The State Comptroller's Report features a laundry list of grave oversights and continuous negligence on the part of the Health Ministry and public hospital management regarding their supervisory role in the performance of thousands of experiments and research studies in which hospital patients were subjects. Bodily harm and even death were potential outcomes of some of these experiments.
According to the report, the Health Ministry ignores its legal obligation to maintain control and enforce regulations pertaining to this sensitive issue. The ministry does not strictly supervise the documentation of all experiments and ignores some of the information that it receives from these hospitals, including the reporting of many deaths and unusual incidents that occurred in conjunction with illegally authorized experiments.
The Health Ministry's failures in this arena is one of the gravest and most significant reports published by the comptroller's office regarding health-care. The comptroller calls for far-reaching, significant changes on the part of the Health Ministry in response to the outcome of this investigation. Moreover, the report criticizes the ministry's legal department for failing, over the past eight years, to complete vital legislation pertaining to experimentation on human subjects in accordance with World Health Organization (WHO) guidelines for such experiments.
According to the comptroller's report, thousands of individuals participated in hospital research studies and medical experiments that were not authorized in accordance with the law. In some cases, no consent was obtained from the elderly and children who participated in these experiments. In other cases, illegal, partial consent was granted, based on the incomplete knowledge of all aspects of the experiment on the part of the elderly, mental patients, and children.
Committees to control experimentation with human subjects were established in hospitals in accordance with Health Ministry protocol implementing the Helsinki Accord signed in 1964, in response to human experiments conducted by the Germans in World War II. These committees, the comptroller found, authorized many experiments, conducted by physicians, including genetic experiments and research studies involving drugs not yet certified for use in Western nations. According to the law, these experiments must also be authorized by national Helsinki committees acting in conjunction with the Health Ministry. Moreover, some of the experiments, performed on children and mental patients, were potentially harmful to their health.
The comptroller noted that unusual occurrences or deaths in conjunction with experiments must be reported completely and swiftly (immediately to hospital authorities and within 48 hours to the hospital committee that oversees experiments), because there is a vital need to decide quickly whether the untoward outcome is associated with the experiment, and whether the experiment should be ceased or modified. According to the Health Ministry, a hospital director must establish a committee to investigate every death connected with a medical experiment, and the probe's conclusions must be reported to the ministry within a week.
Late reporting
The comptroller's investigation revealed that most deaths are reported to the committee at a very late date. In 2003, for example, 90 percent of the 37 deaths of patients involved in medical experiments were reported to relevant hospital committees after the required date. In some cases, it took a month to eight months to report a death.
The hospital committee of the Sheba Medical Center at Tel Hashomer was unaware of 25 unusual incidents or deaths that occurred in 88 drug experiments conducted that year, or did not report them to the Health Ministry in accordance with the law. Three deaths and three grave incidents took place which involved patients suffering from congestive heart failure, and two deaths involved patients exposed to experimental chemotherapy. Moreover, the committee authorized the use of an experimental drug for the treatment of breast cancer when physicians failed to report that there were 31 unusual incidents associated with the use of the same drug in other hospitals.
Ichilov Hospital in Tel Aviv reported the establishment of only one committee to investigate the death of one experimental subject, despite the fact that there were 18 deaths associated with 12 medical experiments between the years 2001-2004.
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.
More.... http://www.haaretz.com/hasen/spages/573805.html
According to the report, the Health Ministry ignores its legal obligation to maintain control and enforce regulations pertaining to this sensitive issue. The ministry does not strictly supervise the documentation of all experiments and ignores some of the information that it receives from these hospitals, including the reporting of many deaths and unusual incidents that occurred in conjunction with illegally authorized experiments.
The Health Ministry's failures in this arena is one of the gravest and most significant reports published by the comptroller's office regarding health-care. The comptroller calls for far-reaching, significant changes on the part of the Health Ministry in response to the outcome of this investigation. Moreover, the report criticizes the ministry's legal department for failing, over the past eight years, to complete vital legislation pertaining to experimentation on human subjects in accordance with World Health Organization (WHO) guidelines for such experiments.
According to the comptroller's report, thousands of individuals participated in hospital research studies and medical experiments that were not authorized in accordance with the law. In some cases, no consent was obtained from the elderly and children who participated in these experiments. In other cases, illegal, partial consent was granted, based on the incomplete knowledge of all aspects of the experiment on the part of the elderly, mental patients, and children.
Committees to control experimentation with human subjects were established in hospitals in accordance with Health Ministry protocol implementing the Helsinki Accord signed in 1964, in response to human experiments conducted by the Germans in World War II. These committees, the comptroller found, authorized many experiments, conducted by physicians, including genetic experiments and research studies involving drugs not yet certified for use in Western nations. According to the law, these experiments must also be authorized by national Helsinki committees acting in conjunction with the Health Ministry. Moreover, some of the experiments, performed on children and mental patients, were potentially harmful to their health.
The comptroller noted that unusual occurrences or deaths in conjunction with experiments must be reported completely and swiftly (immediately to hospital authorities and within 48 hours to the hospital committee that oversees experiments), because there is a vital need to decide quickly whether the untoward outcome is associated with the experiment, and whether the experiment should be ceased or modified. According to the Health Ministry, a hospital director must establish a committee to investigate every death connected with a medical experiment, and the probe's conclusions must be reported to the ministry within a week.
Late reporting
The comptroller's investigation revealed that most deaths are reported to the committee at a very late date. In 2003, for example, 90 percent of the 37 deaths of patients involved in medical experiments were reported to relevant hospital committees after the required date. In some cases, it took a month to eight months to report a death.
The hospital committee of the Sheba Medical Center at Tel Hashomer was unaware of 25 unusual incidents or deaths that occurred in 88 drug experiments conducted that year, or did not report them to the Health Ministry in accordance with the law. Three deaths and three grave incidents took place which involved patients suffering from congestive heart failure, and two deaths involved patients exposed to experimental chemotherapy. Moreover, the committee authorized the use of an experimental drug for the treatment of breast cancer when physicians failed to report that there were 31 unusual incidents associated with the use of the same drug in other hospitals.
Ichilov Hospital in Tel Aviv reported the establishment of only one committee to investigate the death of one experimental subject, despite the fact that there were 18 deaths associated with 12 medical experiments between the years 2001-2004.
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.
More.... http://www.haaretz.com/hasen/spages/573805.html