Beilinson doctors published data from nonexistent trials

By Ran Reznick
Haaretz
Dec. 08, 2006

Senior gynecologists at Beilinson Hospital in Petah Tikva published an article in a medical journal detailing studies on dozens of women, although according to anonymous complaints, the experiments were not carried out in the manner described. This is the third time in the past two years that Beilinson's Obstetrics and Gynecology (OB-GYN) department has published false information about its research.

The article was published in an English-language journal that came out in honor of the 60th anniversary of the hospital, and which was meant to showcase its scientific achievements. Now, about a decade after publication, anonymous complaints about the studies and the way they were presented in the article have been sent to the Health Ministry and the hospital. The results of the internal investigation that ensued are being reported here for the first time.

Five senior gynecologists appear as the authors of the article: Dr. Shmuel Nitka; Dr. Gil Goldman; Professor Benjamin Fisch, the head of the hospital's in-vitro fertilization unit and chairman of the Israeli Society for Fertility Research; Professor Boris Kaplan, deputy director of OB-GYN at Beilinson, coordinator of gynecology for the Clalit Health Maintenance Organization (HMO) in the Dan-Petah Tikva region and also head of the Israeli Menopause Society; and Professor Yardena Ovadia, who served until her retirement in 1996 as director of the unit at Beilinson. The five admitted when questioned that they did not carry out the research as written, and that they had conducted retroactive examinations of patients' files rather than prospective, high-level scientific studies using a random selection of patients.

The article received worldwide attention and was quoted in approximately seven other medical studies. It describes supposedly comparative studies carried out between 1992 and 1995 on 38 patients who underwent surgery for the removal of benign tumors of the ovary by two different methods -- laporoscopy and regular incision.

In the two other cases at Beilinson, Dr. Dov Dicker (and four other senior gynecologists), wrote an unpublished article describing studies that were not undertaken. Another article by five gynecologists and published in a British medical journal, describes medical cases most of which never existed.

No documents left

According to the investigation, the five writers said they no longer had drafts of the article or copies of the data, although they are required to keep these documents for 15 years.

A senior figure in the health system with great experience in human studies, who examined the documents in the affair at the request of Haaretz, said it appeared that the authors had published an article describing a study that was "mendacious and false."

Ovadia told Haaretz a week ago "as far as I remember, the research was planned, and implemented after receiving authorization from the Helsinki committee, and there was random distribution of the patients." However this statement contradicts remarks made by other physicians during the investigation, as well as of Ovadia herself, that this was not a study that required Helsinki Committee authorization.

A senior director at Beilinson told Haaretz yesterday that he believed the case fell somewhere between negligence and lack of professionalism, but that it was not a case of an attempt to mislead or cheat.

A senior physician in the health system said it was indicative of serious and ongoing failings in Israeli medical research, in which a large number of articles are published on the basis of misleading, mendacious or fabricated information.

The article was published in the Israel Journal of Medical Sciences, the journal of the Israel Medical Association, which ceased publication in 1997. Another publication took its place in 1999, edited by Professor Yehuda Shoenfeld, head of internal medicine at Sheba Medical Center, Tel Hashomer, who also edited the special issue of the journal, together with three senior physicians from Beilinson: Dr. Meir Djaldetti, Professor Yaakov Pinchas and Professor Gabriel Dinari, deputy director of Rabin Medical Center. Beilinson, which is a division of the Rabin center, appointed Dinari, together with Dr. Amalia Dvir, to head the committee investigating the complaint.

The Rabin Medical Center responded that the authors of the article admitted that their use of the word "prospective" in the article's introduction was misleading, and that the Dinari committee had uncovered a number of other shortcomings in the article. The hospital also noted that the report was transferred to the Health Ministry and the Clalit HMO, and were not given to the medical journal in which the article was published, since it closed down nine years ago.

The hospital also said it has complete faith in Professor Dinari, and the fact that he was an editor of the journal should not disqualify him from investigating the matter. "As proof," the center said, "all the shortcomings found were described in the report." The center added that it had made do with summoning the authors to the directors authorized to deal with the matter, and that understood the mistake that had been made several years ago. The center said the anonymous complaints, which have been received for years, were from a "negative element trying consistently to do harm." It said the hospital would not stoop to the level of this element because of innocent mistakes made a decade ago.