Dozens still complain of persistent side-effects; Ministry won't oppose gov't inquiry.
By JUDY SIEGEL-ITZKOVICH
The Defense Ministry said Thursday that it will examine the Israel Medical Association's harsh report on Omer 2, the IDF's seven-year clinical trials of an Israeli-developed anthrax vaccine on 716 healthy soldiers.
The report, which the High Court of Justice approved for release late Wednesday, calls for civilian supervision of clinical experimentation and sharply criticized the defense authorities, especially the IDF, for the fact that more than 4,000 soldiers were asked, under psychological pressure, to participate without giving their informed consent.
The ministry added that every effort was made to conduct the clinical trials of the vaccine in "a transparent manner," even though there was none of the civilian medical supervision required by the Helsinki Convention on Human Medical Experimentation. The ministry added that "it would not oppose calls" by soldiers to set up a governmental committee of inquiry to further investigate the issue.
Dozens of ex-soldiers who were vaccinated as far back as 1999 complained of skin, eye, gastrointestinal and other side effects that persist today, but none of them was examined by the IMA committee members, so it's impossible to know if their symptoms resulted from the vaccination.
Although all but one of the committee members, including panel head Prof. Reuven Porat of the Rabin Medical Center, were physicians, the committee was not asked to conduct a medical follow-up of the soldiers who claimed to have been harmed.
The six-member committee was established by Prof. Avinoam Reches, a senior neurologist at Hadassah University Medical Center in Jerusalem's Ein Kerem who is also head of the IMA's Ethics Bureau. He took the initiative a few days after the clinical trials received public attention on Channel 2's Uvda investigative program.
Reches went to Dr. Chezy Levy, then the IDF's chief medical officer, and now deputy director-general in charge of medical services at the Health Ministry.
Levy quickly assented to Reches's request that the IDF allow and cooperate with an IMA investigatory committee.
"The IDF and Levy deserve credit for this, because they didn't have to agree to investigation by a civilian body," said the neurologist, who was not on the committee.
The clinical trials "did not meet the standards of medical experimentation," Reches continued. "The IDF Helsinki Committee had eight members, but all were military people. There could easily have been a conflict of interest," Reches told The Jerusalem Post.
The 90-page report, he noted, describes the committee's interviews with dozens of soldiers who participated in the experiment.
"There were three types of side effects - mild reactions at the site of injection on the skin, some system problems such as headaches and symptoms of fibromyalgia, [a disorder classified by the presence of chronic widespread pain and a heightened and painful response to gentle touch], and a few cases involving the triggering of overactivity of the immune system. But it is impossible to know without studying the cases whether the side effects resulted from the vaccination, were due to conditions that naturally occur among 700 people, or involved psychosomatic reactions," he said.
The pressures on the military to find an defense against biological attacks, including the use of anthrax spores to harm populations, which had caused much concern in the US as well, were huge, said Reches, but the IDF clinical trial group was not representative of the whole Israeli population, as it did not include the elderly, the sick, children and pregnant women.
Prof. Ilan Chet, a former president of the Weizmann Institute of Science and an award-winning microbiologist who pioneered in the development of environmentally friendly microorganisms for biological control of plant diseases, was the only non-physician on the committee.
"The government must take responsibility for the health of the soldiers who participated," Chet said. "These were excellent soldiers with a lot of motivation. Today's soldiers will worry whether if something happens to them, the state will take care of them. Even when the IDF conducts a trial, it must be properly supervised by civilian experts, and volunteers must know the possible side effects and risks. We on the committee were looking for the truth. It was not a benign report. I think that if everything is done properly, soldiers will want to participate in important clinical trials."
Dr. Elinor Goshen, a member of the IMA's Ethics Bureau and an expert in nuclear medicine at Sheba Medical Center, said she didn't know whether the vaccine, which was supposed to have been prepared in large amounts to cover the entire civilian and military population in case of an emergency, was proven successful.
"I don't think they even summarized the results. There are antibiotics treatments for anthrax after exposure; a vaccine could be more effective by preventing infection. Our committee did not examine soldiers but was assigned to check the ethical aspects."
Goshen said she did not oppose performing medical experimentation on soldiers. Attempts to have the anthrax vaccine tried on university students and other civilians did not get off the ground.
"Soldiers exposed to extreme stress can be a model for other stressed groups. The committee meant to say that if you do it, you should do it right," she said. The next step would be to examine soldiers, she added.
"None of the participants has demanded financial compensation. The IDF has to rebuild the confidence of its soldiers, who need to have an address over the long term." Then the Knesset could consider a law to deal with medical experimentation in the IDF, she concluded.
Meanwhile, Physicians for Human Rights-Israel, which took up the soldiers' cause after the Uvda broadcast, called the committee report's publication "an ethical earthquake" that requires an immediate halt to medical experimentation on soldiers and others.
"The cynical use of the soldier population, exploiting their subservience to the military system and their high patriotic motivation, points to the fallacy of leaving decisions about medical experiments on human beings in the hands of the defense establishment, which is inclined toward exaggerated and exploitative use of security measuresâ€š while crushing pillars of ethics, morals and medicine," PHR-Israel said.
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