<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
	>

<channel>
	<title>INTERNATIONAL COALITION FOR DRUG AWARENESS &#187; Placebo</title>
	<atom:link href="http://www.drugawareness.org/tag/placebo/feed" rel="self" type="application/rss+xml" />
	<link>http://www.drugawareness.org</link>
	<description></description>
	<lastBuildDate>Mon, 06 Feb 2012 06:47:59 +0000</lastBuildDate>
	<language>en</language>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=3.3.1</generator>
		<item>
		<title>Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks</title>
		<link>http://www.drugawareness.org/recentcasesblog/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks</link>
		<comments>http://www.drugawareness.org/recentcasesblog/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks#comments</comments>
		<pubDate>Fri, 21 May 2010 18:53:12 +0000</pubDate>
		<dc:creator>Ann Tracy</dc:creator>
				<category><![CDATA[Recent Cases Blog]]></category>
		<category><![CDATA[antidepressants]]></category>
		<category><![CDATA[Back Yard]]></category>
		<category><![CDATA[Bipolar]]></category>
		<category><![CDATA[Digg]]></category>
		<category><![CDATA[Drug Awareness]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Glaxo]]></category>
		<category><![CDATA[Google]]></category>
		<category><![CDATA[homicide]]></category>
		<category><![CDATA[International Coalition]]></category>
		<category><![CDATA[Jim Edwards]]></category>
		<category><![CDATA[Newsvine]]></category>
		<category><![CDATA[Overpass]]></category>
		<category><![CDATA[Paxil]]></category>
		<category><![CDATA[Placebo]]></category>
		<category><![CDATA[Semi Truck]]></category>
		<category><![CDATA[Ssri Antidepressants]]></category>
		<category><![CDATA[Stumbleupon]]></category>
		<category><![CDATA[Suicide Risks]]></category>
		<category><![CDATA[Twitter]]></category>

		<guid isPermaLink="false">http://www.drugawareness.org/recentcases/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks</guid>
		<description><![CDATA[It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.]]></description>
			<content:encoded><![CDATA[<div>
<div>
<div>
<div>
<div id=":7r">
<div>
<div>
<div id=":88">
<div><span style="font-family: Arial; color: #000000; font-size: x-small;"></p>
<div>The only word for this news is &#8221;Criminal!&#8221; I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother&#8217;s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn&#8217;t it?</div>
<div>I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.</div>
<div>As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced &#8211; many the FDA had never seen &#8211; indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?</div>
<div>Ann Blake Tracy, PhD, Executive Director<br />
International Coalition for Drug Awareness<br />
<a href="http://www.drugawareness.org/" target="_blank">www.drugawareness.org</a> &amp; <a href="http://www.ssristories.com/" target="_blank">www.ssristories.com</a></div>
<div><a href="http://industry.bnet.com/pharma/10008290/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks/#comments" target="_blank">http://industry.bnet.com/pharma/10008290/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks/#comments</a></div>
<div>
<div>
<h1>Glaxo Is Testing Paxil on 7-Year-Olds Despite WellKnown Suicide Risks</h1>
<p>By <a><span style="color: #005399;">Jim Edwards</span></a> | May 21, 2010</p>
<div>
<ul>
<li><a title="Share">Share</a>
<div>
<ul>
<li><a title="MyBNET">MyBNET</a></li>
<li><a title="Email">Email</a></li>
<li><a title="Digg">Digg</a></li>
<li><a title="Facebook">Facebook</a></li>
<li><a title="Twitter">Twitter</a></li>
<li><a title="Google">Google</a></li>
<li><a title="Delicious">Delicious</a></li>
<li><a title="StumbleUpon">StumbleUpon</a></li>
<li><a title="Newsvine">Newsvine</a></li>
<li><a title="LinkedIn">LinkedIn</a></li>
<li><a title="My Yahoo">My Yahoo</a></li>
<li><a title="Technorati">Technorati</a></li>
<li><a title="Reddit">Reddit</a></li>
</ul>
</div>
</li>
<li><a title="Print">Print</a></li>
<li>1</li>
</ul>
</div>
</div>
<div>
<p><img title="GSK is researching the safety of Paxil in kids." src="http://i.bnet.com/blogs/noose.jpg" alt="" width="199" height="265" />It was established years ago that <a href="http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm168828.htm" target="_blank"><span style="color: #005399;"><strong>Paxil </strong>carries a risk of suicide</span></a> in children and teens, but <a href="http://clinicaltrials.gov/ct2/show/study/NCT00812812" target="_blank"><span style="color: #005399;"><strong>GlaxoSmithKline </strong>(GSK) has for the last 18 months been conducting a study</span></a> of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its <a href="http://www.newscientist.com/article/mg19726424.600-did-gsk-trial-data-mask-paxil-suicide-risk.html" target="_blank"><span style="color: #005399;">already controversial</span></a> pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.</p>
<p>GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The <a href="http://www.scribd.com/doc/1061942/US-Food-and-Drug-Administration-Paxil-PI" target="_blank"><span style="color: #005399;">drug carries a “black box” warning</span></a> on its patient information sheet, warning doctors and consumers that the antidepressant is twice as <a href="http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0007312" target="_blank"><span style="color: #005399;">likely to generate lethal thoughts</span></a> than a placebo.</p>
<p>The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.</p>
<p>The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.</p>
<p>Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.</p>
<p>To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.</p>
<p>About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.</p>
<p>The trial will wrap up in September.</p>
</div>
</div>
<p></span></div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
]]></content:encoded>
			<wfw:commentRss>http://www.drugawareness.org/recentcasesblog/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>PROZAC/SSRIs: Problematic [DEADLY!] For Bipolars:  Dr. David Gratzer</title>
		<link>http://www.drugawareness.org/recentcasesblog/prozacssris-problematic-deadly-for-bipolars-dr-david-gratzer</link>
		<comments>http://www.drugawareness.org/recentcasesblog/prozacssris-problematic-deadly-for-bipolars-dr-david-gratzer#comments</comments>
		<pubDate>Thu, 04 Feb 2010 14:24:23 +0000</pubDate>
		<dc:creator>Ann Tracy</dc:creator>
				<category><![CDATA[Recent Cases Blog]]></category>
		<category><![CDATA[American Health Care]]></category>
		<category><![CDATA[Antidepressant]]></category>
		<category><![CDATA[antidepressants]]></category>
		<category><![CDATA[Bipolar]]></category>
		<category><![CDATA[Bipolar Disorder]]></category>
		<category><![CDATA[Bipolar Patients]]></category>
		<category><![CDATA[Contributor]]></category>
		<category><![CDATA[discontinuation]]></category>
		<category><![CDATA[Dr David Gratzer]]></category>
		<category><![CDATA[Dr. Tracy]]></category>
		<category><![CDATA[Government Panels]]></category>
		<category><![CDATA[Initial Fears]]></category>
		<category><![CDATA[Placebo]]></category>
		<category><![CDATA[Prozac]]></category>
		<category><![CDATA[Simple Truth]]></category>
		<category><![CDATA[Ssri Antidepressants]]></category>
		<category><![CDATA[SSRIs]]></category>
		<category><![CDATA[Theor]]></category>
		<category><![CDATA[Third Person]]></category>
		<category><![CDATA[Truth Of The Matter]]></category>

		<guid isPermaLink="false">http://www.drugawareness.org/recentcases/prozacssris-problematic-deadly-for-bipolars-dr-david-gratzer</guid>
		<description><![CDATA[Pay for the blue pill that works, not the red one that
doesn't. That's the president's simple prescription for improving American
health care, one that relies on government panels and committees to set
guidelines for doctors and patients alike.

At least, that's the
theory.

The theory met messy reality last week when the U.S. Preventive
Services Task Force recommended that women in their 40s shouldn't get
mammograms. But the secretary of health and human services -- who, incidentally,
oversees this panel -- thinks women probably should. And the American Cancer
Society believes that they definitely should; major private insurance companies,

for the record, will continue to fund the tests.]]></description>
			<content:encoded><![CDATA[<p>NOTE FROM <span class="il">DR</span>. TRACY (<a href="http://www.drugawareness.org" target="_blank">www.drugawareness.org</a>):</p>
<div><span style="font-size: small;">&#8220;<span class="il">Problematic</span>???!!!!!&#8221; How about using the term <span class="il">DEADLY</span>? How did<br />
we get to the point that using <span class="il">SSRIs</span> is the standard &#8220;treatment&#8221; <span class="il">for</span> Bipolar<br />
patients when initially doctors would not prescribe them due to their strong<br />
potential to induce Bipolar?! Time has certainly proven the initial fears to be<br />
true when the number of diagnosis <span class="il">for</span> Bipolar Disorder increased by a whopping<br />
4000% from 1996 to 2004!! No wonder every third person you meet any more has the<br />
Bipolar label!</span></div>
<div><span style="font-size: small;">The simple truth of the matter is (as I discuss at length in<br />
my DVD &#8220;Bipolar, Shmypolar! Are You Really Bipolar or Misdiagnosed Due to the<br />
Use of or Abrupt Discontinuation of an Antidepressant?&#8221;) that antidepressants -<br />
especially the SSRI antidepressants &#8211; are by far the BIGGEST CAUSE on<br />
this planet of Bipolar Disorder! And doctors prescribing these drugs as<br />
&#8220;treatment&#8221; <span class="il">for</span> Bipolar is not only unethical, it is downright criminal! Why<br />
wouldn&#8217;t the placebo outperform the drug?! Placebos don&#8217;t CAUSE Bipolar Disorder<br />
- Antidepressants do!</span></div>
<div><span style="font-size: small;">Paragraph 14 reads:  &#8220;As a physician myself, I know a<br />
thing or two about going by the book and getting it wrong. When I was in<br />
residency, the standard treatment <span class="il">for</span> bipolar patients <strong><em><span style="text-decoration: underline;">suffering<br />
depression was <span class="il">Prozac</span> or its sister drugs</span></em></strong>. It turned out that </span></p>
<p><span style="font-size: small;"><strong><em><span style="text-decoration: underline;"><span class="il">Prozac</span> i</span></em></strong>ntervention was not only </span><strong><em><span style="text-decoration: underline;"><span style="font-size: small;">highly <span class="il">problematic</span>, but also bested by<br />
placebo.&#8221;</span></span></em></strong></p>
<p><strong><em> </em></strong><a title="http://www.washingtonexaminer.com/opinion/columns/Manhattan-Moment/Medicine-isn_t-perfect_-Obamacare-is-even-less-perfect-8582816-72875022.html" href="http://www.washingtonexaminer.com/opinion/columns/Manhattan-Moment/Medicine-isn_t-perfect_-Obamacare-is-even-less-perfect-8582816-72875022.html" target="_blank"><span style="font-size: small;">http://www.washingtonexaminer.com/opinion/columns/Manhattan-Moment/Medicine-isn_t-perfect_-Obamacare-is-even-less-perfect-8582816-72875022.html</span></a><span style="font-size: small;"> </span></p>
</div>
<h1><strong><span class="il">Dr</span>. <span class="il">David</span> <span class="il">Gratzer</span>: Medicine isn&#8217;t perfect, Obamacare is even less<br />
perfect</strong></p>
<p><strong> </strong></h1>
<h3><strong>By: <span class="il">Dr</span>. <span class="il">David</span> <span class="il">Gratzer</span><br />
Op-Ed Contributor<br />
November 25, 2009<br />
</strong></h3>
<div><span style="font-size: small;">Pay <span class="il">for</span> the blue pill that works, not the red one that<br />
doesn&#8217;t. That&#8217;s the president&#8217;s simple prescription <span class="il">for</span> improving American<br />
health care, one that relies on government panels and committees to set<br />
guidelines <span class="il">for</span> doctors and patients alike.</p>
<p>At least, that&#8217;s the<br />
theory.</p>
<p>The theory met messy reality last week when the U.S. Preventive<br />
Services Task Force recommended that women in their 40s shouldn&#8217;t get<br />
mammograms. But the secretary of health and human services &#8212; who, incidentally,<br />
oversees this panel &#8212; thinks women probably should. And the American Cancer<br />
Society believes that they definitely should; major private insurance companies,</p>
<p></span></p>
<p><span class="il"><span style="font-size: small;">for</span></span><span style="font-size: small;"> the record, will continue to fund the tests.</span></p>
<p>Confused<br />
yet?</p>
<p>Recommendation from a largely unknown government panel hardly seems<br />
like typical material <span class="il">for</span> national headlines. But when it involves breast cancer<br />
and the announcement is made in the heat of debate over health reform, people<br />
are &#8212; understandably &#8212; concerned.</p>
<p>The U.S. Preventive Services Task<br />
Force, as it turns out, is not part of a larger Obama White House rationing<br />
conspiracy, as some would have it. Task force members were appointed by<br />
President Bush, and they voted on this recommendation before Obama&#8217;s<br />
inauguration.</p>
<p>As <span class="il">for</span> cost considerations, the task force had none:<br />
Members are mandated not to weigh dollars and cents when considering the risk<br />
and benefits of recommendations.</p>
<p>That&#8217;s not to suggest that their<br />
conclusion isn&#8217;t highly controversial. <span class="il">For</span> starters, it seems counterintuitive:<br />
Early screening <span class="il">for</span> cancer makes sense.</p>
<p>No wonder, then, that a full 87<br />
percent of Americans believed that routine scanning was &#8220;almost always a good<br />
idea&#8221; in a 2004 poll published in the Journal of the American Medical<br />
Association.</p>
<p>Today, American panels and doctors groups are moving away<br />
from the &#8220;scan first, ask questions later&#8221; philosophy. We aren&#8217;t the only ones<br />
having second thoughts.</p>
<p>In Japan, all newborns were screened <span class="il">for</span></p>
<p><span style="font-size: small;">neuroblastoma starting in 1984, but the program was scrapped a few years ago<br />
when more babies died from unnecessary surgeries than the obscure<br />
cancer.</span></p>
<p><span class="il">For</span> many, such reversals are deeply unsettling, a reminder that<br />
medicine is far from an exact science.</p>
<p>&#8220;The history of medicine is a<br />
record not only of brilliant success and stunning progress,&#8221; Theodore Dalrymple,<br />
a British physician, wrote in 2002. &#8220;It is also a litany of mistaken ideas and<br />
discarded treatments, some of which came to appear absurd or downright dangerous<br />
after having once been hailed as unprecedented advances.&#8221;</p>
<p>As a physician<br />
myself, I know a thing or two about going by the book and getting it wrong. When<br />
I was in residency, the standard treatment <span class="il">for</span> bipolar patients suffering<br />
depression was <span class="il">Prozac</span> or its sister drugs. It turned out that <span class="il">Prozac</span><br />
intervention was not only highly <span class="il">problematic</span>, but also bested by<br />
placebo.</p>
<p><span class="il">For</span> those on the left, the answer to the chaos of medicine is to<br />
establish government panels. With Obamacare, <span class="il">for</span> instance, White House officials<br />
propose a commission to cut hundreds of billions from Medicare by improving the<br />
quality of care.</p>
<p>How? By setting up an Independent Medicare Advisory<br />
Commission that would guide clinical decisions <span class="il">for</span> doctors and patients<br />
alike.</p>
<p>The controversy over breast cancer screening, however, shows the<br />
political and practical limitations of this one-size-fits-all approach: Medical<br />
organizations have difficulty in setting and agreeing upon clinical guidelines,<br />
and patients are apt to resent mandates from bureaucrats.</p>
<p>Leaving health<br />
verdicts in the hands of centralized authorities is a sure way to keep making<br />
mistakes in a field where re-examination and reversal are an unavoidable<br />
reality.</p>
<p><em><span class="il">David</span> <span class="il">Gratzer</span>, a physician, is a senior fellow at the<br />
Manhattan Institute and author of &#8220;Why Obama&#8217;s Government Takeover of Health<br />
Care Will Be a Disaster&#8221; (Encounter Books,<br />
2009).<br />
</em></p>
</div>
]]></content:encoded>
			<wfw:commentRss>http://www.drugawareness.org/recentcasesblog/prozacssris-problematic-deadly-for-bipolars-dr-david-gratzer/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Antidepressants No More Effective Than Placebo</title>
		<link>http://www.drugawareness.org/overview/placebo</link>
		<comments>http://www.drugawareness.org/overview/placebo#comments</comments>
		<pubDate>Mon, 03 Aug 2009 17:57:25 +0000</pubDate>
		<dc:creator>Ann Tracy</dc:creator>
				<category><![CDATA[Overview]]></category>
		<category><![CDATA[Abrupt Change]]></category>
		<category><![CDATA[alcohol]]></category>
		<category><![CDATA[anti-depressant]]></category>
		<category><![CDATA[Antidepressant]]></category>
		<category><![CDATA[antidepressants]]></category>
		<category><![CDATA[Benefit]]></category>
		<category><![CDATA[Closest Thing]]></category>
		<category><![CDATA[Depression]]></category>
		<category><![CDATA[disorder]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Hostility]]></category>
		<category><![CDATA[inhibitors]]></category>
		<category><![CDATA[Initial Studies]]></category>
		<category><![CDATA[luvox]]></category>
		<category><![CDATA[mood]]></category>
		<category><![CDATA[New Antidepressants]]></category>
		<category><![CDATA[Pfizer]]></category>
		<category><![CDATA[Placebo]]></category>
		<category><![CDATA[psychosis]]></category>
		<category><![CDATA[Risk]]></category>
		<category><![CDATA[s.s.r.i.]]></category>
		<category><![CDATA[serafem]]></category>
		<category><![CDATA[serotonin]]></category>
		<category><![CDATA[Sertraline]]></category>
		<category><![CDATA[Side Effects]]></category>
		<category><![CDATA[SSRI]]></category>
		<category><![CDATA[Ssri Antidepressants]]></category>
		<category><![CDATA[Sugar Pill]]></category>
		<category><![CDATA[SUICIDE]]></category>
		<category><![CDATA[syndrome]]></category>
		<category><![CDATA[Toilet]]></category>
		<category><![CDATA[Truth]]></category>
		<category><![CDATA[Zoloft]]></category>

		<guid isPermaLink="false">http://s193230320.onlinehome.us/drugawarenesswp/slide-bar/834</guid>
		<description><![CDATA[The end of February 2008 the truth came out about the initial studies done on these new antidepressants. These studies had never before been made public or even submitted to the FDA for their review. Yet these studies showed that the drugs were of no more benefit than a placebo!]]></description>
			<content:encoded><![CDATA[<p><a title="placebo" href="http://www.drugawareness.org/"><img src="http://tbn1.google.com/images?q=tbn:uPoRzEcBmvB1xM:http://www.chemistryland.com/CHM107/Introduction/Audience/placebo.jpg" border="0" alt="placebo" width="115" height="133" align="left" /></a>The end of February 2008 the truth came out about the initial studies done on these new SSRI antidepressants. These studies had never before been made public or even submitted to the FDA for their review. Yet these studies showed that the drugs were of no more benefit than a placebo! What the FDA does is judge the &#8220;Risk to Benefit&#8221; ratio for all drugs. With this new information, our question to them now is: &#8220;If this group of drugs are of no more benefit than a sugar pill and yet now have an FDA imposed Black Box Warning for increased risk of suicide &#8211; the next closest thing to banning a drug and they have warnings of suicide, hostility or psychosis with any abrupt change in dose, where is the Risk to Benefit ratio other than down the toilet? Why are these drugs still on the market with little to no benefit and so great a risk?</p>
]]></content:encoded>
			<wfw:commentRss>http://www.drugawareness.org/overview/placebo/feed</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
	</channel>
</rss>

