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Good To Know: Rehovot is The Place Of Illegal Experimentation On Patients
"...The Kaplan Medical Center in Rehovot, owned by the Kupat Holim HMO and including the Hartzfeld Geriatric Rehabilitation Hospital in Gedera, was cited with the most serious incidents of illegal experimentation on dozens of elderly patients. The comptroller called these cases "extremely grave," and the Health Ministry has set up a committee to investigate this affair, as published in Haaretz.
The Kaplan and Hartzfeld Hospitals were involved in several questionable incidents, said the comptroller, led by the April, 2003 authorization of an experiment, including subjects at Kaplan, age 80 and above, to examine the effectiveness of an invasive procedure involving the introduction of a needle into the bladder. The committee granted its permission although the Health Ministry's authorization was also required, and despite a refusal on the part of a director of two departments at Hartzfeld to conduct the experiment on the patients in her units. The department director refused because of the risks of bleeding and infection resulting from introduction of the needle.
The comptroller found that 40 percent of the individuals who signed a consent form to participate in this experiment - five of them with a fingerprint - suffered from cognitive difficulties impairing their ability to provide informed consent. The comptroller noted that Kaplan officials responded to their investigation by insisting that a geriatric physician examined the participants and determined that they were capable of providing informed consent. However, the comptroller found no evidence that this medical examination took place.
The comptroller also found that two women died after participating in this experiment, and that they had suffered from severe infections of the urinary tract. However, the leading investigator at Kaplan did not report either death to the hospital committee or to the Health Ministry, and a legally required investigation committee was not established.
In another experiment conducted at Kaplan and Hartzfeld, 90 elderly patients were given a low dose of iron. Documentation of that experiment disappeared, and a female participant in that experiment also died without the provision of a timely report to the Health Ministry and without the establishment of an investigative committee at the hospital.
According to the comptroller, several patients died in another experiment at Hartzfeld but the physician who led the investigation did not readily report his conclusions to the investigative committee or the Health Ministry. He provided a report only after the ministry demanded that he do so, in response to a request by the commercial company that initiated the experiment.
The comptroller discovered that Helsinki committees in public hospitals engage in almost no regular supervision of experiments that they authorize, despite their legal obligations, and they do not always establish committees to investigate the deaths of experimental subjects. Moreover, the comptroller found that most patients who participate in medical experiments are promised full insurance coverage, outlined and signed in their consent form, but that these claims are misleading because the nation only insures the physician who conducts these experiments. The comptroller also found serious problems with the way that the information in the consent form is provided to patients who must indicate that they have full knowledge and are willing to participate in a medical experiment.
At Wolfson Hospital in Holon, 90 children were the subjects of an experiment in which remaining blood samples from tests were used, and experiments were performed on the placentas of 50 new mothers without the consent required by the Health Ministry.
The Health Ministry demands the consent of subjects in any experiment that includes the publication of medical records identifying them by name. The comptroller's report found that an experiment was conducted at Hillel Yaffe Medical Center in Hadera, and two other hospitals, where 8,800 subjects did not provide signed consent, and hospital administration and the Health Ministry did not authorize the experiment. The comptroller also found that, according to a Health Ministry committee, founded in response to an article by Akiva Eldar in Haaretz, Beilinson Hospital authorized an experiment in 1995 to prevent smoking in 20 patients, but the experiment was expanded to include 4,000 additional subjects without authorization. These subjects did not sign a consent form as required. Moreover, some of the subjects suffered from light to severe physical side effects that were not reported to a physician but to a psychologist.
The comptroller found that many subjects participated in experiments when they were not fit to be subjects, and without knowledge of vital information in the consent form or without the consent of those who were legally responsible for them. Such was the case in the Be'er Yaakov government psychiatric hospital, the Hartzfeld Geriatric Rehabilitation Hospital in Gedera, the Shalvata Psychiatric Hospital in Hod Hasharon, and the Geha Psychiatric Hospital in Petah Tikva..."
Source: Ran Reznick. Patients were guinea pigs and didn't know it. Haaretz.com (9 May 2005) [FullText]
The Kaplan and Hartzfeld Hospitals were involved in several questionable incidents, said the comptroller, led by the April, 2003 authorization of an experiment, including subjects at Kaplan, age 80 and above, to examine the effectiveness of an invasive procedure involving the introduction of a needle into the bladder. The committee granted its permission although the Health Ministry's authorization was also required, and despite a refusal on the part of a director of two departments at Hartzfeld to conduct the experiment on the patients in her units. The department director refused because of the risks of bleeding and infection resulting from introduction of the needle.
The comptroller found that 40 percent of the individuals who signed a consent form to participate in this experiment - five of them with a fingerprint - suffered from cognitive difficulties impairing their ability to provide informed consent. The comptroller noted that Kaplan officials responded to their investigation by insisting that a geriatric physician examined the participants and determined that they were capable of providing informed consent. However, the comptroller found no evidence that this medical examination took place.
The comptroller also found that two women died after participating in this experiment, and that they had suffered from severe infections of the urinary tract. However, the leading investigator at Kaplan did not report either death to the hospital committee or to the Health Ministry, and a legally required investigation committee was not established.
In another experiment conducted at Kaplan and Hartzfeld, 90 elderly patients were given a low dose of iron. Documentation of that experiment disappeared, and a female participant in that experiment also died without the provision of a timely report to the Health Ministry and without the establishment of an investigative committee at the hospital.
According to the comptroller, several patients died in another experiment at Hartzfeld but the physician who led the investigation did not readily report his conclusions to the investigative committee or the Health Ministry. He provided a report only after the ministry demanded that he do so, in response to a request by the commercial company that initiated the experiment.
The comptroller discovered that Helsinki committees in public hospitals engage in almost no regular supervision of experiments that they authorize, despite their legal obligations, and they do not always establish committees to investigate the deaths of experimental subjects. Moreover, the comptroller found that most patients who participate in medical experiments are promised full insurance coverage, outlined and signed in their consent form, but that these claims are misleading because the nation only insures the physician who conducts these experiments. The comptroller also found serious problems with the way that the information in the consent form is provided to patients who must indicate that they have full knowledge and are willing to participate in a medical experiment.
At Wolfson Hospital in Holon, 90 children were the subjects of an experiment in which remaining blood samples from tests were used, and experiments were performed on the placentas of 50 new mothers without the consent required by the Health Ministry.
The Health Ministry demands the consent of subjects in any experiment that includes the publication of medical records identifying them by name. The comptroller's report found that an experiment was conducted at Hillel Yaffe Medical Center in Hadera, and two other hospitals, where 8,800 subjects did not provide signed consent, and hospital administration and the Health Ministry did not authorize the experiment. The comptroller also found that, according to a Health Ministry committee, founded in response to an article by Akiva Eldar in Haaretz, Beilinson Hospital authorized an experiment in 1995 to prevent smoking in 20 patients, but the experiment was expanded to include 4,000 additional subjects without authorization. These subjects did not sign a consent form as required. Moreover, some of the subjects suffered from light to severe physical side effects that were not reported to a physician but to a psychologist.
The comptroller found that many subjects participated in experiments when they were not fit to be subjects, and without knowledge of vital information in the consent form or without the consent of those who were legally responsible for them. Such was the case in the Be'er Yaakov government psychiatric hospital, the Hartzfeld Geriatric Rehabilitation Hospital in Gedera, the Shalvata Psychiatric Hospital in Hod Hasharon, and the Geha Psychiatric Hospital in Petah Tikva..."
Source: Ran Reznick. Patients were guinea pigs and didn't know it. Haaretz.com (9 May 2005) [FullText]
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