Comments on: How To Solve The Crisis Over Drug Prices http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/ News, Comment and Conversation Fri, 10 Feb 2012 18:20:36 +0000 http://wordpress.org/?v=2.6.2 By: Jack2 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215377 Jack2 Tue, 18 Mar 2008 15:24:53 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215377 Derek Lowe makes some great points Nathan, and typed them out for me, better than I could have, and it saved me the time and outrage. Thanks for the link. Derek Lowe makes some great points Nathan, and typed them out for me, better than I could have, and it saved me the time and outrage. Thanks for the link.

]]> By: Nathan http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215258 Nathan Tue, 18 Mar 2008 14:24:32 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215258 Derek Lowe over at "In the Pipeline" has a nice commentary on this idea. He brings up many of the same concerns that were voiced in the above comments. http://pipeline.corante.com/archives/2008/03/18/a_solution_courtesy_of_the_mit_faculty.php#comments Derek Lowe over at “In the Pipeline” has a nice commentary on this idea. He brings up many of the same concerns that were voiced in the above comments.

http://pipeline.corante.com/archives/2008/03/18/a_solution_courtesy_of_the_mit_faculty.php#comments

]]> By: Former pharma Marketing Exec http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215156 Former pharma Marketing Exec Tue, 18 Mar 2008 13:40:05 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-215156 Actually, this kind of fits with the proposal that was floated last week regarding the government review board overseeing research. So, sure hope that the folks at MIT are talking to the authors of the CPER report we learned about last week here. Actually, this kind of fits with the proposal that was floated last week regarding the government review board overseeing research.

So, sure hope that the folks at MIT are talking to the authors of the CPER report we learned about last week here.

]]> By: Nick Evans http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-214430 Nick Evans Tue, 18 Mar 2008 04:42:36 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-214430 “It is a two-level program in which scientists and other experts would recommend to decision-makers which kinds of drugs to fund the most, “says Finkelstein. “This would insulate development decisions from the political winds.” Frankly, if the government can't insulate the Justice Department from the "political winds" I don't fancy their chances with a DDC. Can you imaging the brawl that would be generated by the religious right over the development of ANY drug with a potential impact on women's reproduction? Forget "Plan B", there'd be open warfare on the streets... (PS - apologies if this comment appears twice, something strange happened when I tried to submit it the first time). “It is a two-level program in which scientists and other experts would recommend to decision-makers which kinds of drugs to fund the most, “says Finkelstein. “This would insulate development decisions from the political winds.”

Frankly, if the government can’t insulate the Justice Department from the “political winds” I don’t fancy their chances with a DDC.

Can you imaging the brawl that would be generated by the religious right over the development of ANY drug with a potential impact on women’s reproduction? Forget “Plan B”, there’d be open warfare on the streets…

(PS - apologies if this comment appears twice, something strange happened when I tried to submit it the first time).

]]> By: Lewis R. Schwarz http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213906 Lewis R. Schwarz Mon, 17 Mar 2008 19:15:46 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213906 Government funding of research is not only desirable, it is necessary. Consider how many OTC, "natural" meds, and legend medications there are that are being used in untested, wasteful,and possibly dangerous applications only because industry will not finance the studies needed to show efficacy or its lack and proper dose regimens. The creation of the GRAS list has helped, but it is only part of a process that needs expansion to be truly effective. Government funding of research is not only desirable, it is necessary. Consider how many OTC, “natural” meds, and legend medications there are that are being used in untested, wasteful,and possibly dangerous applications only because industry will not finance the studies needed to show efficacy or its lack and proper dose regimens. The creation of the GRAS list has helped, but it is only part of a process that needs expansion to be truly effective.

]]> By: Jack2 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213876 Jack2 Mon, 17 Mar 2008 19:02:53 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213876 almost almost

]]> By: Outside the Box http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213744 Outside the Box Mon, 17 Mar 2008 17:57:43 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213744 Nathan makes a good point that raised another set of thoughts in my mind. I think the idea is that the DDC is funded publicly and that this pays for all drug development. The approved products are then passed to a distribution and marketing company and, because the development was publicly funded, the price in the market is substantially lower and the marketing company is permitted a reasonable return (what ever that is). Presumably the new DDC will be significantly more efficient as a result of removing duplicate efforts - although I am not sure how the DDC will determine which compound within a given class will be the successful one given that the industry hasn't solved that problem after trying for decades. Who does the manufacturing now that one group of companies is just discovering and another group is just marketing? Who carries liability for the product in the event that post-launch shows adverse events not seen in trials (one assumes it must be the DDC - this non-profit that is publicly funded and therefore potentially immune?)? Who manages the export market? Who owns the IP? It is almost worth buying the book just to find out how these issues are answered. Nathan makes a good point that raised another set of thoughts in my mind.

I think the idea is that the DDC is funded publicly and that this pays for all drug development. The approved products are then passed to a distribution and marketing company and, because the development was publicly funded, the price in the market is substantially lower and the marketing company is permitted a reasonable return (what ever that is). Presumably the new DDC will be significantly more efficient as a result of removing duplicate efforts - although I am not sure how the DDC will determine which compound within a given class will be the successful one given that the industry hasn’t solved that problem after trying for decades.

Who does the manufacturing now that one group of companies is just discovering and another group is just marketing?

Who carries liability for the product in the event that post-launch shows adverse events not seen in trials (one assumes it must be the DDC - this non-profit that is publicly funded and therefore potentially immune?)?

Who manages the export market? Who owns the IP?

It is almost worth buying the book just to find out how these issues are answered.

]]> By: Nathan http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213722 Nathan Mon, 17 Mar 2008 17:51:14 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213722 By the way: I'll point out that the free-market is well on the way to a similar system, albeit without the government regulation: Big pharma is becoming more of a drug distribution engine while the biotech industry is making many of the major advances again disease. This dichotomy is doing exactly what the professors are proposing: separating drug discovery and drug development into distinct entities. By the way: I’ll point out that the free-market is well on the way to a similar system, albeit without the government regulation: Big pharma is becoming more of a drug distribution engine while the biotech industry is making many of the major advances again disease. This dichotomy is doing exactly what the professors are proposing: separating drug discovery and drug development into distinct entities.

]]> By: Nathan http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213716 Nathan Mon, 17 Mar 2008 17:47:50 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213716 My question is this: How does the money flow? Drug distribution inherently EARNS money while drug development is a continual drain of money. It sounds like this: money flows from the consumer to the drug distribution company to the DDC and then to the drug discovery company. If so, how is this ANY different than the current model? The only difference I see is that you have introduced a new government agency that will likely have more power, more bureaucracy, and greater inefficiency than the FDA. This doesn't sound like a step forward to me... Frankly, if the system is as broken as many people say that it is, the only way that significant change is going to happen is if the entire industry collapses and is rebuilt from scratch. While the current system may not be sustainable for 50 years, I don't see it completely falling apart in the next 10-20 years. I could be wrong... but I hope not. My question is this:
How does the money flow? Drug distribution inherently EARNS money while drug development is a continual drain of money. It sounds like this: money flows from the consumer to the drug distribution company to the DDC and then to the drug discovery company. If so, how is this ANY different than the current model? The only difference I see is that you have introduced a new government agency that will likely have more power, more bureaucracy, and greater inefficiency than the FDA. This doesn’t sound like a step forward to me…

Frankly, if the system is as broken as many people say that it is, the only way that significant change is going to happen is if the entire industry collapses and is rebuilt from scratch. While the current system may not be sustainable for 50 years, I don’t see it completely falling apart in the next 10-20 years. I could be wrong… but I hope not.

]]> By: Dr. Sal Giorgianni http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213702 Dr. Sal Giorgianni Mon, 17 Mar 2008 17:41:27 +0000 http://www.pharmalot.com/2008/03/how-to-solve-the-crisis-over-drug-prices/#comment-213702 The current system of discovery, research and distribution is based on the economic market models of the 1950-60 and the state of pharmaceutical technology from that era. Clearly changes and advances have been made since then in both domains. This is one of the more creative ideas that are floating around out there. No doubt that something must be done as there is too much societal dissatisfaction with the system now in place, even though it has yielded an amazing amount of advances. But, as with all systems, they may not be relevant forever. Yet, I am not quite sure that a completely non-profit model or even a model that is structured as a public good will work. As evidence, take a look at the NIH. Venerable, and very important institutions that play an important role in expanding our knowledge base. Several years ago the esteemed physician Bernadine Healy, when assuming the role of Director, NIH, announced a new mandate for NIH labs –to find practical medicines. Makes sense to this taxpayer. A practical way, you would think, to begin to address the issues that were just beginning to bubble up about R&D. Yet, poor Dr. Healey received such push back from NIH scientists, fundees and Congress it was rather stunning. Back to the drawing board. In the current proposal, I wonder how that non-profit entity would fund its work. Would it take on the structure of an AARP non-profit, or maybe an American Heart Association non-profit? Would it be quasi-governmental such as the USP or the NSF? Or would it be non-profit in the sense of MIT or Harvard. And if it were non-profit who would it be accountable to? Lots of details for the-devil to work out here. I will not claim to have THE solution to the current situation. It could just be that there is none. Innovation costs, someone has to pay for that cost and it is fair for companies to recoupe that cost. Now, if someone can only tell me what society believes is a contemporary answer to “a fair return” on those costs (all of them, including the cost of the risk) we may be able to come up with a good and workable idea. The current system of discovery, research and distribution is based on the economic market models of the 1950-60 and the state of pharmaceutical technology from that era. Clearly changes and advances have been made since then in both domains.
This is one of the more creative ideas that are floating around out there. No doubt that something must be done as there is too much societal dissatisfaction with the system now in place, even though it has yielded an amazing amount of advances. But, as with all systems, they may not be relevant forever. Yet, I am not quite sure that a completely non-profit model or even a model that is structured as a public good will work. As evidence, take a look at the NIH. Venerable, and very important institutions that play an important role in expanding our knowledge base. Several years ago the esteemed physician Bernadine Healy, when assuming the role of Director, NIH, announced a new mandate for NIH labs –to find practical medicines. Makes sense to this taxpayer. A practical way, you would think, to begin to address the issues that were just beginning to bubble up about R&D. Yet, poor Dr. Healey received such push back from NIH scientists, fundees and Congress it was rather stunning. Back to the drawing board. In the current proposal, I wonder how that non-profit entity would fund its work. Would it take on the structure of an AARP non-profit, or maybe an American Heart Association non-profit? Would it be quasi-governmental such as the USP or the NSF? Or would it be non-profit in the sense of MIT or Harvard. And if it were non-profit who would it be accountable to? Lots of details for the-devil to work out here.
I will not claim to have THE solution to the current situation. It could just be that there is none. Innovation costs, someone has to pay for that cost and it is fair for companies to recoupe that cost. Now, if someone can only tell me what society believes is a contemporary answer to “a fair return” on those costs (all of them, including the cost of the risk) we may be able to come up with a good and workable idea.

]]>