Unfortunately, in public discourse, science and reality do not necessarily triumph over pseudo-science. Last year, New York passed a bill to allow
rogue doctors (to) be able to shill their non-evidence-based treatments without worrying about intervention.
prohibits the state Office of Professional Medical Conduct from investigating a licensed physician based solely upon the recommendation or provision of a treatment that is not universally accepted by the medical profession.
Those protections include, but are not limited to, treatments for Lyme disease and other tick-borne illnesses.
The bill, sponsored by the Oregon Lyme Disease Network, says
SECTION 1. (1) The Oregon Medical Board and the Oregon State Board of Nursing shall each adopt rules regarding the diagnosis and treatment of Lyme disease.
(2) The rules adopted under this section must:
(a) Permit professionals regulated by the boards to diagnose and treat, in manners consistent with the standards of care guidelines developed by the International Lyme and Associated Diseases Society, Lyme disease and associated viral, bacterial and parasitic diseases;
(b) Establish disciplinary procedures that consider as a mitigating factor whether, in diagnosing or treating Lyme disease or associated diseases, a professional who is facing discipline followed evidence-based diagnosis and treatment guidelines not recognized by the boards.
There are two sets of Lyme Treatment Guidelines. One is from the Infectious Disease Society of America and is about to undergo an update from the 2006. The guidelines suggest (note the not)
Selected antimicrobials, drug regimens, or other modalities not recommended for the treatment of Lyme disease.
- Doses of antimicrobials far in excess of those provided in tables 2 and 3
- Multiple, repeated courses of antimicrobials for the same episode of Lyme disease or a duration of antimicrobial therapy prolonged far in excess of that shown in table 3
- Combination antimicrobial therapy
- Pulsed-dosing (i.e., antibiotic therapy on some days but not on
- other days)
- First-generation cephalosporins, benzathine penicillin G, fluoroquinolones, carbapenems, vancomycin, metronidazole, tinidazole, trimethoprim-sulfamethoxazole, amantadine, ketolides, isoniazid, or fluconazole
- Empirical antibabesiosis therapy in the absence of documentation of active babesiosis
- Anti-Bartonella therapies
- Hyperbaric oxygen therapy
- Fever therapy (with or without malaria induction)
- Intravenous immunoglobulin
- Intravenous hydrogen peroxide
- Vitamins or nutritional managements
- Magnesium or bismuth injections
I suspect, given the creativity of those who treat chronic Lyme, that this list will grow in the next version of the guidelines. These are the kinds of pseudo-therapies, and there are many more ,that the people with the pseudo-diagnosis of chronic Lyme undergo. All useless, all costly and, occasionally, fatal.
Key in the IDSA guidelines is the avoidance of long term and repeat courses of intravenous antibiotics. Long term antibiotics are not benign. Besides allergic and other side effects, secondary infections of the intravenous catheters can and has killed people.
A 30-year-old woman died as a result of a large Candida parapsilosis septic thrombus located on the tip of a Groshong catheter. The catheter had been in place for 28 months for administration of a 27 month course of intravenous cefotaxime for an unsubstantiated diagnosis of chronic Lyme disease.
Twenty five years of infection control has only served to emphasize that unnecessary intravenous catheters can only cause harm and one of the keystones of non-standard chronic Lyme therapy is prolonged intravenous antibiotics.
The other Lyme treatment guideline is from ILADS, The International Lyme and Associated Disease Society. They differ from the IDSA, as noted by ILADS:
The ILADS panel recommendations differ from those of the IDSA. Different guideline panels reviewing the same evidence can develop disparate recommendations that reflect the underlying values of the panel members, which may result in conflicting guidelines. The IOM explains that conflicting guidelines most often result ‘when evidence is weak; developers differ in their approach to evidence reviews (systematic vs non-systematic), evidence synthesis or interpretation and/or developers have varying assumptions about intervention benefits and harms. Conflicting guidelines exist for over 25 conditions and there is no current system for reconciling conflicting guidelines.
It may be more than a simple difference of opinion. But I would note that every recommendation in the ILADS guidelines is based on
very low-quality evidence.
There are multiple differences in the two approaches to Lyme. First is the belief (belief is what you have when you have no data), unsupported by the preponderance of the scientific medical literature, that Lyme persists despite adequate treatment.
The other major issues concern treatment. ILADS supports prolonged intravenous therapy for Lyme, re-treatment for patients with persisting symptoms after treatment and the use of adjunctive therapies including treatments of co-infections. All are not supported by Lyme research.
ILADS suggests repeat course of intravenous antibiotics for patients who remain symptomatic; IDSA does not and the best studies to date supports the IDSA approach.
There is considerable impairment of health-related quality of life among patients with persistent symptoms despite previous antibiotic treatment for acute Lyme disease. However, in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo.
This is because antibiotics are effective in killing off Lyme
There continues to be no evidence that viable B. burgdorferi persist in humans after conventional treatment with antimicrobials.
Most studies looking for living B.burgdorferi after treatment has failed and those that do have severe flaws. Antibiotics eradicate the organism. In animal models, where they can culture the entire mouse, 5 days of antibiotics is enough to kill off all Lyme
Our findings further document the effectiveness of antibiotic therapy in eradicating cultivable cells of B. burgdorferi, irrespective of tissue or organ site.
The organism does not hide out, protected in some organs, as some believe. As the 2014 NEJM review succinctly puts it
Several carefully conducted, placebo-controlled, randomized trials of prolonged antimicrobial treatment in patients with persistent subjective symptoms after treatment for Lyme disease have shown a minimal benefit or none and a substantial risk of adverse effects. Consequently, prolonged antimicrobial treatment for subjective symptoms is not recommended in patients whose objective signs of Lyme disease have resolved in response to conventional therapy. Consideration of other causes of persistent symptoms is warranted. In most of these patients, nonspecific symptoms resolve over time without additional antimicrobial treatment.
When it comes to adjunctive therapies, ILADS is less proscriptive than the IDSA:
ILADS agrees that first-generation cephalosporins, intravenous hydrogen peroxide and bismuth injections are not recommended. However, ILADS has concluded that it is premature to exclude other potentially beneficial therapies based on the evidence to date. Therefore, ILADS contends that the use of such agents should not be precluded until studies have demonstrated their ineffectiveness in the treatment of Lyme disease.
A real difference in approach to treatment. Given the potential dangers in all medical interventions, therapies should be precluded until studies have demonstrated their effectiveness in the treatment of Lyme disease.
Lyme diagnosis is also at issue in the bill, although the ILADS guidelines do not address issues related to the diagnosis of Lyme. Lyme is classically diagnosed by a two step procedure: a screening ELISA followed by a confirmatory Western Blot, although the ELISA for antibodies against the C6 peptide may be helpful.
There are laboratories, in my practice evidently beloved by naturopaths, that use unvalidated and unreliable non-standard tests, of which there are many. This is because
in the mid–1970s, the FDA began exempting certain diagnostic tests from its approval process. Many of these tests — developed, manufactured, and offered by a single lab, such as in a hospital — were variations on common tests, low-risk, or devised for rare diseases and could not be adequately validated.
And Lyme testing has proliferated with all the subsequent false positives in patients and resultant un-needed therapies. Patients often do not realize that when a lab is CLIA certified it means little as to the validity of the testing offer, just as a restaurant being certified as sanitary says nothing about the quality of the cooking.
The FDA recognizes this is a problem with many kinds of tests
The US Food and Drug Administration, responding to growing concerns that a host of diagnostic tests for illnesses from cancer to Lyme disease may be inaccurately identifying conditions, announced Thursday that it intends to regulate many of the tests.
and there are new guidelines for these tests that may decrease the number of substandard testing.
Also popular in the nonstandard Lyme world is treating co-infections. I once had a patient tell be she also had a Babesia infection as well as Lyme, diagnosed at one of the creative Lyme labs. The accompanying photomicrograph had an arrow point to… a platelet clump labled Babesia. While there are occasionally more than one infection spread with a tick bite, it is not common
Often, the controversial diagnosis of chronic Lyme disease is given to patients with prolonged, medically unexplained physical symptoms. Many such patients also are treated for chronic coinfections with Babesia, Anaplasma, or Bartonella in the absence of typical presentations, objective clinical findings, or laboratory confirmation of active infection…The medical literature does not support the diagnosis of chronic, atypical tick-borne coinfections in patients with chronic, nonspecific illnesses.
The ILADS guidelines mention
A survey of 3090 patients diagnosed with Lyme disease found that laboratory confirmed cases of babesiosis and anaplasmosis were reported by 32.3 and 4.8% of respondents, respectively
Although given that this is a survey, we have no idea as the rigor with which these diagnoses were made; they may have been platelet clumps.
This bill is especially worrisome when combined with HB 3301 in that designates Naturopaths as “primary care” providers. Not only will this bill remove consumer protections from providers of questionable therapies, has the potential to expand the ability for pseudo-doctors with no standards to provide pseudo-therapies for pseudo-diseases.
The reason that the ILADS approach is not embraced by other organizations such as IDSA is that the ILADS recommendations are not based on the best understanding of the treatment and diagnosis of Lyme and ignore or rationalize away high quality evidence.
The IDSA is often vilified for supporting the best data and science. When not supported by the science, organizations often resort to the law, a poor way to adjudicate medicine and science; House Bill 916 is no different in that respect to attempts to legislate the value of pi.
Removing consumer protections and institutionalizing substandard medical care will not benefit the health of Oregonians and will protect those practicing substandard medicine from being held accountable for their practice.
Let me mention, not that it will make any difference, that I do not deny the symptoms of patients with the diagnosis of chronic Lyme. They are often quite ill with something. It is not, however, from Lyme.
As an aside, I will also mention that I have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed above. The odd thing about the world of pseudo-medicine is that most of the time we are accused of being big pharma shills, prescribing vaccines willy-nilly to line the pockets of our masters. Except for Lyme where we are accused of being insurance company shills, not willy-nilly prescribing antibiotics to line the pockets of our masters. Can’t win for trying.
Mark Crislip MD