Lyme, evidenced based medicine, Fallon and the Institute of Medicine

I recently gave a talk about Lyme and EMB, evidenced medicine.  I had no idea that Brittany, who runs my Facebook page, live-streamed and posted the talk on Facebook.

The Institute of Medicine holds a lot of sway in the medical community.  Something called “patient centered medicine” is said to be enshrined.  There are many facets to patient centered care -- the one of interest to me here is that patient preferences are given credence.  In fact, the IOM states not to consider patient preferences is morally wrong, a violation of patient rights.  Vocal critics say this ignores EBM, evidence-based medicine. Not true. EBM is part of the consideration, not the only consideration.

Evidenced based medicine doesn’t require consideration of scientific plausibility.  If the results of a study contradict accepted science or reality, then it is likely the study if flawed. 

This is about where we are with Lyme disease, I think.

All clinical trials are flawed and biased in many ways. The interpretation of results is frequently fraught. Text books of statistics  are full of complex mathematical equations and show innumerable ways of crunching the same data and numbers.   If an investigator does not like the conclusions, other statistical models can be tried until he finds the one meets the objective: support preexistent beliefs.  It is like trying on new shoes. This is particularly true when subjective questionnaires are used for endpoint analysis.

To avoid bias: Methods of statistical analysis is a variable which must be controlled, delineated before the start of the trial and strictly adhered to.  Appropriate clinical questions need be determined  at the outset. 

For medical studies THE statistical question is: did the treatment benefit the treated cohort in a manner that cannot be explained by chance alone?  Or with 95% certainty.

In the Fallon study:  Did treated patients have cognitive improvements 12 weeks after therapy compared to the group given placebo, by statistical analysis?  In the treatment group were improvements in fatigue durable after 24 weeks? The answer in each case is yes.  As Dr. Fallon later states, the study shows efficacy: the treatment works.

Those who claim the study was negative are looking at the wrong question.

The study showed:  IV Rocephin 10 weeks caused cognitive improvements at 12 weeks which later, without further treatment reversed, whereas--improvements of physical symptoms like pain, fatigue and function were maintained at 24 weeks.  

The study conclusion stated the treatment was not effective for PTLDS.

This never sat right with me.  The conclusion is not reflective of what the study shows.  Do University internal politics had something to do with crafting the wording. This process is certainly not transparent.

The terms efficacy and effectiveness sound the same but are different.  Efficacy is the demonstration of A positive clinical response to treatment.   Effectiveness refers to successful clinical use of a treatment as a whole.

The second standard had the same chance of being proved as threading a camel through the eye of a needle.  The first standard shows proof of concept and that is huge. The conclusion does not reflect the paradigm shattering enormity of the study.

The favored null hypothesis of mainstream medicine in 2007 (and now?) was:  Persistent symptoms after Lyme treatment is a post treatment Lyme syndrome, an autoimmune affect, all the (clinically significant) spirochetes (Borrelia burgdorferi) have been eliminated.  

Fallon’s study proves the alternative hypothesis: Post treatment symptoms are associated with persistent infection and respond to additional antibiotics.

The IDSA makes the classic type I mistake of failing to discard the incorrect null hypothesis.

EBM -- IDSA guidelines were written on the basis of a glaring mistake of logic and statistics.

Biological plausibility, although not a necessary consideration here, was not looked at.  The fact that Lyme had not been eradicated in animal models then (and now) suggested that persistence of Lyme in human cases is highly likely.  The results should not have been surprising. 

In the IOM approach, EBM is decided by a closed panel, opinion driven, and at best provides narrow endpoints lacking generalization. The two other key elements of patient oriented medicine are medical judgement and experience – the art of medicine and patient preferences.

The IOM argues that clinical experience is necessary to fill in gaps or gaping holes left with only the EBM approach.  The IOM brilliantly exposes the inherent weakness of EBM.  Within this framework doctors are healers in the traditional sense and allowed to figure out the puzzle each patient is. This is critical when the disease is extremely complex and multisystem.  

My next talk will be about treating Lyme.  I want to get into some specifics.  I hope to tease out the roles of science, EBM, clinical experience, patient preferences, and the principal of first do no harm.

.