Government scientists gave leukemia patients experimental high-dose radiation therapy in a "dismal...substandard" project at Oak Ridge, Tenn., and kept it going so that the U.S. space program could learn how much radiation makes a person sick, according to a magazine article published today.
The patients were not told of theNational Aeronautics and Space Administration's interest, which concerned protecting astronauts so that they would not become nauseated from radiation in space while wearing oxygen masks, Howard L. Rosenberg charges in Mother Jones magazine.
For many of the 194 patients, some treatment other than radiation would have been advisable, Rosenberg alleges. The old Atomic Energy Commission closed the Institute of Nuclear Studies project down in 1974 after an inspector called it "substandard" and said it suffered from poor planning and had produced "dismal" results.
Dr. Clarence Lushbaugh, who monitored the radiation patients for NASA, responded in an interview that the decade of experiments was conducted only for therapeutic purposes and only when medically appropriate, and that NASA funding was not essential to the program. The AEC criticism was uninformed, he said: "The man who wrote that was no particular friend of ours."
The House science investigations subcommittee announced yesterday that it will hold hearings in September on the allegations.
The article says all the cancer patients who passed through the laboratory between 1964 and 1974 were referred by outside doctors and were considered terminal cases. Some of the patients received up to 500 rads of radiation over varying periods of time. For comparison, a sudden dose of 450 rads causes quick death in half the people exposed.
Documents Rosenberg obtained under the Freedom of Information Act show that when the project began in 1957, seven years before NASA's participation, scientists at the Institute of Nuclear Studies did not expect high radiation to help the patients much and made no plans to investigate the technique thoroughly. They said in a report to the AEC, which provided their main funding of about $1.8 million a year, that they hoped instead that the patients' responses to the radiation would "provide a yardstick for comparisons" with future experiments.
"It was not our plan to evaluate the long-range effectiveness of these relatively large individual doses," wrote Dr. G. A. Andrews, who headed the team that included Lushbaugh. "One should not infer from this study that we expected these individual or infrequently given exposures to produce better clinical results" than partial-body doses.
"At present we feel that some pattern of fractionated exposure . . . probably offers a preferable approach."
Rosenberg argues that this meant the scientists knew that patients might have benefited more from some other treatment, and that they administered high-dose radiation anyway. His article cites the case of T. Dwayne Sexton, a 3-year-old Oak Ridge boy sent to the Institute clinic in 1965 for treatment of leukemia, as an example of the clinic's haste to use experimental methods.
The boy was first given a bone marrow irradiation and implantation treatment which was highly experimental at the time. Only when that didn't work was he given chemotherapy, then the conventional approach, Rosenberg said. Later, in 1968, he received 353 rads of radiation at the lab in 3 hours and 38 minutes, a very high dose. He died one month later of an infection.
NASA had become involved with the clinic in 1964, contracting with Lushbaugh to monitor the patients and to survey radiation exposure victims nationwide. Between 1964 and 1974, NASA paid the institute $2.3 million, including $65,000 for a special kind of long-range monitoring device called an "umbilical cord," according to Dr. Stuart Nachtway, now chief of NASA's biomedical applications branch. An Institute spokesman said the clinic's AEC funding from 1957 when it opened to 1974 was $25.4 million.
Lushbaugh said the umbilical cord was useful because "this was a sea of radiation so nurses and supporting staff couldn't go in there. But you had to have the patient under surveillance because these people were sick and you have to take care of them."
Rosenberg said in an interview that the "umbilical cord" was used to monitor Dwayne Sexton's reaction to his 1968 radiation treatment for only two or three days, and then was removed even though the child became progressively sicker.
He contends that this, the financial information, and the minimal expectations for cures suggest that the clinic's radiation program was kept going solely to provide NASA with radiation reaction data.
The AEC inspector found in March, 1974, that the clinic was "essentially isolated from the critical climate of academic clinical investigation" and suffered from having few patients to deal with. In Edwards' unit, "there has been little thought as to therapeutic utility or potential long-range side effects" of the high-dose program, he wrote. "The performance of this division has been dismal."
Criticizing the facilities, he reported that 50 plastic cages of mice suspended under the low-dose radiation area had to be carried through the patient area for cleaning, thus exposing the patients to animal wastes and possible infection when their biological defense mechanisms were crippled from radiation treatment. Lushbaugh said the mice were not under but beside the radiation area and the wastes were "plasticized," carried in a tied plastic bag.
Lushbaugh said the clinic never tried to do long-range studies because it did not have the facilities for them. He said that Andrews, who died last year, was only trying to be modest when he said high-dose radiation was not expected to work very well. "He does say he never planned to see if it worked, but that's not what he meant," Lushbaugh said.