Last year, a report by the Department of Health and Human Services (HHS) Office of the Inspector General (OIG), noted that “the US Centers for Disease Control and Prevention (CDC) failed to identify or resolve potential conflicts of interest among its 2007 advisory committee members more than half the time.”
As we previously noted in our summary of the report, “97% of the 212 disclosure forms the agency certified in 2007 contained at least 1 omission, the report noted.” The OIG also explained that experts serving on CDC committees “are prohibited by federal criminal law from participating in decisions that may benefit them financially.” These laws also prohibit experts from “participating in committee work if they have any apparent conflict of interest, such as a personal or business relationship with individuals who might benefit from the committee’s work.”
OIG also noted that if the need of some experts experience outweighs the potential risk, the agency can resolve such conflicts by issuing a waiver and creating an agreement with the individual detailing how the conflict will be managed. Some of the findings included:
– CDC didn’t identify potential conflicts on 124 individuals (58%) with certified forms.
– Nearly one-third (67 persons) of the 212 certified individuals had conflicts the CDC identified but failed to resolve.
– CDC never created waiver agreements for 49 individuals outlining how these conflicts should be managed, and the agency issued waivers for 18 persons but did not adequately document them.
– CDC did not ensure that 101 of the 246 individuals (41%) serving on committees participated in required ethics training.
Consequently, in keeping track of the progress made since this report, Senator Charles Grassley (R-IA), sent one of his letters last week to Thomas R. Frieden, M.D., M.P.H., the Director of CDC, expressing his concern about conflicts of interest (COI). Citing the same examples he has used for the past two years (Emory, Stanford and Harvard), Mr. Grassley used these exceptions (not examples) to ask for documents and responses to questions, including:
– An update on CDC’s implementation of all seven of HHS OIGs recommendations, specifically listing what CDC has done to satisfy them;
– An update on CDC’s implementation of all seven of HHS OIGs recommendations, including a list of exactly what CDC has done to satisfy them;
– What steps CDC has taken to ensure that OGE Forms 450 are complete;
– Explaining CDC’s policies for handling and SGE that does not fill out accurately OGE Forms 450, as well as a list of all incidents since January 2008 when an SGE did not complete the form, and what actions CDC took to rectify these conflicts; and
– What steps CDC has taken to ensure that Special Government Employees (SGEs) receive ethics training before serving on an FA Committee
In addition to these requests, Senator Grassley asked for all OGE Forms 450 from January 2008 to the present for every SGE at CDC, and a list of all CDC Federal Advisory Committee’s and the Committee members from January 2008 to the present, including the:
– Committee Name
– All SGEs of each specific Committee
– SGE’s Name
– SGE’s Title
– SGE’s conflicts
– SGEs primary institution
Senator Grassley requested the responses to questions and document requests be returned no later than May 6, 2010. (Short time frames for requests from congress are the norm)
As we previously reported last week, a similar issue regarding advisory committees at the FDA is occurring because of a lack of resources the agency has in handling paperwork, and not enough staff.
While the CDC has a considerably larger budget than FDA, it would appear from this report that those resources are not being adequately put to use regarding conflicts of interest.
It is typical for the party out of power to provide “oversight” for the administration by requesting information and releasing the requests to the press to gain political points. It is not common to request information from the CDC on procedural questions not directly affecting the nation’s public health.
Accordingly, any effort for Congress or the CDC to enhance transparency at this agency should be extremely careful not to stifle important work researchers have with industry.
We already have one agency that has over a third of its advisory committees empty, and the last thing we need is our public health agency facing the same shortage at a time when public health is growing exponentially. As a result, CDC and Congress must work closely to preserve the waiver process and to keep highly experienced and trained experts who work with industry on their committees, otherwise CDC will face inadequate resources to address public health concerns.
With 31 million patients entering a system they have rarely step foot into, who knows what kind of public health concerns and findings could result. Having a strong, fully employed CDC with members serving on advisory committees that are the “best and the brightest” will be critical to addressing these issues.