cardiac surgeons violated research standards

The heads of the cardiac surgery departments at Ichilov Hospital in Tel Aviv and Assuta Hospital in Petah Tikva made grossly improper use of hundreds of medical files of heart patients for studies that were published in two leading American medical journals. An internal review conducted in recent months by Ichilov's management, at the request of the journals' editors, found violations of ethical, professional and legal standards in the research methodology and the manner of publication.

An examination by Haaretz has also found that the research was carried out without obtaining prior permission from the committee for human medical studies nor from the patients themselves.
The two articles in question carry the signatures of Professor Gideon Uretsky, head of cardiothoracic surgery at Ichilov, and Professor Rephael Mor, who says he is the one who authored both articles and decided to publish them.

The studies, conducted between 2002 and 2005, looked at the treatment of diabetics who underwent cardiac surgery or catheterization and examined the preferred treatment method: cardiac surgery versus implanting a drug-coated stent through catheterization. According to the doctors, surgery did a better job of reducing the chances of exacerbated heart disease.

The studies involved a retrospective comparison of 500 patients, through reviews of their medical files and telephone interviews.

Ichilov's internal review discovered serious problems with the studies. Some of the doctors' statements and the data they published in the articles do not match the data in the patients' files. Patients were included in the studies selectively and in a manner that substantially contradicts the doctors' statments. Some of patients' data is not confirmed by and has no basis in the files. A portion of the quotations appearing in the articles "were not correct," and the articles published as supposedly separate studies included "entire paragraphs of text that were identical word for word."

Regarding permission from each hospital's Helsinki Committee, Haaretz found that authorization for these studies was granted only in February 2006, long after the fact. Moreover, authorization was granted only at Ichilov, not Assuta.

Ichilov director Professor Gabi Barabash announced last May that the Ichilov doctors involved in the case would be severely punished; the lead author will not be able to conduct any research at Ichilov for five years and the rest for two years. Thereafter, they will be monitored for four years by a committee that will vet their research prior to publication.

The affair came to light in January 2007 after the editors of two Philadelphia-based periodicals, "Journal of Thoracic Cardiovascular Surgery" and "Annals of Thoracic Surgery," raised the suspicion that the heart surgeons had published articles that were similar to the point of constituting the forbidden practices known as "superfluous publication" and "duplicate publication." They also had doubts about the reliability of some of the data. Mohr apologized to the journals for any overlap, but that was not sufficient for the editors, who asked Barabash to investigate the matter.

In a response for this article, Mohr said he was not given an opportunity to present his reservations in full and that the review committee "rushed to take punitive action without doing the doctors justice." He claims that some of the review findings are "completely erroneous" and based on "sloppy documentation" by nurses at Assuta. He further said that he has yet to receive the committee's complete report.

Assuta, which is owned by Maccabi Health Services, said it relied on Ichilov as the lead institute conducting the research, and that "to the best of our knowledge, there are no essential flaws in the article that might undermine the validity of the conclusions."

Regarding the lack of Helsinki approval, Ichilov's management said that it was not initially clear that permission was needed for a retrospective study that did not involve human experimentation, but that once it became clear that permission was needed, the committee approved the study in retrospect, and also retroactively exempted the doctors from obtaining patients' permission to participate.

Source:www.haaretz.com