New York may soon join a handful of other states who reject science-based guidelines for the treatment of Lyme disease in favor of ideological guidelines based on the vociferous lobbying of patients and “Lyme literate” health care providers. Ignoring science is an unfortunate but well-known legislative phenomenon. I’ve discussed it a number of times on SBM, in the form of Legislative Alchemy, the process by which credulous state legislators turn practitioners of pseudoscience into state-licensed health care professionals, such as naturopaths, chiropractors, homeopaths and acupuncturists.
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):
Lyme disease is diagnosed by medical history, physical exam, and sometimes a blood test. It may take four to six weeks for the human immune system to make antibodies against Borrelia burgdorferi and therefore show up in a positive blood test. That is why patients with the Lyme rash usually have a negative blood test and diagnosis is based on the characteristic appearance of the rash. Patients with other clinical manifestations such as Lyme arthritis will usually have a blood test. Anyone who has symptoms for longer than six weeks and who has never been treated with antibiotics is unlikely to have Lyme disease if the blood test is negative.
Treatment with antibiotics usually eliminates the symptoms, but delayed treatment can result in more serious problems.
“Chronic” Lyme disease (CLD) 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:
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.
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 disease. It is these patients who have been victimized by “Lyme literate” doctors and alternative medicine providers. The main treatment for CLD is long-term antibiotics, for which there is no evidence of effectiveness but serious risks. (Also here.) 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. (And here too.)
The whole idea that the scientific community is somehow ignoring the evidence is nonsensical when you think about it. What possible incentive would the IDSA and others have to deny the existence of CLD or reject long-term antibiotic therapy? Infectious disease doctors could make a bundle from treating patients with oral, IM and IV antibiotics, especially if it is fee for service. Of course, doctors who promote these treatments, and provide them, likely make a tidy profit doing so (again, especially if they are fee for service). What do you imagine their incentives are?
State legislatures fall for the manufactroversy
But never let the lack of controversy among scientists get in the way of a good manufactroversy, as we’ve seen again and again over in the anti-vaccination department of the nation’s wildly successful anti-science movement. After the manufactroversy has poisoned the well, a variation on the “teach the controversy” strategy can be deployed, whereby credulous legislators, convinced that a controversy among scientists actually exists, proceed to legislate the manufactorversy into existence. That turns the manufactroversy into a real controversy, you see, because the law now says the controversy exists. (Just like the law says chiropractic subluxations and acupuncture meridians exist.)
Lobbying by CLD advocacy groups has resulted in several states passing laws blocking state medical boards from taking action against a physician because he prescribes long-term antibiotic therapy. Currently, Connecticut, Rhode Island, Massachusetts and California all have these laws on their books. In addition, Maine passed a law requiring state health authorities to provide information to the public about Lyme disease from both the Infectious Diseases Society of America and the International Lyme and Associated Diseases Society, the latter of which promotes the validity of CLD diagnosis and the use of long-term antibiotics. Minnesota, Connecticut and Rhode Island require insurers to cover CLD treatment.
Rhode Island’s law bears a closer look, as it demonstrates how lobbyists can successfully insert unsupported assumptions into a law. In its preamble, the bill which eventually became law states that:
Physicians whose practices are devoted to treating chronic Lyme disease patients, and who continue to provide treatment if they feel such treatment is medically necessary, have noted significant improvement in the condition of their patients.
As Steve Novella explained, this perceived improvement could well be due to the placebo effect. Or, it is possible that the antibiotics are having an anti-inflammatory or other pharmacological effect that offers symptomatic relief, in which case we should explore treatments that offer these benefits without the risks of long-term antibiotics. Yet the Rhode Island legislature saw the reported benefits (which could also be due to a number of other reasons, such as confirmation bias) as reason to exonerate these physicians, while at the same time ignoring the evidence against the existence of CLD and the use of antibiotics to treat it.
The preamble also says that “consensus guidelines for diagnosis and treatment of chronic Lyme disease have not been developed.” I don’t know if that was true in 2002, when the law passed, but it certainly isn’t true now. And just because consensus guidelines haven’t been developed, it doesn’t mean “anything goes.” The law goes on to define “Lyme disease” as an infection consistent with the CDC surveillance criteria,
but also includes other acute and chronic manifestations of such an infection as determined by the physician.
In other words, it gave physicians carte blanche to ignore the substantial evidence disconfirming CLD and warning against long-term antibiotic use.
New York appears poised to join those states protecting “Lyme literate” doctors from prosecution, a position supported by at least one credulous newspaper editorial board. Both the Senate and the Assembly passed just such a bill, which awaits the Governor Cuomo’s signature. He’s indicated he will sign it.
In the hearings leading up to passage of the bill, one legislator said he’d been asked by his constituents “suffering from chronic Lyme disease” to pass legislation like this for a long time because:
This will offer a great amount of relief to families that are truly suffering, that are going bankrupt, they’re mortgaging their homes, trying to find a way to deal with this devastating disease.
Sadly, that indicates to me that a lot of people are being ripped off by “Lyme literate” doctors.
This bill is unlike the others in that it begins with this startling introductory sentence:
Neither the board for professional medical conduct nor the office of professional medical conduct shall identify, charge, or cause a report made to the director of such office to be investigated based solely upon the recommendation or provision of a treatment modality by a licensee that is not universally accepted by the medical profession, including but not limited to, varying modalities used in the treatment of lyme disease and other tick-borne diseases.
This seems to cover not only treatment with long-term antibiotics but pretty much anything any physician wants to dream up in the way of a “treatment modality” for any disease or condition as long as there is not “universal acceptance” that this is not a good idea. Of course, anytime a small group of dissenters wants to take exception to the medical profession, they can argue that there is not “universal acceptance,” no matter how kooky their ideas are.
This interpretation appears to be confirmed by the next sentence in the bill, which says a physician can employ these “varying modalities” as long as the treatment is in accord with this “health freedom” provision of the NY physician practice act that permits the use of:
whatever medical care, conventional or non-conventional, which effectively treats human disease, pain, injury, deformity or physical condition.
I suppose there two outs here for the science-minded. One is that the bill covers only treatments, not diagnoses, perhaps providing some leeway for disciplinary action based on a diagnosis of CLD. The other is the provision in the existing law, which says the treatment must be effective.
All I can say is good luck to the state medical board and the courts in interpreting this one.
The legislature also passed a resolution asking the CDC, the NIH, and other federal agencies for additional Lyme disease prevention efforts and research. One does wonder, however, if they will pay attention to the research produced. If the legislature is ignoring the medical consensus at this point, what exactly is it that would convince them of their folly? And will they go back and repeal the new law (if it becomes law) if this new research somehow persuades them that the IDSA and other responsible experts are, in fact, correct?
Blumenthal: still promoting CLD after all these years
As I explained in an earlier post, former Connecticut Attorney General, and now U.S. Senator, Richard Blumenthal:
sued the Infectious Diseases Society of America (IDSA) and the American Academy of Neurology (AAN) for antitrust violations because both groups reached the same conclusion regarding the non-existence of Chronic Lyme disease.
According to Blumenthal, both groups’ reasoning in reaching the same conclusion “at times used strikingly similar language.” He smelled a conspiracy. In his view, the guidelines “improperly ignored or minimized consideration of alternative medical opinion and evidence regarding Chronic Lyme disease.” Apparently, Blumenthal knew so little about science he didn’t realize that when the same evidence is reviewed by two different groups it is perfectly reasonable for them to come to the same conclusion. Nor did he realize that, in reviewing evidence, it is not appropriate to consider any quack theory that comes along, no matter how ludicrous. The irony is obvious: Blumenthal was willing to accept Chronic Lyme disease despite the lack of evidence that it exists. He then turned around and sued the doctors’ groups for relying on good evidence to support their conclusion that it didn’t.
The suit was settled when the IDSA agreed to review its position. That review has now been completed with the IDSA reconfirming its earlier position after another look at the evidence.
Sen. Blumenthal remains unrepentant and as far as I know has never acknowledge the IDSA’s confirmation of its earlier position in 2010. At a forum last year hosted by, among others, Sen. Blumenthal, he continued to maintain that there is a legitimate controversy in the medical community and that insurers should cover treatments doctors think is best, noting Connecticut’s insurance mandate. The latter sentiment, if applied to quacks and charlatans and all diseases, real or imagined, could drive us all to bankruptcy with increased premiums.
A similar hostility to the current evidence was displayed by U.S. Rep. Chris Gibson (R-NY), who also spoke at the forum. He is the sponsor of legislation recently passed by the House of Representatives, the “Tick-borne Disease Research Transparency and Accountability Act,” now pending in the Senate. Rep. Gibson accused the CDC of “Lyme illiteracy” and spoke of a “bifurcation in the medical community” concerning Lyme disease.
The House bill may not be a bad idea. It forms a “Lyme and Tick-Borne Disease Working Group” to look into the evidence and make recommendations, although it provides no money for the Group to perform its duties. It requires the inclusion of advocacy groups. The bill also requires that a “diversity” of scientific opinion be represented.
As with NY’s effort, however, one wonders exactly what level of evidence would be acceptable to those convinced that their symptoms are due to chronic Lyme disease and that long-term antibiotic therapy is the proper course of treatment. Or to Lyme literate doctors who treat them, whose income is jeopardized by further evidence of the lack of safety and effectiveness. There is clearly a scientific consensus among responsible parties that CLD is not a valid disease and that long-term antibiotic treatment is not only not beneficial, it can be dangerous. What else is necessary to sway the dissenters?
I don’t think anyone doubts there are people who experience fatigue, joint stiffness, neck pain and the like, but for whom no clear diagnosis exists. Nor does anyone doubt that some medical professionals brusquely dismissed their symptoms. And no one doubts that real Lyme disease exists or that improvements in diagnosis and treatment, as well as research into other tick-borne diseases and prevention, is warranted. But none of that is an excuse to take advantage patients with a fake diagnosis of “chronic Lyme disease” or treat them with long-term antibiotics and other dubious remedies. Nor is it a valid reason for advocacy groups to browbeat legislators into enshrining CLD into law or for legislators to equate popularity with scientific evidence.