A colleague sent me an article by Harry Selker and Alastair Wood about the rules for comparative effectiveness research (“evidence-based medicine”) in the House and Senate versions of the health-care bill. The key point:
The [Senate] Finance Committee bill also includes language requested by industry lobbyists (pages 1138-1139) that threatens to withdraw federal funding for 5 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.
Selker and Wood continue:
To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question. In addition, because researchers and their institutions will seek to avoid such punishment, this provision is likely to result in prolonged arguments, taking place out of public view, regarding which data are acceptable to publish, thereby impeding and delaying publication.
I don’t really know anything about the details here–this was just something sent to me by email–but I’m inclined to agree that this kind of gag order can’t be a good idea.
If any of you know more about this, feel free to comment and educate me on this.
P.S. The second author of this article works for Symphony Capital, a New-York based company that describes itself as a “private equity firm dedicated to collaborating with leading innovative biopharmaceutical companies, helping them capture more of the value in their most important clinical development programs.” I don’t know where that puts them on any conflict-of-interest scale. (As a sometime consultant myself, I certainly wouldn’t say that working for a private investment firm should automatically disqualify someone from opining on these topics.
P.P.S. The answer is no. The offending language is no longer in the bill (perhaps in response to Selker and Wood’s article).
P.P.P.S. Somebody checked again, and the offending language is still there!