The devil is the detail

November 23, 2009

Health reform is exciting and both the House and Senate bills have elements that could greatly improve the way care is delivered for millions of people. But, with all those great things, you have to know that there are lots of things in those more than 1,900 pages of the House bill and more than 2,000 in the Senate bill that will be an unhappy surprise for those of us who would like to see some fidelity to the idea that we should be advancing the cause of delivering health care based on research and evidence. Fortunately, there are folks who are delving into the bills to raise the visibility of issues of the greatest concern. In its Nov. 18 issue, the New England Journal of Medicine has done a great service in profiling just such an important issue (Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform).

The article’s authors, Selker and Wood, note that in the Senate Finance Committee health reform bill, there are some major problems with the proposed entity that would perform comparative effectiveness research. First, lobbyists for the medical device manufacturers advocated for and were successful in getting three seats out of the 15 on the governing body. And, second there is a provision of the bill (pages 1138-9) that says that the entity may “withdraw federal funding for five years from any investigator who publishes a report on research funded by the proposed institute that is not ‘within the bounds of and entirely consistent with the evidence.’ Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design.”

Whoa! The idea behind comparative effectiveness research was to have an independent body add to the evidence and help inform practitioners and the public about what works in health care. Advocates for this kind of research thought of it as a place to get “The Truth” — to provide fair and objective research. It was, of course, never intended to be a shill for the industry. We already have one federal agency (the FDA) whose review of the effectiveness of new devices is limited. This new group was supposed to make progress in assessing the value of both devices and procedures. With the American approach to interest based politics, it is not surprising that the industry would attempt to capture this newly developing entity. Indeed, I suppose given how much industry is interested in this new approach comparative effectiveness research, it says something about its potential for impact. If we really want to make progress on delivering medical care based on the evidence, however, this is one devil that needs to get removed from the detail.