On January 28, 2010 the Florida Bar recognized Kerry M. Donahue, CareToLive’s attorney extraordinaire, for his stellar pro bono efforts on behalf of prostate cancer patients.

“The Food and Drug Administration has lost its way”, said Mr. Donahue. “The FDA Advisory Committee advised the FDA to approve Provenge, a safe, effective, non-toxic immunotherapy for men with late stage prostate cancer, and then the FDA delayed it without a rational explanation.”

Kerry sprung into action. He wrote dozens of motions and briefs, spending hundreds of hours trying to right the wrong. Without his efforts, we at CareToLive believe that the FDA would have deferred to the chemo cartel, who never wanted Provenge to see the light of day. He brought enough exposure, to insure that Provenge gets a fair chance for licensure this time around.

The FDA knew the patients were staring death in the face since they granted Dendreon’s Provenge Fast Track Status and Priority Review. It then chose to ignore its handpicked Advisory Committee which voted Provenge safe by a vote of 17-0 and substantial evidence of efficacy, by a vote of 13-4.

Kerry was honored by the President of the Florida Bar, Jesse H. Diner, & the Chief Justice of the Supreme Court of Florida, Peggy A. Quince.

Recently the Acting Director of CBER, Karen Midthun, denied Kerry’s request for a meeting. Ms. Midthun said the reason was as follows: “However, FDA cannot discuss matters with respect to a pending BLA without the express authorization of the sponsor. Therefore, at this time, we respectfully decline your request for a meeting.”

This statement flies in the face of the fact that FDA leaked letters written by Howard Scher, Maha Hussain, and Thomas Fleming all of which were discussing “matters with respect to a pending BLA” which were released “without the express authorization of the sponsor.” FDA picks and chooses when it will violate its own regulations, in order to help its business and political relationships.

At the center of this case is Howard Scher, a SGE for FDA, who was leading trials for treatments in competition with Provenge at the time he sat on the Provenge Advisory Committee. One day later he started working on a letter with the help of NCI’s Alison Martin for the sole purpose of lobbying the FDA to stop Provenge. Scher knew the Advisory Committee vote was a problem for his competing trials, one of which NCI funded, so he sprang into action right away. CTL has documented Mr. Scher’s activities and financial concerns (see Sleepless in Asentar and CTL Writes Interim FDA Commissioner Frank Torti). The astonishing fact is FDA went along and helped Scher by leaking his letter as well as follow-up letters by Hussain and Fleming, all of which discussed matters with respect to a pending BLA.

The FDA then had its legal team block all efforts by Kerry to get the men access to Provenge. Over 80,000 men have died while we waited another 2.5 years for further results. Those results are now in and they confirmed that Provenge is safe and effective. We are still waiting while they drool over the data.

In the meantime Kerry is also fighting for the Freedom of Information data to prove how flawed the process was. They are stymying us again, at every turn. He is determined to bring more oversight and transparency to an agency that has run amuck.

Congratuations to Kerry for receiving the Florida Bar President’s Pro Bono Service Award for 2010. CTL and all the friends of CTL are very proud of you. You are the best that mankind has to offer.

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Tags: Alison Martin, CareToLive, Dendreon, FDA, Howard Scher, Kerry M. Donahue, maha hussain, NCI, Prostate Cancer, provenge, Richard Pazdur, Thomas Fleming

This entry was posted on Friday, February 19th, 2010 at 11:35 am and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.