Flawed Guidelines
Lyme disease treatment options limited by conflicts and questionable science
By Phyllis Mervine

In her Viewpoint Jan. 28, Dr. Sarah Henderson aligns herself with the flawed Lyme disease guidelines of the Infectious Diseases Society of America (IDSA). The IDSA treatment guidelines are highly restrictive, ineffective, and leave seriously ill patients without effective treatment options. The IDSA guidelines panel which developed the guidelines had serious and significant commercial conflicts of interest with vaccine manufacturers, Lyme diagnostic kit distributors, and insurance companies. The panel did not consider the interests of patients and their treating physicians, with the result that it placed commercial interests above quality of patient care. 

The conflicts were so egregious that Connecticut Attorney General Richard Blumenthal launched an antitrust investigation into the IDSA guideline development process. In May 2008, the AG announced a settlement with the IDSA. In a scathing indictment, he concluded that the guidelines process had lacked important safeguards: 

• Several of the most powerful panelists held undisclosed financial interests;

• IDSA failed to follow its own procedures for appointing the panel chair and members;

• The panel refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease and blocked appointment of scientists and physicians with divergent views on chronic Lyme.

Under pressure of the investigation, the IDSA entered into an antitrust settlement agreement with the AG. The settlement agreement forced the IDSA to reconstitute a new panel free of conflicts of interest to re-evaluate its guidelines in a public hearing held on July 30, 2009. The panel is expected to make a decision soon. The settlement requires the panel to consider scientific research the prior panel had ignored and to consider divergent viewpoints. The hearing and the scientific evidence submission of the International Lyme and Associated Diseases Society (ILADS) which included approximately 300 pages of analysis and more than 1,300 pages of peer reviewed scientific evidence disputing the IDSA guidelines recommendations can be viewed at HYPERLINK “http://www.ilads.org/”www.ilads.org.

The IDSA guidelines severely restrict clinical judgment and deny patients access to treatment options. Despite the IDSA claims that its guidelines are “voluntary,” medical boards, insurers, hospitals, schools and even child custody agencies regard them as mandatory and IDSA members enforce the guidelines in unprofessional conduct actions against physicians who fail to comply. The IDSA uses the guidelines as a sword to drive its competitors out of business for non-compliance. 

The hardship caused to patients by these guidelines is severe. A recent CALDA survey of more than 3,600 people with Lyme disease found that the average patient waited over four years, seeing multiple doctors, before being diagnosed and one third waited more than six years to be properly diagnosed. In addition:

• 90 percent had difficulty or extreme difficulty finding a knowledgeable physician to treat Lyme disease. About 51 percent had traveled more than 100 miles to obtain treatment, and 53 percent had been forced to travel out of state to obtain care.

• 54 percent had been treated and failed treatment under IDSA protocols. A resounding 81 percent stated that they would not consider being treated under IDSA protocols.

• More than 60 percent of respondents who failed to improve under IDSA protocols improved with additional treatment.

• 41 percent of patients were not able to afford the medical care they needed.

• 88 percent had to cut back on work, school and household activities; 50 percent had to either quit work or school due to illness, and another 11 percent went from full-time to part-time work or school.

Denying treatment to patients has huge public health implications. People with under-treated Lyme disease often lose their jobs and insurance. They go from being productive, taxpaying citizens to being bankrupt, disabled consumers of state-provided services, including disability benefits and special accommodations under Section 504 of the ADA. Children lose years of their childhood, missing important developmental milestones. They have terrible quality of life. Suicide is a not infrequent way out, accounting for 50 percent of Lyme deaths.

Several state legislatures have passed legislation protecting physicians who treat people with chronic Lyme disease from prosecution by state medical boards, and in several more states legislation is pending. The legislation will ensure that physicians are allowed clinical discretion to treat — including antibiotic treatment for longer than four weeks if needed — according to their best judgment and evaluation of the individual patient. Patients are entitled to make an informed choice of the treatment they prefer, based on their own personal values and situation, just like patients with cancer or other diseases. Anything less is inhumane.

Dr. Henderson should examine the evidence herself and not accept at face value the interpretation of powerful, self-appointed authorities who have vested interests to protect. As a public health officer, her responsibility is doubly important — human lives are in her hands. Sadly, because of the head-in-the-sand attitude of most Oregon health professionals, Oregonians have to travel to California to obtain care for Lyme disease. Patient advocacy groups she denigrates in her article have done their homework. I’m afraid Dr. Henderson has not.

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Phyllis Mervine is president of the California Lyme Disease Association (CALDA), “Empowering Patients Through Advocacy, Education & Research,” www.lymedisease.org