Israeli guinea pigs

An inquiry finds that doctors at 10 hospitals violated ethical standards by conducting experiments on children and geriatric patients without their consent.

Published May 11, 2005 2:15PM (EDT)

A leading Israeli doctor and medical ethicist has called for the prosecution of doctors responsible for thousands of unauthorized and often illegal experiments on small children and geriatric and psychiatric patients in Israeli hospitals. An investigation by the government watchdog, the state comptroller, has revealed that researchers in 10 public hospitals administered drugs, carried out unauthorized genetic testing or undertook painful surgery on patients unable to give informed consent or without obtaining Health Ministry approval.

At one hospital, staff pierced children's eardrums to apply an experimental medication yet to be approved in any country. At another, patients with senile dementia had their thumbprints applied to consent forms for experimental drugs.

Israel's health minister, Dan Naveh, said he was "shocked" at what he described as a failure of his department and some of Israel's hospitals. Jacques Michel, the former director of Hadassah Hospital who triggered the comptroller's inquiry with a public warning about the abuses in 2001, Tuesday called for the prosecution of the doctors.

"These doctors should be punished very severely because they really are criminals," said Michel, who is head of the committee that approves medical experimentation at Hadassah, which is not among the accused hospitals. "They should be stripped of their licenses to practice and they should be prosecuted. If you don't show by example that the medical profession does not accept this kind of conduct, the phenomenon will go on and on. It's not an isolated phenomenon. It spread through different institutions."

The state comptroller, Eliezer Goldberg, found that patients were often not properly informed about the experiments they were agreeing to and, in some cases, not told at all.

Every Israeli hospital has a medical ethics committee to oversee adherence to the 1964 Helsinki code on experimentation. But the comptroller said the committees routinely failed to apply their own regulations and that the Health Ministry was negligent in enforcing standards.

Goldberg described a series of incidents at Harzfeld geriatric hospital as "extremely grave," including the cases of a 101-year-old woman and another age 91 who supposedly consented to experimental drugs without their families being informed. Researchers applied the thumbprints of seven other patients at Harzfeld to consent forms that they were too senile to read or sign. "At this age, 25 to 30 percent of these people are not fit to give informed consent because they suffer from dementia or senility," said Michel. In other cases, doctors were unable to produce the consent forms that they said patients had signed, although the law requires researchers to keep the documents for 15 years.

Kaplan Hospital conducted painful clinical trials on patients to draw urine samples by needle, a procedure normally reserved for extreme circumstances. The comptroller found that 40 percent of the patients who signed consent forms -- five of them with a fingerprint -- were mentally unfit to do so.

Goldberg said two women died from infections, but their deaths were not reported to the ministry, nor was a legally required investigation committee set up. The comptroller said that in some cases the deaths of patients who were part of clinical trials were not immediately reported, which undermined attempts to establish whether the experiments were to blame.

Michel believes some doctors bowed to incentives from pharmaceutical firms to test experimental drugs. "I don't have to explain the enormous power of the pharmaceutical industry to direct research according to its priorities," he said.

Goldberg described how one researcher was also the medical director of a company that initiated the clinical trial he was responsible for.

The Health Ministry said it has already taken steps to tighten supervision following the comptroller's report.

By Chris McGreal

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