Tuesday, May 5, 2009

The Comparative Effectiveness Wars: Three Views from NEJM

Who would have thought that a proposal to funnel $1.1 billion into comparative effectiveness research (CER) would have caused such vicious battles? Battles get this vicious when someone has money to lose, and in this case the biggest losers are those drug companies which depend on me-too drugs for their profits. For them, CER is a stake through the heart.

The current issue of the the New England Journal of Medicine has three articles in its Perspectives section about CER that are well-worth reading if you have the time. (Oddly, the new issue is not yet online, hence the lack of hyperlinks in this posting. Get your act together, Mass Medical Society!)

First, Garber and Tunis put the spotlight on one common argument against CER--that it would somehow stymie efforts to improve personalized medicine. One of the main examples of personalized medicine is using new genetic tests to decide whether specific treatments are likely to work best in specific patients. The authors point out that genomic medicine, as this is sometimes called, has yielded little of clinical use. This is not because the evil insurance companies doen't want to pay for the testing, but because the science has not clearly demonstrated its utility.

I have to agree. In psychiatry, for example, I wrote this article about an ill-fated antipsychotic called iloperidone ("Fanapta") that was being marketed by Vanda Pharmaceuticals as a great advance in personalized medicine. Unfortunately, the company was unable to muster convincing enough data that its genetic testing protocol was truly helpful and the product was rejected by the FDA. Actually, money spent on CER would benefit personalized medicine by helping doctors to decide which genetic tests are valuable, and which are useless.

Next, Jerry Avorn weighs in with a trenchant analysis of how a coalition of pharmaceutical companies and their minions created a series of false debating points which, luckily, have thus far not convinced the Obama administration to scale back the program. Avorn aptly describes the nadir of this debate:

The radio talk-show host Rush Limbaugh then disseminated this message to millions of listeners, warning that once the stimulus bill "computerizes everybody's health record," a new federal bureaucracy "will monitor treatments to make sure your doctor is doing what the federal government deems appropriate."

Actually, CER is all about generating new knowledge to make better medical decisions, and not about denying care. But companies that rely on aggressive marketing rather than creating novel products are threatened by scientific inquiry.

Finally, Naik and Peterson point out that while comparative research is all fine and dandy, without a parallel effort to get doctors to actually use the findings in their practices, the money will be wasted. To quote them: "...a shift is needed from the 'science of recommendation to a science of implementation.'" Wise words indeed.


Ken said...

Oddly enough, Fanapta (Iloperidone) received FDA approval yesterday.

Doug Bremner said...

Isn't 'implementation' what Rush was warning us about? (Snorts of laughter). I actually listen to Rush since with a 20 year car in Atlanta it is one of three things on the radio. We need to get some Canadians to give REAL comparative healthcare descriptions. I put the pdfs from NEJM on my website.

Michael Kirsch, M.D. said...

Agree that comparative effectiveness research will be a survival contest for many of the players. http://mdwhistleblower.blogspot.com/search/label/Health%20Care%20Reform%20Quality
Nevertheless, we must agressively pursue the effort's objective, to determing which medical interventions actually deliver.