Widespread illegal experiment conducted at Meir Hospital
By Ran Reznick
Haaretz
05/07/2006
Professor Mordechai Ravid and five other doctors and interns at Meir Hospital in Kfar Sava conducted an illegal medical experiment on some 60 women, most of whom were Arab.
The experiment was conducted without obtaining the requisite approval of the hospital's Helsinki Committee for human experiments, and without the patients' signed consent.
The experiments were conducted between 2001 and 2003, on diabetic patients aged 45 to 70.
The hospital appointed an internal review board in 2005, which found that some of the doctors involved had provided partly false or misleading information to senior officials in the medical establishment.
The bodies involved in the affair include the Helsinki Committee at Meir, Tel Aviv University's medical school (with which the hospital is affiliated), and a British journal, Diabetic Medicine, which published an article on the experiment unaware it had been illegal.
The article by Ravid and his colleagues said the experiment had been approved by the Helsinki Committee, but the article was approved for publication in 2003. The Helsinki permit was granted in actual fact only three months later and after the research had been conducted on the patients.
Last month the journal ran an announcement that its upcoming issue would contain an unusual clarification, in which it would announce regret for publishing the article in May 2004.
The advertisement said the journal wished readers to be aware of the concern surrounding the ethical management of the study and therefore treat its findings with caution. The move came after the director of Meir Hospital, Dr. Ehud Davidson, informed the journal's editor in December 2005 of the internal review findings.
The object of the experiment in question was to compare two accepted drug treatments for urinary protean secretion in diabetics. For the purpose of the study, patients were randomly divided into two groups, and the study concluded that one drug was preferable to the other and that combining the two was the most effective course.
The application for a Helsinki permit was submitted by Dr. Ina Slavachevsky in November 2003, and stated that the study was part of medical student Amit Moran's final paper. The application said the experiment was at its planning stage, not reporting to the committee, as required, that the doctors were in fact requesting retroactive approval for an experiment they had already performed on some 60 patients two years earlier.
The lead doctors in the study (Ravid, Slavachevsky and Rita Rahmani) told the review board that "to the best of their recollection" a previous application was submitted to the Helsinki Committee in 2001, but "because of failings in the committee's conduct, the application 'was lost' and therefore the permit was not granted on time."
The committee of inquiry found nothing to substantiate this claim and also rejected the doctors' argument that the experiment did not require written consent from patients. The panel said that only the Helsinki Committee is legally authorized to exempt doctors from obtaining patient consent for an experiment.
In addition, the review committee could not verify the study's findings because all of the documentation had disappeared from Ravid's file cabinet.
The hospital reported the inquiry results only to Clalit Health Services' management, and not to the Health Ministry as required. Nor did Clalit's management report the findings to the ministry, keeping the grievous and embarrassing affair in-house.
A senior Health Ministry official told Haaretz that Meir and Clalit were certainly legally and morally obligated to report the results of the probe to the ministry without delay.
Ravid said in response that this was "an administrative and technical screw-up" not "a moral failing." Calling the matter "an unfortunate coincidence," Ravid told Haaretz that "there had been no malice or intent to deceive." He added that the affair is "a tempest in a teacup" and insisted that "there were no forged research or forged records here."
Ravid retired in July 2004 as head of Internal Medicine Department D at Meir Hospital and has since been running Maaynei Hyeshua Medical Center in Bnei-Brak. He said the experiment had been approved and that he had no connection to the documents' disappearance after he left Meir.
Dr. Rahmani declined to comment.
Haaretz
05/07/2006
Professor Mordechai Ravid and five other doctors and interns at Meir Hospital in Kfar Sava conducted an illegal medical experiment on some 60 women, most of whom were Arab.
The experiment was conducted without obtaining the requisite approval of the hospital's Helsinki Committee for human experiments, and without the patients' signed consent.
The experiments were conducted between 2001 and 2003, on diabetic patients aged 45 to 70.
The hospital appointed an internal review board in 2005, which found that some of the doctors involved had provided partly false or misleading information to senior officials in the medical establishment.
The bodies involved in the affair include the Helsinki Committee at Meir, Tel Aviv University's medical school (with which the hospital is affiliated), and a British journal, Diabetic Medicine, which published an article on the experiment unaware it had been illegal.
The article by Ravid and his colleagues said the experiment had been approved by the Helsinki Committee, but the article was approved for publication in 2003. The Helsinki permit was granted in actual fact only three months later and after the research had been conducted on the patients.
Last month the journal ran an announcement that its upcoming issue would contain an unusual clarification, in which it would announce regret for publishing the article in May 2004.
The advertisement said the journal wished readers to be aware of the concern surrounding the ethical management of the study and therefore treat its findings with caution. The move came after the director of Meir Hospital, Dr. Ehud Davidson, informed the journal's editor in December 2005 of the internal review findings.
The object of the experiment in question was to compare two accepted drug treatments for urinary protean secretion in diabetics. For the purpose of the study, patients were randomly divided into two groups, and the study concluded that one drug was preferable to the other and that combining the two was the most effective course.
The application for a Helsinki permit was submitted by Dr. Ina Slavachevsky in November 2003, and stated that the study was part of medical student Amit Moran's final paper. The application said the experiment was at its planning stage, not reporting to the committee, as required, that the doctors were in fact requesting retroactive approval for an experiment they had already performed on some 60 patients two years earlier.
The lead doctors in the study (Ravid, Slavachevsky and Rita Rahmani) told the review board that "to the best of their recollection" a previous application was submitted to the Helsinki Committee in 2001, but "because of failings in the committee's conduct, the application 'was lost' and therefore the permit was not granted on time."
The committee of inquiry found nothing to substantiate this claim and also rejected the doctors' argument that the experiment did not require written consent from patients. The panel said that only the Helsinki Committee is legally authorized to exempt doctors from obtaining patient consent for an experiment.
In addition, the review committee could not verify the study's findings because all of the documentation had disappeared from Ravid's file cabinet.
The hospital reported the inquiry results only to Clalit Health Services' management, and not to the Health Ministry as required. Nor did Clalit's management report the findings to the ministry, keeping the grievous and embarrassing affair in-house.
A senior Health Ministry official told Haaretz that Meir and Clalit were certainly legally and morally obligated to report the results of the probe to the ministry without delay.
Ravid said in response that this was "an administrative and technical screw-up" not "a moral failing." Calling the matter "an unfortunate coincidence," Ravid told Haaretz that "there had been no malice or intent to deceive." He added that the affair is "a tempest in a teacup" and insisted that "there were no forged research or forged records here."
Ravid retired in July 2004 as head of Internal Medicine Department D at Meir Hospital and has since been running Maaynei Hyeshua Medical Center in Bnei-Brak. He said the experiment had been approved and that he had no connection to the documents' disappearance after he left Meir.
Dr. Rahmani declined to comment.
posted by Hanan Elbadry at 8:54 AM
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