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	<title>Comments on: FDA To Require Suicide Studies In Clinical Trials</title>
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	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 12 Mar 2010 23:08:06 +0000</pubDate>
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		<title>By: Truthman</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-122665</link>
		<dc:creator>Truthman</dc:creator>
		<pubDate>Wed, 30 Jan 2008 17:22:44 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-122665</guid>
		<description>"Brian
Truthman,

You never explain how counseling affects the brain. What physical process goes on during the healing process. Let’s keep it to one paragraph. Oh yes, try to do this without using any of your neurotransmitters " 

Sarcasm.. Always the lowest form of wit Brian... 

Ok, if you would like me to explain how councelling affects the brain I will.. 

Say you have someone who has been through a trauma, and they become depressed from this.. By working through the pain and expressing the emotions and feelings has a positive effect and release for the individual, so when they begin to feel better emotionally, their brain begins to produce more happy hormones and chemicals such as serotonin and dopamine.. Just like any emotion can induce chemical effects in the brain and body.. Anger produces cortisol , love produces dopamine etc etc... To cry also releases a buld of up chemicals ... So to numb a person with an SSRI does not allow this release and natural process to take place.. 

Really i would have thought you clever scientists would have figured all this stuff out by now...</description>
		<content:encoded><![CDATA[<p>&#8220;Brian<br />
Truthman,</p>
<p>You never explain how counseling affects the brain. What physical process goes on during the healing process. Let’s keep it to one paragraph. Oh yes, try to do this without using any of your neurotransmitters &#8221; </p>
<p>Sarcasm.. Always the lowest form of wit Brian&#8230; </p>
<p>Ok, if you would like me to explain how councelling affects the brain I will.. </p>
<p>Say you have someone who has been through a trauma, and they become depressed from this.. By working through the pain and expressing the emotions and feelings has a positive effect and release for the individual, so when they begin to feel better emotionally, their brain begins to produce more happy hormones and chemicals such as serotonin and dopamine.. Just like any emotion can induce chemical effects in the brain and body.. Anger produces cortisol , love produces dopamine etc etc&#8230; To cry also releases a buld of up chemicals &#8230; So to numb a person with an SSRI does not allow this release and natural process to take place.. </p>
<p>Really i would have thought you clever scientists would have figured all this stuff out by now&#8230;</p>
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		<title>By: Brian</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-120648</link>
		<dc:creator>Brian</dc:creator>
		<pubDate>Tue, 29 Jan 2008 19:35:20 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-120648</guid>
		<description>Truthman,

You never explain how counseling affects the brain.  What physical process goes on during the healing process. Let's keep it to one paragraph.  Oh yes, try to do this without using any of your neurotransmitters...</description>
		<content:encoded><![CDATA[<p>Truthman,</p>
<p>You never explain how counseling affects the brain.  What physical process goes on during the healing process. Let&#8217;s keep it to one paragraph.  Oh yes, try to do this without using any of your neurotransmitters&#8230;</p>
]]></content:encoded>
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	<item>
		<title>By: truthman</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-120462</link>
		<dc:creator>truthman</dc:creator>
		<pubDate>Tue, 29 Jan 2008 18:23:17 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-120462</guid>
		<description>Nathan Says ...


At risk of descending this discussion further and further into a name-calling food fight, I think I’ll refrain from addressing those various “issues” that you raise. It’s quite clear that both of us have made our minds up about the issue and come to very different conclusions. Fortunately (in my opinion), the FDA and the millions up millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you.
Best of luck convincing a court of law that your views are correct. I think you’ll need it.

PS. I’ll reiterate yet again: I’m not saying these drugs are perfect and without side effects. I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time. We do the best we can. Unlike what you seem to think, we aren’t just in it for the money. (If I were just in it for the money, believe me I would work elsewhere.)


How convenient that you back out of our discussion Nathan just when the going gets tough .. Difficult to defend pharma when the evidence mounts up isn't it?...

You might have run away from this discussion but i'm just beginning ...


For one , the difference between our opinions is not that we have both reched different conclusions, it is a difference of knowledge and experience of the subject matter (ie ... SSRI's) .. You have no arguement, you just keep coming out with the same pharma propaganda.. 
You come to your conclusion not out of real scientific research, but out of a loyalty to your mommy pharma which provides you with all your monetary security...

You don't have an opinion Nathan, you have a bag of corporate catch phrases which i have heard so many times before... (yawn)..

 "millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you"


Where is the proof in that ridiculous statement Natahan?..

Find me just 100 positive SSRI testimonies from the Web... It will never match the 9,900 negative ones on the paxil petition...

http://www.petitiononline.com/mod_perl/signed.cgi?oky71

or the tens of thousands of negative stories from members of Paxilprogress

http://www.paxilprogress.org/forums/index.php

Or many tens of thousands more from the multitude of online SSRI support groups...

You back away form this discussion because you have no eveidence to support your views...

If SSRI cases were trialed in a court of law the truth would come out, thats why the drug companies pay out and gag!!! You know thats what happens... Don't hide behind pharma tag lines which have no meaning.. It is pathetic.. 


"I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time".. Says Nathan... 

Well, i could say exactly the same thing about the "human condition" 

It isn't that complicated Nathan... 
Either a drug is helpful and beneficial, has efficacy and is safe for patients, or it is not?... 
Either a drug company is honest or it is not?
SSRI's have questionable efficacy, very real dangers and very real side effects ...
Which were not disclosed to patients...

That is fraud..

It is devious ,and it is not only morally wrong..
It is inhumane and sinsister to push drugs on people who do not need them, lie about the science (chemical imbalance theory) .. Suppress negative data( study 329 paroxetine) and then deny until the truth eventually comes out..</description>
		<content:encoded><![CDATA[<p>Nathan Says &#8230;</p>
<p>At risk of descending this discussion further and further into a name-calling food fight, I think I’ll refrain from addressing those various “issues” that you raise. It’s quite clear that both of us have made our minds up about the issue and come to very different conclusions. Fortunately (in my opinion), the FDA and the millions up millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you.<br />
Best of luck convincing a court of law that your views are correct. I think you’ll need it.</p>
<p>PS. I’ll reiterate yet again: I’m not saying these drugs are perfect and without side effects. I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time. We do the best we can. Unlike what you seem to think, we aren’t just in it for the money. (If I were just in it for the money, believe me I would work elsewhere.)</p>
<p>How convenient that you back out of our discussion Nathan just when the going gets tough .. Difficult to defend pharma when the evidence mounts up isn&#8217;t it?&#8230;</p>
<p>You might have run away from this discussion but i&#8217;m just beginning &#8230;</p>
<p>For one , the difference between our opinions is not that we have both reched different conclusions, it is a difference of knowledge and experience of the subject matter (ie &#8230; SSRI&#8217;s) .. You have no arguement, you just keep coming out with the same pharma propaganda..<br />
You come to your conclusion not out of real scientific research, but out of a loyalty to your mommy pharma which provides you with all your monetary security&#8230;</p>
<p>You don&#8217;t have an opinion Nathan, you have a bag of corporate catch phrases which i have heard so many times before&#8230; (yawn)..</p>
<p> &#8220;millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you&#8221;</p>
<p>Where is the proof in that ridiculous statement Natahan?..</p>
<p>Find me just 100 positive SSRI testimonies from the Web&#8230; It will never match the 9,900 negative ones on the paxil petition&#8230;</p>
<p><a href="http://www.petitiononline.com/mod_perl/signed.cgi?oky71" rel="nofollow">http://www.petitiononline.com/mod_perl/signed.cgi?oky71</a></p>
<p>or the tens of thousands of negative stories from members of Paxilprogress</p>
<p><a href="http://www.paxilprogress.org/forums/index.php" rel="nofollow">http://www.paxilprogress.org/forums/index.php</a></p>
<p>Or many tens of thousands more from the multitude of online SSRI support groups&#8230;</p>
<p>You back away form this discussion because you have no eveidence to support your views&#8230;</p>
<p>If SSRI cases were trialed in a court of law the truth would come out, thats why the drug companies pay out and gag!!! You know thats what happens&#8230; Don&#8217;t hide behind pharma tag lines which have no meaning.. It is pathetic.. </p>
<p>&#8220;I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time&#8221;.. Says Nathan&#8230; </p>
<p>Well, i could say exactly the same thing about the &#8220;human condition&#8221; </p>
<p>It isn&#8217;t that complicated Nathan&#8230;<br />
Either a drug is helpful and beneficial, has efficacy and is safe for patients, or it is not?&#8230;<br />
Either a drug company is honest or it is not?<br />
SSRI&#8217;s have questionable efficacy, very real dangers and very real side effects &#8230;<br />
Which were not disclosed to patients&#8230;</p>
<p>That is fraud..</p>
<p>It is devious ,and it is not only morally wrong..<br />
It is inhumane and sinsister to push drugs on people who do not need them, lie about the science (chemical imbalance theory) .. Suppress negative data( study 329 paroxetine) and then deny until the truth eventually comes out..</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118952</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Tue, 29 Jan 2008 03:21:28 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118952</guid>
		<description>Nathan,

Jury awarded the Tobin Family more then 8 Million,.... HMMMM,.. I wouldnt consider that pennies.

You are becoming an easy target by being so "Naive"'</description>
		<content:encoded><![CDATA[<p>Nathan,</p>
<p>Jury awarded the Tobin Family more then 8 Million,&#8230;. HMMMM,.. I wouldnt consider that pennies.</p>
<p>You are becoming an easy target by being so &#8220;Naive&#8221;&#8216;</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118943</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Tue, 29 Jan 2008 03:02:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118943</guid>
		<description>Brian,

"What Law Firms pay your bills",... None,.. I dont accept charity. Thank You for asking.</description>
		<content:encoded><![CDATA[<p>Brian,</p>
<p>&#8220;What Law Firms pay your bills&#8221;,&#8230; None,.. I dont accept charity. Thank You for asking.</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118939</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Tue, 29 Jan 2008 02:55:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118939</guid>
		<description>Nathan,

Actually,.. GSK hasnt given me a "DIME".... Unlike you, and, Brian,.. I cant be bought!!!

As far as Lyme Disease is concerned,.. I am grateful that you are taking the time to educate yourself. My daughter had the best medical team money can buy!! Including Dr. Brian Fallon, Asst Professor of Psychiatry, Columbia Presbyterian, NIH Investigator,.. Lyme Disease Research.

Go Ahead,.. take another shot.</description>
		<content:encoded><![CDATA[<p>Nathan,</p>
<p>Actually,.. GSK hasnt given me a &#8220;DIME&#8221;&#8230;. Unlike you, and, Brian,.. I cant be bought!!!</p>
<p>As far as Lyme Disease is concerned,.. I am grateful that you are taking the time to educate yourself. My daughter had the best medical team money can buy!! Including Dr. Brian Fallon, Asst Professor of Psychiatry, Columbia Presbyterian, NIH Investigator,.. Lyme Disease Research.</p>
<p>Go Ahead,.. take another shot.</p>
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	<item>
		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118841</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Tue, 29 Jan 2008 00:51:42 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118841</guid>
		<description>Lisa,
I'm sure GSK didn't pay him a penny -- as it hasn't paid me a penny either.  I've looked up the stuff about you too.  You've made yourself a rather easy target on this website.  It strikes me as very odd that you are completely confident that the drugs caused this behavior and not the lyme disease...which is (now) well known to cause encephalitis accompanied by various neurological problems when left untreated.  

It sounds to me like you just wanted to find someone to blame.  The evil drug companies make a great target.  

There may well be problems with the drugs.  But its not as clear of a link as you and Truthman like to think.

My question is this:  I’m certain that GSK hasn’t paid me or Brian anything.  But how much has it paid YOU??  You’ve probably been paid a pretty penny for raising all the hell you have in the last few years…</description>
		<content:encoded><![CDATA[<p>Lisa,<br />
I&#8217;m sure GSK didn&#8217;t pay him a penny &#8212; as it hasn&#8217;t paid me a penny either.  I&#8217;ve looked up the stuff about you too.  You&#8217;ve made yourself a rather easy target on this website.  It strikes me as very odd that you are completely confident that the drugs caused this behavior and not the lyme disease&#8230;which is (now) well known to cause encephalitis accompanied by various neurological problems when left untreated.  </p>
<p>It sounds to me like you just wanted to find someone to blame.  The evil drug companies make a great target.  </p>
<p>There may well be problems with the drugs.  But its not as clear of a link as you and Truthman like to think.</p>
<p>My question is this:  I’m certain that GSK hasn’t paid me or Brian anything.  But how much has it paid YOU??  You’ve probably been paid a pretty penny for raising all the hell you have in the last few years…</p>
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		<title>By: Brian</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118818</link>
		<dc:creator>Brian</dc:creator>
		<pubDate>Tue, 29 Jan 2008 00:42:23 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118818</guid>
		<description>Lisa,

What law firm pays your bills?</description>
		<content:encoded><![CDATA[<p>Lisa,</p>
<p>What law firm pays your bills?</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118692</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Mon, 28 Jan 2008 23:18:31 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118692</guid>
		<description>Brian,

You want to site neuropsychopharmacology, Then you are a retart,.. have no better explanation, I will leave my case up to the US Attorney General. I see you have done you homework. My question to you is this: How much money did GSK pay you to Verbally attack ME...</description>
		<content:encoded><![CDATA[<p>Brian,</p>
<p>You want to site neuropsychopharmacology, Then you are a retart,.. have no better explanation, I will leave my case up to the US Attorney General. I see you have done you homework. My question to you is this: How much money did GSK pay you to Verbally attack ME&#8230;</p>
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		<title>By: ol cranky</title>
		<link>http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118642</link>
		<dc:creator>ol cranky</dc:creator>
		<pubDate>Mon, 28 Jan 2008 22:15:06 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2008/01/fda-to-require-suicide-studies-in-trials/#comment-118642</guid>
		<description>Brian:

"Do you expect us to seriously believe that a self righteous person as yourself would allow your daughter to be put on a clinical trial without your consent?"

Since enrollment in the trial was done WITHOUT her knowledge (until after the fact) or consent, I don't think she allowed it.  What she did do was raise high holy Hell when she found out.  The majority of findings on audit of investigational sites are related to consent issues; including, but not limited to improperly obtained/documented consent, &#38; lack of consent.  There are also cases of patients being coerced and/or mislead to obtain consent.  I have personally had to make this finding on monitoring reports during my CRA days and have ordered for cause audits of sites due to these sorts of issues but not every monitor has the sense/guts to document these irregularities (especially if the investigator is a company friend/KOL though some do document and are told by their manager/study sponsor to remove negative findings).</description>
		<content:encoded><![CDATA[<p>Brian:</p>
<p>&#8220;Do you expect us to seriously believe that a self righteous person as yourself would allow your daughter to be put on a clinical trial without your consent?&#8221;</p>
<p>Since enrollment in the trial was done WITHOUT her knowledge (until after the fact) or consent, I don&#8217;t think she allowed it.  What she did do was raise high holy Hell when she found out.  The majority of findings on audit of investigational sites are related to consent issues; including, but not limited to improperly obtained/documented consent, &amp; lack of consent.  There are also cases of patients being coerced and/or mislead to obtain consent.  I have personally had to make this finding on monitoring reports during my CRA days and have ordered for cause audits of sites due to these sorts of issues but not every monitor has the sense/guts to document these irregularities (especially if the investigator is a company friend/KOL though some do document and are told by their manager/study sponsor to remove negative findings).</p>
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