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Israeli health ministry lambasted for negligence over medical experiments

BMJ 2005; 330 doi: (Published 19 May 2005) Cite this as: BMJ 2005;330:1170
  1. Judy Siegel-Itzkovich
  1. Jerusalem

    Thousands of Israelis, from infants to demented old people, have in recent years been included in illegal medical experiments, some without informed consent being given by the patient or his or her parent or guardian, as required by the 1964 Declaration of Helsinki.

    This was disclosed by Eliezer Goldberg, Israel's state comptroller, in his semi-annual report monitoring the functions of public bodies. The comptroller severely criticised the health ministry for negligence and carelessness in supervising hospitals' clinical trials, some of which involved potentially harmful invasive tests and treatments.

    He also lambasted the ministry for spending eight years preparing a government bill to regulate experimentation and setting down punishments, which, even now, has not reached the Knesset [parliament].

    On the eve of publication of the comptroller's report, before the official embargo had expired, the country's largest Hebrew tabloid newspaper published information on the government bill leaked by an anonymous ministry official, apparently intending to neutralise criticism of the ministry.

    The report faulted 11 out of 39 geriatric, rehabilitation, psychiatric, and general hospitals, owned by the ministry or the country's largest health insurer, to whom the comptroller's investigators had sent letters demanding documentation of informed consent. Many of the violations cited by the comptroller were against incapacitated patients, some as old as 101. At one geriatric hospital, seven patients “signed” with only an inked fingerprint, even though medical records showed that they had serious cognitive deficits, raising the possibility that their fingerprints were taken unwillingly.

    At two general hospitals, an unapproved drug was tried on infants and toddlers; the experiment required piercing their eardrums, which posed a small risk of hearing loss. Nevertheless, the hospitals' Helsinki committees approved the trials without referring them to the ministry's higher authority for approval.

    In a health fund hospital, researchers took urine samples via suprapubic aspiration after receiving permission only from the hospital's Helsinki committee and not the ministry's supreme Helsinki committee, as required for invasive and potentially dangerous procedures.

    Coded genetic tests identifying the sources of blood were done on samples from dozens of children without parents' or guardians' consent. At the largest state owned hospital, a multicentre clinical trial of a treatment for uterine tumours was done, and patients were not told, as they should have been, that participating centres abroad had found the treatment ineffective.

    Dan Naveh, health minister, said, “I am shocked. This is a failure of a system that involves the ministry and the hospitals. We need significant reorganisation to correct it, and we have started to do so.”

    Jacques Michel, retired director of Hadassah University Hospital on Jerusalem's Mount Scopus and currently head of the Hadassah Medical Organisation's Helsinki committee, urged the transfer of responsibility for supervision from the ministry to a team of experienced retired doctors and researchers working as volunteers.

    Professor Michel, whose Hadassah institutions observed the rules, blamed intense demands on researchers to advance careers and pressure by pharmaceutical companies reluctant for patients to understand all the risks. He demanded that doctors violating the Helsinki guidelines be punished.

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