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Senators Specter and Kerry - CMS Has Some ‘Splaining To Do

August 25th, 2010 | Posted by CTL
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Care To Live says BRAVO to Senator Arlen Specter (PA) and Senator John Kerry (MA) for sending a letter to the Centers for Medicare and Medicaid (CMS) asking them why they are reviewing coverage on FDA approved Provenge.

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8 Responses to “Senators Specter and Kerry - CMS Has Some ‘Splaining To Do”

  1. 1.
    edward simmons
    Says:

    well this is way over due ,my hat is off to these two men spector and kerry ,it is about time they stopped the manipulation of dndn.

     Add karma Subtract karma  +1
  2. 2.
    Bob Sanders
    Says:

    Bravo. I wholeheartedly agree with the letter. As I’ve mentioned in my previous posts, the CMS NCD is baffling for a number of reasons - most importantly, the fact that this is an FDA approved breakthrough treatment, in fact ushering a whole new class of treatment, giving hope to thousands and even tens of thousands of men, potentially leading to other similar treatments and or expansion of provenge or other treatments by Dendreon and others based on similar principles, it is U.S. made and manufactured, leading to thousands of jobs - it is a win/win/win situation for everyone and the absolute worst type of economic activity that we want the government chilling and CMS is doing exactly that before provenge has even been on the market for a few months - talk about chilling further innovation in the American biotech industry.

     Add karma Subtract karma  +2
  3. 3.
    Anonymous
    Says:

    Science appears raped politically. Men may suffer from it while making a loss/win situation. The control was not placebo. A sham placebo can make a sham product look like working.

     Add karma Subtract karma  --1
  4. 4.
    more annonymous people!
    Says:

    here you are again…when will you realize that your placebo arguement is pure BS, dr scher (or hussain or flemming or martin etc etc)????????????? greedy people like you should crawl back under the hole you came from…

     Add karma Subtract karma  +0
  5. 5.
    more annonymous people!
    Says:

    that should be crawl back under the rock*** and i should the following adjectives: corrupt, spineless, dirty, selfish etc etc

     Add karma Subtract karma  +0
  6. 6.
    bob Sanders
    Says:

    Do you have any info as to whether CMS ever responded to the Senators’ letter? If so, isn’t the response FOIAable?

     Add karma Subtract karma  +0
  7. 7.
    Bob Sanders
    Says:

    Doesn’t the existing PROTECT data, which is the only scientific data as far as I can tell with respect to earlier stage PC, argue in favor of off-label CMS coverage. i.e., at the MEDCAC meeting, they will be reviewing all existing data for on label and off label use - on label is pretty easy, the same data that was used for FDA approval should be a slam dunk for CMS coverage.

    With respect to off label, the only data available is PROTECT, which argues in favor of off label coverage - a pretty strong case for off label coverage, especially in conjunction with the data with respect to on label usage. e.g., there is no real scientific evidence to suggest that Provenge does not work for earlier stage PC, and 1) logic (i.e., a vaccine given earlier, when the immune system is stronger and more able to produce an immune response and before the patient has been overcome with cancer, in conjunction with 2) the fact that it actually works for later-stage PC patients, in conjunction with 3) the PROTECT data, means the only data out there argues for off-label coverage as well. Therefore, unless and until there is compelling evidence to suggest Provenge is unlikely to work for off label PC indications, the logical decision is for CMS to cover both on-label and off-label.

    Hope Dendreon and the Prostate Cancer community uses this compelling reasoning to argue for full off-label coverage at the MEDCAC meeting.

     Add karma Subtract karma  +2
  8. 8.
    Donald Boyd
    Says:

    Can anyone explain why putting chemicals in one’s body, that does so many other harmful things besides trying to kill cancer, is even accepted by cms. Why not take that off the market, approve provenge, improve our quality of life. I have pc that has been treated with radiation and If my psa someday climbs back up I would rather have provenge over anything else.

     Add karma Subtract karma  +2

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Death by Wall Street - Rampage of the Bulls
Provenge is approved!

    Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
CATEGORIES

WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.