might not always show up in tests
LETTER from Nick Harris, PhD. (press release Igenex):
February 26, 2001
Response to Phil Baker, NIAID, NIH
Re: Klempner paper Am.J. Med. 110:217-219,2001
Over two years ago, Dr. Mark Klempner approached me. He was doing a study of chronic Lyme disease funded by the National Institutes of Health and wanted to compare the Western Blot with the Lyme Urine Antigen Test (LUAT).
IGeneX agreed to the study and told the New England Medical Center (NEMC), which was providing the samples, that certain handling requirements must be met for the samples, since improper handling can lead to flawed results.
IGeneX received the samples in late 1998, early 99. IGeneX scientists sensed immediately that there was a problem with the samples. l called and spoke with a laboratory supervisor and shared our suspicion that we had received improperly handled specimens.
This supervisor confirmed that the samples had not been kept frozen but were refrigerated for many months. (Our written requirements for the study were that samples must be frozen after collection in a 70C freezer and remain frozen prior to testing to test accurately.)
I called and informed the laboratory manager at NEMC that I would not release the results due to the improper handling of the samples. He informed me that I must send the results anyway because NEMC had paid for them under an NIH grant.
I sent NEMC the results (attachment #1) along with a letter to Dr. Klempner clearly stating that the results could not he considered valid due to improper storage and possible contamination.
Over a half-year later, Munich International Lyme Conference attendees informed me that Dr. Klempner had presented the results of this study, not even mentioning the contamination. I then personally called Dr. Klempner and offered to have IGeneX pay for a repeat study involving an independent third party evaluator.
He reported the offer to his Medical Officer (#2) at the NIAID, and I personally offered the same to Phil Baker, NIH Lyme Program Director. All three refused the offer. We informed our clients of the situation in September 1999 (#3).
Now two years later, Dr. Klempner has published study results using samples that he was personally told by me were contaminated and improperly handled, Science is based upon conclusions drawn from data objectively obtained under controlled conditions so that the variables are reduced.
If the controlled conditions of the study have not been met, the conclusions derived are questionable at best, since the study's basis in science has been lost.
The study should have been terminated, but since it has now been published with the flawed data, science itself requires that a repeat study be performed, and IGeneX again repeats the offer of a third party independent evaluator study for which IGeneX will pay the bill.
Nick Harris, PhD, IGeneX Reference Laboratory, Palo Alto, CA
The Honorable Aden Spector
The Honorable Joseph Pitts, attention Jeri-Lynn Wier
The Honorable Rick Santorum, attention Pete Stein
The Honorable Christopher Smith, attention Andy Napoli
Don Keller, GAO
Hoc Noble, New York Times
NEWS ARTICLE from The New York Times, 7-10-01, By PHILIP J. HILTS
[Dr. Anthony Lionetti: the bacterium might not always show up in tests.]
``... The study, by Dr. Mark S. Klempner of Boston University Medical Center, showed [purports to show] that prolonged treatment with antibiotics was no more effective than placebos among those with persistent Lyme disease symptoms.
Citing its importance to patients and doctors, the [New England Journal of Medicine] posted the study, along with two others and an editorial, on its Web site a month before the scheduled publication date. [In effect, publishing it on 6-12-01, See Coincidences.] ...
Both sides agree that antibiotics work in 90 percent of patients and that the disease never recurs in those patients, at least not from that tick bite. [Without before and after treatment testing by a technique that will directly visualize any spirochetes present, this "90 percent" is just wishful thinking.]
But among the other patients, symptoms either persist or come back after the standard treatment. Do the symptoms recur because the bacteria have been hiding out in the body, only to emerge again later?
Or could the Lyme bacteria, even though they were wiped out by treatment, [no valid evidence being presented that they were wiped out by the treatment] have brought on a secondary disease, a Lyme autoimmune disorder, in which the body's immune system attacks its own cells as if they were the Lyme disease organism? [So, if a patient with the symptoms of chronic Lyme objects to the first-line diagnosis of psychosomatic disease, the patient can be told that it is still all her fault because she is suffering from autoimmune disease, perhaps to be palliatively treated with cheap and very dangerous steroids.] ...
Critics say more answers are needed. Some doctors have been treating persistent Lyme disease with much heavier doses of antibiotics than the Klempner study used, and they believe that has helped. So, they say, the issue will not be resolved until the heavier doses are tested in experiments.
One patient group, the Lyme Disease Foundation, based in Hartford, has sided with heavy antibiotic use until the questions have been resolved.
Dr. Anthony Lionetti, who works in a New Jersey clinic and is associated with the foundation, said that some patients suffered persistent infection that needed to be treated but that the bacterium might not always show up in tests.
He said he sometimes asked patients to take as many as 10 tests before accepting that a patient with symptoms did not have a persistent bacterial infection.
One complicating issue is that among patients who have recurrent Lyme symptoms, at least two distinct groups seem to have emerged.
One group's symptoms are centered on arthritis symptoms like pain and swelling, usually in the knees. A second group has nervous system symptoms like memory loss, confusion, fatigue, muscle weakness and numbness or tingling. [And many of us have both.]
The two sides in the dispute tend to accept the arthritis symptoms as an autoimmune reaction. [If spirocehtes with a taste for cartilage are present deep within the joints, the destruction can then continue with antibiotics being denied.] The dispute is centered on the other patients ...
Dr. Brian A. Fallon, a psychiatrist at Columbia University and director of the Lyme Disease Program at the New York Psychiatric Institute in Manhattan, said that despite the Klempner study, ... it was too soon to give up the "persistent infection" hypothesis.
Dr. Fallon is beginning to recruit patients who complain of chronic Lyme disease and have neurological and cognitive impairments for a study financed by the National Institutes of Health. They will be treated with 10 weeks of intravenous antibiotics in hopes of killing off any bacteria that may be hiding in the brain or other tissues ... ''
[Note that Klempner et al. might be able to obtain some valid data if they test their subjects before and after treatment with a direct spirochete visualization technique such as that provided by:
JoAnn Whitaker, M.D.
Bowen Research and Training Institute, Inc.
P.O. Box 627
Palm Harbor, Florida 34682
Bowen Research & Training Institute
Title: Clinical pathologic correlations of Lyme disease.
Authors: Duray PH
Source: Rev Infect Dis 1989 Sep-Oct;11 Suppl 6:S1487-93
Organization: Department of Pathology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111.
The multisystem effects caused by Borrelia burgdorferi in Lyme disease are multiple, varied, and unpredictable. In some patients, the full extent of the infection consists of a stage I acute systemic viral-like illness.
Stage II primarily involves the cardiovascular system (myocarditis) and/or the central nervous system (CNS) (meningoencephalitis, polyradiculitis).
More inflammatory cells are found in the heart and nervous system structures during this intermediate stage than are found in any tissues involved during stage I.
Stage III is characterized by peripheral neuropathy and CNS disorders such as dementia or transverse myelitis and arthritis and synovitis of large joints such as the knee.
Chronic Lyme disease is also associated with multiple and seemingly unrelated cutaneous manifestations such as acrodermatitis chronica atrophicans, sclerodermoid-like reactions, lichen sclerosus et atrophicus, subcuticular fibrous nodules, eosinophilic fasciitis-like lesions of the extremities, and, possibly, granuloma annulare.
With care, spirochetes can be recovered or demonstrated by SILVER STAINING in most of the above lesions ... ''