Legislation highlights divisions on Lyme disease
Health insurers would have to cover long-term antibiotic treatment for Lyme disease under a measure approved by the Massachusetts Legislature — a vote that places Governor Charlie Baker in the crossfire between mainstream medicine and patient activists.
Baker has until midnight Thursday to sign or veto the legislation or to let it become law without his signature. The governor, a former health insurance executive, has reservations about the bill. In a letter to lawmakers, he wrote that “long-term antibiotic therapy is not clinically recognized as an appropriate form of treatment.”
Massachusetts had the nation’s third highest incidence of Lyme disease in 2014, with 5,600 confirmed and suspected cases.
Dozens of infectious-disease specialists are urging a veto, saying extended antibiotic treatment is ineffective and can be harmful. But patients, often with stories of sickness and recovery, are entreating Baker to sign it, saying weeks-long infusions of antibiotics can relieve lingering symptoms from the tick-borne disease.
Similar mandates have passed in Connecticut and Rhode Island, as advocacy groups push for treatment that runs counter to standard medical advice but that some doctors are willing to provide.
At issue is a condition that patient activists call “chronic Lyme disease” and that the US Centers for Disease Control and Prevention has labeled “post-treatment Lyme disease syndrome.” In a small number of patients, symptoms such as fatigue, muscle aches, joint pains, numbness, and impaired thinking persist after the standard two to four weeks of antibiotic treatment.
The reasons for this reaction are not understood, but most medical specialists blame the symptoms on damage to tissues and the immune system caused by the Lyme bacteria — not on bacteria lingering in the body.
But advocates of long-term antibiotic treatment say the bacteria sometimes survive the first round of treatment and need to be attacked repeatedly.
State Representative David P. Linsky, a Natick Democrat and leading proponent of the legislation, said long-term antibiotics relieved his son of crippling Lyme symptoms, and he knows many others who have had the same experience. But if insurance doesn’t cover it, the treatment can cost $50,000 to $60,000, he said.
Individual anecdotes don’t amount to medical evidence, said Dr. Benjamin Kruskal, chief of infectious disease and travel medicine at Atrius Health, a large group practice. Evidence of what works emerges only from studies that compare people who get the treatment with those who don’t, and such studies have clearly shown no value to long-term antibiotics, Kruskal said.
People who recovered after the treatment might have gotten better anyway, or might have benefited from the placebo effect, in which a patient’s belief in getting better will bring about improvements, doctors say.
Among those writing in opposition to the legislation were the Massachusetts Infectious Disease Society, representing more than 500 infection specialists, along with physicians from hospitals as well as Atrius Health. They noted that long-term antibiotic treatments have serious risks, including blood clots, blood infections, and intestinal infections. Additionally, the overuse of antibiotics promotes the growth of drug-resistant bacteria, they said.
In her letter to Baker, Dr. Christina Hermos of the UMass Memorial Children’s Medical Center described the bill as “dangerous for patients and the community.”
“The small number of providers who treat patients with long-term antibiotics have a consistent record of practicing contrary to the best standards of care,” she wrote.
Sheila M. Statlender, a clinical psychologist in Newton and leading advocate for long-term treatment, said opponents are “cherry-picking the data,” and that some studies do show improvement from long-term antibiotics.
“It’s just mind-boggling. This seems to be not about finding the truth. It seems to be about winning. . . . It’s just not the case that there’s not evidence,” she said.
She referred the Globe to Dr. Brian Fallon, a psychiatrist and director of the Lyme and Tick-Borne Diseases Research Center at Columbia University Medical Center. In a phone interview, Fallon described two small studies suggesting a reduction in fatigue among patient who had the therapy. “The evidence is equivocal,” Fallon said. “We need to be able to identify those patients for whom repeated antibiotic therapy works.”
But Dr. Daniel R. Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital, sees no such ambiguity. He said numerous well-designed studies have proven that prolonged antibiotic treatment doesn’t help. Evidence supporting the treatment is “not considered credible by acknowledged experts in the field” and has not “passed muster in the top-line peer-reviewed journals,” he said.
Currently, insurers will cover two to four weeks of oral or intravenous antibiotic treatment for Lyme disease, and additional treatments in certain circumstances, said Eric Linzer, spokesman for the Massachusetts Association of Health Plans, the insurers’ trade group.
Linzer also noted that the requirement, like all insurance mandates, would disproportionately burden small businesses. Sixty percent of insured people obtain coverage from large employers who are exempt from state rules because they “self-insure,” covering employees themselves rather than buying plans from insurers.
Baker, in his letter to the Legislature, raised another concern. The legislation requires coverage for any federally approved drug that a doctor believes will be helpful, even if the drug was not approved for that purpose, a practice known as off-label use. “Requiring coverage of experimental drugs for off-label use sets a concerning precedent,” Baker wrote.
The governor proposed that the bill be amended to require coverage for the long-term treatment only if prescribed by a board-certified rheumatologist, infectious disease specialist, or neurologist.
The Legislature rejected that idea, and sent the bill back to him in its original form. If he vetoes it, lawmakers could override him by a two-thirds vote as they wrap up the session’s work Saturday and Sunday.