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<p><a href="http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm" target="_blank">http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm197728.htm</a></p>
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<p>A very interesting read in light of the finding of PCV1 and 2 in the rotavirus vaccines last year.</p>
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<div>The issue of informed consent I think is very</div>
<div>important. What is going to be extremely difficult,</div>
<div>particularly in the present atmosphere of all this, which has eased perhaps a little bit but not a lot, antagonism to vaccines in general, probably for not good reasons, and the amount of dis-information that is going to be out there about this and freely available to all is going to be as large if not larger than the amount of information.</div>
<div>So informed consent is going to be a major issue to be dealt with. I don't think there is any choice.</div>
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<p>from pg 184.</p>
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<p>We are talking about a theoretical risk versus a known benefit.</p>
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<p>A different doctor on the committee shares the following opinion</p>
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<div>While at the population level, looking at risks and</div>
<div>benefits is an easier story than it is when you start looking</div>
<div>at individuals who could potentially be affected.</div>
<div>I am impressed by the number of gaps in the science and in the</div>
<div>literature. There are a lot of gaps in evidence.</div>
<div>I think making assumptions around those gaps, and assumptions that</div>
<div>lead one to the conclusion that this is safe, and it is safe</div>
<div>for all infants, I think is potentially erroneous.</div>
<div>I think we will be putting some infants at risk.</div>
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<p>Very interesting...thanks for posting :)</p>
 

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Oy, my head is FULL! Loooots of interesting information in there, and a nice insight into how many of these decisions are researched, who is involved, how decisions are made, what factors are taken into consideration, etc. BTW, I read the <a class="bbcode_url" href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM215266.pdf" target="_blank">transcript here</a>, in case others were wondering where the quotes came from; but there are other interesting transcripts there as well.<br><br>
Thanks for sharing!
 

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Discussion Starter #4
<p>Yes, lots of insight into the decision making process. Thanks for posting a direct link to the transcript. </p>
 
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