Posted by unregistered user at 5/30/08 6:00 p.m.

Joe,

TWO THUMBS UP to you for continuing to tell the tale of Dendreon and Provenge... it's an amazing story with the potential for not only men with prostate cancer, but also for women with ovarian cancer as well as both genders who have lung and colon cancer... imo, Dendreon is on the edge of a major breakthrough in cancer therapy.

Having a local, Ted Girgus, certainly gives you an edge on hearing just how a patient feels about treatments for his disease.

Thank You! for your fair coverage of this saga.

Tony F.

Posted by unregistered user at 5/30/08 6:33 p.m.

Joe,

Thank you once again for the great report. It was a pleasure meeting you. I'm so pleased you told Ted's story. Meeting Ted, and his family was truly a wonderful experience. They are a strong, and loving family. Provenge NOW.

Sincerely,
Monica (MDS)

Posted by unregistered user at 5/30/08 11:40 p.m.

Thank you for helping to expose the travesty and shame that is the FDA's part in thwarting a valuable medicine for dying men. Perhaps eventually we will get back to the values and integrity that made this nation great. Thanks for bringing light to the truth.

Posted by unregistered user at 5/31/08 12:29 a.m.

Posted by phil vardena.

Thank you Joe.

Please let me post the following, just in case someone unaware of the Provenge saga stumbles upon.

The average life expectancy for a terminal prostate cancer victim is about 19 months. The only FDA approved treatment for these patients is a chemotherapeutic drug with severe side effects, which only extends life expectancy some 10 weeks. This drug is so toxic and marginally effective in fact that most terminal prostate cancer patients choose not to take any chemotherapy at all.

Recently, a novel immunotherapy drug (that trains the patients' own body to fight the cancer cells) with almost zero side effects named Provenge (made by a Company named Dendreon) resulted in substantially improved extension of life expectancy. In a study, after 36 months, the number of Provenge patients still alive was three times the number of prostate cancer patients receiving conventional chemotherapy.
Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

On March 29, 2007, an FDA advisory committee of 17 experts met to review the application of this revolutionary drug. The panel met to discuss, then vote and recommend on the issues of a) Safety of Provenge, and b) Efficacy of Provenge.
This FDA panel voted to recommend Provenge for Approval by the FDA by an overwhelming margin. On the matter of safety, the vote was 17-0 for Provenge. On the matter of Efficacy, the vote was 13-4 for Provenge.

Among the NO voters, there where Dr. Scher and Dr. Hussain.

Subsequently, both Dr. Hussain, of the University of Michigan, and Dr. Howard Scher, of Memorial Sloan-Kettering, wrote letters to the FDA reiterating their position that the existing clinical trials for Provenge don't warrant approving the drug. These letters were "leaked" to the media.

I let you judge on the ethics of this behaviour.

In a later decision, the FDA decided not to allow Provenge on the market. It's been the first time ever the FDA did not follow a positive recommendation by its own panel.

If nobody has the gift of foresight, we can have hindsight.
On May 30, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. (Dendreon competitor) up to $440 million for rights to develop the smaller drugmaker's prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?
Do such agreements happen in a couple of weeks? What did the two conflicted doctors know?

Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?

We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn't this revolutionary and extremely safe treatment available NOW?
I can't imagine the motives are about monetary gains.