Comments on: Sherrod Brown: Biologics Should Not Be Subject To An “Endless Monopoly Period” http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/ Sat, 18 Feb 2012 01:44:23 -0600 hourly 1 http://wordpress.org/?v=3.1.2 By: davidrice http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2240 davidrice Tue, 03 Nov 2009 13:04:17 +0000 http://news.firedoglake.com/?p=622#comment-2240 Thank you, Sherrod. Thank you, Sherrod.

]]> By: esseff44 http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2237 esseff44 Tue, 03 Nov 2009 07:40:59 +0000 http://news.firedoglake.com/?p=622#comment-2237 The history of Aranesp and Procrit are a case study of much of what is wrong with how the US drug business has developed. Medicare spends more on this drug than any other. This article from Forbes is from '06. http://www.forbes.com/business/free_forbes/2006/1030/126.html In the last week, this drug has made the news on two fronts and the stories are important as the drugs and how they are prescribed affects millions of people who have cancer and kidney disease. Andrew Cuomo and 14 other AG's filed suit against Amgen and a marketing firm for kickbacks paid to providers who charged Medicaid fraudulently. This suit was joined to a previous suit filed earlier against Amgen. A very important study was published that indicates Aranesp and related drugs do not improve the patients conditions nearly as much as previously thought and doubles the chances of strokes for pre-dialysis patients. Other studies have all shown increased risks and fewer benefits to justify the risks. Medicare policy was in conflict with FDA findings. Patients suffered. Lobbyists lobbied. Bad laws were passed. Attention must be paid. http://www.news-medical.net/news/20091031/Amgen-publishes-Phase-3-study-results-of-Aranesp.aspx http://www.boston.com/news/health/articles/2009/10/31/researchers_question_anemia_drug_benefits/ The history of Aranesp and Procrit are a case study of much of what is wrong with how the US drug business has developed. Medicare spends more on this drug than any other. This article from Forbes is from ’06.

http://www.forbes.com/business/free_forbes/2006/1030/126.html

In the last week, this drug has made the news on two fronts and the stories are important as the drugs and how they are prescribed affects millions of people who have cancer and kidney disease.

Andrew Cuomo and 14 other AG’s filed suit against Amgen and a marketing firm for kickbacks paid to providers who charged Medicaid fraudulently. This suit was joined to a previous suit filed earlier against Amgen.

A very important study was published that indicates Aranesp and related drugs do not improve the patients conditions nearly as much as previously thought and doubles the chances of strokes for pre-dialysis patients. Other studies have all shown increased risks and fewer benefits to justify the risks.

Medicare policy was in conflict with FDA findings. Patients suffered. Lobbyists lobbied. Bad laws were passed. Attention must be paid.

http://www.news-medical.net/news/20091031/Amgen-publishes-Phase-3-study-results-of-Aranesp.aspx

http://www.boston.com/news/health/articles/2009/10/31/researchers_question_anemia_drug_benefits/

]]> By: selise http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2236 selise Tue, 03 Nov 2009 06:46:16 +0000 http://news.firedoglake.com/?p=622#comment-2236 i've got a better idea. since the patent system is a barrier to healthcare causing many unnecessary deaths throughout the world and since the patent system impedes the pace of scientific discovery and innovation -- let's get rid of the patent system for pharmaceuticals. economists have been proposing alternatives (see for example stiglitz, <a href="http://www.project-syndicate.org/commentary/stiglitz81" rel="nofollow">Prizes, Not Patents</a>). patents in healthcare do not serve the common good. get rid of them. i’ve got a better idea. since the patent system is a barrier to healthcare causing many unnecessary deaths throughout the world and since the patent system impedes the pace of scientific discovery and innovation — let’s get rid of the patent system for pharmaceuticals. economists have been proposing alternatives (see for example stiglitz, Prizes, Not Patents).

patents in healthcare do not serve the common good. get rid of them.

]]> By: newtonusr http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2235 newtonusr Tue, 03 Nov 2009 06:45:04 +0000 http://news.firedoglake.com/?p=622#comment-2235 Um, you do not want to do that. Really. Um, you do not want to do that.
Really.

]]> By: pejohb http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2234 pejohb Tue, 03 Nov 2009 06:08:02 +0000 http://news.firedoglake.com/?p=622#comment-2234 your dedication to informed Democracy is quite admirable. not. your dedication to informed Democracy is quite admirable. not.

]]> By: pejohb http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2233 pejohb Tue, 03 Nov 2009 06:05:56 +0000 http://news.firedoglake.com/?p=622#comment-2233 Please look up the definition of biologics, your description belies a level of scientific ignorance that weakens your arguments as a whole. Then take a look at our understanding of how comparable the "biosimilars," to which Brown incorrectly applies the term "generics," are known to be to their pioneer forebears. I can save you some time on the latter, in that there is no clinical data to support the application of bioequivalency standards (developed for chemically identical active ingredients, true generic drugs) for any biologic produced in mammalian cell lines (i.e., the majority of new biologics). None. The latter cannot currently be manufactured to a similar level of structural similarity as generic drugs, when compared to their respective pioneer therapies. Anyone who tells you otherwise is a liar or is scientifically ignorant. The linked FTC report actually advocates giving the FDA the authority to establish whether the biosimilars path is the scientifically justifiable one. The arguments being advocated by you, Brown, and a gaggle of medical students (students!) is an economic one, and is not currently scientifically justifiable. In my opinion, garnered from 23 years of biologic drug development experience, the term "evergreening" is unduly prejudicial as applied here. Our current understanding of biological drug action and clinical safety is too embryonic to allow the uncritical application of patent and copyright precedents developed for toothpaste, ball bearings, and movie soundtracks. Please look up the definition of biologics, your description belies a level of scientific ignorance that weakens your arguments as a whole. Then take a look at our understanding of how comparable the “biosimilars,” to which Brown incorrectly applies the term “generics,” are known to be to their pioneer forebears.

I can save you some time on the latter, in that there is no clinical data to support the application of bioequivalency standards (developed for chemically identical active ingredients, true generic drugs) for any biologic produced in mammalian cell lines (i.e., the majority of new biologics). None. The latter cannot currently be manufactured to a similar level of structural similarity as generic drugs, when compared to their respective pioneer therapies. Anyone who tells you otherwise is a liar or is scientifically ignorant.

The linked FTC report actually advocates giving the FDA the authority to establish whether the biosimilars path is the scientifically justifiable one. The arguments being advocated by you, Brown, and a gaggle of medical students (students!) is an economic one, and is not currently scientifically justifiable.

In my opinion, garnered from 23 years of biologic drug development experience, the term “evergreening” is unduly prejudicial as applied here. Our current understanding of biological drug action and clinical safety is too embryonic to allow the uncritical application of patent and copyright precedents developed for toothpaste, ball bearings, and movie soundtracks.

]]> By: newtonusr http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2232 newtonusr Tue, 03 Nov 2009 06:01:40 +0000 http://news.firedoglake.com/?p=622#comment-2232 I really like Brown. But you know as well as I that his lovely spouse is his Liberal heart. Dawg bless Connie Schultz. I really like Brown. But you know as well as I that his lovely spouse is his Liberal heart.
Dawg bless Connie Schultz.

]]> By: Teddy Partridge http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2231 Teddy Partridge Tue, 03 Nov 2009 05:29:02 +0000 http://news.firedoglake.com/?p=622#comment-2231 win-win-win win-win-win

]]> By: TheLurkingMod http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2230 TheLurkingMod Tue, 03 Nov 2009 04:01:44 +0000 http://news.firedoglake.com/?p=622#comment-2230 watertiger is upstairs! <a href="http://firedoglake.com/2009/11/02/late-night-republicans-to-re-enact-famous-death-scene-from-monty-python-and-the-holy-grail-on-the-floor-of-the-house/" rel="nofollow">Late Night: Republicans to Re-Enact Famous Death Scene From “Monty Python and the Holy Grail” on the Floor of the House</a> watertiger is upstairs!
Late Night: Republicans to Re-Enact Famous Death Scene From “Monty Python and the Holy Grail” on the Floor of the House

]]> By: Kelly Canfield http://news.firedoglake.com/2009/11/02/sherrod-brown-biologics-should-not-be-subject-to-an-endless-monopoly-period/#comment-2229 Kelly Canfield Tue, 03 Nov 2009 03:26:20 +0000 http://news.firedoglake.com/?p=622#comment-2229 And btw, can I tell you how fun it is for me to read dday here? Plus, it's made digby write more. Heh. And btw, can I tell you how fun it is for me to read dday here?

Plus, it’s made digby write more. Heh.

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