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	<title>BioWorld &#187; Vaccine</title>
	<atom:link href="http://bioworld.blogs.bioworld.com/category/vaccine/feed/" rel="self" type="application/rss+xml" />
	<link>http://bioworld.blogs.bioworld.com</link>
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		<title>What’s 10 minus Four? Not Six, Apparently</title>
		<link>http://bioworld.blogs.bioworld.com/2012/11/30/whats-10-minus-four-not-six-apparently/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/11/30/whats-10-minus-four-not-six-apparently/#comments</comments>
		<pubDate>Fri, 30 Nov 2012 19:51:13 +0000</pubDate>
		<dc:creator>Anette Breindl</dc:creator>
				<category><![CDATA[AIDS]]></category>
		<category><![CDATA[HIV]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[David Baltimore]]></category>
		<category><![CDATA[Gary Nabel]]></category>

		<guid isPermaLink="false">http://bioworld.blogs.thompson.com/?p=1224</guid>
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Dec. 1 is World AIDS Day, and when I reflect on AIDS, I generally do it with a sense of amazement about how far we have come in the treatment of HIV since AIDS first came to the attention of...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/11/Blog-11-30-12.jpg" rel="shadowbox[sbpost-1224];player=img;" title="Blog 11-30-12"><img class="alignleft size-full wp-image-1225" title="Blog 11-30-12" src="http://bioworld.blogs.bioworld.com/files/2012/11/Blog-11-30-12.jpg" alt="" width="280" height="200" /></a>Dec. 1 is World AIDS Day, and when I reflect on AIDS, I generally do it with a sense of amazement about <a href="http://bioworld.blogs.bioworld.com/2011/11/06/medical-progress-is-real/" target="_blank">how far we have come</a> in the treatment of HIV <a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/lmrk077.htm" target="_blank">since AIDS first came to the attention of the U.S. medical establishment</a>, in form of a cluster of pneumocystis pneumonia infections in young men, in 1981. An <a href="http://www.pepfar.gov/documents/organization/201386.pdf" target="_blank">AIDS-free generation</a> is no longer a pipe dream.</p>
<p><span id="more-1224"></span></p>
<p>With all the progress that’s being made, though, I’ve been struck how one thing that seems to keep receding into the distance – like a manifestation of the joke that the future is always coming but never here – is a vaccine.</p>
<p>In February 2008, David Baltimore, said at the annual meeting of the American Association for the Advancement of Science that a vaccine has been at least 10 years away for the past 20 years.</p>
<p>Fast-forward to the <a href="http://www.aids2012.org/" target="_blank">July 2012 International AIDS conference</a>, where Gary Nabel, director of the Vaccine Research Institute at the National Institute of Allergies and Infectious Disease, said that vaccines are “at least 10 years away under the best of circumstances.”</p>
<p>The reason this seems so striking to me is that I’ve written about AIDS vaccines for a number of years now, and there were significant advances in the time period between those two statements. In 2008, Baltimore characterized the AIDS vaccine situation as &#8220;there is no AIDS vaccine and no hopeful candidate vaccine.&#8221;</p>
<p>Just a year later, the <a href="http://en.wikipedia.org/wiki/RV_144" target="_blank">RV144 or Thai trial became the first clinical trial to demonstrate efficacy of an HIV vaccine</a>, though the risk reduction was too modest to make the vaccine an option for widespread immunization campaigns.</p>
<p>Since then, dozens of broadly neutralizing antibodies have been identified that might form the basis of a vaccine. Researchers have gained new insights into how the B cell and T cell arms of the immune system each contribute to immunity in experimental HIV vaccines. And in one preclinical trial, about 50 percent of monkeys were protected against contracting SIV, and some appeared to be able to clear the infection, after vaccination with a viral vector-delivered vaccine.</p>
<p>So, dear readers: use the comments and give us your opinion. When will we be five years, instead of 10 years, away from an HIV vaccine? (“In five years” wins smart-aleck points but otherwise does not count.) And what will it take?</p>
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		<title>‘Final Chapter’ on XMRV? Good Luck With That One</title>
		<link>http://bioworld.blogs.bioworld.com/2012/09/24/final-chapter-on-xmrv-good-luck-with-that-one/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/09/24/final-chapter-on-xmrv-good-luck-with-that-one/#comments</comments>
		<pubDate>Mon, 24 Sep 2012 15:42:23 +0000</pubDate>
		<dc:creator>Anette Breindl</dc:creator>
				<category><![CDATA[chronic fatigue syndrome]]></category>
		<category><![CDATA[prostate cancer]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[virus]]></category>
		<category><![CDATA[CFS]]></category>
		<category><![CDATA[Ian Lipkin]]></category>
		<category><![CDATA[Judy Mikovits]]></category>
		<category><![CDATA[XMRV]]></category>

		<guid isPermaLink="false">http://bioworld.blogs.thompson.com/?p=1143</guid>
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Viruses are on the border between living and dead. So are the theories about what some of them cause. Two studies were published last week that showed no link between xenotropic murine leukemia virus-related virus (XMRV) and either chronic fatigue...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/09/blog-9-24-12.jpg" rel="shadowbox[sbpost-1143];player=img;" title="blog 9-24-12"><img class="alignleft size-thumbnail wp-image-1144" title="blog 9-24-12" src="http://bioworld.blogs.bioworld.com/files/2012/09/blog-9-24-12-150x150.jpg" alt="" width="150" height="150" /></a>Viruses are on the border between living and dead. So are the theories about what some of them cause.</p>
<p><span id="more-1143"></span></p>
<p>Two studies were published last week that showed no link between xenotropic murine leukemia virus-related virus (XMRV) and either <a href="http://mbio.asm.org/content/3/5/e00266-12" target="_blank">chronic fatigue syndrome</a> or <a href="http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0044954" target="_blank">prostate cancer</a>.</p>
<p>The scientific journals consider the matter settled with these studies. In theirs new sections, Nature and PLoS ONE wrote about “the nail in XMRV’s coffin” and “<a href="http://blogs.plos.org/everyone/2012/09/18/the-final-chapter-on-xmrv-and-prostate-cancer/" target="_blank">The Final Chapter on XMRV and Prostate Cancer</a>.”</p>
<p>Umm . . . good luck with that.</p>
<p>Actually, the link between XMRV and prostate cancer may be laid to rest fairly easily. That disease doesn’t seem to engender the same level of emotion about what causes it as CFS does, and certainly, if it’s a made up disease, it is made up by the <a href="http://www.ncbi.nlm.nih.gov/pubmed/22018148" target="_blank">screening guidelines</a>. No one accuses men of prostate cancer being all in their imaginations.</p>
<p>For the link between XMRV and CFS, I would not be too surprised if rather than dying, it ends up being one of those unfortunate, undead beliefs, like the autism-vaccine link.</p>
<p>Notably, several of the questions at the press conference where W. Ian Lipkin and his team announced the lack of a link between centered on whether the connection might, in fact be there, but in places unseen by the scientists. Could it be in the other organs rather than blood? Could there be an interaction with host genotype? These are exactly the kind of possibilities that vaccine skeptics love to bring up about autism – and that are impossible to truly disprove. There is always some angle you haven’t looked at.</p>
<p>If the team around Lipkin meets with more success with truly laying the notion of a link between XMRV and CFS to rest than the autism–vaccine contingent, it may be not because of the quality of their data. Instead, the key may lie in the study’s second author Judy Mikovits, whose team published the <a href="http://www.bioworld.com/content/retrovirus-strongly-associated-chronic-fatigue-syndrome-0" target="_blank">original paper</a> claiming a link.</p>
<p>Judy Mikovits has gone to some lengths to defend her theory and her data; at one point, she spent five days in jail for stealing lab equipment and data. She has lost her position at Whittemore Peterson Institute over her conduct in the aftermath of the study, and her affiliation on the paper is listed as “Mikovits Consulting.”</p>
<p>But unlike Andrew Wakefield, who first championed the link between vaccines and autism and has steadfastly refused to let the facts get in the way of his opinion, Mikovits was willing to rigorously test her own theory, along scientists who disagreed with her – and to let the data convince her that her original idea was wrong.</p>
<p>In one sense, this is what scientists do. But she is doing it well, and she deserves kudos for that.</p>
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		<title>Grappling with the Ethics</title>
		<link>http://bioworld.blogs.bioworld.com/2012/09/05/grappling-with-the-ethics/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/09/05/grappling-with-the-ethics/#comments</comments>
		<pubDate>Wed, 05 Sep 2012 13:45:51 +0000</pubDate>
		<dc:creator>Mari Serebrov</dc:creator>
				<category><![CDATA[bioethics]]></category>
		<category><![CDATA[embryonic stem cell research]]></category>
		<category><![CDATA[ethics]]></category>
		<category><![CDATA[genetics]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[Fay Boozman]]></category>
		<category><![CDATA[Federal Circuit]]></category>
		<category><![CDATA[Judge Pauline Newman]]></category>
		<category><![CDATA[Vaccine Act]]></category>

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With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist. From...]]></description>
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			<content:encoded><![CDATA[<p><a href="http://bioworld.blogs.bioworld.com/files/2012/09/blog-9-5-12.jpg" rel="shadowbox[sbpost-1116];player=img;" title="e"><img class="alignleft size-thumbnail wp-image-1117" title="e" src="http://bioworld.blogs.bioworld.com/files/2012/09/blog-9-5-12-150x150.jpg" alt="" width="150" height="150" /></a>With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist.</p>
<p><span id="more-1116"></span></p>
<p>From cloning to stem cell research to genetic testing to patent eligibility to drug pricing to compassionate use to quality-of-life issues, we face a growing number of decisions fraught with moral and ethical questions that cannot be easily answered in a lab or by a textbook. What once were merely philosophical debates about the future promise of science have become gut-wrenching decisions focused on the here-and-now realities of what science is capable of today.</p>
<p>Dealing with these realities is tough enough on a personal level. It becomes infinitely more difficult to answer such questions on a state or national level, knowing that the answers could impact millions of lives. The late Fay Boozman, then head of the <a href="http://www.healthy.arkansas.gov/Pages/default.aspx" target="_blank">Arkansas Department of Health</a>, clued me in on that struggle.</p>
<p>A soft-spoken, compassionate doctor, Fay lived his life to help others. The last time I saw him, Fay was agonizing over health policy decisions he had to make. He confided that because of the advances in science and technology, there were situations in which he didn’t even know how to apply the moral test that had guided his life.</p>
<p>I sensed that same soul searching among a few judges in two recent court decisions involving health care.</p>
<p>One of the cases, a vaccine suit, involved a request for an en banc rehearing in the U.S. Court of Appeals for the Federal Circuit. The denial of the en banc essentially upheld the court’s decision to deny two families compensation under the Vaccine Act when their infants developed Dravet’s syndrome after receiving a second diphtheria-tetanus-acellular pertussis vaccination.</p>
<p>The government conceded that the vaccine triggered the seizures that marked the onset of the disorder, which ordinarily would have led to compensation. But in these cases, the government denied causality because a genetic test, post-vaccination, showed the two girls had a DNA mutation in the SCN1A gene that <em>could</em> have eventually produced the disorder anyway.</p>
<p>In the lone <a href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-5109-5117%20order.pdf" target="_blank">dissent</a> to the Federal Circuit’s decision to deny the rehearing, Judge Pauline Newman said, “These cases raise an important new principle, one that is fundamental to the Vaccine Act, and that could not have arisen but for recent advances in genetic science.”</p>
<p>The Vaccine Act was designed to help the small percentage of children who were injured by vaccines, Newman said. In the past, no one understood why these children were harmed. While genetic testing is now explaining the why, it should not circumvent the need to compensate the families of the children endangered by a vaccination, the judge argued.</p>
<p>(The genetic advances beg a few questions. Now that we know some of the why, should all children undergo genetic testing before they’re vaccinated? If so, are we, as a society, willing to cover that extra cost? If not, are we willing to continue compensating families whose children were perhaps needlessly harmed by a vaccination?)</p>
<p>The other case, <a href="http://www.bioworld.com/content/court-says-yes-stem-cell-funding-boosts-free-speech-1?c2VhcmNoX3dvcmQ9YToyOntpOjA7czoxOToiZW1icnlvbmljIHN0ZW0gY2VsbCI7aToxO3M6MzoiTklIIjt9" target="_blank"><em>Sherley v. Sebelius</em></a>, involved federal funding of embryonic stem cell research. Although Judge Janice Rogers Brown concurred with the U.S. Court of Appeals for the District of Columbia Circuit <a href="http://www.cadc.uscourts.gov/internet/opinions.nsf/6C690438A9B43DD685257A64004EBF99/$file/11-5241-1391178.pdf" target="_blank">decision</a> to uphold the funding, she acknowledged serious concerns that “should trouble the heart.&#8221;</p>
<p>Noting that Congress has grappled with the ethical challenges rising from advances in biotechnology, Brown said, &#8220;Disagreement is inevitable when what lies at the core of the dispute is a profound question about the boundaries of science – one that is irreducibly controversial because the slippery slope is precipitous in both directions.&#8221;</p>
<p>Quoting James Thompson, the researcher credited with being the first to successfully derive human embryonic stem cells, Brown said, “‘If human embryonic stem cell research does not make you at least a bit uncomfortable, you have not thought about it enough.’”</p>
<p>I’m glad these judges wrestled with their decisions. Dealing with such issues should never be easy. And I’m glad they shared their struggle. Perhaps they will inspire other judges and policymakers to engage in some soul searching instead of minimalizing these debates by reducing them to academic or legal exercises.</p>
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		<title>In Vaccines and Autism Debates, the Truth is That it&#8217;s Trust or Consequences</title>
		<link>http://bioworld.blogs.bioworld.com/2012/04/24/in-vaccines-and-autism-debates-the-truth-is-that-its-trust-or-consequences/</link>
		<comments>http://bioworld.blogs.bioworld.com/2012/04/24/in-vaccines-and-autism-debates-the-truth-is-that-its-trust-or-consequences/#comments</comments>
		<pubDate>Tue, 24 Apr 2012 19:43:41 +0000</pubDate>
		<dc:creator>Anette Breindl</dc:creator>
				<category><![CDATA[Autism]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[AAAS]]></category>
		<category><![CDATA[Andrew Wakefield]]></category>
		<category><![CDATA[MMR]]></category>
		<category><![CDATA[World Immunization Week]]></category>

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Editor’s note: Since Dr. Breindl first wrote about vaccines and autism in 2008, the paper linking the MMR vaccine to autism has been retracted by the journal that published it, and its author Andrew Wakefield has lost his medical license....]]></description>
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			<content:encoded><![CDATA[<p><em><a href="http://bioworld.blogs.bioworld.com/files/2012/04/Vaccine-4-24-12.jpg" rel="shadowbox[sbpost-875];player=img;"><img class="alignleft size-thumbnail wp-image-876" src="http://bioworld.blogs.bioworld.com/files/2012/04/Vaccine-4-24-12-150x150.jpg" alt="" width="150" height="150" /></a>Editor’s note: Since Dr. Breindl first wrote about vaccines and autism in 2008, the paper linking the MMR vaccine to autism has been <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960175-4/fulltext" target="_blank">retracted by the journal that published it</a></em><em>, and its author Andrew Wakefield has <a href="http://www.casewatch.org/foreign/wakefield/sanction.shtml" target="_blank">lost his medical license</a></em><em>. But vaccine skepticism is alive and well – and so, during this <a href="http://www.who.int/immunization/newsroom/events/immunization_week/en/" target="_blank">World Immunization Week</a></em><em>, the question remains as pressing as ever: How do you have a productive discussion on policy with people who disagree with you on the facts?</em></p>
<p><span id="more-875"></span></p>
<p>I am not a vaccine skeptic. My children have all their required vaccines and some optional ones as well. We get flu shots – heck, I&#8217;m even up to date on my tetanus shots. How many of you can say <em>that</em> for yourself?</p>
<p>The reason I&#8217;m not a vaccine skeptic is because of the data. I&#8217;m not going to list the studies again because it&#8217;s a lot like global warming, or evolution: if you don&#8217;t believe it by now, it will take something other than my going over the research one more time to change your mind.</p>
<p>So it&#8217;s that &#8220;something other&#8221; that I want to talk about.</p>
<p>&nbsp;</p>
<p><strong>Vaccine Experts: The Role of Listening and Empathy </strong></p>
<p>At the American Association for the Advancement of Science&#8217;s (AAAS) annual meeting in 2008, there was a panel on &#8220;helping the public understand when scientific information is valid&#8221; that included a presentation on vaccines by <a href="http://www.cdc.gov/about/leadership/leaders/schuchat.htm" target="_blank">Anne Schuchat</a>, director of the National Center for Immunization and Respiratory Diseases.</p>
<p>The talk came under the somewhat ominous heading of &#8220;Vaccines: Truth or Consequences.&#8221; But Schuchat&#8217;s message was much more nuanced than that title might lead one to assume.</p>
<p>&#8220;Truth calls to mind, in my mind, humility . . . truth evolves,&#8221; she told the audience. &#8220;There&#8217;s a lot more than truth or consequences to communicating risk.&#8221;</p>
<p>One of Schuchat&#8217;s most interesting points was that what makes people trust expert advice depends on the situation. In low-concern settings, expertise accounts for 85 percent of the credibility that someone weighing in on an issue has. In high-concern settings, that percentage dwindles down to a measly (as it were) 15 percent to 20 percent. The most important factor? Listening skills and empathy, which account for fully half of an expert&#8217;s credibility in a high-concern situation.</p>
<p>Such empathy is still not really the strong suit of doctors and researchers; often, their thinly veiled assumption is that parents who don&#8217;t vaccinate their kids, or who struggle mightily with what seems like a no-brainer (a term just brimming with empathy and respect) to those in the pro-vaccine camp, are unable to understand the quality of the science supporting the opposing views.</p>
<p>One small study showing a possible link between a vaccine and autism, the pro-vaccine thinking goes, gets the same weight as five larger ones showing none; long-debunked associations keep getting trumpeted, and skepticism comes full circle and turns into extreme gullibility for self-proclaimed vaccine authorities.</p>
<p>I&#8217;m sure that happens. But by and large, it hasn&#8217;t been what I&#8217;ve heard about.</p>
<p>&nbsp;</p>
<p><strong>Getting to the Point of Trust</strong></p>
<p>The vaccine-skeptic parents I know understand and believe the epidemiology results fine, as far as they go. But here&#8217;s what an acquaintance of mine who has an autistic daughter had to say about vaccines and autism:</p>
<p>&#8220;I go to a special program for autistic kids every single day. It takes me one hour to get there and one hour back. I am there for 4 hours. In addition, I go to a clinic where my daughter gets more therapy. I have heard (and live) a million &#8216;autism&#8217; stories. It is more than just a 10-minute Oprah news bite to me. . . . Do I think vaccines are evil? No. But I have seen the videotapes of real life people . . . kids who spoke 50 words clearly and then suddenly lost that ability days after getting a vaccination. Can I really fall in line with the Centers for Disease Control and Prevention and call that coincidence? No. I just can&#8217;t.&#8221;</p>
<p>These personal observations combine with an awareness of the fact that genome-wide association studies are uncovering genetic risk factors for diseases literally by the dozen. My acquaintance says that &#8220;there is a yet-to-be-discovered link – maybe a genetic predisposition triggered by vaccines . . . I can&#8217;t put 100 percent of my trust in an agency to say there is no link when I am not convinced that they have exhausted the possibilities.&#8221;</p>
<p>&nbsp;</p>
<p><strong>Vaccines and Autism: New Research</strong></p>
<p>Up until last year, my only question about objections like these was how to get people to understand the difference between anecdotes and data. But, to quote Schuchat again, &#8220;It is daunting to try to be right in a way that will pass the test of time.&#8221; Recent research into the immune system of autistic individuals has led me to truly believe for the first time that these people might be seeing things that I am missing.</p>
<p>When I was in college and graduate school, the dominant view was that the nervous and immune systems are separated by a Chinese Wall. But newer research suggests that wall is as leaky as the one that supposedly separated analysts from bankers in the heyday of the dotcom boom.</p>
<p>At the 2007 annual meeting of the Society for Neuroscience, one of the press conferences was dedicated to &#8220;<a href="http://www.sfn.org/am2007/index.cfm?pagename=app_eventssymposia&amp;session_id=189" target="_blank">The New Neuroimmunology: Immune Proteins in Synapse Formation, Plasticity and Repair.</a>&#8221; It highlighted the many ways in which proteins do double duty in the immune and nervous systems.</p>
<p>And a recent review paper, titled &#8220;The immune response in autism: a new frontier for autism research,&#8221; lists a veritable who&#8217;s who of the immune system cells and molecules that may develop or function differently in autistic individuals, including T cells, monocytes/macrophages, natural killer cells, cytokines, neurokines and immunoglobulin.</p>
<p>At the neuroscience press conference, I asked a researcher whose lab is on the forefront of research whether these newly discovered links between the nervous and immune systems could mean that parents who swear their autistic children had a bad reaction to a vaccine were seeing something other than temporal coincidence, and if so, why such a link was not showing up in the epidemiology data.</p>
<p>She made it very clear that her data don&#8217;t address this question directly; for now, in fact, there&#8217;s no data on whether autistics are any different from neurotypical individuals in the area she studies.</p>
<p>But, she said, it would be consistent with what we know that autistic children could have underlying immune system abnormalities, and odd responses to vaccines due to those abnormalities. No cause and effect, but two different symptoms of the same molecular problem.</p>
<p>&nbsp;</p>
<p><strong>What We Know and Don&#8217;t Know</strong></p>
<p>So, do I believe that vaccines are more dangerous than we think? No. Most autistic individuals have perfectly normal immune systems. Even for those who don&#8217;t, none of the changes I&#8217;ve listed above provides an obvious mechanism for how autistic children might be especially sensitive to vaccines, and the epidemiology data are strong. And so I believe that there is no association between vaccines and autism, or vaccine preservatives and autism. And I believe that any additional data we might have a decade from now will continue to support my current opinion.</p>
<p>But I also believe something else: that we don&#8217;t know everything.</p>
<p>&#8220;We don&#8217;t know everything&#8221; is one of those things that&#8217;s easy to pay lip service to and harder to keep in mind when faced with actual opinions that are different from our own, which are of course, as the saying goes on National Public Radio, always insightful and well-reasoned. But if we want vaccine-skeptic parents to listen to our evidence, we&#8217;re going to have to say it like we mean it. And we&#8217;re going to have to admit – most importantly, to ourselves – that people may disagree with us for other reasons than a pigheaded refusal to understand the data.</p>
<p>Only 0.3 percent of American children receive no vaccinations at all, which suggests that the great majority of vaccine-skeptic parents put careful thought and evaluation into which vaccines to give their children; they are open to our best evidence. But as Schuchat put it at the AAAS meeting, &#8220;You cannot hear statistics until you have trust.&#8221;</p>
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