Medical journal admits, apologizes for ethical lapses

Doctors wrote reviews of drugs despite ties to the manufacturers

February 24, 2000|By LOS ANGELES TIMES

One of the world's most influential medical journal has admitted to an extraordinary betrayal of its own ethics, saying that nearly half the drug reviews published since 1997 were written by researchers with undisclosed financial support from companies marketing the drugs.

The New England Journal of Medicine, in an unusual internal inquiry published in today's edition, found that 19 of about 40 drug therapy reviews violated its tough conflict-of-interest policy. The policy bars researchers with ties to pharmaceutical companies from writing reviews or editorials about company products.

Journal editors conducted the audit in response to reports last fall in the Los Angeles Times identifying eight drug therapy articles that broke the journal's conflict-of-interest rules. In a terse letter, the journal confirmed those findings and noted 11 additional articles that violated the policy.

The authors of the 19 offending articles had disclosed their support from drug companies to journal editors, who disregarded the guidelines.

"We regret our failure to apply our policy correctly," says the letter. It was signed by editor in chief Dr. Marcia Angell, deputy editor Dr. Robert Utiger, and the editor of the drug therapy reviews, Dr. Alastair J. J. Wood.

"We were careless," Angell said in an interview. The editorial staff has "heightened vigilance" to the problem and has implemented new disclosure policies to guard against it, she said.

The 188-year-old weekly has positioned itself as a leading voice in medical ethics and goaded other publications to adopt standards as high as its own.

"They set up an admirable policy, and it's a pity they didn't follow up on it," said Dr. Drummond Rennie, an editor at the Journal of the American Medical Association who has written on ethical dilemmas in publishing.

For a premier journal to err on abasic matter of editorial integrity raises questions about the quality of medical data in lesser publications. In fact, most medical journals would not consider the violations identified by the New England Journal to be a problem.

The ethical breach shows the deep inroads that commercial sponsorship has made into academic research and publishing.

"It's symptomatic of where the money comes from nowadays to do research in medicine," said Mildred Cho, a research scholar at the Stanford University Center for Biomedical Ethics.

That poses a challenge to readers and editors because authors with a drug company's financial support are more inclined to write favorably about its products than are authors lacking such support, studies have shown.

As do most medical publications, the New England Journal prints original studies by researchers with company support and discloses the link to readers. But it allows no such links with authors of editorials and review articles, because those encourage authors to interpret data and express opinions, the guidelines explain.

Angell said the journal does not plan to change its policy, but will tighten the monitoring of it.

"It's a difficult policy to maintain because the connections between academic researchers and the private sector are so close and so manifold," Angell said. "Nevertheless, we believe the rationale for the policy is a good one. So, we're going to soldier on."

She blamed the recent violations on misunderstandings between Wood, who is a pharmacology professor at Vanderbilt University in Nashville, Tenn., and the journal's main editorial office in Boston.

Yesterday's letter consists of three paragraphs and a list of the 18 articles with one or more authors who received commercial support. The journal had identified another article in a letter in November.

All the articles should have been disqualified because of major research support from drug companies, the journal concedes, and three articles had authors who served as company advisers.

The letter offers few details of the journal's internal audit. No explanation is offered of why the audit reached back only to January 1997, the starting date the Times chose for its analysis. The journal implemented its basic conflict of interest policy in 1990, and Wood -- whom Angell singled out as a source of the confusion -- has edited the drug therapy review series for a decade.

The interactions between prospective authors and editors may have entailed as much coercion as carelessness. In some cases, Angell acknowledged, one or more editors may have told prospective authors that it was all right to provide a misleading answer on the journal's mandatory financial disclosure statement.

That appears to have been the case with Dr. Vera Price, a University of California, San Francisco dermatology professor, whose favorable review of hair-loss treatments appeared in the September issue despite her drug company ties.

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