Hello, Dr. Andy!!!!

As I’ve written time and again, including to the FDA’s Office of Investigations and to the HHS’s Office of Investigations, and I contend an investigation of Dr. Howard Isadore Scher of Sloan Kettering in NYC needs to be done for these reasons:

In order to sit in judgment of Provenge, a new immunotherapy treatment for TERMINAL prostate cancer victims, Scher certified to the FDA via his application that he had, but 3 Conflict of Interests. Internet research has shown he has possibly as many as 17–itemized below.

Provenge is applying for approval to treat TERMINAL cancer where the ONLY approved alternative treatment is Taxetore, a highly toxic chemotheraphy which is said to KILL between 1 and 2% of the patients it’s administered to.

Provenge, in stark contrast, has mild chills/fever or flu like symtpoms in “some” patients for 1 or 2 days only. It is an immunotherapy which seeks to rev up one’s own body’s immune system to fight the cancer. Provenge requires a blood extraction every two weeks over a 4 week period–3 times–with the treated blood products re-infused a couple days following extraction after being treated.

Scher has been alleged to have as many as 17 (SEVENTEEN) Conflict of Interests as found on the internet last year after he wrote his letter urging FDA non-approval–which, also coincidentally–found his CONFIDENTIAL FDA letter along with 2 others leaked outside the FDA–again with NO investigation being done as to who leaked these letters.

Scher’s alleged 17 Conflicts of Interest are:

. These 17 (SEVENTEEN) have been found on the internet for Scher.

NOTE particularly items 1 & 17

1. NOVACEA: grants & research support; STUDY CHAIR of DN-101 ;

…. and 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; 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 Mar 6, 07; since removed but cached)

13. CONFOMA THERAPEUTICS: scientific advisory board

14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical 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. Novacea Investor

So, what’s holding up the FDA and the HHS from investigating allegations of federal law violation by Scher???

Specific allegations have been made; no known investigation has been done.

Why not, Dr. Andy?

Not enough money??? Not enough manpower?

That’s baloney simply because we’re talking about TERMINAL prostate cancer patients… not some treatment for a hang nail.

Resign, Dr. Andy, and let someone be in charge who’ll take action to restore the FDA’s tarnished image and get to the bottom of any illegal activities–such as leaking CONFIDENTIAL FDA letters to outside publications and investigating SPECIFIC allegations of wrong doing.

As is clear, my view of influencing reps is also not sanguine. But if _enough_ people write, and write consistently, and show up at rallies, and ask the right questions when the press is there, and so on, and so on….Things _can_ happen.

It takes organization, perseverance, and numbers.

Contacting congresscritters may do little good. But, if the contact is written, individuals have proof (if it can ever be used) to show that the CC cannot claim “I didn’t know.”

Like Lilli, I keep writing . . . and feel “lucky” if I get an automated response (usually, I get no acknowledgement). But first, I’ve ‘vented’ my frustrations (a healthy thing, no?) and I’ve added to the papertrail that precludes claims of ignorance.

Letter writing and voting seem to be our only course of action (short of revolt) . . . and we all recognize that vote-counting is suspect.

You sure know your politics,.. and I cant agree more with your summary of those loveley politicians.

They’ll make the occasional fist-pounding speech, sprinkle in some down-home rhetoric for the rubes back home, and then send out a glossy flier trumpeting “I’m working hard for YOU!” Then look at the bottom, in small print, and note that the brochure was paid for with your tax dollars.

If Congress really wanted to change things, they would implement the solutions I noted above. Think that will happen? Hell no.

I’m moving on, LILLI–if you want the last word, you are welcome to it.

“It is easier to attack the FDA than to assume one’s own share of responsibility. The press, for its part, frequently reports legislators’ criticisms of the agency without providing any analysis of their voting records on FDA appropriations. But the bigger scandal is Congress’s grossly inadequate funding of the agency, which demands swift and decisive action. No longer should our legislators be able to publicly excoriate FDA employees while ignoring their own complicity.”

Amen.

I won’t post the numbers again, but the FDA budget is miniscule compared with other regulatory agencies. And it has been that way for a long time, through both Dem and Rep administrations. Beyond the impact of lobbyists, etc., one can only conclude there is some kind of national death wish.

Behind AVE, there remain the rest of senior management who have also been there a very, very long time. So it will take a good deal of house cleaning.

Now for a second time Von E has refused to answer the question again.

The first time the esteemed Peter Barton Hutt spoke on behalf of the need for more funding for the FDA. Mr. Hutt indicated they needed a lot more funding. Believe it or not, I agree that the FDA needs more funding.

The problem seems to be that the current FDA comisioner is an absolute moron. I am convinced the guy is a complete idiot.

AS LONG AS THIS IDIOT IS AT THE HELM NO AMOUNT OF MONEY WILL MAKE THE FDA FUNCTION PROPERLY.

Mr. Dingell needs to start calling for his resignation. If he does perhaps CareToLive will not hold the planned demonstration outside his Dearborn office on May 30th.

Help the patients. Resign Andrew von Eschenbach. Resign now!!!!

Money is just part of the problem. For FOIA requests the requester pays the cost yet the FDA still cannot timely comply with federal law. The FDA is poorly managed and arguably not controllable by this “leader” who is nothing more than an incompetent figurehead.

It has been nine months and the FDA is unable to comply with federal regulation and properly respond to the CareToLive citizen petition, even thought 83 men a day are dieing to hear.

RESIGN ANDY!!

I argue for personal responsibility. Learn what you are putting in your body before you do so. Don’t trust the FDA to make our drugs safer.

If a drug company misrepresents their drug, we should be able to pierce the corporate veil, and hold individuals responsible. No preemption. No limit on damages that can be awarded in a tort action.

If we do these two things–put drug companies and execs at peril if they don’t tell the truth, and expect people to not just trust doctors, the FDA, and drug companies to protect them, we could have a much, much smaller FDA. And you keep more of your tax dollars.

Yay!