Researchers defend testing water study on humans

The Associated Press
Wednesday November 29, 2000

LOMA LINDA — The risk a study of a toxic water pollutant poses to its human participants is outweighed by its potential benefit to the general public, doctors conducting the research said Tuesday. 

The Loma Linda University Medical Center researchers held a news conference to respond to media reports raising concerns over the ethics of the study, in which people are being given doses of perchlorate, a chemical used in rocket fuels that has contaminated ground water in parts of Southern California. 

The hospital’s institutional review board, which has oversight of clinical trials, concluded that trial participants would face minimal risk. Researchers said the doses of perchlorate being given in the study are about 100 times lower than those given to people who are prescribed perchlorate for thyroid illnesses. 

Dr. Anthony Firek, the study’s principal investigator, said the dosages given in the study are lower than those given in a study published earlier this year by Harvard University. Nine men received 10 milligrams of perchlorate daily in that study. 

But the daily doses in the Loma Linda study are still up to 83 times higher than drinking-water limits for perchlorate recommended by California’s Department of Health Services. That recommendation – 18 parts per billion – is not enforceable. 

The study has been paid for by Lockheed Martin. Hundreds of lawsuits accuse the aerospace company of creating perchlorate pollution and threatening the health of residents in San Bernardino and Riverside counties. Company officials have said the study will help determine the health risk of perchlorate. 

Researchers said the sponsorship poses no conflict of interest because Lockheed Martin had no influence on the study’s protocol, and because the hospital’s review board will make certain the data will not be misused. 

Barry Taylor, Loma Linda’s vice president for research affairs, said university officials discussed the company’s possible motivations. “But on the other hand,” he said, “people on the committee recognized that they could see medical use coming out of this and they decided to proceed with what they saw as a protocol that would help them medically.” 

The idea for the study came from medical researchers, not Lockheed, and the project has been approved by Loma Linda, Boston University and Jerry L. Pettis Memorial Veterans Administration Medical Center, researchers said. 

“I feel extremely comfortable with the trial. Lockheed provides sponsorship and that’s basically it,” Firek said. 

Firek said the study is being conducted to determine how best to diagnose and treat any illnesses that might arise from perchlorate in drinking water. 

Perchlorate has been used as a rocket-fuel oxidizer since the 1940s, and is thought to have contaminated water supplies in parts of Riverside and San Bernardino counties, as well as the San Gabriel Valley east of Los Angeles. 

In large doses, it can slow down the thyroid, which produces the hormone that controls infants’ brain development and growth in older children. 

In adults, the thyroid regulates a host of body activities, including temperature and blood cholesterol. Some people with thyroid illnesses are prescribed perchlorate to help treat their conditions. 

Firek indicated that doctors treating such patients are seeing some problems they think could be related to perchlorate. A clinical trial is the only way to determine whether that is the case, he said. 

The Loma Linda research is giving participants doses ranging from a half-milligram to three milligrams. Half of the participants get placebos. Medical ethicists have questioned the study because unlike many other clinical trials, the findings cannot help the humans taking part, but could harm them. 

Dr. William Saukel, chairman of Loma Linda’s institutional review board, said although there is no benefit to individual participants, the study likely will produce information beneficial to the population as a whole. 

Only eight people have so far enrolled in the study, which began in early October. Researchers hope to eventually enroll 100 people who each will be paid $1,000 for seven months of participation. 

Researchers tried to fend off allegations that participants are largely poor people, saying they are required to have health insurance and a primary care physician, and that all of the participants so far are either working or have a spouse who is working. 

They added that the university did not advertise the perchlorate study or its payoff. People who respond to general ads for Loma Linda clinical trials can choose the perchlorate study from a list of projects. 

Participants are informed of the risks of the research, which include bone marrow suppression, lessening of white and red blood cell counts and thyroid problems. 

Loma Linda is conducting the study in conjunction with the VA hospital, but no veterans are among the participants.