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, I want to following up on yesterday’s bad news about the Court of Appeals decision that will prevent terminal cancer patients from having access to safe drugs. We all need to respond immediately to out members in congress. We want to let them know that we need legislation now that directs the FDA to [...]
Late this afternoon U.S. Court of Appeals for the District of Columbia ruled that terminally ill patients do NOT have the constitutional right to obtain experimental drugs that have not been approved by the FDA! The Abigal Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation argued that terminally ill patients, including [...]
I thought that I would share the testimony I delivered at the recent FDA hearing on Satraplatin: My name is Joel T. Nowak. I am here today as a consumer and as a representative of the advocacy and educational group Malecare. Neither I, nor any member of my family have any financial interest nor received [...]
Lately, I have been writing about the significant disappointment and anger I feel towards the FDA. Congress has directed the FDA and the FDA’s own regulations require that they have a system for accelerated approval of drugs. Yes, they do have the regulations in place, but they have stopped abiding by their own rules. The [...]
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 [...]
Yesterday, I traveled to the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) where they reviewed the application for approval of Satraplatin (see my prior posts). The committee voted 12-0 recommending that the FDA delay the approval until all of the final survival data from the SPARC trial becomes available. [...]
On May 15th I wrote about an application to the FDA for approval of a new treatment Orplatna, trade name of Satraplatin. This hearing, in front of the Oncologic Drugs Advisory Committee (ODAC) is scheduled for July 24 with the session to begin at 1 p.m. Open public comment is projected to begin at 3 [...]
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 [...]
Several thousand people have added their names to the sign-on letter at www.malecare.com, in just the first week. With May 31 as our dead line, many more names will be added. Our prostate cancer community is showing its size and cohesion. As Lance Armstrong so brilliantly advocates, we are living strong. We've also received about [...]
