Legislation Aims To Improve Lyme Disease Care

By Kendra Bobowick

Clashing opinions regarding Lyme disease treatment has prompted action to address a health concern turned controversial.

Targeting the problem is proposed House Bill 6200 that newly elected representative Christopher Lyddy co-introduced: An Act Concerning the Use of Long-Term Antibiotics for the Treatment of Lyme Disease. Current guidelines do not necessarily support long-term antibiotics use, which is the heart of the problem. Essentially the bill seeks to free doctors from treatment constraints. Its statement of purpose is concise: “To allow physicians to prescribe, administer or dispense long-term antibiotics for therapeutic purposes to patients clinically diagnosed with Lyme disease.”

The house bill also proposes amendments to protect doctors, stating, “No physician may be subject to disciplinary action solely for prescribing, administering or dispensing long-term antibiotic therapy … for a patient clinically diagnosed with Lyme.”

Mr Lyddy wants to allow physicians to prescribe long-term treatments for Lyme disease patients. In a recent release he explained, “This bill changes public health policy by ensuring that doctors are free to make decisions that are in the best interest of patients.”

In an email sent this week, Mr Lyddy elaborated, “This bill seeks to ensure that the doctor and patient relationship is preserved and that treatment decisions are driven by the autonomy of this relationship.”

Supporting the bill is resident and grass-roots Lyme Disease Task Force member Maggie Shaw, for whom current treatment and health coverage do not do enough: “There would be no need for our task force if people were getting proper treatment …”

She stressed, “Something has got to change.” She supports the bill that aims primarily to protect doctors. Last month, hundreds of state residents, including Ms Shaw, showed their support of House Bill 6200 in Hartford, offering written or verbal testimony. “This bill is huge. It’s huge,” Ms Shaw explained. Visit the Connecticut General Assembly website at cga.ct.gov to search for the recorded testimony before the Public Health Committee. Describing the extent of her family’s Lyme treatment, Ms Shaw said she and her children travel both out of town and out of state for the care she believes is necessary.

Mr Lyddy also raised this issue in his email: “It has come to our attention that people have started leaving the state to seek medical attention around this issue. This can be extremely burdensome on patients’ and their families’ financial, physical and mental well-being. I want to ensure that patients are protected and have access to care.”

 

The Long-term Argument

Ms Shaw’s perspective — a Lyme disease sufferer with children also infected with tick-borne disease — is not universal.

She turns her attention to the Infectious Disease Society of America’s (IDSA) guidelines for treatment, and the state’s public health department provisions overseeing doctors’ practices.

Her conclusions? “If you’re a doctor and treat [Lyme] longer than the Infectious Disease Society of America recommends …” Rather than finishing that thought, she said instead, “The whole premise of the bill is protection so physicians in Connecticut are not afraid to treat Lyme.” If doctors do continue treatment beyond recommended times, Ms Shaw asserted, “the Connecticut Department of Health might initiate an investigation into the practice.” Department representative could not be reached for comment in time for publication.

Lyme treatment drew State Attorney General Richard Blumenthal’s attention. He sees “serious flaws” with the IDSA’s process for writing its 2006 Lyme disease guidelines, he stated in a release to the press in May 2008 following an investigation. He points to what he believes to be the problem: “The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment … and also strongly influence physician treatment decisions … The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.”

He also concluded after his office’s investigation: “The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme …” He later states: “The IDSA’s Lyme guideline process lacked important procedural safeguards.” He sees the need for “a comprehensive reassessment through a new panel … an independent neutral ombudsman — expert in medical ethics and conflicts of interest, selected by both the IDSA and my office — will assess the new panel for conflicts of interests and ensure its integrity.”

In response, the IDSA has convened a review panel “to examine whether the Society’s Lyme Disease guidelines, published in 2006, should be revised or updated based on a rigorous review of the medical and scientific evidence on the diagnosis and treatment of Lyme Disease,” as stated on the association’s website at www.idsociety.org/lymedisease.htm. Read more about the review panel on this web page.

The IDSA representative Steve Baragona said, “The Connecticut attorney general and Lyme disease advocates have been very vocal, and he is a supporter of long-term care.” Noting Mr Blumenthal’s investigation into the ISDA guidelines for treatment, he said, “In May, we agreed to open the process to a fresh set of eyes and review the guidelines and the evidence out there.” The outcome could determine several things, Mr Baragona said, “They could say the guidelines are fine as is, or they need to be revised.”

Mr Baragona said, “It is a shame that things have gotten to be this controversial. It’s a shame it’s so political.”

 

Is It Debatable?

At the heart of conflict is the length of antibiotic treatment for Lyme. Ms Shaw stands behind longer-term treatments and care, while the IDSA “has no evidence that it’s helpful,” said Mr Baragona. Explaining the current guidelines, he clarified, “They are recommendations based on evidence for the best treatment.” Addressing long-term antibiotic care, he said, “There is a camp that thinks long-term treatment is necessary, but there is no evidence.” Is Lyme chronic, as Mr Shaw and others surmise?

“There is the camp that says it’s chronic, but there is no evidence that a standard course of antibiotics isn’t enough.” About the scrutiny cast upon certain physicians extending treatment, he said medical ethics, not violation of guidelines, are the issue.

Weighing all possibilities he said, “We certainly know of cases where people make miraculous recoveries after long-term treatment.” Mr Baragona also has heard of situations where a placebo has the same result as an antibiotic. “[Patients] recovered at the same rate,” he said.

His main concern is not the ongoing review, however. “We want people to be better,” he said. “Some people are horribly sick.” He questioned then, how much of their sickness was Lyme. “It could be a lot of other things.” Again, he talked about the ongoing treatment debate. “It’s complicated and a shame that this is so politicized.”

Discussing the review panel’s ongoing assessment, Mr Baragona said, “We hope [the review panel] helps clear up some of these issues. We imagine we’ll hear a lot of testimony for long-term benefits.” With words that would please Ms Shaw, he then said, “If evidence comes out that treatments are beneficial, then we’ll back it.”

Newtown Health District Director Donna Culbert said, “I have stated previously that I completely respect the physician-patient relationship and they are the two people who can best decide what is in the best interest of the patient.” Ms Culbert noted, “From a public health perspective, there are concerns regarding the overuse of antibiotics and the emergence of organisms resistant to antibiotics. However, I have to apply that same faith and respect to the physician-patient relationship and believe that antibiotic overuse is incorporated into the specific decisions that are made regarding patient care.”

Locally she has not heard a physician describe feeling restricted to adequately treat patients.

The Infectious Disease Society of America

The IDSA Review Panel assessing the Lyme disease treatment guidelines has initiated a 60-day input period to allow the public to submit information to ensure that all points of view are taken into consideration.

The society’s website www.idsociety.org/lymedisease.htm states: “There will also be an open public hearing to offer a forum for the presentation of relevant information on the diagnosis and treatment of Lyme Disease.

“The 60-day public input period is now open. Interested individuals and organizations may submit information as follows: Submissions must be received by 5 pm, April 3, and must include:

“Name and contact information, Issue(s)/concern(s) and relevance to the 2006 IDSA Lyme disease guidelines and/or issue(s) not covered in the 2006 IDSA Lyme Disease guidelines, reference list of supporting data (if available).

“The Review Panel is committed to considering all points of view. The panel respectfully requests that comments be succinct and focused into approximately 10 pages. Comments should identify specific recommendations from the 2006 guidelines and evidence that either supports or refutes those recommendations. Submissions should be made to the attention of the IDSA Lyme Disease Review Panel at: lyme@idsociety.org.”

The 2006 guidelines also are available at idsociety.org.