Here’s pretty damning critique in the NY Times, of FDA oversight of clinical drug trials:
F.D.A. Is Lax on Oversight During Trials, Inquiry Finds.
It just goes to show that no matter what the rules or guidelines say on paper, if they’re not enforced and part of the insitutional culture, they’re not worth the paper they’re printed on!
In the wake of increased professional, political and public attention the COI posed by physician consulting with the pharmaceutical companies, here’s a story about moves to facilitate disclosure: Doctors face pressure to disclose all side pay.
What remains unclear, however, is what this disclosure will actually accomplish. Will patients use the resulting information to change MDs? Unlikely, particularly in a context of managed care and difficulties accessing health care providers in a timely fashion.
But maybe disclosure will have a an impact on MDs behaviour, because of the blame and shame aspect of declaring that they’re taking money from the big pharmas…
COI, in the context of science policy, is often thought of as a problem primarily for the biomedical sciences, and especially drug development. The following story about US Science Councils, however, provides a good example of how COI can be problematic across a range of advisory bodies.
According to an investigation released today by the nonprofit Center for Science in the Public Interest, the National Coal Council is similar to other unbalanced science panels across the government that give industry inappropriate influence over federal regulatory policy.
Government advisory committees that deliver policy recommendations are supposed to be comprised of members that represent a wide range of stakeholders, including representatives of regulated industries, consumers, and community groups. Government advisory committees that advise agencies on scientific issues are supposed to be made up of scientists without financial ties to industry who can render independent, objective advice. Both types of committee are plagued with problems, according to CSPI.
The issues here are clear. When a government advisory group is supposed to represent a diversity of perspectives – and is labelled as such by govt – and yet its membership is dominated by a particular interest (whether this be industry or various other interest groups), then there’s a serious problem of integrity and legitimacy.