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	<title>Comments on: Senators Specter and Kerry - CMS Has Some &#8216;Splaining To Do</title>
	<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/</link>
	<description>CareToLive &#124; Help Men With Late Stage Prostate Cancer &#124; Provenge Now!</description>
	<pubDate>Fri, 18 May 2012 07:48:45 +0000</pubDate>
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		<title>By: Donald Boyd</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-18037</link>
		<dc:creator>Donald Boyd</dc:creator>
		<pubDate>Mon, 01 Nov 2010 12:24:10 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-18037</guid>
		<description>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.</description>
		<content:encoded><![CDATA[<p>Can anyone explain why putting chemicals in one&#8217;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.</p>
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		<title>By: Bob Sanders</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17759</link>
		<dc:creator>Bob Sanders</dc:creator>
		<pubDate>Sun, 03 Oct 2010 17:07:56 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17759</guid>
		<description>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.</description>
		<content:encoded><![CDATA[<p>Doesn&#8217;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. </p>
<p>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.</p>
<p>Hope Dendreon and the Prostate Cancer community uses this compelling reasoning to argue for full off-label coverage at the MEDCAC meeting.</p>
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		<title>By: bob Sanders</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17725</link>
		<dc:creator>bob Sanders</dc:creator>
		<pubDate>Thu, 30 Sep 2010 16:43:04 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17725</guid>
		<description>Do you have any info as to whether CMS ever responded to the Senators' letter?  If so, isn't the response FOIAable?</description>
		<content:encoded><![CDATA[<p>Do you have any info as to whether CMS ever responded to the Senators&#8217; letter?  If so, isn&#8217;t the response FOIAable?</p>
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		<title>By: more annonymous people!</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17346</link>
		<dc:creator>more annonymous people!</dc:creator>
		<pubDate>Thu, 26 Aug 2010 17:19:54 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17346</guid>
		<description>that should be crawl back under the rock*** and i should the following adjectives:  corrupt, spineless, dirty, selfish etc etc</description>
		<content:encoded><![CDATA[<p>that should be crawl back under the rock*** and i should the following adjectives:  corrupt, spineless, dirty, selfish etc etc</p>
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		<title>By: more annonymous people!</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17345</link>
		<dc:creator>more annonymous people!</dc:creator>
		<pubDate>Thu, 26 Aug 2010 17:18:03 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17345</guid>
		<description>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...</description>
		<content:encoded><![CDATA[<p>here you are again&#8230;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&#8230;</p>
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		<title>By: Anonymous</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17338</link>
		<dc:creator>Anonymous</dc:creator>
		<pubDate>Thu, 26 Aug 2010 03:34:56 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17338</guid>
		<description>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.</description>
		<content:encoded><![CDATA[<p>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.</p>
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		<title>By: Bob Sanders</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17337</link>
		<dc:creator>Bob Sanders</dc:creator>
		<pubDate>Thu, 26 Aug 2010 01:40:40 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17337</guid>
		<description>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.</description>
		<content:encoded><![CDATA[<p>Bravo.  I wholeheartedly agree with the letter.  As I&#8217;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.</p>
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		<title>By: edward simmons</title>
		<link>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17336</link>
		<dc:creator>edward simmons</dc:creator>
		<pubDate>Wed, 25 Aug 2010 22:14:14 +0000</pubDate>
		<guid>http://caretolive.com/2010-08-25/senators-spector-and-kerry-cms-has-some-splaining-to-do/#comment-17336</guid>
		<description>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.</description>
		<content:encoded><![CDATA[<p>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.</p>
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