IDSA antitrust lawsuit thrusts chronic Lyme disease into health care limelight

Eugene Shapiro
Eugene Shapiro

A federal antitrust lawsuit was filed against The Infectious Diseases Society of America, eight insurance companies and seven physicians who have allegedly 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.

Although many patients and advocate groups point to Lyme disease as the culprit for a range of unexplained symptoms, most people that claim to have ‘chronic Lyme’ have never had a confirmed Lyme disease diagnosis.
Source: Shutterstock.com

“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 by the spirochete Borrelia burgdorferi and transmitted by the black-legged tick, causes an estimated 300,000 annual cases 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 and musculoskeletal pain for more than 6 months after the infection has resolved. However, the majority of people that claim to have chronic Lyme disease have never had a Lyme disease diagnosis confirmed either clinically or by lab studies.

The condition that these patients may be experiencing, according Eugene Shapiro, MD, professor of pediatrics and epidemiology at the Yale School of Medicine, is referred to as ‘medically unexplained symptoms.’

“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 inadequately-treated Lyme disease.”

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 on 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.”

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 concurs that antibody tests done early generally will not yield positive results. The recommendation supports the use of testing with signs of disseminated disease, including facial nerve palsy and swollen knees.

The antibody test is not to be used as a screening tool, as the test may yield false positive results for people who have a low chance of contracting Lyme disease. While an erythema migrans, or bull’s eye rash is a sign of infection, patients with this rash may experience false negative antibody test results.

“We know that the erythema migrans 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 rash 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.”

Shapiro also said that Lyme disease can still reliably be diagnosed in the minority of patients who do not develop a rash.

“Patients who have had symptoms for 6 weeks or more should universally have a positive result on antibody tests,” Shapiro said. “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.

He also notes that although the guidelines are helpful in the management of patients with Lyme disease, they are ultimately not the be-all and 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].” – by Katherine Bortz

Disclosure: Shapiro reports no relevant financial disclosures.

For more information on the chronic Lyme disease phenomenon, click here to read our cover story regarding the pervasive misnomer of chronic Lyme disease, the furor of the Lyme community, and how pediatricians and physicians can better prepare themselves for treating people with medically unexplained symptoms.

Eugene Shapiro
Eugene Shapiro

A federal antitrust lawsuit was filed against The Infectious Diseases Society of America, eight insurance companies and seven physicians who have allegedly 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.

Although many patients and advocate groups point to Lyme disease as the culprit for a range of unexplained symptoms, most people that claim to have ‘chronic Lyme’ have never had a confirmed Lyme disease diagnosis.
Source: Shutterstock.com

“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 by the spirochete Borrelia burgdorferi and transmitted by the black-legged tick, causes an estimated 300,000 annual cases 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 and musculoskeletal pain for more than 6 months after the infection has resolved. However, the majority of people that claim to have chronic Lyme disease have never had a Lyme disease diagnosis confirmed either clinically or by lab studies.

The condition that these patients may be experiencing, according Eugene Shapiro, MD, professor of pediatrics and epidemiology at the Yale School of Medicine, is referred to as ‘medically unexplained symptoms.’

“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 inadequately-treated Lyme disease.”

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 on 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.”

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 concurs that antibody tests done early generally will not yield positive results. The recommendation supports the use of testing with signs of disseminated disease, including facial nerve palsy and swollen knees.

The antibody test is not to be used as a screening tool, as the test may yield false positive results for people who have a low chance of contracting Lyme disease. While an erythema migrans, or bull’s eye rash is a sign of infection, patients with this rash may experience false negative antibody test results.

“We know that the erythema migrans 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 rash 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.”

Shapiro also said that Lyme disease can still reliably be diagnosed in the minority of patients who do not develop a rash.

“Patients who have had symptoms for 6 weeks or more should universally have a positive result on antibody tests,” Shapiro said. “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.

He also notes that although the guidelines are helpful in the management of patients with Lyme disease, they are ultimately not the be-all and 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].” – by Katherine Bortz

Disclosure: Shapiro reports no relevant financial disclosures.

For more information on the chronic Lyme disease phenomenon, click here to read our cover story regarding the pervasive misnomer of chronic Lyme disease, the furor of the Lyme community, and how pediatricians and physicians can better prepare themselves for treating people with medically unexplained symptoms.