[olsen]

http://www.pharmamyths.net/files/Bio...arch_Costs.pdf



Demythologizing the high costs of pharmaceutical research
Donald W. Light
and Rebecca Warburton

Program in Human Biology, 450 Serra Mall, Building 20, Stanford University, Stanford, CA 94305, USA.

University of Medicine and Dentistry of New Jersey, c/o 10 Adams Drive, Princeton, NJ 08540, USA.
E-mail: dlight@princeton.edu

School of Public Administration, University of Victoria, Victoria, BC, Canada.
E-mail: rnwarbur@uvic.ca
*Corresponding author.
Abstract:
It is widely claimed that research to discover and develop new pharmaceuticals entails high costs and high risks. High research and development (R&D) costs influence many decisions and policy discussions about how to reduce global health disparities, how much
companies can afford to discount prices for lower- and middle-income countries, and how to design innovative incentives to advance research on diseases of the poor. High estimated costs also affect strategies for getting new medicines to the world’s poor, such as the advanced market
commitment, which built high estimates into its inflated size and prices. This article takes apart the most detailed and authoritative study of R&D costs in order to show how high estimates have been constructed by industry-supported economists, and to show how much lower actual costs may be.

Besides serving as an object lesson in the construction of ‘facts’, this analysis provides reason to believe that R&D costs need not be such an insuperable obstacle to the development of better medicines. The deeper problem is that current incentives reward companies to develop mainly new medicines of little advantage and compete for market share at high prices, rather than to develop clinically superior medicines with public funding so that prices could be much lower and risks to companies lower as well

[lindylanka]

Thanks for posting this, it makes very interesting reading.
Lindy

[RLSmi]

Originally Posted by lindylanka

Thanks for posting this, it makes very interesting reading.
Lindy

I agree, Lindy; very interesting but also very depressing.

What angers me, especially, is the reported agreements the Obama administration made with big pharma when negotiating over whether they (pharma) would not oppose the health care legislation, the Affordable Care Act passed last year. Alas, the very existence of that act now appears endangered by politicians feverishly slashing at it and anything else that the current US administration is attempting to accomplish. I wonder how much smaller the federal deficit would be if pharma were paying their fair share of taxes rather than getting huge R&D tax write-offs for enormously inflated "estimated costs" of what developing drugs and vaccines really are.

Too political, Chemar?

Robert

[paula_w]

Originally Posted by RLSmi

I agree, Lindy; very interesting but also very depressing.

What angers me, especially, is the reported agreements the Obama administration made with big pharma when negotiating over whether they (pharma) would not oppose the health care legislation, the Affordable Care Act passed last year. Alas, the very existence of that act now appears endangered by politicians feverishly slashing at it and anything else that the current US administration is attempting to accomplish. I wonder how much smaller the federal deficit would be if pharma were paying their fair share of taxes rather than getting huge R&D tax write-offs for enormously inflated "estimated costs" of what developing drugs and vaccines really are.

Too political, Chemar?

Robert

not for me this is life and death, but moderators rule. there is a difference between responsible discussion and being offensive. i can't picture you being offensive and this is a free country, tho not for long at this rate.

i just wanted to add that selling out to pharma for not very much money, which means it was less than a trillion these days...not even high number in the billions seals a deal for over a ? year period. I can't recall the number but pharma is safe. No imports if i recall. And support for the health bill? legislators are actually hiding.

But mostly I recall that it was one of the first things he did upon entering office.

And what do we have to show for it? side effects and recall warnings, lawsuits - everyone making money as the middle class and the sick both die.

That's not freedom.

so what about non profit pharmas? there was interest in the concept at BIO last year. i would even be willing to try to present the idea there if someone needs a patient on a panel about it. of course i'm not the expert in finance ..hahaa! and my speech is more like utterances mixed with some lucidity. i can still read and the mic does wonders. i've got so many reasons to do it. peg are you up for this?

who knows how to start up a pharma non profit? Debi Brooks that would be you but we can't pay you....lol. is this even in the realm of being possible? we would find out who is serious about curing and who just wants the money and the prestige. i'd work till my last breath to be involved in pd research directly.

ok i know it's a pipe dream. but would it work instead of trying to protest when we can't talk or walk very well. i'm afraid we don't look too intimidating. perhaps the NFL can lend us all their players - they could carry us. i like that picture; i'll take a steeler.

it would take something that unusual to get any money or mileage out of it. we don't prefer to be carried but if we must it needs to be by those with means, not the very people who are struggling.

It takes a steeler to get me there. One who is volunteering to carry me.

any other ideas to attract attention ?

fast tracking from the fda was after years of delaying duodopa so i''m not sure what fast tracking means. i know some people in Birmingham are moving right along and getting good results. but that doesn't happen enough [FDA consultations] There are always 'conflicts of interest'/ they count when they are from patients. Perry and others consulted about duodopa for solvay but it's been sold.

as for action:

PAN represents us at the NIH and FDA and would possibly support such a scenario as big guys carrying sick people. But i think the idea of becoming pharmas is one to start today if anyone has any vision at all of how this could happen with fewer meetings, less paperwork, online, and just start raising money. I think people at BIO, which is in DC this year, would be interested in investing. Amy Comstock Ric is very open minded, but is restricted due to the nature of PANs legal status. some people at BIO are just walking around looking for places to invest.

ok i'm dreaming now. thank God i can still do that.

[ol'cs]

gotta go sometime, but we should all at least get some quality time, instead of PD torture.

[girija]

Hi All,
Paula, a quick reply to your question regarding not-for-profit organizations that are into drug development. Oneworld health, based in San Francisco has successfully accomplished this dream. Their focus is rather different than what we are talking about, but I dont see why their model cannot be used for other drugs. Take look at their web site.
May be this could be our next project!!

Girija
http://www.oneworldhealth.org/

Core Strengths

OneWorld Health is the first nonprofit pharmaceutical company in the United States. We are a Medical Research Organization which advances global health by developing effective and affordable new medicines for infectious diseases that disproportionately affect people in the developing world.

OneWorld Health's core capacities lie in pharmaceutical product development. Our scientific expertise extends from drug lead identification and optimization to conducting clinical trials and securing regulatory approval of new medicines for patients in the developing world. Our scientific efforts are guided by a mission that ensures our products are safe, effective and affordable for the populations we serve.

In collaboration with hospitals in the US and abroad, OneWorld Health fills the huge gap in the development of new medicines – that is, bringing promising drug research from the lab into the clinic and onto regulatory approval and manufacturing................................

Girija

[paula_w]

It's focus is different but it's a start. I read the Novartis effort and say good for them. The valley of death is the hard part for them too.

http://blogs.forbes.com/helencoster/