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IDSA antitrust lawsuit thrusts chronic Lyme disease into health care limelight
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A federal antitrust lawsuit was filed against The Infectious Diseases Society of America, eight insurance companies and seven physicians who have reportedly denied coverage for the treatment of chronic Lyme disease.
According to an article in Courthouse News, the 28 patients filing the lawsuit claim that the IDSA guidelines have prevented them from obtaining more than a month’s worth of antibiotics. The patients assert that the guidelines were created by consultants who were paid large fees by insurance companies included in the lawsuit.
“While we cannot comment on pending legal matters, we want to assure you that the priority of the IDSA is to promote human health through excellence in infectious disease research, education, prevention and patient care,” the organization said in a statement.
“In developing guidelines for the treatment of infectious diseases, including Lyme disease, IDSA authors rely on evidence-based research performed accordingly to widely accepted scientific standards and consider, when appropriate, anecdotal evidence,” the IDSA continued.
Lyme disease, an infection caused the transmission of the spirochete Borrelia burgdorferi through the black-legged tick, affects an estimated 329,000 people annually in the United States. The 14 states in which the disease is usually contracted are located in the Northeast and Midwest regions, which account for 96% of all cases.
The disease is typically treated with 2 to 4 weeks of antibiotics. Some patients — around 10% to 20% — may experience symptoms such as fatigue, musculoskeletal pain and insomnia for more than 6 months after the infection has resolved.
This condition, which Eugene Shapiro, MD, professor of pediatrics and epidemiology at the Yale School of Medicine and Infectious Diseases in Children board member, believes should be labeled as ‘medically unexplained symptoms,’ has much overlap with other conditions such as fibromyalgia and chronic fatigue syndrome.
“I don’t think the vast majority, if any, of these people are faking [their symptoms],” Shapiro said. “[Medically unexplained symptoms] are complicated, difficult-to-get-at conditions. Certainly, there is no evidence that these problems have anything to do with Lyme disease.”
Lyme disease poses significant challenges for office-based pediatricians, according to William T. Gerson, MD, clinical professor of pediatrics at the University of Vermont College of Medicine.
“Underlying the controversy is the presence of patients who seek care, in the new vernacular for ‘medically unexplained symptoms,” Gerson told Infectious Diseases in Children. “Indeed, these patients have always existed and their presenting categorical list of complaints has also been consistent over time: the fatigue, insomnia, and musculoskeletal pain often seen after an infectious disease and well documented after Lyme disease are joined by symptoms all-to-familiar to pediatricians — headache, abdominal pain, altered bowel function with concomitant school absence, social isolation and family distress.
“The care of patients with such complaints is arduous. However, the mental and behavioral frailty of the human condition, particularly in the developing child and young adult is a rightful part of the practice of pediatric medicine. Preying on their needs by appealing to false diagnoses and hopes is sadly obscene.”
In 2008, the IDSA guidelines for the treatment and testing procedures of Lyme disease were vetted through an antitrust investigation led by the Former Attorney General of Connecticut Richard Blumenthal, in which a new panel to review the guidelines and supporting evidence was appointed. As per the results of the separate investigation, the guidelines were found to be comprehensive and soundly based on current medical and scientific evidence.
These guidelines include the endorsement of previously supported antibiotic use, which included a few weeks of treatment. The use of long-term antibiotics for months and years, according to the IDSA website, has no added advantage and can potentially create fatal complications for patients.
“There is overwhelming evidence to support the validity of the studies in which the guidelines are based,” Shapiro, a physician involved in the lawsuit, told Infectious Diseases in Children. “The studies of long-term antibiotics clearly show that they are of little or no benefit and are associated with substantial risks.”
The guidelines established by the IDSA for Lyme disease are “among the best in medicine and any update will likely build on that strength,” Gerson said.
“The diagnostic criteria, use of laboratory studies and treatment options for Lyme disease are quite clear,” Gerson said. “I do not believe the current lawsuit against the IDSA, health insurance companies and several doctors will alter pediatricians’ diagnostic and treatment considerations, although it will likely lessen the enthusiasm of experts to participate in future guideline development.”
Additionally, standard testing procedures have been called into question. In an article by The Huffington Post, it was indicated that the timing of these tests raise concern about the AAP’s recommendation, supported by Shapiro, which upholds that tests done early generally will not yield results conclusive of Lyme disease. Shapiro suggests that if erythema migrans, or a bull’s eye rash, is present a diagnosis can be based on this symptom.
However, not all patients develop the typical bull’s eye rash. Shapiro claims that this should not concern those who believe they have Lyme disease.
“We know that the rash often develops 7 to 21 days after the tick bite. Antibodies are not detectible for usually 3 to 6 weeks after the infection,” Shapiro said. “We know the vast majority of people who truly have Lyme disease with the erythema migrans will not have a positive antibody test [at that time]. It is not recommended to do the test because they have the characteristic rash, and you can make a diagnosis based on that.”
“In patients who have had symptoms for 6 weeks or more should universally have a positive result on antibody tests,” Shapiro continued. “We know that those are extremely reliable results. Essentially, 100% of patients with Lyme arthritis will have positive antibody tests in their blood.”
According to Shapiro, the IDSA guidelines that promote testing and treatment options for Lyme disease are currently being updated.
“The guidelines are being updated, and I believe they are in the late stages of completing them,” Shapiro said. “Part of the reason for the delay is because of nonsensical lawsuits like this.”
He also notes that although the guidelines are helpful in the management of patients with Lyme disease, they are ultimately not the be-all-end-all of treatment options.
“The IDSA only puts out guidelines,” Shapiro said. “They are nonbinding, and they do not have any authority other than the fact that experts have reviewed the data and come to those conclusions [about Lyme disease].”
Gerson also addressed the treatment of Lyme disease in pediatric patients and prescribing extended antibiotic treatments.
“The diagnosis of chronic Lyme disease in a pediatric patient represents a failure of care,” he said. “When it is my failure to provide the needed care and support for my patient and their family, I can handle the knowledge that in practice I am not always a match for every family. However, when a false diagnosis disrupts an established relationship, exposes a patient to potentially harmful treatments and delays proper diagnosis and care, it represents a more significant ‘failure.’
“Furthermore, given the severity of the offense, it precludes what is often a family’s wish for co-management and ongoing provision of primary care, thus fully fracturing a relationship often years in the making.” – by Katherine Bortz
Disclosures: Gerson and Shapiro report no relevant financial disclosures.