Re: New York Times Dan Hurley ANTI-IGENEX Article OUT!!!!!

the infectious disease doctor ruled it out,but didnt know what it
was,,,,,funny how they dont give any suggestions either,,,,,they just want
you to take the cheap psychiatric medicines...This is another big bash to
getting diagnosed with lyme disease....Now people will get als diagnosis
like i did 11 years ago,,,only they will die because im sure this gives our
low life government a step above lyme disease...Wormsler wont stop till he
kills a bunch of people...im certain some do not have lyme,,,but alot
do,,,and quest shouldnt be allowed to do testing,,,they flat out
suck...whether it be igenex,etc..i feel the cdc,,NOW believes testing is
90%...we know that is far from being true,,due to haveing the tick bite
etc...i went from 190lbs,,,to 140..my stonybrook test came back postive same
as the igenex,,,,7 quest labs came back negative..once recieving iv
antibiotics,,my spinal protein dropped from 118 to 54 in 2 months...and my
als diagnosis was lifted....thats all the clinical trials needed....390.00
to save my life was much cheaper then being hospitalized every few
weeks..mr. harris is really going to have to show some proof,,,and we as
lyme victims really need to stand up for ourselves,,this is the first step
for wormsler,,,now he will be getting lyme treatments stopped,,,even on
patients who actually need them...he is already trying to stop treatment in
Pennsylvania,,,what the hell kind of fool is he i got bit out east..how do
you make treatment areas,when ticks and migratory birds cant read stop signs
or state boundries..WORMSLER,,,HOW STUPID ARE YOU??,,Just my opinion,i pray
you die a slow horrific death in a shitty nurseing home for all the people
you are going to hurt..







CaliforniaLyme <CaliforniaLyme@xxxxxx> wrote in message
news:1124756582.693525.226990@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
> 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.
>
> Skip to next paragraph
>
> 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
> (Page 2 of 2)
>
>
>
> 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."
>


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