In the mid 1800s Ignaz Semmelweis, a Vienna obstetrician and a good observer, noted that women died from puerperal sepsis in his hospital in large numbers, but only when they were delivered by physicians and not mid-wives. When he noted that physicians were going directly from the autopsy room to the delivery room he instituted hand washing with chloride of lime and mortality rates declined to normal rates. For his good works, Semmelweis was ridden out of town on a rail. The profession did not accept his teachings until 60 years later after the works of Robert Koch, Louis Pasteur and Lord Lister and the rise of the germ theory of disease made his observations of patients and research findings comprehensible in a framework that physicians of the day could understand and accept.
Fast forward to 2006. The Infectious Diseases Society of America (IDSA) declares that chronic Lyme disease does not exist! (www.idsociety.org ) This is echoed by the Centers for Disease Control (CDC). Two-tiered testing for Lyme disease (a screening test followed by a Western blot test) is nearly infallible! So says the IDSA and the CDC. So confident of that is the CDC that it advises physicians not to perform a Lyme Western blot if the screening test is negative, because it is so unlikely the individual could have Lyme disease.
If someone remains ill or relapses after a recommended course of antibiotics of 2-4 weeks duration, they could not possibly still have Lyme disease! In fact, a new ‘disease’ has been invented by authors of the IDSA Lyme disease guidelines:
“Post-treatment Lyme disease Syndrome”. Although originally devised as officially neutral on the question of whether this ‘syndrome’ is due to persistent infection or some post-infectious immune derangement, recently it has been increasingly used as though that issue has been settled: it is a post-infection syndrome and the infection could not possibly be present.
This ignores voluminous scientific data which conclusively demonstrates that the Lyme organism can survive the most potent antibiotics known to man in animal models of the disease including the mouse, beagle dog and Rhesus monkey and many well-documented human case-studies in the worldwide peer-reviewed medical and scientific literature.
This is how chronic and debilitating illness can develop in the hapless individual, undiagnosed and untreated, allowed to insidiously deteriorate with loss of ability to function, enjoyment of life, inability to progress in their educations or be gainfully employed to support themselves or their families.
In the ‘heydey’ of syphilis, clinicians were schooled to always consider syphilis in the differential diagnosis of diseases. When confronted by puzzling syndromes or symptoms “lues” (an old fashioned name for syphilis) would be listed high in the differential diagnosis.
We are in the midst of a true epidemic of Lyme disease in the Lower Hudson Valley, with some of the highest incidences of this disease in the world in Westchester, Putnam, Dutchess, Columbia, Rockland, Orange, Ulster and Sullivan Counties. Despite this, sadly, Lyme disease often never even makes it in to the differential diagnosis of ill individuals who present for medical care. Instead of being one of the first things to be considered, it is the last thing to be considered if it is considered at all. If it is considered, over-reliance on presently very imperfect tests can lead to fatal outcomes, including in children.
Then Connecticut Attorney General, now Senator, Richard Blumenthal found, upon investigation that many of the authors of the IDSA 2006 Lyme Disease guidelines had undisclosed conflicts of interest including holding vaccine and diagnostic test patents, consulting arrangements for insurance companies and testifying in court against patients with Lyme disease. Many also testified against physicians who provide care to patients with Lyme disease in hearings before state boards of medical practice should their practices diverge from recommended short term antibiotic treatment as specified by the IDSA guidelines, even though those guidelines contain a caveat that they are voluntary and not mandatory. Physicians and scientists who held a different view and considered that Lyme disease could be a chronic infection were purged from the 2006 IDSA Lyme guidelines panel by its lead author (www.ct.gov/ag/cwp/view.asp?a=2795&q=414284 ).
The Institute of Medicine in their monograph Clinical Practice Guidelines We Can Trust (www.iom.edu/reports/2011Clinical-Practice-Guidelines-We-Can-Trust.aspx ) points to the 2006 IDSA Lyme guidelines as an example of a guidelines development process gone awry. They made specific recommendations for future guideline development which called for inclusion of patient-stakeholders in the composition of guidelines panels as well as inclusion of experts including treating clinicians representing a diversity of views within a field. They specifically recommended entirely avoiding involvement of persons with demonstrated conflicts of interest in guidelines development. If a second set of clinical practice guidelines existed which offered conflicting recommendations, they recommended this be formally acknowledged and an attempt made to ‘reconcile’ the two guidelines.
It has become evident as the IDSA is up-dating their Lyme and Tick-borne Diseases guidelines this year, all of these recommendations of the Institute of Medicine are being flaunted (www.lymedisease.org & www.lymediseaseassociation.org ).
These new guidelines (as was the case with the IDSA 2006 Lyme guidelines) will have a tremendous impact on the care that persons with Lyme disease are able to receive, what care will be reimbursed by insurers and will foreclose the possibility of receiving individualized care from physicians participating in insurance company plans who feel forced to conform to IDSA guidelines. If they do not, they risk sanctioning and potential ‘de-selection’ from their plans. This results in mandatory reporting to the National Practitioner Data Bank and can have severe and potentially career-ending consequences. The CDC has had a link on their web-site only to the IDSA Lyme disease guidelines (www.cdc.gov/lyme/) and CDC has systematically excluded a link to the Lyme disease guidelines of the International Lyme and Associated Diseases Society (ILADS – www.ilads.org).
Martina Ziska, M.D. a fully trained neurologist from the former Czech Republic and then Medical Director of the Lyme Disease Foundation in Hartford, once advised me: “If there is abuse of power, there is only one solution to that. You must gain more power than they have”.
This is why the Federal bill introduced by Congressman Chris Gibson (H.R. 789 The Tick-borne Disease Research Transparency and Accountability Act of 2015-www.congress.gov/bill/114th-congress/house-bill/789) is so vital in order to correct this imbalance of power and its harmful consequences. The CDC, IDSA and NIH have ‘driven’ a research agenda denying the centrality of the chronicity of tick-transmissible infections with a ruthless intransigence which has stale-mated progress in diagnosis and treatment of these disorders for the past thirty years. Persons with Lyme disease deserve better.
- Kenneth B. Liegner, M.D.