IMA to 'supervise' academic medical research to avoid fraud
Move taken after Bikur Holim doctors' reprimand for 'academic fraud'.
By JUDY SIEGEL-ITZKOVICH
Surgeons at Jerusalem's Bikur Holim Hospital have denied claims by Haaretz that a clinical trial originating in 1992 on hundreds of patients who underwent laparoscopy (keyhole surgery) for inguinal hernia was carried out only partially, with most of the data "fabricated" by the researchers.
A month ago, a joint investigation committee of the Health Ministry and the Israel Medical Association ethics bureau quietly issued a condemnation ago against five physicians and stated they were guilty of "academic fraud."
Sunday's Haaretz story was based on a leak of the joint committee's findings. According to the article, the team of Jerusalem physicians presented at a 2004 Barcelona medical conference in a "fraudulent way" and, because a large number of patients from one hospital only was involved, it could have dictated clinical practice in hospitals around the world without being backed up by experience in other hospitals.
The Barcelona lecture came to the IMA's attention when an Israeli surgeon from Carmel Medical Center in Haifa who attended the conference objected to the findings to Prof. Avinoam Reches, a senior Hadassah neurologist who heads the IMA ethics bureau. The surgeon said he himself headed Bikur Holim's surgical department during many of the years the study was allegedly carried out and that during that period, no such clinical trial was conducted. Reches established the committee together with the ministry - the first such investigation related to alleged academic fraud.
An abstract describing the research study was signed by Prof. Arie Durst, former chief of surgery at Hadassah-University Medical Center, who left seven years ago and went to Bikur Holim to head its surgery department.
The other four members of the research team were Dr. Moshe Duda'i (a controversial laparoscopic surgeon who left Bikur Holim years ago and has been accused of falsely using the title "professor"); Dr. Jacques Meshulam, Dr. Oleg Avrutis and Dr. Vladimir Michaelevski, all of whose names were on a research article abstract.
The study claimed to compare the cases of patients who had hernia repair with open abdominal surgery with those who had keyhole surgery - a total of 947 men.
Reches told The Jerusalem Post he would write a full report on the affair in a future issue of the IMA's Zeman Harefuah journal, as Avrutis is ill and cannot speak on his own behalf. Reches declared that the vast majority of Israeli medical research was honest, and that the Bikur Holim case was unusual.
However, said Reches, the affair would mark a "turning point" in medical research.
The ethics bureau, he added, will take responsibility in supervising the honesty of Israeli medical research along with the ministry by accepting complaints and investigating them.
Resnick said the committee found that none of the patients gave their informed consent for participating in the study and that management was also uninformed. He also said that follow-up forms were destroyed and that data collected were fabricated, as "in reality, they were not collected and some of them couldn't have been collected."
In a response to Haaretz, five doctors (excluding Duda'i) maintained that the investigation committee demanded all the medical files of hundreds of surgical patients, some of which had been stored in the archives, and that the hospital did not have the resources to hire doctors for months to pull out all the relevant files.
Bikur Holim's surgical department had a rapid turnover of chairmen, so some may have not been familiar with the study, they argued. The study was presented at the Barcelona conference with an "erroneous title that was later corrected," but was not published in any medical journal, the doctors said.
The investigation committee reprimanded five of the authors but not Durst, who it said "should not have agreed to his name being included as an author of the paper because he didn't contribute anything" to the research. The committee said that Durst should "be very careful not to allow his good name to be used as the author of research he was unfamiliar with and cannot stand behind."
The Health Ministry declined to comment, but an official said it had intended to release a statement on the affair soon, but would not do so after the information had been leaked to the press.
Bikur Holim declined to comment, saying it had not received the committee report, but the doctors (excluding Duda'i) said that the study was fully based on surgery actually performed.
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