Conflict of interest

Advisers on Vaccines Often Have Conflicts, Report Says

By GARDINER HARRIS
Published: December 17, 2009
http://www.nytimes.com/2009/12/18/health/policy/18cdc.html?_r=3&ref=health

WASHINGTON A new report finds that the Centers for Disease Control and Prevention did a poor job of screening medical experts for financial conflicts when it hired them to advise the agency on vaccine safety, officials said Thursday.

Most of the experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts that were never resolved, the report said. Some were legally barred from considering the issues but did so anyway.

In the report, expected to be released Friday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, found that the centers failed nearly every time to ensure that the experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions.

The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers. Thirteen percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely, Mr. Levinson found. And 3 percent voted on matters that ethics officers had already barred them from considering.

The inspector general recommended that the centers do a far better job of screening. In a reply, the agency’s new director, Dr. Thomas R. Frieden, agreed.

“Since the period covered in this review, C.D.C. has strengthened the financial disclosures and conflict-of-interest process by instituting improved business processes and realigning responsibilities and oversight,” Dr. Frieden wrote.

As numerous medicines have been pulled from the market in recent years, worries have grown that experts may be recommending medical products even ones they know to be unsafe in part because manufacturers are paying them.

As a result, government agencies, medical societies and medical journals have become increasingly insistent that experts disclose potential conflicts. And while the experts invariably insist that they have done so, government audits routinely find large gaps between these disclosures and the experts’ actual income from consulting.

Congress tightened the rules on outside consulting after similar conflicts were found among members of advisory panels to the Food and Drug Administration. But little attention has been paid to the potential conflicts of advisers to the C.D.C., even though that agency’s committees have significant influence over what vaccines are sold in the United States, what tests are performed to detect cancer and how coal miners are protected.

Most of the advisers identified by Mr. Levinson had either a job or a grant from a company or other entity whose interests were affected by the committees’ discussions, and a considerable number also owned stock in such companies, the report said.

Representative Rosa DeLauro, a Connecticut Democrat who said she had long been a supporter of the C.D.C., said: “That is why I am so concerned about this report issued by the inspector general exposing serious ethics violations within the C.D.C. All members of the federal advisory committees, whose recommendations direct federal policy, should be without conflict of interest.”