Fed agency to oversee human perchlorate study

Tuesday, Dec. 5, 2000 | 11:17 a.m.

A federal agency responsible for overseeing human safety during research experiments will supervise a controversial Loma Linda University Medical Center study of perchlorate consumption.

Perchlorate is used to improve rocket fuel, dynamite, fertilizers and fireworks. It is produced at an industrial complex in Henderson and has been found in Lake Mead and the Colorado River, which provide drinking water to more than 20 million people.

In special cases it also is used in large doses as a therapy for overactive thyroid glands.

The Office for Human Research Protections, part of the Health and Human Services Department, said Monday it is oversee a current study of 100 people in San Bernardino County, Calif.

Half of the volunteers are taking pills containing perchlorate at levels 83 times higher than traces discovered in drinking water. The other half is taking a placebo.

In general, research on human subjects is considered risky and marginally ethical.

The agency's oversight won't stop the research, but imposes strict guidelines on how it can be conducted. If researchers fail to follow the guidelines, federal officials can shut down the project. Subjects will be monitored after the research ends to ensure no lasting effects.

The six-month Loma Linda study, started in August, is sponsored by Lockheed Martin, a major defense contractor that is being sued by Redland, Calif., residents for exposing them to perchlorate and trichloroethylene via their drinking water. Perchlorate has been found in ground and surface waters in 15 states.

Researchers, in a press conference last week, defended the human trial, saying perchlorate doses, given to participants who are paid $1,000 each, are lower than doses to correct thyroid function.

Loma Linda spokeswoman Anita Rockwell-Hayden said Monday the center was not aware of the federal oversight and refused to comment.

Research in the past three years indicates that perchlorate may affect the thyroid's ability to regulate the human body. Scientists are concerned that such subtle effects may alter brain development in growing children.

Bruce Macler, an toxicologist for the Environmental Protection Agency, said that the study may help scientists looking for effects of the chemical in humans. Current research suggests that at low levels of perchlorate does not disrupt normal human development, he said.

"On the other hand, it is usually considered unethical to experiment on humans," Macler said.

Meanwhile, the EPA is waiting for results from two of eight studies on perchlorate launched by Defense Department contractors and government agencies three years ago. Project Director Kevin Mayer said a March review has been delayed because researchers need more time.

"We first want to know whether a certain amount of perchlorate is a threat to human health," Mayer said. Preliminary results in two studies last year raised concerns about perchlorate's effect on brain development, he said.

Both EPA officials said that the bottom line is to stop perchlorate from entering the Las Vegas Wash leading to the Colorado River.

California and Nevada require water officials to report perchlorate levels above 18 parts per billion.

Last week the Southern Nevada Water Authority said tap water from Lake Mead reached 24 parts per billion for the first time. When first detected in Las Vegas drinking water three years ago, the perchlorate was 11 parts per billion.