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Comparative Effectiveness: Putting Medicine Under a Microscope

April 1st, 2008 @ 4:46 pm

2 Comments

Categories: Management, Research

Tags: Treatment, Health Care, Brownlee, Healthcare, Vertical Industries, Benefits, Enterprise Software, Software, Human Resources, David P. Hamilton

microsope-image-200px.gifMost people don’t know it, but hard evidence as to which medical treatments actually work best is in awfully short supply here in the U.S. The growing scandal over the expensive cholesterol drug Vytorin, which appears to be no more effective than older, cheaper statin drugs, is just the latest example, since data on the drug’s usefulness didn’t emerge until four years after Vytorin was approved — and almost not even then.

It’s hard to overstate the seriousness of the problem. As Shannon Brownlee documents in her new book “Overtreated,” between a fifth and one-third of total U.S. healthcare spending covers treatments that do nothing to improve health, and which in fact often harm patients by exposing them to the risks of avoidable surgeries, hospital-acquired infections and a variety of medical errors. Brownlee cites one estimate that unnecessary care may kill as many as 30,000 Americans a year. (I’ll have more on “Overtreated” in future posts.)

So the news from Reuters (via Pharmalot) that Senators Max Baucus and Kent Conrad (both Democrats) will push to create an independent institute that will study how well new medical devices and drugs stack up against existing treatments — one funded at $200 million a year — comes none too soon. While that bill probably won’t make it into law any time soon, it at least puts down an important marker in advance of the broader debate over healthcare reform that’s likely next year. Both the Clinton and Obama health plans also advocate establishing similar institutes.

(My only quibble, actually, is that comparative effectivness shouldn’t be restricted to drugs and devices. Surgical procedures and medical imaging such as CT scans and MRIs also contribute mightily to unnecessary medical treatment.)

Comparative-effectiveness research isn’t perfect, of course, as the often controversial history of Britain’s decade-old National Institute of Clinical Evidence suggests. It’s also clear that the drug and device industries — quite likely joined by doctors who have profited handsomely under current arrangements — will pull out the stops in opposition. (These groups share a not-entirely-unjustified fear that comparative-effectiveness findings could be used to cut payments for newer, lucrative technology and procedures.) What’s more, even solid research results don’t always change the established behavior of doctors and hospitals, at least not in the short run.

But given the increasingly obvious shortcomings of industry-funded research — including the studies used to justify regulatory approval by the FDA — any move toward closing medicine’s little-understood “evidence gap” has to count as a step in the right direction.

(Image courtesy of Flickr user xmatt under Creative Commons.)

David Hamilton, a former Wall Street Journal reporter, is a freelance writer and blogger in San Francisco.
 
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    jtkaufmann@...

    04/02/08 | Report as spam

    I am probably going to generate tremendous pushback by saying this...

    ... But I see this as yet another example, and further indication, of our (fda + the medical research institutions + big pharma) continual reliance on using animal model studies as our primary source of drug efficacy / safety criteria when we know by now there are other more relaiable alternatives and that the failure rates (while rarely leaked to the press) are quite high and exact substantial tolls (as you read in just one example you provide).

    Conversely, it was only by disregarding the animal study results of Pennicillin that we got it into our health care tool box (it was killing the animals, dogs and rats, used in its testing.)

    Animal models are big business (average dog sells for about $45 and cat about $20 to a recognized research lab) and so eliminating the hundreds of millions them will impact some awfully profitable businesses and since our governmental institutions are well entrenched into this mindset protocol... it will be some real boxing match to change the paradigm.

    But boy ... we can heal a lot of people if we aren't being mis-directed in our expenditures and energies using non-human subjects.

    Former NIH intern / med school drop out turned antivivisectionist

  •  
    2

    David P Hamilton

    04/17/08 | Report as spam

    Animal testing

    To be honest, I'm not sure I see any particular connection to the issue of animal models here. The kind of comparative-effectiveness studies I'm talking about would necessarily have to be conducted in people, as that's the only way you can know anything about how well one drug, for instance, works compared to another. (And even then your information may be limited depending on how many people are studied and what their demographics are.)

    I'm not opposed to animal testing in principle, although like anyone else who gives it half a thought, I'm all for workable alternatives and minimizing animal suffering. The main issue in the drug industry, I think, is that most animal models simply don't work very well in terms of the data they provide. Some toxicity testing in animals seems OK, but efficacy of an experimental drug is notoriously difficult to predict from animal testing. As the old saying goes, researchers have cured cancer thousands of times in rats, but how many times in humans?

    I do, however, strongly doubt that pharma is clinging to animal models in the face of more effective alternatives, if only because the drug companies are painfully aware of how much money is wasted when they pursue drugs based on animal studies that don't ultimately work out.

    Perhaps before long we might see some in vitro testing done in stem-cell derived human tissue or organ culture, which would be a big step forward in many respects. For now, however, the only real way to know if a drug or device intervention really works is to test it in people, and I don't think the FDA is wrong to insist on the best possible information -- even from flawed animal models -- before letting experimental treatments into human testing.

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