On May 11th in, A Lost Hope? Dendreon Derailed While Archaic FDA Promises 'New Era', I wrote, “In the aftermath of FDA’s Complete Response Letter, Dendreon (NASDAQ:DNDN) is hanging on to its life much the same way as its patients were awaiting the promise of Provenge…with a wing and a prayer!”
There are signs that the wings are showing renewed strength, and the prayers are beginning to turn the tide in Provenge’s favor.
The movement started with the Wall Street Journal giving several prominent Doctors and Research fellows from the Hoover Institution the platform to address the state of affairs at the FDA, and to address the recent Approvable Letter for Provenge.
An unexpected ally, Dr. Richard Miller, CEO of Pharmacylics emerged on May 10th with an article titled, “Drug Disaster”. He argued that,
…All medical treatments are important, but not all are equally urgent. We need to recognize that terminally ill patients are in no position to wait. They and their doctors need to be able to choose from among the most promising treatment options available to them today.
On May 10th a WSJ Health Blogs titled, “Cancer Vaccine Activists Unhappy but Unbowed” and “Pharmacyclics CEO Puts FDA Beef in Writing” received 121 and 42 comments respectively and there was “public and professional outcry” demanding an Approval of Provenge.
On May 11th a WSJ Health Blog titled, “Dendreon’s Ups and Downs at FDA and on NASDAQ” received an additional 109 comments.
The 109 comments ranged from outrage to a lengthy and detailed open letter to Dr. Andrew von Eschenbach, imploring the FDA to, “TEAR DOWN THIS WALL”.
More articles ensued. On May 14th, Dr. Mark Thornton, a former medical officer in the FDA Office Oncology Products wrote, “Black Wednesday at FDA” in which he stated,
May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer…
On May 17th, David R. Henderson and Charles L. Hooper of the Hoover Institution wrote, “Our Lawless FDA”. It said, “The Food and Drug Administration spends your money and acts in your name to regulate medicines. It has been acting badly.”
On May 19th, Dr. Henry Miller of the Hoover Institution wrote, “Risk-Adverse FDA Is a Risk to the Public”. In it, Dr. Miller began, “Accountability at the FDA described by Dr. Mark Thornton ("Black Wednesday at the FDA) are only the tip of the iceberg.” And finished with, “The FDA's philosophy seems to be that the way to protect the public from uncertainty about the safety of new drugs is to stop approving any at all. But who will protect the public from the FDA?”
The week was capped off with the former FDA Deputy Commissioner, Dr. Scott Gottlieb appearing on the, “Journal Editorial Report on Fox News.”(This video was copied and posted by a loyal fervent group of Provenge supporters on the investor village message board).
Dr. Gottlieb acknowledged that there is a definite split in the Cancer community on what level of efficacy must be demonstrated in order drugs to be approved.
When asked, “where do you come down”, Dr. Gottlieb responded, “I think we should be able to tolerate a little more uncertainty when it comes to these drugs, in a therapeutic space where the clinicians are very good at reading literature and very good at explaining things to their patients and should be given an opportunity to try out these drugs…”
Are the prayers being answered? Well, we know they are being heard!