Top Dental Journal Alters Policies After Questionable Study

James Brice

June 26, 2012

June 26, 2012 — The Journal of the American Dental Association (JADA) will publish an erratum and explanatory articles in its August issue and is planning to expand its author disclosure requirements for peer-reviewed research in response to issues concerning a laboratory study that appeared in the May issue of the journal.

Editor Michael Glick, DMD, announced his plans June 14 in an exclusive interview with Medscape Medical News after an investigation by the journal confirmed irregularities with a study conducted by Charles John Palenik, PhD, the director of scientific affairs and research for the Organization for Safety, Asepsis and Prevention.

The $90,000 study was funded by disinfectant manufacturer Biotrol in East Earth City, Missouri. Dr. Palenik measured the long-term effect of 6 spray disinfectants and tap water on 9 common dental surfaces. The 2-year study involved 1.2 million individual tests to simulate a year of routine disinfections on the surfaces.

Based on the investigation's findings, Dr. Glick dismissed the possibility of fraud in the handling and reporting of scientific data, but he questioned Dr. Palenik's professional practices. Dr. Palenik conducted the study in 2007 and 2008 as director of infection control research and services at the Indiana University School of Dentistry in Indianapolis.

"It has been 15 years since we had an article that rises to this level of concern," Dr. Glick said in the interview.

Issues concerning the study came to light during routine news coverage by Medscape Medical News shortly after the article was published.

In response, the journal contracted an independent statistician/epidemiologist for a review. He identified 11 methodological problems and 9 concerns about the analytical approach taken by Dr. Palenik, the study's sole author. None of the problems or concerns rose to the level of a fatal flaw that would warrant the study's retraction, Dr. Glick said.

According to Dr. Glick, Dr. Palenik confirmed to him what he had earlier disclosed to Medscape Medical News about his contract with Biotrol, the producer of Birex SE Concentrate and Opti-Cide3 , the 2 best-performing disinfectants in the trial. The company approved the study design, selected products for testing, was given access to results before peer review, and had a contractual right to suppress the release of selected data.

"If I had known that, I would not have accepted the article," Dr. Glick said.

The research was exempted from institutional board review by not involving human or animal subjects. Selected products had been registered with the Environmental Protection Agency as antimicrobial agents that effectively kill Mycobacterium tuberculosis.

Planned Erratum

The erratum to be published in JADA will correct an omission of relevant information about the study design described in the journal. It will report that Opti-Cide3 was not included in the original experimental design — it was added at the request of the sponsor about 10 weeks after testing for the other disinfectants had been completed.

Dr. Palenik conceded to Medscape Medical News that the modification should have been described.

"This was a mistake on my part," he said. "We modified the protocol, but protocols are modified all the time. In this case, we just had the same procedures and surfaces when we resumed testing. It was as similar as humanly possible."

As part of JADA's August coverage, Dr. Palenik will respond to the journal consultant's concerns about his research methods in a question-and-answer-style article.

In addition to the erratum and the dialogue with Dr. Palenik, the journal will disclose details concerning the relationship between the study's author and his sponsor, including the disbursement of funds from the $90,000 contract with Biotrol. Dr. Palenik did not inform JADA about the contract's value on the journal's standard author disclosure form.

The sponsor's rights relating to data ownership and prepublication access to the manuscript will also be addressed with new author disclosure requirements, despite a lack of consensus among dentistry researchers about the appropriate way to address these issues.

Contractual arrangements between a sponsor and a university commonly permit a university researcher to disclose the trial design, results, and draft manuscript to sponsors. Contracts often give the company up to 60 days to review and comment on the manuscript, according to Marjorie Jeffcoat, DMD, a former JADA editor and an advisor for Medscape. "In my experience, the sponsor has never asked for the right to alter or suppress the release of scientific data," she said.

Dr. Palenik told Medscape Medical News that his dealings with Biotrol were consistent with his experience with an estimated 125 sponsored studies since the 1980s. He said he assured Dr. Glick the sponsor had not altered his data.

Still, Dr. Glick believes the overall management of the study did not comply with standard research practices.

"Dentistry is not different than any biomedical science," he said. "We follow exactly the same guidelines and standards as anyone. To do otherwise would cause us to lose our relevance."

Biotrol funded the study, including the costs of the material, laboratory assistants, and Dr. Palenik's travel to a meeting to report results. Dr. Jeffcoat is a paid advisor of Medscape. Dr. Glick has disclosed no relevant financial relationships.

J Am Dental Assoc. 2012;143:472-477. Abstract

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