Informed Consent
Patients have a right to pick among conflicting studies
By Theresa Denham
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I am writing in response to the two Lyme articles published in your newspaper. One by a patient suffering from the illness; the other the rebuttal by Dr. Sarah Hendrickson, who believes that Lyme is rare, easily cured and not a significant threat to Oregonians. The two authors expose the Lyme disease controversy between the Infectious Disease Society of America (IDSA) and the International Lyme and Associated Disease Society (ILADS). This controversy causes problems for Oregon patients, making early diagnosis difficult, and leading to late diagnosis and difficulty in treating this spirochete illness. Oregon Lyme Disease Network (OLDN) has assisted more than 1,000 patients in providing accurate information and advocating for themselves through this controversy.
In recent years, Connecticut State Attorney General Blumenthal investigated and found that IDSA had flawed guidelines Blumenthal said; “My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.” A settlement agreement was achieved, requiring a review of guidelines to include all relevant science. In a letter written by Blumenthal on Feb 1, 2010 it states that the settlement was violated. See a copy of what is transpiring at http://wkly.ws/at
It is apparent that Oregon only uses the IDSA standard of care. This has limited patient access to care by affecting the patient’s ability to find treating physicians and by allowing insurance companies to deny treatment. The environment is hostile for physicians who treat Lyme disease using the ILADS guidelines.
Oregon’s medical standards ignore ILADS standard of care despite published ILADS guidelines easily found in the National Guideline Clearinghouse (NGC) at http://wkly.ws/as — a public resource for evidence-based clinical practice guidelines.
Lyme is indeed in Oregon. It is missed in many patients and misdiagnosed as neurological disorders (i.e. seizures, MS, ALS, Lupus, Parkinson’s, Peripheral Neuropathies), cognitive disorders, musculoskeletal disorders (JRA, connective tissue disease, fibromyalgia.) and in some cases cardiac disorders (heart block, congenital heart deformity)1
Dr. Hendrickson claims Lyme disease is rare in Oregon. Based on a survey of CDC positive patients, many were not included in surveillance reporting or diagnosed with Lyme Disease by their Oregon physician. Oregon (DHS and OHSU Dr. Gilbert) claim they use a “gold standard” tes which override some other tests, however, seronegative testing is a common result2 and there are numerous studies showing that this test is very unreliable. Many patients are never properly tested for Lyme disease ,if tested at all! Acknowledging that Lyme is significant here, the Oregon Veterinary Medicine Association recognized over 500 cases in pets in 2007-083 using a voluntary reporting system.
Dr Hendrickson states that Lyme Disease is easily treated. There is evidence that in some cases “early diagnosis” has good success in treatment. It has also been shown that extended treatment may be required for early disseminated disease and late chronic Lyme disease4.
The IDSA also claims there is no science to support chronic Lyme disease, yet ILADS recognizes late, chronic and persistent Lyme disease using many published scientific studies4 to support their claim.
Oregon does not allow test results from some Lyme disease specialty laboratories, despite the fact that these labs are CLIA certified and CDC proficiency rated very high (92% +) for testing of Lyme disease. This results in fewer surveillance cases, resulting in reported case numbers in Oregon below the actual numbers. It also results in patient denials to obtain treatment in Oregon.
Dr Hendrickson states “some groups” argue chronic Lyme and goes on to imply that those who do, use harsh unproven and unsafe treatment modalities. It is implied that ILADS is included in that group. This is misleading. ILADS is a scientific community of scientists, treating physicians and research physicians who specialize in research and treatment of tick born infections using antibiotics and immune support.
Dr Hendrickson refers to a study done by OHSU’s Dr Gilbert (IDSA reference physician in Oregon) in regards to tick testing. OLDN, both directly and through Attorney General Hardy Myers office, was unable to find or receive information on this study including materials and methods, funding source, field documentation (including inclusion/exclusion criteria such as geographical location), number and type of ticks tested, storage and handling of raw specimens, and handling of laboratory specimens and test procedures used. The study was published but lacks credibility since there is no material produced to substantiate the study. When compared to standards established by credible tick study experts, the Gilbert study appears to be seriously flawed.
The only study OLDN could find was a study by the Center of Disease Control in 1996 and published in 1997 “Isolation Of Borrelia Burgdorferi From Neotoma Fuscipes, Peromyscus Maniculatus, Peromyscus Boylii, And Ixodes Pacificus In Oregon,” showing three southern Oregon areas with 4 to 21 percent positive infection rates in woodrats and whitefooted mouse and 3 percent in ticks. Assuming that ticks reproduce by oviposit between 2,500 and 3,000 eggs which hatch in about two weeks, and this test was in 1996 one can assume the problem has increased exponentially.
IDSA or ILADS? We can only say yes, there is a controversy! and that Oregon patients have the right to know the details surrounding the societies so they can make informed personal decisions on their health. Patients and their personal physicians should have the right to choose between which government approved published guidelines they wish to follow.
Patients should have the right to informed consent, and to decide with their physicians which diagnostic and treatment modality is right.
For more information contact Oregon Lyme Disease Network (541) 312-3081.
Theresa Denham of Bend is president and founder of the Oregon Lyme Disease Network. Her references for this column are:
1) http://www.medicinenet.com/lyme_disease/page2.htm
2) http://oregonlyme.org/PDF/LDSeronegativity.pdf
3) Oregon Veterinary Medical Association
http://oregonvma.org/care-health/lyme-disease
http://www.lymeprevention.com/map.shtml
4) http://oregonlyme.org/PDF/LDPersist.pdf
5) http://www.dhs.state.or.us/dhs/ph/chs/data/newsltr/oht53/trends53shtml
6) http://www.ajtmh.org/cgi/reprint/60/3/453.pdf