Hello list members
A very interesting discussion thread.... I agree with Dr Ash Paul, in
particular, that the cost of R&D is over-played by the industry. As
others have noted, the problem of drug development and drug
distribution in low-income countries is of particular concern due to
current monopoly patent regimes. However, any solution to the problem
will have to engage governments, pharma and the broader public in a
sustainable way. Too often drug company's responses to problems of
global and local drug access have been short-term and aimed at getting
good PR for the company, such as advanced market commitments and
charitable donations.
An international multidisciplinary team is currently investigating the
potential of a new proposal, called the Health Impact Fund (HIF),
which is fundamentally trying to change the way in which we reward
drug companies for new innovation through an alternative scheme where
rewards are related to the health impact of the drug innovation,
rather than just sales. Although there are huge challenges to how
health impact assessment would actually work and plans for pilot
projects are still at an early stage, the Health Impact Fund may be of
interest to list members.
http://www.yale.edu/macmillan/igh -home page for the HIF
Banerjee A, Hollis A, Pogge T. The Health Impact Fund: incentives for
improving access to medicines. Lancet. 2010 Jan 9;375(9709):166-9.
Importantly, it was one of only a few proposals endorsed as
"promising" by a WHO Expert Working Group (EWG) in December 2009.
The EWG Executive Summary is available at
http://apps.who.int/gb/ebwha/pdf_files/EB126/B126_6Add1-en.pdf.
Best wishes
Ami Banerjee
--
Dr Amitava Banerjee
Clinical Research Fellow
Stroke Prevention Unit
University of Oxford
trusttheevidence.net
On 24 May 2010 10:32, Barbani Federico <[log in to unmask]> wrote:
> Hello members. Thank you for interesting discussion.
>
> Just an aphorism I heard: “We are glad that industry earns money with GOOD
> and INNOVATIVE drugs”.
>
> Aren’t we? The core is in the upper-cases …
>
> Kind regards to all.
>
> Federico Barbani
> Healthcare Purchasing Unit
>
> Health Authority Modena, Italy
>
> ________________________________
>
> Da: Evidence based health (EBH)
> [mailto:[log in to unmask]] Per conto di Maskrey Neal
> Inviato: lunedì 24 maggio 2010 10.30
> A: [log in to unmask]
> Oggetto: Re: Government and NICE: Myth busting
>
>
>
> I don’t disagree. But none of this overcomes in a practical sense the need
> for the public-private partnership to get medicines through licensing and
> into manufacture. It’s a major scientific, industrial manufacturing and
> legal process. All this reflects are the terms of those arrangements, which
> I’m not defending and which value based pricing may help address. That’s why
> I put the work in to help the Office of Fair Trading.
>
>
>
> The industry has indeed done well with profits historically way in excess of
> the Fortune 500 index – see
> http://www.citizen.org/documents/Pharma_Report.pdf for example. Hence the
> need for a revised relationship, which has to go MILES beyond the numbers
> and address fundamental culture – the multiple documented gross abuses of
> science no right-thinking person could condone. But despite all that, there
> are millions of people in the UK whose lives are made better thanks to
> pharmaceuticals. When we need some horrible investigation or procedure we
> often take for granted the sedatives, anaesthetics and analgesics. Someone
> with rheumatoid arthritis now has a better chance of a better outcome thanks
> to combination DMARDs and biologics. People with dreadful chronic diseases
> such as heart failure have a better quality of life. And so on and so on.
>
>
>
> Perhaps the UK public sector funding issues are the opportunity for a
> revision of the relationship for the better, but I don’t see anytime soon
> anyone totally abandoning the real-politik of employment and exports.
>
>
>
> I must say it feels a bit strange being placed in a position where I’m
> defending the pharmaceutical industry, when I spend most of my time picking
> apart and debunking THEIR conclusions.
>
>
>
> Best wishes
>
> Neal
>
> Neal Maskrey
>
> National Prescribing Centre
>
> Liverpool UK
>
> ________________________________
>
> From: Evidence based health (EBH)
> [mailto:[log in to unmask]] On Behalf Of Ash Paul
> Sent: 23 May 2010 17:38
> To: [log in to unmask]
> Subject: Re: Government and NICE: Myth busting
>
>
>
> Dear Neal,
>
>
>
> While I fully agree with most of what you have written, there is, in my
> opinion, a need to debunk a few myths, especially within the context of this
> important email trail.
>
>
>
> Regarding the development of drugs, I'd like to start by mentioning a couple
> of drugs:
>
> 1. Eculizumab was developed by the not-for-profit Oklahoma Medical Research
> Foundation (OMRF) and bought out by Alexion Pharmaceuticals for a pittance..
> Today the annual NHS spend on this drug is 30 million pounds to treat 90
> patients (of paroxysmal nocturnal haemoglobinuria PNH) in the UK, at a cost
> of 300,000 pounds per patient annually.
>
> 2. Cerezyme was originally developed by NIH and then bought out by Genzyme.
>
>
>
> A 2004 Interview with Dr Marcia Angell (former Editor of NEJM)
> (http://motherjones. com/politics/ 2004/09/truth- about-drug- companies)
> reveals that the top U.S. drug makers spend 2.5 times as much on marketing
> and administration as they do on research. At least a third of the drugs
> marketed by industry leaders were discovered by universities or small
> biotech companies, but they’re sold to the public at inflated prices. Taxol,
> the cancer drug was discovered by the National Institutes of Health (NIH),
> but is now sold by Bristol-Myers Squibb for $20,000 a year, reportedly 20
> times the manufacturing cost. The company agreed to pay the NIH only 0.5
> percent in royalties for the drug.
>
>
>
> The next important myth to debunk is the one perpetuated by the big
> global pharmaceutical companies about the 'astronomical cost' (800 million
> dollars) of development of these drugs, a figure sworn by and believed in
> blindly by most clinicians of whatever hue, and in whichever country.
>
> Does it does really cost anywhere near 800 million dollars to develop a new
> drug?
>
> Have you read 'The $800 million pill: The truth behind the cost of new
> drugs' by Merrill Goozner?
>
> When the book was first published in 2004, there were book reviews in almost
> every peer-reviewed journal including the BMJ:
>
> http://www.bmj. com/cgi/content/ full/329/ 7465/577
>
> The Journal of Clinical Investigation' s Review of the book was particularly
> good:
>
> http://www.jci. org/articles/ view/23540
>
>
>
> Going back in time, in 2001, researchers at Tufts University, USA published
> a 'seminal' study showing that it cost drug companies approximately $800
> million to develop a new drug and get it approved by the FDA. In the
> intervening years, the drug industry has used that mind-boggling cost
> estimate to justify not only the high cost of new prescription drugs but
> also the need for expedited drug approvals and long patent protection once
> their drugs were approved.
>
> However, the study (A Methodology for Counting costs for Pharmaceutical R&D)
> [http://csdd.tufts.edu/files/uploads/a_methodology_for_counting_costs.pdf] by
> researchers for the Tufts Center for the Study of Drug Development was
> deeply flawed and wildly inflated the actual cost of developing a new drug
> from start to finish. The study’s flaws and the undisclosed conflicts on the
> part of its authors were dissected both in the book by Merrill Goozner, and,
> more importantly, in a paper that two eminent and widely
> respected bioethicists tried to get published in the Journal of Health
> Economics (JHE), which ran the original $800 million estimate.
>
> In a tale that rivals anything out of Machiavelli, the editors of this
> supposedly respectable journal insisted on massive revisions and cuts in the
> bioethicists’ submission and only agreed to publish a milder version of
> their critique after the two threatened to sue the journal for violating
> academic freedoms. The JHE editors were particularly adamant about cutting
> from the critique the fact that authors of the $800 million estimate had
> failed to disclose in their study that they and the Tufts Centre for Drug
> Development are heavily dependent on drug industry funding (although it
> didn't actually fund this particular cost estimate study).
>
> The two bioethicists, Donald Light, a Professor at the University of
> Medicine and Dentistry in New Jersey , and Rebecca Warburton, a health
> economist at the University of London , chronicle their convoluted efforts
> to publish their critique -- in an entertaining piece in the Harvard Health
> Policy Review. They hold their experience up as an example of the need for
> higher ethical standards on the part of many conflict-ridden healthcare
> journals.
>
> You can access the article (Ethical Standards for Healthcare Journals)
> online at:
>
> http://www.hcs. harvard.edu/ ~hhpr/currentiss ue/058-067% 20In%20Focus_
> Light,%20Warburt on.pdf
>
>
>
> Recently, in November 2009, Donald Light, wrote a very illuminating article
> in the Health Affairs Blog about drug prices and health reform:
>
> http://healthaffair s.org/blog/ 2009/11/24/ drug-prices- and-health- reform/
>
>
>
> Dr Marcia Angell, former Editor of the NEJM, also addressed this bogus cost
> in her book, "The Truth About The Drug Companies" in 2004. The actual cost,
> according to her, is a bit over 100 million dollars, if you factor in NIH
> contributions, tax breaks, and so forth.
>
>
>
> Once again, I refer back to Dr Angell's 2004 interview, mentioned a few
> paragraphs before. She states, and I quote '
>
> The industry arrives at that $802 million [per drug] figure by looking at a
> tiny handful of the most costly drugs. Those are drugs that were developed
> entirely in-house, and that are new molecular entities.. That’s a very tiny
> handful of the drugs that come to market each year. They’re the most
> expensive drugs. Second, even for those drugs, they come up with a figure of
> $403 million per highly selected drug. They then double that to $802 million
> simply by adding in what they call the “opportunity costs” — what they could
> have made if they’d spent the same money on investments. Third, the figure
> is inflated by not including the tax deductions and tax credits. They
> get very large tax deductions and credits. So the figure is highly inflated.
> That gets buried in the reporting of it. When you hear the figure, you hear
> it given with the implication that for any random new drug, that’s what it
> costs to develop it. And that’s just simply not so.
>
> No one knows for sure what goes into the R&D budget, because the companies
> aren’t telling. It’s been estimated that about a quarter of it is spent on
> Phase IV clinical trials, many of which are just excuses to pay doctors to
> prescribe the drug. They don’t yield any real scientific information. But no
> one knows for sure.'
>
>
>
> As an aside, if you have the time, you might like to watch the very
> interesting podcast:
>
> Big Bucks Big Pharma
>
> http://www.archive. org/details/ bigbucksbigpharm a
>
>
>
> Regards,
>
>
>
> Ash
>
> Dr Ash Paul
> Medical Director
> NHS Bedfordshire
>
> 21 Kimbolton Road
>
> Bedford
>
> MK40 2AW
>
> Tel no: 01234897224
>
> Email: [log in to unmask]
>
>
>
>
>
> ________________________________
>
> From: Maskrey Neal <[log in to unmask]>
> To: [log in to unmask]
> Sent: Fri, 21 May, 2010 15:18:10
> Subject: Re: Government and NICE: Myth busting
>
> Here's the Office of Fair Trading report on VBP from 2007.
>
> http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf
>
> Re the role of pharma, I don't think life is ever as simple as it is
> sometimes presented. The facts are:-
> (i) that most major developments in medicines have involved a
> partnership between an original thinker or thinkers often outside a
> pharma company - which can then develop through to market only with the
> considerable expertise of large numbers of people in the industry. If
> you've ever seen the sheer volume and effort to get a medicine through
> to licensing these days you'd be amazed. I don't know one medicine in my
> professional lifetime that hasn't needed significant commercial
> development to get to market - and that takes resources.
> (ii) it's a global village, but those countries with existing R&D and
> manufacturing will want to retain that for all sorts of reasons,
> especially economic.
> In addition the link between commerce and health system payers is
> obvious to all of us of course.
>
> It's inevitable then that because of the above that public - private
> partnerships will continue to need to exist in most health care systems.
> The debate is about the terms of that coalition.
>
> I'm not defending the abuses of science and marketing that are well
> documented for one moment. Indeed I'm one of their fiercest critics. But
> then if we are honest there are some pretty dreadful and well documented
> disasters in the public health care systems around the world too.
>
> Back to Atul Gawande then.... "Better is possible......".
>
> Best to all
>
> Neal
>
> Neal Maskrey
> National Prescribing Centre
> Liverpool UK
>
>
>
> -----Original Message-----
> From: Evidence based health (EBH)
> [mailto:[log in to unmask]] On Behalf Of Michael Power
> Sent: 21 May 2010 08:25
> To: [log in to unmask]
> Subject: Re: Government and NICE: Myth busting
>
> Jeremy
>
> I have to disagree with the logic in your final point: "It is also
> relevant, because this is often misunderstood, that patents are NOT
> fundamentally capitalist tools. In fact, they are government conferred
> MONOPOLIES on public knowledge (sometimes discovered with public
> funds)."
>
> Patents are fundamentally tools of capitalists. Like all humans,
> capitalists often say one thing ("we are in favour of competition"),
> while doing another (avoiding competition, and the best tool for this is
> a patent).
>
> Michael
>
> -----Original Message-----
> From: Jeremy Howick [mailto:[log in to unmask]]
> Sent: 20 May 2010 22:56
> Subject: Government and NICE: Myth busting
>
> Dear All,
>
> It is a commonly held myth that IT IS A GOOD THING TO HELP
> PHARMACEUTICAL COMPANIES EARN A 'REASONABLE' RETURN AND PROFIT. The
> dogma upon which this myth is based is that WITHOUT THE TEMPTATION OF
> PROFITS, PHARMACEUTICAL COMPANIES WOULD NOT INNOVATE, and consequently
> WE WOULD HAVE FEW MEDICAL ADVANCES.
>
> In fact, it might be the OPPOSITE. In the UK, the government foots the
> bill for medical expenses. Hence, when the NHS pays for patented
> medication, they pay for R&D, production, and PROFIT. Take away the
> PROFIT, and, by definition, health care costs go down.
>
> Where, then, would our innovations come from? There are many answers to
> this question. First, however consider the other advantage of taking
> profit out of the mix. As Neal correctly pointed out, is that
> patient-relevant (rather than profit-relevant) interventions are
> investigated more vigorously. This, in turn, would increase the quality
> of medical care and also likely reduce the cost.
>
> Perhaps the most fruitful alternative to patent-driven research would be
> to reward fruitful research groups within Universities with more PhD and
> postdoctoral studentships.
>
> It is also relevant, because this is often misunderstood, that patents
> are NOT fundamentally capitalist tools. In fact, they are government
> conferred MONOPOLIES on public knowledge (sometimes discovered with
> public funds).
>
> Best wishes,
>
> Jeremy
>
>
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