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. [...]
Dendreon Corp. has received great news from the FDA about their pending application for the approval of Provenge. STILL TIME TO SIGN PATIENT PETITION TO FDA FOR PROSTATE CANCER TREATMENT APPROVAL and Provengenow news-- Click Here NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) Thursday said the Food and Drug Administration would accept interim trial data to [...]
There are three more day's to put your name forward and sign up to show your support for men with advanced prostate cancer. Even though the Food and Drug Administration is a United States Government agency, it's decisions affect prostate cancer treatment throughout the world. Dr George Cooper has written an excellent letter of understanding [...]
