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	<title>Comments on: FDA OKs Merck&#8217;s Gardasil For Two More Cancers</title>
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	<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 22:17:25 +0000</pubDate>
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		<title>By: harpy</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373919</link>
		<dc:creator>harpy</dc:creator>
		<pubDate>Wed, 17 Sep 2008 16:29:43 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373919</guid>
		<description>I think this "&lt;i&gt;In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva&lt;/i&gt;" is misleading - aren't they really linking HPV to the cause of vaginal and vulvar cancer?  

To put it another way - it is still only preventing (arguably) the same four strains of HPV that cause an estimated "&lt;i&gt;70 percent of cervical cancers and 90 percent of genital warts&lt;/i&gt;."  Asking what percentage of vaginal and vulvar cancer is caused by HPV is almost beside the point (but still worth knowing). 

I call shenanigans on the FDA - if this were a DTC ad, they would be investigating misleading claims.  In my mind, it's akin to saying Chantix prevents lung cancer.  And it really doesn't give Gardisil any more of a leg up on Cervarix than it already has - the way I read it, if it prevents the same strains, it'll have the same indications, no?</description>
		<content:encoded><![CDATA[<p>I think this &#8220;<i>In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva</i>&#8221; is misleading - aren&#8217;t they really linking HPV to the cause of vaginal and vulvar cancer?  </p>
<p>To put it another way - it is still only preventing (arguably) the same four strains of HPV that cause an estimated &#8220;<i>70 percent of cervical cancers and 90 percent of genital warts</i>.&#8221;  Asking what percentage of vaginal and vulvar cancer is caused by HPV is almost beside the point (but still worth knowing). </p>
<p>I call shenanigans on the FDA - if this were a DTC ad, they would be investigating misleading claims.  In my mind, it&#8217;s akin to saying Chantix prevents lung cancer.  And it really doesn&#8217;t give Gardisil any more of a leg up on Cervarix than it already has - the way I read it, if it prevents the same strains, it&#8217;ll have the same indications, no?</p>
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		<title>By: truthman30</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373626</link>
		<dc:creator>truthman30</dc:creator>
		<pubDate>Tue, 16 Sep 2008 12:57:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373626</guid>
		<description>Whenever I read the words "Blockbuster" and "GSK" in the same sentence, I shudder...

Paxil and Avandia were both promoted as wonder drugs, and they were also "blockbusters" for GSK..

They were also extremely dangerous and defective...



http://www.bioportfolio.com/cgi-bin/acatalog/GSK_s_Cervarix_a_future_blockbuster_of_2007.html

GSK's Cervarix a future blockbuster of 2007

The number of blockbusters continues to increase. The number is set to increase to 112 in 2007. Of the products set to receive FDA approval this year and generate blockbuster status on an annual basis, GSK's Cervarix, intended for the prevention of infection and lesions from the two cancer-causing types of HPVs holds great potential.
GSK will earn royalties of up to 10% or $200 million each year from Merck due to sales of the Cervarix cervical cancer vaccine, according to the legal settlement reached last year. This is a new market battle and you need to be part of it.</description>
		<content:encoded><![CDATA[<p>Whenever I read the words &#8220;Blockbuster&#8221; and &#8220;GSK&#8221; in the same sentence, I shudder&#8230;</p>
<p>Paxil and Avandia were both promoted as wonder drugs, and they were also &#8220;blockbusters&#8221; for GSK..</p>
<p>They were also extremely dangerous and defective&#8230;</p>
<p><a href="http://www.bioportfolio.com/cgi-bin/acatalog/GSK_s_Cervarix_a_future_blockbuster_of_2007.html" rel="nofollow">http://www.bioportfolio.com/cgi-bin/acatalog/GSK_s_Cervarix_a_future_blockbuster_of_2007.html</a></p>
<p>GSK&#8217;s Cervarix a future blockbuster of 2007</p>
<p>The number of blockbusters continues to increase. The number is set to increase to 112 in 2007. Of the products set to receive FDA approval this year and generate blockbuster status on an annual basis, GSK&#8217;s Cervarix, intended for the prevention of infection and lesions from the two cancer-causing types of HPVs holds great potential.<br />
GSK will earn royalties of up to 10% or $200 million each year from Merck due to sales of the Cervarix cervical cancer vaccine, according to the legal settlement reached last year. This is a new market battle and you need to be part of it.</p>
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		<title>By: truthman30</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373623</link>
		<dc:creator>truthman30</dc:creator>
		<pubDate>Tue, 16 Sep 2008 12:53:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373623</guid>
		<description>If I was to be a total cynic about  this..
I would say this is the pharmaceutical industry, yet again,marketing the disease and then the drug to treat it..
These vaccines will be a major cash cow for the industry..
And is that not always the bottom line?</description>
		<content:encoded><![CDATA[<p>If I was to be a total cynic about  this..<br />
I would say this is the pharmaceutical industry, yet again,marketing the disease and then the drug to treat it..<br />
These vaccines will be a major cash cow for the industry..<br />
And is that not always the bottom line?</p>
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		<title>By: laurie</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373503</link>
		<dc:creator>laurie</dc:creator>
		<pubDate>Mon, 15 Sep 2008 22:21:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373503</guid>
		<description>" Let’s say that the vaccine is only effective against the virus for a relatively modest 15 years (most vaccines are effective much longer than that). If you vaccinate at 12, she should be protected from HPV till 27. "

Nathan, if these were documented claims, then I wouldn't have such a problem with that aspect. But I've heard anywhere from 4-6 years immunity.The one scientist who worked on this vaccine pointed out that this is a potentially big problem. 
So if we're vaccinating 8 year old, that puts them at 12-14 years when that immunity is no longer there. This is one of the problems I have with this. No one appears to know when this will wear off, so what do we tell these kids when they hit their teens, at the highest risk point. 
Now tack on the adverse reactions and there's enough for me to question it's use. 
Of course it's an individual decision for a parent and child to make, but not having full disclosure, once again, leaves a parent making a decision on only partial information.</description>
		<content:encoded><![CDATA[<p>&#8221; Let’s say that the vaccine is only effective against the virus for a relatively modest 15 years (most vaccines are effective much longer than that). If you vaccinate at 12, she should be protected from HPV till 27. &#8221;</p>
<p>Nathan, if these were documented claims, then I wouldn&#8217;t have such a problem with that aspect. But I&#8217;ve heard anywhere from 4-6 years immunity.The one scientist who worked on this vaccine pointed out that this is a potentially big problem.<br />
So if we&#8217;re vaccinating 8 year old, that puts them at 12-14 years when that immunity is no longer there. This is one of the problems I have with this. No one appears to know when this will wear off, so what do we tell these kids when they hit their teens, at the highest risk point.<br />
Now tack on the adverse reactions and there&#8217;s enough for me to question it&#8217;s use.<br />
Of course it&#8217;s an individual decision for a parent and child to make, but not having full disclosure, once again, leaves a parent making a decision on only partial information.</p>
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		<title>By: AA</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373502</link>
		<dc:creator>AA</dc:creator>
		<pubDate>Mon, 15 Sep 2008 22:19:06 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373502</guid>
		<description>Nathan,

You took what I said out of context.    Here is the whole exert:

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

Don't infer things that aren't there as I didn't say these deaths are insignificant.    One death is one death too many.

My point was that because of these statistics, a vaccine that doesn't have a proven safety record is a big gamble and tilts the risk/benefit ratio greatly towards the risk section.

I saw your post about reported side effects to the FDA.  But if it is anything like with drugs in which it is estimated that only 1 to 10% of all AEDs are ever reported, I would tend to not trust those figures.

Anyway, do you have a link to unbiased research showing the vaccine would reduce the fatalities and cancer rates to back up your claim?

AA</description>
		<content:encoded><![CDATA[<p>Nathan,</p>
<p>You took what I said out of context.    Here is the whole exert:</p>
<p>Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.</p>
<p>Don&#8217;t infer things that aren&#8217;t there as I didn&#8217;t say these deaths are insignificant.    One death is one death too many.</p>
<p>My point was that because of these statistics, a vaccine that doesn&#8217;t have a proven safety record is a big gamble and tilts the risk/benefit ratio greatly towards the risk section.</p>
<p>I saw your post about reported side effects to the FDA.  But if it is anything like with drugs in which it is estimated that only 1 to 10% of all AEDs are ever reported, I would tend to not trust those figures.</p>
<p>Anyway, do you have a link to unbiased research showing the vaccine would reduce the fatalities and cancer rates to back up your claim?</p>
<p>AA</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373501</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Mon, 15 Sep 2008 22:08:53 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373501</guid>
		<description>Nathan,.

FDA conducted a two day hearing on medication Guides.June12th and 13th. Dr Fassler's testimony can be found at the end of the hearing on June 13th. How do I know? I sat beside him. I also noticed you never answered my question,.. would you allow "your children" to be treated with psychotroppic drugs to prevent mental illness? Maybe more important than HPV?!!!!</description>
		<content:encoded><![CDATA[<p>Nathan,.</p>
<p>FDA conducted a two day hearing on medication Guides.June12th and 13th. Dr Fassler&#8217;s testimony can be found at the end of the hearing on June 13th. How do I know? I sat beside him. I also noticed you never answered my question,.. would you allow &#8220;your children&#8221; to be treated with psychotroppic drugs to prevent mental illness? Maybe more important than HPV?!!!!</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373473</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Mon, 15 Sep 2008 19:47:47 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373473</guid>
		<description>Lisa,
Two links I 've found with his testimony say nothing of the sort:

http://www.politicalwatchdog.com/psych_fraud/fassler.htm

http://www.aacap.org/cs/root/resources_for_families/psychiatric_medication/children_and_ssri_antidepressants_information_for_parents_by_david_fassler_md</description>
		<content:encoded><![CDATA[<p>Lisa,<br />
Two links I &#8216;ve found with his testimony say nothing of the sort:</p>
<p><a href="http://www.politicalwatchdog.com/psych_fraud/fassler.htm" rel="nofollow">http://www.politicalwatchdog.com/psych_fraud/fassler.htm</a></p>
<p><a href="http://www.aacap.org/cs/root/resources_for_families/psychiatric_medication/children_and_ssri_antidepressants_information_for_parents_by_david_fassler_md" rel="nofollow">http://www.aacap.org/cs/root/resources_for_families/psychiatric_medication/children_and_ssri_antidepressants_information_for_parents_by_david_fassler_md</a></p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373471</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Mon, 15 Sep 2008 19:16:27 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373471</guid>
		<description>Jack2

Dr. David Fassler(Child and Adolescent Psychiatrist) has testified before FDA and has given many media interviews on this. Please google his name and read for yourself, So I may be able to stay unbiased.</description>
		<content:encoded><![CDATA[<p>Jack2</p>
<p>Dr. David Fassler(Child and Adolescent Psychiatrist) has testified before FDA and has given many media interviews on this. Please google his name and read for yourself, So I may be able to stay unbiased.</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373460</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Mon, 15 Sep 2008 17:07:22 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373460</guid>
		<description>Bob,
Did you read the report?  The report is based largely upon this FDA press release: (page three of the "naturalnews" report)

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html

Please read the FDA press release yourself and see if you come to the same conclusion.  I certainly didn't.  Here's a quote from the FDA press release that supposedly indicates that the FDA believes that HPV and cervical cancer are not linked:
"The HC2 High-Risk HPV DNA Test, manufactured by Digene Corp., of Gaithersburg, Md., can identify 13 of the high-risk types associated with the development of cervical cancer. The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women."

So, technically, you are absolutely correct.  HPV doesn't cause cancer.  Rather, HPV causes cell changes in the cervix which, left untreated, eventually lead to cancer in some women.  

Wow - what a stunning revelation...  I guess technically smoking doesn't cause lung cancer either.  Rather, it causes "changes in lung cells which, left untreated can lead to lung cancer in some smokers."  Good luck with that arguement.  I wouldn't start smoking again if I were you.</description>
		<content:encoded><![CDATA[<p>Bob,<br />
Did you read the report?  The report is based largely upon this FDA press release: (page three of the &#8220;naturalnews&#8221; report)</p>
<p><a href="http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html" rel="nofollow">http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html</a></p>
<p>Please read the FDA press release yourself and see if you come to the same conclusion.  I certainly didn&#8217;t.  Here&#8217;s a quote from the FDA press release that supposedly indicates that the FDA believes that HPV and cervical cancer are not linked:<br />
&#8220;The HC2 High-Risk HPV DNA Test, manufactured by Digene Corp., of Gaithersburg, Md., can identify 13 of the high-risk types associated with the development of cervical cancer. The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women.&#8221;</p>
<p>So, technically, you are absolutely correct.  HPV doesn&#8217;t cause cancer.  Rather, HPV causes cell changes in the cervix which, left untreated, eventually lead to cancer in some women.  </p>
<p>Wow - what a stunning revelation&#8230;  I guess technically smoking doesn&#8217;t cause lung cancer either.  Rather, it causes &#8220;changes in lung cells which, left untreated can lead to lung cancer in some smokers.&#8221;  Good luck with that arguement.  I wouldn&#8217;t start smoking again if I were you.</p>
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		<title>By: BOB FIDDAMAN</title>
		<link>http://www.pharmalot.com/2008/09/fda-oks-mercks-gardasil-for-two-more-cancers/#comment-373457</link>
		<dc:creator>BOB FIDDAMAN</dc:creator>
		<pubDate>Mon, 15 Sep 2008 16:36:12 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=15490#comment-373457</guid>
		<description>Nathan, you may want to read this:

http://www.naturalnews.com/022404.html

I think it's best if we know ALL the facts and not just what Pharma want us to hear.</description>
		<content:encoded><![CDATA[<p>Nathan, you may want to read this:</p>
<p><a href="http://www.naturalnews.com/022404.html" rel="nofollow">http://www.naturalnews.com/022404.html</a></p>
<p>I think it&#8217;s best if we know ALL the facts and not just what Pharma want us to hear.</p>
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