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	<title>Pharma Exec Blog &#187; Side Effects</title>
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		<copyright>&#xA9;Advanstar Communications </copyright>
		<managingEditor>gkoroneos@advanstar.com (Advanstar Communications)</managingEditor>
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		<title>Pfizer Responds to Adverse Events Report</title>
		<link>http://blog.pharmexec.com/2008/10/29/pfizer-responds-to-adverse-events-report/</link>
		<comments>http://blog.pharmexec.com/2008/10/29/pfizer-responds-to-adverse-events-report/#comments</comments>
		<pubDate>Wed, 29 Oct 2008 20:30:58 +0000</pubDate>
		<dc:creator>George Koroneos</dc:creator>
				<category><![CDATA[Safety]]></category>
		<category><![CDATA[adverse reactions]]></category>
		<category><![CDATA[Chantix]]></category>
		<category><![CDATA[ISMP]]></category>
		<category><![CDATA[Pfizer]]></category>
		<category><![CDATA[Side Effects]]></category>
		<category><![CDATA[smoking]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=387</guid>
		<description><![CDATA[A report released last week by the The Institute for Safe Medication Practices (and covered yesterday on PharmExec.com), listed Pfizer&#8217;s smoking cessation drug Chantix as the number one most reported drug for adverse reactions in the first quarter of 2008.
The report states that FDA received 1,001 reports of serious side effects for varenicline (the generic [...]]]></description>
			<content:encoded><![CDATA[<p><img class="size-medium wp-image-391 alignright" title="Chantix" src="http://blog.pharmexec.com/wp-content/uploads/chantix_500px.jpg" alt="" width="268" height="178" />A <a href="http://www.ismp.org/QuarterWatch/2008Q1.pdf" target="_blank">report</a> released last week by the The Institute for Safe Medication Practices (and <a href="http://pharmexec.findpharma.com/pharmexec/Regulatory/Chantix-Heparin-Top-List-of-Adverse-Events/ArticleStandard/Article/detail/561584?contextCategoryId=43753" target="_blank">covered</a> yesterday on <a href="http://PharmExec.com" target="_blank">PharmExec.com</a>), listed Pfizer&#8217;s smoking cessation drug <a href="http://pharmexec.findpharma.com/pharmexec/Rotating+Feature+Article/Brand-of-the-Year-2008/ArticleStandard/Article/detail/490704?searchString=chantix" target="_blank">Chantix</a> as the number one most reported drug for adverse reactions in the first quarter of 2008.</p>
<p>The report states that FDA received 1,001 reports of serious side effects for varenicline (the generic form of Chantix). That&#8217;s significantly more adverse events than <a href="http://pharmexec.findpharma.com/pharmexec/News/Baxter-Suspends-Heparin-Production/ArticleStandard/Article/detail/492609?contextCategoryId=43778&amp;searchString=heparin" target="_blank">heparin</a>, which rang up only 779 reactions (and allegedly killed a few people).</p>
<p>Chantix gartered a ton of headlines during that same period. In January 2008, Pfizer pumped up the warnings on the drug to include suicidal thinking and depression. It is possible that the undo attention could have increased the rate of adverse reaction reporting. ISMP said that it made a point to weed out all the minor reports or possible fakes.</p>
<p>Initial calls to Pfizer weren&#8217;t returned, but the company&#8217;s PR team gave a ring this morning to let me know that a statement was on its way. Here&#8217;s what Pfizer spokesperson Sally Beatty had to say:<span id="more-387"></span></p>
<blockquote><p>There is nothing new about this data. In fact, the number of monthly serious adverse events for Chantix has been decreasing after a peak in January. In fact, ISMP presents no evidence that smokers taking Chantix experience more accidents and injuries than those who havenâ€™t used Chantix to help them quit smoking.</p>
<p>The totality of available data, which are based on complete and current information, reveal no greater frequency of accidents and injuries reported with Chantix than with other medications.</p>
<p>While we welcome ongoing debate on the epidemic of tobacco addiction, we believe that framing that debate in the right context is in the best interest of public health. As part of Pfizerâ€™s commitment to medication safety, Pfizer recently launched a Medicine Safety Education website that describes how safety is evaluated throughout the lifecycle of medications at <a href="http://www.Pfizer.com/medicinesafety" target="_blank">www.Pfizer.com/medicinesafety.<br />
</a></p></blockquote>
<p>I guess we&#8217;ll just have to wait and see what the next quarterly report from ISMP has to say.</p>
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		<title>&quot;Side Effects&quot; and &quot;The Normalization of Suspicion&quot;</title>
		<link>http://blog.pharmexec.com/2008/07/16/150/</link>
		<comments>http://blog.pharmexec.com/2008/07/16/150/#comments</comments>
		<pubDate>Wed, 16 Jul 2008 20:58:49 +0000</pubDate>
		<dc:creator>Patrick Clinton</dc:creator>
				<category><![CDATA[Corporate Responsibility]]></category>
		<category><![CDATA[Safety]]></category>
		<category><![CDATA[Alison Bass]]></category>
		<category><![CDATA[Drug and Device Law blog]]></category>
		<category><![CDATA[GSK]]></category>
		<category><![CDATA[Jones Day]]></category>
		<category><![CDATA[Mark Herrmann]]></category>
		<category><![CDATA[Paxil]]></category>
		<category><![CDATA[Side Effects]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/2008/07/16/150/</guid>
		<description><![CDATA[In today&#8217;s Wall Street Journal, Mark Herrmann, an attorney with Jones Day, co-proprietor of the Drug and Device Law blog, as well as an occasional contributor to Pharm Exec, has a lively review of Alison Bass&#8217;  Side Effects, a new book that tells the story of the campaign against Paxil.
His bottom line is a [...]]]></description>
			<content:encoded><![CDATA[<p>In today&#8217;s <em>Wall Street Journal,</em> Mark Herrmann, an attorney with Jones Day, co-proprietor of the <a href="http://druganddevicelaw.blogspot.com/" target="_blank">Drug and Device Law</a> blog, as well as an occasional contributor to <em>Pharm Exec, </em>has a lively <a href="http://online.wsj.com/article/SB121617344057756659.html?mod=opinion_main_commentaries" target="_blank">review</a> of Alison Bass&#8217;  <a href="http://www.amazon.com/Side-Effects-Whistleblower-Bestselling-Antidepressant/dp/1565125533/ref=pd_bbs_sr_1?ie=UTF8&amp;s=books&amp;qid=1216241390&amp;sr=1-1" target="_blank"><em>Side Effects, </em></a>a new book that tells the story of the campaign against Paxil.</p>
<p>His bottom line is a familiar one for journalists covering the pharmaceutical industry. He writes:</p>
<blockquote><p>&#8220;Side Effects&#8221; belongs to a genre of investigative journalism that involves talking to plaintiffs, their lawyers and their expert witnesses, taking their stories as gospel and denigrating the opposing view because corporate money (apparently less pure than money from the plaintiffs&#8217; side) supposedly has a corrupting effect.Â  <span id="more-150"></span></p></blockquote>
<p>It didn&#8217;t help that, as Bass herself has pointed out elsewhere, GlaxoSmithKline provided minimal input to the book. But it&#8217;s easy to understand the unwillingness of pharma companies to speak these days. The truth that they have to present is nuanced, messy, and filled with uncertaintiesâ€”from clinical trials that ended up proving nothing to reports of adverse events that can&#8217;t be definitively tied to drugs but can&#8217;t be ignored. And the public, for whatever reason, seems unable to tolerate a story that gets complex and murky. Conspiracy theory reigns. As the sociologist Frank Furedi put it in a recent online <a href="http://www.spiked-online.com/index.php?/site/article/5436" target="_blank">article</a>:</p>
<blockquote><p>Contemporary conspiracy thinking helps to fuel suspicion and mistrust of politics. It replaces critical engagement with public life with a destructive search for the hidden agenda; it distracts from the clarification of genuine differences and helps turn public life into a theatre where what matters are the private lives and personal interests of mistrusted politicians. The media, in turn, fuels this attitude by continually suggesting that what really matters today is not what public figures actually say, but rather what their â€˜realâ€™ agenda is. This incites the public to look for hidden motives. No one, apparently, is what he seems to be. The normalisation of suspicion has absolutely no positive element to it.</p></blockquote>
<p>This isn&#8217;t to say that no one&#8217;s a villain. Of course there are  bad, greedy people out there. But in a world in which screwing up, misunderstanding, and outright failure seem to be the true building blocks of life, is villainy really the first hypothesis that should be on the table?</p>
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