A Right To Live Supporters to Rally for FDA Reform and Call for Congressional Action: Provenge NOW

On Tuesday, September 18th, a unique coalition of cancer patients, advocates, and doctors will be celebrating "A Right To Live Day" and protesting recent decisions by the FDA to deny cancer patients new, potentially lifesaving therapies, including Provenge for terminal patients with late-stage prostate cancer. A Right To Live is an all-volunteer advocacy group formed in response to the FDA's refusal to follow the language and intent of Congress regarding an accelerated approval process for oncology drugs/therapies and the hundreds of thousands of patients dying while they wait for new therapies and options to make their way through the FDA's corrupted processes.

It has become very clear over the past few years that the FDA has instituted a decelerated approval process for cancer therapies, in stark opposition to Congress' intent in legislating for accelerated approval pathways

There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency

Chicago, IL (PRWEB) August 23, 2007 -- A Right To Live, a cancer patient advocacy group formed to promote cancer patients' Right to Live through access to potentially life-saving therapies, today announces "A Right To Live Day" to be held September 18, 2007 from 10:00 am to 12:00 noon at the FDA offices in Rockville, MD.

The group will ask the FDA to immediately reconsider its flawed decision on Provenge, among others, and approve this new therapy for immediate use by late-stage prostate cancer patients with no viable alternatives. This new immunotherapy has already been endorsed by an FDA-appointed panel of experts who unanimously (17-0) determined it to be safe for its intended use. Further, the panel voted 13-4 in favor of the 'substantial evidence of efficacy' of Provenge, meeting the statutory requirements for immediate FDA approval. Never in its history had the FDA overturned a positive panel recommendation to deny terminal patients their right to live.

"It has become very clear over the past few years that the FDA has instituted a decelerated approval process for cancer therapies, in stark opposition to Congress' intent in legislating for accelerated approval pathways," said Scott Riccio, founding member and advocate for A Right To Live. The Wall Street Journal lamented this problem back in 2005, noting:

"The problem here is the FDA's unethical--and let us stress, unscientific--placebo-controlled trials, in which a subset of study patients are knowingly denied the new treatment and in some cases denied access to any active treatment at all. This may be moral with an antihistamine; it's certainly not with treatments for a terminal disease. What's more, it's entirely unnecessary. We already know what happens to most cancer patients who don't get treated. They die." (Wall Street Journal, March 24, 2005)

"There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency," according to Mr. Riccio. "Approximately 27,000 men will die this year alone from late-state prostate cancer and tens of thousands of other cancer patients will lose their own fights against cancer this year while they wait in vain for new therapies to make their almost ten-year march from discovery to FDA review. We believe patients have a right to live. We're not asking for the FDA to forego scientific review, we're asking the Agency to catch up to the science that already exists and use it to approve and monitor these lifesaving new therapies while patients and their doctors get informed access to them. We hope that if the FDA continues to abdicate its duty to patients, Congress will make the necessary inquiries and legislative changes to reinstate a true accelerated approval process for them."

Patients, doctors, advocates, and other interested parties should visit http://www.arighttolive.com for more details on getting involved and supporting the public cry for immediate relief for the suffering of patients being denied their right to live.

The rally will be held at 5600 Fishers Lane, Rockville, Maryland, in front of the FDA's offices and will begin at 10:00 am. Featured speakers will include Mr. Frank Burroughs, co-founder of the Abigail-Alliance, Mr. Ray Matyshyn and Mr. Bruce Towers who are both Provenge clinical trials participants, and Mr. Charles Reinwald, President of Cancer Cure Coalition, Inc., along with other distinguished guests.

Who is A Right To Live

A Right To Live is an all-volunteer advocacy group formed in response to the FDA's refusal to follow the language and intent of Congress regarding an accelerated approval process for oncology drugs/therapies and the hundreds of thousands of patients dying while they wait for new therapies and options to make their way through the FDA's corrupted processes. We believe the review process employed by the FDA is not consistent with the law as written by Congress and as applied by current FDA reviewers is fundamentally broken. We believe that Provenge, Genasense, and Junovan should be approved now and would be but for an FDA system highlighted by aggressive incompetence, conflicts of interest, and an incorrect understanding of Congressional intent regarding the accelerated approval process as whole.

For media inquiries, please visit http://www.arighttolive.com or call Scott Riccio at 312-420-3296.

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