Patient Safety Journal Cleans Up After a Conflict-of-Interest Scandal

Early this year, the world of patient safety was rocked when conflicts of interest by one of its champions were exposed. The effects of the scandal continue to be felt, but also addressed.

In February, we told the story of Dr. Chuck Denham in our blog, “Apparent Conflict of Interest Sullies Panel of Patient Safety Experts,” and how, as a leader of the National Quality Forum (NQF), he faced charges of kickbacks after promoting hospital practices in which he had a financial interest.

Last month, the investigative news site ProPublica, in conjunction with NPR, called that incident “patient safety’s first scandal,” and detailed how it continues “to reverberate in the medical community, most recently in the current issue of the Journal of Patient Safety.”

The journal, we should make clear, is a peer-reviewed publication not to be confused with the newsletter of the same name, which has an excellent reputation, and which we read and refer to regularly.

Members of the journal’s editorial staff analyzed 10 of its articles written by Denham, who previously served as editor. They determined that nine had potential conflicts of interest, five of which he did not disclose. (Researchers who have any kind of relationship with any companies, materials, technologies or people involved in the study they are conducting are obliged to disclose such associations in any communications and/or papers they write pertaining to that work.)

In its review of Denham’s articles, the journal team concluded that although it’s unlikely they resulted in patient harm, his work certainly did not enhance the publication’s credibility.

The Journal of Patient Safety was launched in 2005, but, according to ProPublica/NPR, had not adopted some of the conflict-of-interest standards of the International Council of Medical Journal Editors. But now, conflict-of-interest forms will be published with articles, and editors will publish disclosure statements and recuse themselves from decisions in which they might have conflicts.

Denham, who was not a practicing physician, but was considered to be a leader in patient safety as chairman of Texas Medical Institute of Technology (TMIT), a medical research organization. He also served as co-chairman of the NQF Safe Practices committee from 2006 to 2010. The National Qualify Forum reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care.

As ProPublica/NPR summarizes, Denham’s reputation took the initial hit when the U.S. Justice Department accused him of taking $11.6 million in kickbacks from CareFusion, which manufactures ChloraPrep, a surgical antiseptic. Denham wasn’t a party in the civil case, which the company settled for $40 million, but prosecutors alleged that he was paid to influence the NQF to endorse ChloraPrep.

Denham has denied the allegations. But he never disclosed that his company had been paid by CareFusion while he was advocating for ChloraPrep in NQF’s Safe Practices committee.

Both the NQF and the Journal of Patient Safety have severed their relationship with Denham.

After Denham left the journal, a new editorial board was appointed. In their Denham article review, they said they were surprised when he was named editor in 2011, as there had been no formal search process and he lacked the strong resume of published academic articles most serious scientific publications demand for such positions.

The journal’s publisher, Wolters Kluwer Health, told ProPublica/NPR that Denham was appointed because he was a prominent member of the editorial board and that he had been recommended by the previous editor.

The Denham articles reviewed in the journal’s study had no direct references to ChloraPrep, but there were several references to the NQF’s Safe Practices guidelines. That’s a potential conflict of interest because CareFusion could have benefitted from Denham’s control of the guidelines, the editors concluded.

“This is a clear violation of the standards of the Journal,” the editors wrote.

Making lemonade out of lemons, Dr. Albert Wu, the journal’s associate editor, told ProPublica/NPR that the Denham controversy would help the patient safety movement evolve by bringing to light the potential of industry to corrupt medical practice.

“We’re now much more aware that we need to be more vigilant,” Wu said.

Dr. Eric Campbell, a professor of medicine at Harvard Medical School, lauded the journal’s move to come clean, and said it would go a long way toward building trust.

We agree. As we often say, you can’t prevent every mistake, but you can do the right thing after it occurs.

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