Lyme advocates like Debbie Siciliano, co-president of Time for Lyme, a nonprofit dedicated to Lyme disease research, education and advocacy, are hopeful that the assessment of Ms DeLong and her colleagues — delivered at an IDSA public hearing in July 2009 on their 2006 Lyme disease guidelines — will lead to patients with chronic Lyme disease getting the long-term antibiotic treatment needed to successfully manage the disease.

Focusing on the four major NIH-funded studies the IDSA used to create Lyme disease treatment guidelines, Ms DeLong and colleagues reported several problems that make the studies’ findings “inconsistent” with the description of these trials in the Guidelines. These problems include:

Over reliance on two trials (conducted together) that had substantial flaws, including

*insufficient participants to demonstrate and confirm clinically important treatment effects,

*an incomplete analysis that omitted valuable information collected during the study,

*possible bias due to study dropout and differences in baseline scores, and

*assuming that stopping a trial early proves a treatment to be ineffective.

Wrongly dismissing evidence from two trials that retreatment may be effective:

*citing high study dropout despite evidence that this did not affect the findings,

*suggesting that blinding was compromised when the data do not support this claim,

*using the lack of significant improvement on certain outcomes as evidence of overall lack of efficacy, when there were not enough subjects for these particular outcomes to draw any meaningful conclusions,

*ignoring evidence from secondary endpoints that showed improvement on quality of life outcomes such as fatigue and pain.

Ms DeLong’s complete findings and testimony can be accessed online at the IDSA website www.idsociety.org/Content.aspx?id=15026. Included on the page is a webcast of the all-day Lyme disease hearing, where Ms DeLong insists that evidence against retreatment of Lyme disease in patients with continued symptoms after standard treatment “does not exist. The [current treatment] guidelines need to be changed.”

“The two well-run trials enrolled only 37 and 55 Lyme patients. And both studies used the same antibiotic,” Ms DeLong continued. “It is essential that additional larger trials be undertaken to determine the best antibiotic regimens, to examine which patient groups would benefit most from retreatment, and to accurately quantify treatment effects.”

Until now, the IDSA has balked at the idea that Lyme disease in some patients can outlast the standard treatment of 14 to 21 days of oral antibiotics.

This narrow view has led to “countless patients” not being properly diagnosed and treated, Ms Siciliano asserted, as well as to insurance companies refusing to cover the long-term antibiotic use that chronic Lyme disease patients require. This is because physicians, insurance companies, and government agencies like the Centers for Disease Control and Prevention rely on the IDSA to set the “gold standard” for best diagnosing and treating infectious diseases.

“We have long awaited the kind of thorough analysis that Ms DeLong has done, and its presentation in the national medical arena. Lyme disease patients have suffered from misinformation and misdiagnoses for too long,” added Ms Siciliano. “The medical community and our government must come together to help fight this disease and give patients the effective care they deserve.”

IDSA officials said they will decide by the end of December whether to revise treatment guidelines.

“The current Lyme disease treatment abandons patients who don’t respond to typical treatment, or show typical symptoms,” Ms Siciliano continued. “We’re hopeful that as the IDSA looks at these findings, and other similar ones presented in recent months, they will make the needed amendments to treatment protocols.”

Named for the Connecticut town where the disease first emerged, Lyme disease is caused by the bacteria Borrelia burgdorferi, which generally enters the body through a deer tick bite. Symptoms can range from fever, chills, and body aches to joint swelling, weakness, severe fatigue, trouble concentrating, and temporary paralysis. Most, though not all, people infected will see a bull’s-eye rash at the site of the tick bite between three and 30 days after infection.

Although Lyme disease is most common in the Northeast, it has been found in all 50 states. Those who live, or spend time, in grassy or wooded areas are most at risk. According to the CDC, more than 20,000 cases of Lyme disease are reported each year. Yet because many diagnostic tests produce false negatives, the actual number of Lyme disease sufferers could be as high as 200,000 — a figure that would make Lyme disease more prevalent in the United States than AIDS or the West Nile Virus.

Since 1991, the number of those infected with Lyme disease has doubled. The CDC classifies it as an epidemic.