HHS OIG Report on CDC COI Forms: A Case of Different Priorities

 

 

 

 

 

 

 

 

According to a report by the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), “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.”  

The report, which released in December 2009, “was based on a review of documentation for 246 experts—known as Special Government Employees (SGEs)—serving on one of the CDC's 17 committees in 2007.” The methodology of the report “assessed how well the agency followed its own ethics guidelines as well as federal ethics regulations.”

According to OIG, the “experts serving on CDC advisory committees are required to fill out confidential financial disclosure forms detailing their assets and income, liabilities, any positions they hold outside the CDC, and agreements or arrangements they have with outside entities.” In addition, experts are “asked, but not required, to submit a curriculum vitae, to assess whether the individual has any conflicting grants.” Consequently, the report found that “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. Below is a brief summary of some of the results found in the OIG report.

– CDC didn’t identify potential conflicts on 124 individuals (58%) with certified forms.

– The most common potential conflict involved employment and grants (85 individuals), equity ownership (28 individuals), and consulting (11 individuals).

– CDC often did not take the steps necessary a potential conflict even when it was identified.

– 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.

– Sixty-four percent of SGEs had potential conflicts of interest in 2007 that CDC did not identify and/or resolve before it certified their OGE Forms 450.

– 32 percent of SGEs had potential conflicts of interest that CDC identified but did not resolve; and twenty-six percent of SGEs had both CDC-unidentified and unresolved potential conflicts of interest.  

– 13 percent of SGEs participated in committee meetings in 2007 without having current, certified OGE Forms 450 on file.

– 3 percent of SGEs voted on particular matters when their waivers prohibited such participation.

The report made several recommendations, and the CDC concurred with all seven of OIG’s recommendations, which are summarized below:

1)    Ensure that special Government employees’ Confidential Financial Disclosure Reports are complete before certifying them;

2)    Require special Government employees to disclose their involvement in grants and other relevant interests that could pose conflicts but that are not disclosed on the Confidential Financial Disclosure Report;

3)    Identify and resolve all conflicts of interest for special Government employees before permitting them to participate in committee meetings;

4)    Increase collaboration among CDC officials and with the HHS Office of the General Counsel;

5)    Ensure that special Government employees and CDC employees receive ethics training;

6)    Monitor special Government employee compliance with ethics requirements during committee meetings; and

7)    Track special Government employee compliance with ethics requirements.

The lack of controlling conflicts within the CDC as evidenced by the OIG report shows that the regulatory framework for managing potential conflicts is extremely ineffective.  It also shows that the CDC which is focused on issues such as H1N1, SARS, HIV, protecting us from emerging infectious diseases and potential disasters does not necessarily see keeping up with bureaucratic forms as their main mission.

 Attempts at creating similar regulations in other agencies and for physicians or health care entities are extremely troublesome, and obviously an administrative burden that cannot be handled.

Perhaps rather than the HHS OIG criticizing the agency for not collecting forms, they should suggests ways to make those forms easier and perhaps even drop some of the restrictions in the interest of our public’s health.