Glad to see this discussed and I am hopeful that congress follows through on their investigation. I have only one concern, depending on how long this investigation takes it is depriving those in need of treatment as well as allowing the competition to move their clinical trials along. this seems somewhat unjust. Could this be a calculated move by the competition? Regardless of the outcome of the investigations the bottom line is Provenge’s approval and use has been delayed while the competition’s progress continues to move forward.

My favourite questions during the hearing would probably be those below:

On May 9, 2007, “Black Wednesday”, the FDA said “NO” to Provenge, issuing a Complete Response letter. A few weeks after the FDA delaying letter regarding Provenge, on May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. (a competitor to Dendreon) 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?
Also, did Novacea and Schering-Plough Corp. arrange the deal in a couple of weeks? What kind of due diligence was Schering-Plough able to do in twenty days?
What did Dr. Sher and Dr. Hussain know when they sat at the panel?

Regards,
phil

Those familiar with this part of the Provenge tale recall that Scher certified to the FDA that he had 3 conflict of interests–2 competing company associations and 1 personal stock holding — per his filing in late February available at the FDA website.

17 (SEVENTEEN) have apparently been found on the net:

…. please particularly note #1 and #17:

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. CONFOMA THERAPEUTICS: scientific advisory board

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

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

16. MEDIVATION, INC: principal investigator MDV3100

17. 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 17 COI’s found so far on the internet.

Lastly, let’s not forget the 83 men who die EACH DAY from prostate cancer and their families. God Bless them and their loved ones!

Since May 9th FDA adverse decision on Provenge, over 18,011 men have died….. in just 7 months.

Where’s the public outcry against this travesty?

If Provenge can save half of them, if it can make what little time that they have left, better, then they deserves to be allowed to attempt it. I applaud these Congressmen and I am pleasantly shocked that anyone in government can be as responsive.

Keep going… take the corruption out wherever you can grab it cleanly by the neck.

And where is HHS’ Office of the Inspector General (OIG), now that he’s free once again to investigate the FDA? Up to now, an agreement between the FDA and HHS placed the burden of investigation under the FDA…for what good that did! But HHS OIG now is free to pursue the matter independently.

If HHS’ OIG doesn’t move on this quickly, the issue will bury his agency’s credibility together with the FDA’s. But come to think of it, the latter’s credibility and integrity probably are beyond redemption at this point.

And before everyone chimes in,…. Id like to say this.

I believe that this vaccine should be approved, we are talking about medication to treat cancer. If it has the potential to save a life,..GO FOR IT.