Lyme Policy Wonk

The Institute of Medicine (IOM) has released its long awaited report on Lyme disease. So should we celebrate or despair? I think there is room for a little of both. We should certainly celebrate the tone of the report, which characterizes the session as “a walk in the woods” to start dialogue and we should celebrate the contributions made by those who attended and participated, whether as patients, advocacy groups, researchers or physicians. I think these people did their very best to represent a side of Lyme disease that is not often given public voice. We should also recognize the contribution to a better process that was achieved by the three groups who pulled out of the hearing (CALDA, LDA, and Time for Lyme). This action resulted in Dr. Benjamin Luft of Stony Brook University being added to the agenda and may have also added to the “tone” of the report. What we should not lose sight of though, is that a civil tone and the inclusion of some patients’ testimony are not enough. This is a debate about science. Debates are about equal time, opportunities to rebut, and not excluding opposing viewpoints. That did not happen here. And, what the IOM left out or left unchallenged harms patients. Our biggest hits were in diagnosis, the exclusion of the topics chronic Lyme and treatment, and the complete exclusion of any physicians from ILADS. Let me drill down into the details.

When I first became involved with Lyme disease, I remember wondering where the pharmaceutical interest was in the disease. Most of your double blind controlled trials are funded by the pharmaceutical industry. This means that if your disease is not on their radar, you’re going to have a long hard slog getting funding for studies on the efficacy of different treatments. Diseases that are on the agenda of big Pharma have a distinct advantage in evidence based medicine because studies, typically large scale studies, have been funded by someone with a dog in the hunt. In other diseases, the dog in the hunt may be overzealous, promoting treatments and selling drugs with little proof of effectively. But when a disease is neglected by big Pharma, the opposite occurs. Research simply isn’t done. And, that becomes a social justice issue when insurers and specialty societies deny patients access to care because research studies haven’t been funded and aren’t likely to be funded. Drugs are expensive to develop and research is expensive to conduct. Recently, GlobalDate releases a report that explains why Lyme disease is neglected and is likely to remain neglected by big Pharma.

I was surprised. I had just settled into my long read of the 217 page new Institute of Medicine report on guideline reform (Clinical Practice Guidelines, We Can Trust, 2010), when the report took an amazing left turn. No, this is not the IOM report on Lyme disease (no telling when that comes out). This is the one on the need for medical guidelines reform in general—not just for Lyme disease. The IOM points to the Connecticut Attorney General investigation into the IDSA Lyme guidelines and says: “This case highlights the need for standardization and transparency in all aspects of systemic data collection and review, committee administration, and guideline development, so that questions about these issues do not detract from the science. [Guideline developers]. . . must be aware of the many, varied observers who will consider their development processes,
particularly when their recommendations are likely to be controversial.” That’s a public slap on the wrist to the IDSA and it matters.

Today, the Institute of Medicine released a new report “Clinical Practice Guidelines We Can Trust”. I haven’t read the entire report (217 pages), but this emphasis on the word trust is important. Lyme patients have a number of complaints with the treatment guidelines developed by the Infectious Diseases Society of America. Mainly, we don’t trust them. Over 80% of the roughly 4,000 respondents to CALDA’s 2009 survey said that they would not choose to be treated under IDSA guidelines. That’s a boatload of dissatisfaction and distrust. Chief among the complaints about the IDSA guideline development process was that the panel was not balanced and excluded those who would be most affected by the guidelines—patients with chronic Lyme and the physicians who treat them. The IOM new report seeks to change this by recommending involvement in the guidelines process by “clinicians and populations expected to be affected by [the guidelines]” and by recommending that a patient or patient advocate be represented in the guideline development. That’s welcome news.

In the movie “The King’s Speech”, the Duke of York tells his unorthodox speech therapist Logue that he has “been t-t-treated f-or this by the f-f-finest ph-ph-physicians.” Logue responds: They are idiots. When the Duke protests that “Th-they h-h-have knighthoods”, Logue responds “Well, that makes it official that they are idiots.” He is talking about hubris and arrogance interfering with medicine and science. So it is with “eminence based medicine”–guidelines that hinge upon the opinion, bias and arrogance of physicians that hold a particular viewpoint rather than science. The IDSA has been called to task in research by its own members that find that the IDSA’s guidelines are based mostly on opinion—not evidence.

Dr. Ben Beard of the CDC met with directors of CALDA on March 10 as part of an effort to reach out to Lyme patient groups across the nation. After meeting with CALDA, he attended the regularly scheduled meeting of the California State Lyme Disease Advisory Committee, which was created under legislation sponsored by CALDA to encourage dialogue with the California Department of Public Health. If you have not met Ben Beard before, he is both engaging and likable and has a measured tone. CALDA believes that respectful dialogue is essential to moving forward for the Lyme community, and we are pleased with this first step. We also believe that patients need to be meaningful participants in any solution for Lyme disease. We raised a number of concerns about the CDC's Lyme disease policies, including the need to treat to cure disease, the education of physicians and government funding of research. Here are the issues that loom large.

Dr. David Resnik at the University of Wyoming is a plainspoken public health care policy ethicist. When he describes the obligation that governments and others with positions of authority in health care have when communicating with the public, he may sound a bit like your mother. It is "to tell the truth, the whole truth and nothing but the truth". The obligation is to tell the public the information that they need to be able to make individual choices. This includes not exaggerating or preying upon fear to manipulate people-even if you do so with good intention. A recent case study, anecdote if you will, violates each of these tenets, one by one. . . More after the jump.

CALDA has just sent a letter to National Institute of Allergy and Infectious Diseases (NIAID) asking them to pull the plug on an experiment that threatens to harm Lyme patients. The study involves allowing live tick larvae to feed on patients. It is impossible to ensure that ticks are truly sterile and do not carry unidentified pathogens. In addition, tick saliva as well as Borrelia burgdorferi suppress the immune system of patients. Both factors place patients who enroll in the study at risk. Because of this, we feel the study is unethical and could harm patients. Keep reading for details. . .

During 2010, Dr. Stricker and I published nine articles or letters on Lyme disease. Shortly after the New Year, another publication by us came out. This post lists these 10 publications and tells you how to access those that are available without charge. More after the jump. . .

A recent study evaluated over 4,200 IDSA guideline recommendations and concluded that more than half—really?—more than HALF? were based on no more than expert opinion and anecdote, not evidence. As it turns out, only 1 of 7 treatment recommendations were based on high quality research trials. According to a recent article in Reuters, in the absence of a strong evidence base “the recommendations end up depending largely on who's on the guideline-drafting panel and any assumptions or opinions they may bring to the process.” The IDSA likes to paint patients who oppose its Lyme guidelines as “anti-science” misfits, but the truth is that patients just want some honesty and transparency. We’d like a little more evidence and a lot less opinion. We’d like more treatment options when the evidence is poor. Evidence based medicine is supposed to be about wringing the bias out of the process, but expert opinion is all about bias. One doctor who served on many IDSA panels acknowledged that “we are operating on a lot of bias. We recognize we have bias, but it’s impossible to eliminate when there is a dearth of data.” Well, this is clearly wrong. It is easy to acknowledge the lack of evidence and provide treatment options. Just like the prostrate guidelines do. More after the jump. .. .