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	<title>Comments on: Biogen&#8217;s Tysabri Causes Another Brain Infection</title>
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	<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 20:48:23 +0000</pubDate>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384883</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Wed, 17 Dec 2008 01:05:01 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384883</guid>
		<description>Hi Lauren,

Thanks for your note. And please don't misunderstand me - I'm not making any judgement about Tysrabi or its value to MS patients. I simply reported that another case of PML occurred and noted the context, which is that a few other cases were recently reported. 

Again, I think Ivan was confusing the messenger with the message - the case arose and it was reported. I do not believe that writing about the exisnce of another case is the same thing as saying Tysabri is a bad drug. If I wanted to write that, I would have done so. 

Hope this helps,
ed</description>
		<content:encoded><![CDATA[<p>Hi Lauren,</p>
<p>Thanks for your note. And please don&#8217;t misunderstand me - I&#8217;m not making any judgement about Tysrabi or its value to MS patients. I simply reported that another case of PML occurred and noted the context, which is that a few other cases were recently reported. </p>
<p>Again, I think Ivan was confusing the messenger with the message - the case arose and it was reported. I do not believe that writing about the exisnce of another case is the same thing as saying Tysabri is a bad drug. If I wanted to write that, I would have done so. </p>
<p>Hope this helps,<br />
ed</p>
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		<title>By: Lauren Roberts</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384882</link>
		<dc:creator>Lauren Roberts</dc:creator>
		<pubDate>Wed, 17 Dec 2008 00:57:25 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384882</guid>
		<description>Dear Mr. Silverman, please note that this patient that developed PML had a history of MS and prior disease modifying therapies, including beta-interferons..., these prior DMDs could have been Imuran/Azathioprine, CellCept, Remicade, Novantrone, etc.)

Those particular medications can last for years in the body even though the patient has discontinued them for quite some time.

Also, please note that the expert authors of the New England Journal of Medicine attribute PML to a diminished immune system, and not to Tysabri.  See: http://tinyurl.com/2mhn82

So far, it has been determined that each patient which developed PML was severely immune suppressed prior to &#38;/or during Tysabri therapy, thus developing PML.

There are currently over 46,000 patients that have been treated with Tysabri (according to statements made by Biogen)

I honestly believe that Tysabri has been given a bad rap..., the ABCRs efficacies only range from 29% to 34% [respectively], and Tysabri's efficacy is 67% when it comes to preventing further relapses, slowing the disease process down and shows significant improvements with regard to function in some MS patients.

Tysabri is the only MS FDA approved medication which can make that claim.

Respectfully submitted,

Lauren Roberts (MS patient for 33 plus years &#38; and Tysabri patient for more than two years)</description>
		<content:encoded><![CDATA[<p>Dear Mr. Silverman, please note that this patient that developed PML had a history of MS and prior disease modifying therapies, including beta-interferons&#8230;, these prior DMDs could have been Imuran/Azathioprine, CellCept, Remicade, Novantrone, etc.)</p>
<p>Those particular medications can last for years in the body even though the patient has discontinued them for quite some time.</p>
<p>Also, please note that the expert authors of the New England Journal of Medicine attribute PML to a diminished immune system, and not to Tysabri.  See: <a href="http://tinyurl.com/2mhn82" rel="nofollow">http://tinyurl.com/2mhn82</a></p>
<p>So far, it has been determined that each patient which developed PML was severely immune suppressed prior to &amp;/or during Tysabri therapy, thus developing PML.</p>
<p>There are currently over 46,000 patients that have been treated with Tysabri (according to statements made by Biogen)</p>
<p>I honestly believe that Tysabri has been given a bad rap&#8230;, the ABCRs efficacies only range from 29% to 34% [respectively], and Tysabri&#8217;s efficacy is 67% when it comes to preventing further relapses, slowing the disease process down and shows significant improvements with regard to function in some MS patients.</p>
<p>Tysabri is the only MS FDA approved medication which can make that claim.</p>
<p>Respectfully submitted,</p>
<p>Lauren Roberts (MS patient for 33 plus years &amp; and Tysabri patient for more than two years)</p>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384864</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Tue, 16 Dec 2008 21:26:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384864</guid>
		<description>Dear Ivan,

With all due respect, I believe my three-paragraph post was rather straightforward and conveyed basic information about a drug that is widely used, offers a great deal of benefit for many patients, but unfortunately, has also a history of causing a problem for others - to the extent that Tysabri was briefly off the market. You know this much, though, yes?

In running this item, I was providing coverage of what turns out to be an ongoing story. If there are factual mistakes in my post, please point them out and I will correct them, assuming your own facts are accurate. However, I assure you there was no attempt to 'damage companies and stock prices.' There was no hidden agenda and, to be honest, I think your accusations are off base.

Perhaps you would prefer such episodes go unreported. You don't say anything about your own agenda. But there are many reasons that such information should be reported, because there are people - regulators, doctors, patients and, yes, investors, among others - who do need to know. 

Hope this helps,
ed</description>
		<content:encoded><![CDATA[<p>Dear Ivan,</p>
<p>With all due respect, I believe my three-paragraph post was rather straightforward and conveyed basic information about a drug that is widely used, offers a great deal of benefit for many patients, but unfortunately, has also a history of causing a problem for others - to the extent that Tysabri was briefly off the market. You know this much, though, yes?</p>
<p>In running this item, I was providing coverage of what turns out to be an ongoing story. If there are factual mistakes in my post, please point them out and I will correct them, assuming your own facts are accurate. However, I assure you there was no attempt to &#8216;damage companies and stock prices.&#8217; There was no hidden agenda and, to be honest, I think your accusations are off base.</p>
<p>Perhaps you would prefer such episodes go unreported. You don&#8217;t say anything about your own agenda. But there are many reasons that such information should be reported, because there are people - regulators, doctors, patients and, yes, investors, among others - who do need to know. </p>
<p>Hope this helps,<br />
ed</p>
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		<title>By: Ivan</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384851</link>
		<dc:creator>Ivan</dc:creator>
		<pubDate>Tue, 16 Dec 2008 20:34:22 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384851</guid>
		<description>Condor

The yawn was in reply to yet another piece of sensationalist rubbish written by journalists that seemingly have a hidden agenda.  So please do not try to play the emotional blackmail card.  Nobody wants to see people suffer.  

The irony of these, continued and often incorrect media pieces, serves only to muddy the waters for those people wanting to understand the real issues.  

We do not want to read another manufactured ‘gutter press’ article aimed at damaging companies and stock prices and when we see such most of us sigh and, in my case, yawn!

Ivan</description>
		<content:encoded><![CDATA[<p>Condor</p>
<p>The yawn was in reply to yet another piece of sensationalist rubbish written by journalists that seemingly have a hidden agenda.  So please do not try to play the emotional blackmail card.  Nobody wants to see people suffer.  </p>
<p>The irony of these, continued and often incorrect media pieces, serves only to muddy the waters for those people wanting to understand the real issues.  </p>
<p>We do not want to read another manufactured ‘gutter press’ article aimed at damaging companies and stock prices and when we see such most of us sigh and, in my case, yawn!</p>
<p>Ivan</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384837</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Tue, 16 Dec 2008 18:35:03 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384837</guid>
		<description>Thanks Bruce - how is the risk 1 in 1000 when there have only been 4 confirmed cases but (according to Ed's article) between 9700 and 35,000 people have taken the drug?

By the way, there are ~43,000 deaths by car accidents in the US every year.  Our population (250 million) suggests that the "random" death rate is ~1 in 5000 people PER YEAR will be killed by a car accident.  That is about the same risk that people with MS face by taking this drug.  That's hardly a risk in my mind...</description>
		<content:encoded><![CDATA[<p>Thanks Bruce - how is the risk 1 in 1000 when there have only been 4 confirmed cases but (according to Ed&#8217;s article) between 9700 and 35,000 people have taken the drug?</p>
<p>By the way, there are ~43,000 deaths by car accidents in the US every year.  Our population (250 million) suggests that the &#8220;random&#8221; death rate is ~1 in 5000 people PER YEAR will be killed by a car accident.  That is about the same risk that people with MS face by taking this drug.  That&#8217;s hardly a risk in my mind&#8230;</p>
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		<title>By: Bruce</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384834</link>
		<dc:creator>Bruce</dc:creator>
		<pubDate>Tue, 16 Dec 2008 18:26:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384834</guid>
		<description>Nathan
The risk of PML with Tysabri is 1in1000. There have been 3 confirmed cases in MS patients and 1in a crohns patient. I have worked with MS patients for three years and while they are desperate for something to cure them, a lot are not willing to risk death or a vegetative state for that cure. 

Hi Ed. I am still around.</description>
		<content:encoded><![CDATA[<p>Nathan<br />
The risk of PML with Tysabri is 1in1000. There have been 3 confirmed cases in MS patients and 1in a crohns patient. I have worked with MS patients for three years and while they are desperate for something to cure them, a lot are not willing to risk death or a vegetative state for that cure. </p>
<p>Hi Ed. I am still around.</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384820</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Tue, 16 Dec 2008 17:07:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384820</guid>
		<description>Bingo,
I agree that it's hardly worth a yawn - but I disagree that this is any sort of a significant issue.  If we were treating PMS, then I agree that a 0.01% risk of PML is an unacceptable.  But MS?  There really are no good treatment options for MS -- a 1 in 10,000 risk of dying doesn't sound so bad to me....</description>
		<content:encoded><![CDATA[<p>Bingo,<br />
I agree that it&#8217;s hardly worth a yawn - but I disagree that this is any sort of a significant issue.  If we were treating PMS, then I agree that a 0.01% risk of PML is an unacceptable.  But MS?  There really are no good treatment options for MS &#8212; a 1 in 10,000 risk of dying doesn&#8217;t sound so bad to me&#8230;.</p>
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		<title>By: Bingo</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384803</link>
		<dc:creator>Bingo</dc:creator>
		<pubDate>Tue, 16 Dec 2008 15:20:02 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384803</guid>
		<description>Kool-Aid Boy, 

Unfortunately, PML us usually NOT non-fatal in this population.

An NIH website reports that "For non-AIDS individuals with PML, the prognosis remains grim; the disease usually lasts for months and 80 percent die within the first 6 months, although spontaneous improvement has been reported.  Those who survive PML can be left with severe neurological disabilities." 

Hardly worth a yawn, especially among those who have taken the drug.</description>
		<content:encoded><![CDATA[<p>Kool-Aid Boy, </p>
<p>Unfortunately, PML us usually NOT non-fatal in this population.</p>
<p>An NIH website reports that &#8220;For non-AIDS individuals with PML, the prognosis remains grim; the disease usually lasts for months and 80 percent die within the first 6 months, although spontaneous improvement has been reported.  Those who survive PML can be left with severe neurological disabilities.&#8221; </p>
<p>Hardly worth a yawn, especially among those who have taken the drug.</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384792</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Tue, 16 Dec 2008 14:00:35 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384792</guid>
		<description>Condor, 
So you were commenting on Ivan's lack of concern, not on the severity of the problem. 

Ok, so let's have a more reasoned discussion.  What are you saying should happen in responce to these brain infections?  3 out of 35,000 is a pretty small percentage.  MS is a pretty devestating degenerative disease.  I would gladly accept a ~1 in 10,000 risk of a (non-fatal) infection with the hope that I might have another few years of quality life.  Maybe you think about these issues differently.  Please explain.

Thanks, 
Kool-Aid boy</description>
		<content:encoded><![CDATA[<p>Condor,<br />
So you were commenting on Ivan&#8217;s lack of concern, not on the severity of the problem. </p>
<p>Ok, so let&#8217;s have a more reasoned discussion.  What are you saying should happen in responce to these brain infections?  3 out of 35,000 is a pretty small percentage.  MS is a pretty devestating degenerative disease.  I would gladly accept a ~1 in 10,000 risk of a (non-fatal) infection with the hope that I might have another few years of quality life.  Maybe you think about these issues differently.  Please explain.</p>
<p>Thanks,<br />
Kool-Aid boy</p>
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		<title>By: Condor</title>
		<link>http://www.pharmalot.com/2008/12/biogens-tysabri-causes-another-brain-infection/#comment-384789</link>
		<dc:creator>Condor</dc:creator>
		<pubDate>Tue, 16 Dec 2008 13:15:37 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=18619#comment-384789</guid>
		<description>Um, Nathan -- let's get this straight (note spelling): I think feigning boredom (Ivan's "yawn") in response to someone else's suffering. . . is a big deal.

So, to answer your question, Kool-Aid boy: Yes.

Namaste.</description>
		<content:encoded><![CDATA[<p>Um, Nathan &#8212; let&#8217;s get this straight (note spelling): I think feigning boredom (Ivan&#8217;s &#8220;yawn&#8221;) in response to someone else&#8217;s suffering. . . is a big deal.</p>
<p>So, to answer your question, Kool-Aid boy: Yes.</p>
<p>Namaste.</p>
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