Pharma objects to empiricism, part xxx

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What’s wrong — but horribly expected — in this picture? One week the CEO of Lilly attacks the idea of a public health insurance plan because it might reduce consumers’ “ability to choose, in an informed way, from all the available alternatives.” The next week, PhRMA, the trade group this CEO’s company is a part of, launches a campaign to undermine comparative effectiveness studies — which would produce the data necessary for informed consumer choice.

If that’s not enough, this campaign against collecting actual empirical effectiveness data, spearheaded under the astroturf group Partnership to Improve Patient Care (headed by former Rep. Tony Coelho), uses the same logic: Comparative effectiveness data, by giving us more and better information, would somehow make it harder for docs and patients to make informed decisions.

This gets at the deep problem created by allowing pharma to dominate drug-testing with clinical-trial data while we lack any real ability to collect information on how well various drug and other treatments actually work in clinical practice. It takes decades to see how well these drugs really work. Pharma may test and promote a new generation of miracle antipsychotics and antidepressants in the 1980s, and it’s 20 years later we finally have enough meta-analyses of actual clinical use to see they work no better than the drugs they replaced. In the meantime, these drugs have cost us 20 times as much. We’re running largely blind — and must rely on data generated by studies that are designed at the start to get good results, and which are then interpreted and filtered to exaggerate benefits and downplay or outright hide risks (like death and such).

This isn’t an ideological issue — unless you want to call the idea of medicine as an empirical science an ideology. It’s not just a  cost issue — though cost is important, as we’re spending far more than other countries and getting worse outcomes. Cost (a word used with disdain by outfits like this new one formed by pharma, as if cost is the concern only of cynics, cheapskates, and those who don’t “value” human life) is just one concern being addressed by the comparative effectiveness drive, and it’s a legitimate concern, because money spent on mediocre or lousy treatments is money we can’t use to treat the vast unwashed and uninsured.

So yes, costs are a goal. But the true goal of the comparative effectiveness movement is not cost but effectiveness, and the creation of a huge database that will show what works and what does not. That’s not social engineering or socialized medicine. That’s empiricism — and a much truer “consumer” (i.e., patient) empowerment.

I’m all for good, effective drugs. I owe my life and that of most of my family to them. But the damage done by pharma’s worst excesses to the name of medicine — and the cause and definition of medicine as an empirical endeavor — is incalculable. The industry clearly recognizes that comparative effectiveness data — a true measure of what works and what doesn’t — will threaten the tremendous profits it has made from drugs that improve little if at all on existing treatments or no treatment. The industry’s only hope to hang on to those profits is to continue to dominate the information stream on what appears to work and what doesn’t. As it stands now, they’re getting a good decade or so with each generation of drugs — longer than a patent run — before enough clinical information accumulates to really evaluate them. The comparative effectiveness movement threatens to shorten that window.

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