Unproved Lyme Disease Tests Prompt Warnings (Igenex)

Unproved Lyme Disease Tests Prompt Warnings

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By DAN HURLEY and MARC SANTORA
Published: August 23, 2005
Steve Courcier just wanted to know: did he have Lyme disease or didn't
he?


Doctors who tested Mr. Courcier in March at the Mayo Clinic in
Scottsdale, Ariz., ruled out Lyme, a tick-borne illness, as an
explanation for the disabling pain and exhaustion he was suffering.
Then a Texas doctor sent his blood sample to a California laboratory
that indicated he did have Lyme disease. But a New York specialist who
tested his blood a third time, in June, said emphatically that he did
not.


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Allison V. Smith for The New York Times
After several rounds of testing, Steve Courcier, a 38-year-old
executive from Dallas, was told both that he had Lyme disease and that
he didn't. A regimen of antibiotics, he said, was only making him feel
worse.
"It's amazing to me that you could have this much disparity in medical
test results and not have the government do something," said Mr.
Courcier, 38-year-old executive with a consulting firm who lives with
his wife and two young children in a Dallas suburb.


Now the New York State Department of Health has opened an investigation

of the California laboratory, IGeneX Inc., that issued Mr. Courcier's
positive result, after receiving eight complaints from doctors and
patients who said its Lyme tests also gave them positive results not
confirmed by other labs' results.


Concern about Lyme testing goes beyond New York State. This year the
Food and Drug Administration and the Centers for Disease Control and
Prevention released a warning about Lyme tests "whose accuracy and
clinical usefulness have not been adequately established."


The warning did not mention IGeneX or any other lab by name. But Dr.
Paul Mead, a C.D.C. scientist who helped write it, said in a telephone
interview, "Quite simply, we're concerned that patients are being
misdiagnosed through the use of inaccurate laboratory tests." He added
that some of the tests and techniques used by IGeneX were among those
the agencies were concerned about.


Nick Harris, the founder and chief executive of IGeneX, defended his
company's testing, saying that the federal guidelines miss many
patients who have Lyme disease.


Guidelines from the disease control agency recommend Lyme testing only
when patients have symptoms and live in an area of the United States
where ticks are known to be infected with Borrelia burgdorferi, the
organism that causes the disease. Under the guidelines, laboratories
should first conduct a test called Elisa. But the Elisa test often
gives a false positive result, so the agency also calls for a second,
more sensitive test, the Western blot.


The recent warning by the two federal agencies named some tests they
said had not proved useful or accurate. They noted, for instance, that
some laboratories performed a test called polymerase chain reaction "on

inappropriate specimens such as blood and urine." IGeneX offers such
tests on both blood and urine. The alert also warned against methods of

interpreting Western blots "that have not been validated and published
in peer-reviewed scientific literature."


Nationally, reported cases of Lyme disease have more than doubled in a
decade, to at least 23,963 in 2003 (the most recent year for which
statistics are available) from fewer than 9,000 in 1993. Infectious
disease experts agree that infections have been on the rise, but they
worry that part the increase may be due to overdiagnosis.


A misdiagnosis can have serious consequences. In some cases, Dr. Mead
said, Lou Gehrig's disease was misdiagnosed as Lyme by unproved tests.
The patients in those cases, he said, wasted thousands of dollars on
ineffective treatment. The antibiotics used to treat Lyme disease can
also cause complications, including severe allergic reactions.


Some doctors and patients, however, have a different concern. They
believe Lyme is often missed by the traditional tests recommended in
C.D.C. guidelines.


Dr. Harris, of IGeneX, estimated that his laboratory tested 50,000 to
75,000 patients each year. (Prices go up to $390 for a battery of tests

it recommends.) "These are patients who have been bounced around," he
said. "A lot of them were undertreated at some time, and their disease
came back."


Still, he went on, IGeneX runs the traditional tests accurately and
gives doctors guidelines for interpreting them both by the C.D.C.'s
conservative standard and by IGeneX's more liberal standard - even
though he asserted that the conservative standard would miss many cases

of chronic Lyme infection.


Unproved Lyme Disease Tests Prompt Warnings


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Published: August 23, 2005
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He provided a reporter with a document showing that in each year since
2000, IGeneX had achieved scores of at least 97 percent accuracy on the

Western blot and Elisa tests, well above the minimum 80 percent
required by the state.


But Robert Kenny, a spokesman for the State Department of Health, said
the agency was not convinced that IGeneX was performing the recommended

tests for the public in the same manner as it has been performing them
to pass the state's proficiency review.


Moreover, Mr. Kenny said IGeneX had not supplied requested proof that
its urine antigen test can be used to accurately diagnose Lyme disease.



Dr. Harris says IGeneX has been working for more than two years to
supply New York State with the proof it wants. "It's been an
exceedingly long process that's nearing completion," he said. Dr. Mead
at the C.D.C. also confirmed that another laboratory, Bowen Research
and Training Institute Inc. of Tarpon Springs, Fla., went beyond the
agency's recommended tests.


The State of Florida denied its application last year for a license to
perform tests meant to diagnose Lyme, but its founder and president,
Dr. JoAnne Whitaker, asserts that the tests it continues to perform are

for research purposes only.


Some patients insist that IGeneX's tests have been instrumental in
detecting the Lyme disease that other laboratories missed. One such
patient is Ronald Hamlen, 64, a plant biologist from Maryland who
worked at DuPont for 22 years before retiring recently. Tests run by
IGeneX, he said, detected Lyme disease that was missed by other
laboratories.


"If I had not had the positive result at IGeneX, I seriously question
whether I would have been alive at this point," he said in a telephone
interview. Before getting tested by IGeneX and going on intravenous
antibiotics for 10 weeks, he said, "all I could do at that point was
lie on the couch."


In contrast, Mr. Courcier's odyssey into the Lyme testing labyrinth
began last year on the Sunday after Thanksgiving, when a severe pain in

his leg led him to seek care at a walk-in clinic. Preliminary diagnoses

of phlebitis and muscle strain proved inaccurate, and as the pain
increased and spread, he finally went to the Mayo Clinic.


Doctors there told him that an initial test for Lyme disease came back
negative, but they could offer no other clear diagnosis for what was
ailing him.


Back home in Texas, Mr. Courcier was referred to a neurologist
specializing in Lyme disease. The neurologist sent samples of his blood

to IGeneX, as well as to Quest Diagnostics, one of the country's
largest medical testing companies. Each lab followed the two-step
process recommended by the C.D.C.


IGeneX and Quest Diagnostics performed the Elisa and the Western blot
tests on Mr. Courcier's samples. The Elisa came back positive from both

labs, suggesting that Mr. Courcier might have antibodies to B.
burgdorferi.


On the Western blot tests, however, IGeneX sent back positive results,
while the Quest testing came back negative.


Although his doctor started him on antibiotics to treat the possible
infection, Mr. Courcier was encouraged by a colleague to visit Dr. Gary

Wormser, chief of the division of infectious diseases at New York
Medical College in Valhalla, for another opinion. Dr. Wormser repeated
the Western blot test and told him in June that he did not have Lyme
disease.


At first, Mr. Courcier did not know whom to trust, and he remained on
the antibiotics therapy prescribed by his doctor in Texas. But by July
he concluded that he did not have Lyme disease and stopped taking the
antibiotics, which he said were only making him feel worse.


"It's been a hell of an emotional roller coaster," said Mr. Courcier,
who conceded that it was a comfort for a while to have a definite
explanation for the pain and exhaustion that continue to plague him.


Dr. Mead of the C.D.C. said he sympathized with Mr. Courcier's plight.
But for now, he said, patients and physicians should rely on the
recommended two-step process. The tests, he said, are accurate in more
than 90 percent of cases of long-term Lyme infection.


But he added that he was still troubled by the dispute. "We don't want
to be absolutely dogmatic that it's our way or the highway," he said.
"At the same time, it's clear there are tests out there for which there

is really precious little to support their accuracy."

.