Report: Disclosures lacking on drug studies

WASHINGTON - Drug regulators haven't done enough to force disclosure of financial conflicts of interest among the researchers who conduct clinical trials of medications and medical devices, according to a government investigation.

A total of 42 percent of marketing applications approved by the Food and Drug Administration were missing financial information that was supposed to be submitted by drug and device makers, according to a report by the Health and Human Services Department's inspector general. The FDA didn't act against the companies, the report said.

Financial connections between companies that make drugs and devices and the doctors and other researchers who test them on humans may compromise the safety of patients in studies and the integrity of the results, according to the report. Lawmakers, led by Senator Charles Grassley, a Republican from Iowa, have raised concern that conflicts of interest among doctors and manufacturers may influence prescribing decisions.

"FDA should ensure that sponsors submit complete financial information for all clinical investigators," the report said.

Among researchers listed in financial disclosure paperwork, about 1 percent reported a financial interest, according to the report covering fiscal 2007. That represents 206 of 29,691 clinical investigators listed on the forms.

The FDA can't determine whether drug and device makers submitted financial information for all clinical investigators, the report found. The agency doesn't have a complete list of the researchers.

In 31 percent of the applications to market drugs and devices, the agency didn't document that it reviewed any financial information, according to the report. In 20 percent of applications that included disclosures, neither FDA reviewers nor drug and device makers indicated they acted in response to disclosed financial interests.

Clinical trials generally are required for drugs and medical devices, such as pacemakers for the heart, before they can be sold.

Beginning in 1999, the FDA required that companies submitting applications to sell new drugs disclose financial interests of researchers conducting the trials, according to the report.

Companies don't have to report conflicts if they try to get the information from researchers and certify that they acted with "due diligence" to obtain it, according to the report. In 28 percent of applications, drug and device makers used the exemption to say they were unable to provide complete information.

The FDA agreed with most of the report's recommendations except for one saying that drug and device makers submit financial information before clinical trials begin, said agency spokeswoman Karen Riley in an e-mail.