http://youtube.com/watch?v=6Q0uQAL_YDA

Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW!

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Here is a Video of the 2007 Rally

http://www.youtube.com/watch?v=UqAx7uZAS90

MAY 30, 2008 NATIONWIDE PROSTATE CANCER PROTEST

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20% of 42,000 Lives = 8,400 Lives & Counting

Money is very important to most people yet nobody can measure how many dollars one life is worth. There is no amount of money, no matter how much, that is worth trading for one single life. If one life is so very valuable to one family, then how much are 8,400 lives worth?

Ever since the FDA delayed getting Provenge to men with late stage prostate cancer over 42,000 men have died. If they were on Provenge since May 2007, at least 20% would still be alive. That is over 8,400 men that would have benefited.

In other words the FDA would have approved Provenge if it saved 9,240 people, but because it only saved 8,400 people’s lives, they won’t let us have it. The bureacracy must be using artificial intelligence to come up with their faulty conclusion to delay. The FDA already told us the agency is too broken to keep up with the science.

There are currently 90,000 to 100,000 men with Androgen Independent Prostate Cancer (AIPC), or are hormone refractory. That’s 18,000 to 20,000 people. AT LEAST THEY COULD BE SAVED, according to interim data just released. Keep in mind that the final data will even be more impressive.

CareToLive has again written to Dr. Jesse Goodman, the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). CareToLive sent Dr. Goodman a Citizens Petition on July 27, 2007, to reconsider the denial of a license for Provenge, an immunotherapy treatment for men with late stage prostate cancer. The petition was sent to the FDA over a year ago and as per Federal Regulation CareToLive should have received an answer within 180 days after receipt. We are still waiting.

Additional data for Provenge has recently been evaluated and has shown what we at CareToLive have been saying all along. Provenge is safe and Provenge shows a survival benefit. An outside firm has just confirmed that 20% of the men in the Provenge trials survived over placebo, due to the Provenge treatment. It is time for the FDA to grant approval, even if only conditional while more data is gathered, so that men with late stage prostate cancer can begin receiving Provenge NOW!

Link to CareToLive’s Citizen’s Petition http://caretolive.com/caretolivepetition.pdf

Here is the letter CareToLive sent to Dr. Jesse Goodman:

Jesse L. Goodman, M.D., M.P.H.
Director
Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

Re: Docket No. 2007P-0297/CP1

Dear Dr. Goodman,

I am requesting that the FDA reconsider our CareToLive Citizens Petition docket number 2007P-0297/CP1 filed in July 2007, concerning the FDA delay of Provenge licensure for men with late stage prostate cancer. To date we have never received a proper answer and have only received one letter from you, stating that our petition is still pending. Enclosed is additional data obtained from the Independent Data Monitoring Committee (IDMC) from the Interim look, proving that the survival is real. Provenge clearly demonstrated a 20% reduction in the risk of death in the Provenge arm relative to placebo.

My husband Mike Kearney and I both spoke to Paul Richards of the FDA Consumer Affairs CBER Department, whom your office directed us to. He is supposed to be working for Consumer Affairs but he obviously does not have the consumer in mind. Mr. Richards stated that he himself looked at the data and did not see the survival. This is shocking, seeing that even Dr. Maha Hussain, of “leaked letter” fame said at the meeting that she saw the survival. She wanted to make sure it could be attributed to Provenge. This additional IDMC data proves that the survival is indeed due to Provenge. Mr. Richards refused to answer our question as to whether Provenge is safe. The IDMC clearly states that Provenge is safe, and the FDA Advisory Commmitee voted unanimously that Provenge is safe, so that should not be an issue, despite Mr. Richards refusal to admit Provenge’s safety profile. Mr Richards told us that the minority panelists swayed the FDA decision to delay Provenge. Another of the minority panelists, Dr. Howard Scher, also of “leaked letter” infamy, had many undisclosed conflicts of interest, including running a competitior’s trial for prostate cancer with Novacea’s Asentar, a trial that was stopped midstream due to the high number of deaths, possibly caused by Dr. Scher’s trial design, which caused an abundance of toxicity to the poor patients enrolled.

Our Citizens Petition, which is also attached, addressed the shenanigans that took place during the FDA Provenge BLA process. The FDA correctly granted Provenge Fast Track Status and Priority Review since it is a treatment for a life threatening disease where no viable alternatives exist. Regardless of what took place in the past, in light of the corroborating scientific evidence seen at the Interim, it is time to to reconsider our Petition concerning the denial of a license for Provenge for men with late stage prostate cancer.

To date, over 42,000 men have died without the benefit of Provenge. A 20% improvement in survival means that more than 8000 of them might still be alive if given the right to fight for their lives. It is a travesty that the FDA, which is sworn to protect the public health, has instead ignored these men in their battle with prostate cancer.

The FDA can fix this by allowing the 96,000 men who are eligible for Provenge right now, the chance to fight for their lives. Please restore the American people’s faith in the FDA, and in light of the new data, honor that Fast Track Status and Priority Review. Please reconsider the CareToLive Citizens Petition to reconsider the denial of a license for Provenge. This is an emergency!

Thank you for your immediate consideration of this matter.

Very Respectfully,

Rory & Mike Kearney
CareToLive,
a not for profit corporation

Cc: Division of Dockets Management (HFA-305)
Paul Richards, FDA Consumer Affairs
Lanessa Hill, FDA Consumer Affairs
Stephen Ripley, FDA Consumer Affairs

Popularity: 16%

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.”

Continue Reading The FDA Fiddles While 30,000 Men Burn »

Popularity: 50%

House Signon Letter for Provenge Hearings

The time is now, the need is great. The attached letter is now available and will be circulated to interested members of the House for their support. Kudos to Congressman Michaud and his staffer for working through this, for caring about the needs of their constituents, and for taking action to protect the patients in need. These issues demand public hearings in Congress and Congressman Michaud and his staff are helping us ask for them.

As a wise and passionate man once said, “Ask not what your country can do for you, but rather, what you can do for your country.”

What you can do is politely but passionately communicate with your elected Representatives in Congress that you would like them to support this letter, ask them to sign on to the call for hearings, and explain that this will help protect their constituents from continued dysfunction at the FDA that is, quite literally, killing them each and every day by denying them access to promising and potentially life-saving new therapies. They are being denied the true promise of accelerated approvals that was legislated for them by Congress and passed ten full years ago. Congress needs to right that wrong NOW.

Continue Reading The Time is NOW! »

Popularity: 86%

For those of us who have followed the Provenge saga and have been fighting this injustice since May 9 2007, most, if not all the information contained here will not be news to us. Nevertheless, since I have been offered a platform to express my views and opinions, I leaped at the chance to do so. My main concern and motivation for this blog stem from what appears to be FDA corruption and the lack of urgency by Congress to rectify the situation.

I have written to my Senators and Representative so many times, I have lost count. If I am lucky enough to receive a response, the communication exchange usually ends the same way. The Senators and Representative forward my concerns to the FDA. The FDA changes the recipient’s name and sends their already prepared form letter to the Senators and Representative, which is then forwarded to me. The FDA’s response is a blatant disregard for authority. Who is the boss of whom? The FDA is seriously out of control. What is even more disturbing is that Congress has allowed the FDA to get away with thumbing their nose at the boss (Congress). If this was any other employer/employee relationship, the employee would have been shown the door a long time ago. My perception is that FDA officials have become so cocky and removed from the mandate set by Congress, they feel they answer to no one. I apologize for the rant. However, this situation is beyond ridiculous and I am beyond frustrated.

Continue Reading Corruption at Its Finest »

Popularity: 87%

Another day and another story breaks about a member of Congress asking the FDA for answers about how a drug with potentially significant safety issues has made it through the agency’s review process and been approved for full marketing and use. While it is to be applauded when Congress correctly invokes its oversight role in reviewing FDA decisions and processes, one must question if the bigger picture is being missed as Congress focuses on the issue of drugs that have been approved which perhaps should not have been, but fails to make any mention of the drugs or therapies that have NOT been approved that very likely should have been.

Continue Reading Are Congress and the FDA missing the big picture? »

Popularity: 95%