By Laura Kenyon
Amidst the start of an unprecedented investigation by Connecticut Attorney General Richard Blumenthal into Lyme disease treatment guidelines, victims of and experts on the disease are speaking out about its precarious place in the medical world.
In the second of two articles about Lyme disease, the Advertiser considers the varying opinions medical professionals hold regarding such guidelines, the existence of chronic Lyme disease, and long-term antibiotic treatment.
The previous article, published in last week’s issue, focused on local victims.
Freedom of Choice
According to the Centers for Disease Control, 1,810 cases of Lyme disease were reported in Connecticut in 2005, more than any other state besides Massachusetts, New Jersey, New York and Pennsylvania.
In October, the Infectious Diseases Society of America (IDSA) released an updated version of its 2000 Lyme treatment guidelines, which are often used by doctors and insurance companies to determine treatment.
Prompting national contention from many organizations, doctors and sufferers, the guidelines discourage the prolonged use of antibiotics to treat lingering symptoms, saying it “has not proven to be useful.”
They also conclude that there is no “convincing biologic evidence” for the existence of “chronic” or “post-Lyme syndrome.”
These particular findings prompted Mr. Blumenthal, he told the Advertiser, to worry that treatment choices and coverage for long-term Lyme sufferers would be determined by government officials or insurance companies rather than patients and their physicians.
In November, he filed a Civil Investigative Demand to look into possible anti-trust violations by the IDSA during the development of its new guidelines.
The Lyme Disease Association (LDA), a nonprofit organization “representing more Lyme disease patients than any organization in the United States,” quickly issued a press release applauding his move as “vitally necessary to protect the welfare of chronic Lyme patients nationwide.”
Clinical guidelines currently drive the standard of care, it said, and are sometimes used to deny treatment reimbursement. The IDSA guidelines list as “not recommended” “most of the conventional medical treatments prescribed by physicians as well as alternative treatments often chosen by patients for any Lyme manifestation.”
Dr. David Reed, New Canaan’s assistant director of health, does not believe IDSA had “ulterior motives” or “some sort of political agenda.” Calling the attorney general’s move “highly unusual,” he said it will have “repercussions.”
“These are nonprofit organizations. They don’t have, in my opinion, profit motives,” said Dr. Reed, who declined the opportunity to speak about chronic Lyme or long-term antibiotics.
First Selectman Judy Neville, who battled the disease for seven years in the 1990s, said treatment choices should be made only by patients and their doctors and Mr. Blumenthal is “doing what is necessary to protect Lyme patients.”
The Lyme Disease Association contends that the guidelines will negatively affect the number of treating physicians “since clinical discretion is not recommended by the guidelines” — a statement that Dr. Raymond Dattwyler, chief of Allergy, Immunology and Rheumatology at Westchester Medical Center and one of the authors of the IDSA guidelines, said is false.
“I think that one should really read the guidelines first before they should really make any judgments,” he told the Advertiser Friday. “They’re guidelines. They’re not cast in stone, and ultimately it states that that they allow individuals’ physicians to make their own judgments.”
Many Sides
Dr. Steven Phillips of Wilton, who served as president of the International Lyme and Associated Diseases Society (ILADS) from 2003-05, estimates that more than 25 percent of Lyme victims develop chronic symptoms and finds it “unsettling” the IDSA would exclude “a significant percentage of the Lyme disease population” in its findings.
“A great number of patients derive benefits from long-term antibiotics,” he told the Advertiser.
Chronic Lyme has been documented in thousands of medical journals, he said, but in composing its guidelines the IDSA referred to just 400 of more than 10,000 studies, many of which support the existence of chronic Lyme.
“If they’re going to pick a random sample,” he said, “it has to be random.”
They should have taken a “more even stance,” he added.
Dr. Dattwyler said between everyone who worked on the IDSA guidelines, “we probably read the overwhelming majority of stuff that’s ever been published on Lyme disease.”
The guidelines cited 405 papers. They were chosen, Dr. Dattwyler said, based on criteria including study design and the quality of the publishing journal. The group primarily choose articles in the “premier” journals, as rated by the National Library of Medicine, such as the New England Journal of Medicine, Nature and Annals of Internal Medicine.
“It’s really just a review of the literature published in respected medical journals,” he said, adding that there are “some really bizarre papers” out there.
“Most of us wrote a lot of these papers,” he said, citing one of his own published in the New England Journal of Medicine.
Both ILADS and IDSA offer guidelines for Lyme disease, and both differ in their findings.
While IDSA concludes that long-term antibiotic treatment “is not proven to be effective and may be dangerous,” and that there is no “convincing” evidence for the existence of “so-called ‘chronic’ Lyme disease,” ILADS believes antibiotic treatment should be “tailored to the individual” and cites chronic Lyme as “a growing epidemic.”
The 30-year-old daughter of New Canaan resident Judy Larson, who has battled Lyme since age 12 and was featured in last week’s Advertiser, initially improved while on intravenous antibiotics, but suffered “toxic” side effects — one forcing the removal of her gall bladder.
On the other side, New Canaan Director of Human Services Cheryl Jones was on intravenous antibiotics for four months in 2000 and oral antibiotics for more than a year, and said “for me, (they) were the only choice.”
Ms. Jones was initially diagnosed with Multiple Sclerosis in 1990 and believes the Lyme was overlooked during the next 10 years — not a rare story in either direction, according to Dr. Dattwyler.
Many people — “80 percent or more,” he said — are misdiagnosed with Lyme disease when they really have something else. That is why IDSA states that patients who believe they have “chronic” Lyme symptoms should ensure they do not in reality have another affliction, such as Multiple Sclerosis or cancer.
A year-long study at the Yale University Lyme Disease Clinic that studied 209 patients with a “presumptive diagnosis” (by their physicians, themselves or both) — published in the March 1, 1998, Annals of Internal Medicine and cited by Dr. Dattwyler — found that only 21 percent met the criteria for active Lyme disease, 19 percent were previously but no longer infected, and 60 percent had no evidence of current or previous infection.
A study published in the June 24, 2003, issue of Neurology, cited by Dr. Phillips, found that patients given 28 days of antibiotic treatment (ceftriaxone) showed improvement in “disabling fatigue.” The study also found adverse side effects and little or no improvement in cognitive or persistent function, however, and concluded that it “does not support the use of additional antibiotic therapy with parental ceftriaxone in post-treatment.”
The study was penned by Stony Brook University Medical Center doctors, including Dr. Dattwyler.
Authors of an April 15, 2004, Journal of Clinical Investigation article explored both sides, stating that a small percentage of patients with “well-documented Lyme disease” may develop post-Lyme disease syndrome symptoms (including musculoskeletal pain and fatigue) for months or years after antibiotic treatment, but that prolonged antibiotic therapy “may be harmful.” When treating those with chronic Lyme, they advocated following the guidelines for chronic fatigue syndrome or fibromyalgia, a “similar” affliction.
The Future
“The biggest problem,” Ms. Larson said, “is nobody really knows what the answer is and it’s a very elusive thing that can take many forms. There needs to be a lot more research on it. I think it’s an epidemic that people haven’t really recognized in the medical community.”
Many diseases, “not only tick-borne infectious diseases,” are in need of further study, Dr. Dattwyler said, but organizations such as the National Institutes of Health and the Center for Infectious Disease need more funding in order to do so.
While its existence may be controversial, he said that the pain felt by those diagnosed with chronic Lyme disease is real and modern medicine does not always provide them with the answers they are seeking.
The bottom line on both sides, Dr. Phillips said, is that patients must become educated about Lyme and other diseases, and become “their own advocates.”
© Copyright 2006 by Hersam Acorn newspapers
