November 26, 2007

The FDA Fiddles While 30,000 Men Burn

Posted in: The Cause, The Dysfunctional FDA, The Lawsuit

DUBLIN, OHIO, November 25, 2007 /CTL/ — CareToLive, a not for profit corporation, received a set back in a lower Federal Court last Wednesday in its fight against the FDA on behalf of terminal cancer patients. Undeterred, they announced that they will immediately file an appeal in the 6th Circuit Court in Ohio.

“Men are dying while a safe, effective treatment languishes outside of their grasp,” said CareToLive spokesperson, Melody Davis. “Congress needs to wake up and hold hearings immediately! We are going to intensify our advocacy efforts on behalf of cancer patients. We feel the real reasons for the delay were financial and political conflicts. The FDA continues to ignore the cries of the 30,000 men dying of prostate cancer each year in the United States alone, and refuses to protect their health and well being as they are sworn to do.”

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

There has been only one approved treatment for late stage prostate cancer in over 42 years. The FDA decision was unprecedented in a late stage disease where the FDA special Advisory Panel of experts voted overwhelmingly that Provenge is safe and effective and no viable alternatives exist. Financially conflicted panel members, after failing to sabotage Provenge during the advisory meeting, “leaked” letters fraught with misinformation to improperly lobby FDA decision-makers and place public pressure on those decision-makers.

“The FDA makes up its rules as it goes along,” Mr. Kearney continued, “and it does not follow its own rules, ignores congressional mandates and apparently answers to no one. The lower court indicated that the case is not reviewable as the FDA has not yet made a final decision on Provenge. It is a catch 22 situation because the FDA may never make a different decision than the 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 to violate the Constitutional rights of the very people they are sworn to protect?” asked CareToLive Attorney Kerry Donahue. “CareToLive organized rallies, took out a half page ad in the Washington Post, ran bus ads, wrote thousands of letters and lobbied Congress. We fought like hell but Congress remains asleep. We are going to stand up for these men’s rights.”

Scott Riccio, founding member, patient advocate and lobbyist for A Right To Live, who organized the recent rally at the FDA offices in conjunction with CareToLive, is continuing to focus on advocacy efforts aimed at Congress to hold public hearings on issues of FDA dysfunction, including the Provenge debacle. According to Mr. Riccio, the FDA fails to comply with its mission as established in the 1997 Food and Drug Administration Modernization Act (FDAMA). “This legislation clearly communicated to the FDA that Congress desired a change in Agency policies to not just protect the public from unsafe drugs but to also promote the public health by efficiently and promptly reviewing and delivering new therapies for patients fighting life threatening diseases like cancer,” Mr. Riccio said. “There are very serious questions about the role conflicts of interest, internal politics, and outdated policies are playing at the FDA and getting answers to these questions would be greatly expedited by the holding of public hearings on the matter.”

1 in 6 men will get prostate cancer in their lifetime. CareToLive is asking the public to help by contacting their elected officials to ask for a congressional hearing, visit the CareToLive website, digg their blogs, and join in the battle.

CareToLive sent this Press Release out on the newswire which will go to all major news organizations in the US.

For information

http://caretolive.com/

http://caretolive.com/2007-11-15/the-time-is-now/

http://caretolive.com/ways-to-help/

http://www.arighttolive.com

http://www.provenge.blogspot.com

Contact Information:

E-mail:

Melody Davis, Public Relations - MDavis@caretolive.com

Mike Kearney - PublicRelations@caretolive.com

Mailing Address: