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	<title>Avelient BioPharm Blog &#187; Sociology</title>
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	<link>http://avelient.com/BioPharmBlog</link>
	<description>A blog on Biotech, the Pharmaceutical industry, and Personal Health</description>
	<pubDate>Wed, 19 Nov 2008 02:36:22 +0000</pubDate>
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	<language>en</language>
			<item>
		<title>Obesity and Our Bacterial Friends</title>
		<link>http://avelient.com/BioPharmBlog/2008/11/13/obesity-and-our-bacterial-friends/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/11/13/obesity-and-our-bacterial-friends/#comments</comments>
		<pubDate>Thu, 13 Nov 2008 05:24:26 +0000</pubDate>
		<dc:creator>Scott Alexander</dc:creator>
		
		<category><![CDATA[Personal Health]]></category>

		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[bacteria]]></category>

		<category><![CDATA[obesity]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=294</guid>
		<description><![CDATA[One of the persistent arguments in today&#8217;s world is whether obesity is in our genes or something that can be controlled by diet and exercise (and a good night&#8217;s sleep and low stress and &#8230;).  On my way drive home from work last week, I heard a very interesting story on NPR about research on the [...]]]></description>
			<content:encoded><![CDATA[<p>One of the persistent arguments in today&#8217;s world is whether obesity is in our genes or something that can be controlled by diet and exercise (and a good night&#8217;s sleep and low stress and &#8230;).  On my way drive home from work last week, I heard a very interesting story on NPR about research on the effect of gut bacteria on weight gain/loss.</p>
<p>Studies compared mice born and kept in a sterile environment with no bacteria in their gut against mice born and kept in a non-sterile environment.  Both sets of mice were fed the same amount of food.  The bacteria-free mice stayed skinny while the mice with gut bacteria gained weight.  The reason is that the bacteria in the intestines of the mice raised in a non-sterile environment were able to break down the food and turn it into calories, while the food passed right through the intestines of the bacteria-free mice undigested.</p>
<p>These findings beg the question: can we manipulate the bacteria in our intestines in order to control weight gain or loss?  For more information on the research and its implications, check out the printed article on the NPR website <a href="http://www.npr.org/templates/story/story.php?storyId=95900616" target="_blank">here</a>.</p>
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		</item>
		<item>
		<title>Are your Political Views Biologically Programmed?</title>
		<link>http://avelient.com/BioPharmBlog/2008/11/04/are-your-political-views-biologically-programmed/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/11/04/are-your-political-views-biologically-programmed/#comments</comments>
		<pubDate>Tue, 04 Nov 2008 04:01:38 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[democrat]]></category>

		<category><![CDATA[political]]></category>

		<category><![CDATA[republican]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=284</guid>
		<description><![CDATA[I was sitting down for a drink the other day with a longtime friend when the topic of politics came up for discussion.  Growing up in Massachusetts, I rarely encountered somebody of a conservative mindset, let alone someone who would admit to being so in such a heavily democratic state, so I had always assumed [...]]]></description>
			<content:encoded><![CDATA[<p><img class="align-left size-medium wp-image-283" title="0512-0801-1418-4009" src="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/11/0512-0801-1418-4009.jpg" alt="" width="100" height="76" /><img class="size-medium wp-image-282 align-left" title="0512-0801-1418-3556" src="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/11/0512-0801-1418-3556.jpg" alt="" width="100" height="84" />I was sitting down for a drink the other day with a longtime friend when the topic of politics came up for discussion.  Growing up in Massachusetts, I rarely encountered somebody of a conservative mindset, let alone someone who would admit to being so in such a heavily democratic state, so I had always assumed she was a democrat.  Much to my surprise, she wasn&#8217;t, and staunchly so.  She had grown up in the same type of environment I had, and she had been exposed to the same propaganda, and I thought had pretty much the same views that I had when it came to how an ideal world should work.</p>
<p>I think the surprise must have registered pretty immediately on my face, because she seemed almost apologetic after that; not apologetic for her views as a republican, but for the shock she had just imparted on me. For me it was just more of a surprise that my assumption was incorrect.<span id="more-284"></span></p>
<p>I remember the first time I really cared about politics was the election of 1984, a landslide victory of Regan against Mondale.  I was around 10 years old at the time and remember arguing with my grandparents, whom I had discovered had voted republican, about why they were wrong to have voted the way they did.  I didn&#8217;t understand anything about politics and only had a vague understanding of the classic Democratic platform vs. the classic Republican platform, but I remember being so passionate that I actually tried to convince them that what they were doing was bad for the country.  Seriously?  What did I know?</p>
<p>The fact is, that response may have been pre-programmed in me, according to a new study I just read about <a title="Born to Party" href="http://www.boston.com/bostonglobe/ideas/articles/2008/11/02/born_to_party/" target="_blank">in the Boston Globe</a>.  The article, by Eve LaPlante and published on November 2nd, argues that our reactions to politics may be more related to how we feel in our gut about an issue more than our rationalization of it.  This theory and the associated study, coauthored by several political scientists driving an emerging field called &#8220;political physiology,&#8221; challenges the notion that poticial views are nurtured rather than ingrained in our psyche based on our environment.  The hypothesis is that when we debate on issues, we&#8217;re asserting our individuality rather than trying to make a political point.</p>
<p>The scientists in the study say that people with different political views perceive the world differently:</p>
<blockquote><p>Conservatives are more easily startled by threats, and when performing a habitual task they have more difficulty switching to a new response. Liberals, on the other hand, react less vigorously to threatening stimuli, and in performing a habitual task they are quicker to provide a new response.(1)</p></blockquote>
<p>This theory that there could be some genetic basis to political views was first borne out in a study done with identical and fraternal twins at Rice University, published in 2005 in the American Political Science Review.  In their examination of thousands of sets of volunteers, identical twins were far more likely to share political views than their fraternal counterparts.  The conclusion was that 40-50% of political and social attitudes are heritable, and therefore significantly influenced by some genetic component.</p>
<p>The research team, using the Rice University study as a basis for their hypothesis, conducted experiments using images and sounds to evoke responses from their subjects and used their reaction as a marker for their political disposition.  The study found that test subjects&#8217; responses to these stimuli, specifically what they felt threatened by, ended up being reliable predictors of their conservative or liberal values.</p>
<p>One of the most frustrating things as a liberal or as a conservative is not being able to understand why anyone would not think the same way you do.  Doubly frustrating is the inability to understand the opposing person&#8217;s thought process, and why they may choose a path that to you is so obviously wrong.  Perhaps this study shows us that our tendency towards one end of the spectrum or another is not only shaped by our experiences, but how we&#8217;re wired to perceive those experiences through time.</p>
<p>My friend did surprise me with her revelation that day, but I never felt like I would hold it against her.  I know many conservatives and liberals, and think no less of them if their views differ from mine.  Our forefathers wrote the Constitution well aware of the diversity of opinions that shape who we are, and seemed to understand that we could find strength in our diversity.  Though political rhetoric sometimes rules Washington, I am hopeful that as we understand what drives our political instinct we can more harmoniously determine a path for this country that will deliver us through the next 219 years.</p>
<p>What do you think?</p>
<p>(1) &#8220;<a title="Boston.com: Born to party" href="http://www.boston.com/bostonglobe/ideas/articles/2008/11/02/born_to_party/?page=2" target="_blank">Born to party</a>&#8220;, Boston.com, Eve LaPlante, November 22nd, 2008, pg2.</p>
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		<item>
		<title>Compassionate Use for Investigational Drugs</title>
		<link>http://avelient.com/BioPharmBlog/2008/10/14/compassionate-use-for-investigational-drugs/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/10/14/compassionate-use-for-investigational-drugs/#comments</comments>
		<pubDate>Tue, 14 Oct 2008 05:01:45 +0000</pubDate>
		<dc:creator>Scott Alexander</dc:creator>
		
		<category><![CDATA[Legal]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[compassionate use]]></category>

		<category><![CDATA[expanded access program]]></category>

		<category><![CDATA[named patient program]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=257</guid>
		<description><![CDATA[In the Avelient BioPharm Blog article &#8220;A Brief FDA History Lesson&#8220;, Mariano Di Fabio provided some background on the events that lead to the establishment of the FDA&#8217;s current clinical trial framework, and he questioned if this framework should be changed so that experimental drugs could be released for use by terminally ill patients.  Mariano [...]]]></description>
			<content:encoded><![CDATA[<p>In the Avelient BioPharm Blog article &#8220;<a href="http://avelient.com/BioPharmBlog/2007/10/23/a-brief-fda-history-lesson/" target="_blank">A Brief FDA History Lesson</a>&#8220;, Mariano Di Fabio provided some background on the events that lead to the establishment of the FDA&#8217;s current clinical trial framework, and he questioned if this framework should be changed so that experimental drugs could be released for use by terminally ill patients.  Mariano is not alone in his call. </p>
<p>In today&#8217;s healthcare environment, with the internet and media coverage providing early stage insight into developmental pipelines, more and more physicians and patients are calling for access to drugs before they are approved for marketing.  However, it&#8217;s not always the FDA that stands in the way.  The drug companies also have to agree to provide their developmental products for special access. For various reasons, they are not always willing to do it.  <span id="more-257"></span></p>
<p>The treatment of a seriously ill patient with an unapproved drug is often referred to as &#8220;compassionate use&#8221;.  The FDA has had regulations in place for the compassionate use of drugs since 1987.  In the U.S., when a patient is not able to enroll in a manufacturer-sponsored clinical trial, the patient has two options to obtain access to an investigational product: (1) an expanded access program or (2) single patient access by special/compassionate exemption. </p>
<p>With an expanded access program (EAP), the sponsor (the drug manufacturer or a health organization such as the National Cancer Institute) must apply to the FDA to provide special access to a group of patients.  The EAP is conducted as a research protocol in a clinical setting such as a doctor&#8217;s office or university research facility.  This type of program is typically offered in the later stages of clinical trials when the safety and efficacy of the product have been fairly well established.  In addition, an EAP works well when the patients live in the same general area near the research facility.</p>
<p>If no EAP is offered by the sponsor (e.g. for drugs used to treat rare diseases) or the patient is not eligible for an EAP due to program criteria, location or other factors, then the patient&#8217;s physician may apply for a special exemption.  First, the doctor must get the drug company on board. Then, the doctor, with assistance from the drug company, applies to the FDA for authorization to provide the drug to the patient.</p>
<p>The FDA states that it rarely blocks access to unproven medications for those with serious illness; however, it does reserve the right to reject applications for special access when it feels that the drug is not safe (even if the patient is already dying).  While the FDA does sometimes reject requests for compassionate use, it is often the drug manufacturers that withhold their products.  Compassionate use programs can be very expensive and time-consuming.  The companies are under no legal obligation to provide access to the drugs, and the FDA has no authority to compel the pharmas to offer EAP&#8217;s or single patient access. </p>
<p>Some of the reasons that a drug company may choose not to offer a compassionate use program are:  </p>
<ul>
<li>The company&#8217;s ultimate goal is to get the product approved for marketing. Compassionate use programs divert time and resources away from achieving this goal.</li>
<li>Compassionate use regulations can be complex and different from country to country. The regulatory affairs department must be prepared to wrestle with these regulations or the company must pay an outside vendor to deal with the health authorities.</li>
<li>The company must take on additional costs to manufacture, distribute and track the product.</li>
<li>The company must perform pharmacovigilance in order to monitor the products safety and efficacy as well as track, assess and report adverse events.</li>
<li>These programs cannot be promotional in any way. Companies are not able to solicit patients and physicians without heavy fines.</li>
<li>The drug is often offered free-of-charge to the patients as part of the program. Thus, there may not be any money coming in to recoup the costs of the program.</li>
<li>In the end, the product may not be approved. Why go above and beyond the clinical trials that are already required?</li>
</ul>
<p>On the other hand, drug companies are starting to realize that compassionate use programs provide a number of benefits.  First and foremost, these programs help patients that are in desperate need for treatment.  This should be priority #1 for drug manufacturers.  Other benefits include: </p>
<ul>
<li>If the manufacturer does not provide access to product, patients may use other means to get their hands on it. These programs give manufacturers tighter control over the patient population and the distribution network.</li>
<li>While these programs are not a replacement for clinical trials, they provide additional real-world safety data over clinical trials alone.</li>
<li>The programs allow a company to get into a market earlier than usual. The patients that participate in the program remain patients (customers) after the product goes to market.</li>
<li>Physicians and opinion leaders get involved earlier in the development process. They become the initial adopters that build industry confidence in the product and accelerate growth once the product is approved. This is especially important in countries where the manufacturer may not have existing relationships within the healthcare arena.</li>
<li>The company will have a better idea how to market the product. It will have a more complete understanding of the customers and their needs.</li>
</ul>
<p>While the public perception is that the FDA restricts access to experimental products, the arguments above contend that this is not always the case.  The FDA has provided a framework for compassionate use programs, but this framework relies on the willingness of drug companies to provide access to their drugs.  And unfortunately, the reward of compassionate use programs often does not always outweigh the risk. Perhaps more incentives are needed? Or streamlined processes around compassionate use programs? </p>
<p>What do you think?  Your thoughts are welcome.</p>
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		<title>Latest Tactics to Stifle Generic Competition</title>
		<link>http://avelient.com/BioPharmBlog/2008/09/30/latest-tactics-to-stifle-generic-competition/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/09/30/latest-tactics-to-stifle-generic-competition/#comments</comments>
		<pubDate>Tue, 30 Sep 2008 05:01:32 +0000</pubDate>
		<dc:creator>Scott Alexander</dc:creator>
		
		<category><![CDATA[General]]></category>

		<category><![CDATA[Legal]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[generic competition]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=238</guid>
		<description><![CDATA[In the last half of this decade, it is estimated that $100 billion worth of brand name drugs have lost (or will lose) patent exclusivity. Each year, generic drugs take more and more of the market share from brand-name drug manufacturers.  In fact, the percentage of drug prescriptions dispensed for generics increased from 47% to [...]]]></description>
			<content:encoded><![CDATA[<p>In the last half of this decade, it is estimated that $100 billion worth of brand name drugs have lost (or will lose) patent exclusivity. Each year, generic drugs take more and more of the market share from brand-name drug manufacturers.  In fact, the percentage of drug prescriptions dispensed for generics <a href="http://content.nejm.org/cgi/content/full/357/20/1993" target="_blank">increased from 47% to 63% between 1999 and 2007</a>.  It seems like a losing battle for the brand-name manufacturers, so as the old saying goes&#8230; if you can&#8217;t beat ‘em, join ‘em.  The big pharmas are starting to take their slice out of the generic industry. <span id="more-238"></span></p>
<p>There are a number of strategies that the brand-name manufacturers have employed since the Hatch-Waxman Act in 1984 in order to stave off generic manufacturers and retain market exclusivity.  The most common tactic is a combination of &#8220;evergreening&#8221; and aggressive litigation.  With evergreening, the company stockpiles patents on as many aspects of the product as possible.  When a generic company attempts to get marketing authorization, the brand-name manufacturer takes the generic company to court over claimed infringements with some patented aspect of the product.  This allows the drug manufacturer to delay the entry of competition and retain its big profits (for up to 30 months or longer in the U.S.).</p>
<p>However, litigation is only a short-term strategy - eventually the generic drug makers will enter the market.  Other tactics meant to invoke a more gentle decrease in product price once the generics invade are: </p>
<ul>
<li>Patents on new formulations / combinations - Coming up with better delivery methods, simpler administration routes (e.g. once a day versus three times a day), combination products and new isometric forms may stifle competition and keep doctors and patients coming back to the brand name</li>
<li>Patents on improvements in the manufacturing process in order to decrease costs</li>
<li>Aggressive advertising campaigns to keep their products fresh in the minds of doctors and patients. In addition, brand-name manufacturers jump on every opportunity to promote bad press about unexpected adverse events with generics (i.e. the heparin from China fiasco) or poor manufacturing controls (such as the FDA ban of 30 generics from Ranbaxy). These negative advertising campaigns are meant to scare consumers aware from generics.</li>
</ul>
<p>Lately though, the market is starting to take a different turn. In a number of ways, the brand-name manufacturers are starting to play more of a hand in the generics market. </p>
<ul>
<li>Some brand-name manufacturers have begun marketing their own &#8220;authorized generic&#8221; to compete with the first generic manufacturer to gain entry. This may be done through a subsidiary or through a licensing deal with another generic manufacturer. The brand-name manufacturer gets a slice of the pie while decreasing the profits for the first generic competitor. When paired with the delays and costs of an aggressive litigation campaign from the brand-name company, the generic drug maker may be deterred from entering the market at all.</li>
<li>A number of big pharmas have started purchasing generic companies. This serves three purposes: (1) it allows the brand-name company to launch their own &#8220;authorized generics&#8221; through a subsidiary that is better suited for the generic business, (2) it enables brand-name manufacturers to have a presence in countries that cannot yet afford brand-name prices - such as Brazil - and (3) it decreases competition, allowing prices and profits to remain higher. This has started a domino effect as big generic companies are forced respond in kind - case in point: Teva&#8217;s recent purchase of Barr Pharmaceuticals.</li>
<li>In some recent cases, the brand-name manufacturer has resorted to financial arrangements - or what some may call payoffs - in order to stifle competition. For example, see Pfizer&#8217;s settlement with Ranbaxy to delay their generic version of Lipitor by 20 months. While these arrangements may violate antitrust laws, the government has not levied any punishments yet.</li>
</ul>
<p>So while the percentage of drug prescriptions dispensed for generics has steadily increased over recent years, the brand-name manufacturers have been able to keep their percentage of sales fairly high (<a href="http://content.nejm.org/cgi/content/full/357/20/1993" target="_blank">84% in 2007, down from 88% in 1999</a>).  Surely, this battle will continue to rage on for years to come. Hopefully, the generic industry will be strong enough to keep prices affordable for consumers, while the brand-name drug makers get enough market share to continue to bring innovative products to patients. Balance will be the key.</p>
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		<item>
		<title>Pharmaceutical Profile: Sequenom</title>
		<link>http://avelient.com/BioPharmBlog/2008/09/23/pharmaceutical-profile-sequenom/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/09/23/pharmaceutical-profile-sequenom/#comments</comments>
		<pubDate>Tue, 23 Sep 2008 05:01:42 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Clinical Trials]]></category>

		<category><![CDATA[Pediatric Medicine]]></category>

		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[Technology]]></category>

		<category><![CDATA[amniocentesis]]></category>

		<category><![CDATA[Sequenom]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=229</guid>
		<description><![CDATA[I was reading my monthly copy of Pharmaceutical Executive magazine when I came across Joanna Breitstein&#8217;s excellent article profiling the latest trend in the pharmaceutical arena: big deals that are safe bets.  In her article, &#8220;Place your Bets,&#8221; Breitstein characterizes Roche&#8217;s bid to acquire Genentech as a reflection of the cautious approach to deal-making that [...]]]></description>
			<content:encoded><![CDATA[<p>I was reading my monthly copy of <a title="Pharmaceutical Executive" href="http://pharmexec.findpharma.com" target="_blank">Pharmaceutical Executive</a> magazine when I came across Joanna Breitstein&#8217;s excellent article profiling the latest trend in the pharmaceutical arena: big deals that are safe bets.  In her article, &#8220;<a title="Pharmaceutical Executive: Place your Bets" href="http://pharmexec.findpharma.com/pharmexec/Deals+Articles/Place-Your-Bets/ArticleStandard/Article/detail/548225?searchString=sequenom" target="_blank">Place your Bets</a>,&#8221; Breitstein characterizes Roche&#8217;s bid to acquire Genentech as a reflection of the cautious approach to deal-making that big Pharma is using these days, and indicates that with patent expiration on the heels of many blockbuster drugs, especially Pfizer&#8217;s Lipitor, there is a strong demand for small company buyout targets with promising products in their pipeline.</p>
<p>Sequenom is one such company on the list that I found particularly interesting.  <span id="more-229"></span></p>
<p>As I approach my mid-thirties, along with many of my friends, I find myself still at the early stages of raising my own familial unit, with future children on my mind.  This is in sharp contrast to the experience of our parents, who most likely at this point were finished with that stage of their lives and had children many years older than ours.  We all have our reasons for starting our families at a time that would be considered &#8220;late&#8221; by our parents&#8217; standards, but one of the downsides is increased (albeit still small) risk to the baby for Down Syndrome.  Amniocentesis is one of the best accepted methods to screen for this disorder, but it carries with it a risk of miscarriage and can only postiviely identify 70 to 90 percent of the cases prior to birth.  Sequenom, however, has developed a method that could trump amniocentesis at identifying Down Syndrome cases &#8212; so far with 100% accuracy in clinical trials &#8212; and do so with minimal risk using only a prenatal blood test.</p>
<p>Sequenom&#8217;s technology, dubbed <a title="SEQureDx information site" href="http://www.sequenom.com/getdoc/6f032f26-50f1-4d2e-a534-f0ad6fb7c776/Fetal-Nucleic-Acid-Technology.aspx" target="_blank">SEQureDx</a>(TM), targets fetal DNA circulating in the mother&#8217;s blood to examine the genetic status of the fetus.  The first application identified a fetus&#8217; risk for RhD disease, which occurs when the blood of an expectant mother is incompatible with her unborn child.  Jaundice, anemia, brain damage, heart failure and even death can result from the incompatibility, so identifying it early is crucial to taking measures against it.  Showing that it can additionally be applied as a method for testing a fetus for Down Syndrome would be an added incentive for any potential buyers for the company.</p>
<p>I am encouraged by the company&#8217;s charter to make &#8220;<a title="About Sequenom" href="http://www.sequenom.com/Diagnostic/PrenatalDx" target="_blank">safe, non-invasive prenatal testing available to all women, independent of age and other factors that may contribute to pregnancy complications</a>,&#8221; and am hopeful that the knowledge gained in this kind of research could lead to an increased understanding of the kind of defects that could affect the normal development of an unborn fetus.  As parents, knowing in advance how we should be prepared for any difficulties an unborn little one might have is invaluable and gives us the opportunity to prepare for what might be.</p>
<p>The obvious win for any pharmaceutical company that entertains the idea of Sequenom as an acquisition is an increase in the number of parents willing to run the test.  Like many parents, I fear the risks of amniocentesis, despite the information it will give me.  If the risk is mitigated, then wouldn&#8217;t more parents do it?  Would it just become part of the standard barrage of tests that expectant mothers are put through?</p>
<p>They say knowledge is power.  Today, we may be having our children later, but we know a lot more about them before they are born than our parents ever did.  Gender, heartbeat, skeletal development, and soon even certain genetic diseases can be safely screened well before the baby is born and steps can be taken to prepare for or even prevent hardship for the child later in life.  But does this take any of the excitement or anticipation out of child birth?  Does knowing any of this information change the way you feel about a child growing inside your wife (or you)?  Or does knowing the information help you prepare to be a better parent?</p>
<p>Your thoughts, as always, are welcome.</p>
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		<item>
		<title>The New War on Drugs: Vaccinations?</title>
		<link>http://avelient.com/BioPharmBlog/2008/09/04/the-new-war-on-drugs-vaccinations/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/09/04/the-new-war-on-drugs-vaccinations/#comments</comments>
		<pubDate>Thu, 04 Sep 2008 05:18:08 +0000</pubDate>
		<dc:creator>Scott Alexander</dc:creator>
		
		<category><![CDATA[Clinical Trials]]></category>

		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[Celtic Pharmaceuticals]]></category>

		<category><![CDATA[cocaine addiction]]></category>

		<category><![CDATA[cocaine vaccine]]></category>

		<category><![CDATA[TA-CD]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=205</guid>
		<description><![CDATA[Ask yourself, when your child grows up, do you want him to be a cocaine addict? What if there was something you could do to prevent it? What if it was as easy as protecting your child against tetanus or the mumps?  We may not be far away from the first vaccine to fight against [...]]]></description>
			<content:encoded><![CDATA[<p>Ask yourself, when your child grows up, do you want him to be a cocaine addict? What if there was something you could do to prevent it? What if it was as easy as protecting your child against tetanus or the mumps?  We may not be far away from the first vaccine to fight against cocaine.  According to their website, <a href="http://www.celticpharma.com/" target="_blank">Celtic Pharmaceuticals</a> plans to submit their cocaine vaccine, TA-CD, for marketing approval in the US or EU in 2010. <span id="more-205"></span></p>
<p>TA-CD essentially works just like vaccines that are used to fight traditional diseases (such as tetanus or the mumps). It gets the body to recognize cocaine as an invader and uses the body&#8217;s immune system to prevent the cocaine from doing what it normally does: get the user high. </p>
<p>As we know, the body doesn&#8217;t normally treat cocaine as a harmful trespasser, so TA-CD pairs deactivated cocaine molecules (norcocaine) with deactivated cholera toxin molecules.  The body recognizes cholera as an enemy, and since it is paired with cocaine molecules, the body builds anti-bodies to fight both foreign substances.  The anti-bodies bind to the cocaine molecules, and the resulting bound molecules become too large to enter the user&#8217;s brain.  As a result, the patient does not feel the high associated with cocaine use.  In other words, the patient builds immunity to cocaine.</p>
<p>Celtic reports that it completed four Phase II trials with 161 patients prior to 2007 and a larger Phase II trial was slated for 2007.  Preliminary results from the Phase II trials showed efficacy (an increase in cocaine-free days) in a significant number of patients in the treatment group (see the <a href="http://www.medicalnewstoday.com/articles/45654.php" target="_blank">article</a> in Medical News Today for more information).</p>
<p>Of course, Celtic does not plan to lobby to get TA-CD introduced into the list of common childhood vaccinations just yet.  They intend to market the product to assist in the fight against cocaine addiction.  Celtic reports that 800,000 patients in the US attend in-patient programs and out-patient clinics seeking treatment for cocaine addiction, and more than 95% of all cocaine addicts who try to quit relapse.  This is a significant patient population that can benefit from this product.  Along with counseling and the support of family and friends, it will be a tool to help addicts quit. </p>
<p>Further back in Celtic&#8217;s pipeline is TA-NIC, a nicotine vaccine.  If TA-CD is successful, it may pave the way for TA-NIC as well.  It&#8217;s not hard to imagine a full suite of vaccines against our pharmacological vices (marijuana, MDMA, heroin, crystal meth, etc.) on the market some day.</p>
<p>I&#8217;ll be looking for answers to some of the following questions in the Phase III studies: </p>
<ul>
<li>How long will the vaccine last before a booster dose is needed?</li>
<li>How many patients will overdose because they increase their cocaine intake in hopes of overwhelming the anti-bodies and getting their high?</li>
<li>How many patients will switch to another drug (e.g. methamphetamines) to get their fix?</li>
</ul>
<p>And if the product makes it to market, how will our society react? </p>
<ul>
<li>Will addicts really submit to the vaccinations if the product promises to kill their high for, say, 10 years like a tetanus shot? That&#8217;s a big commitment for an addict - there&#8217;s no turning back.</li>
<li>Will parents vaccinate their children against cocaine?</li>
<li>Will employers require their employees to be vaccinated?</li>
<li>How will cocaine producers innovate in order to retain their business?</li>
</ul>
<p>This is an interesting product to keep an eye on.  Your thoughts and comments are welcome.</p>
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		<title>Back to Virtuality</title>
		<link>http://avelient.com/BioPharmBlog/2008/06/17/back-to-virtuality/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/06/17/back-to-virtuality/#comments</comments>
		<pubDate>Tue, 17 Jun 2008 21:50:29 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[Technology]]></category>

		<category><![CDATA[Autism]]></category>

		<category><![CDATA[Second Life]]></category>

		<category><![CDATA[Virtual Reality]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=101</guid>
		<description><![CDATA[It&#8217;s been a while since I last wrote on the blog, and for those of you that follow regularly, I apologize.  We&#8217;ve had a lot going on in our company, and if you haven&#8217;t already heard, we re-designed our web site (go to www.avelient.com to see the new site) and released our first major [...]]]></description>
			<content:encoded><![CDATA[<p>It&#8217;s been a while since I last wrote on the blog, and for those of you that follow regularly, I apologize.  We&#8217;ve had a lot going on in our company, and if you haven&#8217;t already heard, we re-designed our web site (go to <a href="http://www.avelient.com" title="Avelient Home page" target="_blank">www.avelient.com</a> to see the new site) and released our first major product, a development platform for small town business alliances, called HOLMES.  I encourage you to check out the changes that have been made when you get a chance!</p>
<p>But this week, we return to blogging with another entry into the virtual world of Second Life.  I was excited last Wednesday evening, June 11th, to be able to attend a talk hosted by Simon Bignell, a lecturer at the University of Derby in the United Kingdom.  Using his Second Life alter ego, Milton Broome, Simon gave us about an hour of his time as he told us about the research that&#8217;s being done in virtual worlds on Autism spectrum disorder and Asperger&#8217;s (to keep tabs on what Milton is up to, <a href="http://www.miltonbroome.com" title="The Milton Broome web site" target="_blank">check out his web site</a>).<span id="more-101"></span></p>
<p><a href="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/06/lecture-on-autism-attendees_001.png" title="Attendees"><img src="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/06/lecture-on-autism-attendees_001.thumbnail.png" alt="Attendees" align="left" hspace="10" /></a>This was my first experience using the voice features of Second Life, and I must say I was impressed by the fluidity of the lecture given that I could now hear the virtual presenter speak as opposed to just listening to text being typed on a keyboard before a paragraph appeared on my screen (to read more about the first lecture I attended, which was not voice enabled, click <a href="http://avelient.com/BioPharmBlog/?p=62" title="Ann Myers Medical Center 2: Virtual meeting" target="_blank">here</a>).   There were some technical difficulties to start (objects creating the ever-present sound of waves in the background, for example), but once the lecture began I thought things went very well; it was clear to me that Simon/Milton had done this before.</p>
<p><a href="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/06/lecture-on-autism-attendees_002.png" title="Milton Broome"><img src="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/06/lecture-on-autism-attendees_002.thumbnail.png" alt="Milton Broome" align="right" hspace="10" /></a>The objective of Simon&#8217;s project is to determine if Second Life, and virtual worlds like it, can be used as a medium to help develop the social and communication skills of those people who might be suffering with some form of Autism.  Firstly, in spite of promoting its voice capabilities more and more, the ability to have typewritten conversations in Second life is really an advantage to people in this group; because of their difficulty at quickly and correctly interpreting social situations, the autism community has embraced this medium  because it effectively slows down the social interaction to a point where they can keep pace and learn the dynamic skills necessary to react appropriately.  Simon emphasized this by pointing out that the average colloquial conversation occurs at 150 to 200 words per minute; the typewritten conversation, at best, occurs at 15 to 20 words per minute, 10 times slower than a spoken conversation.  Therefore, in spite of all the advances made with voice communications in Second Life, and the ability to have a real lecture in a virtual world, the autistic community might not be ready to embrace this kind of advancement as readily  as some of their  non-suffering counterparts.</p>
<p>In fact, most of the work Simon is currently doing revolves around understanding the needs and developing programs to assist the growing community of people living with Autism in Second Life and he&#8217;s clearly not alone.  You may recall my blog entry in January, &#8220;<a href="http://avelient.com/BioPharmBlog/?p=79" title="Bridging Solitary to Socail Via Virtual Reality" target="_blank">Bridging Solitary to Social Via Virtual Reality</a>,&#8221; where I wrote about Center for Brain Health at the University of Texas at Dallas, who developed a virtual town in Second Life as a kind of treatment area for Autsim.  I&#8217;ve posed the question before: is there a possibility that a Second Life could serve as a therapeutic instrument for a First Life?</p>
<p>A critical component of that is better understanding the condition you&#8217;re trying to treat.  To that end, I was pretty interested to hear that Simon is working on an &#8220;Autism Simulator,&#8221; similar in scope to the Schizophrenia simulator I visited very early in the existence of this blog (see: &#8220;<a href="http://avelient.com/BioPharmBlog/?p=29" title="Schizophrenia with a Technology Twist" target="_blank">Schizophrenia with a Technology Twist</a>&#8220;).  With it, Simon hopes to reproduce some of the sensations someone living with Autism might experience, including alterations in light, noise, touch, and even obsessions and comorbidity.  Ultimately, he hopes to use this project as a platform for collaboration among the many groups in Second Life who strive to understand more about this condition and ways to treat it.</p>
<p>There is no doubt in my mind that Second Life and people like Simon Bignell provide novel ways to investigate and understand the challenges associated with social conditions such as Asperger&#8217;s and Autism.  While I still feel today, as I did a year ago, that things are probably not yet where they need to be in order to bring the technology to the masses, I do feel that there is progress.  The greatest difficulty, perhaps, is conveying the idea that places like Second Life are more than just a platform for gaming; they are worlds that can be shaped entirely by the power of human imagination &#8212; that is, of course, if the technology can keep up.</p>
<p>What do you think?</p>
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		<title>Super Blog</title>
		<link>http://avelient.com/BioPharmBlog/2008/02/05/super-blog/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/02/05/super-blog/#comments</comments>
		<pubDate>Wed, 06 Feb 2008 04:52:43 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[General]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[augmentation]]></category>

		<category><![CDATA[bionics]]></category>

		<category><![CDATA[superhuman]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=85</guid>
		<description><![CDATA[This week seems to be a week for supers.  The Superbowl was on Sunday, with the New York Giants defeating the near-perfect New England Patriots in a stunning upset and deserved victory.  Today is Super Tuesday, and Democrats and Republicans are vying for the top candidacy spot in their respective parties.  And [...]]]></description>
			<content:encoded><![CDATA[<p>This week seems to be a week for supers.  The Superbowl was on Sunday, with the New York Giants defeating the near-perfect New England Patriots in a stunning upset and deserved victory.  Today is Super Tuesday, and Democrats and Republicans are vying for the top candidacy spot in their respective parties.  And I am sitting here, late Tuesday night after a long and busy day, wishing I had super-speed, or some other super capability to help get this post done quickly!  I found myself longing for the <a href="http://avelient.com/BioPharmBlog/?p=60" title="From Mighty Mice to Mighty Humans" target="_blank">Resveratrol pill being developed by Sirtris Pharmaceuticals Inc</a>. that I wrote about a few weeks ago.  I figured at least that might give me the endurance, speed and presence of mind to be able to complete the post quickly and effectively.<span id="more-85"></span></p>
<p>I decided to do a search on Google for &#8220;superhuman biotechnology&#8221; when I found an article written by Brian Alexander on MSNBC.com entitled, &#8220;<a href="http://www.msnbc.msn.com/id/13054181/" title="MSNBC.com: Is there a human right to be superhuman?"" target="_blank">Is there a human right to be superhuman?</a>&#8220;Â  The article was a bit dated, published on May 31 of 2006, but it was an interesting analysis of the concept of transhumanism, which seeks to augment human abilities through use of emerging technologies.Â  It describes a meeting that took place at Stanford University sponsored by its Center for Law and the Biosciences, its center for Cognitive Liberty and Ethics and the Institute for Ethics and Emerging Technologies.Â  The leaders of the latter two organizations had some surprising assertions that were discussed as part of the meeting; specifically, it seems they not only believe that enhancements to the human body is a possibility, but it&#8217;s a right.</p>
<p>The article goes on to describe some new drugs and technologies that were being developed at the time that would fall under the category of science fiction only a few years prior.Â  And with some of the research we&#8217;ve even discussed on this very blog, it would appear that we aren&#8217;t far off from the day where medical procedures and drugs will be developed that will help bring augmentations to the human body to reality.</p>
<p>However, what happens when we do?Â  What kind of implications will that have for our race?Â  Will the ability to augment one&#8217;s own body be tied to money?Â  Does this thrust towards a bigger divide among people who achieve success because they have the means to do so, and those who cannot because they do not have the resources to realize that success?Â  And what happens if augmented abilities do become more prolific?Â  How would our measure of success change as our path to it becomes easier?</p>
<p>When I was small, I had frequent dreams of being Superman, using my powers to help people in need.Â  Even now, the thought of pushing my body beyond the capabilities with which I was born is an intriguing thought.Â  However, if everybody shared the same kinds of abilities I did, how would those powers differentiate me from anyone else?Â  And how would they offer protection against those who might use them for more nefarious purposes?Â  These questions may seem like they belong in the realm of comic books and science fiction, but if scientists continue to explore at the rate they have over the last 10 years, the bridge between fiction and reality may be completed sooner than one might think.</p>
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		<title>Appreciating Happiness through Melancholy</title>
		<link>http://avelient.com/BioPharmBlog/2008/01/25/appreciating-happiness-through-melancholy/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/01/25/appreciating-happiness-through-melancholy/#comments</comments>
		<pubDate>Sat, 26 Jan 2008 04:55:41 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[happiness]]></category>

		<category><![CDATA[melancholy]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=82</guid>
		<description><![CDATA[I&#8217;m sitting here on my couch tonight, my nose red and sore, my lips chapped, my nose running, and my entire body feeling that familiar achy feeling that comes on as a virus takes control of my body and becomes a cold.  I&#8217;m most certainly not at my happiest, and it shows, both in [...]]]></description>
			<content:encoded><![CDATA[<p>I&#8217;m sitting here on my couch tonight, my nose red and sore, my lips chapped, my nose running, and my entire body feeling that familiar achy feeling that comes on as a virus takes control of my body and becomes a cold.  I&#8217;m most certainly not at my happiest, and it shows, both in my own thought process and in my interactions with other people.  As I sat down to sift through the various articles I had accumulated this week for today&#8217;s post, I came across one that addressed the subject of melancholy and how it should be celebrated as a natural, and necessary, part of our lives.  In the article, &#8220;In Praise of Melancholy,&#8221; published in the January 18th issue of The Chronicle Review, author Eric G. Wilson tackles the growing idea in American culture that constant happiness in one&#8217;s life is &#8220;normal&#8221; and the ultimate goal is elimination of melancholy.<span id="more-82"></span></p>
<p>Wilson quotes a recent poll performed by the Pew Research Center indicates that nearly 85% of Americans believe they are at least pretty happy.  Several psychologists and scientists are even examining this phenomenon of &#8220;happiness,&#8221; attempting to map how the brain works when it feels happiness.  Fields of research are emerging to battle against melancholy, attempting to eliminate it from our lives and help people using therapy, drugs, and any number of other venues.  But, he argues, that we&#8217;re doing ourselves a disservice by trying to numb ourselves to the pain associated with melancholy, and we&#8217;re setting ourselves up to live with a diluted version of happiness because of our attempt to eliminate its counterpart.</p>
<p>After reading his argument, I sat here for a moment, thinking of my own predicament, suffering from a bad cold, and I couldn&#8217;t help the strong desire to disagree with him.  I&#8217;m pretty miserable right now, and would give anything to be healthy and happy.  But as I thought more about Wilson&#8217;s words, it occurred to me that under &#8220;normal&#8221; conditions I would probably agree with him.  I can remember growing up that whenever things seemed to go wrong in life, I reminded myself that what I was facing was necessary in order to appreciate the good, happy moments in life.  It&#8217;s a philosophy that I think I&#8217;ve lost over time, constantly seeking to retain happiness in both my own life and the life of my family.</p>
<p>My wife lost her childhood dog several months ago. We were on vacation when he died, but no one told us of his death until we returned home.  I found out moments before my wife did, and I remember the distinct feeling of my heart sinking to the floor.  My instinct was to make the whole thing not true; I wanted to immediately drive over to her parents&#8217; house, where the dog had lived, and pick him up to bring him back to our house. What was more devistating for me, however, was when she found out. I will never forget her reaction, and how helpless I felt as a watched the pain encase her in a shell from which she would not emerge until several days later.</p>
<p>Upon seeing a loved one suffer, I believe most of us instinctually want to remove that source of suffering, much as I did when I saw my wife suffer with her loss.  But these moments are often counterbalanced by something positive at some point, and both are critical to our appreciation of what we have for the period of time we have it.  As the author states in the article, &#8220;The porcelain rose is not as pretty as the one that decays.  Melancholia over time&#8217;s passing is the proper stance for beholding beauty.&#8221;(1)  It is our understanding that nothing is permanent that helps us appreciate the beauty of something more that we would if that feeling of loss didn&#8217;t exist.</p>
<p>This is not to say that all levels of melancholy are typical.  In fact, the author states, in several instances there is a strong case for drugs and psychological therapy for those people suffering from an unrelenting, deep depression.  But, and this is my own thought here, I think we live in a society where instant gratification is quite often the norm, and if recovery is nothing short of immediate there is an expectation that a drug or intensive therapy should be explored as an option.  Should we explore the possibility that we aren&#8217;t even giving our own coping mechanisms the chance to work?  My wife, as devastated as she was, has managed to recover from her loss and function completely normally without the use of drugs, and with little psychological therapy, though it did take time.  I have suffered from my own losses and have managed to deal with them without any kind of drug to help me along.  We certainly still think these things are tragedies, but can now appreciate the beauty as we would a decaying rose.</p>
<p>What motivates us to eliminate this feeling from our lives, according to Wilson, is fear.  &#8220;Most hide behind a smile because they are afraid of facing the world&#8217;s complexity, its vagueness, its terrible beauties.&#8221;(2)  My reluctance to travel around the world is a perfect example of this because I fear what might happen to me if I go.  I fear death away from home ever since 9/11, I fear the possibility that I will never return to a familiar place, I fear the melancholy and loneliness I will feel if I can&#8217;t communicate or can&#8217;t understand the people, culture, and artifacts I might see.  Yet, in doing so, I deny myself the adventure of seeing the wonders that the world offers, and the splendor and magnificence of things I just can&#8217;t see at home.</p>
<p>So I agree with the author that acceptance, not elimination, of melancholy is the answer that we must seek in order for us to avoid diluting our happiness.  As Wilson best puts it when he paraphrases John Keats, &#8220;To deny death and calamity would be to live only a partial life, one devoid of creativity and beauty.&#8221;  I welcome the beauty that sadness may bring, even if its fresh, but decaying petals may not always be immediately evident.</p>
<p>What do you think?</p>
<p>Eric G. Wilson adapted his work in the Chronicle Review Newsletter from his book <a type="amzn" asin="1201325822"> </a><strong><a href="http://www.amazon.com/gp/redirect.html?ie=UTF8&amp;location=http%3A%2F%2Fwww.amazon.com%2FAgainst-Happiness-Melancholy-Eric-Wilson%2Fdp%2F0374240663%3Fie%3DUTF8%26s%3Dbooks%26qid%3D1201325822%26sr%3D8-1&amp;tag=avebioblo-20&amp;linkCode=ur2&amp;camp=1789&amp;creative=9325" target="_blank">Against Happiness: In Praise of Melancholy</a><img src="http://www.assoc-amazon.com/e/ir?t=avebioblo-20&amp;l=ur2&amp;o=1" style="border: medium none  ! important; margin: 0px ! important" border="0" height="1" width="1" /></strong>.  He is a professor of English at Wake Forest University in Winston-Salem, NC.</p>
<p>(1) See &#8220;In Praise of Melancholy,&#8221; Eric G. Wilson, The Chronicle Review, January 18, 2008, B12.</p>
<p>(1) See &#8220;In Praise of Melancholy,&#8221; Eric G. Wilson, The Chronicle Review, January 18, 2008, B14.</p>
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		<title>Bridging Solitary to Social Via Virtual Reality</title>
		<link>http://avelient.com/BioPharmBlog/2008/01/15/bridging-solitary-to-social-via-virtual-reality/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/01/15/bridging-solitary-to-social-via-virtual-reality/#comments</comments>
		<pubDate>Wed, 16 Jan 2008 03:57:13 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Personal Health]]></category>

		<category><![CDATA[Research]]></category>

		<category><![CDATA[Sociology]]></category>

		<category><![CDATA[Technology]]></category>

		<category><![CDATA[Autism]]></category>

		<category><![CDATA[Second Life]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=79</guid>
		<description><![CDATA[It&#8217;s not often that 2 subjects that pique my interest converge so nicely into one article.
As you know from a number of posts on this blog, I&#8217;ve been writing extensively about my experiences in Second Life, and how pioneers in this virtual world are leveraging its unique characteristics to either further their educational mission or [...]]]></description>
			<content:encoded><![CDATA[<p>It&#8217;s not often that 2 subjects that pique my interest converge so nicely into one article.</p>
<p>As you know from a number of posts on this blog, I&#8217;ve been writing extensively about my experiences in Second Life, and how pioneers in this virtual world are leveraging its unique characteristics to either further their educational mission or help people with what ails them.  In my post entitled &#8220;<a href="http://avelient.com/BioPharmBlog/?p=29" title="Schizophrenia with a Technology Twist" target="_blank">Schizophrenia with a Technology Twist</a>,&#8221; Dr. Peter Yellowlees was one of those pioneers in his work with schizophrenia and building an experience that communicates some of the sights and sounds a person suffering with schizophrenia might experience in their everyday lives.  I wrote 2 posts on the Ann Myers Medical Center in Second Life, each focusing on different people within that group and how they&#8217;re leveraging Second Life for its educational values in a variety of areas in the medical field (see posts <a href="http://avelient.com/BioPharmBlog/?p=29" title="A Virtual Resource: The Ann Myers Medical Center" target="_blank">1</a> and <a href="http://avelient.com/BioPharmBlog/?p=62" title="The Ann Myers Medical Center Part 2: Virtual Meeting" target="_blank">2</a> by clicking on their respective numbers).<span id="more-79"></span></p>
<p>In addition, because of my young son, I&#8217;ve been profoundly interested in research on autism given its suggested link to vaccinations in children.  I&#8217;ve explored this debate on a couple of occasions, both in my post on &#8220;<a href="http://avelient.com/BioPharmBlog/?p=38" title="The Vaccination Debate" target="_blank">The Vaccination Debate</a>,&#8221; spurred by Jenny McCarthy&#8217;s appearance on the Oprah Winfrey show in September, and on last Friday&#8217;s post named, &#8220;<a href="http://avelient.com/BioPharmBlog/?p=78" title="Hot Spots, Hot Topic" target="_blank">Hot Spots, Hot Topic,</a>&#8221; where I read and posted my thoughts on the recent confirmed link of 1% of autism cases to spontaneous defects in DNA that were not passed to children by their parents.</p>
<p>The convergence of the two topics occurred this week in the Information Technology section of the Chronicle of Higher Education, where the author Katherine Mangan writes about treating those afflicted with autism by using the facilities available in Second Life.  In reality, I wasn&#8217;t really surprised that this had happened; I suggested that autism might be a good candidate for treatment in a virtual world at the end of &#8220;Schizophrenia with a Technology Twist.&#8221;   But it was encouraging to see that there is a group currently working to apply the technology to real-world patients, and finding some success in the treatment.</p>
<p>According to Mangan, the Center for <a href="http://www.brainhealth.utdallas.edu/" title="The Center for Brain Health at the University of Texas at Dallas" target="_blank">Brain Health at the University of Texas at Dallas</a> has developed a virtual town in Second Life where patients suffering from Asperger&#8217;s disease, a milder form of autism marked by normal intelligence, can roleplay different, simulated scenarios that might have caused them stress in real life.  According to the center&#8217;s director, Susan B. Chapman, the virtual world can be tuned by a clinician to match a patient&#8217;s needs, and statistics can be gathered easily measuring their response to the exercise.  The safe environment gives the patients an opportunity to &#8220;do-over&#8221; if they deem the results of their exercise unsatisfactory.</p>
<p>Voice plays a role in these interactions, and bring a real-world feel to the virtual environment.  On any given day, patients can be seen interacting in the fabricated world as if they were really meeting in a park, or a store, some other venue.  Clinicians and volunteers also interact and assist patients with small talk and conflict resolution, apparently with some success.</p>
<p>One example of this success is Matt Kratz, a 35-year-old graduate student with Asperger&#8217;s syndrome.  Treated by the program, he feels better prepared to interact socially with people in the real world, and is more capable of identifying situations in which something he says or does may be interpreted in a negative way.  His experience is supported by brain-imaging and neurocognitive tests that were taken on patients before and after their virtual-world experience.  The three patients tested so far have shown positive results in several areas where they may previously have been hindered, including, as the article puts it, &#8220;social appropriateness.&#8221;</p>
<p>I tried my hand at logging into Second Life and finding the center, but was unsuccessful in my pursuit.  It&#8217;s likely been made private to keep out stray, prying eyes (like mine), who could interrupt the work that&#8217;s being done there.  I will try to get a tour and write up my experiences here at some point in the future (perhaps this might be an interesting virtual field trip for the members of the New York Biotechnology and Pharmaceutical meetup group?).  In the meantime, there appear to be several groups within the virtual world designed to support those who might be suffering with anything from severe autism to the milder Asperger&#8217;s disease.  If you know someone who suffers from one of these disorders, it might be a benefit to them to explore this venue as a place where they can connect with others who better understand how they feel and what they experience daily.</p>
<p>Do you think that virtual reality is a good way to treat some of these mental disorders?  What is your experience with autism, Asperger&#8217;s or any other mental disorder that might be appropriate for this model of treatment?  I&#8217;d be curious to know if this kind of treatment needs to be perpetual, or if, at some point, a person is considered &#8220;cured.&#8221;  Additionally, I&#8217;d be curious to know if researchers have considered the possibility that some patients might need a chemical component to their treatment, or if the virtual treatment would be enough.  We certainly are embarking into an intriguing new therapeutic area as these worlds become more prolific, but for what consequences, if any, should we prepare ourselves as we delve in further?</p>
<p>As always, I welcome your thoughts.</p>
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