Shelter Island has among the highest Lyme disease incidence rates in New York State.
Mr. Blumenthal's findings of actual conflicts of interest led to a public hearing in Washington D.C. last Thursday during which a new panel heard testimony on why the guidelines should or should not be changed. Most at issue was whether, or how, chronic Lyme disease could be defined. If it cannot be defined, definitive guidelines cannot be written on how to treat it.
The new panel heard from 18 experts, two of whom were on the 2006 panel. When the final report is issued, which is expected by the end of the year, the IDSA review panel can recommend no changes be made, revisions to certain sections or a complete re-write of the guidelines. “Should our review panel recommend a change, IDSA will convene a separate panel to carry out that task,” Review Panel Chair Carol Baker stated in a press release prior to the hearing.
Though he did not attend the hearing, Mr. Blumenthal watched via webcast, which is available for viewing on IDSA's website at idsociety.org/Content.aspx?id=15026. Afterwards, he told the Greenwich Time newspaper, “The panelists seemed to be listening very intently, asking probing and perceptive questions, which augurs well for the outcome.”
What that outcome will be remains to be seen. Those arguing to change the guidelines and those advocating for keeping them were far apart on basic issues. Dr. Gary Wormser, who chaired the 2006 IDSA panel, quoted the guidelines when he said during the hearing, “IDSA considers adherence to these guidelines to be voluntary.”
That statement ran in direct contradiction to the words of Lorraine Johnson, CEO of the California Lyme Disease Association. The “highly restrictive” IDSA guidelines, she said, “preclude the meaningful exercise of clinical judgment” and “deprive patients of treatment options.”
That is because, she went on to say, the guidelines “are treated as mandatory” by health and disability insurers, medical boards, physicians, hospitals and even school systems and child care agencies.
“My patients are being denied treatment based on the IDSA guidelines,” added physician Daniel Cameron of the International Lyme and Associated Diseases Society (ILADS).
The other main disagreement between the two sides was on whether there is such a thing as chronic Lyme disease and if there is, how to treat it.
There is no real definition of chronic Lyme disease, Dr. Eugene Shapiro, a 2006 IDSA panel member, said. Though patients may exhibit chronic symptoms, he added, they may show no objective signs of Lyme disease. If there is such a thing as chronic Lyme disease, Dr. Wormser said, “reinfection needs to be excluded.”
It can be, said a former ILADS president, Raphael Stricker. He said persistent infection causing persistent symptoms is plausible. In those cases, prolonged treatment is relatively safe and justifiable. Dr. Wormser said the few studies that do suggest persistence of Lyme symptoms are either unconfirmed or could not be replicated when attempted.
Going a step further was Arthur Weinstein of Georgetown University's medical school. He said post-Lyme syndrome should not be defined separately. Further studies, he said, could “shed light on its pathophysiology and appropriate treatment.”
To those who disagree, or who would argue that extensive treatment is necessary, said Dr. Phillip Baker of the American Lyme Disease Foundation, “it is incumbent upon them to design and conduct a randomized, placebo-controlled trial ... to demonstrate efficacy and safety. If that can be done, I am certain that the results would be accepted by the medical and scientific community and this controversy would come to an end.”
Dr. Steven Phillips of ILADS said the IDSA selectively chose its evidence. Pointing to evidence not cited in the guidelines, he said there is such a thing as persistent Borrelia burgdorferi infection, even after single and multiple rounds of recommended antibiotic therapy.
That treatment might not work if the patient is misdiagnosed, Dr. Sunil Sood of Schneider Children's Hospital in Manhasset said. He told a story of a patient being “stymied by a diagnosis of ‘chronic Lyme disease.'” She received supporting treatment, he said, during which she became “more anxious” and experienced symptoms ranging from vision changes, “weird hallucinations,” involuntary muscle twitches, headaches described as “a stab in the dead center of the brain” and nerves “on fire.”
The patient had no known tick bites, he said, and after a Lyme disease serology her physical examination returned “completely normal.”
He recommended she discontinue antibiotic treatment and told the panel, “I can only hope that she ultimately took my advice. The fault is not hers, nor of her parents. The problem is the refusal of her physicians to use the evidence-based IDSA 2006 guidelines.”
This is not an argument that will end any time soon, regardless of the panel's recommendations on changing the current IDSA guidelines.