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	<title>Comments on: Diving into Transhumanism III &#8211; Singularity</title>
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		<title>By: Anyone seen a nanobot lately &#171; BIOpinionated</title>
		<link>http://biopinionated.com/2009/01/02/diving-into-transhumanism-iii-singularity/#comment-320</link>
		<dc:creator><![CDATA[Anyone seen a nanobot lately &#171; BIOpinionated]]></dc:creator>
		<pubDate>Sun, 11 Jan 2009 16:20:45 +0000</pubDate>
		<guid isPermaLink="false">http://sciphu.wordpress.com/?p=91#comment-320</guid>
		<description><![CDATA[[...] finishing Ray Kurzweils book &#8220;The singularity is near&#8221; I had some thoughts on why his predictions on timing was probably a bit off.  One thing I didn&#8217;t mention, [...]]]></description>
		<content:encoded><![CDATA[<p>[...] finishing Ray Kurzweils book &#8220;The singularity is near&#8221; I had some thoughts on why his predictions on timing was probably a bit off.  One thing I didn&#8217;t mention, [...]</p>
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		<title>By: Daniel MacArthur</title>
		<link>http://biopinionated.com/2009/01/02/diving-into-transhumanism-iii-singularity/#comment-311</link>
		<dc:creator><![CDATA[Daniel MacArthur]]></dc:creator>
		<pubDate>Mon, 05 Jan 2009 13:33:15 +0000</pubDate>
		<guid isPermaLink="false">http://sciphu.wordpress.com/?p=91#comment-311</guid>
		<description><![CDATA[Hey Nils,

Sure safety testing costs lives - it holds back some drugs that would otherwise be out there saving lives. At the same time, of course, it SAVES many lives by holding back some drugs that would otherwise be out there killing people. The balance between these two forces is determined by the precise form of regulation.

And regulatory hurdles certainly DO discourage development of new drugs. You argue that &quot;cash is not a major problem for the drug industry&quot;, which may or may not be true (the recent mass lay-offs and general belt-tightening in the sector suggest otherwise to me), but TIME certainly is: pharma companies only have a limited window to market their products before their exclusive patents expire, and every extra year of safety testing means one less year to make back their investment in R&amp;D. The more regulatory hurdles pharma companies have to jump through the less profitable new drug development becomes, pushing pharma towards re-formulating existing active ingredients (which are easier to get approval for) rather than developing novel compounds.

I&#039;m not saying that safety testing isn&#039;t important - no-one wants to live in a world of zero-regulation anarchy - but rather that it is important to bear in mind that it comes at a cost, both in terms of lives lost by approval delays and reduced incentive for innovation.]]></description>
		<content:encoded><![CDATA[<p>Hey Nils,</p>
<p>Sure safety testing costs lives &#8211; it holds back some drugs that would otherwise be out there saving lives. At the same time, of course, it SAVES many lives by holding back some drugs that would otherwise be out there killing people. The balance between these two forces is determined by the precise form of regulation.</p>
<p>And regulatory hurdles certainly DO discourage development of new drugs. You argue that &#8220;cash is not a major problem for the drug industry&#8221;, which may or may not be true (the recent mass lay-offs and general belt-tightening in the sector suggest otherwise to me), but TIME certainly is: pharma companies only have a limited window to market their products before their exclusive patents expire, and every extra year of safety testing means one less year to make back their investment in R&amp;D. The more regulatory hurdles pharma companies have to jump through the less profitable new drug development becomes, pushing pharma towards re-formulating existing active ingredients (which are easier to get approval for) rather than developing novel compounds.</p>
<p>I&#8217;m not saying that safety testing isn&#8217;t important &#8211; no-one wants to live in a world of zero-regulation anarchy &#8211; but rather that it is important to bear in mind that it comes at a cost, both in terms of lives lost by approval delays and reduced incentive for innovation.</p>
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		<title>By: sciphu</title>
		<link>http://biopinionated.com/2009/01/02/diving-into-transhumanism-iii-singularity/#comment-310</link>
		<dc:creator><![CDATA[sciphu]]></dc:creator>
		<pubDate>Sat, 03 Jan 2009 14:55:16 +0000</pubDate>
		<guid isPermaLink="false">http://sciphu.wordpress.com/?p=91#comment-310</guid>
		<description><![CDATA[Daniel. I do not mean to say that safety should get in the way of new treatments, but rather that safety must serve as the primary guide to find out, as you say: &quot;where exactly the line should be drawn regarding the level of risk that is “acceptable&quot;&quot;. Of course there&#039;s a trade-off but certainly not on your argument that &quot;safety testing cost lives too&quot;. It doesn&#039;t ! - since the question is purely hypothetical ! An &quot;effective&quot; drug is not &quot;effective&quot; if it has devastating side-effects and hence you will not know if you have an &quot;effective&quot; drug until safety-testing is finished. Your argument that dollars spent on clinical trials could have been spent on research is not valid either, - cash is not a major problem for the drug industry, - more cash will not mean more research, - changing business models and restructuring the industry on the other hand......]]></description>
		<content:encoded><![CDATA[<p>Daniel. I do not mean to say that safety should get in the way of new treatments, but rather that safety must serve as the primary guide to find out, as you say: &#8220;where exactly the line should be drawn regarding the level of risk that is “acceptable&#8221;". Of course there&#8217;s a trade-off but certainly not on your argument that &#8220;safety testing cost lives too&#8221;. It doesn&#8217;t ! &#8211; since the question is purely hypothetical ! An &#8220;effective&#8221; drug is not &#8220;effective&#8221; if it has devastating side-effects and hence you will not know if you have an &#8220;effective&#8221; drug until safety-testing is finished. Your argument that dollars spent on clinical trials could have been spent on research is not valid either, &#8211; cash is not a major problem for the drug industry, &#8211; more cash will not mean more research, &#8211; changing business models and restructuring the industry on the other hand&#8230;&#8230;</p>
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		<title>By: Daniel MacArthur</title>
		<link>http://biopinionated.com/2009/01/02/diving-into-transhumanism-iii-singularity/#comment-309</link>
		<dc:creator><![CDATA[Daniel MacArthur]]></dc:creator>
		<pubDate>Fri, 02 Jan 2009 16:06:59 +0000</pubDate>
		<guid isPermaLink="false">http://sciphu.wordpress.com/?p=91#comment-309</guid>
		<description><![CDATA[Hey Nils,

You say: &quot;Safety should always be put first, regardless of the treatment potential. Deviating from this rule truly puts us at risk.&quot;

I wouldn&#039;t go that far. There are many late-stage cancer patients who are more than willing to set aside safety concerns regarding experimental treatments when the alternative is an awful, inevitable death. 

More generally, it&#039;s worth bearing in mind that the safety testing process costs lives too. Every year that an effective new drug is delayed by regulatory hurdles results in the deaths of tens of thousands of patients that the drug would have saved; every dollar spent by pharma companies in ever-larger clinical trials is one less dollar that can be spent on developing new drugs. In a world where the &quot;safety first&quot; mentality was taken to an extreme we would NEVER allow new drugs to be released, because there an infinite number of tests on an infinite number of sub-groups (e.g. obese, female, diabetic teenagers of african ancestry who are currently regularly taking paracetamol) that would need to be performed to rule out all possible harm.

There&#039;s a fundamental trade-off here: saving lives with new drugs requires taking risks. So the issue isn&#039;t whether safety should be put first, but rather where exactly the line should be drawn regarding the level of risk that is &quot;acceptable&quot;.]]></description>
		<content:encoded><![CDATA[<p>Hey Nils,</p>
<p>You say: &#8220;Safety should always be put first, regardless of the treatment potential. Deviating from this rule truly puts us at risk.&#8221;</p>
<p>I wouldn&#8217;t go that far. There are many late-stage cancer patients who are more than willing to set aside safety concerns regarding experimental treatments when the alternative is an awful, inevitable death. </p>
<p>More generally, it&#8217;s worth bearing in mind that the safety testing process costs lives too. Every year that an effective new drug is delayed by regulatory hurdles results in the deaths of tens of thousands of patients that the drug would have saved; every dollar spent by pharma companies in ever-larger clinical trials is one less dollar that can be spent on developing new drugs. In a world where the &#8220;safety first&#8221; mentality was taken to an extreme we would NEVER allow new drugs to be released, because there an infinite number of tests on an infinite number of sub-groups (e.g. obese, female, diabetic teenagers of african ancestry who are currently regularly taking paracetamol) that would need to be performed to rule out all possible harm.</p>
<p>There&#8217;s a fundamental trade-off here: saving lives with new drugs requires taking risks. So the issue isn&#8217;t whether safety should be put first, but rather where exactly the line should be drawn regarding the level of risk that is &#8220;acceptable&#8221;.</p>
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