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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John Stossel from the Fox Business Network asks this very important question. Next he asks “Who owns your body?” You can watch his documentary as he weighs in on whether the government should have control over our bodies and the medications we take.

http://video.foxbusiness.com/v/4056081/who-owns-your-body/?playlist_id=87050

This touches all of us at CareToLive since we have been fighting the FDA for three years now for Provenge access for late stage prostate cancer patients. Stossel includes footage from the FDA Rally we held in Rockville, Maryland on September 18, 2007, with myself included at the Rockville Rally.

Stossel uses video of our beloved Bruce Tower. Bruce died while waiting for the FDA to approve Provenge, never having been able to receive it himself. He did participate in the Dendreon Trials, but he unfortunately only received a placebo, and not the actual immunotherapy.

The memory of Bruce, along with other CTL members, Stephen Study, John Fish, Howard Cassell, and Richard Ripp, makes us want to shout right along with John Stossel when he tells the FDA, “Why don’t you just butt out?”

The FDA can say it makes its decision based on science but we know that is all a bunch of baloney. Even Forbes writer, Matthew Herper, can tell you that. Remember this quote from his article back in April 2007:

Provenge’s fate “will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

And then there was the testimony by Harry Markopolos before Congress during the Bernie Madoff investigation:

Congressman: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

Care To Live is glad to hear Harry Markopolos has written a book called “No One Would Listen”  due out March 2nd.

In the meantime, check out John Stossel’s report and then write to your Senators and Congressmen and tell them to tell the FDA to butt out!

Hey, FDA, approve Provenge NOW!

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