Controversial editor and patient safety expert had undisclosed COIs in 9 of 10 papers

A new editorial in the Journal of Patient Safety accuses former editor and patient safety expert Charles Denham of having undeclared conflicts of interest in nine out of ten articles he published in the journal.

Denham was at the center of massive controversy earlier this year, when the government accused him of taking more than $11 million in kickbacks from medical supply company CareFusion. Supposedly, he took the money to influence the National Quality Forum, where Denham was a co-chair of safe practices, to endorce ChloraPrep, a CareFusion antiseptic.

Cheryl Clark, at HealthLeaders Media, was first to report on the new editorial. Here’s what the editors wrote:

Of the 10 JPS articles reviewed, Dr Denham was the first author of 6 and a coauthor of 4 (Table 1). The 10 articles included original articles, reviews, and editorials. Potential conflicts were identified in 9 of the 10 reviewed articles. There were no significant disagreements between the 2 reviewers.

Seven of the articles cited and encouraged adoption of the NQF Safe Practices for health care. Another 2 articlespromoted the TMIT Greenlight program, whose mission includes adoption of the NQF Safe Practices.

There were no COIs declared for 5 of the articles with potential COIs (other than being funded or from TMIT in 4 of these articles). These articles were published in 2010 through the first half of 2012 and covered topics of the National Transportation Safety Board for Health Care, Partnership for Patients, The Greenlight Project, and Story Power. In another 2 articles, conflicts were listed on the COI form but were not contained in the published article (other than being from TMIT).

CareFusion was listed as a declared ongoing relationship for 1 article, as a past relationship on the COI forms (but not in the article) for 3 other articles, and as a funding source for a fifth article. The HCC was also listed as a funder for this article.Dr Denham was listed as being a consultant with General Electric Co. (GE) and Siemens in an article of medical imaging.The article by Frush et alwas also on medical imaging, but no potential conflicts were listed in the published article, although a past relationship with Siemens and GE was declared on the COI form. An article concerning electronic health records (EHRs)also disclosed a past relationship with Siemens (Siemens makes EHRs) and GE only on the COI form.

Here are the changes the editorial board is making to ensure something like this never happens again:

Dr Denham has resigned as editor-in-chief, and after a comprehensive search and evaluation process, Dr Bates has agreed to serve as editor-in-chief. The JPS supports full disclosure of COIs according to the International Committee of Medical Journal Editors (ICJME) standards (http://www.icmje.org/recommendations/). As such, the JPShas taken the several measures to reduce the probability that such undisclosed conflicts will occur again. Measures to be taken to reduce both real and perceived conflict by both authors and editorial staff include the following:

– The Journal will post COI forms online along with the published articles.

– Aspects of the rigorous standards for COI endorsed by the ICJME will be incorporated into the Journal’s operations.

– The Journal will ask reviewers to declare their own potential COIs with any of the authors on the article.

– Editors will publish regular disclosure statements about potential COIs related to the commitments of the journal staff. Guest editors will follow these same procedures.

– Editors who make final decisions about manuscripts will be instructed to recuse themselves from editorial decisions if they have COIs or relationships that pose potential conflicts related to articles under consideration.

– Other editorial staff members who participate in editorial decisions will provide editors with a current description of their financial interests or other conflicts (as they might relate to editorial judgments) and recuse themselves from any decisions in which a COI exists.

– Editorial staff will be explicitly prohibited from using information gained through working with manuscripts for private gain.

– Future appointments of editors-in-chief, made by the journal owner, will be guided by the evaluation of a panel of independent experts, as recommended by the ICMJE (http://http://www.icmje.org/recommendations/).

– Members of the public will be invited to share information that they have about perceived COIs by authors or editors.

We did a short Q&A with corresponding author of the editorial Albert Wu for more details:

Will you attach a note to them indicating conflict of interest, or otherwise let future readers know what happened? Will there be any retractions? 

I’m not sure there will be retractions – we are discussing this internally. I think we will attach a note to the papers referencing our editorial.

I’m also curious what the process was like – were the ten articles you reviewed the only 10 that Denham published in the journal, or were they picked as a representative sample?

We reviewed all of the articles that were published after he had become editor-in-chief, and then a couple more that were likely in process during the time his appointment was being considered.

Why the nearly year-long delay between the discovery of Denham’s conflicts of interest and the publication of this note?

We started our review of his papers immediately, but went then went through a few rounds of review – Journal lawyers, etc.  I would have liked for the piece to have come out much sooner, but we did want to get it right.

The New England Journal of Medicine conducted their own investigation into a study on ChloraPrep that the NQF used to support its safety and efficacy, but found no conflicts of interest in the study design or conduct.

Denham popped up on our radar last year, when the Journal of Patient Safety retracted a paper by an airplane pilot and “cardiologist” who turned out to not be a doctor at all.

We’ve reached out to Denham, and will update with anything we learn.