Advanced Prostate Cancer Newsletter

Feb
12
2008

Public Petition About Conflicts of Interest At The FDA

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I received an e-mail this morning from Leslie who was the producer and director of the short video I filmed about the Provenge issue at the FDA.
(you can view the video at: Joel’s Provenge Video

Leslie asked that I sign a petition asking for a formal inquiry into the conflict of interest (COI) issues that have been raised around the FDA’s decision about the vaccine, Provenge.

I have signed the petition and I am asking that you too consider signing the petition. All FDA decisions, including Provenge, must be made solely on the best interest of the general public and particularly with the interests of the people suffering from all sorts of illnesses. Just the appearance of any COIs is detrimental for everyone and requires that we eliminate it.

The COI issue goes beyond just Provenge, but includes all drugs and treatments that are reviewed by the FDA. The huddles that currently exist are already extensive and set very high. Approvals should not be decided based upon individual drug company’s profits or investor profits.
In cases where there might be even just an appearance of a conflict the FDA must step in and remove the potential issue from the table.

To be totally honest, I do not believe that the when push comes to shove Congress will actually hold these hearings. However, I do still believe that signing the petition is very important. The petition does send a clear message about our outrage that these types of issues are allowed to enter the drug approval process.

So please read Leslie’s letter and make our collective voice heard in Congress and by the media.

    Leslie’s Email

Provenge, a new prostate cancer vaccine was voted safe 17-0 and that it showed substantial evidence of efficacy 14-3 at an FDA advisory committee back in March 2007. By that criteria, it met the bar for Conditional Approval set by the US Congress. But the FDA decided to wait pending more data. It may take until 2010 to get that data. Nearly 30,000 men will die of prostate cancer every year until the vaccine is approved — 82 men every single day. My uncle died of prostate cancer a while back. I have several friends that are struggling against the disease.

The decision to delay Provenge was highly controversial. There were many irregularities in the process and the petition I am sending you only asks that those irregularities be investigated.

The Petition for you to sign.
Note: link in this document to the signing page:
http://www.petitiononline.com/provenge/petition.html

Some Background Reading:
Letter from three Congressmen requesting hearing re: Provenge approval process.
Some details provided:
http://www.pharmalot.com/wp-content/uploads/2007/12/congress-provenge-letter.pdf

Three more Congressmen request hearing re: Provenge approval process:
http://www.pharmalot.com/2008/01/more-congressmen-call-for-provenge-probe/

Letter from Physicians for Provenge urging Congressional hearings.
None of the Doctors hold any stock in the company.
http://www.pharmalot.com/wp-content/uploads/2008/02/physicians-for-provenge.pdf

FDA Commissioner denies having any documents relevant to COI inquiry.
But Freedom of Information Act had already produced documents that show relevant letters had been addressed to him.
http://www.pharmalot.com/2008/01/fda-commish-on-provenge-what-letters/

Undisclosed Conflicts of Interest: Howard Scher, Provenge Advisory Committee Member.
http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/

There’s a lot more information for anybody who wants to pursue this further. If you can see your way clear to sign the petition, I believe you will be doing a very good thing for America. All it does is ask for hearings to determine if the delay of Provenge was the result of inappropriate — possibly illegal — pressures brought on the FDA. Let’s have a full hearing and let the chips fall where they may.

Sincerely,
Leslie Mulkey

This is an important issue that will have repercussions for all of us for many years. We need to have all appearances of any type of conflict of interest removed from the entire FDA process.

We also need Provenge approved so that it will be available to those of us who are dieing.

Joel T. Nowak MA, MSW

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