The Lyme spirochete, the bacteria that causes Lyme disease (but not “chronic Lyme” disease).
In yet another example of the ubiquitous practice of Legislative Alchemy, bills are pending in several state legislatures this year giving sustenance to the fake diagnosis of “chronic Lyme” disease and its treatment with unorthodox and potentially dangerous means. The most troublesome bills protect so-called “Lyme literate” physicians and other practitioners from discipline for substandard practice. “Chronic Lyme” patients want to protect their doctors from what they see as persecution by the medical establishment, even as these same patients are being fleeced out of thousands of dollars for unproven treatments. Other bills force insurers to pay for discredited treatments for “chronic Lyme” or require that burdensome and misleading disclosures be given to patients about Lyme disease.
Before we get to the specifics of these proposals, a brief refresher on “chronic Lyme” and “Lyme literate” physicians, a subject we’ve covered covered many times on SBM.
Lyme literacy
Lyme disease is an infectious disease transmitted by a tick bite. Its symptoms are a rash, fever, headache and fatigue, although not all symptoms may appear. According to the Infectious Diseases Society of America (IDSA), it is diagnosed by medical history, physical exam, and sometimes a blood test. Treatment with a short course of antibiotics usually eliminates the symptoms, but delayed treatment can result in more serious problems.
“Chronic Lyme” is not recognized as a disease in the medical community. Its symptoms are, well, pretty much anything. One description from a post by Harriet Hall:
[Chronic] Lyme is a multi-systemic illness, and may affect every part of the body causing fatigue, stiff neck, headaches, light and sound sensitivity, tinnitus (ringing in the ears), anemia, dizziness, joint and muscle pain, brain fog, tingling, numbness and burning sensations of the extremities, memory and concentration problems, difficulties with sleep (both falling asleep and frequent awakening), chest pain and palpitations and/or psychiatric symptoms like depression and anxiety.
As Dr. Hall correctly notes, “that pretty much covers everyone.”
A new term, post-treatment Lyme disease syndrome, has been coined for those who had Lyme disease but whose symptoms remain, although there is no good evidence that these symptoms can be attributed to persistent Lyme infection. There is no scientific controversy, however, that “chronic Lyme” disease, as applied to patients with nonspecific symptoms who show no objective evidence that they have been infected with Lyme disease, is a fabricated diagnosis. (As are the newer, move-the-goalposts putative infections to which “Lyme literate” doctors attribute “chronic Lyme.”) It is these patients who have been victimized by “Lyme literate” physicians and alternative medicine practitioners.
As you would expect in cases where a collection of vague symptoms have been bootstrapped into a disease (e.g., chronic candidiasis, adrenal fatigue) there are also a number of bogus diagnostic techniques and worthless quack treatments available. The main treatment is long-term antibiotics, for which there is no evidence of effectiveness but serious risks. (Also, here and here.)
The CDC, the Infectious Diseases Society of America (IDSA), the American Academy of Pediatrics, the American College of Physicians, the Medical Letter, and the American Academy of Neurology all reject the notion that “chronic Lyme” exists and that long-term antibiotics are an appropriate treatment. Over a dozen international organizations, like the Canadian Public Health Network and the European Federation of Neurological Societies, agree.
That has not stopped “Lyme literate” doctors from banding together to form the International Lyme and Associated Diseases Society (ILADS) and issuing their own guidelines for the diagnosis and treatment of “chronic Lyme,” guidelines based on very low levels of evidence that are accepted only by themselves and, in contrast to the IDSA guidelines, no other professional medical organization. ILADS teaches physicians and other practitioners how to become “Lyme literate.” ILADS, again in contrast to IDSA, is not an ACCME-accredited provider of continuing medical education and, to my knowledge, none of its courses qualify for continuing medical education credit. Nor are ILADS guidelines taught as appropriate in any medical school, residency or fellowship program.
Making a fake diagnosis and treating the patient with unnecessary long-term antibiotics can put a “Lyme literate” doctor on the state medical board’s radar, especially when patients are harmed by the treatment or there is a failure to diagnose the patient’s real condition, such as Parkinson’s disease. Hence, the need to protect the “Lyme literate” from prosecution. This effort is assisted by a small but vocal contingent of patients who see their “Lyme literate” doctors as saviors and flood medical boards with letters of support. These same patients, armed with anecdotes of their supposed cures, petition their legislators for protection of what they deem persecution of their physicians.
Maryland: All in on “chronic Lyme”
In 2016, the Maryland legislature passed a bill substituting its healthcare advice for that of physicians. The law requires labs to tell patients that current tests for Lyme are “problematic,” that a negative test does not mean they don’t have Lyme disease, and that they should contact a health care provider if they continue to exhibit “unexplained symptoms” to “inquire about the appropriateness of retesting or initial or additional treatment.”
The IDSA opposes this type of notice as “non-evidence based.” That being the case, I question the constitutionality of the law because:
the First Amendment prohibits the government from compelling people [including physicians] to make false or misleading statements or to express the government’s point of view as their own.
At the time, Delegate Kathy Afzali, a co-sponsor of the bill, whose background is in theater and real estate, said it was only the first of a series of bills she hoped to get through the legislature:
The question is, what is the proper treatment for the disease [sic] There’s many different schools of thought. We want to be able to pass legislation that helps these patients who have long-term treatment for Lyme.
Even though there are not “many different schools of thought,” true to her word, Delegate Afzali and 38 of her fellow Delegates are sponsoring a bill (House Bill 880) in this legislative session forcing insurers to pay for long-term antibiotic treatment of “chronic Lyme” disease, which includes a clinical diagnosis that does not meet the CDC’s criteria:
but presents other acute, persistent, or chronic signs or symptoms of Lyme disease as determined by a licensed physician, whether that diagnosis is based on knowledge obtained through medical history and physical examination only or in conjunction with testing.
In other words, if the “Lyme literate” physician says it’s Lyme, it’s Lyme, and the health insurer must provide coverage for:
the full length of the long-term antibiotic treatment to be administered in the manner prescribed . . . [The insurer] may not impose a quantitative limitation on the long-term antibiotic treatment . . . [and] may not deny coverage . . . solely because the treatment may be categorized as unproven, experimental, or investigational in nature.
In sum, Maryland legislators, including the Senators who support a companion bill (Senate Bill 793) are willing to put the force of law behind a fake diagnosis, as well as unproven treatments for the fake diagnosis, and make everyone (though the shared cost of insurance) pay for it. This won’t be the first time. In 2016, Massachusetts legislators were so enamored of a similar bill that they overrode Governor Baker’s veto so insurers would have to pay for long-term antibiotic treatment.
Sadly, testimony in favor of the bills only serves to demonstrate just how badly “Lyme literate” physicians are scamming patients. In one media report, a mother said she had taken her daughter to 51 doctors before she was “properly diagnosed” with “chronic Lyme.” One legislator told a reporter that people were being bankrupted paying for long-term treatment. That’s unsurprising, considering media reports that “chronic Lyme” treatment can cost $10,000 to $35,000. (After one of my posts on the discipline of a “Lyme literate” physician by a state medical board, I received a thank-you email from a parent who had been scammed out of $30,000 for a child’s treatment.) In contrast, the cost of the IDSA-recommended treatment for Lyme disease with antibiotics is about $40 and is covered by most insurance. Fortunately, good citizens with no connection to the insurance industry showed up as well (although in far fewer numbers) to testify against these bills.
But that’s not the worst “chronic Lyme” bill pending in Maryland. That honor goes to House Bill 1266 and its companion Senate Bill 950. These would protect not only “Lyme literate” physicians from disciplinary action by the medical board, but “Lyme literate” chiropractors and naturopaths as well – anyone, in fact, who is licensed under the state’s health practitioner licensing statutes. Typical of the ill-advised state laws protecting quacks in general, the bills allow a “Lyme literate” practitioner to avoid the constraints of evidence-based medicine as long as he or she makes a few disclosures. The bills’ saving grace may be that they are so poorly drafted that the quack practitioner won’t be able to figure out how to comply, thus forgoing the proposed law’s protection.
“Lyme literate” practitioners could not be disciplined:
solely because of the . . . practitioner’s diagnostic evaluation, testing, or treatment of Lyme disease or another tick-borne disease in a patient if [he] . . . discloses to the patient
that the evaluation, test or treatment:
- is integrative, complementary, alternative, nontraditional or nonconventional, but none of these terms is defined;
- has risks and benefits, and what they are, and its FDA “status;”
- may not be widely recognized in the medical profession and “subject to disagreement among qualified medical experts.”
If the patient has a “potentially significant medical condition” and hasn’t yet had a “conventional diagnosis or treatment,” she must be told of medical specialties that may provide her with other options. All patients must be told of “significant known risks of deferring widely accepted treatments, if any, for the patient’s condition.”
This last bit really got me confused. If the practitioner thinks the patient has “chronic Lyme,” does that mean no other specialties could provide her with other options, because no other specialties believe in its existence? Or, on the other hand, is the “Lyme literate” practitioner going to be forced to consider that she may have a “conventional” disease or condition and not “chronic Lyme,” in which case, how is he going to justify his ruling out that condition in favor of “chronic Lyme?” And when determining the risks of deferring accepted treatments for the patient’s condition, do we pretend the condition is “chronic Lyme” or are we talking about the patient’s real condition?
In any event, none of this exempts the practitioner from discipline if the evaluation, testing or treatment has a “significant safety risk greater than the conventional methods” and the risk is not outweighed by the potential benefits. By “conventional” medical standards, this would seem to rule out long-term antibiotics in every case. But, having been legislatively forced to accept the existence of “chronic Lyme,” do we also have to accept the benefits of long-term antibiotics claimed by “Lyme literate” practitioners, or are we allowed to point out that several clinical trials showed that they provide no benefit?
In other words, once pseudoscience is made into fact by this bit of Legislative Alchemy, will the medical board prosecutors be allowed to rely on science at all in making their case? Just how far does the medical board have to go in pretending to believe in a fake diagnosis and its attendant “treatment?”
While passing a law shielding substandard practice is ill-advised and will make prosecution more difficult, fortunately it is not an absolute bar to prosecution. In 2014, New York passed a similar bill. Yet, 2017, two leading lights of ILADS were successfully prosecuted by that state’s medical authorities using the clever strategy of avoiding the “chronic Lyme” issue altogether and simply focusing on the atrociously bad medical care these two delivered. After all, if a physician is willing to ignore efficacy and safety to the point of prescribing long-term antibiotics for a fake diagnosis, it is unlikely he or she is otherwise meeting the standard of care in his overall treatment of patients. One particular requirement that tripped up these “Lyme literate” physicians was failure to keep adequate medical records, such as documenting a rationale for treatment.
The “Lyme literate” cabal seems to have learned from its substantial experience in disciplinary proceedings. Maryland’s proposed legislation also protects them from being disciplined for record-keeping and, much more broadly, all other regulatory requirements, “for acts or omissions that arise from professional differences of opinion” if the practitioner has acted in good faith to comply with the intent of the requirements. It is interesting to note that only “chronic Lyme” practitioners are legislatively blessed with this particular good faith exception.
Finally, if the medical, chiropractic or other healthcare practitioner board uses a system of peer review in standard of care cases, these bills ensure that at least one member of the review panel include a practitioner with “demonstrated training, competence, and experience in the same methods” as the licensee facing discipline, thereby insuring that quacks will be protected by other quacks.
Pennsylvania, Indiana and Illinois
Similar bills are pending in Pennsylvania, Indiana, and Illinois, although none is as complicated, or provides as much protection for “Lyme literate” practitioners, as Maryland’s.
Pennsylvania House Bill 174 begins with a swipe at the IDSA, noting that there are “multiple” diagnostic and treatment guidelines for Lyme disease but the National Guideline Clearinghouse maintains only the ILADS guidelines, having removed the IDSA guidelines because of their being “outdated and not in compliance with current standards.” (In fact, the IDSA is reviewing the evidence and developing new guidelines.) The bill fails to note the very low level of evidence that support the ILADS guidelines.
HB 174 forces insurers to cover antibiotic treatment for Lyme and related tick-borne illnesses even if the treatment is “unproven, experimental or investigational” for whatever “duration the health care practitioner determines appropriate for the patient” for controlling both the patient’s [presumed] infection or symptoms. It also provides immunity to physicians, nurse practitioners and physician’s assistants from disciplinary action “solely for” diagnosing Lyme disease or prescribing long-term antibiotic therapy as long as the diagnosis, treatment plan and ongoing monitoring has been documented in the patient’s records.
HB 174 passed in the House and has moved to the Senate for consideration. A similar bill, Senate Bill 100, is also pending there.
Indiana’s Senate Bill 284 manages to combine these provisions (which are almost identical to Pennsylvania’s) as well as those similar to Maryland’s law requiring that patients be told that standard lab tests for Lyme are “problematic” and “often result in false negative and false positive results” and that, if the patient’s results are negative, it doesn’t necessarily mean he doesn’t have Lyme disease. If he continues to have symptoms, according to the mandated statement, he should consult a health care provider about retesting “or additional treatment.” Even though this sort information isn’t back by good evidence, it is the perfect segue into the “Lyme literate” physician’s office, who will happily offer unvalidated testing and “additional treatment.”
Finally, in Illinois, House Bill 4515, also prohibits the medical board from disciplining physicians who diagnose and treat “chronic Lyme.” The physician must have examined the patient, gotten informed consent, provide a “medical reason” for the treatment, informed the patient of “other treatment options” and his or her credentials, and make a medical judgment based on “a thorough review of all available clinical information on Lyme disease.” Of course, “Lyme literate” physicians already rationalize their way through all of these steps to a diagnosis of “chronic Lyme,” so how much protection this offers patients is questionable. On the other hand, patients can be comforted by the fact that the legislation requires the physician to determine:
the treatment will not, in the opinion of the [physician], result in the direct and proximate death of or serious bodily injury to the patient.
Indirect causation of death and minor bodily injury are apparently ok and no risk-benefit analysis appears to be required.
You can gauge the passion behind HB 4515 by what the Illinois General Assembly calls “witness slips,” indicating pro and con stances on the bill. There are 286 witness slips in favor of the bill and only one opponent, the Illinois Department of Financial and Professional Regulation, upon whose unfortunate shoulders will fall the task of trying to discipline “Lyme literate” physicians after the legislature ties one hand behind its back.
You can check on the status of bills mentioned in this post by clicking on the links, which will take you to the states’ legislatures’ websites. The website Lyme Science has a list of all state “chronic Lyme” bills with summaries and links to bills and other helpful information. (Yes, there are more, although none, as of this date, protecting “Lyme literate” practitioners from prosecution.) To oppose these efforts, check out the American Lyme Disease Foundation’s excellent list of questions and answers exposing common misinformation about Lyme disease. The IDSA also has helpful materials on its website, especially its Lyme Disease and State Policy Primer for State Legislators.
Don’t just complain about quackery. Do something about it.