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	<title>Comments on: FDA Scraps Helsinki Rule On Human Subjects</title>
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	<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 20:23:25 +0000</pubDate>
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		<title>By: Former pharma Marketing Exec</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356594</link>
		<dc:creator>Former pharma Marketing Exec</dc:creator>
		<pubDate>Tue, 13 May 2008 12:26:10 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356594</guid>
		<description>Nathan,

I do not mean to purposely mislead you, your comments are well intentioned and would fit well if I could give you more information.  

Lets just say this; a couple of months into the trial he found out he was in the placebo arm of the trial.  You will just have to trust me on this one.

I am interested on the comments about a CRO.  These trials, regardless of who actually manages them, be it a CRO or a drug company still must go through the IRB's and ethical committees of the hospitals - no?  This is what is so disturbing.  What will be interesting to find out is what information does the ethics committee get that allows them to allow the trial to go forward in their institution?

Interesting thread...</description>
		<content:encoded><![CDATA[<p>Nathan,</p>
<p>I do not mean to purposely mislead you, your comments are well intentioned and would fit well if I could give you more information.  </p>
<p>Lets just say this; a couple of months into the trial he found out he was in the placebo arm of the trial.  You will just have to trust me on this one.</p>
<p>I am interested on the comments about a CRO.  These trials, regardless of who actually manages them, be it a CRO or a drug company still must go through the IRB&#8217;s and ethical committees of the hospitals - no?  This is what is so disturbing.  What will be interesting to find out is what information does the ethics committee get that allows them to allow the trial to go forward in their institution?</p>
<p>Interesting thread&#8230;</p>
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		<title>By: Chris</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356579</link>
		<dc:creator>Chris</dc:creator>
		<pubDate>Tue, 13 May 2008 01:30:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356579</guid>
		<description>I'm interested in 2 comments here about CROs and their apparent immunity to the same approval processes followed by pharma or academic or research institutions (Bob and Matt). Ar eyou saying that CROs operate under different rules and approval systems - that's not been my understanding. Is there more you could offer so I get it clear?
tks</description>
		<content:encoded><![CDATA[<p>I&#8217;m interested in 2 comments here about CROs and their apparent immunity to the same approval processes followed by pharma or academic or research institutions (Bob and Matt). Ar eyou saying that CROs operate under different rules and approval systems - that&#8217;s not been my understanding. Is there more you could offer so I get it clear?<br />
tks</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356577</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Tue, 13 May 2008 00:59:36 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356577</guid>
		<description>FPME -- that is heartbreaking -- but I don't think you can infer anything about big pharma clinical trials based on that experience.  That was not a placebo controled trial.  The definition of a placebo is: "a substance having no pharmacological effect but given merely to satisfy a patient who supposes it to be a medicine."  

Your friend seems to have gotten into some diabolical human experimentation that has little or no relevance to the type of cancer research going on in the pharma industry.

(alternate definition of placebo: "a substance having no pharmacological effect but administered as a control in testing experimentally or clinically the efficacy of a biologically active preparation.")</description>
		<content:encoded><![CDATA[<p>FPME &#8212; that is heartbreaking &#8212; but I don&#8217;t think you can infer anything about big pharma clinical trials based on that experience.  That was not a placebo controled trial.  The definition of a placebo is: &#8220;a substance having no pharmacological effect but given merely to satisfy a patient who supposes it to be a medicine.&#8221;  </p>
<p>Your friend seems to have gotten into some diabolical human experimentation that has little or no relevance to the type of cancer research going on in the pharma industry.</p>
<p>(alternate definition of placebo: &#8220;a substance having no pharmacological effect but administered as a control in testing experimentally or clinically the efficacy of a biologically active preparation.&#8221;)</p>
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		<title>By: Bob Freeman</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356572</link>
		<dc:creator>Bob Freeman</dc:creator>
		<pubDate>Mon, 12 May 2008 22:58:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356572</guid>
		<description>Thanks, RTW.  Could you clarify a point?  when a new oncology drug is developed for refractory patients what is the standard of care?  anyone of a number of cocktails vs. the cocktail plus the new drug?  Thanks in advance.

It's been a while since I've looked at oncology trials and would appreciate an update.

I completely agree with the reluctance to use a placeo-controlled trial for a cancer patient, regardless of Stage.</description>
		<content:encoded><![CDATA[<p>Thanks, RTW.  Could you clarify a point?  when a new oncology drug is developed for refractory patients what is the standard of care?  anyone of a number of cocktails vs. the cocktail plus the new drug?  Thanks in advance.</p>
<p>It&#8217;s been a while since I&#8217;ve looked at oncology trials and would appreciate an update.</p>
<p>I completely agree with the reluctance to use a placeo-controlled trial for a cancer patient, regardless of Stage.</p>
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		<title>By: RTW</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356570</link>
		<dc:creator>RTW</dc:creator>
		<pubDate>Mon, 12 May 2008 22:22:32 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356570</guid>
		<description>The FDA has been pushing to do placebo controlled trials in oncology to presumably get a better picture of the efficacy of anticancer drugs. Almost all oncologists would be very squeamish about this, and it would be tantamount to dividing a group of cancer patients into two camps randomly, one of which isn't getting any treatment. Cancer trials have always compared standard treatment to new and usually combination therapy.  Additionally Cancer trials are as much about the new drug as the protocol for administering it.  

Placebo controlled trials are not as big an ethical consideration in CNS, and cardiovascular indications where the threat to ones immediate well being isn't as great as it might be in Viral, Bacterial and Cancer indications.  Millions walk around untreated for high BP, depression, pain etc, but their conditions are not likely to progress that much more into an irreversible state from which even the best treatment won't bring you back as it does when dealing with Viral, Bacterial infections and cancer.</description>
		<content:encoded><![CDATA[<p>The FDA has been pushing to do placebo controlled trials in oncology to presumably get a better picture of the efficacy of anticancer drugs. Almost all oncologists would be very squeamish about this, and it would be tantamount to dividing a group of cancer patients into two camps randomly, one of which isn&#8217;t getting any treatment. Cancer trials have always compared standard treatment to new and usually combination therapy.  Additionally Cancer trials are as much about the new drug as the protocol for administering it.  </p>
<p>Placebo controlled trials are not as big an ethical consideration in CNS, and cardiovascular indications where the threat to ones immediate well being isn&#8217;t as great as it might be in Viral, Bacterial and Cancer indications.  Millions walk around untreated for high BP, depression, pain etc, but their conditions are not likely to progress that much more into an irreversible state from which even the best treatment won&#8217;t bring you back as it does when dealing with Viral, Bacterial infections and cancer.</p>
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		<title>By: Bob Freeman</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356565</link>
		<dc:creator>Bob Freeman</dc:creator>
		<pubDate>Mon, 12 May 2008 21:45:24 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356565</guid>
		<description>The only "placeo" I can think of in a cancer trial is watchful waiting in men over a certain age who have prostate CA.  (I'm not fishing for information, FPME, just thinking out loud.  I am sorry for the loss of your friend)

I recall one breast cancer trial that compared agressive lab work as the control vs. tamoxifen for bc risk reduction. That was not an industry trial--It was the Eastern Oncology Group, I believe.

To Matt, if I never work with a CRO again it will be too soon.</description>
		<content:encoded><![CDATA[<p>The only &#8220;placeo&#8221; I can think of in a cancer trial is watchful waiting in men over a certain age who have prostate CA.  (I&#8217;m not fishing for information, FPME, just thinking out loud.  I am sorry for the loss of your friend)</p>
<p>I recall one breast cancer trial that compared agressive lab work as the control vs. tamoxifen for bc risk reduction. That was not an industry trial&#8211;It was the Eastern Oncology Group, I believe.</p>
<p>To Matt, if I never work with a CRO again it will be too soon.</p>
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		<title>By: M Helm, MD</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356555</link>
		<dc:creator>M Helm, MD</dc:creator>
		<pubDate>Mon, 12 May 2008 20:36:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356555</guid>
		<description>FPME,

I'm very sorry about your friend.  I would be willing to bet that the trial was administered by a Contract Research Organization.  I can not imagine a research institute/ university Institutional Review Board would approve such a trial.

But, CROs are a different ethical problem.</description>
		<content:encoded><![CDATA[<p>FPME,</p>
<p>I&#8217;m very sorry about your friend.  I would be willing to bet that the trial was administered by a Contract Research Organization.  I can not imagine a research institute/ university Institutional Review Board would approve such a trial.</p>
<p>But, CROs are a different ethical problem.</p>
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		<title>By: Former pharma Marketing Exec</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356554</link>
		<dc:creator>Former pharma Marketing Exec</dc:creator>
		<pubDate>Mon, 12 May 2008 20:18:06 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356554</guid>
		<description>Jack2 - Yes I have citations, but no I am not sharing them here - sorry hate to be secretive but there is already a law suit in the works and well, I would rather not be the one who spoils it...

Nathan, the patient knew he was in the placebo because he was actually getting nothing.....No radiation, no chemo - nothing...Bizarre as it all sounds.

Heart Breaking...</description>
		<content:encoded><![CDATA[<p>Jack2 - Yes I have citations, but no I am not sharing them here - sorry hate to be secretive but there is already a law suit in the works and well, I would rather not be the one who spoils it&#8230;</p>
<p>Nathan, the patient knew he was in the placebo because he was actually getting nothing&#8230;..No radiation, no chemo - nothing&#8230;Bizarre as it all sounds.</p>
<p>Heart Breaking&#8230;</p>
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		<title>By: James</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356547</link>
		<dc:creator>James</dc:creator>
		<pubDate>Mon, 12 May 2008 18:06:01 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356547</guid>
		<description>Hate to tell you guys, but the reason the FDA went with this standard instead of the one initially proposed in the draft guidance 4 years ago is...

this is how they've been doing things already.  Nothing new.</description>
		<content:encoded><![CDATA[<p>Hate to tell you guys, but the reason the FDA went with this standard instead of the one initially proposed in the draft guidance 4 years ago is&#8230;</p>
<p>this is how they&#8217;ve been doing things already.  Nothing new.</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/05/fda-scraps-helsinki-rule-on-human-subjects/#comment-356545</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Mon, 12 May 2008 17:43:05 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13553#comment-356545</guid>
		<description>FPME says: "unfortunately I have seen that they have used placebo’s in a cancer trial. A good friend of mine is now dead because he agreed to be in the trial."

How do you know that your friend was on the placebo end of the trial?  I thought that patients generally never found out which arm of the trial that they were in.  Could it simply be that the drug failed?  As I'm sure you know, the efficacy of cancer drugs is notoriously unpredictable.  We've created miracle drugs for rats that fail to do a thing in humans.</description>
		<content:encoded><![CDATA[<p>FPME says: &#8220;unfortunately I have seen that they have used placebo’s in a cancer trial. A good friend of mine is now dead because he agreed to be in the trial.&#8221;</p>
<p>How do you know that your friend was on the placebo end of the trial?  I thought that patients generally never found out which arm of the trial that they were in.  Could it simply be that the drug failed?  As I&#8217;m sure you know, the efficacy of cancer drugs is notoriously unpredictable.  We&#8217;ve created miracle drugs for rats that fail to do a thing in humans.</p>
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