Head to Head / Prof. Jacques Michel, is it safe for people to participate in clinical experiments in Israel?
Senior Health Ministry officials are outraged by the State Prosecutor's decision to close criminal files against six doctors suspected of undertaking illegal clinical experiments.
Senior Health Ministry officials are outraged by the State Prosecutor's decision to close criminal files against six doctors suspected of undertaking illegal clinical experiments on patients at Kaplan Hospital in Rehovot and Hartzfeld Geriatric Hospital in Gedera. The cases were closed for lack of evidence and because of a dispute among specialists about medical conduct. The files were sent to the Health Ministry, which will decide whether to take disciplinary action against the doctors. Prof. Jacques Michel, who heads the Helsinki Commission that approves clinical experiments at Jerusalem's Hadassah Medical Center, chaired the Health Ministry committee that investigated the affair.
Prof. Michel, Is it safe for people in Israel today to participate in clinical experiments on humans?
You can't say that doctors in Israel perform unethical experiments. The vast majority of experiments are carried out by honest people, in accordance with the rules, but to my regret, there have been a few exceptions. It's like driving on the roads. Most of the drivers are OK, but when one goes wild, he has to be taken off the roads in order not to endanger the others. This minority is extremely dangerous and can harm medical research in Israel. Things like this affect the image of the entire medical profession. I don't support doctors who carry out experiments against the rules, and if we don't condemn this behavior, we will be cooperating with it passively.
Does Israeli law today protect those participating in experiments on humans?
There's a large gap today between the ethical standards required when carrying out an experiment according to the international Helsinki Convention and those existing in the law. In Israel, the law includes the convention from 1975, but five new versions have been published between then and 2008, and that's a shame. In 2005, the State Comptroller published a report on human experiments which found irregularities in many places - in other words, a relaxation of the rules. You also need to remember that the first to discover the affair at Kaplan and Hartzfeld was not the Health Ministry but the State Comptroller's Office.
Did the Health Ministry act properly in the affair?
The fact that the Health Ministry committee could not publish its findings was part of the problem, although parts of our report did become known and were published, and that was a good thing. If things aren't published, nothing happens. The Health Ministry and the Israel Medical Association have an agreement that that they don't publish findings of oversight and quality committees, even though witnesses were summoned, recordings were made, and protocol was taken - the same as in ministry committees of inquiry that are not confidential. Theoretically, the director general of the ministry can receive a very serious report and just file it away. But in this particular case, the director general at the time, Prof. Avi Yisraeli, chose to address the findings and turned them over to the attorney general who later ordered a police investigation. In my opinion, the Health Ministry should have addressed the issue. There are always good reasons not to discuss these matters because they're uncomfortable - sometimes because the police are investigating and sometimes because the prosecution is, but meanwhile, some of the doctors involved go on working. I have no personal interest in cracking down on these doctors. It's not a personal thing. It's about preventing things like this from happening again.
What do you say to those in the prosecution who decided to close the criminal cases?
In my opinion, if the existing law had adopted the latest version of the Helsinki Convention, the prosecution would have had an easier time submitting indictments to the courts. I believe that offenses of this sort need to be judged by the way they're carried out and by the results - whether the patient died or not. In any event, whether or not the patient was harmed, the offense that was committed has to be treated like an offense. In the Kaplan-Hartzfeld experiments, there were patients who died without it being reported to the Health Ministry and there were patients who were not able to understand, who participated in the study without their guardians granting permission. I'm not a legal expert so it's difficult for me to decide whether these are criminal offenses, but they are offenses when it comes to the Health Ministry's regulations. In my personal opinion, carrying out research on people who are not justiciable, without their agreement, borders on assault. I would have felt more comfortable if the issue had had been discussed in court. It troubled me that the prosecution closed the case, apparently because they feared they wouldn't get a conviction. But this is the trend nowadays - to close cases where they think they can't get a conviction.
What kind of message does this convey to the Israeli public?
The message should have been forceful and categorical - that there is no place in Israel for crimes of this sort and that anyone who commits them has to be punished. To my regret, the message that was conveyed is very problematic. The way experiments are performed today on humans reflects, to a large extent, our society. It is possible that a disciplinary process will begin in the Health Ministry but the findings in that case would only be submitted 10 years after the fact, and then it won't be worth much.
Neither did the Israel Medical Association's ethics committee make any decisions about the doctors involved in the affair. I feel it should have been much more resolute because it has an ethical code that requires doctors to observe international conventions in the field of human experiments - and I doubt whether doctors have internalized this. One of the problems is that the ethics committee doesn't have any teeth today. All it can do is expel members, but nothing more than that. That's very different from the ethics committee of the Israel Bar Association.
In recent years, the Health Ministry has been trying to promote a new law about human experiments. Could this lead to an improvement?
In the sphere of experiments on humans, there are many gray areas and the law itself is problematic because it refers to experiments with drugs and treatments, but in Israel, you can perform experiments on students outside the hospital and then they're not defined as 'clinical' and are not subject to legal supervision. There are universities here where in certain faculties the students are obliged to be subjects in research experiments in order to get credit for a degree. That's a scandal. If a psychologist wants to perform an experiment at Hadassah Hospital, he has to appear before the Helsinki committee, but in the university's psychology department, he doesn't need to get any kind of approval. I believe that the law regulating experiments on humans must be more comprehensive than the one being proposed today, and more progressive. It has to demonstrate that the aim is to move forward and not backward. Obviously there are people who aren't interested in the law because they don't want any limits put on them, but the state has to make some order here.
Do you think the Kaplan-Hartzfeld affair reduce the willingness of Israelis to participate in clinical experiments?
There's no doubt that one of the repercussions will be less willingness to participate in medical experiments. Around the world, there's been a drop in the number of participants in medical experiments because of stories of this kind - it's not only happening in Israel. When I carried out research decades ago, 90 percent of the patients who were asked agreed to participate. Today, in the best case, it's 50 percent and sometimes even less.
Does the health ministry undertake appropriate oversight?
There's not sufficient oversight today. It's true that the Health Ministry does oversee some cases and that there's internal oversight in the hospitals, but it's not sufficient. People need to realize that oversight is not meant to punish people but rather to improve processes and the quality of work. People mustn't be afraid of this.
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