IMA calls to raise level of clinical research [p. 7]

By JUDY SIEGEL-ITZKOVICH
The Israel Medical Association (IMA) has called for fully-fledged legislation to regulate clinical research and require all medical students and medical researchers to undergo Good Clinical Practice (GCP) courses, run possibly under the aegis of UNESCO. A 31-page report, prepared for the IMA's ethics bureau over a period of six months by a committee of leading physicians and public representatives and approved by the IMA leadership as a whole, was presented at a Tel Aviv press conference on Monday. Ethics bureau chairman Prof. Avinoam Reches, who also chaired the committee, said the doctors' union wanted to lead a program to raise the level of clinical research. The Israeli pharmaceutical industry invests just $300 million a year on medical research; this figure constitutes a mere 0.3 percent of the $100 billion spent around the world on medical research. Currently, although there is a law regulating experimentation on animals, there is no equivalent law governing human medical experimentation; instead, said the committee, there is only a collection of state regulations, and the Supreme Helsinki Committee on Human Experimentation deals mostly with genetic research. The lack of a solid body of laws relating to clinical experimentation is responsible for shortcomings raised in May 2005 by then-state comptroller Eliezer Goldberg in his semi-annual report. He disclosed that thousands of Israelis, from infants to demented elderly, 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. Goldberg severely criticized 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 set down punishments, which has still not reached the Knesset. Then-health minister, Dan Naveh, commented then: "I am shocked. This is a failure of a system that involves the ministry and the hospitals. We need significant reorganization to correct it, and we have started to do so." Asked to comment on the IMA initiative, ministry associate director-general Dr. Boaz Lev said the government-sponsored bill to regulate medical experimentation is now ready to go to the Knesset, and Lev added he hoped it would be voted on in the upcoming session. "It is very advanced, even compared to laws in other Western countries," said Lev, who added that he did not know of the IMA press conference and report. He agreed, he said, that the Supreme Helsinki Committee should be interdisciplinary and cover many more research disciplines. He also welcomed the idea of mandatory GCP courses for medical students and researchers. An improved Supreme Helsinki Committee, the IMA said, would speed up the time between applications and approval of clinical studies.