Last update - 00:00 06/05/2007
Health Ministry panel exposes medical study as fraudulent
By Dan Reznick, Haaretz Correspondent
A hernia study of seemingly great significance at Jerusalem's Bikur Holim Hospital turned out to be partly based on illegal and unethical research on hundreds of patients without their agreement.
Some of the study's results are based on reports of research that was never done and on "false and unreliable reports," according to a committee set up by the Health Ministry and Israel Medical Association's (IMA) ethics bureau. The committee had investigated a complaint against six senior surgeons at Bikur Holim who had signed an essay on this research.
The committee ruled that the study was deliberately deceptive, and part of its presentation at the European Association for Endoscopic Surgery (EAES) Congress in Barcelona in June 2004 was false and "bordering on fraud." The six surgeons also presented the study at the Endoscopic Surgeons Meeting in Florida in April 2005.
The essay's synopsis says the research adhered to the highest scientific standards and was conducted on 947 patients. The study compared two surgery methods to treat hernia in the groin on groups of patients from 1992 to 2001. One method was Laparoscopic surgery, also called minimally invasive surgery (MIS), and the other was standard surgery.
Such large-scale research in one hospital is not customary, and its publication could affect the method chosen by surgeons all over the world.
Among the surgeons who signed the essay is Professor Arye Durst, 72, director of Bikur Holim's surgical ward and former surgical ward director at Hadassah Hospital.
He is considered one of the most senior surgeons in Israel.
The committee called on Durst to be very careful in allowing his name to be used in papers he was not familiar with and could not vouch for.
The Health Ministry decided to take disciplinary steps against the chief surgeon who conducted the research, Dr. Oleg Avrutis, for conduct unsuitable for a doctor. Avrutis is also the hospital's deputy surgical ward director.
The Health Ministry's ombudsman, Professor Shimon Glick, wrote that all the doctors who signed the essay were responsible for it. "This paper violated several norms of decency and integrity beyond violating accepted academic procedures."
The synopsis is signed by Doctors Avrutis, Durst, Moshe Dudai, Zack Meshulam, On Sibirsky and Vladimir Mikhalevsky.
Professor Eitan Shiloni, head of a surgical department at Haifa's Carmel Hospital, attended the Barcelona congress when Avrutis presented the study. He complained to Professor Avinoam Reches, chairman of the IMA's ethics bureau, that the study "was not based on true data."
Shiloni said he himself ran Bikur Holim's surgical department from 1995 to 1997 and no such research had been conducted there at the time.
In response to the complaint, Avrutis wrote in the six doctors' names that they were proud of the paper and that it was reliable and accurate and contained complete detailed documentation on the patients.
The examination committee, which presented its findings in January this year, found that the research was conducted without the management's authorization and patients' consent. In addition, the research follow-up documents had been destroyed and the doctors presented their findings in a misleading way.
The committee also found "false reports" of data purportedly gathered in research, and discrepancies and contradictions of over 20 percent between the number of patients appearing in the study and the number reported on by the doctors themselves.
The committee ruled that the study's writers, headed by Avrutis, knew that it was false and that unauthorized research on patients was an ethical and legal breach.
The committee recommended reprimanding Dudai, suspending Avrutis from the IMA for six months and advising the editors of Israeli medical papers not to publish Avrutis' works for at least two years. It also ruled that every academic institution that considers giving Avrutis, Dudai, Meshulam and Mikhalevsky an academic degree should take their conduct in this affair into consideration.
The Bikur Holim surgeons said that "all the data presented in the study were based on actual surgery. We presented the surgery log books with the patients' names but the committee demanded the operations' medical sheets, which were archived and the hospital did not have the resources to retrieve them."
They said authorization for research on customary treatment, or the Health Ministry's permit to gather materials, were not required at the time and that the study began in 1992 at the initiative of the department director.
They said that when the first study was sent to Barcelona the title was erroneous but was corrected before the study was presented. There was therefore no deception and the doctor who presented the study drew the congress chairman's attention to the mistake in the original version. This comment was given in the name of Durst, his deputy Avrutis, Meshulam and Mikhalevsky.