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	<title>Avelient BioPharm Blog &#187; Pediatric Medicine</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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			<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>
		<item>
		<title>Speaking of Vaccinations&#8230;</title>
		<link>http://avelient.com/BioPharmBlog/2008/09/09/speaking-of-vaccinations/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/09/09/speaking-of-vaccinations/#comments</comments>
		<pubDate>Tue, 09 Sep 2008 05:01:34 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

		<category><![CDATA[Personal Health]]></category>

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

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

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

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

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

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=213</guid>
		<description><![CDATA[In February, I posted an article about the increasing amounts of research being done with the Measles, Mumps and Rubella (MMR) vaccinations and how there is an increasing number of studies being done that disprove the vaccination&#8217;s link to autism.  In it, I gave a little history on Andrew Wakefield, the British scientist who [...]]]></description>
			<content:encoded><![CDATA[<p><img class="align-left size-medium wp-image-216" title="Drug Ampoule" src="http://avelient.com/BioPharmBlog/wp-content/uploads/2008/09/drug_ampoule_jpn-218x300.jpg" alt="" width="153" height="210" />In February, I <a title="MMR Vaccine: More Meticulous Research" href="http://avelient.com/BioPharmBlog/2008/02/15/mmr-vaccine-and-autism-more-meticulous-research/" target="_blank">posted an article</a> about the increasing amounts of research being done with the Measles, Mumps and Rubella (MMR) vaccinations and how there is an increasing number of studies being done that disprove the vaccination&#8217;s link to autism.  In it, I gave a little history on Andrew Wakefield, the British scientist who originated the theory of the causal relationship between the MMR vaccination and autism, and speculated as to why his theory might have been financially motivated.</p>
<p>On September 3rd, <a title="CNN: Study: No link between measles vaccine and autism" href="http://www.cnn.com/2008/HEALTH/09/03/measles.autism/" target="_blank">CNN posted an article</a> which casts further doubt on Wakefield&#8217;s theory, punctuated by the fact that his co-author, Irish pathologist John O&#8217;Leary, is also a co-author on the new study.  <span id="more-213"></span>Published in the peer-reviewed journal of the Public Library of Science, PLoS ONE, the new study concludes that the MMR vaccine causes neither autism nor gastrointestinal disorders, adding to a growing body of evidence against the claim.</p>
<p>Wakefield&#8217;s original theory attempted to establish that in some children, the measles virus used in the MMR vaccine would grow in the intestinal tract of some children, leading to inflammation that would make the bowel porus.  Toxic material would then seep from the bowel into the body, affecting the nervous system and causing symptoms of autism.  John O&#8217;Leary and the rest of the new study&#8217;s team of investigators replicated Wakefield&#8217;s experiments in the same lab that was used for the original analysis, using samples from 38 children with bowel disorders, 25 of whom had autism.  They found that only one child in each group had trace amounts of the measles virus in their samples.</p>
<p>Further, there was no evidence that there was a relationship between the children showing symptoms of autism or GI disorders and timing of the vaccine; the three events appeared to be independent of one another.</p>
<p>For the researchers involved in the study, along with many who have read the study itself, the evidence appears to be conclusive.  Even the vice president for scientific affairs of &#8220;Autism Speaks,&#8221; an advocacy group, indicated he believed the results were indisputable. However, other organizations such as the Autism Society of America and the National Autism Association feel that further study is needed and that the PLoS ONE study may even be flawed.</p>
<p>What is more frightening to me, however, is the fact that all of this is causing a decline in the number of parents opting for vaccinations for their children.  While I can understand one&#8217;s trepidation (just the thought of managing a child with autism is something that unnerves me) the fact is that this kind of decision is now starting to play out in statistics within the US.  Measles levels are at their highest in more than a decade, with nearly half of those involving children whose parents rejected vaccinations, according to another <a title="CNN: Measles outbreaks may be linked to vaccine fears" href="http://www.cnn.com/2008/HEALTH/08/21/measles.outbreaks.ap/index.html" target="_blank">CNN report on August 21st</a>.</p>
<p>The number of cases reported this year is still relatively small at 131 through July, but doctors are worried because this is already over triple the 42 cases that were reported for all of last year.   The disease is no longer endemic to the US, but is brought in from people visiting from other countries or students studying abroad.  Once it gets here though, proliferation of the disease in children has been held in check, widely credited to the aggressive childhood vaccination rates.</p>
<p>But what happens when those vaccinations are undermined by information linking them to autism?  You put parents in a very precarious situation.  A decision as to whether they should defend their children against diseases that can kill by using vaccinations, or defend their children against what can be a debilitating social disorder that is autism.  Unfortunately, because we&#8217;re dealing with the health and safety of children, any study is discredited by its detractors and the result is almost a political debate where the burden of proof falls not on the person presenting the evidence, but on the person listening, having to waddle through technical and medicinal jargon that they may not understand.</p>
<p>Ultimately, I believe it comes down to the trust that you have in your doctor, and the trust that you have in yourself as a parent.  Being able to prevent your child from having to live with autism would be a wonderful thing, but I don&#8217;t personally believe that there&#8217;s enough evidence to indicate there is a way to prevent it.  Vaccinations, I believe, are a red herring in this case and divert our attention from the real cause of the problem.  But before we can move forward, we&#8217;ll need to find certainty in a study that will help us all move on and fish for something else.</p>
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		<item>
		<title>Superbugs</title>
		<link>http://avelient.com/BioPharmBlog/2008/02/29/superbugs/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/02/29/superbugs/#comments</comments>
		<pubDate>Sat, 01 Mar 2008 02:45:08 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

		<category><![CDATA[Personal Health]]></category>

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

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

		<category><![CDATA[drug resistance]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=91</guid>
		<description><![CDATA[Last week, my son was not himself.  He was easily frustrated, especially given that it was difficult to express what was bothering him at his current level of language development.  Both my wife and I attributed his behavior to his teeth likely bothering him, but my mother-in-law on Wednesday mentioned that she thought [...]]]></description>
			<content:encoded><![CDATA[<p>Last week, my son was not himself.  He was easily frustrated, especially given that it was difficult to express what was bothering him at his current level of language development.  Both my wife and I attributed his behavior to his teeth likely bothering him, but my mother-in-law on Wednesday mentioned that she thought he might be getting an ear infection.  We didn&#8217;t heed her advice right away, and, well, shame on us (note to self: always heed the advice of an Italian mother &amp; grandmother).  When he finally had a meltdown during lunch on Friday, we knew the home remedies we had been trying weren&#8217;t working and we made an appointment on Friday with his pediatrician.  Sure enough, he had an ear infection.<span id="more-91"></span></p>
<p>We filled his prescription for antibiotics and gave it to him over the weekend, and I fully expected a quick recovery.  After all, when I had been a child and fought my share of ear infections, I remember antibiotics as my saving grace, and knew that they would bring relief within a day or two.  Well, he did seem a little better initially and gave us the impression that he was on his way to recovery when he took a turn for the worse on Wednesday night.  He was up several times over the course of the night, had a slight fever, was generally cranky and unusually clingy.  My wife and I collectively managed to get ourselves out of bed the next morning and, based on his behavior, we knew he wasn&#8217;t feeling better.  My wife decided that he was still not himself, enough so that she decided to call the doctor again.  We got another appointment that afternoon.</p>
<p>I insisted that a trip to the doctor probably was an overreaction; he was on an antibiotic, so if he wasn&#8217;t feeling well then whatever he had must be viral and therefore untreatable beyond using a humidifier in his bedroom, keeping him hydrated and giving him soup at meals.  Imagine my surprise, then, when the doctor came in, examined my son, and said, &#8220;He still has the ear infection, and it looks like it&#8217;s in both ears.&#8221;  <em>Both</em> ears?  Seriously?  Had the magical antibiotic concoction that I had depended on as a child been broken?  We left the office with a script for a stronger type of antibiotic for my son, but nothing hit me harder than the fact that his illness was the embodiment of what I had been reading about for a long time: drug-resistant bacteria had invaded my son, and he had to fight the pain for a longer period as we found something that would kill off the bug.</p>
<p>Perhaps I&#8217;m being a bit of an alarmist in my conclusion; maybe his ailment is viral, and trying these different drugs really won&#8217;t help him fight things off.  But I was always  under the impression that ear infections were always the result of something bacterial, and a fever was also a pretty clear indicator.</p>
<p>You may recall my recounting my own <a href="http://avelient.com/BioPharmBlog/?p=23" title="Killing the Cure" target="_blank">little battle with a sinus infection last summer</a>, for which my doctor struggled with whether to give me a short-term antibiotic that was less effective, or give me a longer-term antibiotic that was more certain to kill the bug the first time.  I opted to go for the longer-term treatment, feeling like it was my duty not to dilute the effectiveness of antibiotics by taking something that might not kill off the bacteria that was in my system and leave it to adapt and grow so that it could resist even better the next time.  A possible outcome of not making such a decision was embodied in my son&#8217;s sickness, who after the doctor&#8217;s visit was finally enjoying the ride quietly behind us.</p>
<p>This month&#8217;s Pharmaceutical Executive tackled this issue in more detail, making me realize that the problem is far bigger than we see from a simple trip to the doctor.  In, &#8220;Fight Resistance,&#8221; Joanna Breitstein examines the proliferation of antibiotics in the 3rd world, and how its ubiquitous presence and haphazard prescription methods that are causing bacteria to evolve into something more powerful than it was before, something that we can no longer fight with a standard penicillin of yesteryear.  Breitstein starts her article with the tale of nurse Jacky Tumusiime, a New Zeland native fighting disease in a Ugandan clinic.  According to her:</p>
<blockquote><p>&#8220;These doctors dish out antibiotics like sweets,&#8221; says Tumusiime.  &#8220;In fact, it&#8217;s rare to leave a doctor&#8217;s office without at least two types of antibiotics.  They are prescribed for everything from broken bones to a lump on the head from falling off a bike.&#8221;  Many patients, she says, skip doctors&#8217; visits and just get antibiotics. (1)</p></blockquote>
<p>According to Tumusiine, this massive overprescribing and misprescribing of antibiotics is a global problem, and is supported by studies of the Alliance for the Prudent Use of Antibiotics, which estimates that between 40 and 90 percent of antibiotics prescriptions are unnecessary.(2)  All of this misuse is starting to add up to increasing strains of disease that are resistant to the weapons we have to fight them, and researchers and pharmaceutical companies are not able to keep pace.  The article highlights several diseases, once controlled by antibiotics, that are now making an impact again in society.  In South Asia, for example, resistant strains of the bacteria that causes typhoid fever have emerged and are resulting in mortality rates that are nearly the same as they were before the introduction of antibiotics.  Several sexually transmitted diseases in Asia have become a death sentence because the drugs used to treat them are becoming less effective.  And these only scratch the surface of the problem.</p>
<p>Bacteria of all types grow and multiply quickly; the article estimates that some types of single bacteria can have up to a billion offspring in a day.  With those offspring come several mutations, which occur far more frequently than anyone had first suspected.  When penicillin was first used in the 1940s it managed to kill off most of the bacteria against which it was intended to be used; but because of the numerous mutations that occur, if a population wasn&#8217;t completely killed off, it was likely that some future mutation would develop a resistance to the drug, and it eventually did. (3)</p>
<p>Because of this constant back-and-forth struggle with stronger bacteria resisting more powerful drugs, pharmaceuticals slowed their investment in antibiotic research and instead focused on drugs that could deal with more chronic diseases.</p>
<p>The World Health Organization (WHO) has tried in recent years to contain the problem, but it has met with some difficulty especially in getting underdeveloped nations to comply with new guidelines they&#8217;ve issued.  The FDA has run into some different, but equally challenging issues in the drug companies are hard-pressed to spend the millions necessary to develop a drug if there&#8217;s no guarantee that it will meet a resistant strain of the disease within the lifetime of its patent on that drug.  The FDA additionally insists on large trials to test the efficacy and safety of the drug, which further discourages pharmaceuticals from investing resources in these types of drugs.  It indicates to me that not only do the diseases have the upper hand, but we may be helping them with our inability to stay ahead.</p>
<p>The story does offer some hope, however.  There are programs that have been approved that will allow the FDA to provide incentives to companies that are capable of researching and developing new products that will address these diseases.  Other legal acts will set guidelines for developing drugs more intelligently, and offering better information to empower those that dispense them to do so more effectively.</p>
<p>Overall, I am worried.  No one likes to see a child suffer, especially his or her own, and if we don&#8217;t manage to get control over this problem, we may see more instances where one treatment of antibiotics just isn&#8217;t enough.</p>
<p>It really reminds me of the end of the movie &#8220;War of the Worlds,&#8221; in which earth is invaded by aliens who devastate the human race in a single week, but in the end succumb to germs (bacteria), to which man had adapted years ago and managed to conquer.  Bacteria&#8217;s increasing resistance to our treatments should be a warning to us that we should not be so arrogant as to believe that we can conquer all, and without careful planning and prescription practices in the future, these bugs could become a David to the Goliath that is the human race.</p>
<p>(1) See &#8220;Fight Resistance,&#8221; Joanna Breitstein, Executive Editor, Pharmaceutical Executive, February 2008, pg. 52.</p>
<p>(2) See (1)</p>
<p>(3) See &#8220;Fight Resistance,&#8221; Joanna Breitstein, Executive Editor, Pharmaceutical Executive, February 2008, pg. 54.</p>
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		<item>
		<title>Sea-ing is Believing: New Way to Treat Cold Symptoms in Children</title>
		<link>http://avelient.com/BioPharmBlog/2008/01/22/sea-ing-is-believing-new-way-to-treat-cold-symptoms-in-children/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/01/22/sea-ing-is-believing-new-way-to-treat-cold-symptoms-in-children/#comments</comments>
		<pubDate>Wed, 23 Jan 2008 04:50:01 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

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

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

		<category><![CDATA[cold treatment]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=81</guid>
		<description><![CDATA[In the last few months, drug companies and the FDA have made efforts to communicate the dangers of using cough and cold medicines in children under 2, and the possibility that they could be ineffective in any children under 12.  We&#8217;ve explored the news items here in 2 posts, &#8220;Feed a Cold, Because Cough [...]]]></description>
			<content:encoded><![CDATA[<p>In the last few months, drug companies and the FDA have made efforts to communicate the dangers of using cough and cold medicines in children under 2, and the possibility that they could be ineffective in any children under 12.  We&#8217;ve explored the news items here in 2 posts, &#8220;<a href="http://avelient.com/BioPharmBlog/?p=46" title="Feed a Cold, Because Cough &amp; Cold Meds are Gone" target="_blank">Feed a Cold, Because Cough &amp; Cold Meds are Gone</a>,&#8221; which was published when the news first broke and the cough and cold medications were recalled, and in last Friday&#8217;s &#8220;<a href="http://avelient.com/BioPharmBlog/?p=80" title="Need Money, Will Warn of Dangerous Drugs" target="_blank">Need Money, Will Warn of Dangerous Drugs</a>,&#8221; in which we reported that the FDA had made it official these cold medications were not good for younger children.  Unfortunately, this means that parents can no longer take comfort in giving a sick child a cough or cold medicine as a remedy, and they&#8217;ll need to look to other means to help.</p>
<p>In the original post I wrote, there are some home remedies you can use to treat an ailing child: <span id="more-81"></span>add some humidity to their bedroom at night, Tylenol, Motrin or Advil for fever control, and plenty of fluids.  A study done in Amsterdam even gives credence to the old adage of feeding a cold and starting a fever.  As new parents, and having been through treatment for the respiratory virus RSV early in our child&#8217;s life, we&#8217;re always interested in this advice whenever we can get it.</p>
<p>Researchers in Europe, in a study conducted on children ages 6 to 10, have discovered that treating colds with a nasal spray that dispenses a nebulized dose of Atlantic Ocean seawater might have the ability to ease cold symptoms faster than with nothing at all.  The research, reported on the Reuters web site on Monday, January 21st, was conducted by Dr. Ivo Slapak and his colleagues at the Teaching Hospital of Brno in the Czech Republic (click <a href="http://www.reuters.com/article/latestCrisis/idUSN18307400" title="Reuters: Seawater spray cures kids colds-Czech researchers" target="_blank">here </a>for the full article).  The study was published as part of the January issue of the Archives of Otolaryngology, and was intended to strengthen the existing, but poor scientific evidence that saline washes are effective as a treatment for colds.</p>
<p>Goemar Laboratories La Madeline, a drug company based in Saint-Malo, France, was the sponsor for the study and also makes Physiomer, the seawater nasal spray used in the investigation.Â  360 children participated in the study who showed signs of uncomplicated flu symptoms.Â  Some of the children were given standard treatments such as nasal decongestants, while others received the same medications plus the nasal saline wash.Â  Lasting for 12 weeks in 2006, children given the regular doses of salt water seemed to get better more quickly and had fewer relapses.Â  In addition, the saline group children were less likely to need fever-reducing drugs, nasal decongestants, mucous-reducing medications or even antibiotics.Â  They were sick less often and missed fewer school days.</p>
<p>I initially had a problem with these study results, mainly because the article indicated the children were given the nasal spray <em>in addition</em> to &#8220;standard treatments, such as nasal decongestents.&#8221;(1)Â  Yet at the conclusion of the study the data seems to indicate that these kinds of medications had no effect on the duration or relapses of the colds, corroborating the recommendations released by the FDA last week, and supporting the saline spray as a viable treatment for colds.</p>
<p>It&#8217;s unclear why the saline works the way it does right now; it could be that the saltwater clears mucus more effectively, or that there are trace chemical elements that act as a barrier for the proliferation of the virus in the body.Â  Further studies, however, may result in an answer that could have even more children picking up a sample of seawater during the next flu season.</p>
<p>As a parent, you always look for ways to keep your child healthy and minimize the time that they&#8217;re sick.Â  For many years, our culture sought the use of drugs to help make that happen, and we just assumed what worked for us would work for our children.Â  Like food, however, a child metabolizes drugs differently than we do, and we need to make sure the kinds of treatments we give them take that into consideration.Â  Cough and cold medicines don&#8217;t appear to be effective aids in keeping our children healthy, and therefore more study needs to be done to find out what does work.Â  The Czech study is just one example of a group taking the initiative to do this.</p>
<p>In addition, and perhaps I&#8217;m being naive, but why look only for drugs that can do everything?Â  As we&#8217;ve seen in a couple of the more recent studies from Europe, the answer might be as easy as a comforting, hearty bowl of soup, or cleaning out the little ones&#8217; noses with a spray of water from the Atlantic.Â  A sensible balance between synthesized and home remedies might be just the prescription we need.</p>
<p>What do you think?</p>
<p>(1) SeeÂ  &#8220;<a href="http://www.reuters.com/article/latestCrisis/idUSN18307400" title="Reuters: Seawater spray cures kids colds-Czech researchers" target="_blank">Seawater spray cures kids colds - Czech researchers</a>,&#8221; Michael Conlon, Reuters, January 21st, 2008.</p>
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		</item>
		<item>
		<title>Hot Spots, Hot Topic</title>
		<link>http://avelient.com/BioPharmBlog/2008/01/11/hot-spots-hot-topic/</link>
		<comments>http://avelient.com/BioPharmBlog/2008/01/11/hot-spots-hot-topic/#comments</comments>
		<pubDate>Sat, 12 Jan 2008 01:53:07 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

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

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

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

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=78</guid>
		<description><![CDATA[Back in September, I took an opportunity to write a post on my blog about The Vaccination Debate, centered around the profound increase in autism cases throughout the US and the work and their possible link to the series of vaccinations given to children early in their life.  Though argued by the Center of [...]]]></description>
			<content:encoded><![CDATA[<p>Back in September, I took an opportunity to write a post on my blog about <a href="http://avelient.com/BioPharmBlog/?p=38" title="The Vaccination Debate" target="_blank">The Vaccination Debate</a>, centered around the profound increase in autism cases throughout the US and the work and their possible link to the series of vaccinations given to children early in their life.  Though argued by the Center of Disease Control (CDC) and the Food and Drug Administration (FDA) as an unlikely link, a growing body of research suggests that chemicals used to preserve the vaccinations are the primary triggers that cause the increased incidence of Autism in children today.</p>
<p>Though the link exists, the proof behind it seems to be inconclusive.  <span id="more-78"></span>We have decided to continue to vaccinate our child and ensure those vaccinations are free of thimerosal, the mercury-based chemical used as a preservative that is suspected of precipitating the disease.  In fact, all shots given to children before their second birthday have some thimerosal-free formulation, but you should check with your pediatrician if you&#8217;re not sure whether they&#8217;re using the options available.</p>
<p>I do not debate parents&#8217; instinct to blame vaccinations as the cause of autism in their children; enough circumstantial evidence has been documented, even on YouTube, to suggest otherwise (a quick <a href="http://www.youtube.com/results?search_query=autism&amp;search=Search" title="YouTube Autism search" target="_blank">search on autism</a> there results in a list of videos with parents&#8217; experiences).  I do believe, however, that the link is not causal; vaccinations aren&#8217;t <em>causing</em> autism, though they may elicit its appearance.</p>
<p>This belief has been substantiated by a couple of articles I came across this week while reading up on the subject.  The first I encountered was &#8220;<a href="http://www.wired.com/wired/archive/9.12/aspergers_pr.html" title="Wired Magazine: The Geek Syndrome" target="_blank">The Geek Syndrome</a>,&#8221; which appeared in the December 2001 issue of Wired Magazine.  It actually was a fairly comprehensive review of the disorder, starting with its discovery by 2 doctors almost simultaneously in the 1940s.  The first diagnosis came from a child psychiatrist by the name of Leo Kanner who was observing curious behaviors in 11 of his patients at Johns Hopkins Hospital in Baltimore in 1943.  A year later in Vienna, a pediatrician named Hans Asperger published a paper in which he observed children sharing many unusual traits including detachment and introversion.  Both doctors, though neither knew of the other&#8217;s work, called the condition autism from the Greek <em>autÃ²s</em>, meaning self.</p>
<p>The article further distinguishes between the two scientists&#8217; findings, and focuses specifically around some of the specific characteristics that Hans Asperger discovered during his research, all of which is a fascinating read.  I was particularly interested, however, in the section of the article exploring the possibility of genetic predisposition to the disease.  It grants that there is a heated debate ongoing about whether environmental factors are catalysts for triggering the disorder, such as those that have been discussed here and in other articles on the disease.  However:</p>
<blockquote><p>The one thing that almost all researchers in the field agree on is that genetic predisposition plays a crucial role in laying the neurological foundations of autism in most cases. Studies have shown that if one identical twin is autistic, there&#8217;s a 90 percent chance that the other twin will also have the disorder. If parents have had one autistic child, the risk of their second child being autistic rises from 1 in 500 to 1 in 20. After two children with the disorder, the sobering odds are 1 in 3. (So many parents refrain from having more offspring after one autistic child, geneticists even have a term for it: <em>stoppage</em>.) The chances that the siblings of an autistic child will display one or more of the other developmental disorders with a known genetic basis - such as dyslexia or Tourette&#8217;s syndrome - are also significantly higher than normal.(1)</p></blockquote>
<p>This kind of data would seem to support the theory that autism is completely genetic in origin, but further empirical data released this week by Boston based researchers make an even stronger case.  Released in the New England Journal of Medicine on January 9th, an extensive genome scan was performed for autism and found that in just over 1 percent of people with autism, a chunk of 25 genes had been duplicated or deleted, mostly caused by spontaneous mutations not carried by their parents.  While the percentage may sound small, it&#8217;s a significant step forward in this research, according to Dr. David T. Miller of Children&#8217;s Hospital Boston.</p>
<p>Understanding how these genetic mutations occur could lead to the discovery of additional genes that could reveal more information about the disorder.  That&#8217;s what the new Boston group, the Autism Consortium, hopes to do by bringing together families, doctors and researchers to solve the complex riddles behind autism.  The current discovery they&#8217;ve had in Chromosome 16 may only be found in about 1 percent of autism patents, but in an extensive DNA study they performed in Iceland in recent years, the same mutation was only found in one-tenth of 1 percent of people diagnosted with different language or psychiatric problems, and only one hundredth of 1 percent of the general population.  As research continues to develop, the group hopes to establish tests that can explain up to 75% of all autism cases, possibly even linking them directly to the toxins that trigger the mutation, as we&#8217;ve seen thus far with thimerosal.(2)</p>
<p>What does this mean for us?  We will probably continue treating our on the schedule recommended by his pediatrician for vaccinations because the truth is none of this knowledge can fully support or refute the link between autism and vaccinations.  Caution, of course, is necessary to ensure that he has limited exposure to toxins that may trigger the disorder, and he is not over-vaccinated.  But the alternative, I believe, is more serious than autism&#8230;imagine ceasing all vaccinations and bringing back polio, smallpox, hepatitis and any other number of disease that can cause severe sickness or even death.  In spite of the fact that autism is a terrible disorder that afflicts more and more children each year, and in spite of the fact that I would not wish it upon any of the children I know, especially my own, we continue to be steadfast in our decision to vaccinate, as long as it&#8217;s done with caution.</p>
<p>What do you think?</p>
<p>(1) See &#8220;<a href="http://www.wired.com/wired/archive/9.12/aspergers_pr.html" title="Wired Magazine: The Geek Syndrome" target="_blank">The Geek Syndrome</a>,&#8221; Steve Silberman, Wired Magazine, December 2001.</p>
<p>(2) See &#8220;<a href="http://www.boston.com/news/health/articles/2008/01/10/rare_genetic_hot_spot_is_linked_to_autism/" title="Boston.com: Rare Genetic Hot Spot Linked to Autism" target="_blank">Rare Genetic Hot Spot Linked to Autism</a>,&#8221; Carey Goldberg, Boston.com (Boston Globe online edition), January 10, 2008.</p>
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		<title>Feed a Cold, because Cough &#038; Cold Infant Meds are Gone</title>
		<link>http://avelient.com/BioPharmBlog/2007/10/19/feed-a-cold-because-cough-cold-infant-meds-are-gone/</link>
		<comments>http://avelient.com/BioPharmBlog/2007/10/19/feed-a-cold-because-cough-cold-infant-meds-are-gone/#comments</comments>
		<pubDate>Fri, 19 Oct 2007 17:03:10 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

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

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=46</guid>
		<description><![CDATA[Earlier this week, my sister-in-law (the one who&#8217;s pregnant) and my mother-in-law told my wife and me about a large voluntary recall by drug companies of their over-the-counter cold and cough medications.  For today&#8217;s blog, I decided to research the issue further, because we regularly give our son Tylenol on those days when his [...]]]></description>
			<content:encoded><![CDATA[<p>Earlier this week, my sister-in-law (the one who&#8217;s pregnant) and my mother-in-law told my wife and me about a large voluntary recall by drug companies of their over-the-counter cold and cough medications.  For today&#8217;s blog, I decided to research the issue further, because we regularly give our son Tylenol on those days when his teeth seem to be bothering him because they&#8217;re erupting through the gums in his mouth.  Having battled <strong>RSV</strong>, <strong>Croup</strong>, <strong>Pneumonia</strong>, <strong>Rotavirus</strong> and a number of other bad colds and sickness, we didn&#8217;t want something we were doing to cause him any more distress than what he&#8217;s already been through.</p>
<p>According to warnings from federal regulators and doctors, the issue is that there are potential health risks with cough and cold medications for kids under 6 years old.  <span id="more-46"></span>Statistics gathered by researchers from the <strong>Food and Drug Administration</strong> (FDA) show that 54 children had died from 1969 to 2006 after taking medication specifically for children with the ingredients ephedrine, pseudoephedrine and phenylephrine.  They also found that 69 deaths in the same period resulted from use of antihistamines that contained diphenhydramine, brompheniramine and chlorpheniramine.  Most of these children were under 2 years old, and the FDA added that the medicine didn&#8217;t even seem to provide any benefit to children in this age group. (1)</p>
<p>The <strong>Consumer Healthcare Products Association</strong> (CHPA) represents the collective public voice of drugmakers in the US.  Its president, Linda Suydam, acknowledged that there could be issues with &#8220;rare patters of misuse leading to overdose,&#8221; particularly in infants.  But drugmakers insist that the medicines are safe and effective when used as directed, especially given that &#8220;the vast majority of parents and caregivers&#8221; use them properly. (2)</p>
<p>Still, as a result of the warnings issued by the FDA and private doctors, over-the-counter cold medicines such as Tylenol, Dimetapp, Robitussin, Triaminic and Little Colds were voluntarily recalled by the drug companies that make them for children under 2.  They are suggesting to the FDA that labels in these products be changed from &#8220;ask a doctor&#8221; before using to &#8220;do not use&#8221; in children under 2 years.  The complete list of products is as follows:</p>
<p><span id="BlankRADControl" /></p>
<ul>
<ul>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">DimetappÂ® Decongestant Plus Cough Infant Drops</a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">DimetappÂ® Decongestant Infant Drops </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">Little ColdsÂ® Decongestant Plus Cough </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">Little ColdsÂ® Multi-Symptom Cold Formula </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">PEDIACAREÂ® Infant Drops Decongestant</a> (containing pseudoephedrine)</em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">PEDIACAREÂ® Infant Drops Decongestant &#038; Cough</a> (containing pseudoephedrine)</em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">PEDIACAREÂ® Infant Dropper Decongestant</a> (containing phenylephrine)</em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">PEDIACAREÂ® Infant Dropper Long-Acting Cough </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">PEDIACAREÂ® Infant Dropper Decongestant &#038; Cough</a> (containing phenylephrine)</em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">RobitussinÂ® Infant Cough DM Drops </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">TriaminicÂ® Infant &#038; Toddler Thin StripsÂ® Decongestant </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">TriaminicÂ® Infant &#038; Toddler Thin StripsÂ® Decongestant Plus Cough </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">TYLENOLÂ® Concentrated Infants&#8217; Drops Plus Cold </a></em></li>
<li><em><a target="_blank" href="http://www.chpa-info.org/NR/rdonlyres/75F81B19-9267-49A5-A13F-6BF17E6796D8/0/ProductsGrouped.jpg">TYLENOLÂ® Concentrated Infants&#8217; Drops Plus Cold &#038; Cough</a>   (3)</em></li>
</ul>
</ul>
<p><strong>USA Today</strong> interviewed a group of doctors when this story was released, who offered some advice to parents trying to treat a cold (read the full interview <a title="USA Today's Doctor Interview on Infant Medicines" target="_blank" href="http://www.usatoday.com/money/industries/health/drugs/2007-10-11-cold-medicine-advice_N.htm">here</a>).  Household treatment methods, such as extra humidity in the air, extra fluids to drink, and Tylenol, Motrin or Advil for fever, are all suggested as alternatives to the cold medicines.  Since there is no proven benefit from the use of these medicines and studies show that there is risk, one Atlanta pediatrician Jennifer Shu said, &#8220;Why chance it?&#8221;  Indeed, our pediatrician has never recommended the use of these medicines in my son, although I can distinctly remember a couple of instances where we were very tempted to use one of these products.  Instead, we ended up buying a humidifier, an aspirator to keep his nose clear (he didn&#8217;t love us for that), and a nebulizer for those times when he was really sick.  We&#8217;re happy to do it to relieve his symptoms, even if it is more work.</p>
<p>In addition, in an article on the <strong>New Scientists</strong> web site from January 2002 named &#8220;&#8216;Feed a cold, starve a fever&#8217; may be right,&#8221; Michael Le Page indicates that the adage expressed in its title may be supported by scientific fact.  At first, it indicates that saying was regarded as myth by most doctors and nutritionists.  But a study by Dutch scientists &#8220;found that eating a meal boosts the type of immune response that destroys the viruses responsible for colds, while fasting stimulates the response that tackles the bacterial infections responsible for most fevers.&#8221; (4)</p>
<p>The study was started by Gijs van den Brink of the Academic Medical Center in Amsterdam.  He wanted to see if alcohol had any effect in the immune system, and after a Christmas dinner with his colleagues, they took blood samples of the guests and examined them for changes.  They were surprised to find that it was not alcohol, but food that caused a change in their body chemistry.  Extending the study, they invited 6 participants to fast overnight and then come in the next day for tests.  On one occasion they were given a liquid, but nutritional meal, on the other just water to distend the stomach.</p>
<p>Six hours after the liquid meal, the participants&#8217; blood samples showed that their level of gamma interferon had quadrupled, an indication that killer T-cells in their body could be readily produced to consume any cells that had been infected by pathogens, the type of response expected in a viral infection, as in a cold, for example.   When they drank only water, however, the levels of this gamma interferon fell slightly and another chemical messenger, interleukin-4, nearly quadrupled.  This chemical is an indicator of the body preparing its defenses for pathogens lurking outside cells, usually indicative of a bacterial infection and the cause of a fever.</p>
<p>So in addition to any home remedies you use to attack the symptoms of a cold or fever, keep your child fed to stave off that cold, even if his or her appetite is not quite where it usually is.  Thankfully, our son loves to eat, so this shouldn&#8217;t be a problem for us.  And, based on the evidence, a little Tylenol for aching gums is okay &#8212; but probably not something we should be doing every day.</p>
<p>What do you think?  If children&#8217;s cold and cough remedies are relegated to containers that warn parents not to use them if their children are under 2, will you follow that guideline?  If you&#8217;ve given the medicines to your children before, do you feel that they did work, and the recommendations by doctors and the FDA are overly cautious?  Would a combined risk of 123 deaths over the 37 years between 1969 and 2006 be enough to convince you that there is a risk to your own child?  Please, share your thoughts!</p>
<p>(1) See &#8220;<span class="inside-head"><a target="_blank" title="Kids' cough, cold medicine pulled" href="http://www.usatoday.com/money/industries/health/2007-10-11-cough-cold-recall_N.htm">Kids&#8217; cough, cold medicines pulled</a>&#8220;, Edward Iwata, USA Today, </span>October 12, 2007.</p>
<p>(2) See (1)</p>
<p>(3) See &#8220;<a target="_blank" title="CHPA News Release" href="http://www.chpa-info.org/ChpaPortal/PressRoom/NewsReleases/2007/10_11_07_CCMedicines.htm">Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medications</a>&#8220;<span class="inside-head">, News Release for the Consumer Healthcare Products Association (CHPA), </span>October 11, 2007.</p>
<p>(4) See &#8220;<a target="_blank" title="New Scientist Feed a Cold, Starve a Fever article" href="http://www.newscientist.com/article/dn1777.html">&#8216;Feed a cold, starve a fever&#8217; may be right</a>&#8220;<span class="inside-head">, Michael Le Page, New Scientist, </span>January 11, 2002.</p>
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		<title>Banking Baby&#8217;s Blood</title>
		<link>http://avelient.com/BioPharmBlog/2007/10/12/banking-babys-blood/</link>
		<comments>http://avelient.com/BioPharmBlog/2007/10/12/banking-babys-blood/#comments</comments>
		<pubDate>Sat, 13 Oct 2007 01:54:33 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[Pediatric Medicine]]></category>

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

		<category><![CDATA[umbilical cord blood banking]]></category>

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=44</guid>
		<description><![CDATA[You may recall my article from a few weeks ago entitled, &#8220;Living in the 3rd Dimension,&#8221; when I wrote about my sister-in-law and the 3D Ultrasound she was planning for her baby.  I wrote about her experience (which was, technologically speaking, not without problems but resulted in some great pictures of my future nephew [...]]]></description>
			<content:encoded><![CDATA[<p>You may recall my article from a few weeks ago entitled, &#8220;<a href="http://avelient.com/BioPharmBlog/?p=20" title="Living in the 3rd Dimension">Living in the 3rd Dimension</a>,&#8221; when I wrote about my sister-in-law and the <strong>3D Ultrasound</strong> she was planning for her baby.  I wrote about her experience (which was, technologically speaking, not without problems but resulted in some great pictures of my future nephew Max), the experience my wife and I had with it and our own  baby, and the possible applications of the technology in other areas of medicine.  As expectant parents, my wife and I were more aware of the advertisements for this service as our baby&#8217;s due date approached, and excited at the prospect of getting a glimpse of our baby before he was actually born.</p>
<p>The same sister-in-law and I were having a conversation the other night and we talked briefly about <strong>banking her baby&#8217;s umbilical cord blood</strong>.  <span id="more-44"></span>I remember being bombarded with information about this procedure from a variety of places, including books, magazines, doctors and parenting web sites.  I never really paid it much attention, as it seemed to me that most of the advertisements were for private companies looking to store the blood for you for an undefined amount of time as an &#8220;insurance&#8221; measure for any future diseases your child or other children in your family may have or someday develop.</p>
<p>Umbilical cord blood is special because it is rich in hematopoietic stem cells, which are unspecialized blood cells that could eventually adapt themselves to perform specific functions within the blood system of the child.  The blood at this stage is useful because of its potential to treat a variety of genetic or oncologic diseases though stem cell transplantation with a matching donor.  Most of the research has been encouraging, but it is still early and there are many factors which dictate whether the blood is acceptable for use in treatment.</p>
<p>Private blood cord banks such as <strong>VitaCord</strong> and <strong>Cord Blood Registry (CBR)</strong> have made big business out of the practice of saving umbilical cord blood.  Though I don&#8217;t have complete information on VitaCord, CBR charges approximately $2000 for the initial year of storage, and $125 annual fee thereafter until the child is 18.  You can see more information on CBR&#8217;s pricing structure <a href="http://www.cordblood.com/cord_blood_banking_with_cbr/pricing_domestic.asp" title="Cord Blood Registry" target="_blank">here</a>.    The procedure is most often advertised as a kind of &#8220;biological insurance,&#8221; an analogy I&#8217;ve seen echoed by people on internet parenting forums who invested in the system.  Obviously this is a pretty significant up-front cost for cord blood storage, especially for first-time parents who might be just starting out and might not have the money readily available to pay for such a service.</p>
<p>In addition to the potentially prohibitive cost of the procedure, the <strong>American Academy of Pediatrics (AAP)</strong> does not support the use of private storage as simply &#8220;biological insurance.&#8221;  Not communicated by the private firms is that there is little or no scientific evidence to show that the donor will ever benefit from a transplant of his or her own cord blood, known as autologous transplantation.  In fact, the only time such private storage would be advisable by the APP is if there is a family member with a &#8220;current or potential need to undergo a stem cell transplantation.&#8221;  (1)  This might be the case for someone suffering with leukemia, for example.</p>
<p>What the AAP <em>does</em> support, however, is the philanthropic donation of blood, at no cost to the expectant parents, to public banks that can direct the use of the blood for research or for use by a possible recipient who may closely match the donor&#8217;s blood type.  There is anecdotal evidence that there is a greater chance of the blood being used in this type of scenario than if it were to be stored in a private blood bank, which some estimate to be 0.1% to 0.002% chance over the child&#8217;s life. (2)  Cord blood stored at public banks is treated as community blood; if a child or his or her relative should need a transplant of cord blood in the future, it is unlikely that he or she will be getting his or her own.  However, because the public banks are set up to screen and identify matches for cord blood, it is more likely that patients will receive a matching transplant.</p>
<p>For our son, my wife and I discussed the possibility of storing his cord blood in a bank and paying the yearly fee to maintain it in a freezer somewhere.  There is powerful literature suggesting that &#8220;no cost&#8221; is worth the life of your child.  But I am mathematical by nature, and the possibility that first, his cord blood would be needed in the future <strong>and</strong> second, he&#8217;d be able to use his own cord blood is a considerably slim margin, especially given our family history and our own relatively good health.</p>
<p>We considered the benefits of donating his cord blood to a public bank, but at that point in the pregnancy it seemed to be more of a hassle to set it up than it was worth.</p>
<p>With the onslaught of articles that were advertised in baby magazines, articles sent in mailers and a wide range of opinions from parents discussing the topic on the web, a small part of me couldn&#8217;t help but wonder if I was letting an opportunity pass that might make a difference in our son&#8217;s life in the future.  But after taking this careful opportunity to look back and review the information that&#8217;s available out there, I&#8217;m more confident that we made the right decision.  Private storage hasn&#8217;t gotten to the point that I&#8217;m convinced that it would help us or my present and future children.</p>
<p>Public cord banking, however, seems to have more potential for benefiting us in the future.  Adding cord blood to this type of bank, that may possibly be used for future research in improving treatments for disease, does have an appeal to me, as I&#8217;m sure it does my wife.  And the lack of a fee to harvest and store the blood is likely more appealing to parents still trying to establish themselves.</p>
<p>In either case, if you or someone you know is an expectant parent, your decision should be well-informed and one that you feel is right for you.  You are not obligated to have the cord blood of your child harvested, and any attempt to do so without your consent is both immoral and illegal. Know and understand your decision before your bundle of joy comes into this world &#8212; there won&#8217;t be any time once you go into labor!</p>
<p>How does this make you feel?  Did you have a situation where you opted to bank cord blood, either publicly or privately?  What was your experience?  Have you ever been in a situation where you actually had to use banked blood, either public or private?</p>
<p>Please, let me know!</p>
<p>(1) <a href="http://aappolicy.aappublications.org/cgi/content/full/pediatrics;104/1/116" title="Cord Blood Banking for Potential Future Transplantation: Subject Review">See &#8220;Cord Blood Banking for Potential Future Transpantation: Subject Review&#8221; from the American Academy of Pediatrics.</a></p>
<p>(2) <a href="http://pediatrics.about.com/od/agesandstages/i/cord_blood_bank_2.htm" title="Cord Blood Banking" target="_blank">See &#8220;Cord Blood Banking,&#8221; by Dr. Vincent Iannelli, on About.com</a></p>
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		<title>The Vaccination Debate</title>
		<link>http://avelient.com/BioPharmBlog/2007/09/21/the-vaccination-debate/</link>
		<comments>http://avelient.com/BioPharmBlog/2007/09/21/the-vaccination-debate/#comments</comments>
		<pubDate>Sat, 22 Sep 2007 00:30:52 +0000</pubDate>
		<dc:creator>Mariano DiFabio</dc:creator>
		
		<category><![CDATA[General]]></category>

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

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

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

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

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

		<guid isPermaLink="false">http://avelient.com/BioPharmBlog/?p=38</guid>
		<description><![CDATA[I was making myself a snack the other night when I noticed Jenny McCarthy on the TV program my wife happened to be watching.  Having not seen her as much in recent years as I did when I was younger, I was curious as to whether she was on a talk show because she [...]]]></description>
			<content:encoded><![CDATA[<p>I was making myself a snack the other night when I noticed <strong>Jenny McCarthy</strong> on the TV program my wife happened to be watching.  Having not seen her as much in recent years as I did when I was younger, I was curious as to whether she was on a talk show because she was making a comeback.  Asking my wife for more information, I found out that McCarthy was on the <strong>Oprah Winfrey Show</strong> to discuss her son who has autism, how she&#8217;s been dealing with and treating the disorder, and her theory as to the trigger for its onset.</p>
<p>Having a son of our own who is younger than McCarthy&#8217;s was when he was diagnosed with the disorder, I found the topic interesting and I asked my wife to save the show for me so I could watch later.  I managed to finish the show today, and I found myself enveloped by her story, but I took particular interest in what she identified was the catalyst for her son&#8217;s Autism: the measles, mumps and rubella (<strong>MMR</strong>) vaccination, which her son received just before his second birthday.<span id="more-38"></span></p>
<p>The MMR vaccination is recommended in two doses now by the Center of Disease Control (CDC).  According to <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/00053391.htm" target="_blank" title="Center for Disease Control">their web site</a>, they suggest children get the first shot at 12-15 months, and the second between 4 and 6 years.  The chemical mixture uses a substance called thimerosal as a preservative for the 3 vaccines it contains, which is suspected by many parents to be the root cause of increased incidences of Autism in children at around age 2.  Thimerosal is an organic compound containing mercury, or organomercurial, and has been used since the 1930s in a number of drug products, including vaccines, to help prevent their contamination by harmful microbes before administration. [UPDATE, 9/24: The MMR vaccine does NOT contain thimerosal,  and though some childhood vaccinations have in the past, there has been considerable effort by the FDA to remove the substance from vaccinations administered today.]</p>
<p><strong>Sallie Bernard</strong>, Chair of the Board of Directors of <a href="http://www.cureautismnow.org" title="Cure Autism Now" target="_blank"><strong>Cure Autism Now</strong></a>, believes that autism is a novel form of mercury poisoning in children.  Rejecting her assertion, the Food and Drug Administration (FDA) and Institute of Medicine (IOM) have conducted their own studies between 2001 and 2004 and found limited evidence of a causal relationship between the mercury content in the preservative thimerosal.  Discouraged but not defeated, Bernard asserts:</p>
<blockquote><p><em>Cure Autism Now believes the Institute of Medicine&#8217;s recent report, which rejects a causal link between MMR and thimerosal-taining vaccines and autism, is premature and should not be considered definitive. The IOM report unfortunately places greater emphasis on population-based epidemiologic studies using statistical analyses than on existing and emerging biological data from studies of individuals with autism which present biological mechanisms that may indicate a causal relationship. Cure Autism Now is aware of at least 15 ongoing studies, some of which are funded by CAN, that explore the potential biological mechanisms for vaccine-induced autism and believes these should be given serious consideration before a final verdict is made. (<a href="http://www.cureautismnow.org/site/apps/nl/content2.asp?c=bhLOK2PILuF&amp;b=1289185&amp;ct=1696889" title="Premature findings" target="_blank">click here for full article</a>)</em></p></blockquote>
<p>At last count, the incidence rate of autism is now 1 in 150 children in the United States, up from 1 in 166 when it was last studied in 2004.</p>
<p>Interestingly, in spite of their belief of no correlation between thimerosal and autism incidents, the Public Health Service, comprised of the FDA, CDC and other national health organizations, has initiated an effort to urge vaccine manufacturers to significantly reduce or eliminate the preservative from their vaccines as soon as possible, starting in 1999.  In addition, as part of the Oprah Winfrey Show episode I was watching, Ms. Winfrey&#8217;s team contacted the CDC to determine whether a link between Autism and vaccinations existed, and their response proved interesting:</p>
<blockquote><p><em>CDC places a high priority on vaccine safety and the integrity and credibility of its vaccine safety research. This commitment not only stems from our scientific and medical dedication, it is also personalâ€”for most of us who work at CDC are also parents and grandparents. And as such, we too, have high levels of personal interest and concern in the health and safety of children, families and communities. We simply don&#8217;t know what causes most cases of autism, but we&#8217;re doing everything we can to find out. The vast majority of science to date does not support an association between thimerosal in vaccines and autism. But we are currently conducting additional studies to further determine what role, if any, thimerosal in vaccines may play in the development of autism. It is important to remember, vaccines protect and save lives. Vaccines protect infants, children and adults from the unnecessary harm and premature death caused by vaccine-preventable diseases. (<a href="http://www2.oprah.com/tows/slide/200709/20070918/slide_20070918_350_106.jhtml" target="_blank" title="Oprah Winfrey: Jenny McCarthy and her experience with autism">click here for a link to the website with more quotes and a summary of the episode</a>)<br />
</em></p></blockquote>
<p>Since the show, Oprah&#8217;s discussion boards have been bombarded with comments from mothers describing similar experiences as they deal with their own children who exhibit the symptoms of autism.  It has piqued my interest in the subject, and I know now my wife and I are struggling with making the &#8220;right&#8221; decisions as our son faces immunizations at every pediatric visit.</p>
<p>I should note that though this could be a serious problem that will have a great impact on the decisions we make as parents, we will undoubtedly continue to vaccinate our children.  It is because of vaccines and the work of Louis Pasteur that we no longer have to worry about debilitating illnesses such as smallpox, polio, diphtheria, tetanus, and a plethora of others.  The show made a point of indicating that the argument wasn&#8217;t necessarily against all vaccinations in general, but an argument against the &#8220;One size fits all&#8221; mentality that the CDC promotes when making its recommendations.  Perhaps the levels of mercury that build up after significant exposure to thimerosal are the cause of the problem, and they simply crest at 2 years old when the MMR vaccine is given?  Perhaps all vaccinations should be spread out over a longer period of time as a preventative measure?  The answers to these questions will likely come as more studies are conducted and completed by the CDC and the FDA, but what do we parents do now, for those of our children who are scheduled to get those vaccines?  What do we trust?  In the absence of definitive test results, do we go with our gut?</p>
<p>I&#8217;d be interested to hear your thoughts on this topic, and find out what you would do in my situation.  Additionally, if you feel you have something you&#8217;d like to say to our meetup group on the topic, I&#8217;d love to schedule you as a speaker!  Feel free to leave a comment below.</p>
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