Ethicists Look at Radiation Tests
While standards are stricter today, subjects were not warned of experimental risks
WASHINGTON — ETHICAL standards for medical experimentation on humans are stricter than they were in the 1940s and '50s, when the federal government sponsored highly controversial tests involving radiation that are only now coming to light.
But, say medical ethicists, the standards that applied then should have been enough to keep researchers from conducting some of these experiments.
``There are two problems,'' says Dr. David Orentlicher, a physician and lawyer, and secretary to the American Medical Association's Council on Ethical and Judicial Affairs. ``The people weren't told of the risks. And they were subject to risks they shouldn't have been.''
A spate of news reports on human radiation experiments has spawned national outrage and led Energy Secretary Hazel O'Leary to launch an investigation into the program conducted by the Atomic Energy Commission (AEC), now the Department of Energy. An 800 number set up by the department to handle inquiries has been swamped with calls. New tack at Energy
``We've known about many of these experiments for some time,'' says Dr. David Egilman, a practicing physician and expert on the AEC's human radiation research. ``What's new is that Hazel O'Leary is secretary of Energy, and she's an honest person.''
Dr. Kenneth Mossman, president of the Health Physics Society, says that the new glasnost at the traditionally secretive Energy Department started under Ms. O'Leary's predecessor, Adm. James Watkins, but that O'Leary is the first energy secretary to talk about the human radiation question - and to propose compensation for victims.
The latest example aired involves the Fernald State School in Waltham, Mass. The Boston Globe reported this week that from 1946 to 1956, retarded boys were fed radioactive milk and iron supplements in research on human digestion.
One of the researchers, Constantine Maletskos, formerly of the Massachusetts Institute of Technology, still defends the experiment and maintains that it produced valuable information, the results of which were published. But, before the experiment began, letters to the boys' parents describing the research reportedly did not disclose that radiation would be involved.
Some of the boys, now grown men, are starting to come forward and report that they recall being members of the ``Fernald Science Club,'' as the research subjects were called, and that the experiments caused pain.
Ethicists point out that even though exact federal guidelines on human experimentation weren't established until the early 1970s, the Nuremberg Code had been in existence since 1947. The code, which was meant to prevent future unethical research involving humans like that conducted at Nazi concentration camps, requires the informed consent of humans involved in research and seeks to shield them from injury.
Still, says Dr. Jack Geiger, former president of Physicians for Social Responsibility, ``it's fair to say [the code] wasn't part of the culture of the medical establishment then. Real informed consent wasn't a part of practice. Patients didn't have the kind of safeguards they have today.'' But, he adds, doctors in 1946 had another credo that's been in existence for 1,000 years: ``Do no harm.''
Now, any test involving human beings must be approved by an independent review board, which consists of an ethicist, a member of the public, and a scientific expert. Full informed, voluntary consent of the people involved or their guardians is also required.
Analogies to Nazi medical experimentation were raised early on in the Atomic Energy Commission's radiation research program. A 1950 memo from Dr. Joseph Hamilton, a top radiation biologist with the AEC, to Dr. Shield Warren, a senior official at the AEC, said the experiments might have ``a little of the Buchenwald touch,'' referring to a Nazi camp where experiments on humans were conducted. Dr. Hamilton was expressing concern about a plan to expose soldiers to radiation. Dr. Egilman also notes that thousands of people will now wonder if they were somehow victims of such experiments. Other experiments
In other experiments that have come to light in recent weeks, one involved the injection of 18 patients with plutonium. Another experiment reported by the Albuquerque (N.M.) Tribune involved the injection of newborn boys, all but one of them black, with radioactive iron to study the function of thyroid glands.
``We need to be clear that these people were not Joseph Mengele conducting bizarre experiments on victims of concentration camps,'' says Dr. Geiger. ``But look at who the subjects were: blacks, prisoners, pregnant women, the retarded. Almost always, they were helpless.''
Physicians warn that the public should not become alarmed about all medical uses of radiation, which does play a role in the diagnosis and treatment of some diseases. And they also warn that not all the human radiation experiments that are being hotly debated should be lumped together under a column called bad science.
For example, Geiger says another experiment involving Fernald School boys - one in which they were given radioactive iodine to test for thyroid abnormalities - had a legitimate scientific purpose and was not risky.