Howard C. and John Fish were the two late stage prostate cancer patients who gave Care To Live Attorney Kerry Donahue, standing to file our lawsuit against the FDA in Federal Court in Ohio, two years ago. Had Howard and John been able to receive Provenge when it should have been approved, they might still be with us today.

“Attached hereto as “Exhibit E”, is the signed letter by Howard CXXXXX who is an AIPC patient in Ohio who seeks Provenge now. Howard is very ill and in late stage of prostate cancer. He hopes that if he can’t get Provenge in time to help him that he can at least help others to receive it. John Fish (letter attached to Plt mot. for inj, exhibit H), also from Ohio is a late stage cancer patient who wants Provenge now.”

Our dysfunctional FDA coupled with a corrupt cast of characters, needs to be overhauled and made to serve the public by bringing better, safer, more humane treatments, like Provenge, on the market without years of delay.

The system is so flawed that after we filed more than a dozen motions fighting to have the corrupt decision addressed, the FDA, defended by the Department of Justice, paid for with our tax dollars, received a ruling by the Federal Court saying that since the decision is not final, as the Provenge application is still pending, the case is not ripe to be heard.

Tell Howard C. and John Fish and Stephen Study, and the Wicks, and the 60,000 other men who have gone on to die from prostate cancer during this unjust approval delay, that the decision by the FDA was not final.

With the unambiguous and robust survival results that were just shown in the THIRD confirmatory phase 3 trial, the FDA needs to immediately make Provenge available to the thousands of the men who would be eligible to be treated with the Provenge immunotherapy, in order to empower them  to fight for their lives.

Every man should have the same chance Eduardo Garcia had. He had given up on life when his daughter enrolled him in the Provenge trials 8 years ago, and after 3 treatments in a doctors office, he crawled out of bed and is alive and well.

Howard provided a great service to mankind by stepping forward to say that men with prostate cancer matter. All the Care To Live Members and Supporters hearts and prayers go out to Howard and his family.

Grow a heart FDA. You have delayed this long enough. There is no excuse to keep men waiting another year while you follow your draconian protocol. There can be no doubt that it works. Now let’s get it to the men today!

Answer our CareToLive Citizens’ Petition that has been languishing in your office for almost 2 years and Approve Provenge NOW!

Read and Leave Comments on our FDA CareToLive Citizens’ Petition Request to Reconsider the Failure to Approve Provenge >>

http://www.regulations.gov/search/search_results.jsp?css=0&N=0&Ntk=All&Ntx=mode+matchall&Ne=2+8+11+8053+8054+8098+8074+8066+8084+8055&Ntt=FDA-2007-P-0168-0011%20%20&sid=121682D41130

We need everybody and be the voice that Howard no longer has, and to contact the FDA, Congress, and the Press in the link below.

Operation Accelerate Approval >>http://caretolive.com/2009-04-28/operation-accelerate-approval-update/

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Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/ .

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

We are protesting the terrible decision to deny Ted Girgus and thousands of other men like him with end stage prostate cancer ted-girgus-ad1a.pdf

Ted’s Doctor wants Ted on Provenge NOW!

1 in 6 men get prostate cancer. 27,000 American men die from it every years. Provenge is an immunotherapy that harnesses the bodies healthy cells and retrains them to target the cancer.

On May 28, 2007, in an unprecedented and horrendous decision, the FDA decided to delay treatment to these men.We would like to take a few moments to remember two of our CareToLive members who have passed away since the FDA turned its back on the men without explanation or cause.

We tried to get Congress to hold hearings over the shenanigans that went on at the FDA that day, including conflicts of interest with competing drugs, “leaked letters” and the corruption that took place at the dysfunctional FDA.

Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings.

They prefer to leave these men seeking Provenge in FDA purgatory. It is over a year since denial of Provenge licensure but the FDA claims the decision is not final, it is just a delay. Congress says they won’t hold hearings because the decision is still pending. Tell that to our Ted Girgus. 2/13/08.

Here is Dingell and Pallone’s passing the buck. micha001.pdfThree Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

It is over a year and so many of our members, like Ted Girgus, who is desperately seeking Provenge, could be on Provenge NOW, getting the benefits that people like Eduardo Garcia and Bruce Tower received, two men who participated in the Provenge trials and are both still around to tell.

Come on Congress. Come on FDA. Do the right thing. APPROVE PROVENGE NOW!

Support the ACCESS ACT CareToLive Member Stephen Study’s son writes about the passing of his fatherwho was never given the chance to receive Provenge“I’ll Never forgive the FDA for what they did to Dad” (click to read)part IIhttp://caretolive.com/wp-content/uploads/2008/04/caretoliverockvillegazette4ad-part-2web.pdf

Also please support the ACCESS ACT! http://www.pharmalot.com/2008/05/a-bill-for-experimental-meds-for-terminally-ill/

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