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	<title>Reality Base &#187; FDA</title>
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	<link>http://blogs.discovermagazine.com/realitybase</link>
	<description>A blog about science, politics, and how to let each help the other without compromising them both.</description>
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		<title>Drug Industry 1, Country 0: Big Pharma Can Now Hawk Unapproved Drugs</title>
		<link>http://blogs.discovermagazine.com/realitybase/2009/01/14/drug-industry-1-country-0-big-pharma-can-now-hawk-unapproved-drugs/</link>
		<comments>http://blogs.discovermagazine.com/realitybase/2009/01/14/drug-industry-1-country-0-big-pharma-can-now-hawk-unapproved-drugs/#comments</comments>
		<pubDate>Wed, 14 Jan 2009 23:14:35 +0000</pubDate>
		<dc:creator>Melissa Lafsky</dc:creator>
				<category><![CDATA[Health Care]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[medicine]]></category>

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		<description><![CDATA[From the wires: The FDA has just completed a fresh set of guidelines that will permit pharmaceutical companies to tell doctors about unapproved uses of their medicines—in effect, giving big pharma carte blanche to hawk unapproved drugs.
Specifically, the new regulations allow drug companies to &#8220;distribute copies of medical journal articles that describe unapproved uses&#8221; of [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://www.nytimes.com/2009/01/13/business/13label.html" target="_blank">From the wires</a>: The FDA has just completed a fresh set of guidelines that will permit pharmaceutical companies to tell doctors about unapproved uses of their medicines—in effect, giving big pharma carte blanche to hawk unapproved drugs.</p>
<p>Specifically, the new regulations allow drug companies to &#8220;distribute copies of medical journal articles that describe unapproved uses&#8221; of their drugs to all the doctors they want.</p>
<p>Technically this reg isn&#8217;t new; it was in place until 2006, then lapsed until industry lobbyists made sure it was proposed again last year, despite heavy criticism from Democrats and drug industry critics. And now, conveniently one week before the Bush administration draws its final, sputtering breath, the rule has made its way back into the final FDA guidelines.</p>
<p>Big pharma spokespeople pooh pooh the reg as <a href="http://finance.yahoo.com/news/FDA-OKs-sharing-unapproved-apf-14036181.html" target="_blank">nothing more than a formality</a>: &#8220;Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care,&#8221; said Alan Bennett, an attorney representing the pharmaceutical industry.</p>
<p><span id="more-392"></span></p>
<p>It&#8217;s true that these journal articles are required to be peer-reviewed—though whether that means anything <a href="http://finance.yahoo.com/news/FDA-OKs-sharing-unapproved-apf-14036181.html" target="_blank">remains to be seen</a>:</p>
<blockquote><p>The reliability of medical journal articles came into question earlier this year when drugmaker Merck &amp; Co. Inc. was accused of ghostwriting several articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons.</p>
<p>Reports published in the Journal of the American Medical Association alleged that Merck paid academics to take credit for articles which were actually written by the company. Merck denied the allegations, calling them false and misleading.</p></blockquote>
<p>For every <a href="http://blogs.discovermagazine.com/realitybase/2009/01/05/bye-bye-freebies-drug-companies-ax-free-goodies-to-doctors/">one step forward</a>, two steps back.</p>
<p>Related:<br />
RB: <a href="http://blogs.discovermagazine.com/realitybase/2009/01/05/bye-bye-freebies-drug-companies-ax-free-goodies-to-doctors/">Bye Bye Freebies! Drug Companies Ax Free Goodies to Doctors</a><br />
RB: <a href="http://blogs.discovermagazine.com/realitybase/2008/12/19/is-nothing-sacred-nobel-prize-engulfed-in-drug-company-scandal/">Is Nothing Sacred? Nobel Prize Engulfed in Drug Company Scandal</a><br />
RB: <a href="http://blogs.discovermagazine.com/realitybase/2008/12/04/clinic-to-reveal-all-doctor-drug-industry-ties-on-the-internet/">Clinic to Reveal All Doctor-Drug Industry Ties on the Web</a></p>
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		<title>Think Your Bread Is &#8220;Made With Whole Grain&#8221;? Check Again</title>
		<link>http://blogs.discovermagazine.com/realitybase/2008/07/29/think-your-bread-is-made-with-whole-grain-check-again/</link>
		<comments>http://blogs.discovermagazine.com/realitybase/2008/07/29/think-your-bread-is-made-with-whole-grain-check-again/#comments</comments>
		<pubDate>Tue, 29 Jul 2008 19:30:47 +0000</pubDate>
		<dc:creator>Melissa Lafsky</dc:creator>
				<category><![CDATA[Nutrition & Obesity]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[food]]></category>

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		<description><![CDATA[Here&#8217;s a heartening example of advocates calling out the food industry on its blatant label obfuscation: Baked goods giant Sara Lee has agreed (after some aggressive prompting) to change the &#8220;whole grain goodness&#8221; label on its best-selling Soft &#38; Smooth bread to indicate the truth: that the bread&#8217;s composition of whole grains is only 30 [...]]]></description>
			<content:encoded><![CDATA[<p><img src="http://blogs.discovermagazine.com/realitybase/files/2008/07/sara-lee.jpg" alt="Sara Lee" align="left" />Here&#8217;s a heartening example of advocates calling out the food industry on its blatant label obfuscation: Baked goods giant Sara Lee has agreed (after some aggressive prompting) to change the &#8220;whole grain goodness&#8221; label on its best-selling Soft &amp; Smooth bread to indicate the truth: that the bread&#8217;s composition of whole grains is only 30 percent, meaning 70 percent of it is made from <a href="http://www.naturaldiabetics.com/index.php/blood-sugar-influences/negative-diabetes-factors/refined-flour.html" target="_blank">ultra-unhealthy refined white flour</a>.</p>
<p><em>BusinessWeek</em> <a href="http://www.businessweek.com/bwdaily/dnflash/content/jul2008/db20080722_962380.htm" target="_blank">reports</a> that the company acquiesced to the change after threat of a lawsuit came from the <a href="http://www.cspinet.org/" target="_blank">Center for Science in the Public Interest</a>, a non-profit watchdog group that specializes in nutrition and food safety. But what about the FDA? Shouldn&#8217;t it be regulating misleading labeling of so-called &#8220;healthy&#8221; products?</p>
<p>It&#8217;s no secret that the food industry is notorious for slapping &#8220;healthy-sounding&#8221; labels on food that barely scrape by the minimum requirements, but so far the agency has done little to stamp out the practice. In 2006, it <a href="http://www.cfsan.fda.gov/~dms/flgragui.html" target="_blank">released a statement</a> acknowledging that unqualified &#8220;whole grain&#8221; labels could be confusing to consumers and stating the following:</p>
<p><span id="more-139"></span></p>
<blockquote><p>Manufacturers can make factual statements about whole grains on the label of their products, such as &#8220;10 grams of whole grains,&#8221; &#8220;½ ounce of whole grains,&#8221;&#8230; and &#8220;100% whole grain oatmeal&#8221;&#8230; provided that the statements are not false or misleading &#8230; and do not imply a particular level of the ingredient, i.e., &#8220;high&#8221; or &#8220;excellent source.&#8221;</p></blockquote>
<p>So what was the food industry&#8217;s response? Use unqualified wording like &#8220;made with whole grains&#8221; to sidestep FDA guidelines.</p>
<p>Given the fact that despite a ramp-up in nutrition education for consumers, obesity rates are <a href="http://www.physorg.com/news136467510.html" target="_blank">going nowhere but up</a>, it might be worth the FDA&#8217;s time to consider cracking down on some of the innumerable gray areas in food packaging and advertising. Otherwise, Skittles won&#8217;t be the only candy on the shelf touting &#8220;All Natural Flavoring&#8221; and &#8220;Made from natural ingredients.&#8221;</p>
<p><em>Image: Flickr/<a href="http://flickr.com/photos/agilitynut/1631845556/">agilitynut</a></em></p>
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