The new version of the Helsinki Convention, established recently, tightens the ethical standards that apply to scientists who conduct experiments on humans. The people of the pharmaceutical industry and many researchers claim that the patients will actually lose from this
By Yanai Ofran
At the beginning of the month, the battle over the Helsinki Convention, the convention that defines the ethical standards for conducting medical experiments on humans, was decided in Edinburgh. After half a decade of all-out war, with the participation of scientists, doctors, patients, human rights activists, ethics experts, huge corporations, and of course lawyers and politicians, several amendments to the convention were eventually introduced. The amendments include new restrictions on medical research in humans, to the dismay of the pharmaceutical companies and many doctors and researchers, and the opponents of the changes are already making implicit threats that there will be no escape, and they will be forced to obey the new rules, or at least to round corners.
The story begins in 1964, when the memory of the experiments carried out by Nazi doctors and researchers still echoed in the background. The World Medical Association (WMA) then initiated the convention, which defined what was allowed and what was not allowed in human experiments. Following the convention, special committees to oversee medical research were established in all academic institutions that conduct medical research around the world. These committees, which were predictably called the Helsinki Committees, can prevent or stop any experiment that does not comply with the rules. The scientific journals also rallied to stand up to the breach and prevented the publication of studies that do not comply with the convention. This whip usually ensured compliance with the convention also by the pharmaceutical companies, which are not subject to the university committees but depend on the journals.
At the heart of the convention was the statement that the progress of medicine must be based on human experiments, and therefore clear rules must be established for this research. The ultimate method for testing a new treatment or drug is the use of a placebo - a dummy drug. In such a trial, half of the patients receive the experimental drug, while the other half receive a dummy drug that has no active ingredient. Almost always, the very fact that the patient receives some kind of treatment improves his condition. Even patients who take a flour pill three times a day feel better, and sometimes even recover. That's why the researchers (and the authorities too) are careful before they declare that a new treatment is indeed a cure. Only if there is a statistically significant difference, over time, between the experimental drug and the placebo, can the new drug be approved.
But there are medical ethics experts who find the placebo method uncomfortable. Such experiments, they say, are a good solution when there is no treatment for the problem being tested. But what happens when there is a treatment that helps even a little? In such a case, is it permissible to take patients who had any chance of improving their condition and give them injections of salt water, or starch pills, in order to test a new drug?
This quiet, theoretical debate exploded with a big bang when a major pharmaceutical company asked three years ago to test a new drug against AIDS. The drug was supposed to prevent transmission of the virus from an infected mother to the fetus. After experiments in laboratories and animals came the stage of experimentation on humans. The problem was that just then another, rather expensive drug came into use in the West, which improved the chances of fetuses leaving the womb of their infected mother without the virus. But the researchers at the pharmaceutical company hoped that their drug would be dozens of times more effective and several times cheaper than the new drug. They decided to carry out the experiment in a rural area in an African country. There, they said, most women are not candidates for treatment with the new drug anyway. If not for the experiment, none of them would receive any treatment, while the experiment allows some of them to receive at least the experimental drug.
The experiment drew a burst of angry reactions from political organizations, who claimed that the poor of the Third World were being used as test animals for the people of the North.
The memory of the Tuskegee affair was raised again in these debates as the classic example of the ethical crimes of medical research. Tuskegee, an American syphilis researcher, sought to document the development of syphilis. For this purpose, starting in the thirties, he collected black and poor syphilis patients in the United States and followed their illness without giving them treatment. At the same time, he followed richer patients, who received the best medical care, and made scholarly comparisons between the groups. During the years of experimentation an effective cure for syphilis was found, but Tuskegee did not discover the ear of his black patients. Only an accidental discovery of the affair by a journalist in the XNUMXs, and headlines that embarrassed the Nixon administration, which funded the research, stopped the experiment. Tuskegee also claimed at the time that his unfortunate beggars would not have received any treatment anyway, and he only took advantage of the existence of this population to promote syphilis research and save other patients.
The comparison between the two cases led the researchers and jurists to a careful study of the Helsinki Convention. Many argued that the argument of the pharmaceutical company that asked to test the drug against the AIDS disease is a possible interpretation of the wording of the treaty (this is what the editors of the leading medical journals also thought, who expressed a willingness to publish the results of the research). This discussion touched, as expected, many exposed nerves. The original wording of the convention states that the treatment given to the placebo group must be no less good than the standard treatment. In the remote villages of Africa the "standard treatment" is to ignore. When a Western researcher arrives there, is he obliged to apply the standards used in the University Hospitals of San Francisco?
From her question it became clear that it also concerns a lot of research going on in the western world. Medicine offers some kind of treatment for almost every problem. Sometimes these treatments are not specific or ineffective, but is it permissible to prevent them in order to try a new drug? The supporters of the experiments claim that if they ban the use of placebo even in such cases, the damage to medicine will be irreversible. Without placebo trials, they say, it is difficult to determine with certainty that a particular drug is actually helpful. If it is necessary to do other types of experiments, the time it will take to carry them out, and their cost, will mean that it will be a long time before the medicine reaches the market, and many patients who could have benefited from it may suffer for nothing or die. The trials will then also be more expensive, which will also raise the price of the drugs and again put patients at risk.
The new wording of the convention states that every new treatment must be tested against the best existing treatment for the same problem. The US Food and Drug Administration (FDA), which actually sets the global standards for drug approval, reacted with embarrassment. The yearning for FDA approval for new drugs, and the rigor it practices in granting these approvals, are one of the main reasons why pharmaceutical companies conduct such rigorous trials. The administration demands unequivocal results. Usually this rigidity is seen as protection for the citizen against untested drugs. But the charter's new wording implicitly accuses the administration of enforcing unethical standards. At this point, the FDA says that they are studying the new decisions, but it is clear that they will not easily agree to change the drug approval procedures there.
Other changes introduced in the document lead to less sharp debates, but they also threaten to bring about sweeping changes in the world of research. Thus, for example, one of the new sections states that each research participant must know who is funding the research and if there may be conflicts of interest between his various treatment providers (the hospital, doctors, drug manufacturers) and the research funders. To date, the authors of the studies have preferred to hide this data from the participants. The new document also states that it is mandatory to publish any result of medical research on humans. It is clear that the drug companies (and probably also the researchers at the universities) prefer to avoid publishing results that do not compliment their drugs (or their theories). The editors of the journals also prefer to reserve the space of the newspaper for successful and sensational studies and not for Sisyphean and dreary failures. Changing these conventions requires a structural revolution of the journals and the reporting of studies.
The convention, the commentators are careful to mention, has no legal status. Its absolute acceptance in the entire world of research was rooted in the basic understanding of all participants, which is impossible otherwise. The question now is, if the new treaty will manage to maintain this status in a much less centralized world than the one in which the first treaty was based.
{Appeared in Haaretz newspaper, 26/10/2000}
https://www.hayadan.org.il/BuildaGate4/general2/data_card.php?Cat=~~~302800807~~~140&SiteName=hayadan
