<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
		>
<channel>
	<title>Comments on: While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers</title>
	<atom:link href="http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/feed/" rel="self" type="application/rss+xml" />
	<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/</link>
	<description>News and analysis from the intersection of genomics, personalized medicine and the law</description>
	<lastBuildDate>Thu, 09 Feb 2012 16:46:43 +0000</lastBuildDate>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=3.3.1</generator>
	<item>
		<title>By: Paul Corinthians</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-9534</link>
		<dc:creator>Paul Corinthians</dc:creator>
		<pubDate>Tue, 24 Aug 2010 07:10:39 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-9534</guid>
		<description>While they were sleeping - Asleep at the Wheel with (salmonella) Egg on Their Face

Other examples include the FDA&#039;s passing of “silicon crunch” for use, beginning October of 2007, in snack foods as it bonds well to artificial flavors and sweeteners and is made from ground up re-cycled glass. This may explain why several FDA scientists resigned in protest and where they bestow their loyalty.</description>
		<content:encoded><![CDATA[<p>While they were sleeping &#8211; Asleep at the Wheel with (salmonella) Egg on Their Face</p>
<p>Other examples include the FDA&#8217;s passing of “silicon crunch” for use, beginning October of 2007, in snack foods as it bonds well to artificial flavors and sweeteners and is made from ground up re-cycled glass. This may explain why several FDA scientists resigned in protest and where they bestow their loyalty.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Paul Corinthians</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-9533</link>
		<dc:creator>Paul Corinthians</dc:creator>
		<pubDate>Tue, 24 Aug 2010 06:59:55 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-9533</guid>
		<description>So busy protecting their financial interests they forgot about protecting the quality of our food consumption by serving the basic interests of consumers and screening our egg supply.</description>
		<content:encoded><![CDATA[<p>So busy protecting their financial interests they forgot about protecting the quality of our food consumption by serving the basic interests of consumers and screening our egg supply.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Paul Corinthians</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-9058</link>
		<dc:creator>Paul Corinthians</dc:creator>
		<pubDate>Thu, 12 Aug 2010 17:20:39 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-9058</guid>
		<description>Maybe FDA is getting ready to collude with some pharmaceutical company earmarked to make some new drug for AD or other genetic related diseases with mutated viral treatments previously proven to kill monkeys. The FDA’s relationship with big pharmaceutical companies is about as wholesome and impartial as that between the “Minerals Management Company” and BP (and oil companies in general).


From the July 2006 Idaho Observer: 

FDA internally adopts &quot;final rule&quot; on pharmaceuticals Federal public &quot;health&quot; autocrats decide consumers cannot sue makers of FDA-approved drugs for damages WASHINGTON, D.C.— It is estimated that as many as 200,000 people die each year from adverse reactions to prescription drugs approved by the U.S. Food and Drug Administration (FDA) and about 2.2 million people are injured each year by FDA-approved drugs. FDA-approved Vioxx alone may have killed as many as 60,000 people—more U.S. fatalities than the Vietnam War. On June 30, 2006, the FDA ’ s &quot;final rule&quot; regarding pharmaceutical drug liability claims went into effect. The FDA, which is now arguably the nation ’ s number one killer, has decided that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug ’ s manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data. In a move so shocking and transparent (and baseless in legal contemplation), the FDA is attempting to eliminate any responsibility whatsoever for the suffering and death caused by the deadly pharmaceutical drugs it approves for the marketplace. According to health advocate and author Mike Adams, &quot;In the preamble of the FDA ’ s new ‘ final rule ’ ....the agency asserts that FDA approval of prescription drugs—and their implied safety —may no longer be second- guessed by consumers or organizations of any kind. 

The FDA ’ s stamp of approval, the agency claims, is an absolute declaration of safety of all such drugs, for any use whatsoever, including off-label use (the use of drugs on health conditions that were never tested in clinical trials).&quot; In the last couple of years the corrupt collusion between the FDA, drug companies and the medical &quot;research&quot; they sponsor has been reported in the mainstream press. The highly -publicized Vioxx scandal and others indicate that the FDA and cronies in the private sector are beginning to lose their grip on their $multi-billion drug approval scam and, out of desperation, have approved their &quot;final solution&quot;—they will administratively hold back the flood of damages suits for as long as they can. Meanwhile, the FDA keeps approving drugs, doctors keep prescribing them, people keep taking them and America just gets sicker and sicker... 

Page 1 of 1 Idaho Observer:            FDA internally adopts &quot;final rule&quot; on pharmaceuticals 

10/5/2008 
http://www.proliberty.com/observer/20060710.htm</description>
		<content:encoded><![CDATA[<p>Maybe FDA is getting ready to collude with some pharmaceutical company earmarked to make some new drug for AD or other genetic related diseases with mutated viral treatments previously proven to kill monkeys. The FDA’s relationship with big pharmaceutical companies is about as wholesome and impartial as that between the “Minerals Management Company” and BP (and oil companies in general).</p>
<p>From the July 2006 Idaho Observer: </p>
<p>FDA internally adopts &#8220;final rule&#8221; on pharmaceuticals Federal public &#8220;health&#8221; autocrats decide consumers cannot sue makers of FDA-approved drugs for damages WASHINGTON, D.C.— It is estimated that as many as 200,000 people die each year from adverse reactions to prescription drugs approved by the U.S. Food and Drug Administration (FDA) and about 2.2 million people are injured each year by FDA-approved drugs. FDA-approved Vioxx alone may have killed as many as 60,000 people—more U.S. fatalities than the Vietnam War. On June 30, 2006, the FDA ’ s &#8220;final rule&#8221; regarding pharmaceutical drug liability claims went into effect. The FDA, which is now arguably the nation ’ s number one killer, has decided that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug ’ s manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data. In a move so shocking and transparent (and baseless in legal contemplation), the FDA is attempting to eliminate any responsibility whatsoever for the suffering and death caused by the deadly pharmaceutical drugs it approves for the marketplace. According to health advocate and author Mike Adams, &#8220;In the preamble of the FDA ’ s new ‘ final rule ’ &#8230;.the agency asserts that FDA approval of prescription drugs—and their implied safety —may no longer be second- guessed by consumers or organizations of any kind. </p>
<p>The FDA ’ s stamp of approval, the agency claims, is an absolute declaration of safety of all such drugs, for any use whatsoever, including off-label use (the use of drugs on health conditions that were never tested in clinical trials).&#8221; In the last couple of years the corrupt collusion between the FDA, drug companies and the medical &#8220;research&#8221; they sponsor has been reported in the mainstream press. The highly -publicized Vioxx scandal and others indicate that the FDA and cronies in the private sector are beginning to lose their grip on their $multi-billion drug approval scam and, out of desperation, have approved their &#8220;final solution&#8221;—they will administratively hold back the flood of damages suits for as long as they can. Meanwhile, the FDA keeps approving drugs, doctors keep prescribing them, people keep taking them and America just gets sicker and sicker&#8230; </p>
<p>Page 1 of 1 Idaho Observer:            FDA internally adopts &#8220;final rule&#8221; on pharmaceuticals </p>
<p>10/5/2008<br />
<a href="http://www.proliberty.com/observer/20060710.htm" rel="nofollow">http://www.proliberty.com/observer/20060710.htm</a></p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Stefan Long</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-8001</link>
		<dc:creator>Stefan Long</dc:creator>
		<pubDate>Fri, 23 Jul 2010 02:01:58 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-8001</guid>
		<description>Does the FDA actually believe a educational DNA Tests fit the the 201(h) definition of a medical device?  Wow - I just can&#039;t spin the verbiage into that shape not matter how hard I try.  Maybe sneaking out the &quot;letters&quot; to another 14 companies before the 2-day public meeting is part of the new government transparency program.  Surely that must be it, because the FDA&#039;s reckless and incompetent approach is crystal clear me.  Seriously - let the regulatory agencies that exist today (CLIA, FQS, AABB etc..) regulate the Genetic Testing industry, after all - most labs pay them tens of thousands of dollars per year for the simple privilege of doing business.  Once again, the U.S. is the laughing stock of the DNA Testing world...good job FDA.  The genetic testing industry will never see eye-to-eye with the FDA as long as they rely on creative interpretation of ineffectual standards and continue to use spin instead of competence as their champion.  The time for robust resistance is indeed here as Mr. Grimaldi suggests.</description>
		<content:encoded><![CDATA[<p>Does the FDA actually believe a educational DNA Tests fit the the 201(h) definition of a medical device?  Wow &#8211; I just can&#8217;t spin the verbiage into that shape not matter how hard I try.  Maybe sneaking out the &#8220;letters&#8221; to another 14 companies before the 2-day public meeting is part of the new government transparency program.  Surely that must be it, because the FDA&#8217;s reckless and incompetent approach is crystal clear me.  Seriously &#8211; let the regulatory agencies that exist today (CLIA, FQS, AABB etc..) regulate the Genetic Testing industry, after all &#8211; most labs pay them tens of thousands of dollars per year for the simple privilege of doing business.  Once again, the U.S. is the laughing stock of the DNA Testing world&#8230;good job FDA.  The genetic testing industry will never see eye-to-eye with the FDA as long as they rely on creative interpretation of ineffectual standards and continue to use spin instead of competence as their champion.  The time for robust resistance is indeed here as Mr. Grimaldi suggests.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: VubJabVanny</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-7989</link>
		<dc:creator>VubJabVanny</dc:creator>
		<pubDate>Thu, 22 Jul 2010 20:43:07 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-7989</guid>
		<description>Регистрируюсь на форуме.</description>
		<content:encoded><![CDATA[<p>Регистрируюсь на форуме.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Keith Grimaldi</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-7964</link>
		<dc:creator>Keith Grimaldi</dc:creator>
		<pubDate>Thu, 22 Jul 2010 10:39:42 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-7964</guid>
		<description>A bit more on the 2006 GAO (against consumer genetic testing) - 99% of the press of course just regurgitated the GAO press release (written before hearing evidence from the companies) and they still do. There was no analysis of the report, the defence or the &quot;forensic&quot; process - it has become a &quot;Google Fact&quot; that the GAO exposed a scam. However:

According to David Castle - philosopher/ethicist with speciality in nutrigenomics (http://bit.ly/c08cxW):

&quot;Although there are several methodological flaws in the report, the conclusion that at-home genetic tests offered to consumers are snake-oil was uncritically repeated. The flaws in the methodology and conclusions of the GAO report are serious and potentially damaging to private interests in nutrigenomics, as well as public confidence in the Food and Drug Administration (FDA).&quot; in MINN. J.L. SCI. &amp; TECH. 2008;9(1):37-60, http://bit.ly/cHusuQ (pdf)

And:

&quot;While geneticist Ruth DeBusk concedes that there are “absolutely legitimate issues of concern” about nutritional genetic testing and many genetics labs, she calls the GAO report “irresponsible.”
“It’s clear the GAO investigators did not understand what nutritional genomics was all about,” DeBusk says. She says that some genetic-testing labs are doing solid research and offering legitimate genetic tests.&quot; (Washingtonian, April, 2010 - http://bit.ly/9FhRqC)

So DTC companies beware, we made plenty of mistakes in DTC (from 2001 onwards!), one was not to robustly fight back against the GAO etc, don&#039;t repeat it...</description>
		<content:encoded><![CDATA[<p>A bit more on the 2006 GAO (against consumer genetic testing) &#8211; 99% of the press of course just regurgitated the GAO press release (written before hearing evidence from the companies) and they still do. There was no analysis of the report, the defence or the &#8220;forensic&#8221; process &#8211; it has become a &#8220;Google Fact&#8221; that the GAO exposed a scam. However:</p>
<p>According to David Castle &#8211; philosopher/ethicist with speciality in nutrigenomics (<a href="http://bit.ly/c08cxW" rel="nofollow">http://bit.ly/c08cxW</a>):</p>
<p>&#8220;Although there are several methodological flaws in the report, the conclusion that at-home genetic tests offered to consumers are snake-oil was uncritically repeated. The flaws in the methodology and conclusions of the GAO report are serious and potentially damaging to private interests in nutrigenomics, as well as public confidence in the Food and Drug Administration (FDA).&#8221; in MINN. J.L. SCI. &amp; TECH. 2008;9(1):37-60, <a href="http://bit.ly/cHusuQ" rel="nofollow">http://bit.ly/cHusuQ</a> (pdf)</p>
<p>And:</p>
<p>&#8220;While geneticist Ruth DeBusk concedes that there are “absolutely legitimate issues of concern” about nutritional genetic testing and many genetics labs, she calls the GAO report “irresponsible.”<br />
“It’s clear the GAO investigators did not understand what nutritional genomics was all about,” DeBusk says. She says that some genetic-testing labs are doing solid research and offering legitimate genetic tests.&#8221; (Washingtonian, April, 2010 &#8211; <a href="http://bit.ly/9FhRqC" rel="nofollow">http://bit.ly/9FhRqC</a>)</p>
<p>So DTC companies beware, we made plenty of mistakes in DTC (from 2001 onwards!), one was not to robustly fight back against the GAO etc, don&#8217;t repeat it&#8230;</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Keith Grimaldi</title>
		<link>http://www.genomicslawreport.com/index.php/2010/07/21/14-more-fda-letters/comment-page-1/#comment-7956</link>
		<dc:creator>Keith Grimaldi</dc:creator>
		<pubDate>Thu, 22 Jul 2010 08:37:39 +0000</pubDate>
		<guid isPermaLink="false">http://www.genomicslawreport.com/?p=3999#comment-7956</guid>
		<description>This is worrying - what also worries me is the GAO investigation (my past experience with the GAO, particular the &quot;forensic&quot; department doesn&#039;t fill me with confidence). According to the memo you cite:

“the genetic testing market appears to have expanded rapidly and consumer fraud in this area is on the rise.”

They are worried about consumer fraud so who do they choose to investigate? Pathway, Navigenics, 23andme and deCODE!! These companies have been accused of many things but no-one really seriously has ever accused them of fraud.

As in 2006, the GAO have picked the wrong companies for their &quot;forensic&quot; activities - another worry is that in the previous &quot;hearing&quot; the press release with the GAO conclusions was given to us as we filed into the hearing, before it even began (and they had already appeared in the press the evening before).

If they are really worried about fraud, why do they not investigate companies that really deserve it - what is going on? Politicians looking to grab easy headlines and be seen to be &quot;doing something&quot; or is there something else behind all this (OK Dan, not expecting you to answer these questions).</description>
		<content:encoded><![CDATA[<p>This is worrying &#8211; what also worries me is the GAO investigation (my past experience with the GAO, particular the &#8220;forensic&#8221; department doesn&#8217;t fill me with confidence). According to the memo you cite:</p>
<p>“the genetic testing market appears to have expanded rapidly and consumer fraud in this area is on the rise.”</p>
<p>They are worried about consumer fraud so who do they choose to investigate? Pathway, Navigenics, 23andme and deCODE!! These companies have been accused of many things but no-one really seriously has ever accused them of fraud.</p>
<p>As in 2006, the GAO have picked the wrong companies for their &#8220;forensic&#8221; activities &#8211; another worry is that in the previous &#8220;hearing&#8221; the press release with the GAO conclusions was given to us as we filed into the hearing, before it even began (and they had already appeared in the press the evening before).</p>
<p>If they are really worried about fraud, why do they not investigate companies that really deserve it &#8211; what is going on? Politicians looking to grab easy headlines and be seen to be &#8220;doing something&#8221; or is there something else behind all this (OK Dan, not expecting you to answer these questions).</p>
]]></content:encoded>
	</item>
</channel>
</rss>

