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	<title>MPP Blog &#187; FDA</title>
	<atom:link href="http://blog.mpp.org/tag/fda/feed/" rel="self" type="application/rss+xml" />
	<link>http://blog.mpp.org</link>
	<description>Marijuana Policy Project</description>
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		<title>Inventor of Fake Marijuana Wants the Real Thing Taxed and Regulated</title>
		<link>http://blog.mpp.org/prohibition/inventor-of-fake-marijuana-wants-the-real-thing-taxed-and-regulated/09302011/</link>
		<comments>http://blog.mpp.org/prohibition/inventor-of-fake-marijuana-wants-the-real-thing-taxed-and-regulated/09302011/#comments</comments>
		<pubDate>Fri, 30 Sep 2011 21:44:37 +0000</pubDate>
		<dc:creator>Morgan Fox</dc:creator>
				<category><![CDATA[Prohibition]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[ban]]></category>
		<category><![CDATA[Clemson]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Huffman]]></category>
		<category><![CDATA[K2]]></category>
		<category><![CDATA[Spice]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=4501</guid>
		<description><![CDATA[The news has been all abuzz for the last several months about various forms of designer drugs meant to mimic marijuana. Called Spice, K2, and a million other mildly clever names, these substances usually consist of a synthetic cannabinoid sprayed over plant matter. The resulting euphoria is supposed to be similar to the effects of [...]]]></description>
			<content:encoded><![CDATA[<p>The news has been all abuzz for the last several months about various forms of designer drugs meant to mimic marijuana. Called Spice, K2, and a million other mildly clever names, these substances usually consist of a synthetic cannabinoid sprayed over plant matter. The resulting euphoria is supposed to be similar to the effects of marijuana. Unfortunately, it is also untested and has been reported to have all sorts of nasty side effects. Enter the DEA, who recently asked the FDA to temporarily ban several of these chemicals, pending a more permanent solution.</p>
<p>Needless to say, most people probably wouldn’t use these chemicals if they could legally use marijuana. Many users of the synthetics report drug tests for probation or work to be their main reason for using it. The Navy had to start testing for it regularly, so prevalent was its use among the oft-drug-tested sailors. <a href="http://blog.mpp.org/tax-and-regulate/free-downloads-of-%E2%80%98marijuana-is-safer%E2%80%99-to-be-offered-on-420/04192010/">Once again, we have prohibition encouraging people to use drugs more dangerous than marijuana.</a></p>
<p>The inventor of these substances, John W. Huffman of Clemson University, strongly warns against using them and thinks they should be banned. What does he think should be legal?</p>
<p>&nbsp;</p>
<p>In an <a href="http://www.latimes.com/news/nationworld/nation/la-na-killer-weed-20110928,0,4248522,full.story">interview</a> this week with the L.A. Times, Huffman said marijuana should be taxed and regulated, and had this to say:</p>
<blockquote><p>&#8220;You can&#8217;t overdose on marijuana, but you might on these compounds,&#8221; he said. &#8220;These things are dangerous, and marijuana isn&#8217;t, really.&#8221;</p></blockquote>
<p>I wonder if the DEA will listen. Probably just the “dangerous” part.</p>
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		<slash:comments>2</slash:comments>
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		<item>
		<title>Since Feds Won’t Change Policy, We Must Change Federal Law</title>
		<link>http://blog.mpp.org/medical-marijuana/since-feds-won%e2%80%99t-change-policy-we-must-change-federal-law/07122011/</link>
		<comments>http://blog.mpp.org/medical-marijuana/since-feds-won%e2%80%99t-change-policy-we-must-change-federal-law/07122011/#comments</comments>
		<pubDate>Tue, 12 Jul 2011 21:48:27 +0000</pubDate>
		<dc:creator>Morgan Fox</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[Prohibition]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[Department of Justice]]></category>
		<category><![CDATA[Drug Enforcement Administration]]></category>
		<category><![CDATA[enforcement]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Holder]]></category>
		<category><![CDATA[HR 2306]]></category>
		<category><![CDATA[Obama]]></category>
		<category><![CDATA[Ogden Memo]]></category>
		<category><![CDATA[providers]]></category>
		<category><![CDATA[Teen Use Report]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=4289</guid>
		<description><![CDATA[The last two weeks have been full of announcements from the federal government about marijuana policy. None of them has been positive, and none of them should be surprising. First, the Department of Justice stated that it retained the ability to prosecute anyone who cultivates, processes, or distributes medical marijuana, regardless of state law. As [...]]]></description>
			<content:encoded><![CDATA[<p>The last two weeks have been full of announcements from the federal government about marijuana policy. None of them has been positive, and none of them should be surprising.</p>
<p>First, the Department of Justice stated that it retained the ability to prosecute anyone who cultivates, processes, or distributes medical marijuana, regardless of state law. <a href="http://blog.mpp.org/medical-marijuana/doj-clarification-of-medical-marijuana-policy-still-unclear/07072011/">As noted earlier on this blog</a>, this is not really a change in policy, but it is certainly disappointing to see the Department of Justice is unwilling to publicly recognize the legitimacy of state medical marijuana laws and would rather have patients purchasing their medicine from dangerous, illicit dealers.</p>
<p>Then, in a move that shouldn’t have surprised anyone, the Drug Enforcement Administration, the agency tasked with determining the legal status of drugs according to the Controlled Substances Act, decided to keep marijuana as a Schedule I substance. This classification means that the DEA will continue to assert that marijuana has no accepted medical use and should continue to be a high enforcement priority. Never mind the growing mountain of peer-reviewed studies that show the medical efficacy and relative safety of marijuana. The DEA will only pay attention to government studies, which are not approved unless the goal is to find negative effects, not medical benefits. We should not expect them to reschedule marijuana in the foreseeable future, especially since marijuana enforcement is an easy source of cash and prestige. <a href="http://www.safeaccessnow.org">Americans for Safe Access</a> is currently appealing the decision in federal court, however, and hopefully they will gain some traction on this point and force the DEA to recognize the evidence in support of medical marijuana.</p>
<p>All this was followed by the release of the <a href="http://www.whitehousedrugpolicy.gov/strategy/index.html">National Drug Control Strategy</a>, which basically states that the Obama administration will continue to use scarce resources to combat the use of marijuana through criminal justice means, as well as a slightly increased program of harm reduction (<a href="http://blog.mpp.org/prohibition/obama-thinks-drug-policy-is-serious-issue-and-not-much-else/01282011/">which the President has said was going to be his primary focus</a>). The strategy admits that marijuana use is at its highest in the last eight years, yet wants to continue the same strategy it has been utilizing during that same period!</p>
<p>The new strategy also mentions medical marijuana and, while admitting that there may be some medical uses for individual components of marijuana, continues to say that it should pass through the FDA approval process. This would be nice, if we could get all the federal agencies whose stamps of approval are needed to actually allow such research. So far the efforts of those trying to go through the official research and approval process have been blocked. In addition, the new strategy claims that medical marijuana “sends the wrong message to children” and increases the likelihood of adolescents using marijuana. This point ignores the fact that in most medical marijuana states, teen use has actually <em>decreased</em> since passing medical marijuana laws. Data supporting this can be found in the Marijuana Policy Project’s <a href="http://www.mpp.org/library/research/teen-use-report.html">Teen Use Report</a>.</p>
<p>So what does all this mean?</p>
<p>It means that all we can expect from the federal government is support of the status quo. We might get some minor concessions here and there, and the fact that the Ogden Memo has been (mostly) followed by the DOJ should not be overlooked. However, we should not look to the federal government to change policy in any drastic way simply of its own free will. They must be legally compelled to do so.</p>
<p>This is why we don’t need statements of policy, nice as they may be. We need different laws. We need something much more binding than policy statements, which can be distorted and rescinded at any moment without legal backing. It is imperative that we convince our legislators to support bills that will weaken the federal government’s control over marijuana policy and enforcement.</p>
<p><a href="https://secure2.convio.net/mpp/site/Advocacy?cmd=display&amp;page=UserAction&amp;id=985">Please contact your representative in Congress, and tell them to support H.R. 2306.</a> This bill would remove the federal government’s ability to interfere with state marijuana laws and policies. Legal change is what we really need if we want to see positive change in federal behavior.</p>
<p>&nbsp;</p>
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		<slash:comments>35</slash:comments>
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		<title>Pain.com Invites MPP to Weigh In On Medical Marijuana</title>
		<link>http://blog.mpp.org/medical-marijuana/pain-com-invites-mpp-to-weigh-in-on-medical-marijuana/12112009/</link>
		<comments>http://blog.mpp.org/medical-marijuana/pain-com-invites-mpp-to-weigh-in-on-medical-marijuana/12112009/#comments</comments>
		<pubDate>Fri, 11 Dec 2009 17:25:36 +0000</pubDate>
		<dc:creator>Bruce Mirken</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[Craker]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[pain]]></category>
		<category><![CDATA[science]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=1933</guid>
		<description><![CDATA[Check out this point/counterpoint on medical marijuana on the new medical Web site, Pain.com. They tell us that as of this morning it was the most popular item on the site.]]></description>
			<content:encoded><![CDATA[<p>Check out this <a href="http://www.pain.com/go/default/practitioner/pointcounter-point/should-the-fda-legalize-marijuana/fda-medical-marijuana-point/" target="_blank">point/counterpoint on medical marijuana</a> on the new medical Web site, Pain.com. They tell us that as of this morning it was the most popular item on the site.</p>
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		<slash:comments>33</slash:comments>
		</item>
		<item>
		<title>Medical Marijuana: The Drug Czar is Wrong (Again)</title>
		<link>http://blog.mpp.org/medical-marijuana/medical-marijuana-the-drug-czar-is-wrong-again/11112009/</link>
		<comments>http://blog.mpp.org/medical-marijuana/medical-marijuana-the-drug-czar-is-wrong-again/11112009/#comments</comments>
		<pubDate>Wed, 11 Nov 2009 22:02:19 +0000</pubDate>
		<dc:creator>Bruce Mirken</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[AMA]]></category>
		<category><![CDATA[drug czar]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Netherlands]]></category>
		<category><![CDATA[ONDCP]]></category>
		<category><![CDATA[science]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=1759</guid>
		<description><![CDATA[In its official response to the AMA’s recent call for a review of marijuana’s status as a Schedule I drug (barring any medical use) under federal law, the White House Office of National Drug Control Policy stated that it would defer to &#8220;the FDA&#8217;s judgment that the raw marijuana plant cannot meet the standards for [...]]]></description>
			<content:encoded><![CDATA[<p>In its official response to the <a href="http://www.latimes.com/news/nationworld/nation/la-na-marijuana-ama11-2009nov11,0,3003312.story?track=rss" target="_blank">AMA’s recent call for a review of marijuana’s status </a>as a Schedule I drug (barring any medical use) under federal law, the White House Office of National Drug Control Policy stated that it would defer to &#8220;the FDA&#8217;s judgment that the raw marijuana plant cannot meet the standards for identity, strength, quality, purity, packaging and labeling required of medicine.&#8221;</p>
<p>While we’re not used to factual accuracy from ONDCP, in this case they’re wrong not once, but twice.</p>
<p><img class="aligncenter size-medium wp-image-1761" title="potje_bedrocan_400" src="http://blog.mpp.org/wp-content/uploads/2009/11/potje_bedrocan_400-300x224.jpg" alt="potje_bedrocan_400" width="300" height="224" /></p>
<p>First, there is absolutely no reason that plant medicines can’t be standardized and controlled for purity and potency. Indeed, the Netherlands has been doing just that for years, with <a href="http://www.cannabisbureau.nl/en/MedicinalCannabis/" target="_blank">medical marijuana distributed in Dutch pharmacies</a> that is “of pharmaceutical quality and complies with the strictest requirements,” according to the Dutch government.</p>
<p>Second, the FDA has never said that a natural plant product can’t be a medicine. Indeed the agency has a lengthy <a href="http://www.fda.gov/downloads/AboutFDA/CentersOffices/CenterforDrugEvaluationandResearch/ucm106136.pdf" target="_blank">“Guidance for Industry: Botanical Drug Products,”</a> specifically designed to aid developers of plant medicines. The document not only doesn’t rule out plants as medicines, it even states, “In the initial stage of clinical studies of a botanical drug, it is generally not necessary to identify the active constituents or other biological markers or to have a chemical identification and assay for a particular constituent or marker.” Given that the active components of marijuana are already well-known and extensively researched, marijuana is well ahead of where the FDA says plant products need to be to start the process of seeking FDA licensing.</p>
<p>Yes, the FDA did put out <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108643.htm" target="_blank">a press release</a> in 2006 saying that “smoked marijuana” had not been shown to be a safe and effective medicine. That statement was utterly unscientific, as <a href="http://www.medscape.com/viewarticle/531038" target="_blank">we pointed out at the time</a>, but it was absolutely not a declaration that the plant could never be a medicine.</p>
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		<slash:comments>56</slash:comments>
		</item>
		<item>
		<title>Drugs That Kill and a Drug That Doesn&#8217;t</title>
		<link>http://blog.mpp.org/medical-marijuana/drugs-that-kill-and-a-drug-that-doesnt/07062009/</link>
		<comments>http://blog.mpp.org/medical-marijuana/drugs-that-kill-and-a-drug-that-doesnt/07062009/#comments</comments>
		<pubDate>Mon, 06 Jul 2009 19:43:43 +0000</pubDate>
		<dc:creator>Bruce Mirken</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[pharmaceuticals]]></category>
		<category><![CDATA[science]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=1063</guid>
		<description><![CDATA[ProCon.org, whose goal is to &#8220;promote critical thinking, education, and informed citizenship&#8221; by presenting information on controversial issues &#8220;in a straightforward, nonpartisan, primarily pro-con format,&#8221; did an interesting experiment recently. They filed a Freedom of Information Act request with the Food and Drug Administration seeking information on reported deaths due to marijuana and 17 FDA-approved [...]]]></description>
			<content:encoded><![CDATA[<p><!--StartFragment--></p>
<p class="MsoNormal"><a href="http://www.procon.org" target="_blank">ProCon.org</a>, whose goal is to &#8220;<span>promote critical thinking, education, and informed citizenship&#8221; by presenting information on controversial issues &#8220;in a straightforward, nonpartisan, primarily pro-con format,&#8221; did an interesting experiment recently. They filed a Freedom of Information Act request with the Food and Drug Administration seeking information on reported deaths due to marijuana and 17 FDA-approved prescription drugs. Five of those drugs were chosen because they are widely used and well known, while the other 12 are used to treat many of the symptoms for which medical marijuana is also used.</span></p>
<p class="MsoNormal"><span>The folks at ProCon.org took the FDA&#8217;s figures and put them into </span><a href="http://medicalmarijuana.procon.org/viewresource.asp?resourceID=145" target="_blank">a detailed report</a><span>, and the results don&#8217;t look good for the pharmaceutical industry.<span id="more-1063"></span><br />
</span></p>
<p class="MsoNormal"><span>The approved drugs, which included anti-nausea drugs, anti-spasmodics, anti-psychotics, and such well-known drugs as Vioxx, Ritalin, and Viagra, were suspected as the primary cause of 10,008 deaths and as a secondary cause in 1,679 more. Marijuana was the primary suspect in zero deaths and a suspected secondary factor in 279.</span></p>
<p class="MsoNormal"><span>A few disclaimers are needed here: First, the FDA&#8217;s reporting system does not attempt to prove definitively that a given drug caused a particular death. It&#8217;s designed to warn of possible dangers, and physicians are encouraged to report suspected reactions. The numbers may well be overestimates of actual deaths related to various drugs.</span></p>
<p class="MsoNormal"><span>Second, the list of drugs compared by ProCon.org doesn&#8217;t completely reflect the pharmaceuticals for which marijuana might substitute. Some might complain, for example, about the inclusion of Vioxx, which was taken off the market due to health risks and which was the suspected main cause of some 4,500 deaths. On the other hand, plenty of other pain drugs that can be toxic weren&#8217;t included, including acetaminophen (the active ingredient in Tylenol), a drug about which an FDA advisory committee recently </span><a href="http://health.usnews.com/articles/health/healthday/2009/06/30/fda-advisers-urge-smaller-doses-of-acetaminophen.html" target="_blank">sounded a warning</a><span> and which is reported to cause hundreds of overdose deaths annually.</span></p>
<p class="MsoNormal"><span>A few weeks ago a TV network news producer told me she found published studies of medical marijuana &#8220;unpersuasive&#8221; because &#8220;they didn&#8217;t show marijuana was better than the other drugs.&#8221; I don&#8217;t know about you, but I think &#8220;less deadly&#8221; pretty definitely qualifies as &#8220;better.&#8221;</span></p>
<p><!--EndFragment--></p>
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		<slash:comments>29</slash:comments>
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		<title>Speaking of Drugs More Dangerous Than Marijuana&#8230;</title>
		<link>http://blog.mpp.org/medical-marijuana/speaking-of-drugs-more-dangerous-than-marijuana/06302009/</link>
		<comments>http://blog.mpp.org/medical-marijuana/speaking-of-drugs-more-dangerous-than-marijuana/06302009/#comments</comments>
		<pubDate>Tue, 30 Jun 2009 19:59:33 +0000</pubDate>
		<dc:creator>Bruce Mirken</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[acetaminophen]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Tylenol]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=1052</guid>
		<description><![CDATA[An FDA panel just recommended reducing the maximum dose of acetaminophen, the active ingredient in Tylenol. Taken by millions of Americans every day as either a stand-alone medication or as an ingredient in various over-the-counter cold remedies, acetaminophen is the leading cause of liver failure in the U.S., resulting in hundreds of deaths by overdose [...]]]></description>
			<content:encoded><![CDATA[<p><!--StartFragment--></p>
<p class="MsoNormal"><img class="aligncenter size-full wp-image-1053" title="images" src="http://blog.mpp.org/wp-content/uploads/2009/06/images.jpeg" alt="images" width="130" height="92" /></p>
<p class="MsoNormal">An FDA panel just recommended <a href="http://www.google.com/hostednews/ap/article/ALeqM5iAaMZR2NEacGDWrzy-QZLjoLO7wQD9955HTG2" target="_blank">reducing the maximum dose of acetaminophen</a>, the active ingredient in Tylenol. Taken by millions of Americans every day as either a stand-alone medication or as an ingredient in various over-the-counter cold remedies, acetaminophen is the leading cause of liver failure in the U.S., resulting in hundreds of deaths by overdose every year.</p>
<p class="MsoNormal">And they say marijuana is too dangerous to be medicine?</p>
<p><!--EndFragment--></p>
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		<slash:comments>62</slash:comments>
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		<item>
		<title>Marijuana, the FDA, and the Broken System of Pharmaceutical Research</title>
		<link>http://blog.mpp.org/medical-marijuana/marijuana-the-fda-and-the-broken-system-of-pharmaceutical-research/09192008/</link>
		<comments>http://blog.mpp.org/medical-marijuana/marijuana-the-fda-and-the-broken-system-of-pharmaceutical-research/09192008/#comments</comments>
		<pubDate>Fri, 19 Sep 2008 22:36:07 +0000</pubDate>
		<dc:creator>Bruce Mirken</dc:creator>
				<category><![CDATA[Medical Marijuana]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[junk science]]></category>
		<category><![CDATA[science]]></category>

		<guid isPermaLink="false">http://blog.mpp.org/?p=136</guid>
		<description><![CDATA[Medical marijuana advocates often hear that marijuana can&#8217;t be a real medicine because it hasn&#8217;t been approved by the FDA. One common response to this is that the Drug Enforcement Administration continues to block the only avenue that could produce the research needed to seek FDA approval for medical marijuana, over a year and half [...]]]></description>
			<content:encoded><![CDATA[<p><!--StartFragment--></p>
<p class="MsoNormal"><a href="http://blog.mpp.org/wp-content/uploads/2008/09/images1.jpeg"><img class="alignnone size-full wp-image-138" title="images1" src="http://blog.mpp.org/wp-content/uploads/2008/09/images1.jpeg" alt="" width="135" height="98" /></a></p>
<p class="MsoNormal">Medical marijuana advocates often hear that marijuana can&#8217;t be a real medicine because it hasn&#8217;t been approved by the FDA. One common response to this is that the Drug Enforcement Administration continues to block the only avenue that could produce the research needed to seek FDA approval for medical marijuana, over a year and half after an administrative law judge <a href="http://www.mpp.org/states/massachusetts/news/judge-backs-professors-bid-to-g.html" target="_blank">ruled that the project should go ahead</a>. </p>
<p class="MsoNormal">But that&#8217;s just the start. The <em>Journal of the American Medical Association </em><span>recently published<a href="http://jama.ama-assn.org/cgi/content/extract/300/9/1069" target="_blank"> a scathing critique of the drug company research that </a></span><em><a href="http://jama.ama-assn.org/cgi/content/extract/300/9/1069" target="_blank">does </a></em><span><a href="http://jama.ama-assn.org/cgi/content/extract/300/9/1069" target="_blank">lead to FDA approval</a>,<span>  </span>demonstrating that the system is even more fundamentally rotten than most of us suspected. The author is Marcia Angell, former editor-in-chief of the </span><em>New England Journal of Medicine</em><span>, arguably the most prestigious medical journal on the planet, and now a professor at Harvard Medical School.<span id="more-136"></span><br />
</span></p>
<p class="MsoNormal">&#8220;Drug companies now finance most clinical research on prescription drugs,&#8221; Angell writes, &#8220;and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer.&#8221; Angell walks readers through a depressing litany of conflicts of interest, showing how researchers, the academic institutions they work for, and even members of FDA review panels are financially in bed with the drug companies whose products they test and evaluate. Drug company control of research on their products is now so complete, she explains, that the companies &#8220;often design the studies; perform the analysis; write the papers; and decide whether, when, and in what form to publish the results.&#8221;</p>
<p class="MsoNormal">Companies controlling research on their products not only skew that research to produce positive results, they suppress negative results that would interfere with marketing &#8212; suppression that, Angell explains, has often only been uncovered as a result of lawsuits or congressional hearings. The bottom line, this esteemed physician and journal editor writes, is that bias in favor of drug company products &#8220;permeates the entire system. <em>Physicians can no longer rely on the medical literature for valid and reliable information </em><span>[italics mine].&#8221;</span></p>
<p class="MsoNormal">Natural marijuana, of course, has no drug company sponsor. And yet we&#8217;re told it can&#8217;t be a real medicine because it hasn&#8217;t been fully run through this broken, biased, dysfunctional system.</p>
<p><!--EndFragment--> </p>
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