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	<title>Comments on: Mommy, Where Do Drugs Come From?</title>
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	<pubDate>Fri, 10 Feb 2012 15:43:17 +0000</pubDate>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364708</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Mon, 30 Jun 2008 05:10:56 +0000</pubDate>
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		<description>Ford's very complexity may be relevant to the discussion.  On the one hand, much of what Dr. Helm writes is, as far as I know, correct.  Ford's use of the assembly line in innovative ways was also, of course, key to the company's success.  Those were the days, in Motown.

And, at the same moment, Ford was virulently anti-immigrant, isolationist, anti-union, and anti-Semitic.  The relevant history and his relationship with Nazi Germany/Hitler up to the outbreak of WW2 need not be reiterated.

What's the relevance?  Ford's success and genuinely good intentions in many areas, I believe, is part of what blinded him to his weaknesses and limits of vision.  I think there is a lesson there for all essentially "good institutions" and especially if they are successful and large - pharma, Harvard, and even lawyers!  The "bigger" they are, the more careful they need to be.

Ford was an essentially moral guy who became, at certain points in his career, a grandiose, even hateful, moralist.  In his way, he, too, was involved in a narrowing either-or obsession over "who should get the credit" (and who is to blame).</description>
		<content:encoded><![CDATA[<p>Ford&#8217;s very complexity may be relevant to the discussion.  On the one hand, much of what Dr. Helm writes is, as far as I know, correct.  Ford&#8217;s use of the assembly line in innovative ways was also, of course, key to the company&#8217;s success.  Those were the days, in Motown.</p>
<p>And, at the same moment, Ford was virulently anti-immigrant, isolationist, anti-union, and anti-Semitic.  The relevant history and his relationship with Nazi Germany/Hitler up to the outbreak of WW2 need not be reiterated.</p>
<p>What&#8217;s the relevance?  Ford&#8217;s success and genuinely good intentions in many areas, I believe, is part of what blinded him to his weaknesses and limits of vision.  I think there is a lesson there for all essentially &#8220;good institutions&#8221; and especially if they are successful and large - pharma, Harvard, and even lawyers!  The &#8220;bigger&#8221; they are, the more careful they need to be.</p>
<p>Ford was an essentially moral guy who became, at certain points in his career, a grandiose, even hateful, moralist.  In his way, he, too, was involved in a narrowing either-or obsession over &#8220;who should get the credit&#8221; (and who is to blame).</p>
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		<title>By: M Helm, MD</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364705</link>
		<dc:creator>M Helm, MD</dc:creator>
		<pubDate>Mon, 30 Jun 2008 04:12:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364705</guid>
		<description>CMC, and others, thanks for the kind comments over the week.

CMC, I particularly like your analogy and illustration of the drug development story as a journey.  What seems to be topic of this particular debate is who gets most credit for the trip - the travel agent or the airline pilot? 

One of the stories about Mr Ford's genius was that he intended to build a car every working man could afford.  Problem was he couldn't do it initially.  His solution: pay his workers more money, so they could afford to buy the product they made.  The story goes that this drove up wages among other employers around Detroit, expanding the base of potential customers even more.  (At the time, auto manufacturing was a far more local phenomenon.)  I believe this to be a true story, though I haven't thoroughly researched it.  I'm not creative enough to have invented it myself.

I have a recollection of hearing Dr. Angell at a plenary session at some convention I attended in the past few years.  I can't recall which one, but I remember the arguments being made, with the clear presumption that PhRMA and BIO companies were profiteering usurpers.  I recall finding a fair number of assumptions in the arguments unsound, and I'm pretty that after a few minutes, I just started reviewing my itenerary for the day.  I was left with a profound unasked/unanswered question at the end:  "So what?"

I think we are all obligated to ask these authorities - regardless of the tilt of their argument: "Assuming you are correct, what difference does this make?  How are you proposing to improve innovation, expidite new discover, development and commercialization of  technologies proven to provide real value to people suffering from significant medical problems?"  Maybe I should throw in a question about how to reduce the costs and improve the likelihood of success.

If I ever have the opportunity again, I will do my best to ask.  Keeping with the car theme, I recall one of the US companies briefly adopting a slogan of "lead, follow or get out of the way."

Bob Freeman is correct about critiques (Dr. Angell's and others) regarding promotional spending vs. R&#38;D.  There are issues there, and they are not new. But that's also a different discussion.  If physicians really cared about the balance of R&#38;D versus promotion, they could simply refuse to see reps and refuse to accept samples.  (This was a different plenary speaker topic.)</description>
		<content:encoded><![CDATA[<p>CMC, and others, thanks for the kind comments over the week.</p>
<p>CMC, I particularly like your analogy and illustration of the drug development story as a journey.  What seems to be topic of this particular debate is who gets most credit for the trip - the travel agent or the airline pilot? </p>
<p>One of the stories about Mr Ford&#8217;s genius was that he intended to build a car every working man could afford.  Problem was he couldn&#8217;t do it initially.  His solution: pay his workers more money, so they could afford to buy the product they made.  The story goes that this drove up wages among other employers around Detroit, expanding the base of potential customers even more.  (At the time, auto manufacturing was a far more local phenomenon.)  I believe this to be a true story, though I haven&#8217;t thoroughly researched it.  I&#8217;m not creative enough to have invented it myself.</p>
<p>I have a recollection of hearing Dr. Angell at a plenary session at some convention I attended in the past few years.  I can&#8217;t recall which one, but I remember the arguments being made, with the clear presumption that PhRMA and BIO companies were profiteering usurpers.  I recall finding a fair number of assumptions in the arguments unsound, and I&#8217;m pretty that after a few minutes, I just started reviewing my itenerary for the day.  I was left with a profound unasked/unanswered question at the end:  &#8220;So what?&#8221;</p>
<p>I think we are all obligated to ask these authorities - regardless of the tilt of their argument: &#8220;Assuming you are correct, what difference does this make?  How are you proposing to improve innovation, expidite new discover, development and commercialization of  technologies proven to provide real value to people suffering from significant medical problems?&#8221;  Maybe I should throw in a question about how to reduce the costs and improve the likelihood of success.</p>
<p>If I ever have the opportunity again, I will do my best to ask.  Keeping with the car theme, I recall one of the US companies briefly adopting a slogan of &#8220;lead, follow or get out of the way.&#8221;</p>
<p>Bob Freeman is correct about critiques (Dr. Angell&#8217;s and others) regarding promotional spending vs. R&amp;D.  There are issues there, and they are not new. But that&#8217;s also a different discussion.  If physicians really cared about the balance of R&amp;D versus promotion, they could simply refuse to see reps and refuse to accept samples.  (This was a different plenary speaker topic.)</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364703</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Mon, 30 Jun 2008 03:36:07 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364703</guid>
		<description>All is well; I've always appreciated your comments.  As I think you know, I am not a lawyer, even though I've been active in the preemption issue and a few others that have legal aspects.  Luckily, Harvard did provide me with some very smart roommmates who are high-falutin' lawyers (corporate, government, labor, et. al.) so I ask them about the law, and they ask me about fly fishing.</description>
		<content:encoded><![CDATA[<p>All is well; I&#8217;ve always appreciated your comments.  As I think you know, I am not a lawyer, even though I&#8217;ve been active in the preemption issue and a few others that have legal aspects.  Luckily, Harvard did provide me with some very smart roommmates who are high-falutin&#8217; lawyers (corporate, government, labor, et. al.) so I ask them about the law, and they ask me about fly fishing.</p>
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		<title>By: CMC guy</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364702</link>
		<dc:creator>CMC guy</dc:creator>
		<pubDate>Mon, 30 Jun 2008 03:22:21 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364702</guid>
		<description>JIM- you're welcome.  I trust you catch I am (mostly?) poking fun at Harvard (and Lawyers too) and I actually have had friends from both so am redirecting some of those interactions since you can sound like them at times.  If I offend please ignore and accept unintentional nature.</description>
		<content:encoded><![CDATA[<p>JIM- you&#8217;re welcome.  I trust you catch I am (mostly?) poking fun at Harvard (and Lawyers too) and I actually have had friends from both so am redirecting some of those interactions since you can sound like them at times.  If I offend please ignore and accept unintentional nature.</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364696</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Mon, 30 Jun 2008 02:04:32 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364696</guid>
		<description>CMC - Thank you for taking the time to explain the situation you did.  I think it is exactly such particular cases that we need to get beyond the "who gets credit" debate which, as we all seem to agree, is mostly a political club used by each side to bash the  other.  Just as you suggest, when you get down to particulars, the generalizations of talking points don't last very long.  This is very valuable stuff, and - yes - not what makes easy headlines.

I carry no brief for Harvard, btw.  Last time I was there (my 25th reunion) some guy from the contribution committee (I guess their equivalent of marketing) literally berated our class and said, almost in these words, that we "owed Harvard" several million bucks based on what other 25th anniversary classes had given.  And we had better pay up.  Pronto.

So, to me, Harvard is mainly a brand name, and obviously a pretty successful one.</description>
		<content:encoded><![CDATA[<p>CMC - Thank you for taking the time to explain the situation you did.  I think it is exactly such particular cases that we need to get beyond the &#8220;who gets credit&#8221; debate which, as we all seem to agree, is mostly a political club used by each side to bash the  other.  Just as you suggest, when you get down to particulars, the generalizations of talking points don&#8217;t last very long.  This is very valuable stuff, and - yes - not what makes easy headlines.</p>
<p>I carry no brief for Harvard, btw.  Last time I was there (my 25th reunion) some guy from the contribution committee (I guess their equivalent of marketing) literally berated our class and said, almost in these words, that we &#8220;owed Harvard&#8221; several million bucks based on what other 25th anniversary classes had given.  And we had better pay up.  Pronto.</p>
<p>So, to me, Harvard is mainly a brand name, and obviously a pretty successful one.</p>
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		<title>By: CMC guy</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364254</link>
		<dc:creator>CMC guy</dc:creator>
		<pubDate>Fri, 27 Jun 2008 15:33:16 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364254</guid>
		<description>JIM I don’t know if this comes off as a “treatise” and sorry if not on point to what you are seeking but reflects how my opinions regarding things said by (or attributed to) Angell. 

1; Drug Innovation.  As noted earlier public/private contribution issue not B&#38;W since tends to be intertwined thus not easy to separate out what is “more” important (see below).  It is like describing a trip and depends on what is part talked about.  One can focus on the preparation and packing then the start of journey.  Otherwise may talk about excitement of reaching the destination, review of stops/sights along the way or the price of gas/flat tires/wrong turn/getting lost.  Same trip may be spin into mini-tales that have different significance to listeners even though is a single event.
In terms of predicament defining innovation I offer a comparison example: was Henry Ford an innovator in automotive industry (homage to MI?)? He neither invented cars nor the assembly line concept, it has been argued most of what he did do was based on others ideas.  Does that deflect from the accomplishments and industry that resulted?  He accumulated a fortune, does that make him evil?
Here’s the puzzle.  I apply a reaction learned in grad school (funded largely by NIH grants) to develop a novel and scalable route (patented) to make a drug. The drug being developed came from a small biotech through collaboration with a university lab (not sure which was source of idea) but required a fair bit of optimization before candidate selection.  Previous syntheses were technically problematic, barely supplied clinical demand and not commercially viable (bench level).  The new chemistry allowed multi-kilo production thus progress into multiple clinical studies which ultimately lead to approval.  Fellow lab mates, other support groups, pilot plant and manufacturing personnel all involved in the implementation.  The project along the way faced formulation issues, analytical challenges, supply chain issues, chemical hazards, regulatory hurdles and marketing questions (plus possible list of other details).  Do I credit NIH for financing my education which lead to the connection and application I was able to make?  I am thankful but I would look more to my Prof, who obtained the grant, assigned me the project and guided me for several years.  The reaction came from literature out of Japanese university which I found searching myself after chemistry recommended by Prof was unsuccessful.
The attitude expounded by Angell and others appears to only focus on the “collaboration with a university lab, NIH funding, Japanese university” as the keys.  I don’t ignore that such was present but without all the stuff done by industry people the drug never would have made it in to patients.

I won’t have time to go over costs of drug development issue(s).  You are correct that newer number is &#62;$1B (I just pulled line as is) and I understand controversial nature of calculations.  I can say have seen Phase 3 studies costs projected at $30-60M (not accounting for earlier R&#38;D) so it doesn’t take much to blow past the $100M mark.

Sorry if seem trapped in refuitiation mode as I do agree heartly with Dr. Helm's list and need to move forward.  It hard to sit still when such BS (not the degree kind) comes out of "educated" people and then public/media take as "truth".

We can argue about Harvard's leaning and lawyer another time.</description>
		<content:encoded><![CDATA[<p>JIM I don’t know if this comes off as a “treatise” and sorry if not on point to what you are seeking but reflects how my opinions regarding things said by (or attributed to) Angell. </p>
<p>1; Drug Innovation.  As noted earlier public/private contribution issue not B&amp;W since tends to be intertwined thus not easy to separate out what is “more” important (see below).  It is like describing a trip and depends on what is part talked about.  One can focus on the preparation and packing then the start of journey.  Otherwise may talk about excitement of reaching the destination, review of stops/sights along the way or the price of gas/flat tires/wrong turn/getting lost.  Same trip may be spin into mini-tales that have different significance to listeners even though is a single event.<br />
In terms of predicament defining innovation I offer a comparison example: was Henry Ford an innovator in automotive industry (homage to MI?)? He neither invented cars nor the assembly line concept, it has been argued most of what he did do was based on others ideas.  Does that deflect from the accomplishments and industry that resulted?  He accumulated a fortune, does that make him evil?<br />
Here’s the puzzle.  I apply a reaction learned in grad school (funded largely by NIH grants) to develop a novel and scalable route (patented) to make a drug. The drug being developed came from a small biotech through collaboration with a university lab (not sure which was source of idea) but required a fair bit of optimization before candidate selection.  Previous syntheses were technically problematic, barely supplied clinical demand and not commercially viable (bench level).  The new chemistry allowed multi-kilo production thus progress into multiple clinical studies which ultimately lead to approval.  Fellow lab mates, other support groups, pilot plant and manufacturing personnel all involved in the implementation.  The project along the way faced formulation issues, analytical challenges, supply chain issues, chemical hazards, regulatory hurdles and marketing questions (plus possible list of other details).  Do I credit NIH for financing my education which lead to the connection and application I was able to make?  I am thankful but I would look more to my Prof, who obtained the grant, assigned me the project and guided me for several years.  The reaction came from literature out of Japanese university which I found searching myself after chemistry recommended by Prof was unsuccessful.<br />
The attitude expounded by Angell and others appears to only focus on the “collaboration with a university lab, NIH funding, Japanese university” as the keys.  I don’t ignore that such was present but without all the stuff done by industry people the drug never would have made it in to patients.</p>
<p>I won’t have time to go over costs of drug development issue(s).  You are correct that newer number is &gt;$1B (I just pulled line as is) and I understand controversial nature of calculations.  I can say have seen Phase 3 studies costs projected at $30-60M (not accounting for earlier R&amp;D) so it doesn’t take much to blow past the $100M mark.</p>
<p>Sorry if seem trapped in refuitiation mode as I do agree heartly with Dr. Helm&#8217;s list and need to move forward.  It hard to sit still when such BS (not the degree kind) comes out of &#8220;educated&#8221; people and then public/media take as &#8220;truth&#8221;.</p>
<p>We can argue about Harvard&#8217;s leaning and lawyer another time.</p>
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		<title>By: Justice in MI</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364043</link>
		<dc:creator>Justice in MI</dc:creator>
		<pubDate>Thu, 26 Jun 2008 21:21:49 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364043</guid>
		<description>Thanks for the H&#38;R, guys.  I think the $800 M figure is now officially upped to one billion according to PhRMA.  It is richly debated by many.  Goozner and Public Citizen also take issue with the industry claim, but with different esitmates, based on somewhat different grounds, than MA.

As you know, the opportunity cost half is one place where opinions sharply diverge.</description>
		<content:encoded><![CDATA[<p>Thanks for the H&amp;R, guys.  I think the $800 M figure is now officially upped to one billion according to PhRMA.  It is richly debated by many.  Goozner and Public Citizen also take issue with the industry claim, but with different esitmates, based on somewhat different grounds, than MA.</p>
<p>As you know, the opportunity cost half is one place where opinions sharply diverge.</p>
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		<title>By: Bob Freeman</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364032</link>
		<dc:creator>Bob Freeman</dc:creator>
		<pubDate>Thu, 26 Jun 2008 20:35:07 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364032</guid>
		<description>I really wish I could find a reliable source for the  $200K but I haven't.  It's also now a dated estimate, at least a couple of years old.

Agree with your hit and run.  I'm in the same category today.</description>
		<content:encoded><![CDATA[<p>I really wish I could find a reliable source for the  $200K but I haven&#8217;t.  It&#8217;s also now a dated estimate, at least a couple of years old.</p>
<p>Agree with your hit and run.  I&#8217;m in the same category today.</p>
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		<title>By: CMC guy</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-364022</link>
		<dc:creator>CMC guy</dc:creator>
		<pubDate>Thu, 26 Jun 2008 19:59:05 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-364022</guid>
		<description>JIM Hit &#38; Run without any time to go into whys but at least two Angell portions that I find Incredulous (Extracted Source Wikipedia, believe represents what I have read elsewhere)

1) The few drugs that are truly innovative have usually been based on taxpayer-supported research done in nonprofit academic medical centers or at the National Institutes of Health.  
2)The pharmaceutical industry estimates that each new drug costs them $800 million to develop and bring to market, but Angell and Relman estimate the cost to them is actually closer to $100 million

If Bob is correct about "profit has no basis in health care delivery" faction I would also say is off course there(Don't MD get paid rather well in most cases?)

Bob $200K seems low for Sales type but assumes does not cover Med. and other Benefits.</description>
		<content:encoded><![CDATA[<p>JIM Hit &amp; Run without any time to go into whys but at least two Angell portions that I find Incredulous (Extracted Source Wikipedia, believe represents what I have read elsewhere)</p>
<p>1) The few drugs that are truly innovative have usually been based on taxpayer-supported research done in nonprofit academic medical centers or at the National Institutes of Health.<br />
2)The pharmaceutical industry estimates that each new drug costs them $800 million to develop and bring to market, but Angell and Relman estimate the cost to them is actually closer to $100 million</p>
<p>If Bob is correct about &#8220;profit has no basis in health care delivery&#8221; faction I would also say is off course there(Don&#8217;t MD get paid rather well in most cases?)</p>
<p>Bob $200K seems low for Sales type but assumes does not cover Med. and other Benefits.</p>
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		<title>By: Bob Freeman</title>
		<link>http://www.pharmalot.com/2008/06/mommy-where-do-drugs-come-from/#comment-363745</link>
		<dc:creator>Bob Freeman</dc:creator>
		<pubDate>Thu, 26 Jun 2008 00:50:22 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=14283#comment-363745</guid>
		<description>In fairness to her, and she needs no defense from me, she raises the issue of marketing expenses vs. R &#38; D. very effectively.  Industry tries to explain it away by pointing out that Phase IIIB and Phase IV research is included but when you figure it costs about $200K annually per sales rep, the marketing costs add up pretty quickly.  (The $200K is salary plus fringe, bonus, car, etc.) And, when one recognizes that Phase IIIB and IV research is for marketing purposes (and sometimes for new indications) it doesn't strenghten their argument.

(Sorry I don't have a link/reference for the cost/rep.)</description>
		<content:encoded><![CDATA[<p>In fairness to her, and she needs no defense from me, she raises the issue of marketing expenses vs. R &amp; D. very effectively.  Industry tries to explain it away by pointing out that Phase IIIB and Phase IV research is included but when you figure it costs about $200K annually per sales rep, the marketing costs add up pretty quickly.  (The $200K is salary plus fringe, bonus, car, etc.) And, when one recognizes that Phase IIIB and IV research is for marketing purposes (and sometimes for new indications) it doesn&#8217;t strenghten their argument.</p>
<p>(Sorry I don&#8217;t have a link/reference for the cost/rep.)</p>
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