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	<title>BioWorld &#187; Vivus Inc</title>
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		<title>It’s the Pounds, Stupid</title>
		<link>http://bioworld.blogs.bioworld.com/2012/05/24/its-the-pounds-stupid/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/05/24/its-the-pounds-stupid/#comments</comments>
		<pubDate>Thu, 24 May 2012 20:58:02 +0000</pubDate>
		<dc:creator>Marie Powers</dc:creator>
				<category><![CDATA[Diabetes]]></category>
		<category><![CDATA[Drug Approval]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Obesity]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Type 2 Diabetes]]></category>
		<category><![CDATA[MPH]]></category>
		<category><![CDATA[MS]]></category>
		<category><![CDATA[Treat French]]></category>
		<category><![CDATA[Vivus Inc]]></category>

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At a family wedding earlier this month, an uncle was salivating over the prospect that the Vivus Inc. drug Qnexa could soon become the first in a new generation of obesity drugs to gain FDA approval. He needed to lose...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/05/Blog-May-24-20125.jpg" rel="shadowbox[sbpost-939];player=img;"><img class="alignleft size-thumbnail wp-image-948" src="http://bioworld.blogs.bioworld.com/files/2012/05/Blog-May-24-20125-150x149.jpg" alt="" width="150" height="149" /></a>At a family wedding earlier this month, an uncle was salivating over the prospect that the <a href="http://www.vivus.com/" target="_blank">Vivus Inc.</a> drug <a href="http://www.bioworld.com/content/obesity-drug-qnexa-scores-knockout-emdac-bout?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo1OiJRbmV4YSI7fQ==" target="_blank">Qnexa</a> could soon become the first in a new generation of obesity drugs to gain <a href="http://www.fda.gov/" target="_blank">FDA</a> approval. He needed to lose 50 pounds, he confided, and the drug seemed the answer to his prayers. Since we’ve written extensively about <a href="http://www.bioworld.com/content/obesity-drugs-underweight-market-seeks-sales-growing-problem?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo4OiJGZW4tUGhlbiI7fQ==" target="_blank">obesity</a> and these drugs in <a href="http://www.bioworld.com/" target="_blank"><em>BioWorld Today</em></a>, he wanted my opinion.</p>
<p><span id="more-939"></span></p>
<p>I politely inquired whether he had considered dieting and exercise, which could produce similar results without the potential side effects of a prescribed drug – especially one in a category that’s been dogged by <a href="http://www.bioworld.com/content/emdac-digesting-benefits-risks-obesity-drugs?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo1OiJRbmV4YSI7fQ==" target="_blank">cardiovascular risks</a>.</p>
<p>“That’s just too hard,” my uncle replied, with a mixture of helplessness and disdain.</p>
<p>Sadly, that’s exactly the attitude parents seem to be passing on to their children, and the results have been catastrophic.</p>
<p>Last week, the journal <a href="http://pediatrics.aappublications.org/" target="_blank"><em>Pediatrics</em></a> published <a href="http://pediatrics.aappublications.org/content/early/2012/05/15/peds.2011-1082.full.pdf+html?sid=98c0bb39-f813-4c64-901d-53e695e68d95" target="_blank"><em>Prevalence of Cardiovascular Disease Risk Factors Among U.S. Adolescents, 1999-2008</em></a>, which provided a sobering look at the twin epidemics of obesity and <a href="http://diabetes.niddk.nih.gov/dm/pubs/overview/index.aspx" target="_blank">diabetes</a> in teenagers.</p>
<p>Authors Ashleigh L. May, MS, PhD, Elena V. Kuklina, MD, PhD, and Paula W. Yoon, ScD, MPH, of the <a href="http://www.cdc.gov/" target="_blank">U.S. Centers for Disease Control and Prevention</a> in Atlanta concluded that obesity in the teenage population was unchanged, with one in three adolescents between the ages of 12 and 19 officially overweight or obese, with a <a href="http://www.nhlbisupport.com/bmi/" target="_blank">body mass index</a> of 25 to 30 or greater than 30, respectively. That figure is shocking in its own right.</p>
<p>But the horrifying change was a doubling in the prevalence of <a href="http://diabetes.niddk.nih.gov/dm/pubs/insulinresistance/" target="_blank">prediabetes</a> and diabetes in teens over the same period, from 9 percent to 23 percent, along with cardiovascular disease risk factors formerly seen only in adults.</p>
<p>Really, parents? What part of this picture do you not understand?</p>
<p>Diabetes is a devastating chronic condition that can cause life-changing complications such as nerve damage, blindness, amputation, kidney damage, heart attack, stroke and, of course, death. And unlike the pounds that can be shed from an overweight teen, diabetes is irreversible and incurable. It’s a life sentence.</p>
<p>What’s the best prevention for <a href="http://diabetes.niddk.nih.gov/dm/pubs/type2_ES/" target="_blank">Type II diabetes</a>, which results from lifestyle factors and accounts for more than 90 percent of cases of the disease? Not a pill or a shot, but simple exercise and a diet that maintains normal body weight.</p>
<p>No right-minded parent would push their child in front of a moving train, but that’s exactly what many parents are doing when it comes to the health of their children. It’s hard – but not too hard – to fix that. Trust me. I raised two teens and I’ve heard all the excuses.</p>
<p>For starters, get them off the couch before their only muscles are located in the fingers that do their texting. Make them walk the dog, cut the grass, take out the trash and ride a bike. Even better, encourage them to play soccer, swim, or run track. I started jogging at the age of 40 with my 12-year-old daughter, who wanted to make her middle school basketball team. It’s turned into a family pastime.</p>
<p>Substitute milk or water for soda. Treat French fries as a luxury instead of a staple. Give them carrots and celery – without the dip. Contrary to popular belief, fresh vegetables are cheap and don’t require a culinary degree to prepare. The <a href="http://www.usda.gov/wps/portal/usda/usdahome" target="_blank">U.S. Department of Agriculture’s</a> <a href="http://www.choosemyplate.gov/" target="_blank">ChooseMyPlate.gov</a> offers simple <a href="http://www.choosemyplate.gov/healthy-eating-on-budget.html" target="_blank">tips</a> for healthy eating on a budget.</p>
<p>And while you’re at it, take the same medicine, because children are smart. They watch their parents sit on their smartphones, upsize their burgers and guzzle their mocha Frappuccinos, and believe those habits signify adulthood. Instead, many children are slowly being steered into a lifetime of blood sugar monitoring, special diets and medications – and that’s if they’re lucky enough to avoid the more dreadful complications of diabetes.</p>
<p>Which brings me back to my uncle. It’s one thing for a 60-something adult to pack on 50 extra pounds and become a ticking time bomb, all the while hoping the approval of Qnexa, <a href="http://www.bioworld.com/content/orexigen-adding-90m-publicly-ready-contrave-cvot-trial?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo4OiJDb250cmF2ZSI7fQ==" target="_blank">Contrave</a>  or <a href="http://www.bioworld.com/content/arena-scores-emdac-vote-lorcaserin-expanded-contract?c2VhcmNoX3dvcmQ9YToxOntpOjA7czo1OiJRbmV4YSI7fQ" target="_blank">lorcaserin</a> will avert an explosion. It’s quite another for an adolescent to face the same potential fate.</p>
<p>Parents need to step up to the plate, and make it a healthier one, at that. The future of our children is too important to abdicate this responsibility to ignorance or indifference.</p>
<p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Fbioworld.blogs.bioworld.com%2F2012%2F05%2F24%2Fits-the-pounds-stupid%2F&amp;title=It%E2%80%99s%20the%20Pounds%2C%20Stupid" id="wpa2a_2"><img src="http://bioworld.blogs.thompson.com/wp-content/plugins/add-to-any/share_save_171_16.png" width="171" height="16" alt="Share"/></a></p>]]></content:encoded>
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		<item>
		<title>Indecent Disclosure: The Press Release Balancing Act</title>
		<link>http://bioworld.blogs.bioworld.com/2011/05/04/indecent-disclosure-the-press-release-balancing-act/</link>
		<comments>http://bioworld.blogs.bioworld.com/2011/05/04/indecent-disclosure-the-press-release-balancing-act/#comments</comments>
		<pubDate>Wed, 04 May 2011 15:57:38 +0000</pubDate>
		<dc:creator>Trista Morrison</dc:creator>
				<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[Complete Response Letter]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Adam Feuerstein]]></category>
		<category><![CDATA[Cell Therapeutics Inc]]></category>
		<category><![CDATA[Vivus Inc]]></category>

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Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2011/05/16212CBI.jpg" rel="shadowbox[sbpost-120];player=img;"><img class="alignleft size-thumbnail wp-image-121" src="http://bioworld.blogs.bioworld.com/files/2011/05/16212CBI-150x150.jpg" alt="" width="150" height="150" /></a>Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news.</p>
<p><span id="more-120"></span></p>
<p>Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial.” Not until the second paragraph did readers find out the most important tid-bit: that the FDA had denied their appeal regarding the cancer drug, which received a complete response letter last year.</p>
<p>Meanwhile, Vivus Inc. issued first quarter earnings late Monday, but the piece of news everyone was most interested in – the path forward for obesity drug Qnexa (phentermine/topiramate) following its complete response letter – didn’t emerge until the fourth paragraph.</p>
<p>Other companies seem to think everything they do is newsworthy. The Street’s Adam Feuerstein wrote a funny post yesterday on Cel-Sci Corp.’s apparent need to issue 16 press releases regarding the start of a Phase III trial with immunotherapy Multikine for head and neck cancer: <a title="http://www.thestreet.com/story/11103809/1/cel-sci-the-multikine-sweet-16.html/" href="http://bit.ly/l4K3ZH" target="_blank">http://bit.ly/l4K3ZH</a></p>
<p>Another guilty party in this category is <strong>Spencer</strong> Pharmaceuticals Inc., which issued a string of press releases last fall announcing a dinner with acquirer Al-Dora, then that the dinner had been postponed, and then that the dinner had been confirmed. <a href="http://bit.ly/eCl8n3" target="_blank">http://bit.ly/eCl8n3</a></p>
<p>While investors might have been interested in a play-by-play of Spencer’s dining plans, if I held the stock, I’d be more curious just how much money they’re spending with PR Newswire.</p>
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