[Ip-health] [A2k] Diagnostic Testing and NICE

Els Torreele etorreele at sorosny.org
Thu Feb 9 08:14:55 PST 2012

It may be useful to also keep in mind what/who is driving the "personalized medicine" approach: not science, but ideology and profit potential.

Remember RC Lewontin's excellent "Biology as Ideology: The Doctrine of DNA"?
That was in 1993...

Of course there's been much written and said on the topic since then, mostly blindly promoting the genetic basis of health and disease.
However, despite billions of $ of public and private investments in research including the human genome project, there still is no evidence to show a genetic basis for most diseases, let alone that genetic variation would determine people's response to specific medicines. There are a few notable exceptions, but overall there's nothing.
Strikingly after all these efforts to no avail, geneticists are now twisting their discourse to say that the lack of evidence merely points to the fact that they have not yet FOUND the "Missing Heritability of Complex Diseases" (Manolio et al. Nature 2009).
Any other scientific hypothesis would long have been dismissed...

But of course there's loads of money being pumped into marketing campaigns (including front-line "patient groups", talk shows, a stream of articles in popular media such as US Today, paying off "experts", etc) to make us all believe that we will benefit from all that genetic testing - no different from the classical pharmaceutical industry overmarketing their statins or psychotropic drugs (including creating needs/demand by turning perfectly halthy/normal conditions into a diseases that can be medicated)

And this deafens any critical voices...

Highly recommended - more critical- reading on this:
The great DNA data deficit
Jonathan Latham and Allison Wilson

and also:
Phantom Heritability' Indicates Poor Predictive Value of Gene Tests
Helen Wallace, GeneWatch UK

Direct-to-Consumer DNA Testing and the Myth of Personalized Medicine:
Spit Kits, SNP Chips and Human Genomics

And even in the more rare cases that a clear genetic association has been found between mutations and disease risk, such as in the case of certain types of breast cancer, it remains a matter of debate whether genetic testing has any impact on the health outcomes. See for example:


-----Original Message-----
From: ip-health-bounces at lists.keionline.org [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Jamie Love
Sent: Wednesday, February 08, 2012 6:35 PM
To: Peter Pitts
Cc: a2k at lists.keionline.org; ip-health
Subject: Re: [Ip-health] [A2k] Diagnostic Testing and NICE

NICE tries to make rational use of a limited budget, and that includes looking at cost effectiveness.  If governments would learn to de-link R&D incentives from high product prices, you would not have to ration access to
these new technologies.   But when budgets are limited, and companies have
legal monopolies on products, access is going to be limited too.    Jamie

On Wed, Feb 8, 2012 at 4:25 PM, Peter Pitts <ppitts at cmpi.org<mailto:ppitts at cmpi.org>> wrote:

> NICE has issued draft guidance recommending against the use of three
> breast cancer diagnostics to guide decisions about chemotherapy use in
> women with estrogen receptor-positive, lymph node-negative,
> HER2-negative breast cancer.
> According to NICE, the tests aren't cost effective because evidence
> for their clinical efficacy is "limited."
> But isn't that the whole idea of personalized medicine?  And "limited"
> for whom?
> Molecular diagnostics are what make medicines personal. Diagnostics
> are how drugs can be made safer through safe use. They make the "four rights"
> (right medicine for the right patient in the right dose at the right
> time) possible. And the four rights lead to lower costs through better outcomes.
> Studies show that testing for HER2 breast cancer delivers savings that
> are
> 65 times its cost. That reimbursement should be based on value rather
> than activity is an essential paradigm shift.
> This message is finally reaching a mass audience. Consider the recent
> USA Today story, "Genetic testing boosts efficacy in cancer care,"
> which reports that "tailoring cancer therapies to fit a person's
> genetic makeup could spare thousands of patients from harmful side
> effects and save millions of dollars a year."
> Even NICE said the test's incremental cost-effectiveness ratio (ICER)
> -- aka cost effectiveness ratio -- per quality-adjusted life year
> (QALY) was "dominant" compared to current practice -- but the lack of
> data on analytical reliability and clinical utility made a
> recommendation for widespread use unwarranted "at this time."
> In other words, no reimbursement until more data is available. Whether
> or not that's a convenient excuse or a scientifically based belief
> -it's the wrong decision to dissuade the use of a validated diagnostic
> tool that saves lives though (1) more personalized care and (2) saves
> money by not spending it where it isn't going to work.
> NICE noted that most studies were retrospective, which it said is
> associated with increased bias compared to prospective trials. Maybe so.
>  But tell that to the 20 percent of women whose lives are at risk.
> Research shows, not surprisingly, that many breast cancer patients who
> might benefit from Herceptin are not receiving it, while some women on
> the drug had never been properly tested.
> "Our review of the literature suggests that there are important
> knowledge gaps regarding the real world use of HER2 testing and
> trastuzumab," said Elena Elkin, a researcher at Memorial
> Sloan-Kettering Cancer Center in New York. "Filling these gaps may
> help optimize limited healthcare resources and improve care for women with breast cancer."
> But how will data be collected if these tests aren't being used in
> regular clinical practice? (And they won't be without reimbursement.)
> Are these approved and validated tests to be relegated to the narrow
> confines of lengthy clinical trials? What message does this send to
> the developers of advanced diagnostics - and for those who invest it
> such enterprises? What message does it send to pharmaceutical
> companies about the future of high-risk adaptive clinical trials? What
> message does it send about the future of targeted therapeutics?
> To borrow an over-used adjective from the world of global climate
> change - what does this say about our ability to protect "sustainable" innovation?
> Most disturbingly, what message does NICE's decision send about
> medical ethics in the age of personalized medicine? Is this but the
> latest malignant manifestation of choosing short-term savings over
> long-term results, of cost-based choices over patient-centric care?
> Skimping on a diagnostic test today but paying for an avoidable
> hospital stay later is a fool's errand, pernicious to both the public purse and the public health.
> The implications for the healthcare debate in the United States are
> uncomfortably obvious.
> And considering the white-hot debate over the Komen Foundation/Planned
> Parenthood imbroglio - where's the anger and indignation?
> More research?  By all means.  Better-designed research? Absolutely.
> But by denying reimbursement for HER-2 tests until this research is
> designed, fielded, studied, reported and debated many lives will be
> lost and many millions of dollars wasted.
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James Love.  Knowledge Ecology International http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am using my MaxRoam number: +447937390810 twitter.com/jamie_love _______________________________________________
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