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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.