2.5. Violations of the Nuremberg Code

The physicians who designed the 1953/54 oxygen-restricting Cooperative Study of Retrolental Fibroplasia did not only disregard the methods of science, they also knowingly violated their most fundamental ethical and legal obligations towards their patients. They openly expressed their and their colleagues' judgment that the lives of people at risk for blindness are expendable. The purposes of their study were:

"(1) to determine whether the incidence of RLF is positively associated with the duration of exposure of the premature infant to an oxygen-enriched environment,
(2) to evaluate the effect on mortality of lessening the amount of oxygen given the premature infant after the age of 48 hours, and
(3) to obtain information of a general nature concerning the premature infant and his parents that might be of use both in interpreting the data obtained and in formulating any future investigations."⁵⁴

They ignored thus several of the mandates in the Nuremberg Code of medical ethics⁵⁵ which American physicians and judges had established just a few years earlier to outlaw unethical medical experiments on unconsenting subjects. Articles 5 and 7 of this Code state:

"5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;" and

"7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death."

Each one of these Articles alone should have ruled out any tinkering with the life-saving oxygen.

The concept of withholding life-saving oxygen to observe how many of the oxygen-deprived babies will die is not different in principle from the concept of the infamous Tuskegee syphilis study in which American physicians withheld life-saving treatment from patients for decades, until 1972, to observe the natural course of the disease⁵⁶, or even from the concept of the horrible high-altitude experiments in which Nazi physicians deprived people of oxygen to observe how fast they died⁵⁷.

All the rules of ethics, medical or other, insist that needlessly exposing other people to possible harm is wrong, whether in the interest of science or any other, and whether the victims are put in harm's way by coercion, as in the concentration camps, or by deceit, as in the syphilis and oxygen studies.

The deceit in the oxygen study was blatant. Nuremberg Article 1 says the voluntary consent of the test subject is absolutely essential, and that this consent must be based on full disclosure of all the hazards reasonably to be expected. Similarly, the United States' laws about informed consent say that physicians have a duty to fully disclose all the facts which will allow a patient to balance the probable risks against the probable benefits⁵⁸.

Yet, according to Dr. Silverman's chronicle of the oxygen trial's aftermath, those neonatologists who kept up with their field must have been aware of the mass dying their therapy caused. He recounts that already in 1957, the year after the final report about the Cooperative Study had been published, a Dr. Harry Gordon pointed out in a letter to Pediatrics that the 48-hour delay may have produced a misleading conclusion about oxygen withholding not affecting mortality⁵⁹.

Neither this irrefutable comment, nor the shocking autopsy review from Baltimore, nor even the abnormally high day-of-birth mortality rates themselves brought about an immediate reversal of the harmful oxygen withholding policies, and the withholding physicians did not tell the trusting public about the deadly side effect from their cure for the preemie blinding epidemic.

They also cannot have informed the parents about the study's purpose of risking death to prevent blindness, or about the brain damage they knew to expect from oxygen deprivation but omitted to mention even to themselves among the highly probable side-effects to be evaluated.

Most parents would no doubt have refused to enroll their baby if they had been told honestly that s/he would risk dying from easily avoided breathing problems, or else growing up retarded and/or crippled, in the hope that he or she or some other preemie might perhaps not lose their sight.

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