www.sfgate.com        Return to regular view

Agency could shut lab tied to S.F. medical examiner
Lyme disease tests called unreliable
Sabin Russell, Chronicle Medical Writer
Monday, December 10, 2001
©2001 San Francisco Chronicle

URL: -

A Peninsula company with close ties to San Francisco Medical Examiner Boyd Stephens is being threatened with closure by federal regulators in the wake of long-standing complaints about unreliable tests for Lyme disease and other illnesses.

The federal agency that monitors the quality of medical testing labs had ordered Igenex Inc., of Palo Alto, to cease all testing as of last Friday. But that deadline has been lifted to give the company time to appeal. Igenex already had been cited this year for deficiencies in its testing and a lack of training among lab staffers.

The probe against Igenex could pose problems for Stephens, who serves as the company's medical director. Under sanctions proposed by the federal Centers for Medicare and Medicaid Services, he would be barred for two years from serving as director of any commercial laboratory.

As county medical examiner, Stephens is also in charge of San Francisco's forensics laboratory, which performs medical tests in criminal cases -- including blood alcohol tests for suspected drunken drivers.

Federal and state authorities responsible for monitoring the quality of commercial labs have no jurisdiction over crime labs. But sanctions on Stephens' moonlighting career could be used to challenge the results of the lab he runs by day.

"It isn't going to affect my work here as medical examiner," Stephens said yesterday. "But any time an organization is found not to be in compliance, it casts a pall. . . . I'm sure it will come up in court."

Igenex president Nick Harris would also be forbidden to own a clinical lab for the same period. The company could face fines of $3,000 a day, and its permission to bill Medicare and Medicaid for services would be revoked.

Igenex is one of the only private providers of Lyme disease tests. It is caught in a roiling national controversy that pits patients against medical authorities who contend that faulty Lyme disease tests are prompting thousands to seek costly antibiotic treatments for a disease they don't have.

The company has been in hot water for more than two years, since the New York state health department charged that its Lyme disease tests had failed a series of experimental challenges. California regulators also have been watching the company, citing it for inadequate training and quality control.

Harris said the effect of the latest regulatory actions would put him out of business.

"They are still salivating, trying to shut us down by the end of the year," said Harris, who contends his company has been the target of harassment by government and academic researchers who deny the scope of the Lyme disease epidemic.

"If they admit they are wrong, they'd have to admit they've mistreated an awful lot of patients," Harris said. "We give honest, sensitive answers, and we help a lot of people."

Igenex is staunchly supported by patient groups, many of them linked on the Internet, who are convinced that only 10 percent of the nation's Lyme disease cases are recognized and reported. Caused by a tick-borne bacteria, Lyme disease can cause serious arthritis-like symptoms as well as neurological and heart disorders.

Harris maintains that Igenex has never failed a proficiency test -- a controlled experiment in which the company runs its screens on samples known by monitors to be either positive or negative.

But documents obtained by The Chronicle show that, in the view of New York state health regulators, Igenex performed terribly on proficiency tests for both Lyme disease and babesiosis, a rare, malaria-like illness carried by the same ticks.

In April 2000, the New York Department of Health wrote Stephens that Igenex had failed a "proficiency challenge" involving 20 samples. The test failed to find two samples that had been "spiked" with Borrelia burgdorferi, the bacteria that cause Lyme disease. The tests incorrectly reported as positive four of 14 negative samples.

Similarly, the New York department had Igenex perform tests for Babesia microti, the bacteria that cause babesiosis. One type of test had a false positive rate of 80 percent, another of 50 percent. A third test using microscopic analysis had a 90 percent overall error rate.

"Igenex's results were clearly unsatisfactory and failed to meet even minimal standards for diagnostic testing," wrote Richard Jenny, acting director of the state's clinical laboratory evalution program.

In the ensuing period, Igenex was engaged in an ongoing battle with inspectors from California's Laboratory Field Services Unit, which monitors the safety and effectiveness of medical testing labs -- and works as an agent for federal regulators.

In April, federal regulators formally threatened to impose sanctions on Igenex for repeatedly failing to measure up after inspections found deficiencies -- many involving paperwork errors or lack of training among lab staffers. Payments from the Medicare program were suspended.

But in June, the Centers for Medicare and Medicaid Services dropped its case and reinstated Medicare payments, declaring that the lab was then "in minimal compliance" with federal rules. However, Igenex officials were also warned, "Your laboratory will not again be afforded such an excessively protracted time period to make corrections," should further inspections yield problems.

In September, another federal inspection uncovered new deficiencies, this time in quality control documentation. Just before Thanksgiving, the agency issued its order that all testing stop on Dec. 7 -- an order now on hold while the company attempts again to comply.

Word of the possible closure of Igenex is circulating in the Internet community of patients who support the company and believe their illnesses are being underdiagnosed across the country.

"We have concerns that this is the beginning of a witch hunt," said Pat Smith, a mother of two daughters who have been treated for Lyme disease for more than 13 years. She is president of the Lyme Disease Association, based in Jackson Township, N.J.

Smith feels that Igenex had finally been cleared of a raft of technical violations -- and then was slammed again. "It looks like double jeopardy to me, " she said.

San Francisco Medical Examiner Stephens, who has been medical director at Igenex and its predecessors for 20 years, also stood up for the company.

"This is a good laboratory. I have a great deal of faith in it," he said.

Stephens said the quality control issues leveled against the lab only came up with the controversy over Lyme disease diagnosis. He said the failed tests involving New York's health department were unfair because they were presented as research samples and thus were treated differently from a typical proficiency test.

"So much of this, I'm afraid to say, is largely political, rather than science," Stephens said.

Janice Caldwell, associate regional administrator for the Centers for Medicare and Medicaid Services, defends the federal action. The federal inspection, she said, found "too many of the same things" that state inspectors had previously found wrong with the laboratory.

"People advocating on their behalf do not know there is a long history of noncompliance. We are finally drawing a line in the sand," she said.

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

©2001 San Francisco Chronicle   Page A - 1