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Peninsula lab gets a clean bill of health
Tick-illness specialists had been under federal scrutiny since 1999
Sabin Russell, Chronicle Medical Writer
Thursday, December 13, 2001
©2001 San Francisco Chronicle

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In an abrupt turnabout, federal inspectors have dropped threats to close a Peninsula medical laboratory that performs controversial tests for Lyme disease and other tick-borne illnesses.

"After three years, it's over," said Igenex President Nick Harris, who had been facing imminent shutdown of his business and a two-year ban on running a similar lab. "We were able to show what we said all along, which is that we are a very good laboratory."

Igenex's clearance is also a relief to San Francisco Medical Examiner Boyd Stephens, who serves as the company's medical director and was threatened with a similar two-year ban. Although a ban would not affect his role as director of the city's forensics lab, it could have caused major headaches from defense attorneys challenging the accuracy of crime lab work.

The decision came after members of Congress, including Anna Eshoo, D-Palo Alto, intervened in response to complaints from patients with a Lyme disease diagnosis who felt that the lab had been unfairly singled out.

"I'd like to think that a clean bill of health is not only good for the company, but good for patients," said Eshoo, who said her office became involved in the case last April. Eshoo said the Centers for Medicare and Medicaid Services, the federal agency that regulates commercial medical labs, was not pressured to clear Igenex Inc. of Palo Alto.

"You cannot let political science overrule the health professions," she said. "We just served as a bridge, to get the agency people to meet with the Igenex people."

Critics of Igenex charge that allegedly unreliable tests are luring patients into costly and dangerous antibiotic treatments for a disease they don't really have.

"Some people are being exploited," said Dr. Eugene Shapiro, a Lyme disease expert at Yale University School of Medicine, who called one Igenex Lyme disease test, phased out in April, "worthless."

Igenex has been battling with federal and state regulators since 1999, after the New York Department of Health complained that its tests for Lyme disease were unreliable. After repeated run-ins with the California Department of Health Services laboratory inspection unit, the company was declared "minimally in compliance" with quality control rules in June.

After Igenex failed a recertification inspection in September, the Centers for Medicare and Medicaid Services ordered Igenex to cease testing as of Dec. 7. But last week that order was set aside to give the Igenex a third chance to comply.

After a review of the company response, and after a surprise inspection on Tuesday, the federal agency relented. Igenex will be recertified for one year, but it still faces an unspecified fine for failing to come into compliance last month.

"They are now instituting good laboratory practices, which they didn't seem to have done before," said Dan Hersh, a health insurance specialist at the federal agency, who works on laboratory regulation cases.

Hersh acknowledged that his office has fielded numerous calls from members of Congress responding to complaints from laboratory supporters.

"We're a federal agency," he said. "We're very conscientious about responding to inquiries from members of Congress."

After word surfaced last week that the company was facing imminent closure, patients who support the company bombarded the federal agency with faxes, e- mails and telephone calls. These patients contend that Igenex is being persecuted for providing evidence that Lyme disease is vastly underreported -- with 90 percent of cases going undiagnosed.

Barbara Barsocchini, a Malibu woman who is vice president of the Lyme Disease Resource Center, said she was relieved that Igenex will remain open.

"This is one of the only labs with tests sensitive and specific enough to diagnose tick-borne illnesses," she said. "If they had closed it, they could sweep Lyme disease under the carpet."

E-mail Sabin Russell at srussell@sfchronicle.com.

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