Journal Has Docs Disclose Conflicts

In response to the failure of three Harvard researchers to disclose their financial ties to companies related to their studies, the Journal of the American Medical Association (JAMA) has modified its conflict of interest policy in an attempt to ensure full disclosure of such financial connections.

JAMA released an editorial in its July 12 issue announcing the stricter requirements for researchers.

Prior to July, JAMA required that all researchers report their potential conflicts of interest in a document separate from their manuscript. The document was normally sent to the journal’s editors after the manuscript was already submitted.

Now JAMA will require that all researchers provide potential conflicts up front at the same time that they submit their manuscripts.

As a result of the new policy, the determination of whether a conflict of interest exists will happen earlier in the process, according to a spokeswoman for JAMA who asked not to be named due to the association’s policy.

The spokeswoman added that most researchers are not trying to hide their connections.

“They don’t think it’s relevant to the paper they’re writing,” she said. “Most of it’s not intentional.”

In a letter to readers posted on the JAMA website Monday, JAMA Editor in Chief Catherine D. DeAngelis, MD, MPH said it was “somewhat surprising” that three consecutive cases of nondisclosures involved researchers from the Harvard Medical School.

DeAngelis also wrote that Dean of the Medical School Joseph B. Martin told her that he will write and distribute a letter to all 8,000 Harvard Medical School faculty members describing the updated disclosure policies of both JAMA and the New England Journal of Medicine.

She added, however, that a study should not be discredited if the authors fail to disclose all potential conflicts.

“Failure of the authors to fully disclose their financial ties does not automatically translate to the article being flawed,” she wrote.

The letter from Dean Martin has yet to be sent to faculty members, according to HMS spokesman John Lacey, who would not specify when it would be sent.

Earlier this year, Dr. Lee S. Cohen of the HMS-affiliated Massachusetts General Hospital and other researchers he worked with were criticized after they released a study that found that depression was likely to recur in pregnant women who discontinue use of depression medication.

Cohen did not initially disclose that he has received money in the past from drug companies that manufacture depression-related medications.

Another study that drew criticism was by a team that included Dr. Tobias Kurth of Brigham and Women’s Hospital, also an HMS affiliate.

The study, published on July 19, examined the connection between migraines and cardiovascular disease, but the six authors did not initially disclose that they have all received funding from drug companies that produce medications related to migraines or cardiovascular disease.

In the wake of JAMA’s July 12 announcement that it would increase its scrutiny of possible cases of conflict of interest, Kurth and his team disclosed their connections to the drug companies.

Kurth told The Crimson that he could not explain why the most publicized medical conflict of interest cases this year have come from studies connected with Harvard.

“I don’t think this problem is Harvard-specific,” he said. “The problem is certainly not our medical school.”

Kurth added that requiring researchers to list all connections with companies funding research studies has its disadvantages.

“The danger here is that if you have a long list of all relationships, the relevant relationships are not apparent to readers,” he said.

He added that editors from many medical journals should have a common policy about how to determine which connections are relevant and need to be printed with the publication of a study.

“It’s a good opportunity to come up with a common policy,” he said.

—Staff writer Katherine M. Gray can be reached at kmgray@fas.harvard.edu.