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	<title>Comments on: Prizes, Not Patents: Jamie Love Explains The Idea</title>
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	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 17:40:29 +0000</pubDate>
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		<title>By: Ann</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24137</link>
		<dc:creator>Ann</dc:creator>
		<pubDate>Thu, 01 Nov 2007 13:36:09 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24137</guid>
		<description>The current business model encourages companies to seek the broadest indications for a relatively few compounds in which they can prove efficacy and safety.  This benefits the largest number of people.  Wouldn't the "prize" model encourage companies to seek very narrow indications for a large number of compounds.  This would increase the number of drugs on the market without providing much benefit for the majority - medical balkanization so to speak?

Also, what happens to the incentive to actually invest in manufacturing, distribution or communication of infromation about the drug when the innovator can just take the prize money and run?  Why bother with actually selling drugs to sick people?</description>
		<content:encoded><![CDATA[<p>The current business model encourages companies to seek the broadest indications for a relatively few compounds in which they can prove efficacy and safety.  This benefits the largest number of people.  Wouldn&#8217;t the &#8220;prize&#8221; model encourage companies to seek very narrow indications for a large number of compounds.  This would increase the number of drugs on the market without providing much benefit for the majority - medical balkanization so to speak?</p>
<p>Also, what happens to the incentive to actually invest in manufacturing, distribution or communication of infromation about the drug when the innovator can just take the prize money and run?  Why bother with actually selling drugs to sick people?</p>
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		<title>By: TODD</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24071</link>
		<dc:creator>TODD</dc:creator>
		<pubDate>Thu, 01 Nov 2007 02:20:52 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24071</guid>
		<description>This is an incredibly bad idea - here is my reason and it is different from other views.  But those views are also very valid and there are so many reasons to criticize this idea.

When a manufacturer applies for a NDA their manufacturing facility is inspected and pharmacokinetics are a big part of the drug profile.  So this in essence takes R&#38;D companies out of manufacturing.  So there is no standard to compare against - everyone has their own yardstick from each generic company.  When a generic company files a ANDA they must approve approximate bioequivalence (80%-125% AUC) and manufacturing control.  ANDA's take 36 months.  So say GSK discovers a new compound, given its track record, no one is lining up to manufacture due to their poor track record.  So if it does come out, either only 1-2 companies are ready to go - giving them monopoly pricing; or no one is ready and it takes a couple of years to get it on the market</description>
		<content:encoded><![CDATA[<p>This is an incredibly bad idea - here is my reason and it is different from other views.  But those views are also very valid and there are so many reasons to criticize this idea.</p>
<p>When a manufacturer applies for a NDA their manufacturing facility is inspected and pharmacokinetics are a big part of the drug profile.  So this in essence takes R&amp;D companies out of manufacturing.  So there is no standard to compare against - everyone has their own yardstick from each generic company.  When a generic company files a ANDA they must approve approximate bioequivalence (80%-125% AUC) and manufacturing control.  ANDA&#8217;s take 36 months.  So say GSK discovers a new compound, given its track record, no one is lining up to manufacture due to their poor track record.  So if it does come out, either only 1-2 companies are ready to go - giving them monopoly pricing; or no one is ready and it takes a couple of years to get it on the market</p>
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		<title>By: Joseph DiMasi</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24031</link>
		<dc:creator>Joseph DiMasi</dc:creator>
		<pubDate>Wed, 31 Oct 2007 19:56:14 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24031</guid>
		<description>Ed,

The interview and comments are interesting.  I can contribute an article that my colleague Henry Grabowski and I have recently had published that discusses some problems in implementation and in practice that we believe this and related proposals would likely create if enacted (http://www.nature.com/clpt/journal/v82/n5/pdf/6100393a.pdf).  The article was written post the introduction of a Sanders prize fund bill in the House, but just prior to the introduction of his Senate bill.  Earlier (2004) we had submitted a longer critique of proposals like this to the WHO's Commission on Intellectual Property Rights, Innovation and Public Health.  That paper can be found here: http://www.who.int/intellectualproperty/news/en/Submission3.pdf</description>
		<content:encoded><![CDATA[<p>Ed,</p>
<p>The interview and comments are interesting.  I can contribute an article that my colleague Henry Grabowski and I have recently had published that discusses some problems in implementation and in practice that we believe this and related proposals would likely create if enacted (http://www.nature.com/clpt/journal/v82/n5/pdf/6100393a.pdf).  The article was written post the introduction of a Sanders prize fund bill in the House, but just prior to the introduction of his Senate bill.  Earlier (2004) we had submitted a longer critique of proposals like this to the WHO&#8217;s Commission on Intellectual Property Rights, Innovation and Public Health.  That paper can be found here: <a href="http://www.who.int/intellectualproperty/news/en/Submission3.pdf" rel="nofollow">http://www.who.int/intellectualproperty/news/en/Submission3.pdf</a></p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24024</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Wed, 31 Oct 2007 18:55:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24024</guid>
		<description>One other point: Mr. Love on one hand criticizes "me-too" drugs (lack of innovation) and simultaneously criticizes excessive drug prices.  However, the main  reason that the FDA (until recently) approved "me-too" drugs was to spur competition and therefore drive prices down.  The new focus of the FDA on safety has resulted in reduced competition among new drugs.  New drugs must be superior to existing drugs -- and therefore there is no meaningful competition among new drugs, allowing companies to charge whatever they want.  

People should be careful when tinkering with drug prices and drug safety together â€“ the two are very interdependent and progress in one area is often to the detriment of the other.</description>
		<content:encoded><![CDATA[<p>One other point: Mr. Love on one hand criticizes &#8220;me-too&#8221; drugs (lack of innovation) and simultaneously criticizes excessive drug prices.  However, the main  reason that the FDA (until recently) approved &#8220;me-too&#8221; drugs was to spur competition and therefore drive prices down.  The new focus of the FDA on safety has resulted in reduced competition among new drugs.  New drugs must be superior to existing drugs &#8212; and therefore there is no meaningful competition among new drugs, allowing companies to charge whatever they want.  </p>
<p>People should be careful when tinkering with drug prices and drug safety together â€“ the two are very interdependent and progress in one area is often to the detriment of the other.</p>
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		<title>By: Jack</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24014</link>
		<dc:creator>Jack</dc:creator>
		<pubDate>Wed, 31 Oct 2007 18:27:27 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24014</guid>
		<description>Well it's an interesting idea.  I don't think any other business operates like this, but what other business is like healthcare (where the person who chooses the product - the doctor, the person who uses the product - the patient, and the person who buys the product - the insurance company are all different).

I feel like he fell back on, "well it's complicated to determine prices now."  I didn't read the bill, but what he proposes, to have an esteemed group of impartial, cross-functional experts award 10s of billions of dollars fairly sound impossible to me.  It also seems like a system primed for corruption.  The devils in the details.</description>
		<content:encoded><![CDATA[<p>Well it&#8217;s an interesting idea.  I don&#8217;t think any other business operates like this, but what other business is like healthcare (where the person who chooses the product - the doctor, the person who uses the product - the patient, and the person who buys the product - the insurance company are all different).</p>
<p>I feel like he fell back on, &#8220;well it&#8217;s complicated to determine prices now.&#8221;  I didn&#8217;t read the bill, but what he proposes, to have an esteemed group of impartial, cross-functional experts award 10s of billions of dollars fairly sound impossible to me.  It also seems like a system primed for corruption.  The devils in the details.</p>
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		<title>By: Grief</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24013</link>
		<dc:creator>Grief</dc:creator>
		<pubDate>Wed, 31 Oct 2007 18:22:31 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24013</guid>
		<description>I don't see the role of drug safety in this model and am surprised by this.  Bernie Sanders, registered as an independent not a socialist in the Senate, was the only senator to vote against the PDUFA/Drug Safety bill in the Senate last Spring.  I am unaware of all his reasons, but I am sure the fact that many good drug safety facets of the bill were stripped out by Pharma had something to do with it. 

One problem I see with the comments above is their emphasis on the profit incentive and declaration that there is no possible replacement for it.  But the problem with this mindset has been and is the fact that it does not take drug safety into account.  Pharmaceutical companies each have a line item to pay individuals or their families when a family member is harmed or killed by a drug.  This is just factored into doing business - the ethic is just not there.  This is an industry that is not selling soap, though that is how it seems to behave.</description>
		<content:encoded><![CDATA[<p>I don&#8217;t see the role of drug safety in this model and am surprised by this.  Bernie Sanders, registered as an independent not a socialist in the Senate, was the only senator to vote against the PDUFA/Drug Safety bill in the Senate last Spring.  I am unaware of all his reasons, but I am sure the fact that many good drug safety facets of the bill were stripped out by Pharma had something to do with it. </p>
<p>One problem I see with the comments above is their emphasis on the profit incentive and declaration that there is no possible replacement for it.  But the problem with this mindset has been and is the fact that it does not take drug safety into account.  Pharmaceutical companies each have a line item to pay individuals or their families when a family member is harmed or killed by a drug.  This is just factored into doing business - the ethic is just not there.  This is an industry that is not selling soap, though that is how it seems to behave.</p>
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		<title>By: Casual Observer</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24009</link>
		<dc:creator>Casual Observer</dc:creator>
		<pubDate>Wed, 31 Oct 2007 17:41:40 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24009</guid>
		<description>Regardless of its chances for passage, this bill is an awful idea, and here's why:

There is no replacement for the profit incentive.  Currently, drug innovators are motivated to develop drugs that best meet the demands of consumers.  The better their drugs do this, the more profits they earn.  Patent laws help to achieve this process, because they assure innovators that their efforts (if successful) are rewarded commensurate with their ability to provide the most desired treatments.  

Sandersâ€™ bill attempts to replace the profit motive with a government granted reward â€“ which, by the way, has to come from somewhere, i.e. taxpayers.  If you were developing a life-saving treatment, which would you rather receive?  A cookie-cutter reward from the government, or the right to exclusively market your drug and directly reap the benefits of your ingenuity?  

Does this bill plan to reward treatments based on how well they meet the needs of the general public?  Not a chance.  At best, such a program would attempt to reward the more â€œimportantâ€ discoveries with higher amounts of cash.  Making such decisions would require extensive research and pharmacoeconomic analysis, and even then would probably not match up with the needs of the general public.

What about the $200 billion in annual savings, you ask?  Iâ€™m assuming this savings refers to the benefits consumers would receive from lower drug prices as a result of the bill.  Fine.  Prices would indeed be much lower.  What this methodology fails to take into account, is the less obvious costs of imposing a law like this.  As mentioned, taxpayers are forced to fund the program.  It erodes IP rights and therefore erodes incentives to innovate.  In the end, the taxpayer, the patient, and yes, big pharma â€“ we all lose.  (Except for politicians and generic companies, who I might add arenâ€™t all that worse for the wear in their current circumstances).   

Yes, as Love says, business models do change.  But the basic laws of economics do not.  Please donâ€™t remove my drug innovatorâ€™s motive to keep providing me and my family with life-saving treatments.</description>
		<content:encoded><![CDATA[<p>Regardless of its chances for passage, this bill is an awful idea, and here&#8217;s why:</p>
<p>There is no replacement for the profit incentive.  Currently, drug innovators are motivated to develop drugs that best meet the demands of consumers.  The better their drugs do this, the more profits they earn.  Patent laws help to achieve this process, because they assure innovators that their efforts (if successful) are rewarded commensurate with their ability to provide the most desired treatments.  </p>
<p>Sandersâ€™ bill attempts to replace the profit motive with a government granted reward â€“ which, by the way, has to come from somewhere, i.e. taxpayers.  If you were developing a life-saving treatment, which would you rather receive?  A cookie-cutter reward from the government, or the right to exclusively market your drug and directly reap the benefits of your ingenuity?  </p>
<p>Does this bill plan to reward treatments based on how well they meet the needs of the general public?  Not a chance.  At best, such a program would attempt to reward the more â€œimportantâ€ discoveries with higher amounts of cash.  Making such decisions would require extensive research and pharmacoeconomic analysis, and even then would probably not match up with the needs of the general public.</p>
<p>What about the $200 billion in annual savings, you ask?  Iâ€™m assuming this savings refers to the benefits consumers would receive from lower drug prices as a result of the bill.  Fine.  Prices would indeed be much lower.  What this methodology fails to take into account, is the less obvious costs of imposing a law like this.  As mentioned, taxpayers are forced to fund the program.  It erodes IP rights and therefore erodes incentives to innovate.  In the end, the taxpayer, the patient, and yes, big pharma â€“ we all lose.  (Except for politicians and generic companies, who I might add arenâ€™t all that worse for the wear in their current circumstances).   </p>
<p>Yes, as Love says, business models do change.  But the basic laws of economics do not.  Please donâ€™t remove my drug innovatorâ€™s motive to keep providing me and my family with life-saving treatments.</p>
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		<title>By: Ed Silverman</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24007</link>
		<dc:creator>Ed Silverman</dc:creator>
		<pubDate>Wed, 31 Oct 2007 17:33:42 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24007</guid>
		<description>Hi Ed and Nathan,

To Ed: I understand your point about Sanders' socialist leanings or beliefs. I simply listed as I did because he was voted in as an independent, as opposed to as a Republican or Democrat on a formal basis. If I'm incorrect about that, though, I will gladly make the correction.

To Nathan: I posted this interview simply because the legislation is provocative and I'm interested not only in the reactions but the larger issues it raises. You make some good points in response and I hope that others will do the same thing. Whether the bill lives or dies, perhaps some greater understanding can be achieved.

Thanks to you both for writing in,

ed at Pharmalot</description>
		<content:encoded><![CDATA[<p>Hi Ed and Nathan,</p>
<p>To Ed: I understand your point about Sanders&#8217; socialist leanings or beliefs. I simply listed as I did because he was voted in as an independent, as opposed to as a Republican or Democrat on a formal basis. If I&#8217;m incorrect about that, though, I will gladly make the correction.</p>
<p>To Nathan: I posted this interview simply because the legislation is provocative and I&#8217;m interested not only in the reactions but the larger issues it raises. You make some good points in response and I hope that others will do the same thing. Whether the bill lives or dies, perhaps some greater understanding can be achieved.</p>
<p>Thanks to you both for writing in,</p>
<p>ed at Pharmalot</p>
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		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24005</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Wed, 31 Oct 2007 17:24:28 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24005</guid>
		<description>As someone who feeds their family from a job in the pharma industry, I can tell you that I would be TERRIFIED if a bill like this came under serious consideration.  There are numerous problems with this idea that demonstrate Mr. Love's lack of knowledge of the pharmaceutical business, but I'll just point out one.  He states "Only 14 percent of new drug approvals are both new and better than older products, and clinical trials for me-too products are about twice as large as for innovative drugs."
Here's a couple points about this statement:
1.) He states that only 14% of new drug approvals are for new and better products.  He fails to mention that most of the other 86% of approvals are for new indications for an existing drug.  Is he saying this is of no value?  His proposal would certainly not change the FDA approval process -- so this 14%/86% ratio would remain approximately constant.
2.) In the "post-Vioxx" era, the FDA will not approve "me-too" drugs unless they clearly demonstrate either improved efficacy or improved safety.  Hence the huge number of "approvable" letters going out.  (4 out of 5 drugs that GSK submits to the FDA after a positive phase III trial are rejected with an "approvable" letter)  I would challenge Mr. Love (or anyone else) to give me an example of a post-Vioxx "me-too" drug that was approved by the FDA without showing some significant advantage over the existing standard of care.
3.) Clinical trials for "me-too" drugs are larger than for "innovative" drugs because there is a higher hurdle they must clear: they have to be better than the existing treatment.  This is hard to prove unless you have a very large population sample to look at.  

Fortunately for all of us, I think that this system has virtually no chance of passage.  For starters, the entire world would have to simultaneously shift to this new paradigm, which is very unlikely.  Moreover, it represents a huge shift away from free-market driven research to government driven research.  When is the last time the NIH developed a real drug that is currently on the market?</description>
		<content:encoded><![CDATA[<p>As someone who feeds their family from a job in the pharma industry, I can tell you that I would be TERRIFIED if a bill like this came under serious consideration.  There are numerous problems with this idea that demonstrate Mr. Love&#8217;s lack of knowledge of the pharmaceutical business, but I&#8217;ll just point out one.  He states &#8220;Only 14 percent of new drug approvals are both new and better than older products, and clinical trials for me-too products are about twice as large as for innovative drugs.&#8221;<br />
Here&#8217;s a couple points about this statement:<br />
1.) He states that only 14% of new drug approvals are for new and better products.  He fails to mention that most of the other 86% of approvals are for new indications for an existing drug.  Is he saying this is of no value?  His proposal would certainly not change the FDA approval process &#8212; so this 14%/86% ratio would remain approximately constant.<br />
2.) In the &#8220;post-Vioxx&#8221; era, the FDA will not approve &#8220;me-too&#8221; drugs unless they clearly demonstrate either improved efficacy or improved safety.  Hence the huge number of &#8220;approvable&#8221; letters going out.  (4 out of 5 drugs that GSK submits to the FDA after a positive phase III trial are rejected with an &#8220;approvable&#8221; letter)  I would challenge Mr. Love (or anyone else) to give me an example of a post-Vioxx &#8220;me-too&#8221; drug that was approved by the FDA without showing some significant advantage over the existing standard of care.<br />
3.) Clinical trials for &#8220;me-too&#8221; drugs are larger than for &#8220;innovative&#8221; drugs because there is a higher hurdle they must clear: they have to be better than the existing treatment.  This is hard to prove unless you have a very large population sample to look at.  </p>
<p>Fortunately for all of us, I think that this system has virtually no chance of passage.  For starters, the entire world would have to simultaneously shift to this new paradigm, which is very unlikely.  Moreover, it represents a huge shift away from free-market driven research to government driven research.  When is the last time the NIH developed a real drug that is currently on the market?</p>
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		<title>By: Ed Thomas</title>
		<link>http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24003</link>
		<dc:creator>Ed Thomas</dc:creator>
		<pubDate>Wed, 31 Oct 2007 17:18:40 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/2007/10/jamie-love-interview/#comment-24003</guid>
		<description>Mr. Silverman:

Bernie Saunders should not be referred to as "an independent from Vermont."  He is an avowed socialist and the only one in U.S. Congress to my knowledge.</description>
		<content:encoded><![CDATA[<p>Mr. Silverman:</p>
<p>Bernie Saunders should not be referred to as &#8220;an independent from Vermont.&#8221;  He is an avowed socialist and the only one in U.S. Congress to my knowledge.</p>
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