<?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: New mainstream coverage of rethinkers</title>
	<atom:link href="http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm/feed" rel="self" type="application/rss+xml" />
	<link>http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm</link>
	<description>Reviewing scientific paradigms and other general beliefs in the light of the scientific amd professional literature</description>
	<lastBuildDate>Fri, 10 Sep 2010 18:05:52 -0600</lastBuildDate>
	<generator>http://wordpress.org/?v=2.8.4</generator>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
		<item>
		<title>By: Truthseeker</title>
		<link>http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm/comment-page-3#comment-546</link>
		<dc:creator>Truthseeker</dc:creator>
		<pubDate>Sat, 09 Dec 2006 10:07:02 +0000</pubDate>
		<guid isPermaLink="false">http://paradigmoverthrow.com/blog/?p=253#comment-546</guid>
		<description>Kleinman et al., using Western blot with a criterion of 3 positive bands plus env found zero false positives out of over 5 million samples in an ultralow prevalence population. That strikes me as rather good.  

Sorry, a copy of this 1998 study in JAMA not in front of us now, but according to our notes this showed only a 9% confirmation by Western Blot of each 100 (91% false) of the 4,650 double checked positives Elisa yielded, which you have acknowledged, and then when 9% of them seemed questionable (&quot;possible false positivity&quot;) and  were checked by PCR half of them proved false, ie 4.8% (20 out of 39) were invalid, ie about 1/2 per cent more were invalid.

So nearly 92 per cent of the original Elisas were wrong.  Half of the questionable WBlots were wrong too - 20.  How many more were there that were not examined? 380.  How many were wrong?  We don&#039;t know. Where do you get zero from in all this?

Your expression above seems to be incorrect and perhaps you should refine it. To repeat, 5% of the WBlot confirmations were wrong. But only 9% of the Elisa doubly tested positives  were examined. So half those questionable were wrong. How many of the others would have withstood checking is unknown but other indications suggest PCR does not correlate very well with Western Blot.

So where do you get your 100% faith in WBlot in very low prevalence populations?  

You keep saying that problems arise only in low prevalence populations. But Harvard&#039;s Max Essex and colleagues found 80 per cent Elisa and 80% WBlots in the Congo with its high prevalence population were invalid.

They concluded that high exposure to bacteria gives a high level of cross reactions and false positivity - such as TB, leprosy and others. There is tremendous TB in these areas, maybe as much as half the population. And that&#039;s just one interfering factor. Another is hypergammaglobulinemia ie high levels of immunoglobulin G or IgG from multiple assaults on the system.  How can anyone expect these tests to be meaningful at these rates of error, even if HIV did any damage?  Of course, it is the high rates of error that suggest it isn&#039;t HIV that is the problem at all.

Readers should pop over to Hank&#039;s You Bet Your Life and check out the Maniotis post today, a brilliantly written Brief Guide to the History of AIDS, in which he reminds all of the numerous disastrous deficits of logic and evidence in the paradigm that have emerged year after year, all swept under the carpet by the ruling clique. 

Just the ones to do with testing are enough to bring this thread to a screeching halt:

 Thus it has been about 22 years since Dr. Gallo rushed that same day to patent the first &quot;HIV&quot; test kit, and was subsequently convicted of scientific misconduct by the Dingell Commission and the Office of Scientific Integrity of the NIH for attempting to steal Luc Montagnier&#039;s so-called &quot;HIV-virus isolate [1].&quot;

It has also been about 22 years since chimp colonies were injected with &quot;isolates&quot; of &quot;HIV&quot; obtained from AIDS patients, but have yet to become ill, as they sit in their new 27 million dollar retirement homes [2].

At the beginning of HIV testing, it was known that â€œ68% to 89% of all repeatedly reactive ELISA (HIV antibody) tests represent false positive results among sperm donors [3], and 14 years ago, it was reported that â€œHIV-like sequences exist in normal in human, chimpanzee, and rhesus monkey DNAs&quot; [4].  That same year, it was reported that the hepatitis B vaccine causes false positive &quot;HIV&quot; test results [5]. 

It has been 11 years since it was reported that flu vaccines cause false positive &quot;HIV&quot; test results [8] 

t has also been about 7 years since it was known that goats and cows test &quot;HIV-positiveâ€ [11].

2 years since the Red Cross reported that even after repeated testing using different test kits, low-risk populations, such as blood donors (or military recruits) will typically yield 12 (PCR) positive or 2 (ELISA) positive results out of 37,000,000 samples, leaving potentially 10 out of 12 false positives, depending on which test kit you believe [15]. 

Andrew Maniotis is a Program Director in the Cell and Developmental Biology of Cancer unit of the Department of Pathology, Anatomy and Cell Biology, and Bioengineering, College of Medicine, University of Illinois at Chicago.  He first appeared to us when he wrote a letter supporting the Al Bayati autopsy review of Eliza Jane. He is also the author of the ABCs of AIDS Denialists featured on The AIDS Wiki.

We especially like the point he brings up about goats and cows testing positive for HIV.  This also applies to dogs, we happen to know. Why have Anthony Fauci and his drug company friends in the politics of HIVâˆ«AIDS not exploited this fact before now?  There is a vast market for antiretrovirals which is being totally neglected.

Save our cows, goats and dogs from HIV now!
</description>
		<content:encoded><![CDATA[<p>Kleinman et al., using Western blot with a criterion of 3 positive bands plus env found zero false positives out of over 5 million samples in an ultralow prevalence population. That strikes me as rather good.  </p>
<p>Sorry, a copy of this 1998 study in JAMA not in front of us now, but according to our notes this showed only a 9% confirmation by Western Blot of each 100 (91% false) of the 4,650 double checked positives Elisa yielded, which you have acknowledged, and then when 9% of them seemed questionable (&#8221;possible false positivity&#8221;) and  were checked by PCR half of them proved false, ie 4.8% (20 out of 39) were invalid, ie about 1/2 per cent more were invalid.</p>
<p>So nearly 92 per cent of the original Elisas were wrong.  Half of the questionable WBlots were wrong too &#8211; 20.  How many more were there that were not examined? 380.  How many were wrong?  We don&#8217;t know. Where do you get zero from in all this?</p>
<p>Your expression above seems to be incorrect and perhaps you should refine it. To repeat, 5% of the WBlot confirmations were wrong. But only 9% of the Elisa doubly tested positives  were examined. So half those questionable were wrong. How many of the others would have withstood checking is unknown but other indications suggest PCR does not correlate very well with Western Blot.</p>
<p>So where do you get your 100% faith in WBlot in very low prevalence populations?  </p>
<p>You keep saying that problems arise only in low prevalence populations. But Harvard&#8217;s Max Essex and colleagues found 80 per cent Elisa and 80% WBlots in the Congo with its high prevalence population were invalid.</p>
<p>They concluded that high exposure to bacteria gives a high level of cross reactions and false positivity &#8211; such as TB, leprosy and others. There is tremendous TB in these areas, maybe as much as half the population. And that&#8217;s just one interfering factor. Another is hypergammaglobulinemia ie high levels of immunoglobulin G or IgG from multiple assaults on the system.  How can anyone expect these tests to be meaningful at these rates of error, even if HIV did any damage?  Of course, it is the high rates of error that suggest it isn&#8217;t HIV that is the problem at all.</p>
<p>Readers should pop over to Hank&#8217;s You Bet Your Life and check out the Maniotis post today, a brilliantly written Brief Guide to the History of AIDS, in which he reminds all of the numerous disastrous deficits of logic and evidence in the paradigm that have emerged year after year, all swept under the carpet by the ruling clique. </p>
<p>Just the ones to do with testing are enough to bring this thread to a screeching halt:</p>
<p> Thus it has been about 22 years since Dr. Gallo rushed that same day to patent the first &#8220;HIV&#8221; test kit, and was subsequently convicted of scientific misconduct by the Dingell Commission and the Office of Scientific Integrity of the NIH for attempting to steal Luc Montagnier&#8217;s so-called &#8220;HIV-virus isolate [1].&#8221;</p>
<p>It has also been about 22 years since chimp colonies were injected with &#8220;isolates&#8221; of &#8220;HIV&#8221; obtained from AIDS patients, but have yet to become ill, as they sit in their new 27 million dollar retirement homes [2].</p>
<p>At the beginning of HIV testing, it was known that â€œ68% to 89% of all repeatedly reactive ELISA (HIV antibody) tests represent false positive results among sperm donors [3], and 14 years ago, it was reported that â€œHIV-like sequences exist in normal in human, chimpanzee, and rhesus monkey DNAs&#8221; [4].  That same year, it was reported that the hepatitis B vaccine causes false positive &#8220;HIV&#8221; test results [5]. </p>
<p>It has been 11 years since it was reported that flu vaccines cause false positive &#8220;HIV&#8221; test results [8] </p>
<p>t has also been about 7 years since it was known that goats and cows test &#8220;HIV-positiveâ€ [11].</p>
<p>2 years since the Red Cross reported that even after repeated testing using different test kits, low-risk populations, such as blood donors (or military recruits) will typically yield 12 (PCR) positive or 2 (ELISA) positive results out of 37,000,000 samples, leaving potentially 10 out of 12 false positives, depending on which test kit you believe [15]. </p>
<p>Andrew Maniotis is a Program Director in the Cell and Developmental Biology of Cancer unit of the Department of Pathology, Anatomy and Cell Biology, and Bioengineering, College of Medicine, University of Illinois at Chicago.  He first appeared to us when he wrote a letter supporting the Al Bayati autopsy review of Eliza Jane. He is also the author of the ABCs of AIDS Denialists featured on The AIDS Wiki.</p>
<p>We especially like the point he brings up about goats and cows testing positive for HIV.  This also applies to dogs, we happen to know. Why have Anthony Fauci and his drug company friends in the politics of HIVâˆ«AIDS not exploited this fact before now?  There is a vast market for antiretrovirals which is being totally neglected.</p>
<p>Save our cows, goats and dogs from HIV now!</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: trrll</title>
		<link>http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm/comment-page-3#comment-545</link>
		<dc:creator>trrll</dc:creator>
		<pubDate>Sat, 09 Dec 2006 07:06:06 +0000</pubDate>
		<guid isPermaLink="false">http://paradigmoverthrow.com/blog/?p=253#comment-545</guid>
		<description>&lt;blockquote&gt;Assuming there is Western Blot available, however, the outcome doesn&#039;t seem much better. &lt;/blockquote&gt;

&lt;a href=&quot;http://jama.ama-assn.org/cgi/content/full/280/12/1080#TABLEJTO80012T2&quot; rel=&quot;nofollow&quot;&gt;Kleinman et al.&lt;/a&gt;, using Western blot with a criterion of 3 positive bands plus env found  zero  false positives out of over  5 million  samples in an ultralow prevalence population. That strikes me as rather good.

&lt;blockquote&gt;Then you seem to believe that PCRs come in to save the day. But these will be uniformly positive for HIV detection if the dilution cutoff is low enough, is that not so? &lt;/blockquote&gt;

I suppose that if you are really determined to get the wrong answer, you can certainly find conditions under which PCR (or indeed, any kind of assay) will give you incorrect results. But why would you want to? Of course, in practice these assays are done with positive and negative controls, so if you somehow screw up the assay conditions, you&#039;ll know.

&lt;blockquote&gt;It is hard to see how a PCR test like Roche&#039;s Amplicor can be that useful in screening (which you seem to have said) when its insert says &quot;not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&quot; Why would Roche Diagnostic Systems print that if it could do either? &lt;/blockquote&gt;

This is a doubtless financial issue. It would cost a huge amount for Roche to do the studies to prove to the FDA that the test works for this purpose, and the potential return on that investment is small, because (as we saw above) for most practical purposes, ELISA backed by Western blot works quite well, so it is not a large potential market. It simply isn&#039;t worth the investment to the company. You&#039;ll see this for a lot of drugs as well. The company will only do the tests to qualify a drug for the largest market, even though it may also work for a lot of other indications. Doctors who use the drug for other indications do it &quot;off label.&quot; But even though Roche may not want to pay for the studies, research studies by individual investigators have confirmed the validity of PCR for evaluation of HIV infection. Indeed, PCR is now firmly established as the standard method for measuring nucleic acid sequences of any sort, not just HIV. Such independent studies are more convincing than studies paid for and carried out by the manufacturer, anyway.</description>
		<content:encoded><![CDATA[<blockquote><p>Assuming there is Western Blot available, however, the outcome doesn&#8217;t seem much better. </p></blockquote>
<p><a href="http://jama.ama-assn.org/cgi/content/full/280/12/1080#TABLEJTO80012T2" rel="nofollow">Kleinman et al.</a>, using Western blot with a criterion of 3 positive bands plus env found  zero  false positives out of over  5 million  samples in an ultralow prevalence population. That strikes me as rather good.</p>
<blockquote><p>Then you seem to believe that PCRs come in to save the day. But these will be uniformly positive for HIV detection if the dilution cutoff is low enough, is that not so? </p></blockquote>
<p>I suppose that if you are really determined to get the wrong answer, you can certainly find conditions under which PCR (or indeed, any kind of assay) will give you incorrect results. But why would you want to? Of course, in practice these assays are done with positive and negative controls, so if you somehow screw up the assay conditions, you&#8217;ll know.</p>
<blockquote><p>It is hard to see how a PCR test like Roche&#8217;s Amplicor can be that useful in screening (which you seem to have said) when its insert says &#8220;not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&#8221; Why would Roche Diagnostic Systems print that if it could do either? </p></blockquote>
<p>This is a doubtless financial issue. It would cost a huge amount for Roche to do the studies to prove to the FDA that the test works for this purpose, and the potential return on that investment is small, because (as we saw above) for most practical purposes, ELISA backed by Western blot works quite well, so it is not a large potential market. It simply isn&#8217;t worth the investment to the company. You&#8217;ll see this for a lot of drugs as well. The company will only do the tests to qualify a drug for the largest market, even though it may also work for a lot of other indications. Doctors who use the drug for other indications do it &#8220;off label.&#8221; But even though Roche may not want to pay for the studies, research studies by individual investigators have confirmed the validity of PCR for evaluation of HIV infection. Indeed, PCR is now firmly established as the standard method for measuring nucleic acid sequences of any sort, not just HIV. Such independent studies are more convincing than studies paid for and carried out by the manufacturer, anyway.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: YossariansGhostbuster</title>
		<link>http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm/comment-page-3#comment-544</link>
		<dc:creator>YossariansGhostbuster</dc:creator>
		<pubDate>Sat, 09 Dec 2006 04:46:45 +0000</pubDate>
		<guid isPermaLink="false">http://paradigmoverthrow.com/blog/?p=253#comment-544</guid>
		<description>TS,

You are on a roll, go for it. You&#039;re right, they do not have a valid wasserman and they&#039;re passing out the bismuth for life.</description>
		<content:encoded><![CDATA[<p>TS,</p>
<p>You are on a roll, go for it. You&#8217;re right, they do not have a valid wasserman and they&#8217;re passing out the bismuth for life.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Truthseeker</title>
		<link>http://www.scienceguardian.com/blog/new-mainstream-coverage-of-rethinkers.htm/comment-page-3#comment-543</link>
		<dc:creator>Truthseeker</dc:creator>
		<pubDate>Sat, 09 Dec 2006 04:19:09 +0000</pubDate>
		<guid isPermaLink="false">http://paradigmoverthrow.com/blog/?p=253#comment-543</guid>
		<description>The Comments of our stalwart defenders of the faith seem to us to be nothng more than the worms one encounters when one opens the can of testing and its accuracy.



There seems to be some lack of intellectual honesty here, whether intended or not ie whether with other people or with oneself, as they conduct defense after defense which misses the main point, which is a) are these tests a good guide to the presence of actual HIV or not, and b) do they show the quantity present?



It seems quite clear and admitted that Elisa tests in a low risk population are over 91% incorrect when they detect HIV antibodies.  That means to us that they are probably totally useless in a situation such as testing Africans where cross reactions due to antibodies to many other diseases are very prevalent.



So Elisas are totally useless in Africa.



Then the argument seems to be, well they are OK if they are confirmed by Western Blot as in the US.  But the Western Blot is not very widely available in Africa, is it?  Testing in Africa is either none or Elisas.



Assuming there is Western Blot available, however, the outcome doesn&#039;t seem much better.  Western Blots tested in 1993 on those in a low risk population (blood donors) who scored negative on an Elisa turned out 20-40% indeterminate as to whether positive or negative. An insert from the WB from Epitope/Organon Teknika Corporation famously reads &quot;do not use this test as sole basis of diagnosis of HIV-1 infection.&quot; 



Then you seem to believe that PCRs come in to save the day. But these will be uniformly positive for HIV detection if the dilution cutoff is low enough, is that not so?  Copies of HIV sequences will be detected in all of us. It is hard to see how a PCR test like Roche&#039;s Amplicor can be that useful in screening (which you seem to have said) when its insert says &quot;not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&quot;  Why would Roche Diagnostic Systems print that if it could do either? Yet we are told that is the insert.



Apparently it was forced to.



Checking on the Web we find on PR Newswire from 1996 



 &quot;The U.S. Food and Drug Administration (FDA) today approved for marketing Roche Molecular Systems&#039; (RMS) AMPLICOR HIV-1 MONITOR(TM) Test, the first test to accurately and precisely measure quantities of HIV-1 RNA in the blood (viral &quot;load&quot;). Using polymerase chain reaction (PCR) technology, a process that allows the amplification and identification of specific DNA or RNA sequences, the AMPLICOR HIV-1 MONITOR(TM) Test is able to quantitate viral load levels accurately and reproducibly over a broad dynamic range.&quot; 



But then we read also:



 &quot;DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

1401 Rockville Pike

Rockville MD 20852--1448



March 2, 1999



Alex Wesolowski

Roche Molecular systems, Inc.

1080 US Highway 202

Branchburg, NJ 08876



Re: 	BP950005, Supplement 3

Product: 	Roche AMPLICOR HIV-1 MONITOR Test

Date Received: 	June 24, 1997

Amended: 	10-APR-1998



Dear Mr. Wesolowski:



The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your response of April 10, 1998 to our comments. We are pleased to inform you that your premarket approval application (PMA) supplement for the AMPLICOR HIV-1 MONITOR Test intended to be used as an aid in management of patients on anti-viral therapy for HIV disease is approved subject to the conditions described below and in the &quot;Conditions of Approval&quot; (enclosed). You may begin commercial distribution of the device upon receipt of this letter.



The post-approval conditions to which you have agreed in your December 14, 1998 faxed letter include the following:



The Intended Use Statement should be modified to read as follows:



The AMPLICOR HIV-1 MONITOR Test is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effect of antiviral therapy by serial measurement of plasma HIV-1 RNA levels during the course of antiviral treatment. Monitoring the effects of antiviral therapy by serial measurement of plasma HIV-1 RNA has been validated for patient swith baseline viral loads â‰¥25,000 copies/mL.



&lt;b&gt;The AMPLICOR HIV-1 MONITOR Test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&quot;&lt;/b&gt; (Bold added).



So PCR is hardly a screening test for HIV.



Since it must have something to amplify, however, presumably it only works if whatever it is amplifying is there. The question is, is that something indicating HIV antibodies or antibodies from any one of many other cross reactive diseases?



The bottom line appears to be, these darn tests simply dont know what they are detecting - whether it is HIV antibodies or some other kind.



That fits in perfectly with the HIV debunkers, whose view is that all that is happening in Africa is that AIDS testing (what there is of it) whether real or imaginary (assumed) is simply tracking other illnesses across Africa, which is a warm continent which has bred all kinds of ills to attack the poor and inadequately fed.



All the HIV testers are doing in a poor and ill fed population in Africa is finding (other than pregnancy) illness - leprosy, dengue fever, diarrhea and other parasitic infections, worms and parasites, and dozens of others which result in high levels of response which all Elisas measure.



You are simply finding all present and past illness in Africa and calling it AIDS and dumping expensive ARVs on them.



Perhaps you ought to reflect on your contribution to human welfare.</description>
		<content:encoded><![CDATA[<p>The Comments of our stalwart defenders of the faith seem to us to be nothng more than the worms one encounters when one opens the can of testing and its accuracy.</p>
<p>There seems to be some lack of intellectual honesty here, whether intended or not ie whether with other people or with oneself, as they conduct defense after defense which misses the main point, which is a) are these tests a good guide to the presence of actual HIV or not, and b) do they show the quantity present?</p>
<p>It seems quite clear and admitted that Elisa tests in a low risk population are over 91% incorrect when they detect HIV antibodies.  That means to us that they are probably totally useless in a situation such as testing Africans where cross reactions due to antibodies to many other diseases are very prevalent.</p>
<p>So Elisas are totally useless in Africa.</p>
<p>Then the argument seems to be, well they are OK if they are confirmed by Western Blot as in the US.  But the Western Blot is not very widely available in Africa, is it?  Testing in Africa is either none or Elisas.</p>
<p>Assuming there is Western Blot available, however, the outcome doesn&#8217;t seem much better.  Western Blots tested in 1993 on those in a low risk population (blood donors) who scored negative on an Elisa turned out 20-40% indeterminate as to whether positive or negative. An insert from the WB from Epitope/Organon Teknika Corporation famously reads &#8220;do not use this test as sole basis of diagnosis of HIV-1 infection.&#8221; </p>
<p>Then you seem to believe that PCRs come in to save the day. But these will be uniformly positive for HIV detection if the dilution cutoff is low enough, is that not so?  Copies of HIV sequences will be detected in all of us. It is hard to see how a PCR test like Roche&#8217;s Amplicor can be that useful in screening (which you seem to have said) when its insert says &#8220;not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&#8221;  Why would Roche Diagnostic Systems print that if it could do either? Yet we are told that is the insert.</p>
<p>Apparently it was forced to.</p>
<p>Checking on the Web we find on PR Newswire from 1996 </p>
<p> &#8220;The U.S. Food and Drug Administration (FDA) today approved for marketing Roche Molecular Systems&#8217; (RMS) AMPLICOR HIV-1 MONITOR(TM) Test, the first test to accurately and precisely measure quantities of HIV-1 RNA in the blood (viral &#8220;load&#8221;). Using polymerase chain reaction (PCR) technology, a process that allows the amplification and identification of specific DNA or RNA sequences, the AMPLICOR HIV-1 MONITOR(TM) Test is able to quantitate viral load levels accurately and reproducibly over a broad dynamic range.&#8221; </p>
<p>But then we read also:</p>
<p> &#8220;DEPARTMENT OF HEALTH AND HUMAN SERVICES</p>
<p>Public Health Service</p>
<p>Food and Drug Administration</p>
<p>1401 Rockville Pike</p>
<p>Rockville MD 20852&#8211;1448</p>
<p>March 2, 1999</p>
<p>Alex Wesolowski</p>
<p>Roche Molecular systems, Inc.</p>
<p>1080 US Highway 202</p>
<p>Branchburg, NJ 08876</p>
<p>Re: 	BP950005, Supplement 3</p>
<p>Product: 	Roche AMPLICOR HIV-1 MONITOR Test</p>
<p>Date Received: 	June 24, 1997</p>
<p>Amended: 	10-APR-1998</p>
<p>Dear Mr. Wesolowski:</p>
<p>The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your response of April 10, 1998 to our comments. We are pleased to inform you that your premarket approval application (PMA) supplement for the AMPLICOR HIV-1 MONITOR Test intended to be used as an aid in management of patients on anti-viral therapy for HIV disease is approved subject to the conditions described below and in the &#8220;Conditions of Approval&#8221; (enclosed). You may begin commercial distribution of the device upon receipt of this letter.</p>
<p>The post-approval conditions to which you have agreed in your December 14, 1998 faxed letter include the following:</p>
<p>The Intended Use Statement should be modified to read as follows:</p>
<p>The AMPLICOR HIV-1 MONITOR Test is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effect of antiviral therapy by serial measurement of plasma HIV-1 RNA levels during the course of antiviral treatment. Monitoring the effects of antiviral therapy by serial measurement of plasma HIV-1 RNA has been validated for patient swith baseline viral loads â‰¥25,000 copies/mL.</p>
<p><b>The AMPLICOR HIV-1 MONITOR Test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.&#8221;</b> (Bold added).</p>
<p>So PCR is hardly a screening test for HIV.</p>
<p>Since it must have something to amplify, however, presumably it only works if whatever it is amplifying is there. The question is, is that something indicating HIV antibodies or antibodies from any one of many other cross reactive diseases?</p>
<p>The bottom line appears to be, these darn tests simply dont know what they are detecting &#8211; whether it is HIV antibodies or some other kind.</p>
<p>That fits in perfectly with the HIV debunkers, whose view is that all that is happening in Africa is that AIDS testing (what there is of it) whether real or imaginary (assumed) is simply tracking other illnesses across Africa, which is a warm continent which has bred all kinds of ills to attack the poor and inadequately fed.</p>
<p>All the HIV testers are doing in a poor and ill fed population in Africa is finding (other than pregnancy) illness &#8211; leprosy, dengue fever, diarrhea and other parasitic infections, worms and parasites, and dozens of others which result in high levels of response which all Elisas measure.</p>
<p>You are simply finding all present and past illness in Africa and calling it AIDS and dumping expensive ARVs on them.</p>
<p>Perhaps you ought to reflect on your contribution to human welfare.</p>
]]></content:encoded>
	</item>
</channel>
</rss>
