Pharma objects to empiricism, part xxx

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, deep problem created by allowing pharma to dominant drug testing data while we lack the ability to collect information on how well various drug and other treatments actually work in clinical practice. We're working on decades-long lags to see how these drugs really work; pharma tests and promotes a new generation of miracle antipsychotics and antidepressants in the 1980s; 20 years later we finally have enough meta-analyses of actual clinical use to see they work no better than the drugs they replaced, though they have in the meantime cost us 20 times as much. We're running largely blind -- and must rely on data generated by studies designed by highly interested parties who have a track record of designing studies that will reflect well on their products -- and then exaggerating benefits and downplaying or outright hiding risks (like death and such) anyway.

This isn't a left-right issue or an ideoiogical issue -- unless you want to call the idea of medicine as an empirical science an ideology. And it's not even a pure cost issue -- though cost is important, as we're spending far more than other countries and getting worse outcomes. So 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 obviously one concern being addressed by the comparative effectiveness drive -- and it's a legitimate concern, because big money spend on so-so 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 -- and the great potential gain -- of the comparative effectiveness movement is not cost but effectiveness, and the creation of a huge database that will show what really works in actual practice and what does not. That's not social engineering or socialized medicine. That's empiricism -- and a much truer "consumer" (i.e., patient) empowerment.

Let me state again I'm all for good, effective drugs -- indeed, know well that I owe my life and that of most of my family to same. But damage already done by pharma's worst excesses to the name of medicine -- and the cause and definition of medicine as an empirical endeavor -- is already incalculable. The industry clearly recognizes that comparative effectiveness data -- a true measure of what works and what doesn't -- will threaten the tremendous profits they've made from drugs that improve little or not at all on existing treatments or (most cost-effective of all) no treatments. Their 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 --l onger than a patent run -- before enough clinical information exists to really evaluate them. The comparative effectiveness movement threatens to reduce that window sharply. Their statements and efforts -- and every move made by the Partnership to Improve Patient Care -- should be evaluated in that light.