There is so much we don’t know about Lyme–the disease’s course and unusual symptoms, nor how to diagnose Lyme accurately, let alone agreement on how to treat the disease. Part 1 of the Lyme Wars gave some of the background as to the different perspectives of major guidelines from Infectious Diseases Society of America (IDSA), the International Lyme and Associated Diseases Society (ILADS), and the UK’s National Institute for Health and Care Excellence (NICE).
Here I review diagnostic and treatment issues. This was prompted by IDSA (written with the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR)) inviting people to comment on their draft guidelines. You can comment until August 10, here.
TL:DR summary. IDSA puts more weight on current lab tests, “2-tiered testing” than the others. They also have strict treatment guidelines. The International Lyme and Associated Diseases Society (ILADs) will accept more home-brewed tests and may treat patients indefinitely, depending on symptoms. And National Institute for Health and Care Excellence (NICE) is in the middle, with firm guidelines, but which have some flexibility based on symptoms and the physician’s clinical experience.
We know that serology can be falsely negative, especially if a patient has taken antibiotics, yet IDSA says that a negative assay “essentially rules out the diagnosis of Lyme.” I agree it makes it far less likely, but I hate categorically dismissing the possibility, especially in someone with exposure in a high-risk area.
As I’ve mentioned previously, diagnostics are dismal and the amount of government spending on surveillance and diagnostics pales in proportion to their impact both on patients’ lives and economic impact. Johns Hopkins estimates the costs of Lyme to be up to $ 1.3 billion a year, not including indirect and societal costs.
Yet the NIH and CDC spend just $ 768 and $ 302 for each new case of Lyme disease, according to the HHS report to Congress.
There is considerable controversy over tests. I understand that tests need to be validated and that some “home brewed” tests had too many false positives—saying normal healthy people had Lyme. IDSA states tests should use “clinically validated assays.” But current assays miss up to 30% percent of cases—an unacceptably high percentage if you are a patient.
Further, because antibody tests may be positive for years, there is no good way to know if someone has been reinfected by a second tick.
Lorraine Johnson, JD, MBA, CEO of LymeDisease.org, expressed her concern to me that FDA-“cleared” tests are not verified for accuracy and that requiring tests be approved or cleared will “leave out innovators.”
With most people believing in climate change and the documented spread of ticks through wider swaths of the country, why aren’t tick-borne diseases getting more attention and funding? What will it take to have an accurate test for Lyme disease?
Here we get into more differences between recommended treatment regimens. For acute Lyme with rash, IDSA recommends 10 days of doxycycline or fourteen days of a penicillin type drug. NICE recommends 21 days, and ILADS 4-6 weeks.
NICE says, “Consider a second course of antibiotics for people with ongoing symptoms,” using a different antibiotic. They add, evidence to guide treatment “is of poor quality, out-dated and often based on small studies.”
NICE recommends Lyme disease should not be ruled out by negative tests if it is strongly suggested by the clinical assessment.
For arthritis, IDSA recommends 28 days, as well as an additional course if the arthritis is refractory, concurring with NICE more than elsewhere.
I view the NICE guidelines as less dogmatic and more focused on the individual patients. For example, NICE recommends to do a Western blot (immunoblot test), despite an initial negative ELISA when there is clinical suspicion of Lyme disease
NICE also decided that longer courses of 21 days of treatment should be offered, if clinically indicated, because of their concern at low cure rates in some studies and the lack of clear evidence for shorter courses.
I reached out to Dr. Sam Donta, a former Boston University professor and physician experienced in treating Lyme disease. He stressed that he feels we should regard treating Lyme similarly to tuberculosis, where 18 months of antibiotics used to be standard treatment. “If you’ve been sick for a year or two, a three-month trial (of antibiotics) is inadequate,” Donta said, questioning the data regarding duration of treatment. Coming back to our lack of decent tests to guide therapy, Donta added, “In the absence of direct tests, clinical observations are important.”
ILADS’ recommendations are at the opposite end of the spectrum from IDSA’s, emphasizing patient preference. This is appropriate up to a point, but assumes that the physician a) is knowledgeable of risks and benefits b) can and will communicate the risks of prolonged antibiotic therapy to patients and c) doesn’t have significant conflicts of interest. This last point is huge. Prolonged IV antibiotics, in particular, can be quite profitable for physicians and clinics and raise my alarms. Many patients and physicians also appear to underestimate risks. Since my practice included seeing patients with complications of antibiotics and IV catheters, including sepsis and death, I am conservative about antibiotic use.
I also cringe at the label “Lyme literate” practitioner, which implies that those who disagree are uneducated or behind the times.
I feel the same way about blind adherence to “patient preference.” Although not an official ILADS position, there appear to be many practitioners who advertise themselves as Lyme “literate” and offer “treatments” of dubious value, like ozone therapy, homeopathy, and aroma therapy, all because “that’s what patients want.” That seems grossly irresponsible and akin to letting a toddler run the household.
Composition of IDSA guidance committee
One of the strong criticisms of the IDSA guidelines committee is that its membership excluded ILADs members (like Dr. Donta) and members of the Tick Borne Disease Working Group who would have challenged their proposals. I understand the difficulties of reaching a consensus but it is counterproductive to have this level of antipathy between the two groups, each of whom have dramatically different visions of what will provide the best outcomes for Lyme patients.
Mainstream press coverage
We’ve had two article this past month in mainstream news that are further complicating diagnosis and treatment. The first, which I addressed here, downplayed the seriousness of Lyme and how difficult it can be to treat. The second, focusing on difficulties in diagnosis, was quite good, except for the last line, which inaccurately says that ticks have to be attached for 48 hours to transmit Lyme.
Since only half of people who live in an area at risk for Lyme take precautions to prevent bites, perhaps the media should emphasize community education.
As I mentioned previously, the best that we can hope for immediately is to reduce cases by beefing up prevention:
“Treat clothes, shoes, and socks with permethrin. It is safe and effective and is the best thing you can do.
Use DEET, picaridin, oil of lemon eucalyptus, or other EPA registered insect repellents.”
There is some evidence that promptly bathing after being in tick habitat and putting clothes in the dryer on hot can reduce tick bites as well.
What this discussion about Lyme and how guidelines come to be illustrates is how little we know about Lyme: neither the disease’s course, nor how to diagnose it, let alone have agreement on how to treat it.