2. For the new folks reading Ed’s continuing coverage on this debacle who are unaware of why folks are calling for an investigation of Scher here is some internet data gathered.

One must remember, he personally certified to the FDA he had 3 Conflict of Interests; the internet shows some 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 MYERSSQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisoryboard;

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 PCClinical Trials-P1 and P2

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

16. MEDIVATION, INC: principal investigator MDV3100

17. PROQUEST INVESTMENTS, Board of Directors, Advisor. Invested in Novacea.

Advisory panel members: you now have the go-ahead to make those lucrative deals with competitors of drugs/vaccines you are reviewing.

IMHO Pazdur wins again. He (and his underlings) can continue to leak information to hedge funds and big pharma with no impunity.

“FDA has not yet made a final decision on this product, and it is the practice of this Committee to allow a regulatory agency such as FDA to complete its statutorily-mandated processes and render a final decision before initiating formal investigative action”

Call me optimistic, but this to me boils down to: If you don’t approve, we investigate!

That said, we know Provenge works. Investors will have their reward.

My thoughts are with PC patients, who are being denied a chance to live longer and live better.

Regards,
phil

The fact is, this was not about approval…the FDA has set in motion, with Dendreon, the protocols necessary to obtain approval for Provenge.

As for the new COI rules and regulations, had they been in place before March 29, 2007, a study released prior to the Provenge Advisory Committee meeting demonstrated that neither Dr. Scher nor Dr. Hussain would have been permitted to participate in that meeting.

(BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS MARCH 26, 2007)

“Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.”

Re Dr. Maha Hussain: “The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn’t even be at the table if the new policy were in effect.”

But all this is closing the barn door after the horse escaped!

The call for hearings in the House Committee on Energy and Commerce, plain and simple, was to investigate alleged ethical and legal COI violations by two special government employees. The violations were centered around their participation during and following the Provenge March 29, 2007, Provenge Advisory Committee meeting, and involved such things as letters disparaging Provenge (requested by someone within the FDA, in the case of Dr. Scher’s letter) that were ghost-written, in part, by government employees at NCI (and possibly the FDA); letters written to the FDA by Drs. Scher, Hussain, and Fleming that were leaked to The Cancer Letter; the relationships among Dr. Scher, ProQuest Investments, Novacea, and Schering Plough; the announcement of a $440 million co-development deal for Asentar (in the same prostate cancer space as Provenge) between Novacea and Schering Plough, just 3 weeks after the FDA sent Dendreon a Complete Response letter, and other “interesting” events and associations.

All of which raises an interesting question for the House Committee on Energy and Commerce:

Who represents the American Public – and, especially, prostate cancer patients - in this travesty?

Who is responsible for investigating what surely must be seen by all, at this point, as “suspect activities” worthy of someone’s attention?

FDA Ethics? They certainly have been notified, and are, I’m sure aware of the situation.

HHS Office of the Inspector General (OIG)? He regained the ability to oversee the FDA just a few months ago, but as far as I can see, he, too, is missing in action (MIA).

The SEC? They were pretty quick to jump all over a previous head of the FDA for infractions that involved stock market holdings, and there’s no question, given the fact that Dendreon has been on the RegSHO list for months and months, now, that they are aware of the situation…but they haven’t weighed in yet, either. It might be interesting to know why they haven’t looked, for example, at the increase in short interest following the favorable March 29, 2007, Advisory Committee meeting. Did someone on the Street know something about which we mere mortals were not aware?

GAO Fraudnet? It would seem to me that this organization might wonder what FDA and NCI employees were doing helping a private citizen (remember, Dr. Scher submitted his letter on Memorial Sloan Kettering stationery) write a letter to the government, disparaging a drug that was under FDA review…especially since Dr. Scher served as a special government employee during the Advisory Committee meeting. To what account were the federal employees charging their time while they worked on a private citizen’s business?

Again, Congress, who is looking out for our interests?

Inquiring minds would like answers.