SAN BERNARDINO, Calif. -- On behalf of military contractor Lockheed Martin, Loma Linda University is conducting the first large-scale tests of a toxic drinking water contaminant on human subjects -- a precedent medical researchers and Environmental Working Group condemned as morally unethical and scientifically invalid.
The Los Angeles Times reported Nov. 27 that Loma Linda Medical Center in San Bernardino is paying 100 people $1,000 to eat a dose of perchlorate every day for six months. Perchlorate is a toxic component of rocket fuel that damages thyroid function, preventing healthy development of fetuses and children and causing cancer. It is found in hundreds of water supplies in California, most of them in Los Angeles and surrounding counties. Although Loma Linda researchers defended their study by claiming that perchlorate also has therapeutic value, EWG has learned that its use as a medicine has been discredited since 1966, when Israeli researchers reported that large doses caused deaths and severe illness among already-ill test subjects.
The Times quoted Richard Wiles, research director of Environmental Working Group, who said, "These tests are inherently unethical." (Documents from the Loma Linda study are available here.) "It shouldn't take a rocket scientist to know that medical researchers shouldn't feed toxic chemicals to humans," Wiles added.
The Loma Linda subjects are being fed up to 83 times the "safe" level of perchlorate currently set by the state health department, which is expected to review its perchlorate standards in coming months. Next year, the U.S. EPA will begin national testing of water supplies for percholorate in preparation for adopting national standard
If Lockheed Martin can persuade the state and EPA not to set strict standards for perchlorate in drinking water, the company will save millions of dollars in cleanup costs. The rocket maker is also being sued for unspecified damages by a group of San Bernardino County citizens who suffer thyroid cancer and other disorders from ingesting perchlorate that leached from a now-closed Lockheed Martin plant into area water supplies. According to the Riverside Press-Enterprise, the residents' attorney, Gary Praglin, said of the Loma Linda study: "I think they ought to be ashamed of themselves."
The Times said the Loma Linda study, sponsored by both Lockheed Martin and the U.S. Air Force, is apparently the first large-scale study to use human subjects to test the harmful effects of a water pollutant. The EPA has no protocols or regulations for human testing, and to date only industry-sponsored studies have employed human subjects. In September the agency's science advisory panel said human testing should be used only with "the greatest degree of caution."
But two members of the panel dissented strongly, calling the studies dangerous and insufficient to judge the safety of pollutants, especially for children. In their dissent, EPA panel members Dr. Herb Needleman of the University of Pittsburgh School of Medicine and Dr. J. Routt Reigart of the Medical University of South Carolina wrote that allowing human testing "lays the ground for a flood of research that should not be conducted and should not be accepted by the EPA for regulatory purposes."
In an editorial today, the Los Angeles Times noted that Lockheed Martin claims "It is trying to promote science and human health, but the study is designed in ways that could downplay perchlorate's dangers. . . . Regulators should be wary of dubious research like the Lockheed study."
The director of the Loma Linda study, Dr. Anthony Firek, defended the use of human subjects by saying that perchlorate is also used as a therapeutic drug in rare cases to treat hyperthyroidism. He said if perchlorate were only a toxic pollutant, he would have declined to conduct the human tests.
But use of perchlorate as a hyperthyroidism treatment has been discredited for more than 30 years.
In 1966 Israeli researchers conducted a study in which large doses of perchlorate were fed to a group of 76 patients with hyperthyroidism. The study found 10 serious complications among the group, including two deaths, one of a patient who developed aplastic anemia, where bone marrow fails to produce blood cells, and another who died of agranulocytosis, where there is a marked decrease in a type of white blood cell critical to immune function. In addition to the fatalities, there were two more cases of agranulocytosis and two of leukopenia, a significant decrease of white blood cell count. The authors wrote: "In our opinion the results do not justify the continued use of perchlorate in the therapy of thyrotoxicosis." In a report on the Loma Linda tests in this week's U.S. News & World Report, Dr. Gina Solomon of the Natural Resources Defense Council, member of a recent EPA advisory committee, said: "They are giving people a chemical that flunked as a medicine."
A recent study by the Arizona state health department of infants near Lake Mead, Ariz., which is contaminated with perchlorate, found that many were born with altered thyroid function. The director of the study, Dr. Ron Breckner, told EWG he was surprised that the Loma Linda subjects were not told of the 1966 Israeli study.
In a letter to the president of Loma Linda University, EWG warned that the ethical and scientific cloud over human testing means that "the human subjects in this experiment, including Loma Linda University students in all likelihood, will have accepted risks during the course of an experiment that will yield results that are unusable for any regulatory purposes."
"I am writing to express serious ethical, scientific, and policy concerns about this human study, and to strongly urge the university to terminate it immediately," EWG President Ken Cook wrote in a Nov. 22 letter to Loma Linda President B. Lyn Behrens. Cook said Loma Linda should not "be complicit in a corporate strategy to permit long-term perchlorate contamination of tap water, and associated exposure to many thousands of individuals in proximity to the University, in large parts of Southern California, and in other states."
Cook also urged the Jerry L. Pettis Memorial VA Center, where some of the Loma Linda tests are being conducted, and Boston University, which employs one of the researchers, to terminate their participation in the study.
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