I noted with understanding that the Doubtful News can’t take it anymore. The relentless tsunami sewage slurry of pseudo-science (who says I can’t alliterate?) has worn her down. She is:
currently experiencing a phase in which I can’t seem to bring myself to promote another ridiculous story in the media about a haunted location, scary sounds from the sky, or the latest outrage fueled by ancient superstition. You might call that… jaded. It’s been over four years now of nearly daily effort to keep track of the weird world of woo. It can wear one down when virtually or literally the same thing appears and reappears over and over as if it hasn’t already been passed around a million times.
I sympathize. I have had a touch of SCAM ennui of late. It is a bit due to the repetitiveness of the SCAMs. I still find the variations on the theme of pseudo-sciences curious. It is like infectious diseases where every case has unique and subtle diversity so no two SCAMs are the same. But there are almost 4,000 clinical trials on acupuncture and I would wager that they all have several of the same half-dozen fatal errors. It is like hand hygiene at work. We have known for, oh what, 160 years, that hand hygiene prevents the spread of disease but people still can’t do it right. We know how to do a good clinical trial but the SCAMsters just can’t seem to figure it out.
The ennui is not the seeming futility of the endeavor. I have always been comfortable with futility, secure, as an example, in the knowledge that someday I will be consumed by the bacteria I spent a career killing. Unless, of course, they get me cremated right away. I keep looking for a motto for the SfSBM; I am attracted to “Sisyphus had it easy.”
The painful necessities of Lyme literacy
There are some topics I feel an obligation to cover, a necessity that is hard to tackle with enthusiasm, like taking out the trash. But after six years of writing for this blog I fear I am running out of ways to discuss SCAMs in novel ways. Simply rolling my eyes and making a gagging motion is hardly a sufficient blog entry, which was my initial response to “Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease” over at the National Guideline Clearinghouse (NGC). Not unlike Publishers Clearing House, the NGC are not responsible for the content of the product they offer as long as the guidelines meet their criteria, but I doubt they are going to send me a big check.
Some of those criteria include:
A description of study selection that includes the number of studies identified, the number of studies included, and a summary of inclusion and exclusion criteria.
A synthesis of evidence from the selected studies, e.g., a detailed description or evidence tables.
A summary of the evidence synthesis (see 3d above) included in the guideline that relates the evidence to the recommendations, e.g., a descriptive summary or summary tables.
I am reminded of several posts ago where I discussed how the system was gamed to allow a naturopathic clinic to be a center of excellence. I have filed a Freedom of Information request for more information on that farce. I get the hint that these Lyme guidelines are the same. This guideline is like that curious incident of the dog in the night-time; it is what is not mentioned that is interesting.
An update and a downvote
There are numerous issues with the International Lyme and Associated Disease Society (ILADS) guidelines, some of which I have discussed in the past. One problem I have as I write this is that the Infectious Disease Society of America (IDSA) guidelines are being updated with an expected release date in the fall of 2016. So we have at least a year to wait before we have a more reality-based approach to Lyme disease.
Time and energy preclude addressing every part of even this brief guideline. I hope that when the IDSA releases their guidelines they will also do a compare and contrast with ILADS. But I will not hold my breath. When it has come to Lyme and vaccination the IDSA has not been on the front lines of defending science against pseudo-science.
So I will focus on one section, the need for retreatment of Lyme:
…in the panel’s judgment, antibiotic retreatment will prove to be appropriate for the majority of patients who remain ill. Prior to instituting antibiotic retreatment, the original Lyme disease diagnosis should be reassessed and clinicians should evaluate the patient for other potential causes of persistent disease manifestations. The presence of other tick-borne illnesses should be investigated if that had not already been done. Additionally, clinicians and their patients should jointly define what constitutes an adequate therapeutic trial for this particular set of circumstances.
When antibiotic retreatment is undertaken, clinicians should initiate treatment with 4 to 6 weeks of the selected antibiotic; this time span is well within the treatment duration parameters of the retreatment trials. Variations in patient-specific details and the limitations of the evidence imply that the proposed duration is a starting point and clinicians may, in a variety of circumstances, need to select therapeutic regimens of longer duration.
What do you call a recommendation based on very low quality data? Belief. Belief is what you do in the absence of data. Like most the ILADS recommendations, the recommendations, often strong recommendations, are based on low-quality data. But more than basing their suggestions on low quality data, they ignore the fact that there is data that contradicts their position.
There are clinical trials that address the issue of re-treating Lyme. Like all clinical trials, you can find issues in study design when you read them carefully. But they say more or less the same thing: treating patients with persisting symptoms of Lyme has no long-lasting effects:
- “A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy“:
IV ceftriaxone therapy results in short-term cognitive improvement for patients with post-treatment Lyme encephalopathy, but relapse in cognition occurs after the antibiotic is discontinued.
- “Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial“:
Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.
- “Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease“:
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.
You can quibble over issues in these studies. I can with every clinical trial. But all the information points in the same direction: there are no persisting symptoms after treatment for Lyme that are amenable to further antibiotic therapy. And it is better data than that used to support retreatment.
I love killing microscopic corkscrews
As an ID doc who spends a lot of time with hard-to-kill organisms, spirochetes are refreshingly susceptible to antibiotics and die with ease. I am well aware of the various arguments to suggest that Lyme has developed ways to avoid being killed by antibiotics. That would be a blog entry in itself, but I have read the papers and find them less than compelling and, when considering the biology of spirochetes, probably not even wrong. I have suspected that the complete lack of response to even months-long courses of IV antibiotics is a strong clinical suggestion that there is nothing there to kill. Patient being treated for chronic Lyme just never seem to get better with ILADS-based therapies.
Don’t trust the antitrust
In 2006 there was an antitrust investigation by the Connecticut Attorney General that cost the IDSA money they could ill afford. They settled and as part of the settlement the IDSA agreed:
to convene a Review Panel whose task would be to determine whether or not the 2006 Lyme Guidelines were based on sound medical/scientific evidence and whether or not these guidelines required change or revision.
I will also mention with no irony that one of the complaints about the IDSA guidelines was that those who were involved with their production were compromised by ties with industry, and biased against chronic Lyme and its treatment. The National Guidelines Clearinghouse document was written in part by the President of ILADS, the organization that is the biggest proponent for the long term treatment of Lyme. Oh no, no bias here. Keep on moving.
And now the big reveal!
To date, there is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease.
Panel Determination/Discussion – The Review Panel determined that this recommendation is medically/scientifically justified in light of all of the evidence and information provided (7-1).
Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (>6 months) subjective symptoms after recommended treatment regimens for Lyme disease (E-I).
Panel Determination/Discussion – The Review Panel determined that this recommendation is medically/scientifically justified in light of all of the evidence and information provided (8-0)
And they further noted on review:
- The prospective, controlled clinical trials for extended antibiotic treatment of Lyme disease have demonstrated considerable risk of harm, including potentially life- threatening adverse events.
- Prospective, controlled clinical trials have demonstrated little benefit from prolonged antibiotic therapy. Nearly all primary outcome measures have failed to demonstrate a benefit to prolonged antibiotic therapy. Statistically significant improvements in treatment groups were not demonstrated across studies, were nonspecific, were of unclear clinical importance, and in one case, not sustained at the end of the trial.
- The risk/benefit ratio from prolonged antibiotic therapy strongly discourages prolonged antibiotic courses for Lyme disease.
Emphasis in original, citations removed. The NGC guidelines not only use weak data, they ignore the data that doesn’t fit their world view. I suspect next they will run for President of the United States.