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The Scrutiny Ends For Igenex Labs – A Lyme Disease Specialty
Lab
By Mark Leavitt, 11/18/05
"In light of the numerous hearings
on Lyme disease across the country, to follow the CDC recommended guidelines will miss many patients resulting
in misdiagnosis that can be devastating if the disease progresses to a later stage. Awareness of the flawed CDC
two tier testing system demonstrates the need for State and Local governments to step in to help the patients that
are being misdiagnosed or under diagnosed because of the CDC’s flawed testing. IGeneX Labs has recently passed
two inspections for its biannual recertification from the State of California. A federal inspector also arrived
simultaneously. The inspection was intense, with a focus on the Western Blots. The lab has been fully recertified."
-Nick Harris, CEO, IGeneX Labs, Statement to the Greater Hartford Lyme Disease
Support and Action Group, 11/19/05
We can all breathe a sigh of relief, Igenex labs that specialize in tick-borne disease testing passed certification
not only by the state of California, but by the state of New York that put a big blot on the labs Western Blot
Lyme disease test prompting for investigation because Igenex purportedly performs inaccurate lyme disease testing.
Igenex was put through this scrutiny due to an article that came out in the New York Times on August 2005. The
article starts off profiling a patient with disabling pain and exhaustion. Doctors couldn't figure out what was
wrong with him and even ruled out Lyme disease until one doctor sent his blood work to Igenex Labs. The controversy
started when the results came back from Igenix positive for Lyme disease by the ELISA and Western Blot test. Another
doctor got involved in the case from New York and tested the patient's blood numerous time for Lyme with negative
results using a different lab and insisted he did not have Lyme disease. Then, the New York State Department of
Health started investigation proceedings on Igenex labs located in California.
What is interesting in all of this is Lyme Disease is a clinical diagnosis and testing is supportive only. Most
Lyme disease specialists agree that testing can be inaccurate and should not be relied upon for definitive diagnosis
of the disease. The ELISA is the most performed and least expensive Lyme disease test and can be inaccurate. The
more expensive Western Blot test is better but is not performed if the ELISA is negative. The Western Blot also
takes longer for results. The CDC recommends this two-tier approach and is what most doctors follow: the ELISA
test is performed first then the Western Blot only if the ELISA is positive. What many patients do not know is
they can have a negative ELISA test but have positive results from the Western Blot indicating Lyme disease. The
patient may never get to the second tier (Western Blot) resulting in misdiagnosis that can be devasting if the
disease progresses to a later stage.
One has to ask the question how does the ELISA test know if you had the Western Blot and why is the two-tier recommendation
strongly emphasized by the CDC? Dr. Paul Mead of the Center of Disease and Control stated in the article on using
this recommended two-tier approach as well as his concerns with Igenex laboratory tests in regard to accuracy and
clinical usefulness. Yet, Dr. Mead stated at the state of Connecticut Department of Public Health Hearing on Lyme
Disease in January 29, 2004; "there will always be some patients with Lyme Disease whose illness does not
meet the national surveillance case definition. For this reason, CDC has stated repeatedly that the surveillance
case definition is not a substitute for sound clinical judgment. Given other compelling evidence, a physician
may choose to treat a patient with Lyme Disease when their condition does not meet the case surveillance definition."
The challenge for better Lyme disease testing as well as needed research into this disease seems to be apparent
and is long overdue. Is it because one may be crucified or ridicule along the way? Igenex Labs created two new
tests in 2001 called the Lyme Disease urine antigen Assay (LDA) and the Reverse Western Blot (RWB). Both of these
tests detect Lyme antigen shed in the urine. Dr. Paul Mead at the Connecticut Lyme disease hearing stated; "the
CDC supports national surveillance, epidemiologic response, field and laboratory research, consultation and educational
activities through intramural initiatives."
Is Lyme disease testing only good if it's created under the guidelines and watchdog of the CDC as suggest by Dr.
Paul Mead when he states through intramural initiatives. If that is the case, it is no wonder lyme disease
testing as well as a cure for this illness is going no where. Lyme disease has reached its 30th anniversary this
year and were no better off then thirty years ago except for public awareness. Doctors are still confused on testing,
diagnosis and treatment. Lyme disease specialists in the state of Connecticut are far and few in the very heartland
where the disease was first brought to public attention in Old Lyme, CT. The doctors that are willing to treat
the disease are always at risk of being persecuted for using long term antibiotics if they feel the patient meets
the clinical diagnosis. In the past, some Connecticut Lyme doctors have been investigated and risked losing their
medical licensee. This has resulted in the very low numbers of doctors willing to treat the disease in Connecticut
and many other states.
Many patients are told they don't have Lyme disease and a postive lyme test means negative. The doctors do not
want to touch this disease and now laboratories are being scrutinized. Long term antibiotics are considered a death
sentence for the use of Lyme disease yet they are used long term for teenagers for acne and other disorders. Lyme
patients end up taking medications to alleviate symptoms of muscle and joint pain and other discomforts. Many are
told they need to a see a psychiatrist that usually starts a new battery of psychiatric drugs. What about the side
effects of these type of drugs? In fact, most psychiatric drugs we do not understand how they work on the brain
and what the damage long term may be, yet this is perfectly acceptable.
In the end, the patient suffers enduring worsening symptoms over time. Let me repeat that statement one more time,
because nobody seems to hear this: the patient suffers in the end with worsening symptoms. I truly believe
this disease can be cured but for some reason we don't want to. The public and social demand as well the economics
and political bureaucracy will determine the future of Lyme disease.
In the meantime, you have to sort through this maze yourself and endure a roller coaster ride of our current medical
system and make your own personal assessment if you have Lyme disease or not. I only hope the right decision is
made for anybody in this predicament because the wrong decision will lead to more treatment trails and health complications
due to this dreaded illness.
Email Mark about this story
Related Information:
New York Times:
Unproved Lyme Disease Tests Prompt Warnings on Igenex, 8/23/05 PDF
Media Statement by Nick Harris, CEO, IGeneX Labs, 11/15/05
IGeneX Clincal Laboratory Certificate of
Compliance PDF
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