In this case, as with so many others, it’s the public that probably needs protection from the over-empowered officials at the FDA but then that is called just another conspiracy theory. They will now read rules so that the public becomes arrestable if they speak up during the meetings.

Sadly, there is no arm of the government, no office or branch that is left uncorrupted by the temptations of power and influence and of the inherent ability to profit by your position. In the FDA’s case, it is merely rampant.

Once, having testified several times, I finally said something like “It must be the culture of the FDA to never give eye contact to a family member whose son was killed by Zyprexa, to never offer condolences or a handshake, to never comment on the story of the death, to sit like zombies waiting impatiently for the minute time limit to be up. I thought this agency was about the PUBLIC HEALTH”. Well, after that outburst, for the one and only time, every member of the panel (risk communication, I think) came up and shook my hand, gave me a card, a condolence, etc. It was the darndest thing. And it hasn’t happened since. During public testimony, FDA behavior is usually look down at the table stonefaced.

It’s always easy to claim being a “victim” and garnering appropriate sympathy. It’s another, of course, to produce the FACTS and corroborating e-mails, letters etc.

Scher and Hussain have played the “victim” role to the hilt while shamelessly helping to deny FDA approval of DNDN’s product, Provenge.

Meanwhile, the REAL victims are the THOUSANDS of men with advanced prostate cancer who might have benefitted from Provenge injections.

But I forgot, Hussain and Scher are both staunch advocates of CHEMOtherapy for PCa.
Approval of a revolutionary vaccine with very few side-effects and survival benefits would certainly jeopardize all the money from Big Pharma that flows their way.

There is no PROOF yet that Hussain/Scher ever got any real serious threats. But one could imagine such circumstances, especially from a desperately sick man, father, brother, husband or grandfather who was denied a chance for prolonged survival by their shameful actions.

The $2000 reward remains unclaimed!!

And thank God also, for the Ed Silvermans of this world.

A study published by BioCentury, The Bernstein Report On BioBusiness®, March 26, 2007, noted the following regarding new COI rules that were under consideration even before the Provenge Advisory Committee meeting:

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

As regards to 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.”

Vince Tolino, Director, Ethics and Integrity Staff, FDA, should never have forwarded Scher’s and Hussain’s waiver requests to Randall Lutter, Ph.D., Associate Commissioner for Policy and Planning, FDA, and the latter never should have approved them.

There still is no indication that the proposed revisions to the FDA COI rules have been adopted.

What a pitiful excuse for a Federal agency. As for their Office of FDA Ethics, one has to wonder whether or not anyone is minding the store! The same may be said of HHS’ Office of the Inspector General! The failure to pursue the obvious COI provisions represents a total failure of the agency, right up to the very top of the leadership ladder.

She can sit in her high chair and demand order, but it is my supplicative hope that a critical, and questioning public question her COIs at EVERY turn. If she has nothing to hide…answer the questions…transparency should be held to the highest degree for these so called experts who are above the very rules they create to subvert questioning of their own actions.