Knight Ridder/Tribune
Jacquie Paul , The Press-Enterprise, Riverside, Calif.
November 30, 2000
Nov. 29--LOMA LINDA, Calif.--Standards for the amount of a rocket-fuel chemical allowed in drinking water will not be set by results of a Loma Linda University Medical Center study, doctors and a university official said Tuesday.
The medical center has been criticized for the study, in which volunteers ingest small doses of perchlorate, a chemical which has been found in the water supplies in Redlands, Loma Linda and Riverside. Perchlorate can interfere with the thyroid gland's production of hormones required for normal growth and development. But a university official said it also is given -- in much larger amounts than are used in the test -- as a medication to treat hyperthyroidism.
The study will result in "too little information" to set such a standard, said Barry Taylor, vice president of research affairs at Loma Linda University. "It just would be an inadequate study."
A spokeswoman for Lockheed Martin, which is funding the study, said the company wants to help regulators set perchlorate levels in drinking water. Although the state has a recommended perchlorate level of 18 parts per billion, no enforceable standard exists.
Spokeswoman Gail Rymer said the study still could be useful in that effort, even if the results cannot be used independently.
Rymer said earlier this week that the study is likely to be used in the company's defense of about 800 lawsuits filed by Redlands residents who claim they had been sickened by chemicals -- including perchlorate -- that leached into their water system from Lockheed's former Mentone plant. The plant closed nearly 30 years ago.
Rymer said Lockheed will rent space in a Loma Linda University building where doctors employed by the company can examine those who have sued. The examinations have been approved by the court, but defense attorneys said they may file motions to narrow the scope of the exams.
According to Rymer, numerous perchlorate studies are under way, including tests on animals.
Human tests also have been done. In a recent study, nine men between the ages of 22 and 30 ingested small amounts of perchlorate. No adverse effects were found, according to the study results published in the journal Thyroid.
Hospital officials said they don't know when the Loma Linda tests will be completed.
Researchers screened 2,000 candidates, but have found only eight who qualified to participate. Doctors would like to have 100 participants, but could produce results with as few as 20, said Dr. Anthony Firek, who is leading the study.
Firek said the screening program was intense. All eight who were chosen are healthy, are employed (or have a spouse who is employed), have health insurance and a primary care provider.
Participants were chosen from those who responded to newspaper advertisements calling for volunteers for a variety of clinical trials. The callers were allowed to choose the study in which they were interested.
Volunteers in the perchlorate study, who are paid $1,000 each, are tested over a seven-month period. The first group began tests in October.
Also participating in the study are Boston University and Jerry L. Pettis Memorial VA Medical Center in Loma Linda, even though no veterans are part of the study, according to officials.
The Loma Linda study has drawn criticism because it tests a potentially harmful substance on people and because it is funded by Lockheed.
Loma Linda officials said Lockheed's funding of the study went before the university's Institutional Review Board, which determines which human studies should be undertaken.
"There was some discussion of these factors as to what Lockheed Martin's goal was," Taylor said.
Dr. William Saukel, review board chairman, said that all of the hundreds of human clinical trials conducted at the hospital are funded by private companies, mostly pharmaceutical corporations. "We recognize there's some motivation that is questionable," he said.
Board members weigh those concerns and many others against a study's benefits, Taylor said. The perchlorate trial was allowed because the chemical also is a medication that has been used for many years to treat hyperthyroidism, he said.
Firek said he is "extremely comfortable with the trial."
"Lockheed provides sponsorship for it. That's basically it," he said.
Firek said he believes the study is important from a medical standpoint because it may let doctors know whether low doses of perchlorate, such as that found in drinking water, will affect people's health.
The only long-term studies that have been done involve high doses of the substance, Firek said. The amount being used in the Loma Linda study is 100 times lower than the amount given to treat hyperthyroidism, Firek said.
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(c) 2000, The Press-Enterprise, Riverside, Calif. Distributed by Knight Ridder/Tribune Business News.
