More on Research Ethics & Conflicts of Interest

Lots of good blogversation on issues of research ethics and conflicts of interest. 

First, there is the release of the results from the ENHANCE trial, which did not show that ezetimibe (brand name: Vytorin) was effective in preventing heart attacks.

There is good background from Health Care Renewal Blog here, and further discussion and linkage here.

Howard Brody has some perspectives worth reading here and here.  Ed Silverman notes that Merck & Schlering-Plough have decided to suspend DTC TV ads for Vytorin.

Second, the revelation that a number of studies with negative findings regarding the efficacy of SSRIs has received substantial analysis on the Clinical Psychology and Psychiatry Blog.

Bernard Carroll provides detailed discussion of the ethics involved in promoting atypical antipsychotics like risperidone, and Dr. Brody and ClinPsyc also weigh in.

Third, OIG has released a new report (PDF) entitled National Institutes of Health: Conflicts of Interest in Extramural Research.  The results are difficult to stomach, though working on COIs in research and practice tends to inure one to surprise on these matters.  The upshot of the report is that reporting -- let alone management and action -- of conflicts of interest in NIH-sponsored extramural research is inadequate.  Among OIG's findings:

NIH could not provide an accurate count of the financial conflict-of-interest reports that it received from grantees during fiscal years 2004 through 2006.

NIH is not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported and most conflict-of-interest reports do not state the nature of the conflict.

Many Institutes' primary method of oversight is reliance on grantee institutions' assurances that financial conflict-of-interest regulations are followed.

Hardly reassuring, eh? OIG recommended (1) increased oversight of grantee institutions; (2) requiring that grantee institutions disclose the details of the reported financial COIs; and (3) requiring Institutes to forward all COI reports to the Office of Extramural Research.