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Beilinson Hospital and the Kupat Holim Clalit health maintenance organization will compensate thousands of patients who were administered a controversial anti-smoking treatment that was provided against Health Ministry directives.

The decision - which was accorded binding status by the Tel Aviv District Court - was made as part of an agreement reached following a class-action lawsuit filed by two of the patients against the hospital.

The treatment in question was administered to 4,000 patients between 1997 and 2003 by the Institute of Pulmonary Medicine at Beilinson Hospital. The trial was overseen by the institute's deputy director, Dr. Gershon Fink.

The settlement requires a payout of NIS 1,500 for each of the patients who participated in the study. Participants in the trial will be reimbursed NIS 880, which was the original cost of the treatment; NIS 270 for interest and adjustment for inflation; and NIS 250 for bodily harm. Patients will receive compensation even if they did not manage to quit smoking as a result of the treatment. The plaintiffs argued that they were misled by the hospital and the HMO.

The method of weaning smokers off cigarettes is based on two research studies conducted in 1994 and 1996. The trials, which were conducted at Beilinson, were said by hospital officials to have been concluded successfully. The treatment was subsequently marketed to the public in media advertisements.

Hospital officials claimed that 37 percent of those who underwent the treatment between 1997 and 2003 successfully kicked the habit. Yet an inquiry panel appointed by the Health Ministry criticized the hospital's decision to make the method available to the wider public even though it was still in the experimental phase.

In early 2003, three of the patients who were given the treatment were rushed to emergency rooms after reporting serious side effects, including hallucinations, restlessness, accelerated heart rate and urinary retention.

In his deposition before the panel, Prof. Mordechai Kramer, the Pulmonary Institute director, said that the treatment included one injection of three medications: atropine, scopolamine, and chlorpromazine. In addition, doctors observed the patients for a half-hour following the injections. The subjects of the trial were then given the drug nirvaxal orally for a period of 20 days, during which they were also required to undergo cognitive behavioral therapy in group sessions run by a psychologist.

In January 2003, an internal inquiry panel at Beilinson Hospital determined that a number of lapses and irregularities were discovered in the therapy protocol prior to the patients' hospitalization due to the side effects. Yet in August that year the panel announced that the hospital had no intention of discontinuing the treatment.

Ministry probe

The Health Ministry, meanwhile, conducted its own inquiry into the matter. In September 2003, a ministerial committee ruled that the hospital was authorized to administer the treatment to a limited number of patients under guidelines mandated by the Declaration of Helsinki, the document which codifies ethical issues regarding human experimentation.

Despite the Health Ministry's ruling, doctors at Beilinson continued running clinical trials of the treatment without authorization from the state. As a result, a ministry committee recommended that the hospital cease the experiments. A Health Ministry inquiry panel of headed by Prof. Yona Amitai determined that the hospital was initially permitted to administer the treatment to just 20 patients. "The treatment that was given with a course of three drugs includes agents that prevent withdrawal symptoms," the committee determined. "This treatment was not within the realm of authorized medications, thus it should not be administered as part of a trial."

The panel also discovered that the patients reported side effects to the psychologist who was treating them rather than to a doctor. According to the panel, the medications were deemed safe, yet treating a large number of patients with the drugs "increases the chances of damage caused by the medicine or an error in its administering."

In a legal opinion rendered by Tel Aviv District Court judge Anat Baron, who signed the class-action settlement, the treatment of patients who were unwittingly administered an experimental combination of drugs represents a violation of patients' rights. "One may assume that the members of the group relied on the misleading presentation according to which they were receiving treatment that would help them quit smoking and that they would pay the hospital in exchange for said treatment, which resulted in financial loss as well as an infringement of their rights as patients," the court ruled.

A spokesperson for Beilinson Hospital replied in a statement: "The hospital respects the court ruling, and will implement it."

Ruthie Gorenstein, one of the plaintiffs in the suit, is a 67-year-old mother of three and grandmother of 12. She first became aware of an anti-smoking workshop after hearing about it from a relative, who ended up as a co-plaintiff. "We saw an advertisement in the newspaper about a workshop that looked serious and promising," she said. "I was under the impression that this is a treatment offered by a large, recognized hospital."

One day after being injected with the drugs, Gorenstein fell ill to the point where she needed help exiting her car and reaching her house. The treatment failed to kick her smoking habit. "I felt cheated because the hospital led me astray and squeezed money out of me through faulty claims," she said.