IDSA makes it official–input period extended for all to April 24th

Lyme patients take a lot of heat, frankly too much heat. Sometimes reporters make errors, don’t have enough facts, and aren’t fully informed. And that is rough. But it is even rougher when reporters are informed and given the correct information and then ignore half of it. So what do you do? Well, CALDA has written the Chicago Tribune protesting the highly biased reporting in its December 8, 2010 article on Lyme disease. We have asked them to publish an Op Ed piece by CALDA. We believe that reporters have an ethical obligation to report on stories in a balanced manner. They also owe it to patients to set out both sides of a scientific debate. To do otherwise, puts the lives and health of thousands of sick people in danger. What do you think? If you are interested in supporting this effort, please write the Tribune (emails below). Ask them to publish an Op-Ed by CALDA to set the record straight. A tip of the hat to Ellen and the NYC Lyme Activism group for their wonderful work on this project. More information after the jump. . .

Some of you know that I am honored to be a patient representative for the PCORI patient engagement panel. PCORI stands for Patient Centered Outcomes Research Institute, an agency created by Congress that funds $500 million dollars of research a year.) What is unique about PCORI is that it funds research that is “patient centered”—research that puts patients at the center of the process. Today, PCORI has released the standards for measuring whether research is truly patient centered. These include involving patients in determining the research questions and the characteristics of study participants, monitoring the conduct of the research, participating in study recruitment and data collection, and the dissemination of study results. The standard calls for reciprocal relationships where researchers and patients learn from each other. It also calls for patient/researcher partnerships and an environment of trust, transparency and honesty. Now, doesn’t that sound like something that Lyme patients need?

The parallels between breast cancer and Lyme disease are not obvious, are they? I was surprised by them myself. Breast cancer patients have two treatment options (sound familiar?). Mastectomy removes the entire breast, while the newer procedure, a lumpectomy removes only the tumor and immediately surrounding tissue. Consider this: lumpectomies used to be controversial and were opposed by an entrenched medical establishment. It’s hard to imagine, isn’t it? Even harder to imagine is that women had to pass legislation in 20 states to obtain the right to choose between lumpectomy and a radical mastectomy. Physicians were afraid to perform lumpectomies for fear of losing their license. We have passed legislation in 3 states so far protecting physicians who treat Lyme in defiance of the IDSA guidelines from medical board action. But, wait there's more..

A recent article in Lancet written primarily by authors of the IDSA Lyme guidelines aims ”to blow apart the world of the Lyme disease advocates”–a goal that sounds more appropriate to warfare than medical journalism. Most of the authors of the article were under investigation by the Connecticut Attorney General for violation of antitrust laws in connection with the development process for the IDSA Lyme guidelines. The opinion piece is included in Lancet’s “personal view” section and reads like a personal vendetta from those named in the antitrust investigation, referring to patient advocacy groups as “antiscience” and making ad hominem attacks on physicians who treat chronic Lyme disease.

Today, ILADS sent a letter to the IOM expressing its concerns about the lack of balance in the panel and the speaker list for the Lyme State of the Science conference. Not surprisingly, it was concerned primarily about the exclusion of ILADS physicians from presenting at the conference and with the large roles handed to Dr. Wormer, chair of the IDSA Lyme guidelines panel, and Dr. Aguera-Rosenfeld, who until recently worked at NYMC with him, are both known to have biased views regarding the diagnosis and treatment of Lyme disease. Exclusionary conduct on the part of the IDSA has prevented the type of scientific debate that is essential to understanding where the science in Lyme disease rests. ILADS took issue with the large roles handed to the IDSA in the diagnosis and treatment issues at the conference, stating: “There is a significant disconnect between IDSA and the community of physicians who treat Lyme disease. There is also an urgent need for transparency in recognizing the limitations of the existing Lyme research. The bulk of the research on Lyme treatment has been controlled by IDSA researchers. Their research is based on sample populations that do not reflect those seen in clinical practice.” Lyme treatment research has been plagued by sample sizes that are too small to measure clinically relevant treatment effects and that do not reflect the types of patients seen in clinical practice. The link to the ILADS letter follows the jump. . .

Now that two studies have shown that IDSA guidelines are generally long on opinion and short on evidence, what should the IDSA guideline panel do? The study by Lee, discussed in yesterday's blog, found that IDSA frequently makes strong recommendations, but that these strong recommendations are supported by strong evidence only 15% of the time. Dr. Maloney found that the majority of recommendations in the IDSA Lyme guidelines were based on the weakest level of evidence–expert opinion. Shouldn't clinical judgment only be suppressed when there is strong evidence? That's what the American Academy of Pediatrics says in its guidelines on making guidelines.