Israeli State Comptroller Blasts Researchers for Experimenting on Patients without Consent

Israeli State Comptroller Blasts Researchers for Experimenting on Patients without Consent

Tue, 26 Jul 2005

Patients the world over need adeaquate protection from overreaching physicians who use patients to test experimental drugs and procedures without their informed consent.

Jacques Michel, a retired director of Hadassah Hospital in Jerusalem who also heads the hospital ethics committee, triggered an investigation of 39 hopsitals by Israel’s State comptroller, the government watchdog.

The findings of non-consensual experiments conducted primarily on children, the elderly and psychiatric patients, shocked Israelis.

On May 8 a report by Eliezer Goldberg, the state controller, “found the health ministry guilty of negligence and carelessness.

The violations were found to be worst in geriatric, rehabilitation, and psychiatric hospitals, where some children had their eardrums deliberately pierced so that a drug could be applied. In another painful procedure, a needle was used to draw urine from the bladder for testing without health ministry approval.”

“Anyone who performs a medical experiment on someone who doesn’t or is unable to give his informed consent should be tried for physical assault.”

A bill to control such experimentation has been languishing for 8 years–hopefully this scandal will lead Israeli legislators to rein in lawless physicians.

A striking difference between this and similar research scandals at major US medical centers:

In Israel, the whistleblower was the head of the hospital’s ethics committee (equivalent to US IRB).

When has the chairman of an IRB–or even a voting member of an IRB–ever raised concerns leading to a government investigation of an institutions research practices?

Contact: Vera Hassner Sharav
212-595-8974

World Report Accusations of negligence and carelessness have been directed at the Israeli health ministry after a report revealed that thousands of medical experiments, most involving children or elderly patients, had been done without obtaining proper consent. Sharmila Devi reports from Jerusalem.

www.thelancet.com Vol 365 June 4, 2005 1915

Research scandal forces Israel to tighten up supervision
State controller Eliezer Goldberg accused the health ministry of negligence
AP

Israel is considering legislation to tighten up supervision of the health system after the country’s main government watchdog found that elderly patients and children had been used in thousands of hospital medical experiments, often without permission from their legal guardians.

The report, issued on May 8 by Eliezer Goldberg, the state controller, found the health ministry guilty of negligence and carelessness. A bill to control such experimentation is still unfinished after 8 years of work. The violations were found to be worst in geriatric, rehabilitation, and psychiatric hospitals, where some children had their eardrums deliberately pierced so that a drug could be applied. In another painful procedure, a needle was used to draw urine from the bladder for testing without health ministry approval.

“Further supervision has been undertaken to ensure that the general procedures imposed by the health ministry more than a year ago are being followed”, said a spokesman for Danny Naveh, the health minister.

Israeli hospitals are party to the 1964 World Health Organization’s Helsinki Accord, formulated in response to human experiments conducted by the Nazis in World War II.

Under the accord, patients must be fully informed about the risks involved in a medical experiment. A leading Israeli physician has called for the prosecution of doctors involved in the unauthorised experimentation.

Jacques Michel, the retired director of Jerusalem’s Hadassah Hospital and head of the Hadassah Medical Organisation’s Helsinki committee on medical experimentation, triggered the state controller’s investigation of 39 hospitals with a lecture he gave in 2001.

No fault was found at any of the Hadassah institutions. “Those doctors who violate the Helsinki Declaration guidelines should be punished. They should have their medical licences suspended or taken away”, Michel told the daily Jerusalem Post.

“Anyone who performs a medical experiment on someone who doesn’t or is unable to give his informed consent should be tried for physical assault.”

The controller’s report said the experiments, conducted by physicians, included genetic experiments and research studies involving drugs not certified for use in western nations.

Under Israeli law, these studies should be authorised by national Helsinki committees and the health ministry. In addition, unusual occurrences or deaths should be reported immediately to hospital authorities and within 48 h to the hospital committee that oversees experiments. The controller’s report found many deaths were reported too late. In 2003, for example, 90% of the 37 deaths of patients involved in medical experiments were reported after the required time.

The Sheba Hospital committee was unaware of, or did not report to the health ministry, 25 unusual incidents or deaths in 88 drug experiments in 2003.

Three deaths and three serious incidents took place involving congestive heart failure and two deaths involved experimental chemotherapy. The committee also authorised an experimental drug for breast cancer after doctors failed to report there were 31 unusual incidents with the same drug in other hospitals. The Ichilov Hospital was also cited in the report for faulty death reporting.

Among the faults listed in the report were: use of unapproved medicines on young children through the piercing of their eardrums and several incidents involving patients 80 years and older who were subjected to suprapubic aspiration.

This was done after a Hartzfeld director refused approval in her unit because of the risks of bleeding and infection. Two women died after the experiments.

In addition, geriatric patients had their fingers inked to give fingerprints authorising the tests even though they suffered from senile dementia. At the Wolfson Hospital, experiments were performed on the placentas of 50 new mothers without consent.

“This is a failure of a system that involves the ministry and the hospitals”, Naveh told the Jerusalem Post. “We need significant reorganisation to correct it.”

Sharmila Devi

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