'What we’ve got here is failure to communicate.'

The Ongoing 30-Year Lyme Disease War: Case Study of a Failure to Communicate

Lyme disease, dubbed one of the “deadly dozen” by a recent Wildlife Conservation Society report, could skyrocket as global shifts in temperature and precipitation transform ecosystems.

From a public policy standpoint, the situation is compounded by the communications issues complicating it, bringing to mind the well-known quote from the late actor Strother Martin in the 1967 film “Cool Hand Luke” — What we’ve got is failure to communicate.

News Analysis

Lyme and other diseases transmitted to humans via insects are called vector-borne diseases. Like the insects that act as the vectors, they tend to be specific to a distinct ecosystem. Experts believe climate change may lead to a loss of these natural boundaries, allowing for an increase in rates of Lyme and other infectious diseases.

Tick Life Cycle
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Ixodes Scapularis Life Cycle

Connecticut is the epicenter of Lyme disease. The Constitution State already has the nation’s highest Lyme disease prevalence – averaging 90 cases per 100,000 people in 2007 – and each year the number of reported cases rises.

The most common tick-borne disease in the Northern Hemisphere, Lyme is caused by the bacteria Borrelia burgdorferi. The bacteria are transmitted to humans via the bite of an infected deer tick, known as Ixodes scapularis. White-footed mice are the principal reservoirs of infection, as larval and nymphal (juvenile) ticks feed upon them and become vectors for Lyme disease. The nymphs infect humans only after staying attached for 36-48 hours and becoming fully engorged with blood. Once engorged, the nymphs detach and molt into an adult tick. Adult deer ticks wait on stalks of grass to latch onto deer, the preferred host, or onto other large mammals.

Lyme: A Study in Ecology and Wildlife Management

The incidence and migration of Lyme disease throughout the upper East Coast and Midwest presents a study in ecology and wildlife management. The restoration of the deciduous forests of the eastern United States after their near total destruction at the hands of European immigrants represents one of the crowning achievements of the conservationist movement. The new habitat generally lacked large predators – once again the result of desires and actions of humans – allowing many large mammals to flourish unfettered.

Because the adult deer tick must have a large animal as its host, the existence and extent of Lyme disease correlate closely to the density of deer.

German physician Alfred Buchwald in 1883 first described a red, expanding, bulls eye rash known clinically as erythema migrans or EM. The EM rash and other symptoms associated with Lyme disease, such as joint pains, were noted but little understood throughout the twentieth century.

Lyme disease has since been considered the cause of everything from psychiatric problems to chronic pain. The first documented case of an expanding EM rash acquired in the United States occurred in 1970.

By 1977, Boston physician and rheumatologist Allen Steere, M.D., a leading medical researcher and Lyme disease pioneer, reclassified a clustering of previously misdiagnosed cases of juvenile arthritis as Lyme arthritis. He named the newly discovered disease process for the location of the patient cluster – Lyme in southwestern Connecticut.

Science ‘Undisputed’ … but Scientists Left Mystified

The controversy surrounding the diagnosis of chronic Lyme disease or post Lyme disease syndrome mystifies most scientists. To them, the science is undisputed: Four independent, prospectively randomized clinical studies have demonstrated no biological evidence for the existence of chronic Lyme disease infection among patients given the recommended antibiotic treatment regimen for the acute infection. Additional research on this point seems futile.

Patient advocacy groups vehemently disagree with these scientists but have not generated sound, contesting scholarship. Nonetheless, their “court of public opinion” tactics have allowed them to enjoy outsized influence over policy makers.

Leading scientists such as Professor Durland Fish, of the Yale Schools of Public Health and Forestry and Environmental Studies, express concerns. “The misinformation [about chronic Lyme disease] and its consequences may be causing a bigger public health problem than Lyme disease itself,” Fish says. “Lyme disease has become a wonderful example of what can go wrong communicating science.”

In May 2007, Richard Blumenthal, Connecticut’s Attorney General, subpoenaed the Infectious Diseases Society of America (IDSA) for allegedly violating state and federal anti-trust statutes. Blumenthal’s office accused IDSA of “lessening competition in the provision of healthcare services for Lyme disease by refusing to deal or inducing third parties to refuse to deal with others in the sale of such services.”

The state demanded all documents pertaining to IDSA’s 2000 and 2006 Lyme disease treatment guidelines panel and research related to chronic Lyme disease or post-Lyme disease syndrome. This latest volley in the 30-year Lyme war alleged a conflict of interest and implied that scientific conclusions were modified for financial gain.

IDSA, representing more than 8,000 physicians, scientists, and other healthcare professionals specializing in infectious diseases, is like most other health professional societies – it provides training, holds conferences, promotes educational and research, and establishes treatment guidelines. IDSA contends that its Assessment, Treatment, and Prevention of Lyme Disease Guidelines were developed only after proper review of medical and scientific studies and a review by a panel of experts. It said it used the same process in finding an absence of chronic Lyme disease.

The Connecticut Attorney General’s counter? IDSA has a “monopoly of information and has failed to consider other opinions.”

These dramatic events come as no surprise given the contentious history of Lyme disease: Lyme has been controversial and politicized since its discovery.

The recent skirmishes surrounding the diagnosis of chronic Lyme disease in fact are a remarkable instance of deja vu. GlaxoSmithKline received Food and Drug Administration (FDA) approval for its recombinant LYMErix vaccine to address the rising Lyme disease epidemic in 1998. LYMErix’s high cost combined with the lack of reimbursement from health insurance carriers in slowing its clinical adaptation. Further, vaccine recipients, often supported by patient advocacy groups, filed class-action lawsuits against GlaxoSmithKline alleging LYMErix caused autoimmune side effects and other health problems. Despite studies by the FDA and the Centers for Disease Control and Prevention (CDC) finding no connection between the vaccine and the patient complaints, the never-robust sales for LYMErix plummeted, and GlaxoSmithKline ceased vaccine production in 2002.

A ‘Cautionary Tale’ Involving ‘Unfounded Public Fears’

The medical literature by and large describes the fate of LYMErix as a “cautionary tale,” while a March 16, 2006 editorial in Nature saw it as an instance where “unfounded public fears place pressures on vaccine developers that go beyond reasonable safety considerations. This just shows how irrational the world can be … There was no scientific justification for the first vaccine [LYMErix] being pulled.”

With the passage of the years, all interested parties now have been able to obtain additional knowledge and perspective regarding Lyme disease. Yet the toxic environment surrounding the Lyme disease and the LYMErix vaccine inhibits significant scientific discourse, and we proceed with an analogous decade-old scenario driven by advocates whose opinions were made without the appropriate scientific training.

The lawsuit brought by Connecticut Attorney General Blumenthal against the scientists and the IDSA never reached trial. An April 30, 2008, settlement agreement stipulated establishment of an independent panel to review the scientific evidence and create new assessment, treatment, and prevention guidelines for Lyme disease. In addition to panel meetings, a public hearing open to all stakeholders is required prior to the voting and adoption of recommendations and a final report. Finally, an ombudsman unaffiliated with the IDSA and without infectious disease experience is required to review the entire process.

In a press release related to the agreement, Blumenthal stated, “This agreement vindicates my investigation – finding undisclosed financial interests and forcing a reassessment of IDSA guidelines.” He gave no specific information regarding the financial interests or nature of purported biases. The vague phrasing suggests an association or mutual benefit between scientists and pharmaceutical companies in the treatment of Lyme disease, but the IDSA’s Lyme disease treatment guidelines recommended reducing the duration of antibiotic treatment.

Blumenthal’s press release further stated, “The [IDSA] panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease.” This statement particularly infuriates scientists as it disregards the four previous studies that had determined chronic Lyme disease nonexistent.

Critics say they are concerned that the Connecticut Attorney General’s actions may be unduly driven by concerns raised by Lyme disease advocacy groups. Some find the actions taken against the scientists and IDSA particularly ominous for all medical and scientific societies that issue practice recommendations or treatment guidelines. They fear other medical or scientific treatment guidelines could be at risk of challenge from their respective advocacy organizations. GlaxoSmithKline’s experience with the LYMErix vaccine demonstrates that pharmaceutical companies can also share in the fate of advocacy trumping science.

Lyme disease is indeed a cautionary tale. It teaches that scientists must modify their practice of publishing solely for scholarly journals and must also communicate their findings to a larger audience. Their scientific expertise can help in contesting advocacy interests and policy makers unfamiliar with the full scientific picture. In the absence of that fuller understanding, potential climate-driven ecological changes could lead to increased incidences of widespread infection, and the toxic scientific environment surrounding Lyme disease could become a perfect storm that fuels a significant epidemic.

Leslie King, MD, MPH, is Founding Director of Flying Physicians International. She currently is completing a one-year mid-career masters at the Yale School of Forestry and Environmental Studies, focusing on communications on impacts of climate change on human health.

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