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	<title>Side Effects of Antidepressants, Antipsychotics, Psychostimulants, Hypnotics and More</title>
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		<title>Side Effects of Antidepressants, Antipsychotics, Psychostimulants, Hypnotics and More</title>
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		<title>Involuntary Commitment and how to beat the Baker Act</title>
		<link>http://psychdrugs.wordpress.com/2009/10/27/involuntary-commitment-and-how-to-beat-the-baker-act/</link>
		<comments>http://psychdrugs.wordpress.com/2009/10/27/involuntary-commitment-and-how-to-beat-the-baker-act/#comments</comments>
		<pubDate>Wed, 28 Oct 2009 03:12:02 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Involuntary Commitment]]></category>
		<category><![CDATA[Baker Act]]></category>

		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1158</guid>
		<description><![CDATA[There is alot of controversy about The Baker Act which is the involuntary commitment act in Florida.  It appears that the United States has a statute that adheres to ensure a pesrson is deemed a danger to themselves or to others and needs a court order before involuntary commitment occurs.  However, the State of Florida [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1158&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>There is alot of controversy about The Baker Act which is the involuntary commitment act in Florida.  It appears that the United States has a statute that adheres to ensure a pesrson is deemed a danger to themselves or to others and needs a court order before involuntary commitment occurs.  However, the State of Florida has a statute, The Baker Act, that enables anyone to be involuntarily committed for 72 hours without a court order.  A law enforement official (police offer) or any family member or the like can have a doctor state the person should be Baker Acted.<span id="more-1158"></span></p>
<p>I came acoss this video made by someone who had been involuntarily committed and states she knows how to play the game in order to be discharged.</p>
<p>Check out her detailed video! </p>
<p>Baker Act Abuse and involuntary commitment</p>
<p><a href="http://intentions.wordpress.com/2008/06/13/baker-act-abuse-and-involuntary-commitment/">http://intentions.wordpress.com/2008/06/13/baker-act-abuse-and-involuntary-commitment/</a></p>
<p>UPDATE: If your loved one has been involuntarily commitmented and you wish to help them visit <a href="http://www.cchrflorida.org/">www.cchrflorida.org</a> in the state of Florida visit or check <a href="http://www.cchrint.org">www.cchrint.org</a> worldwide.</p>
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			<media:title type="html">Your Friend</media:title>
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		<title>What&#8217;s Wrong with Psychiatry? A Psychiatrist Explains&#8230;</title>
		<link>http://psychdrugs.wordpress.com/2009/10/26/whats-wrong-with-psychiatry-a-psychiatrist-explains/</link>
		<comments>http://psychdrugs.wordpress.com/2009/10/26/whats-wrong-with-psychiatry-a-psychiatrist-explains/#comments</comments>
		<pubDate>Mon, 26 Oct 2009 17:14:54 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[psychiatry]]></category>
		<category><![CDATA[Psychiatrist]]></category>
		<category><![CDATA[Psychiatrists]]></category>

		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1154</guid>
		<description><![CDATA[If you have ever heard someone speak poorly about psychiatry and never knew why, you should watch this video.  Most people who support psychiatry are individuals who prefer to hear from a professional.  You can hear a psychiatrist, Dr. Niall McLaren, former Head of Department of Psychiatry, Repatriation Hospital in Australia, practicing psychiatry for 22 [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1154&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p style="line-height:14.25pt;"><span style="font-family:Georgia,serif;font-size:10pt;">If you have ever heard someone speak poorly about psychiatry and never knew why, you should watch this video.  Most people who support psychiatry are individuals who prefer to hear from a professional.  You can hear a psychiatrist, Dr. Niall McLaren, former Head of Department of Psychiatry, Repatriation Hospital in Australia, practicing psychiatry for 22 years; tell us exactly what is wrong with psychiatry and psychiatric drugs.  <span id="more-1154"></span></span></p>
<p style="line-height:14.25pt;"><span style="font-family:Georgia,serif;font-size:10pt;">Check out this YouTube video:</span></p>
<p style="line-height:14.25pt;"><span style="font-family:Georgia,serif;font-size:10pt;"><a href="http://www.youtube.com/watch?v=nzdu3WQyIZg">http://www.youtube.com/watch?v=nzdu3WQyIZg</a></span></p>
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			<media:title type="html">Your Friend</media:title>
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		<title>Antidepressants &amp; Psychiatric Drug Side Effects Search Engine</title>
		<link>http://psychdrugs.wordpress.com/2009/08/01/antidepressants-psychiatric-drug-side-effects-search-engine/</link>
		<comments>http://psychdrugs.wordpress.com/2009/08/01/antidepressants-psychiatric-drug-side-effects-search-engine/#comments</comments>
		<pubDate>Sat, 01 Aug 2009 16:19:03 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[ADD]]></category>
		<category><![CDATA[ADHD]]></category>
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		<category><![CDATA[Antidepressants]]></category>
		<category><![CDATA[Antidepressants - Stories]]></category>
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		<category><![CDATA[Antipsychotics - Stories]]></category>
		<category><![CDATA[Anxiety]]></category>
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		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1145</guid>
		<description><![CDATA[Want to know the side effects of these drugs: antidpressants, anti-psychotics, psychostimulants (ADHD drugs and the like), and more?  Why shoud I tell you about the side effects of psychiatric drugs when experts can tell you this in the brand new, first ever, searchable database.  Check it out!  http://www.youtube.com/watch?v=gDdA7WPgeDM or visit
Psychiatric Drug Side Effects Search Engine
  [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1145&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>Want to know the side effects of these drugs: antidpressants, anti-psychotics, psychostimulants (ADHD drugs and the like), and more?  Why shoud I tell you about the side effects of psychiatric drugs when experts can tell you this in the brand new, first ever, searchable database.  Check it out!  <a href="http://www.youtube.com/watch?v=gDdA7WPgeDM">http://www.youtube.com/watch?v=gDdA7WPgeDM</a> or visit<br />
<a href="http://www.cchrint.org/psychdrugdangers/" target="_blank">Psychiatric Drug Side Effects Search Engine</a></p>
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			<media:title type="html">Your Friend</media:title>
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		<title>Supplement to Petition to the FDA to ban the antidepressant drug nefazadone (SERZONE)</title>
		<link>http://psychdrugs.wordpress.com/2009/05/17/supplement-to-petition-to-the-fda-to-ban-the-antidepressant-drug-nefazadone-serzone/</link>
		<comments>http://psychdrugs.wordpress.com/2009/05/17/supplement-to-petition-to-the-fda-to-ban-the-antidepressant-drug-nefazadone-serzone/#comments</comments>
		<pubDate>Sun, 17 May 2009 14:06:26 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Antidepressants]]></category>
		<category><![CDATA[Serzone]]></category>
		<category><![CDATA[Serzone Liver Failure]]></category>
		<category><![CDATA[Serzone Liver Toxicity]]></category>
		<category><![CDATA[Serzone Side Effects]]></category>

		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1132</guid>
		<description><![CDATA[Public Citizen sent a petition to the the FDA in support of banning Serzone, an antidepressant, approved by the FDA in 1994, which has been known to cause liver toxicity and several deaths around the world.  In addition Public Citizen sent a supplement to that petition which you may read online.  They state that Canada, [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1132&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>Public Citizen sent a petition to the the FDA in support of banning Serzone, an antidepressant, approved by the FDA in 1994, which has been known to cause liver toxicity and several deaths around the world.  In addition Public Citizen sent a supplement to that petition which you may read online.  They state that Canada, Europe and Scandanavia had banned the drug in 2003.  The article was written in 2003, but to date, Serzone is still on the market in the U.S.  The FDA only made the makers of Serzone, Bristol Myers Squibb Company, place a warning of life-threatening (liver) failure on the drug. <span id="more-1132"></span></p>
<p>To read the article, Supplement to Petition to the FDA to ban the antidepressant drug nefazadone (SERZONE) (HRG Publication #1681)&#8221; by Public Citizen and find the long list of side effects go to: <a title="Supplement to Public Citizen Petition" href="http://www.citizen.org/publications/release.cfm?ID=7288" target="_blank">http://www.citizen.org/publications/release.cfm?ID=7288</a></p>
<p>The FDA publicaly lists any negative reports of drugs online.  You can see the medical reports for Serzone at: <span style="color:#008000;"><a title="Serzone Errors" href="http://www.fda.gov/cder/drug/MedErrors/serzone.pdf" target="_blank">www.fda.gov/cder/drug/MedErrors/serzone.pdf</a>.  <span style="color:#000000;">Let&#8217;s face it, not many people report the adverse reactions of drugs to the FDA, therefore, keep that in mind when reading this list.  Do report any adverse side effect to the FDA.<br />
</span></span></p>
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			<media:title type="html">Your Friend</media:title>
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		<title>In Memory of Indiana: Effexor Infant Death, Antidepressants and Pregnancy &#8211; Mothers Act</title>
		<link>http://psychdrugs.wordpress.com/2009/03/19/in-memory-of-indiana-effexor-infant-death-antidepressants-and-pregnancy-mothers-act/</link>
		<comments>http://psychdrugs.wordpress.com/2009/03/19/in-memory-of-indiana-effexor-infant-death-antidepressants-and-pregnancy-mothers-act/#comments</comments>
		<pubDate>Fri, 20 Mar 2009 02:09:03 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Effexor]]></category>
		<category><![CDATA[Mother's Act]]></category>
		<category><![CDATA[Pregnancy]]></category>
		<category><![CDATA[pregnancy depression]]></category>

		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1127</guid>
		<description><![CDATA[A message from AbleChild
A Non-profit parents rights organization
Defeat Mother&#8217;s Act by Mother&#8217;s Day!
Please Take Action and Call Your Representative 
Ablechild has been following The Mother&#8217;s Act, a bill that clearly violates informed consent and places mothers and children at risk. This bill would mandate the government to screen all new mothers for subjective mental conditions.   We [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1127&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p class="EC_MsoNormal" style="text-align:left;"><span style="font-family:Arial;"><strong>A message from AbleChild</strong></span></p>
<p class="EC_MsoNormal" style="text-align:left;"><strong><span style="font-family:Arial;">A Non-profit parents rights organization</span></strong></p>
<p class="EC_MsoNormal" style="text-align:center;" align="center"><span style="color:#3c3c3c;font-family:Arial;"><strong>Defeat Mother&#8217;s Act by Mother&#8217;s Day!</strong></span></p>
<p class="EC_MsoNormal" style="text-align:center;" align="center"><span style="color:#3c3c3c;font-family:Arial;"><strong>Please Take Action and Call Your Representative</strong></span> </p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Ablechild has been following <em>The Mother&#8217;s Act</em></span><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">, a bill that clearly violates informed consent and places mothers and children at risk. This bill would mandate the government to screen all new mothers for subjective mental conditions.<span>  </span><span> </span>We would like to update you on this act and request that you take the time to familiarize yourself with it.<span>   <span id="more-1127"></span></span></span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Ablechild strongly opposes <em>The Mother&#8217;s Act</em></span><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">.<span>  </span>This special interest bill entitled <em>The Mother&#8217;s Act</em></span><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;"> should fool NO MOTHER into thinking it is harmless!<span>   </span>It is truly lethal.<span>  </span>Take a look:</span></p>
<p class="EC_MsoNormal"><a class="moz-txt-link-freetext" title="http:///" href="http:///"><span style="font-size:small;font-family:Arial;"><a class="moz-txt-link-freetext" title="http:///" href="http:///"><font face="Arial" size="3"><a href="http://www.youtube.com:80/watch">http://</a></font></a></span></a><a href="http://www.youtube.com:80/watch"></a><span style="font-size:small;font-family:Arial;">www.youtube.com:80/watch</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Every call, fax and e-mail to your representative counts.<span>  </span>It is simple.<span>  </span>Tell them you strongly oppose the Mothers Act by going <a title="http://salsa.democracyinaction.org/dia/track.jsp?v=2&amp;c=jkv/L+siUI75wwQee/LdQdCm3hLBecyb" href="http://salsa.democracyinaction.org/dia/track.jsp?v=2&amp;c=jkv/L%2BsiUI75wwQee/LdQdCm3hLBecyb">here</a>.</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">For more information and understanding of this act and the consequences that could result if this form of legislation gets passed into law please view <a title="http://salsa.democracyinaction.org/dia/track.jsp?v=2&amp;c=UNWXwErgBGn5s6citW40QEqDTBFwulIY" href="http://salsa.democracyinaction.org/dia/track.jsp?v=2&amp;c=UNWXwErgBGn5s6citW40QEqDTBFwulIY">http://www.uniteforlife.org/</a></span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Once again, thank you for making a difference!</span></p>
<p><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Patricia Weathers</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Sheila Matthews</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Co-Founders</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">Ablechild</span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;"><a title="http://www.ablechild.org" href="http://www.ablechild.org/">http://www.ablechild.org</a></span></p>
<p class="EC_MsoNormal"><span style="font-size:11pt;color:#3c3c3c;font-family:Arial;">203-594-1700</span></p>
<p align="center">Copyright 2001- 2007 Ablechild (Parents for Label and Drug Free Education). All rights reserved.<br />
Ablechild is a nonprofit, tax-exempt, Section 501(c) (3) charitable organization,<br />
and donations are deductible under the provisions of the IRS Tax Code.<br />
Ablechild and the Ablechild logo is a Trademark of Ablechild, Inc.
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<p align="center">This article is used with its permission.</p>
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		<title>Seroquel: A Silenced Drug Study Creates An Uproar</title>
		<link>http://psychdrugs.wordpress.com/2009/03/18/seroquel-a-silenced-drug-study-creates-an-uproar/</link>
		<comments>http://psychdrugs.wordpress.com/2009/03/18/seroquel-a-silenced-drug-study-creates-an-uproar/#comments</comments>
		<pubDate>Thu, 19 Mar 2009 03:18:46 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Seroquel]]></category>
		<category><![CDATA[Seroquel Children]]></category>
		<category><![CDATA[Seroquel Side Effects]]></category>

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		<description><![CDATA[Seroquel is not FDA approved for children.  It has a black box suicide warning for kids and the elderly.  See FDA drug label here:  http://tmap.wordpress.com/the-drugs/ 
 
Quote from story: &#8220;Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry, said an editorial this month in the American Journal of Psychiatry, the flagship journal of the American Psychiatric [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1123&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">Seroquel is not FDA approved for children.  It has a black box suicide warning for kids and the elderly.  See FDA drug label here:  </span><span style="font-size:10pt;"><a title="http://tmap.wordpress.com/the-drugs/" href="http://tmap.wordpress.com/the-drugs/"><span style="font-family:Arial;">http://tmap.wordpress.com/the-drugs/</span></a></span><span style="font-size:10pt;font-family:Arial;"> </span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;"><span style="font-family:Times New Roman;"> </span></span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">Quote from story: &#8220;<span style="font-family:Arial;">Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry, said an editorial this month in the American Journal of Psychiatry, the flagship journal of the American Psychiatric Association.</span>&#8220;<span id="more-1123"></span></span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;"><span style="font-family:Times New Roman;"> </span></span><span style="font-size:10pt;"><span style="font-family:Times New Roman;"> </span></span></p>
<p class="MsoNormal" style="margin:0;"><em><strong><span style="font-size:10pt;font-family:Arial;">Letters to the editor:</span></strong></em><span style="font-size:10pt;font-family:Arial;"> </span><span style="font-size:10pt;"><a title="mailto:letters@washpost.com" href="mailto:letters@washpost.com"><em><strong><span style="font-family:Arial;">letters@washpost.com</span></strong></em></a></span><span style="font-size:10pt;font-family:Arial;"> </span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Tahoma;"><br />
</span><strong><span style="font-size:10pt;font-family:Arial;">Washington</span></strong><strong><span style="font-size:10pt;font-family:Arial;"> Post </span></strong>
</p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;"><span style="font-family:Times New Roman;"> </span></span></p>
<p class="MsoNormal" style="margin:0;"><strong><span style="font-size:10pt;font-family:Arial;">A Silenced Drug Study Creates An Uproar</span></strong></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">By Shankar Vedantam<br />
March 18, 2009<br />
The study would come to be called &#8220;cursed,&#8221; but it started out just as Study 15.</span></p>
<p>It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15&#8217;s results suggested otherwise.</p>
<p>As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don&#8217;t like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found &#8212; and raised serious concerns about an entire new class of expensive drugs.</p>
<p>Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International &#8212; including nearly $12 billion in the past three years. 
</p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;"><br />
The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of Study 15 were provided only to the Food and Drug Administration &#8212; and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain.</span></p>
<p>AstraZeneca spokesman Tony Jewell defended the Seroquel research and said the company had disclosed the drug&#8217;s risks. Since 1997, the drug&#8217;s labeling has noted that weight gain and diabetes were seen in study patients, although the company says the data are not definitive. The label states that the metabolic disorders may be related to patients&#8217; underlying diseases.</p>
<p>The FDA, Jewell added, had access to Study 15 when it declared Seroquel safe and effective. The trial, which compared patients taking Seroquel and an older drug called Haldol, &#8220;did not identify any safety concerns,&#8221; AstraZeneca said in an e-mail. Jewell added, &#8220;A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret.&#8221;</p>
<p>The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.  
</p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;"><br />
</span><span style="font-size:10pt;font-family:Arial;">Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry, said an editorial this month in the American Journal of Psychiatry, the flagship journal of the American Psychiatric Association.</span></p>
<p>&#8220;The public and private resources available for the care of our patients depend upon the public perception of the integrity of our profession as a whole,&#8221; wrote Robert Freedman, the editor in chief, and others. &#8220;The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation.&#8221;</p>
<p>Details of Study 15 have emerged through lawsuits now playing out in courtrooms nationwide alleging that Seroquel caused weight gain, hyperglycemia and diabetes in thousands of patients. The Houston-based law firm Blizzard, McCarthy &amp; Nabers, one of several that have filed about 9,210 lawsuits over Seroquel, publicized the documents, which show that the patients taking Seroquel in Study 15 gained an average of 11 pounds in a year &#8212; alarming company scientists and marketing executives. A Washington Post analysis found that about four out of five patients quit taking the drug in less than a year, raising pointed doubts about its effectiveness.</p>
<p>An FDA report in 1997, moreover, said Study 15 did offer useful safety data. Mentioning few details, the FDA said the study showed that patients taking higher doses of the drug gained more weight.</p>
<p>In approving Seroquel, the agency said 23 percent of patients taking the drug in all studies available up to that point experienced significant weight increases, compared with 6 percent of control-group patients taking sugar pills. In 2006, FDA warned AstraZeneca against minimizing metabolic problems in its sales pitches.</p>
<p>In the years since, taxpayer-funded research has found that newer antipsychotic drugs such as Seroquel, which are 10 times as expensive, offer little advantage over older ones. The older drugs cause involuntary muscle movements known as tardive dyskinesia, and the newer ones have been linked to metabolic problems.</p>
<p>Far from dismissing Study 15, internal documents show that company officials were worried because 45 percent of the Seroquel patients had experienced what AstraZeneca physician Lisa Arvanitis termed &#8220;clinically significant&#8221; weight gain.</p>
<p>In an e-mail dated Aug. 13, 1997, Arvanitis reported that across all patient groups and treatment regimens, regardless of how numbers were crunched, patients taking Seroquel gained weight: &#8220;I&#8217;m not sure there is yet any type of competitive opportunity no matter how weak.&#8221;</p>
<p>In a separate note, company strategist Richard Lawrence praised AstraZeneca&#8217;s efforts to put a &#8220;positive spin&#8221; on &#8220;this cursed study&#8221; and said of Arvanitis: &#8220;Lisa has done a great &#8217;smoke and mirrors&#8217; job!&#8221;</p>
<p>Two years after those exchanges, in 1999, the documents show that the company presented different data at an American Psychiatric Association conference and at a European meeting. The conclusion: Seroquel helped psychotic patients lose weight.</p>
<p>The claim was based on a company-sponsored study by a Chicago psychiatrist, who reviewed the records of 65 patients who switched their medication to Seroquel. It found that patients lost an average of nine pounds over 10 months.</p>
<p>Within the company, meanwhile, officials explicitly discussed misleading physicians. The chief of a team charged with getting articles published, John Tumas, defended &#8220;cherry-picking&#8221; data.</p>
<p>&#8220;That does not mean we should continue to advocate&#8221; selective use of data, he wrote on Dec. 6, 1999, referring to a trial, called COSTAR, that also produced unfavorable results. But he added, &#8220;Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR.&#8221;</p>
<p>Although the company pushed the favorable study to physicians, the documents show that AstraZeneca held the psychiatrist in light regard and had concerns that he had modified study protocols and failed to get informed consent from patients. Company officials wrote that they did not trust the doctor with anything more complicated than chart reviews &#8212; the basis of the 1999 study showing Seroquel helped patients lose weight.</p>
<p>For practicing psychiatrists, Study 15 could have said a lot not just about safety but also effectiveness. Like all antipsychotics, Seroquel does not cure the diseases it has been approved to treat &#8212; schizophrenia and bipolar disorder &#8212; but controls symptoms such as agitation, hallucinations and delusions. When government scientists later decided to test the effectiveness of the class of drugs to which Seroquel belongs, they focused on a simple measure &#8212; how long patients stayed on the drugs. Discontinuation rates, they decided, were the best measure of effectiveness.</p>
<p>Study 15 had three groups of about 90 patients each taking different Seroquel doses, according to an FDA document. Approximately 31 patients were on Haldol. The study showed that Seroquel failed to outperform Haldol in preventing psychotic relapses.</p>
<p>In disputing Study 15&#8217;s weight-gain data, company officials said they were not reliable because only about 50 patients completed the year-long trial. But even without precise numbers, this suggests a high discontinuation rate among patients taking Seroquel. Even if every single patient taking Haldol dropped out, it appears that at a minimum about 220 patients &#8212; or about 82 percent of patients on Seroquel &#8212; dropped out.</p>
<p>Eight years after Study 15 was buried, an expensive taxpayer-funded study pitted Seroquel and other new drugs against another older antipsychotic drug. The study found that most patients getting the new and supposedly safer drugs stopped taking them because of intolerable side effects. The study also found that the new drugs had few advantages. As with older drugs, the new medications had very high discontinuation rates. The results caused consternation among doctors, who had been kept in the dark about trials such as Study 15.</p>
<p>The federal study also reported the number of Seroquel patients who discontinued the drug within 18 months: 82 percent.</p>
<p>Jeffrey Lieberman, a Columbia University psychiatrist who led the federal study, said doctors missed clues in evaluating antipsychotics such as Seroquel. If a doctor had known about Study 15, he added, &#8220;it would raise your eyebrows.&#8221;  
</p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;"> </span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">Link to story: <a title="http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html?hpid=moreheadlines" href="http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html?hpid=moreheadlines">http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html?hpid=moreheadlines</a></span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;"> </span></p>
<div class="MsoNormal" style="text-align:center;margin:0;"><span style="font-size:10pt;font-family:Arial;"></p>
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			<media:title type="html">Your Friend</media:title>
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		<title>APA Admits there is no test for &#8220;chemical imbalance&#8221;</title>
		<link>http://psychdrugs.wordpress.com/2009/03/13/apa-admits-there-is-no-test-for-chemical-imbalance/</link>
		<comments>http://psychdrugs.wordpress.com/2009/03/13/apa-admits-there-is-no-test-for-chemical-imbalance/#comments</comments>
		<pubDate>Sat, 14 Mar 2009 02:04:01 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Chemical Imbalances]]></category>
		<category><![CDATA[American Psychiatric Association]]></category>
		<category><![CDATA[APA]]></category>
		<category><![CDATA[Brain Chemical Imbalance]]></category>
		<category><![CDATA[Chemical Imbalance]]></category>
		<category><![CDATA[Chemical Imbalance in Children]]></category>

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		<description><![CDATA[In an explosive admission, American Psychiatric Association President Steven Sharfstein did a 180-degree turnaround from his TODAY show interview (June 27) and admitted that there is no way to test for a “chemical imbalance” as the cause for mental disorders. PEOPLE magazine (July 11), quoted Dr. Sharfstein conceding, “We do not have a clean-cut lab [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1117&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><div>In an explosive admission, American Psychiatric Association President Steven Sharfstein did a 180-degree turnaround from his TODAY show interview (June 27) and admitted that there is no way to test for a “chemical imbalance” as the cause for mental disorders. PEOPLE magazine (July 11), quoted Dr. Sharfstein conceding, “We do not have a clean-cut lab test.”<span id="more-1117"></span></div>
<p>Dr. Sharfstein is not alone. Elliot Valenstein, Ph.D. says, “[T]here are no tests available for assessing the chemical status of a living person’s brain.” The late Dr. Loren Mosher stated, “…there are no external validating criteria for psychiatric diagnoses.”</p>
<p>In 2004, psychiatrist M. Douglas Mar debunked the theory that brain scans can help diagnose mental diseases stating, “There is no scientific basis for these claims [of using brain scans for psychiatric diagnosis].”</p>
<p>Harvard University professor, Joseph Glenmullen, author of “Prozac Backlash,” said the questionnaires of symptoms used to “diagnose” depression “may look scientific,” but “are utterly subjective measures.”</p>
<p>“But unfortunately, the tragedy in this misinformation campaign has been the children who have been pegged with these invented illnesses and given life-destroying drugs,” said Marla Filidei, VP of CCHR International. “We’ve seen hundreds of cases where children’s lives have been destroyed as a result of these labels.”</p>
<p>Ten-year-old Shaina Dunkle collapsed and died from toxic levels of the psychiatric drug she was prescribed. “Shaina looked into my eyes as her life ended and I could do nothing to save her. It’s been two years and I relive those last few minutes every day. Believe me, it is a nightmare no parent should ever have to live with, said Mrs. Vicki Dunkle.</p>
<p>At age 7, Matthew Smith was diagnosed with ADHD. His parents were told he needed to take a stimulant to help him focus and that non-compliance could bring criminal charges for neglecting their son’s educational and emotional needs. The parents acceded to the pressure and put Matthew on a psychiatric drug and on March 21, 2000, while skateboarding, Matthew suffered a heart attack and died from the effects of the drug.</p>
<p>By their own admission, psychiatrists cannot cure. Norman Sartorius, President of the World Psychiatric Association from 1996-1999 concluded that “the time when psychiatrists considered that they could cure the mentally ill is gone&#8221;</p>
<dt></dt>
<dt>Contact Information:</dt>
<dd class="contactName">Ben Williams </dd>
<dd>Public Relations </dd>
<dd>CCHR </dd>
<dd>800-869-2247 </dd>
<dd><a href="mailto:humanrights@cchr.org" target="_blank">humanrights@cchr.org</a></dd>
<p>&#8220;APA Admits there is no test for &#8220;chemincal imbalance&#8221;.  Saturday, July 02, 2005. <a class="alignleft" title="APA Admits there is no test for &quot;chemical imbalance&quot;" href="http://www.webwire.com/ViewPressRel.asp?aId=3180" target="_blank">WEBWIRE</a>.  March 13, 2009.</p>
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		<title>Written Testimony Needed &#8211; Florida Child Antipsychotic Drugging</title>
		<link>http://psychdrugs.wordpress.com/2009/03/01/written-testimony-needed-florida-child-antipsychotic-drugging/</link>
		<comments>http://psychdrugs.wordpress.com/2009/03/01/written-testimony-needed-florida-child-antipsychotic-drugging/#comments</comments>
		<pubDate>Sun, 01 Mar 2009 17:25:46 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Antipsychotics]]></category>
		<category><![CDATA[Children]]></category>

		<guid isPermaLink="false">http://psychdrugs.wordpress.com/?p=1114</guid>
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The Florida Agency for Health Care Administration is inviting the public to provide written testimony (until December 24) concerning the Medicaid coverage of atypical antipsychotics on children.    This is the official notice: http://ahca.myflorida.com/docs/AdHocWebCancellationMessagev2.pdf

 
Atypical antipsychotics are the newest, most expensive high powered antipsychotic drugs - heavily marketed to state Medicaid programs. (Your tax dollars) 
&#8220;Evidence is mounting that they can cause rapid weight [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1114&subd=psychdrugs&ref=&feed=1" />]]></description>
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<div><span style="font-family:Arial;">The Florida Agency for Health Care Administration is inviting the public to provide written testimony (until December 24) concerning the Medicaid </span><span style="font-family:Arial;">coverage of atypical antipsychotics <span class="125570021-19122008">on </span>children. <span class="921052219-19122008">   <em>This is the official notice: </em><a title="http://ahca.myflorida.com/docs/AdHocWebCancellationMessagev2.pdf" href="http://ahca.myflorida.com/docs/AdHocWebCancellationMessagev2.pdf"><span style="color:#0000ff;"><em>http://ahca.myflorida.com/docs/AdHocWebCancellationMessagev2.pdf</em></span></a></span></span></div>
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<div><span style="font-family:Arial;">Atypical antipsychotics are the newest, most expensive<span class="921052219-19122008"> </span><span class="921052219-19122008">high powered </span>antipsychotic drugs<span class="921052219-19122008"> - heavily marketed to state Medic<span class="687004021-19122008">aid </span>programs. (Your tax dollars) </span></span></div>
<div><span style="font-family:Arial;"><span class="921052219-19122008"><em>&#8220;Evidence is mounting that they can cause rapid weight gain, diabetes, even death&#8221;.</em></span><span class="921052219-19122008"> St. Petersburg Times, July 29, 2007<span id="more-1114"></span>  <span class="125570021-19122008"> </span></span></span></div>
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<div><span class="921052219-19122008"><span class="125570021-19122008"><span style="font-family:Arial;">Florida allows these antipsychotic drugs on very young children but other states such as California prohibit their use on such young children<span class="687004021-19122008">  (5 and under)</span>. </span></span></span></div>
<div><span style="font-family:Arial;"><span class="921052219-19122008"><em></em></span></span> </div>
<div><span style="color:#0000ff;"><span class="921052219-19122008"></p>
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<div><span class="140131502-25062008"><span class="031355211-25062008"><span class="343500016-19122008"><span class="796130316-19122008"><span class="921052219-19122008"><span style="color:#000000;font-family:Arial;">Despite the fact that recent major government studies have determined that these atypical antipsychotics are no more effective than the older antipsychotics which </span></span></span></span></span></span><span class="140131502-25062008"><span class="031355211-25062008"><span class="343500016-19122008"><span class="796130316-19122008"><span class="921052219-19122008"><span style="font-family:Arial;"><span style="color:#000000;">are much cheaper (and also have horrific side effects) <span class="125570021-19122008"> the new atypical antipsychotics are being used by </span>Florida Medicaid <span class="125570021-19122008"> costing tax payers millions of dollars. </span></span></span></span></span></span></span></span></div>
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<div><span class="vitstoryheadline"><span class="921052219-19122008"><span style="font-family:Arial;">The Florida psychiatrist who has a hand in all this is Rajiv Tandon.  He is known as the Chief of Psychiatry &#8211; State of Florida and is over the Florida Department of Children<span class="125570021-19122008"> </span></span></span></span><span class="vitstoryheadline"><span class="921052219-19122008"><span style="font-family:Arial;">and Families.  <span class="656585321-19122008"> He has received funding form all the </span>atypical antipsychotic drug makers.</span></span></span></div>
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<div><span class="vitstoryheadline"><span class="921052219-19122008"><span style="font-family:Arial;">For full article see:</p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">St. Petersburg</span><span style="font-size:10pt;font-family:Arial;"> Times, “Drug Research: to Test or to Tout?” July 29, 2007</span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;"> </span></p>
<p class="MsoNormal" style="margin:0;"><span style="font-size:10pt;font-family:Arial;">For additional information on atypical antipsychotics: <a title="http://tampabay.com/news/health/article454391.ece" href="http://tampabay.com/news/health/article454391.ece">http://tampabay.com/news/health/article454391.ece</a> </span></p>
<p class="MsoNormal" style="margin:0;"> </p>
<p></span></span></span></div>
<div></div>
<div><span class="687360317-25112008"><strong><em><span style="font-size:medium;font-family:Arial;">Testimony should be sent here: </span></em></strong><a title="mailto:AHCACommunications@ahca.myflorida.com" href="mailto:AHCACommunications@ahca.myflorida.com"><span style="font-size:medium;font-family:Arial;"><strong><em>AHCACommunications@ahca.myflorida.com</em></strong></span></a></span> </div>
</div>
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		<title>Bipolar Children, Antipsychotics, and Dr. Joseph Biederman</title>
		<link>http://psychdrugs.wordpress.com/2009/03/01/bipolar-children-antipsychotics-and-dr-joseph-biederman/</link>
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		<pubDate>Sun, 01 Mar 2009 17:07:39 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Antipsychotics]]></category>
		<category><![CDATA[BiPolar]]></category>
		<category><![CDATA[Children]]></category>
		<category><![CDATA[Bipoar Disorder]]></category>

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&#8220;Papers reveal push on drug firm funds Prominent doctor tied to efforts&#8221;
 
Newly disclosed court documents portray Dr. Joseph Biederman, a leading Harvard child psychiatrist, as courting drug company money by promising that his work at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder.
 





Biederman is one of [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1112&subd=psychdrugs&ref=&feed=1" />]]></description>
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<div id="toolsYahooB" class="utility"><span style="font-weight:normal;font-size:10pt;font-family:Arial;">&#8220;Papers reveal push on drug firm funds Prominent doctor tied to efforts&#8221;</span></div>
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<div class="utility"><span style="font-family:Arial;">Newly disclosed court documents portray Dr. Joseph Biederman, a leading Harvard child psychiatrist, as courting drug company money by promising that his work at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder.<span id="more-1112"></span></span></div>
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<div class="relatedBox" style="padding-bottom:4px;"><span style="font-family:Arial;">Biederman is one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry. He could not be reached for comment yesterday, but Massachusetts General Hospital said it would thoroughly investigate the allegations against him.</span></div>
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<p><span style="font-family:Arial;">The psychiatrist is the country&#8217;s most prominent advocate of diagnosing bipolar disorder in children, even those under age 6, and using antipsychotic drugs to treat many of them, even when federal regulators have not approved the drugs for that use. Congressional investigators led by Senator Charles E. Grassley, an Iowa Republican, accused<strong> </strong>Biederman this summer of failing to disclose more than $1 million in payments from drug companies. Harvard Medical School is investigating those reporting discrepancies.</span></p>
<p><span style="font-family:Arial;">He is now also emerging as a key witness in a huge, multistate lawsuit brought on behalf of more than 2,000 patients, including children, who claim to have been injured by psychiatric drugs known as atypical antipsychotics, including the Johnson &amp; Johnson drug Risperdal, also known as risperidone.</span></p>
<p><span style="font-family:Arial;">Biederman is not a defendant in the case, but the plaintiffs&#8217; lawyers submitted more than two dozen documents aiming to present him as an exam ple of how drug companies and researchers conspired to boost &#8220;off-label&#8221; prescriptions that go beyond federally approved uses of a drug.</span></p>
<p><span style="font-family:Arial;">The plaintiffs&#8217; lawyers sought to compel Biederman to let them interview him &#8211; a legal fight they won. He is expected to be interviewed under oath by January.</span></p>
<p><span style="font-family:Arial;">Biederman issued a statement earlier this year saying he had complied with conflict of interest rules at Mass. General and Harvard.</span></p>
<p><span style="font-family:Arial;">It is legal for doctors to prescribe drugs for off-label purposes, but not for drug companies to actively market such uses. To get around that restriction, drug marketers recruit and pay respected &#8220;opinion leaders&#8221; like Biederman to discuss their off-label prescribing experiences with colleagues at company-sponsored &#8220;educational&#8221; talks or meetings.</span></p>
<p><span style="font-family:Arial;">In one internal 2002 e-mail that the plaintiffs&#8217; lawyers submitted, executives of Janssen Pharmaceuticals &#8211; the Johnson &amp; Johnson subsidiary that markets Risperdal <strong>- </strong>discuss Biederman&#8217;s repeated proposals for the company to help fund<strong> </strong>a center on pediatric bipolar disorder at Massachusetts General. &#8220;The rationale of this center is to generate and disseminate data supporting the use of risperidone in this patient population,&#8221; it says.</span></p>
<p><span style="font-family:Arial;">It wasn&#8217;t until five years later, in 2007, that the Food and Drug Administration approved Risperdal for children with bipolar disorder.</span></p>
<p><span style="font-family:Arial;">Another document, the 2002 annual report of the center that was ultimately created and directed by Biederman, states that one of the center&#8217;s &#8220;essential features&#8221; is its ability to conduct research that &#8220;will move forward the commercial goals of J&amp;J&#8221; &#8211; Johnson &amp; Johnson. An e-mail from November of that year mentions at least $700,000 in Johnson &amp; Johnson payments to the center.</span></p>
<p><span style="font-family:Arial;">Massachusetts General Hospital issued a statement yesterday saying that the center, the MGH-Johnson &amp; Johnson Center for the Study of Pediatric Psychopathology, existed from 2002 to 2006 and gave many researchers &#8220;the infrastructure necessary to complete projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner.&#8221;</span></p>
<p><span style="font-family:Arial;">The hospital controlled the center&#8217;s programs, it said, and, &#8220;The grant agreements stated that the center was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson &amp; Johnson and its affiliates.&#8221;</span></p>
<p><span style="font-family:Arial;">The allegations in the Risperdal case &#8220;have raised significant questions and concerns about the implementation of those agreements,&#8221; the statement said. &#8220;The MGH takes these allegations very seriously and intends to investigate these issues thoroughly.&#8221;</span></p>
<p><span style="font-family:Arial;">Attempts to reach Biederman at his office were unsuccessful.</span></p>
<p><span style="font-family:Arial;">Some of the legal documents reflect the ticklish dealings that drug company employees had with Biederman.</span></p>
<p><span style="font-family:Arial;">In one 1999 e-mail, a Janssen employee seeking to make sure Biederman receives $3,000 that the company owes him writes frantically to his superiors: &#8220;Dr. Biederman is not someone to jerk around. He is a very powerful national figure in child psych and has a very short fuse.&#8221;</span></p>
<p><span style="font-family:Arial;">Another document in the court case suggests that Janssen employees ghost-wrote a summary of a study, to be presented at a 2002 meeting of child psychiatrists, on which Biederman was to be listed as presenting author. They appeared to seek his help in making the results appear more positive for Risperdal. In a reply, he agreed to be named as author but it was not clear whether he provided the requested help.</span></p>
<p><span><span style="font-size:small;"><span style="font-family:Times New Roman;"><span><span style="font-size:10pt;font-family:Arial;">Carey Goldberg,<strong> </strong><strong><span style="font-weight:normal;font-family:Arial;">Boston Globe, &#8220;Papers reveal push on drug firm funds Prominent doctor tied to efforts&#8221; </span></strong>November 25, 2008<strong>  </strong></span></span></span></span></span></div>
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		<title>Seroquel Maker Wants to Seal Info from You, for You</title>
		<link>http://psychdrugs.wordpress.com/2009/03/01/seroquel-maker-wants-to-seal-info-from-you-for-you/</link>
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		<pubDate>Sun, 01 Mar 2009 15:33:34 +0000</pubDate>
		<dc:creator>Your Friend</dc:creator>
				<category><![CDATA[Seroquel]]></category>

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		<description><![CDATA[AstraZeneca, maker of the blockbuster anti­psychotic Seroquel, is battling to keep information about the drug out of the public&#8217;s view &#8230; for the public&#8217;s own good.
Later this month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm &#8220;a vulnerable patient [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=psychdrugs.wordpress.com&blog=4101297&post=1108&subd=psychdrugs&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>AstraZeneca, maker of the blockbuster anti­psychotic Seroquel, is battling to keep information about the drug out of the public&#8217;s view &#8230; for the public&#8217;s own good.</p>
<p>Later this month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm &#8220;a vulnerable patient population.&#8221;<span id="more-1108"></span></p>
<p>&#8220;This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,&#8221; lawyers for the drugmaker said in a recent filing in federal court.</p>
<p>Seroquel is approved only for schizophrenia and bipolar disorder, but its use for everything from depression to insomnia to ADHD in kids is so widespread that the drug has been prescribed for more than 22 million patients. Its $4.5 billion in sales last year put it among the top-selling drugs in the world.</p>
<p>In light of Seroquel&#8217;s popularity, the argument that hiding information protects patients has public health advocates nearly swinging from the rafters.</p>
<p>&#8220;They don&#8217;t want anybody to know about the side effects of their drug, and they&#8217;re keeping secret the results of studies from patients, their doctors and the FDA,&#8221; said Dr. David Egilman, clinical associate professor at Brown University&#8217;s Department of Community Health. </p>
<p>&#8220;Saying they&#8217;re protecting the patient is a self-serving, fraudulent argument.&#8221;</p>
<p>Though Egilman is merely an observer of the Seroquel proceedings, he knows the power of sealed documents in drug liability cases. He played a key role when similar lawsuits were lodged against another mega-selling antipsychotic, Eli Lilly&#8217;s drug Zyprexa. As in the Seroquel cases, thousands upon thousands of patients claimed Zyprexa caused weight gain and diabetes.</p>
<p>Hired as an expert witness for the plaintiffs in Zyprexa cases, Egilman was given access to reams of internal Lilly documents that had been sealed by the court. The documents showed that the drugmaker had ignored evidence of diabetes among patients while pushing Zyprexa&#8217;s off-label use for anxiety and dementia.</p>
<p>Egilman defied the judge&#8217;s orders and helped leak thousands of damaging Lilly documents to the New York Times. Egilman ended up paying a $100,000 fine to Lilly for releasing the sealed documents.</p>
<p>The leaked documents, meanwhile, helped the U.S. Department of Justice build a criminal case against Lilly. The company pleaded guilty to marketing Zyprexa illegally and last month paid a record $1.4 billion fine. Though a landmark amount, Lilly&#8217;s fine amounts to about 3.5 percent of the $39 billion in revenues Zyprexa has posted since the FDA approved it 1996.</p>
<p>Seroquel&#8217;s parent, Astra­Zeneca, has a similarly valuable franchise to protect. The anti­psychotic accounted for 14 percent of AstraZeneca&#8217;s sales of $31.6 billion last year. Avoiding negative publicity &#8211; one of the reasons the company wants to seal documents in the Orlando cases &#8211; is critical as it seeks to maximize sales before Seroquel loses patent protection in about three years.</p>
<p>The skirmish over document disclosure in Orlando is part of a hornet&#8217;s nest of litigation against AstraZeneca, a British company with U.S. headquarters in Wilmington, Del. More than 15,000 patients have filed over 9,000 personal injury lawsuits. About 40 percent of these claims have been consolidated for pretrial motions in U.S. District Court for the Middle District of Florida.</p>
<p>Plaintiffs say the company knew as early as 2000 that Seroquel caused diabetes, weight gain and other health problems, but failed to adequately warn patients and doctors.</p>
<p>Dr. William C. Wirshing, a California psychiatrist, has lectured doctors on AstraZeneca&#8217;s behalf and has prescribed Seroquel to as many as 5,000 patients. Though he has been a paid consultant for the drugmaker, in a pretrial deposition he left no question about the links he sees between the drug, weight gain and diabetes.</p>
<p>&#8220;You literally just got to watch them get bigger &#8230; it was riveting to me,&#8221; said Wirshing who estimated that several hundred of his patients developed diabetes.</p>
<p>AstraZeneca denies the allegations and has spent more than $500 million defending itself against Seroquel claims. Key to the company&#8217;s strategy has been its insistence that millions of pages of documents produced in discovery should remain under seal, out of the public eye.</p>
<p>To Egilman, such blanket agreements in drug liability cases are outrageous. &#8220;Confidentiality agreements that prohibit disclosure of important information that may impact public health to state and federal authorities should be illegal,&#8221; he said. &#8220;The court should at least send all discovery in drug cases to the FDA and DOJ (Department of Justice) for review if they intend to seal them.&#8221;</p>
<p>The upcoming hearing is expected to focus on specific items that the plaintiffs&#8217; lawyers say have no legal right to secrecy. Among them: unpublished results of several drug studies, sales reps&#8217; notes on Seroquel&#8217;s marketing strategies and letters from the FDA.</p>
<p>The drugmaker also hopes to keep under seal information about sexual relationships that Dr. Wayne MacFadden, AstraZeneca&#8217;s former U.S. medical director for Seroquel, had with an independent researcher as well as with a woman who wrote papers supporting the drug&#8217;s safety and efficacy. Correspondence shows that MacFadden, who was also director of clinical research for neuroscience drugs, &#8220;promised sexual favors in exchange for intelligence on AstraZeneca&#8217;s competitors.&#8221;</p>
<p>The plaintiffs say the affairs &#8220;can create bias which can affect the integrity of the science.&#8221;</p>
<p>Lawyers for the drugmaker counter that the affairs are not relevant to the lawsuits. Other disputed documents, they say, contain trade secrets, could taint the jury pool and could &#8220;harm public health.&#8221;</p>
<p>AstraZeneca&#8217;s lawyers say the information to be discussed at the hearing scheduled Feb. 26 is so sensitive that the court should be closed to the public. &#8220;The potential harm of dissemination of documents at this stage in the litigation far outweighs the public&#8217;s right of access, particularly when trials in these cases are on the near horizon,&#8221; company lawyers said in a filing Feb. 6. &#8220;The whole picture will be presented to the public at once.&#8221;</p>
<p>The judge has not ruled on the request.</p>
<p>There&#8217;s a good chance that many of these cases will never come to trial, and the underlying documents will never become public. In a victory for Astra­Zeneca, the judge dismissed the first two cases in late January, saying plaintiffs had not sufficiently established that their health problems were caused by Seroquel. Up to nine trials are slated for 2009.</p>
<p>In the Zyprexa litigation, Lilly paid $1.2 billion to settle injury claims involving 31,000 patients. Damaging company documents were never released by the court, though they were available on the Internet after Egilman leaked them and excerpts appeared in the New York Times.</p>
<p>Egilman is well aware of the big money in liability lawsuits, having made $2.3 million as an expert witness in Vioxx cases. He contends that patients&#8217; lawyers are motivated by maximizing their share of any settlement, which can be 30 percent or more. He says attorneys should be required to get their client&#8217;s approval before agreeing to seal documents.</p>
<p>&#8220;The client may be more interested in making sure that health information gets to their doctor than money,&#8221; he said. &#8220;They have a real interest and it&#8217;s called their health.&#8221;</p>
<p>Gary Farmer, a Fort Lauderdale lawyer who represents more than 100 Seroquel patients, said Egilman has a point.</p>
<p>&#8220;If we can get the documents to win the case and get compensation, you have to ask yourself, &#8216;Is it necessary to make that information public?&#8217; &#8221; he said.</p>
<p>Whether the mountains of Seroquel material now sealed in Orlando&#8217;s federal court ever see the light of day may depend on the progress of related cases. Four states &#8211; Pennsylvania, Montana, Arkansas and South Carolina &#8211; are suing Astra­Zeneca for off-label marketing of Seroquel.</p>
<p>The company said it is aware that the U.S. Attorney&#8217;s Office in Philadelphia is investigating Seroquel&#8217;s marketing practices, most likely based on whistle blower complaints.</p>
<p>Regulators also seem to be taking note. In December, the FDA sent AstraZeneca a warning letter after learning a sales rep had pitched Seroquel to a doctor as a treatment for depression. Though doctors can prescribe a drug for any use, it is illegal for pharmaceutical companies to promote such uses.</p>
<p>The FDA also reportedly sent AstraZeneca two letters in late December, telling the company to strengthen Seroquel&#8217;s warnings about diabetes. The drugmaker declined to comment, saying its communications with the FDA are confidential. The letters remain sealed in Orlando&#8217;s federal court.</p>
<p>Kris Hundley, St. Petersburg Times, Tampa Bay, FL, February 15, 2009</p>
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