I believe you are looking at the wrong FDA man regarding cancer… it should be Dr. Richard Pazdur, of the FDA’s CDER division. From sources on the net, it appears that he’s annointed himself “King” of the FDA Oncology Division because he was not appointed as FDA Commissioner and he does not take lightly to having a cancer treatment reviewed by another FDA unit (CBER).

The recent and particular case of Dendreon’s Provenge is an excellent example. Provenge treats TERMINAL prostate cancer victims (having about 18 months of life left) and who have but 1 other treatment available–the horrible chemo, Taxetore, which actually kills 1 to 2% of the patients taking this treatment. Ironic the “cure” is worse than the disease for those men taking Taxetore!

Prostate cancer kills 82 men each and every day; far more by multiples than the loss of our young men and women in the Iraq and Afghanistan Wars. If the Nightly News media put up these statistics, we’d get something done about this tragedy… “Tonight, 8 U.S. military were lost in the Middle East; on the home front, 82 men died in the U.S. today from prostate cancer”.

On March 29th, the FDA called a meeting of 17 experts in immunotherapy, oncology, statistics and other disciplines. This expert group voted 17 to 0 that Provenge was safe; they voted 13 to 4 that it showed substantial efficacy.

Two ONCOLOGY experts… Maha Hussain of Michigan and Howard Isador Scher of Sloan-Kettering voted NO on the efficacy vote, but voted YES that Provenge was safe.

Despite the overwhelmingly positive recommendation of this Advisory Committee–a vote which the FDA has traditionally followed–the FDA postponed for perhaps up to 2 or 3 years allowing Provenge to Market last May 9th. This action followed an unprecedently PUBLIC lobbying by these two ONCOLOGISTs (chemo treating doctors) where each actually wrote “CONFIDENTIAL” letters to the FDA imploring the FDA to deny approval; these private letters were leaked to and printed by “The Cancer Letter” PRIOR to the FDA’s decision.

It’s speculated in the media that Pazdur had knowledge of or a hand in writing/having these letters written in an attempt to delay/derail Provenge which could have become the “standard of care” for cancer patients.

Provenge is an immunotherapy revving up the body’s own defenses to fight the cancer; Taxetore is a deadly poinson–a chemotherapy–which kills both the cancer cells and “good” body cells.

In order to sit on the FDA’s Advisory Committee judging Provenge, members were required to tell the FDA of any/all Conflict of Interests (COI). Scher reported only 3 COI’s to the FDA which appears to be composed of ownership of 1 stock and 2 competing industry interest.

Internet research shows the following for Scher thus far–PLEASE note items #1 and #16 in particular!!!!

1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge

2. GPB BIOTECH: financial conflict of interest per Scher in MedPage

3. PHARMION: financial conflict of interest per Scher in MedPage

4. SANOFI-AVENTIS: grants & research support

5. BRISTOL MYERS SQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;

8. INNOVIVE PHARMACEUTICALS: principal investigator

9. INFINITY PHARMACEUTICALS: principal investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)

13. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

14. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

15. MEDIVATION, INC: principal investigator MDV3100

16. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest

There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 16 COI’s found so far on the internet. For Scher to “forget” so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.

Even more disturbing is the FDA’s Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI’s than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.

As a “temporary government employee” at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn’t, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.

Cancer advocates, patients, physicians and others are gathering at the Washington FDA offices Sept 18th – 10 a.m. – to Rally in support of cancer patients. Info is at http://www.caretolive.com and at http://www.arighttolive.com Come join in supporting cancer victims or help cancer patients in your local area however you can!

Thanks, again, for a wonderful article in support of cancer victims!!!