Blumenthal Investigating IDSA’s Lyme Disease Guidelines

HARTFORD — Connecticut Attorney General Richard Blumenthal has launched an antitrust investigation against a Virginia-based doctors’ group, saying its new diagnosis and treatment guidelines might harm Lyme disease patients.

The Infectious Diseases Society of America (IDSA) might be effectively limiting insurance coverage and medical options for those patients through its overly strict recommendations for diagnosing and treating Lyme disease, the Attorney General said.

“These rules diminish the options available to doctors and their patients in ways that can sanction insurance company decisions to deny coverage, so they have an economic impact that could be very serious, not to mention the health care effect,” Mr Blumenthal said.

The society is a nonprofit organization based in Alexandria, Va., and represents about 8,300 health care professionals nationwide. In a related story, a grassroots effort mustrered hundreds of Lyme disease patients to protest last November against the IDSA guidelines.

Patients from across the country, joined by many Lyme disease advocates, gathered at Westchester Medical Center/New York Medical College in Valhalla, home to three of the IDSA committee members, including lead author Dr Gary Wormser, to demand a retraction of the guidelines.

Society spokesman Steve Baragona said its new guidelines, enacted in October, are carefully researched and sound. They are only suggestions, however, and are not intended to alter any individual doctor’s judgment, he said.

“We’re not trying to claim that these people aren’t suffering, but we’re not sure that what they have is Lyme disease,” Mr Baragona said. “They may travel to a doctor who doesn’t know what’s wrong with them, and we know that’s frustrating for them and for their doctors.”

Experts agree that a course of antibiotics is the best treatment for Lyme disease, but physicians, advocacy groups, legislators, and patients often disagree about when and how long to administer those antibiotics.

Lyme disease, a tick-borne illness named for the Connecticut town in which it was first identified in 1975, can cause severe headaches, heart palpitations, and arthritis. According to the Connecticut Department of Public Health, 1,810 new cases were reported in the state last year, an increase of 34 percent over 2004.

The doctors’ society believes most Lyme disease patients are cured with a single course of 10 to 28 days of antibiotics, with some requiring a second course. Those with chronic Lyme disease, where symptoms such as fatigue and joint pain persist, should not get more antibiotics, according to the society.

The group wants to avoid the possibility that a Lyme strain might develop resistance to the medication, as well as preventing potential infections caused by intravenously administered drugs, Mr Baragona said.

However, many patients and others who have researched the disease believe the bacterium that causes might survive in the body through the first round of treatment, evading the immune system and short-term antibiotics courses.

Greenwich resident Debbie Siciliano, co-president of Time for Lyme Inc, an affiliate of the national Lyme Disease Association, said the society’s strict guidelines have limited treatment and insurance coverage for some patients.

“They’re the people that others look to for answers for infectious diseases and these current guidelines are very restrictive, and this is where it’s going to hurt people,” said Ms Siciliano, whose son has been treated for Lyme disease.

Pat Smith, president, Lyme Disease Association, said in a recent statement that new guidelines make it far more likely that Lyme disease will be missed in the early stages, when it is easier to treat.

“As a result, the guidelines set the stage for creation of a new generation of chronic Lyme disease patients, individuals with Lyme disease diagnosed and treated so late that they may never be cured,” she wrote. “In a nutshell, the reckless new IDSA guidelines forbid doctors from using clinical discretion in determining whether or not patients have Lyme disease. Instead, they require that doctors either see a characteristic rash known to occur in about half the patients, or that patients register positive on the two tests recommended by the Centers for Disease Control & Prevention [CDC] — tests known to miss up to half the patients.”

At any stage of disease, as many as half the patients may remain undiagnosed, she added. The IDSA guidelines also deny that chronic persistent infection exists, arbitrarily dismissing all studies documenting persistent infection after short-term therapy and ignoring mounting evidence that more treatment is beneficial in chronic cases.

Mr Blumenthal, who once led an effort to secure mandatory coverage for the disease, said the society’s guidelines might also violate antitrust rules, depending on how the guidelines were reached. He sent an administrative subpoena last month to the group as part of his investigation. Mr Baragona said the society is cooperating fully.