an e-mail this morning from Leslie who was the producer and director of the short video I filmed about the Provenge issue at the FDA. (you can view the video at: Joel's Provenge Video Leslie asked that I sign a petition asking for a formal inquiry into the conflict of interest (COI) issues [...]
Today’s New York Times carried a story written by Reed Abelson entitled “Financial Ties Are Cited as Issue in Spine Study.” The story explained that some of the nation’s most prominent spine surgeons hailed as a medical breakthrough a study of nearly 240 patients with lower back pain. The doctors said that Prodisc, an artificial [...]
Many of my prior posts about Provenge have discussed the issue of what appeared to be a conflict of interest of some of the members on the FDA advisory committee that reviewed the drug. When the committee voted to recommend that Provenge be approved, among those members who voted against the approval were Drs. Scher [...]
I have had the privilege of working with Leslie Mulkey, an independent video producer on a short "You Tube" video about Provenge. Our hope is that our question, "Should terminally ill patients have access to promising new therapies?" will become a part of the next national presidential debate. You can view our video by clicking [...]
An opinion piece written by Ronald Trowbridge and Steven Walker appeared today in the WSJ. The piece is centered on the recent decision of the full D.C. Circuit Court of Appeals that reversed its own smaller panel’s 2 to 1 decision to allow dying, terminal patient’s access to investigational drugs that have been found to [...]
Today’s Wall Street Journal (8-2-07) had a front-page piece entitled Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch. Geeta Anand of the Wall Street Journal wrote it. The story is about Garo Armen and the biotech company, Antigenics Inc., which he founded 12 years ago and at a cost of 300 million [...]
Recently, there has been uproar in the prostate cancer community over the FDA's handling of the approval of Provenge. The conflict between patients looking for new treatments and the FDA's attempt to protect the public is one with a long-standing history and with complex dynamics. The new activism of the prostrate cancer community is one [...]
From clinical cancer research: Rethinking Therapeutic Cancer Vaccine Trials Ongoing therapeutic cancer vaccine trials have yet to show evidence of vaccines spurring a patient's immune system to shrink tumors -- yet patients who receive these vaccines in trials tend to live longer and respond better to subsequent treatment. In the July 1 issue of Clinical [...]
Here it is June 11 and my frustration with the Prostate Cancer Community continues to climb. On May 31, I wrote that the FDA had compromised over the issue of the approval of Provenge. At that time, it was announced that the FDA would be willing to use the interim results of Dendreon’s current, on [...]
Prostate Cancer advocates continue to press the FDA to approve Provenge by staging marches in Washington and Chicago as well as continuing to add their names to Malecare's Action Letter. The advocacy has even caught the attention of the major news services, which have been carrying many stories about the efforts of the prostate community. [...]
