Re: Unproved Lyme Disease Tests Prompt Warnings- NY TIMES (IGENEX testing)
- From: "CaliforniaLyme" <CaliforniaLyme1@xxxxxxx>
- Date: 26 Oct 2006 08:05:37 -0700
georgia wrote:
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.
.
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