DISQUS

Tony F · 2 years ago

Great piece on "Provenge and the Private Eye"; there's a LOT more to this story than has gotten out to date.

A compilation of Conflict of Interest (COI) for Dr. Howard Isador Scher of Sloan Kettering-NYC who sat on the Provenge March 29 FDA Advisory Committee and who voted “YES” that Provenge was substantially safe and “NO” that is showed substantial efficac is below. Sources are public information available on the internet.

Scher reported only 3 COI’s to the FDA in his Waiver Application permitting him to sit in judgment of Provenge which appears to be composed of ownership of 1 stocks and 2 competing industry interest.

Internet research shows the following for Scher thus far--particularly note Items #1 and #16!

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. MEDIVATION, INC: principal investigator MDV3100

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

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. It seems incomprehensible for someone with the training and education Scher has 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.

Additionally, Scher sent an most unusual letter AFTER the positive vote at the FDA AC meeting strenuously objecting to the apparent approval coming for Provenge. His "Confidential" letter was conveniently "leaked" to "The Cancer Letter"... hence, the subpeona to the latter.

Scher was also named a Defendant in a lawsuit asking an EMERGENCY injunction against the FDA forcing them to allow Provenge to be marketed; the suit is pending.

Advocates, cancer patients, family and others will Rally at the FDA in Washington on Sept 18. Details are at www.caretolive.com Support cancer victims according to your ability… come to the Rally, join caretolive, volunteer to drive or sit with a cancer victim… however, you can. If we don’t help them, who will?

Thank You! For you article bringing the FDA’s action and the tip of the iceberg on the lawsuit to the public view.