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PHEN’S THOMAS FARRINGTON ON BOARD THE PROVENGE TRAIN

January 20th, 2008 | Posted by CTL
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WHAT A GREAT DAY FOR PROSTATE CANCER SUFFERERS. TOM FARRINGTON of PHEN Prostate Health Education Network

THE ROAD TO PROVENGE APPROVAL

(click here to read full article)
By: Thomas A. Farrington
President and Founder
PHEN

During the first two weeks of 2008 the US Food and Drug Administration’s (FDA’s) delayed approval of Provenge, the first ever prostate cancer therapeutic immunotherapy vaccine, continues to be a headline issue as it was for most of 2007. In fact the issue seems to be gaining momentum with a focus on reasons “why” the treatment was not approved by the FDA after being recommended for approval by an FDA advisory committee in March 2007.

“In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA’s decision last May to delay approval of Provenge;” states the editorial in the January issue of “Nature Biotechnology.”(The Nature Biotechnology article can be found on our articles page)

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WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.