Investigation Reveals Conflicts of Interest in Vaccine Approval Process

In August of 1999, the Committee on Government Reform launched an investigation into Federal vaccine policy as it pertained to possible conflicts of interest among Federal policy-makers. The Committee focused its investigations on the CDC’s Advisory Committee on Immunization Practices (ACIP) and members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Their investigation found numerous conflicts of interest among members of both committees and raised significant concerns regarding the approval process for vaccines, including the RotaShield vaccine. 

Conflicts identified with VRBPAC included: 

• Many VRBPAC committee members were found to have significant ties to industry, owned stock, or else received funding from pharmaceutical companies.
• VRBPAC members reported concerns regarding RotaShield but still chose to vote for the vaccine.
• For the RotaShield vaccine approval vote, five temporary members were permitted to vote even though the committee’s charter only allowed for four.
• Committee members who were ineligible to vote due to conflicts were still allowed to participate in discussions.
• Despite term limits, several committee members were permitted to remain on committees for many years. Additionally, some members were found to serve on both the FDA and the CDC even though this was against policy.

Conflicts identified with ACIP included: 

• ACIP members did not fully declare their conflicts of interest.
• Committee members were given a blanket waiver that allowed them to participate in discussions on any topic, even if there was a conflict of interest.
• ACIP members were permitted to vote on vaccine recommendations, even when they had financial ties to drug companies developing similar or related vaccines.
• ACIP liaison members were not required to disclose their organization’s financial conflicts of interest.
• For the ACIP rotavirus work group, seven out of the ten members had identifiable conflict of interests with vaccine interest groups and pharmaceutical products. Additionally, the meetings were held in private and no meeting notes were taken. One work group member who had significant conflicts of interest and was ineligible to vote on RotaShield use was permitted to work extensively on the recommendations.
• ACIP failed to include any consumer representatives even though they were required to.

The review of the ACIP and VRBPAC practices resulted in the following recommendations to the Department of Health and Human Services (DHHS) by the Committee on Government Reform: 

“1. Individuals who serve on advisory committees involving vaccines should have no financial ties to vaccine manufacturers.

2. Public participation on ACIP and VRBPAC needs to be increased substantially.
3. Conflict of Interest waivers should be used more stringently.
4. A balance of policy perspectives should be incorporated into consideration of appointments of committee members.
5. Any level of stock ownership in vaccine manufacturers should not be allowed by committee members.
6. Department personnel need to ensure that all documentation is fully and adequately completed.
7. Full explanation of participation as expert witnesses in legal cases needs to be a part of financial disclosures.
8. Individuals who have patents for vaccines for the same disease under discussion should not be allowed to participate in the discussion or vote of ACIP or VRBPAC.
9. Individuals who are developing vaccines for the same disease under discussion should be not be allowed to participate in the discussion or vote of ACIP and VRBPAC.
10. Working groups should be replaced by fully constituted Subcommittees on both the VRBPAC and ACIP.
11. Individuals should not be allowed to participate on two DHHS advisory committees at the same time.
12. Individuals should not serve excessively long terms on a committee.
13. The FDA should reconsider its policy on using temporary voting members.
14. ACIP should not consider making a recommendation on a vaccine until it has been licensed by the FDA.
15. CDC should follow the same policy in identifying affected companies for vaccine discussions as the FDA does and exclude participation of any individual who has a conflict.
16. Organizations who send liaison members to participate in council meetings, should offer full disclosure of ties to the pharmaceutical industry.
17. The Department should review its policies and practices regarding conflicts of interest, participation on advisory committees, and terms of service, public participation, and balance of views and expertise.”