Washington.--Politicians and the public are recoiling at revelations of government-sponsored nuclear experiments on unwitting victims in the early post-war period. But rogue science conducted with official blessings is not merely a historical relic. It continues today, despite a multitude of safeguards designed to assure compliance with rules of informed consent and the first canon of medicine: Do no harm.
Consider, for example, trials of vaccines for pertussis, or whooping cough, financed last year in Italy and Sweden by the U.S. National Institutes of Health, renowned as the world's leading biomedical-research institution. The trials organized by the NIH would be illegal in this country because the experimental design called for vaccinating thousands of infants, except for a control group that would get a placebo, i.e., no vaccine.
No matter. There are ways around that, though without vaccination, the infants would be vulnerable to whooping cough, a seriously debilitating disease that can lead to a variety of dangerous and sometimes fatal complications. That's why the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend pertussis inoculations. Virtually all states require it along with diphtheria and tetanus vaccinations -- the familiar DPT shots. As a result, whooping cough is a rarity in the U.S. And because an effective preventive is available for the disease, a placebo experiment is ethically out of bounds.
Doubts remain, however, about the side effects of pertussis vaccines and the relative merits of traditional and bio-engineered versions. So, as revealed in documents I recently obtained under the Freedom of Information Act, in 1989 the NIH looked for countries which would permit experiments on their infants that are forbidden on American infants.
Needed for the experiments were fairly high levels of whooping cough -- a condition met by Sweden and Italy, where pertussis vaccination is not mandatory and inoculation levels are relatively low.
The Swedes apparently signed on without a quibble, and last year, according to the NIH, shots were administered to nearly 10,000 Swedish infants -- of whom 2,000 received a placebo in place of pertussis vaccine. The results are now being monitored.
The Italians balked at the idea of administering placebos to infants, but their qualms were overcome by the $11.5 million contract offered by NIH.
Initially rejecting the experimental design, officials at the Rome-based counterpart of the NIH stated that "for ethical as well as practical reasons, a placebo group will not be possible." Noting that pertussis vaccination is recommended by the Italian Ministry of Health, they added, "For this reason, we do not feel a placebo would be ethical, however small the group would be." They expressed doubt that inclusion of a placebo would be approved by their ethics review boards.
The NIH, however, was adamant -- placebo or nothing. The Italian researchers yielded and turned their attention to luring mothers into enrolling their infants in the American-financed experiment. To do this, the documents show, they organized groups of mothers into "four focus groups guided by a group of psychologists." The focus groups revealed that the mothers regarded whooping cough as a "particularly severe illness" and were repelled by the idea that their children might receive a placebo instead of an effective vaccine.
Based on this information, the Italian researchers devised a strategy of public persuasion underpinned by special training for the nurses in the local clinics who routinely meet with mothers of newborns. The NIH was assured that the nurses would be trained in "convincing the mothers to participate" and would "meet with each mother bringing her child to the first compulsory immunization and will be responsible for obtaining informed consent."
In a year-long program that began in September 1992, 15,550 infants throughout Italy were enrolled, of whom about 10 percent received a placebo instead of a pertussis vaccination. In the experimental design, it was estimated that about 5 percent, or about 75 of the unvaccinated infants, would come down with pertussis. The results are to be monitored through 1995.
The pertussis experiment satisfied all the requirements of ethical review in the U.S. and Italy.
It does invite wonder about what else is going on out there in this supposedly enlightened era in which the scientific sins of long ago cannot possibly occur.
Daniel S. Greenberg is a syndicated columnist specializing in the politics of science and health.