Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.

During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.

We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.

The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.

Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.

CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.

This should never be allowed to happen again.

Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.

We are not about to let that happen. Care To Live Continue Reading Care To Live Submits Moment of Silence to CMS »

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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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CareToLive Believes that the lower Court was in error when it chose to summarily dismiss our lawsuit against the FDA, Richard Pazdur and Howard Scher along with our motion for emergency injunctive relief. We will never stop fighting until this injustice is overturned.

Click here to
read the brief requesting oral argument filed today.

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A tribute to John Fish.

We are very saddened to tell you that CareToLive member John Fish passed away from prostate cancer on Tuesday, December 18, 2007, without ever having the benefit of receiving provenge, the immunotherapy which he so desperately wanted. He was so hopeful that he would be able to get it 7 months ago, when it came before the FDA Advisory Committee of experts who voted it unanimously safe and 13 to 4 substantial evidence of efficacy (2 of the naysayers who “leaked” letters may be called before a Congressional Hearing – read on). Instead the FDA delayed approval, claiming they needed more data. Over 10 years of trials showing survival benefits, were not enough for them, despite the fact that 30,000 American men with PC are out of options, and the treatment has almost no side effects or safety issues. The chicanery going on at the FDA knows no bounds.

We can never thank John enough for all his efforts to right the wrongs in the FDA delay of Provenge. John was one of the lead Plaintiffs in our unprecedented, ongoing, CareToLive lawsuit filed by our attorney Kerry Donahue against the FDA, unfortunately under appeal, but not in time to help John. It was dismissed under a Catch 22, whereby the Court refused to hear the case concerning the delay of Provenge due to the fact that is was not denied, only delayed, so far for 7 months and what could be forever. Tell John that it is still pending. A lot of good that does him. For all intents and purposes Provenge is dead, until the FDA Commissioner Andrew Von Eschenbach decides whether to approve, delay or not approve, depending on whatever baloney is being dished out over at the FDA that day. Continue Reading One Fish, Two Fish, We are all Blue Fish — John Fish We Will Miss You »

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It is over 7 months since the FDA denied the Provenge Biologics License Application for Prostate Cancer. Last week John Fish, suffering from late stage prostate cancer, was admitted to a hospice without ever having been given the opportunity to receive this immunotherapy to try to strengthen his body to fight for his life. John has however, joined with CareToLive and hopefully although it may be too late for him, he and his wife Marlilyn have courageously stood toe to toe with us, along with many of our other members with prostate cancer, to try to make this treatment available for the rest of the 30,000 men who will surely die this year without it.

Finally! Thanks to the efforts of CareToLive, a non profit, led by attorney Kerry Donahue, and Scott Riccio of ARightToLive, and the many, many members and supporters of CareToLive and Provenge, an immunotherapy voted overwhelmingly safe and effective by an FDA panel of experts to approve this treatment for prostate cancer, and then denied without adequate explanation by the FDA, three of our congressmen, Mike Michaud of Maine, Dan Burton of Indiana, and Tim Ryan of Ohio are asking for a congressional hearing into what happened. We must continue to be vigilant and to contact our representatives in the Congress to keep the pressure on, and to demand a congressional hearing.

CONGRESSIONAL LETTER ASKING FOR A HEARING  PDF (click here) Please fax this letter to your own congressional representatives and ask them to join this action. TIA

An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!

This is a grassroots movement. We need EVERYBODY’S help. See you at the hearings!

Please visit our website and read our blogs to learn about the 3 “leaked” letters and so much more, Continue Reading The FDA Said NO, CareToLive & ARightToLive say GO FISH! »

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