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	<title>Karen De Coster &#187; FDA</title>
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		<title>Pay Big Bucks to Get Hysterical</title>
		<link>http://karendecoster.com/pay-big-bucks-to-get-hysterical.html</link>
		<comments>http://karendecoster.com/pay-big-bucks-to-get-hysterical.html#comments</comments>
		<pubDate>Wed, 12 May 2010 01:31:20 +0000</pubDate>
		<dc:creator>Karen De Coster</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[genomic medicine]]></category>

		<guid isPermaLink="false">http://karendecoster.com/?p=9426</guid>
		<description><![CDATA[Personalized genomic medicine &#8211; at a Walgreens near you! From an article in the Washington Post: Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer&#8217;s disease, breast [...]]]></description>
			<content:encoded><![CDATA[<p>Personalized genomic medicine &#8211; <a href="http://www.newser.com/story/88386/drugstores-will-sell-genetic-tests.html">at a Walgreens</a> near you! From <a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/05/10/AR2010051004904.html?hpid=topnews">an article in the </a><em><a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/05/10/AR2010051004904.html?hpid=topnews">Washington Post</a></em>:</p>
<blockquote><p>Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer&#8217;s disease, breast cancer, diabetes and other ailments.</p>
<p>The test also claims to offer a window into the chances of becoming obese, developing psoriasis and going blind. For those thinking of starting a family, it could alert them to their risk of having a baby with cystic fibrosis, Tay-Sachs and other genetic disorders. The test also promises users insights into how caffeine, cholesterol-lowering drugs and blood thinners might affect them.</p>
</blockquote>
<p>While the FDA is drooling to declare this &#8220;illegal,&#8221; and wrongly so (because the FDA never does anything good or right), such a genetic &#8220;self-assessment&#8221; in the hands of dependent Americans who are hooked on Big Pharma&#8217;s &#8220;magic&#8221; will be a huge windfall for &#8230;&#8230; well, Big Pharma and the monopoly medical establishment. Can you imagine all of the self-diagnosed &#8220;diseases&#8221; people would ultimately suffer from, and all the pills that will be needed to steer clear from all of the (purported) propensities toward illness and disease?</p>
<p>Note that the FDA appears to be fine with <a href="http://karendecoster.com/got-fat-take-drugs.html">approving &#8220;anti-obesity&#8221; drugs</a>.</p>
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		<title>The State&#8217;s New Lifestyle Demons: Tanning and Salt</title>
		<link>http://karendecoster.com/the-states-new-lifestyle-demons-tanning-and-salt.html</link>
		<comments>http://karendecoster.com/the-states-new-lifestyle-demons-tanning-and-salt.html#comments</comments>
		<pubDate>Thu, 22 Apr 2010 01:53:30 +0000</pubDate>
		<dc:creator>Karen De Coster</dc:creator>
				<category><![CDATA[Lifestyle Fascism]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[food nazis]]></category>
		<category><![CDATA[salt]]></category>
		<category><![CDATA[tanning salons]]></category>

		<guid isPermaLink="false">http://karendecoster.com/?p=9241</guid>
		<description><![CDATA[A lead story in the news this week has been the latest in a series of propaganda pieces on tanning beds: they are bad for you. The story now goes that tanning salons are bad because they attract people with addictive behavioral patterns. Some dermatology study was produced that will become another piece of ammunition [...]]]></description>
			<content:encoded><![CDATA[<p>A lead story in the news this week has been the latest in a series of propaganda pieces on tanning beds: <a href="http://www.aolnews.com/health/article/study-tanning-salon-clients-show-addictive-behavior/19443265">they are bad for you</a>. The story now goes that tanning salons are bad because they attract people with addictive behavioral patterns. Some dermatology study was produced that will become another piece of ammunition for the proposed taxes on tanning.</p>
<p>The title of the piece in the <em><a href="http://archderm.ama-assn.org/current.dtl">Archives of Dermatology</a></em> is, &#8220;Addiction to Indoor Tanning: Relation to Anxiety, Depression, and Substance Use.&#8221; I can&#8217;t wait to see the science behind that correlation. Tanning salon customers, it is said, are prone to using drugs, alcohol, and smoking. I guess that&#8217;s sort of like saying people who are attracted to Florida condominiums are prone to arthritis, bingo, and aging.</p>
<p>After the government&#8217;s long and destructive &#8220;war&#8221; on the sun, it has been widely reported &#8211; even in the mainstream press &#8211; that people are lacking in Vitamin D, and the whole obsession with high-SPF sunscreen <a href="http://www.naturalnews.com/001264.html">has been misplaced</a>. The Lifestyle Nazis, for some reason, just hate tanning salons. They hate that people freely make the choice to exchange their cash for time &#8216;neath the artificial bulbs. I kind of like the argument that the <a href="http://article.wn.com/view/2010/03/30/Tanning_Salon_Tax_Is_Racist_Says_Doc_Thompson_FillIn_Host_Fo/">tanning salon tax is racist</a>. Note the dermatologist in the video who states, &#8220;The tanning salons know their days are numbered.&#8221;</p>
<p>Next &#8230;</p>
<p>Lo and behold &#8211; yesterday, after months/years of rumblings, t<a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/04/19/AR2010041905049_pf.html">he FDA announced its long-term plan</a> for controlling the kind of food you can access.</p>
<blockquote><p>The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans, saying that less sodium in everything from soup to nuts would prevent thousands of deaths from hypertension and heart disease. The initiative, to be launched this year, would eventually lead to the first legal limits on the amount of salt allowed in food products.</p>
<p>&#8230;The legal limits would be open to public comment, but administration officials do not think they need additional authority from Congress.</p>
</blockquote>
<p>Legal limits on salt in processed foods. And the FDA has unlimited authority to bypass your (equally totalitarian) elected legislature. One source from the FDA stated that the government&#8217;s goal is to change the &#8220;embedded tastes in a whole generation of people&#8221; &#8230;.. by slowly boiling the frog, that is. This will be a 10-year program of gradual totalitarianism, as the Feds work to slooooowly change your personal taste. They will gradually lower the allowed limits on salt and wean you off the &#8220;taste.&#8221; Excuse me &#8211; &#8220;embedded taste?&#8221; I am being completely objective, here, as I do not ever eat <span style="text-decoration: line-through;">landfill</span> processed foods. But it&#8217;s a choice, and no matter how bad a choice, some people choose it.</p>
<p>One of my most hated tyrants in all the land, Michael Jacobson of the Center for Science in the Public Interest, stated, <em>&#8220;Limiting sodium might be the single most important thing the FDA can to do to promote health.&#8221;</em></p>
<p>Accordingly, we know that this has nothing to do with some great concern for the health of individuals. For the same state that rails against processed food makers enables and subsidizes the foods &#8211; processed and agriculture &#8211; that have been making Americans obese and disgustingly unhealthy for decades. These subsidies have been luring Americans away from more expensive, healthy, whole foods (that actually take time to prepare) and toward quick-and-easy processed, garbage foods. The salt grab is another control tactic to be used to socially engineer society under the guidance of the self-aggrandizing Central Planners.</p>
<p>Ask yourself this question: after the FDA/Department of Agriculture/Feds limit the amount of salt in the processed foods you buy, what do you do when you cook it at home? Hmmmm, add salt from your salt shaker? Is it really that easy? Yes, that is, until you need a special license to have a salt shaker and buy salt, and jack-booted thugs from the FDA are kicking in your door for a salt shaker search.</p>
<p><em><br />
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		<title>Big Pharma Has You By the Balls</title>
		<link>http://karendecoster.com/big-pharma-has-you-by-the-balls.html</link>
		<comments>http://karendecoster.com/big-pharma-has-you-by-the-balls.html#comments</comments>
		<pubDate>Sat, 19 Dec 2009 11:25:14 +0000</pubDate>
		<dc:creator>Karen De Coster</dc:creator>
				<category><![CDATA[Big Pharma]]></category>
		<category><![CDATA[Health Tyranny]]></category>
		<category><![CDATA[Crestor]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://karendecoster.com/?p=7922</guid>
		<description><![CDATA[Despite the maddening nature of this paragraph from an article in the Wall Street Journal Pharmaceutical Daily, hardly no one who reads the story will notice it: A measure to allow the importation of cheaper prescription drugs from Canada and some other countries fell short in the Senate Tuesday night, but lawmakers were working on [...]]]></description>
			<content:encoded><![CDATA[<p>Despite the maddening nature of this paragraph <a href="http://online.wsj.com/article/SB126093494955393151.html?mod=djemHL">from an article</a> in the <em><span style="text-decoration: line-through;">Wall Street Journal</span> Pharmaceutical Daily</em>, hardly no one who reads the story will notice it:</p>
<blockquote><p>A measure to allow the importation of cheaper prescription drugs from Canada and some other countries fell short in the Senate Tuesday night, but lawmakers were working on other ways to squeeze concessions from the pharmaceutical industry.</p>
</blockquote>
<p>If you have read that correctly, you will note that certain members of our Senate body are begging the wealthy and powerful pharmaceutical interests to <em>allow</em> the (formerly) free people of the United States to voluntarily purchase prescription drugs from other countries where the drugs are cheaper and Big Pharma does not influence and run the federal government. Another snippet from the article:</p>
<blockquote><p>Pharmaceutical makers opposed the measure, saying the U.S. couldn&#8217;t ensure the safety of drugs from Canada, Europe, Japan and Australia.</p>
</blockquote>
<p>I repeat: &#8220;pharmaceutical makers opposed the measure&#8230;&#8221; Therefore, they have bought an appropriate number of politicians so they can be assured that Americans are not able to freely contract with retailers in other countries who can offer a lower price. The totalitarian American political system (along with those who continue to elect its agents and thereby sanction the current system) allows this racket to continue without a single challenge. No media outlet is ashamed of arrogantly admitting to, and admiring, the clout of America&#8217;s omnipotent corporate state giants.</p>
<p>In <a href="http://online.wsj.com/article/SB10001424052748704398304574598402303007392.html?mod=djemHL">a related story</a>, Big Pharma giant AstraZeneca has the power of the FDA behind it in its latest attempt to deceive and dope up hapless Americans who have been taken captive by the fear mongering of the tyrannical medical mainstream. The drug maker&#8217;s cholesterol-lowering drug Crestor has fallen flat on revenues, and the typical backup plan with these patent-protected drugs that run of steam is to find another use for them that seems necessary and good, and promote it heavily to paid-for politicians, their FDA operatives, and the duped public.</p>
<p>So what is this miracle cure claimed for Crestor that &#8230; just &#8230; came out of nowhere? Crestor is now &#8220;a preventative treatment for cardiovascular disease.&#8221; The FDA&#8217;s panel of &#8220;outside medical experts&#8221; voted 12-4 to recommend that the &#8220;FDA broaden the indication for Crestor as a preventative treatment for cardiovascular disease.&#8221; Yes, these are the same &#8220;medical experts&#8221; who are paid by the industry and drug makers they recommend. The WSJ article discusses a study called &#8220;Jupiter&#8221; in which patients on Crestor were compared to patients receiving a placebo or fake pill. The study was the usual dose of logical fallacy whereby correlation proves causation. In fact, the article states that &#8220;the study results were so strong that the study was stopped early.&#8221; Note that the FDA usually follows the panel&#8217;s recommendations.</p>
<p>During the panel meeting, &#8220;the FDA said there was a &#8220;statistically significant&#8221; increase in the number of patients who developed diabetes in the Crestor group compared to the placebo group,&#8221; and also, &#8220;there were 13 deaths due to gastrointestinal disorders compared to one in the placebo group, but the FDA said a further review of the deaths suggest the &#8220;imbalance is a chance finding,&#8221; a view with which the panel agreed.&#8221; In addition, &#8220;18 patients in the Crestor arm of the study reported a &#8220;confusional state&#8221; compared to four in the placebo group, but the panel also said it wasn&#8217;t likely Crestor played a role in the imbalance.&#8221; (So, correlation proves causation, but only when convenient &#8211; such as when it accommodates the end goals of increased patent protection and billions of dollars in profits.) How advantageous is it to pay the salaries of the &#8220;experts&#8221; who influence whether or not your drug is deemed the next patented miracle cure for a whole host of diseases?</p>
<p>To understand the timing of this Crestor news about its new miracle cure, please see <a href="http://www.reuters.com/article/idUSLDE5BD08V20091214?type=swissMktRpt">related information about AstraZeneca&#8217;s patent battles</a> for Crestor. AstraZeneca is losing its grip on Crestor as a revenue machine. Therefore, the company is scrambling to keep the drug alive. Accordingly, an <a href="http://www.reuters.com/article/idUSN1125957420091211">article on Reuters </a>states this:</p>
<blockquote><p><span id="articleText"> Gbola Amusa of UBS believes the Jupiter results could expand the overall statin market by 20 percent to 50 percent in volume terms, lifting AstraZeneca&#8217;s Crestor sales to some $8 billion in 2012 from $3.6 billion last year.</span></p>
</blockquote>
<p><span>For related Big Pharma lies and abuses, see:</span></p>
<p><span> &#8220;<a href="http://karendecoster.com/pharmaceutical-tyranny.html">Tyranny of the Pharmaceutical-Congressional-Medical Complex</a>.&#8221;</span></p>
<p><span>Also see &#8220;<a href="http://karendecoster.com/big-day-for-big-pharma.html">Big Day for Big Pharma</a>.&#8221;<br />
 </span></p>
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		<title>FDA on Another Shakedown</title>
		<link>http://karendecoster.com/fda-on-another-shakedown.html</link>
		<comments>http://karendecoster.com/fda-on-another-shakedown.html#comments</comments>
		<pubDate>Mon, 16 Nov 2009 18:36:15 +0000</pubDate>
		<dc:creator>Karen De Coster</dc:creator>
				<category><![CDATA[Totalitarian Government]]></category>
		<category><![CDATA[alcohol]]></category>
		<category><![CDATA[caffeine]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://karendecoster.com/?p=7657</guid>
		<description><![CDATA[From today&#8217;s Wall Street Journal: The Food and Drug Administration is taking aim at caffeinated alcoholic drinks, saying it will pull them off the market unless manufacturers can prove the beverages are safe to drink. On Friday, the FDA sent letters to nearly 30 companies, giving them 30 days to provide evidence that their drinks [...]]]></description>
			<content:encoded><![CDATA[<p>From today&#8217;s <a href="http://online.wsj.com/article/SB125816088527947933.html?mod=djemHL"><em>Wall Street Journal</em></a>:</p>
<blockquote><p>The Food and Drug Administration is taking aim at caffeinated alcoholic drinks, saying it will pull them off the market unless manufacturers can prove the beverages are safe to drink.</p>
<p>On Friday, the FDA sent letters to nearly 30 companies, giving them 30 days to provide evidence that their drinks don&#8217;t pose health or safety risks. The FDA hasn&#8217;t approved the use of caffeine in alcoholic beverages, and companies might have to show that experts generally think mixing caffeine and alcohol is safe for consumers.</p>
</blockquote>
<p>The government just hates all of these modern beverages loaded with all kinds of stimulants that it knows little about, but loves to demonize. The <a href="http://en.wikipedia.org/wiki/Ephedra">anti-Ephedra campaign</a> is still going on. Look, I am the last person to like these horrible beverages with all of the sugar or stimulants in them. Most people are too sedentary to be drinking this stuff as much as they do. The marketing of these products is geared toward enticing people into the &#8220;easy energy&#8221; fix. The perfect customers for such gimmicks are lazy, high time preference Americans who are easily swayed by the &#8220;instant energy&#8221; advertising hooks. But these choices belong to the individual. As to the alcohol drinks that contain caffeine &#8211; why doesn&#8217;t the FDA have to prove that these drinks <em>do pose</em> a safety risk before they are yanked off the shelf and branded an unsafe product? Why then, isn&#8217;t the FDA concerned about establishments that serve <a href="http://coffeetea.about.com/od/hotcoffeealc/tp/spirits.htm">coffee drinks</a>? Perhaps in the near future, the FDA will be busting down my door to confiscate my Starbucks Barista coffee maker and my Kahlua, Courvoisier, and Irish Cream liquors.</p>
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		<title>Big Day for Big Pharma</title>
		<link>http://karendecoster.com/big-day-for-big-pharma.html</link>
		<comments>http://karendecoster.com/big-day-for-big-pharma.html#comments</comments>
		<pubDate>Sat, 17 Oct 2009 12:48:06 +0000</pubDate>
		<dc:creator>Karen De Coster</dc:creator>
				<category><![CDATA[Big Pharma]]></category>
		<category><![CDATA[Health Tyranny]]></category>
		<category><![CDATA[cervarix]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[gardasil]]></category>

		<guid isPermaLink="false">http://karendecoster.com/?p=7184</guid>
		<description><![CDATA[In a previous blog, I mentioned a couple of points about Merck&#8217;s Gardasil and GlaxoSmithKline&#8217;s Cervarix, with both companies competing for guinea pigs to increase their customer base for HPV vaccines. First, GlaxoSmithKline had applied to the FDA for approval to sell its HPV vaccine, Cervarix, in the United States. Second, Merck had applied to [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://karendecoster.com/pharmaceutical-tyranny.html">In a previous blog</a>, I mentioned a couple of points about Merck&#8217;s Gardasil and GlaxoSmithKline&#8217;s Cervarix, with both companies competing for <a href="http://www.lewrockwell.com/blog/lewrw/archives/38730.html">guinea pigs</a> to increase their customer base for HPV vaccines. First, GlaxoSmithKline had applied to the FDA for approval to sell its HPV vaccine, Cervarix, in the United States. Second, Merck had applied to the FDA for approval of its HPV vaccine, Gardasil, as a vaccine for <strong>boys</strong> and men to prevent genital warts. Both vaccines are touted as offering &#8216;protection&#8217; against the more common strains of HPV. <a href="http://www.gardasilaccessprogram.org/x/File/emea-leaflet-h703en%20PPI.pdf">Merck claims that Gardasil protects</a> against the four most common strains of HPV: types 6, 11, 16 and 18, with HPV types 16 and 18 accounting for 70% of cervical cancers and HPV types 6 and 11 accounting for 90% of all cases of genital warts. Glaxo claims protection from strains 16 and 18 with its Cervarix.</p>
<p>When Merck could smell its competition coming up behind &#8216;em as Cervarix was destined for approval in the U.S., it began to promote Gardasil as an effective tool in the prevention of genital warts in <strong>boys</strong> and men (ages 9-26). Glaxo also claimed protection against an additional strain (strain 31) of the HPV virus, so it could differentiate its product, too. Meanwhile, the <a href="http://www.lewrockwell.com/blog/lewrw/archives/38730.html">deaths of Natalie Morton and Stacy Jones</a> (in the UK), both occurring after Cervarix shots, were quietly brushed aside and/or covered up. <a href="http://www.bloomberg.com/apps/news?pid=20601103&amp;sid=aA60zcLRsbKQ">This week</a> the FDA <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm">approved the use of Gardasil</a> for males for prevention of genital warts and it <a href="http://finance.yahoo.com/news/FDA-approves-Glaxos-cervical-apf-2176177020.html?x=0&amp;sec=topStories&amp;pos=3&amp;asset=&amp;ccode">approved Cervarix</a> for use in the U.S. This is from <a href="http://www.bloomberg.com/apps/news?pid=20601103&amp;sid=aA60zcLRsbKQ">the Bloomberg story</a> on Gardasil&#8217;s new approval:</p>
<blockquote><p>Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.</p>
<p>“This is an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus,” said Richard Haupt, executive director of Merck Research Laboratories, in the company&#8217;s statement.</p>
</blockquote>
<p>However, when researchers use their QALY formula (quality adjusted life years), analysts say that the &#8220;public-health benefit may not outweigh the expense.&#8221; Of course, the story later reports what we all know from educating ourselves about this dilemma: &#8220;While 20 million Americans are infected with HPV, most will be able to fight off the infection naturally.&#8221; Thus, there is no need for a vaccine other than making big bucks for Big Pharma by scaremongering people into believing they must have protection for every disease, every wart, every headache, every pimple, every fall, every sneeze, and every imagined disorder. Thanks to all the readers (there were many) so sent links to me related to the FDA&#8217;s approval.</p>
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