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	<title>Comments on: Clinical trials lack serious oversight in the United States</title>
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	<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/</link>
	<description>General interest observations and true web-log.</description>
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		<title>By: Angel H. Wong</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-812011</link>
		<dc:creator>Angel H. Wong</dc:creator>
		<pubDate>Mon, 01 Oct 2007 22:19:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-812011</guid>
		<description>Is that a snap from Metallica&#039;s video &quot;ONE&quot;?</description>
		<content:encoded><![CDATA[<p>Is that a snap from Metallica&#8217;s video &#8220;ONE&#8221;?</p>
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		<title>By: Mister Mustard</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811688</link>
		<dc:creator>Mister Mustard</dc:creator>
		<pubDate>Mon, 01 Oct 2007 16:00:29 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811688</guid>
		<description>#17 - Nookyular One

Why would the trial administrators give a shit how the trial came out?  They&#039;re being paid by the drug companies, and they get the same amount of money if the drug works or doesn&#039;t work.  And virtually all phase 3 clinical trials are multi-center, so if they doctor up the results to make it looks like the drug works at THEIR institution, but it doesn&#039;t work at others: Automatic Red Flag.  

Besides, the trials are virtually all double-blind, and if the blind is broken before the trial is over, it leaves a paper trail.

What you are suggesting is a pervasive corruption that permeates the regulatory agencies, the drug companies, the medical community, and the government, all working in concert to sell you a drug that is dangerous or does not work.

I hope you&#039;ve still got that tin-foil hat.

In the future, it might be good if you restricted your comments to something you know about.</description>
		<content:encoded><![CDATA[<p>#17 &#8211; Nookyular One</p>
<p>Why would the trial administrators give a shit how the trial came out?  They&#8217;re being paid by the drug companies, and they get the same amount of money if the drug works or doesn&#8217;t work.  And virtually all phase 3 clinical trials are multi-center, so if they doctor up the results to make it looks like the drug works at THEIR institution, but it doesn&#8217;t work at others: Automatic Red Flag.  </p>
<p>Besides, the trials are virtually all double-blind, and if the blind is broken before the trial is over, it leaves a paper trail.</p>
<p>What you are suggesting is a pervasive corruption that permeates the regulatory agencies, the drug companies, the medical community, and the government, all working in concert to sell you a drug that is dangerous or does not work.</p>
<p>I hope you&#8217;ve still got that tin-foil hat.</p>
<p>In the future, it might be good if you restricted your comments to something you know about.</p>
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		<title>By: Mr. Fusion</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811577</link>
		<dc:creator>Mr. Fusion</dc:creator>
		<pubDate>Mon, 01 Oct 2007 14:16:16 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811577</guid>
		<description>#16, MM

&lt;i&gt;The notion that an IRB somehow “doctors up” the results of a clinical trial is so laughable I’m ashamed of you for even bringing it up. &lt;/i&gt;

And how do we know that? Because the people doing the experiments say so? Would I be allowed to verify a trial first hand? Plus, it is not the Review Board that would doctor the results, more probably the actual trial administrators.

History has repeatedly shown us that organizations can not be trusted to police themselves. Although I have no specific knowledge of any malfeasance here, neither would I put a blanket trust on any “Review Board” that is tied to the trial or even industry itself. </description>
		<content:encoded><![CDATA[<p>#16, MM</p>
<p><i>The notion that an IRB somehow “doctors up” the results of a clinical trial is so laughable I’m ashamed of you for even bringing it up. </i></p>
<p>And how do we know that? Because the people doing the experiments say so? Would I be allowed to verify a trial first hand? Plus, it is not the Review Board that would doctor the results, more probably the actual trial administrators.</p>
<p>History has repeatedly shown us that organizations can not be trusted to police themselves. Although I have no specific knowledge of any malfeasance here, neither would I put a blanket trust on any “Review Board” that is tied to the trial or even industry itself.</p>
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		<title>By: Mister Mustard</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811264</link>
		<dc:creator>Mister Mustard</dc:creator>
		<pubDate>Mon, 01 Oct 2007 04:39:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811264</guid>
		<description>&gt;&gt;The joke is on anyone that actually believes in the 
&gt;&gt;benevolent “institutional review board”. 

Obviously, you have no first hand (or even second hand) experience with IRBs.  Or clinical trials, or the FDA, or much of anything else related to this post.

&gt;&gt;That is not to say or even suggest that the results are 
&gt;&gt;routinely doctored.  But I will say that because we never 
&gt;&gt;know, it is possible.

See above.  I think all that radiation is getting to you Isotopic One.  The IRB has nothing whatsoever to do with the &quot;results&quot; of a clinical trial.  None.  They review protocols and monitor safety issues.  And in doing that, they are even more stringent than the FDA.  The notion that an IRB somehow &quot;doctors up&quot; the results of a clinical trial is so laughable I&#039;m ashamed of you for even bringing it up.

</description>
		<content:encoded><![CDATA[<p>&gt;&gt;The joke is on anyone that actually believes in the<br />
&gt;&gt;benevolent “institutional review board”. </p>
<p>Obviously, you have no first hand (or even second hand) experience with IRBs.  Or clinical trials, or the FDA, or much of anything else related to this post.</p>
<p>&gt;&gt;That is not to say or even suggest that the results are<br />
&gt;&gt;routinely doctored.  But I will say that because we never<br />
&gt;&gt;know, it is possible.</p>
<p>See above.  I think all that radiation is getting to you Isotopic One.  The IRB has nothing whatsoever to do with the &#8220;results&#8221; of a clinical trial.  None.  They review protocols and monitor safety issues.  And in doing that, they are even more stringent than the FDA.  The notion that an IRB somehow &#8220;doctors up&#8221; the results of a clinical trial is so laughable I&#8217;m ashamed of you for even bringing it up.</p>
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		<title>By: pedro</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811213</link>
		<dc:creator>pedro</dc:creator>
		<pubDate>Mon, 01 Oct 2007 03:23:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811213</guid>
		<description>#14 you mean doctored because they&#039;re made by doctors?</description>
		<content:encoded><![CDATA[<p>#14 you mean doctored because they&#8217;re made by doctors?</p>
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		<title>By: Mr. Fusion</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811200</link>
		<dc:creator>Mr. Fusion</dc:creator>
		<pubDate>Mon, 01 Oct 2007 02:37:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811200</guid>
		<description>#1, #2, &amp; #3

I guess you guys can&#039;t see the forest for the trees. The review panels and oversight committees are all on the same side. That is not the same as an independent oversight from a disinterested party such as the FDA. Your oversight has a lot of bias and conflict of interest involved.

That is not to say or even suggest that the results are routinely doctored. But I will say that because we never know, it is possible.</description>
		<content:encoded><![CDATA[<p>#1, #2, &amp; #3</p>
<p>I guess you guys can&#8217;t see the forest for the trees. The review panels and oversight committees are all on the same side. That is not the same as an independent oversight from a disinterested party such as the FDA. Your oversight has a lot of bias and conflict of interest involved.</p>
<p>That is not to say or even suggest that the results are routinely doctored. But I will say that because we never know, it is possible.</p>
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		<title>By: ECA</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811173</link>
		<dc:creator>ECA</dc:creator>
		<pubDate>Mon, 01 Oct 2007 01:35:46 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811173</guid>
		<description>12,
That is one UGLY lady under all those bandages..
I still like the one about the Rich guy that TRIES to make it look Asif&#039; the world is ending to others...Then has a mental breka down, and All he see&#039;s is the End of the world, even tho it didnt.</description>
		<content:encoded><![CDATA[<p>12,<br />
That is one UGLY lady under all those bandages..<br />
I still like the one about the Rich guy that TRIES to make it look Asif&#8217; the world is ending to others&#8230;Then has a mental breka down, and All he see&#8217;s is the End of the world, even tho it didnt.</p>
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		<title>By: Joshua</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811154</link>
		<dc:creator>Joshua</dc:creator>
		<pubDate>Mon, 01 Oct 2007 01:26:02 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811154</guid>
		<description>Oh...and Ed, thats one of my favorite Twilight Zone episodes......lol      ;0</description>
		<content:encoded><![CDATA[<p>Oh&#8230;and Ed, thats one of my favorite Twilight Zone episodes&#8230;&#8230;lol      ;0</p>
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		<title>By: Joshua</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811151</link>
		<dc:creator>Joshua</dc:creator>
		<pubDate>Mon, 01 Oct 2007 01:25:15 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811151</guid>
		<description>Nothing&#039;s perfect and there are always the unethical, as we are well aware of.  The reporter is making his story as *wnd of the world as we know it* as he can, but that dosen&#039;t mean there are not problems.
The FDA, I think does a pretty decent job considering how much their budget has been cut over the years.  In many goverments, reducing funding, as has been done at the FDA, of a department with such a huge mandate would totally cripple it, but all in all the FDA still manages to keep the human existance ending plagues to a minimum.

I&#039;m really begining to agree with the isolantionists a bit, after Bush is gone and we end our envolvement in Iraq and Afganistan, we should pull back into ourselves, it would give the world what it claims to want and allow us to concentrate on making this country viable again, in health care, education, infrastructure, science and maths.

Departments like the FDA and others are struggling to keep their heads above water and thats wrong.</description>
		<content:encoded><![CDATA[<p>Nothing&#8217;s perfect and there are always the unethical, as we are well aware of.  The reporter is making his story as *wnd of the world as we know it* as he can, but that dosen&#8217;t mean there are not problems.<br />
The FDA, I think does a pretty decent job considering how much their budget has been cut over the years.  In many goverments, reducing funding, as has been done at the FDA, of a department with such a huge mandate would totally cripple it, but all in all the FDA still manages to keep the human existance ending plagues to a minimum.</p>
<p>I&#8217;m really begining to agree with the isolantionists a bit, after Bush is gone and we end our envolvement in Iraq and Afganistan, we should pull back into ourselves, it would give the world what it claims to want and allow us to concentrate on making this country viable again, in health care, education, infrastructure, science and maths.</p>
<p>Departments like the FDA and others are struggling to keep their heads above water and thats wrong.</p>
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		<title>By: Maxmars</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811091</link>
		<dc:creator>Maxmars</dc:creator>
		<pubDate>Sun, 30 Sep 2007 22:58:37 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811091</guid>
		<description>To #1:

The joke is on anyone that actually believes in the benevolent &quot;institutional review board&quot;.  Usually an elite set of university medical and research oriented individuals all drooling at the prospect of another &quot;wonder drug&quot;  that could net the university millions in their &#039;cut&#039;, and by the way the ONE individual who is put on the board who isnt a member of the professional community is &#039;appointed&#039; by the President of sponsoring organization.  What a schill!!!</description>
		<content:encoded><![CDATA[<p>To #1:</p>
<p>The joke is on anyone that actually believes in the benevolent &#8220;institutional review board&#8221;.  Usually an elite set of university medical and research oriented individuals all drooling at the prospect of another &#8220;wonder drug&#8221;  that could net the university millions in their &#8216;cut&#8217;, and by the way the ONE individual who is put on the board who isnt a member of the professional community is &#8216;appointed&#8217; by the President of sponsoring organization.  What a schill!!!</p>
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		<title>By: Phillep</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811062</link>
		<dc:creator>Phillep</dc:creator>
		<pubDate>Sun, 30 Sep 2007 22:08:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811062</guid>
		<description>I think the previous posters are assuming the reporter played it straight. 

Call Ripley&#039;s if he did. I&#039;ve never known it to happen with anything I was familiar with, aside from some specialty press. 

Journalists are experts at writing articles that grab the attention. Seldom anything else. </description>
		<content:encoded><![CDATA[<p>I think the previous posters are assuming the reporter played it straight. </p>
<p>Call Ripley&#8217;s if he did. I&#8217;ve never known it to happen with anything I was familiar with, aside from some specialty press. </p>
<p>Journalists are experts at writing articles that grab the attention. Seldom anything else.</p>
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		<title>By: ECA</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-811017</link>
		<dc:creator>ECA</dc:creator>
		<pubDate>Sun, 30 Sep 2007 20:42:53 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-811017</guid>
		<description>A person in a closed environment, tends to see What is there.  AND ONLY there..  NOTHING in the next location, or the next.
you cant see past your own Limits..
And unless you were involved..as in checking ALL the facilities, WORKING at ALOT of facilities, or Suppling the durg/material/treatments...  You cant see what WAS/IS happening.</description>
		<content:encoded><![CDATA[<p>A person in a closed environment, tends to see What is there.  AND ONLY there..  NOTHING in the next location, or the next.<br />
you cant see past your own Limits..<br />
And unless you were involved..as in checking ALL the facilities, WORKING at ALOT of facilities, or Suppling the durg/material/treatments&#8230;  You cant see what WAS/IS happening.</p>
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		<title>By: Mister Mustard</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-810921</link>
		<dc:creator>Mister Mustard</dc:creator>
		<pubDate>Sun, 30 Sep 2007 17:45:04 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-810921</guid>
		<description>&gt;&gt;we have no idea what may be done under-wraps in terms 
&gt;&gt;of “unofficial” clinical trials

Can&#039;t really blame the FDA for that.  Read &quot;Pure Evil&quot; by Greg Iles for an idea of what might be going on deep in the bowels of a bomb shelter beneath an abandoned bakery, in the name of science.

The FDA monitors (among other things) drug research conducted by legitimate pharmaceutical companies.  And, all things considered, they do a pretty good job.  They&#039;re not the CIA, FBI,  NSA, or the local police, and their mandate is not to track down evil scientists conducting clandestine research.</description>
		<content:encoded><![CDATA[<p>&gt;&gt;we have no idea what may be done under-wraps in terms<br />
&gt;&gt;of “unofficial” clinical trials</p>
<p>Can&#8217;t really blame the FDA for that.  Read &#8220;Pure Evil&#8221; by Greg Iles for an idea of what might be going on deep in the bowels of a bomb shelter beneath an abandoned bakery, in the name of science.</p>
<p>The FDA monitors (among other things) drug research conducted by legitimate pharmaceutical companies.  And, all things considered, they do a pretty good job.  They&#8217;re not the CIA, FBI,  NSA, or the local police, and their mandate is not to track down evil scientists conducting clandestine research.</p>
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		<title>By: Gangrened Toe</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-810895</link>
		<dc:creator>Gangrened Toe</dc:creator>
		<pubDate>Sun, 30 Sep 2007 16:56:28 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-810895</guid>
		<description>Although clinical trials are officially pretty well controlled in the USA, we have no idea what may be done under-wraps in terms of &quot;unofficial&quot; clinical trials.
Watch the movie &quot;The Constant Gardener&quot; for an idea of what could actually be happening in the name of research.</description>
		<content:encoded><![CDATA[<p>Although clinical trials are officially pretty well controlled in the USA, we have no idea what may be done under-wraps in terms of &#8220;unofficial&#8221; clinical trials.<br />
Watch the movie &#8220;The Constant Gardener&#8221; for an idea of what could actually be happening in the name of research.</p>
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		<title>By: Mister Mustard</title>
		<link>http://www.dvorak.org/blog/2007/09/30/clinical-trials-lack-serious-oversight-in-the-united-states/comment-page-1/#comment-810890</link>
		<dc:creator>Mister Mustard</dc:creator>
		<pubDate>Sun, 30 Sep 2007 16:41:19 +0000</pubDate>
		<guid isPermaLink="false">http://www.dvorak.org/blog/?p=13847#comment-810890</guid>
		<description>&gt;&gt;my tendency is to agree with #1. 

Ditto.  

And if we want tighter controls on American-grown E. coli vegetables, kiddie cold medicines, cures for cancer, and lead-painted toys, we are going to have to PAY for it.  That means either higher taxes, or taking some of the hundreds of billions of dollars we waste every year and redirecting them to programs that actually benefit Americans.  Those are the only two options.</description>
		<content:encoded><![CDATA[<p>&gt;&gt;my tendency is to agree with #1. </p>
<p>Ditto.  </p>
<p>And if we want tighter controls on American-grown E. coli vegetables, kiddie cold medicines, cures for cancer, and lead-painted toys, we are going to have to PAY for it.  That means either higher taxes, or taking some of the hundreds of billions of dollars we waste every year and redirecting them to programs that actually benefit Americans.  Those are the only two options.</p>
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