CareToLive Reports: The FDA Fiddles While 30,000 Men Burn

Monday, November 26, 2007 General News
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DUBLIN, Ohio, Nov. 26 /CTL/ -- CareToLive, a not forprofit corporation, received a set back in a lower Federal Court lastWednesday in its fight against the FDA on behalf of terminal cancer patients.Undeterred, they announced that they will immediately file an appeal in the6th Circuit Court in Ohio.

"Men are dying while a safe, effective treatment languishes outside oftheir grasp," said CareToLive spokesperson, Melody Davis. "Congress needs towake up and hold hearings immediately! We are going to intensify our advocacyefforts on behalf of cancer patients. We feel the real reasons for the delaywere financial and political conflicts. The FDA continues to ignore the criesof the 30,000 men dying of prostate cancer each year, and refuses to protecttheir health and well being as they are sworn to do."

"The evidence clearly shows our government violated these men's right tolive," said Mike Kearney, a CareToLive board member. "They can say it, explainit, and infer it any way they want, but the truth is they allowed over 16,000men to die since May 8th without treatment, while other men profitedhandsomely during their demise."

There has been only one approved treatment for late stage prostate cancerin over 42 years. The FDA decision was unprecedented in a late stage diseasewhere the FDA special Advisory Panel of experts voted overwhelmingly thatProvenge is safe and effective and no viable alternatives exist. Financiallyconflicted panel members, after failing to sabotage Provenge during theadvisory meeting, "leaked" letters fraught with misinformation to improperlylobby FDA decision-makers and place public pressure on those decision-makers.

"The FDA makes up its rules as it goes along," Mr. Kearney continued, "andit does not follow its own rules, ignores congressional mandates andapparently answers to no one. The lower court indicated that the case is notreviewable as the FDA has not yet made a final decision on Provenge. It is acatch 22 situation because the FDA may never make a different decision thanthe one they already made which was not to approve. The Court basically said"we the people" have no recourse."

"Where are we headed if our government is left unchecked and allowed toviolate the Constitutional rights of the very people they are sworn toprotect?" asked CareToLive Attorney Kerry Donahue. "CareToLive organizedrallies, took out a half page ad in the Washington Post, ran bus ads, wrotethousands of letters and lobbied Congress. We fought like hell but Congressremains asleep. We are going to stand up for these men's rights."

Scott Riccio, founding member, patient advocate and lobbyist for A RightTo Live, who organized the recent rally at the FDA offices in conjunction withCareToLive, is continuing to focus on advocacy efforts aimed at Congress tohold public hearings on issues of FDA dysfunction, including the Provengedebacle. According to Mr. Riccio, the FDA fails to comply with its mission asestablished in the 1997 Food and Drug Administration Modernization Act(FDAMA). "This legislation clearly communicated to the FDA that Congressdesired a change in Agency policies to not just protect the public from unsafedrugs but to also promote the public health by efficiently and promptlyreviewing and delivering new therapies for patients fighting life threateningdiseases like cancer," Mr. Riccio said. "There are very serious questionsabout the role conflicts of interest, internal politics, and outdated policiesare playing at the FDA and getting answers to these questions would be greatlyexpedited by the holding of public hearings on the matter."

1 in 6 men will get prostate cancer in their lifetime. CareToLive isasking the public to help by contacting their elected officials to ask for acongressional hearing, visit the CareToLive website, digg their blogs, andjoin in the battle.For information

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