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	<title>Comments for Science-Based Pharmacy</title>
	
	<link>http://sciencebasedpharmacy.wordpress.com</link>
	<description>Turning an eye on the profession, separating fact from fiction on both sides of the counter</description>
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		<title>Comment on Vaccines work: By the numbers by nic</title>
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		<dc:creator><![CDATA[nic]]></dc:creator>
		<pubDate>Thu, 16 May 2013 00:10:22 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11237</guid>
		<description><![CDATA[Gaffe,

you make too many unsubstantiated or flat out false assumptions about adenovirus vaccine. 

&quot;So from the looks of the released data, for each life saved it probably killed someone else.&quot;

Which data? If you don&#039;t support this statement by a study, then you&#039;re just flat out making stuff up and fearmongering. The CDC site you quote does not mention death or mortality anywhere, nor does it reference any study or dataset for the side effects mentionned. Here&#039;s the monography on the new oral vaccine, which is only given to military personnel, and the side-effect profile looks good (hint: no one died by the vaccine).

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM247515.pdf

On the other hand, adenovirus DOES kill, extremely rarely but it does.

http://wwwnc.cdc.gov/eid/article/18/3/11-1238_article.htm

Fortunately, the vaccine is very effective at preventing adenovirus.

http://www.afhsc.mil/viewMSMR?file=2012/v19_n03.pdf#Page=2

So, who&#039;s more conservative with people&#039;s lives again?]]></description>
		<content:encoded><![CDATA[<p>Gaffe,</p>
<p>you make too many unsubstantiated or flat out false assumptions about adenovirus vaccine. </p>
<p>&#8220;So from the looks of the released data, for each life saved it probably killed someone else.&#8221;</p>
<p>Which data? If you don&#8217;t support this statement by a study, then you&#8217;re just flat out making stuff up and fearmongering. The CDC site you quote does not mention death or mortality anywhere, nor does it reference any study or dataset for the side effects mentionned. Here&#8217;s the monography on the new oral vaccine, which is only given to military personnel, and the side-effect profile looks good (hint: no one died by the vaccine).</p>
<p><a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM247515.pdf" rel="nofollow">http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM247515.pdf</a></p>
<p>On the other hand, adenovirus DOES kill, extremely rarely but it does.</p>
<p><a href="http://wwwnc.cdc.gov/eid/article/18/3/11-1238_article.htm" rel="nofollow">http://wwwnc.cdc.gov/eid/article/18/3/11-1238_article.htm</a></p>
<p>Fortunately, the vaccine is very effective at preventing adenovirus.</p>
<p><a href="http://www.afhsc.mil/viewMSMR?file=2012/v19_n03.pdf#Page=2" rel="nofollow">http://www.afhsc.mil/viewMSMR?file=2012/v19_n03.pdf#Page=2</a></p>
<p>So, who&#8217;s more conservative with people&#8217;s lives again?</p>
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		<title>Comment on Vaccines work: By the numbers by Lorie</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/0RWl0qtVpUE/</link>
		<dc:creator><![CDATA[Lorie]]></dc:creator>
		<pubDate>Tue, 14 May 2013 00:10:14 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11219</guid>
		<description><![CDATA[Sorry but I posted the narcolepsy rates backwards:  The rate of narcolepsy among vaccinated children was estimated to be about .00002, while the background risk was estimated, on the low end, to be .00025.]]></description>
		<content:encoded><![CDATA[<p>Sorry but I posted the narcolepsy rates backwards:  The rate of narcolepsy among vaccinated children was estimated to be about .00002, while the background risk was estimated, on the low end, to be .00025.</p>
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		<title>Comment on Vaccines work: By the numbers by Lorie</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/1USiI7nvzUM/</link>
		<dc:creator><![CDATA[Lorie]]></dc:creator>
		<pubDate>Mon, 13 May 2013 23:52:18 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11218</guid>
		<description><![CDATA[@ Gaffe, the monitoring system follows extensive and usually very large pre-approval phase clinical trials that demonstrate safety. Safety is a relative term because risks are weighed against benefits, as they should be.  Post- market monitoring allows for very rare side-effects to be discovered and evaluated because much larger populations can be studied, involving hundreds of thousands or millions of people, while not withholding clinically proven life-saving (or misery and disability-reducing) vaccinations. 

The Pandemrix flu vaccine was shown to likely cause (at least in part) an increase in narcolepsy risk among children in Finland and Sweden.  This indicates that the monitoring system was working (and improvements are being made worldwide to these systems).  Pandemrix was never used in the US (because of more stringent standards for the use of adjuvants, which should be reassuring to Americans).   

And, the increased narcolepsy risk, while not trying to minimize its importance, should be put into perspective: it was still very rare.  The background narcolepsy rate in children before the vaccine was .00002, while the risk to vaccinated children was determined to be about .00025.  A &quot;13-fold risk increase&quot; to a tiny number is still a very small number -- especially if the pandemic had taken off, because it&#039;s always about risk versus benefits. 

 Because the pandemic ended up being lighter than some anticipated, the increased narcolepsy risk appeared more devastating.  But it&#039;s pretty hard to predict the outcome of a flu epidemic. Kind of like predicting earthquakes, in my opinion.  You want to be prepared for the big one even if a big one hasn&#039;t hit in ages.   If the pandemic had been catastrophic, parents would have been livid if a vaccine had been withheld because of a rare narcolepsy risk.  Vaccines save lives and prevent disabilities.  Good article: http://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2013-02-27-swine-flu-jab-narcolepsy-risk-is-very-small/]]></description>
		<content:encoded><![CDATA[<p>@ Gaffe, the monitoring system follows extensive and usually very large pre-approval phase clinical trials that demonstrate safety. Safety is a relative term because risks are weighed against benefits, as they should be.  Post- market monitoring allows for very rare side-effects to be discovered and evaluated because much larger populations can be studied, involving hundreds of thousands or millions of people, while not withholding clinically proven life-saving (or misery and disability-reducing) vaccinations. </p>
<p>The Pandemrix flu vaccine was shown to likely cause (at least in part) an increase in narcolepsy risk among children in Finland and Sweden.  This indicates that the monitoring system was working (and improvements are being made worldwide to these systems).  Pandemrix was never used in the US (because of more stringent standards for the use of adjuvants, which should be reassuring to Americans).   </p>
<p>And, the increased narcolepsy risk, while not trying to minimize its importance, should be put into perspective: it was still very rare.  The background narcolepsy rate in children before the vaccine was .00002, while the risk to vaccinated children was determined to be about .00025.  A &#8220;13-fold risk increase&#8221; to a tiny number is still a very small number &#8212; especially if the pandemic had taken off, because it&#8217;s always about risk versus benefits. </p>
<p> Because the pandemic ended up being lighter than some anticipated, the increased narcolepsy risk appeared more devastating.  But it&#8217;s pretty hard to predict the outcome of a flu epidemic. Kind of like predicting earthquakes, in my opinion.  You want to be prepared for the big one even if a big one hasn&#8217;t hit in ages.   If the pandemic had been catastrophic, parents would have been livid if a vaccine had been withheld because of a rare narcolepsy risk.  Vaccines save lives and prevent disabilities.  Good article: <a href="http://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2013-02-27-swine-flu-jab-narcolepsy-risk-is-very-small/" rel="nofollow">http://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2013-02-27-swine-flu-jab-narcolepsy-risk-is-very-small/</a></p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/bmewjemq7Xk/</link>
		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 18:35:03 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11215</guid>
		<description><![CDATA[And I didn&#039;t say there isn&#039;t a safety monitoring system. I said &quot;there are absolutely no PREVENTATIVE measures in place&quot;.

Safety monitoring is not preventative, it&#039;s reactive. And not useful for preventative style treatments that affect large groups at once. 

I&#039;m not saying that system is useless, at least now we know, but it is too little, too late.]]></description>
		<content:encoded><![CDATA[<p>And I didn&#8217;t say there isn&#8217;t a safety monitoring system. I said &#8220;there are absolutely no PREVENTATIVE measures in place&#8221;.</p>
<p>Safety monitoring is not preventative, it&#8217;s reactive. And not useful for preventative style treatments that affect large groups at once. </p>
<p>I&#8217;m not saying that system is useless, at least now we know, but it is too little, too late.</p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/F0I2A6qNne4/</link>
		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 18:29:46 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11214</guid>
		<description><![CDATA[A monitoring system that identifies a safety issue after it already caused serious harm isn&#039;t a method of preventing problems. If you vaccinate everyone and 30 years later we all die, it won&#039;t do any good to say oh, well oops! 

Isn&#039;t it great we had this system in place to find out what went wrong?

It&#039;s a little late don&#039;t you think?

For most medical treatments systems like this make sense because you don&#039;t affect large parts of the population. So you find out something is doing harm then you stop doing it. 

But in the case of vaccines that does not work, so there should be a higher standard for preventative safety measures. That&#039;s what I am saying.]]></description>
		<content:encoded><![CDATA[<p>A monitoring system that identifies a safety issue after it already caused serious harm isn&#8217;t a method of preventing problems. If you vaccinate everyone and 30 years later we all die, it won&#8217;t do any good to say oh, well oops! </p>
<p>Isn&#8217;t it great we had this system in place to find out what went wrong?</p>
<p>It&#8217;s a little late don&#8217;t you think?</p>
<p>For most medical treatments systems like this make sense because you don&#8217;t affect large parts of the population. So you find out something is doing harm then you stop doing it. </p>
<p>But in the case of vaccines that does not work, so there should be a higher standard for preventative safety measures. That&#8217;s what I am saying.</p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/XPJu7b_Aqp4/</link>
		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 18:19:22 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11212</guid>
		<description><![CDATA[Ok, here it is in more detail:

According to this study:
http://www.nejm.org/doi/full/10.1056/NEJM200103223441204

there was &quot;1 death for every 420 children vaccinated&quot; prevented.

Basic math tells you that this is a 0.23% rate of effectiveness for it&#039;s intended purpose.

According to this:
http://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm

There were 134million people vaccinated against the flu recently. And that is just one vaccine, the flu. 

Over 99% of these people did not need it, and were exposed to possible harm. Note I said possible, not proven.

There is always some amount of risk. We don&#039;t know how much, but we know that even if the risk/harm is minimal, affecting only about 0.23% of the population it outweighs the rewards because over a billion dollars is spent on these vaccinations (don&#039;t ask me for a reference, just use math - multiply $10 a dose, per costs listed here http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html
times 134 million people).

I don&#039;t know of too many medical treatments that have such an awesome safety record that there are no problems at all in less than 1/4% of cases, do you? So, while we lacking better data, it is not reasonable to assume this treatment is any different?

I&#039;m not sure which part of these facts or evidence are in dispute here when people keep saying I need to present more evidence. Is it the math or the source of the data that everyone here is not agreeing with?

I kind of thought it was obvious the vaccines rely on the principle of vaccinating many to prevent just a few deaths. 

Clearly many others don&#039;t see the risks involved in such an approach, but I still don&#039;t get why not.

Proving something kills you and there being a RISK of something going wrong are two different things. I didn&#039;t say I could prove it. By the time anyone can prove it it will be too late, don&#039;t you think?]]></description>
		<content:encoded><![CDATA[<p>Ok, here it is in more detail:</p>
<p>According to this study:<br />
<a href="http://www.nejm.org/doi/full/10.1056/NEJM200103223441204" rel="nofollow">http://www.nejm.org/doi/full/10.1056/NEJM200103223441204</a></p>
<p>there was &#8220;1 death for every 420 children vaccinated&#8221; prevented.</p>
<p>Basic math tells you that this is a 0.23% rate of effectiveness for it&#8217;s intended purpose.</p>
<p>According to this:<br />
<a href="http://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm" rel="nofollow">http://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm</a></p>
<p>There were 134million people vaccinated against the flu recently. And that is just one vaccine, the flu. </p>
<p>Over 99% of these people did not need it, and were exposed to possible harm. Note I said possible, not proven.</p>
<p>There is always some amount of risk. We don&#8217;t know how much, but we know that even if the risk/harm is minimal, affecting only about 0.23% of the population it outweighs the rewards because over a billion dollars is spent on these vaccinations (don&#8217;t ask me for a reference, just use math &#8211; multiply $10 a dose, per costs listed here <a href="http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html" rel="nofollow">http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html</a><br />
times 134 million people).</p>
<p>I don&#8217;t know of too many medical treatments that have such an awesome safety record that there are no problems at all in less than 1/4% of cases, do you? So, while we lacking better data, it is not reasonable to assume this treatment is any different?</p>
<p>I&#8217;m not sure which part of these facts or evidence are in dispute here when people keep saying I need to present more evidence. Is it the math or the source of the data that everyone here is not agreeing with?</p>
<p>I kind of thought it was obvious the vaccines rely on the principle of vaccinating many to prevent just a few deaths. </p>
<p>Clearly many others don&#8217;t see the risks involved in such an approach, but I still don&#8217;t get why not.</p>
<p>Proving something kills you and there being a RISK of something going wrong are two different things. I didn&#8217;t say I could prove it. By the time anyone can prove it it will be too late, don&#8217;t you think?</p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/0BrOCjLl38g/</link>
		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 17:51:02 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11209</guid>
		<description><![CDATA[I admit that was a bad example, and I will try to avoid caps in the future.]]></description>
		<content:encoded><![CDATA[<p>I admit that was a bad example, and I will try to avoid caps in the future.</p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/vfOnpVBpPL8/</link>
		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 17:47:02 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11208</guid>
		<description><![CDATA[I guess we have different interpretations of &quot;It is not clear whether these mild or serious problems were caused by the vaccine or occurred after vaccination by chance.&quot;

To you that reads &quot;so it&#039;s safe&quot;

and to me it reads &quot;so they have no idea therefore it&#039;s probably dangerous&quot;.

I guess I&#039;m just more conservative with people&#039;s lives than you are, but you have a right to your opinion.]]></description>
		<content:encoded><![CDATA[<p>I guess we have different interpretations of &#8220;It is not clear whether these mild or serious problems were caused by the vaccine or occurred after vaccination by chance.&#8221;</p>
<p>To you that reads &#8220;so it&#8217;s safe&#8221;</p>
<p>and to me it reads &#8220;so they have no idea therefore it&#8217;s probably dangerous&#8221;.</p>
<p>I guess I&#8217;m just more conservative with people&#8217;s lives than you are, but you have a right to your opinion.</p>
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		<title>Comment on Vaccines work: By the numbers by Scott</title>
		<link>http://feedproxy.google.com/~r/CommentsForScience-basedPharmacy/~3/C4zCG06Z0-s/</link>
		<dc:creator><![CDATA[Scott]]></dc:creator>
		<pubDate>Mon, 13 May 2013 17:40:28 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11207</guid>
		<description><![CDATA[I&#039;m confused. You point to vaccine safety monitoring systems that identified an adverse event associated with a particular brand of a vaccine as your evidence that there isn&#039;t a safety monitoring system for vaccines?]]></description>
		<content:encoded><![CDATA[<p>I&#8217;m confused. You point to vaccine safety monitoring systems that identified an adverse event associated with a particular brand of a vaccine as your evidence that there isn&#8217;t a safety monitoring system for vaccines?</p>
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		<title>Comment on Vaccines work: By the numbers by Gaffe</title>
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		<dc:creator><![CDATA[Gaffe]]></dc:creator>
		<pubDate>Mon, 13 May 2013 17:34:53 +0000</pubDate>
		<guid isPermaLink="false">http://sciencebasedpharmacy.wordpress.com/?p=4925#comment-11206</guid>
		<description><![CDATA[You all keep suggesting that logic dictates we do something dangerous then say &quot;until you can prove exactly how it kills you we can claim it has no risks&quot;. The problem is I don&#039;t agree that premise is logical.

I believe we should have some basis for believing something is safe before recommending that the entire population subject themselves to it. 

It isn&#039;t &quot;fear&quot; to point out that you are doing something dangerous and the odds of something unfortunate happening are high when you engage in high risk activities.

Any medical professional who thinks performing medical procedures on the entire population is not a high risk activity I think is reckless, and the only thing I am afraid of here is people like this influencing policy makers into making bad decisions. 

As I said, I cannot prove every vaccine&#039;s various side effects. That would require millions of dollars and long term research. 

But I can give you a few specific recent examples you all asked for:

Flu Vaccine causing narcolepsy proven:
http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html

Lymerix Vaccine causing chronic neurological impairment with sufficient evience that it was pulled from the market:
http://www.docguide.com/neurological-impairment-seen-patients-given-lymerix-lyme-disease-vaccine-presented-ana

I would especially like to draw your attention to the first example, here is the reuters article about it:
http://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122

especially note the following:

Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden&#039;s 21 regions.

The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.

While estimates vary, Stiernstedt says Sweden&#039;s mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.

With hindsight, this risk-benefit balance is unacceptable. &quot;This is a medical tragedy,&quot; he said. &quot;Hundreds of young people have had their lives almost destroyed.&quot;



The only thing I am &quot;afraid&quot; of is that we have not learned any lesson from this incident and much worse things are coming.

The fact that this vaccine was a mistake isn&#039;t my point. Mistakes happen and people die all the time. My point is that there are absolutely no preventative measures in place to prevent things like this (only even more serious) from happening in the future.]]></description>
		<content:encoded><![CDATA[<p>You all keep suggesting that logic dictates we do something dangerous then say &#8220;until you can prove exactly how it kills you we can claim it has no risks&#8221;. The problem is I don&#8217;t agree that premise is logical.</p>
<p>I believe we should have some basis for believing something is safe before recommending that the entire population subject themselves to it. </p>
<p>It isn&#8217;t &#8220;fear&#8221; to point out that you are doing something dangerous and the odds of something unfortunate happening are high when you engage in high risk activities.</p>
<p>Any medical professional who thinks performing medical procedures on the entire population is not a high risk activity I think is reckless, and the only thing I am afraid of here is people like this influencing policy makers into making bad decisions. </p>
<p>As I said, I cannot prove every vaccine&#8217;s various side effects. That would require millions of dollars and long term research. </p>
<p>But I can give you a few specific recent examples you all asked for:</p>
<p>Flu Vaccine causing narcolepsy proven:<br />
<a href="http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html" rel="nofollow">http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html</a></p>
<p>Lymerix Vaccine causing chronic neurological impairment with sufficient evience that it was pulled from the market:<br />
<a href="http://www.docguide.com/neurological-impairment-seen-patients-given-lymerix-lyme-disease-vaccine-presented-ana" rel="nofollow">http://www.docguide.com/neurological-impairment-seen-patients-given-lymerix-lyme-disease-vaccine-presented-ana</a></p>
<p>I would especially like to draw your attention to the first example, here is the reuters article about it:<br />
<a href="http://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122" rel="nofollow">http://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122</a></p>
<p>especially note the following:</p>
<p>Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden&#8217;s 21 regions.</p>
<p>The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.</p>
<p>While estimates vary, Stiernstedt says Sweden&#8217;s mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.</p>
<p>With hindsight, this risk-benefit balance is unacceptable. &#8220;This is a medical tragedy,&#8221; he said. &#8220;Hundreds of young people have had their lives almost destroyed.&#8221;</p>
<p>The only thing I am &#8220;afraid&#8221; of is that we have not learned any lesson from this incident and much worse things are coming.</p>
<p>The fact that this vaccine was a mistake isn&#8217;t my point. Mistakes happen and people die all the time. My point is that there are absolutely no preventative measures in place to prevent things like this (only even more serious) from happening in the future.</p>
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