Wednesday, March 09, 2011

Video: Did an Undisclosed Conflict of Interest Delay Review and Publication of Denture Cream Study?

Well, perhaps but the author of the study says no.

A study suggesting neurologic damage from overuse of denture cream was delayed for 2 years by a reviewer with undisclosed conflicts of interest charges a news report televised February 8 on ABC's World News Tonight with Diane Sawyer.

But the lead author of the study, published in the American Academy of Neurology (AAN) journal Neurology in 2008, has told Medscape Medical News that she saw nothing wrong with the peer review process that assessed her research.

In fact, says Sharon Nations, MD, associate professor of neurology at the University of Texas Southwestern Medical Center in Dallas, the suggestions made by all 3 reviewers were excellent and led her and her team to improve the paper.

The peer review did not lead to a delay in publication, as alleged by ABC News, she maintains.

The reviewer in question, Kenneth Shay, DDS, a dentist who practices in Ann Arbor, Michigan, admits that he was wrong not to disclose that he had a conflict of interest with regard to Procter & Gamble but assumed that the journal had gotten his name from the company's site.

He also admits to sending the manuscript to someone at the company to "double-check" his facts, an action that he now calls a "big mistake."

That being said, Dr. Shay insists that he gave a fair and unbiased review of the study and sent his suggestions for revision in a timely manner.

"I did not comment on the paper as a Procter and Gamble employee. I came at it as somebody who knows a lot about denture adhesives," he told Medscape Medical News.

Color me skeptical.

I think the entire study should be viewed within the framework of the Procter and Gamble employee reviewer. It is not an independent set of findings and the ethical dealings of Dr. Shay should disqualify him from further reviews - by any journal.

Contemptible is the word for his conduct - even as he complains he was not even paid for the review.

Robert A. Gross, MD, PhD, the editor-in-chief of Neurology, was unavailable to comment on the ABC News report. But in a statement conveyed by the AAN's press office, Dr. Gross condemned Dr. Shay's actions.

"Dr. Shay did not disclose any conflict of interest to the editor-in-chief of Neurology," he writes. "Furthermore, it appears that Dr. Shay improperly shared the manuscript authored by Dr. Sharon Nations to Procter and Gamble, in violation of the journal's confidentiality policy."

"Neurology considers violations of our ethics policies to be egregious misconduct, and the academy's general counsel is reviewing its options with the editors," Dr. Gross adds. "Furthermore, we will continue our ongoing review of policies for authors and reviewers to ensure that the integrity of Neurology is preserved for our readers and the patients and caregivers affected by the research we publish."

The numerous lawsuits will ferret out the facts, especially in the depositions of Dr. Shay and Dr. Nations. The communictions between Dr. Shay and Procter and Gamble, plus P & G's internal memos should make for some very interesting reading.

I foresee a nice settlement from the company prior to a trial - but they will drag it out.

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