Published online 14 October 2010 | Nature | doi:10.1038/news.2010.542

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Confusion over correct treatment for persistent symptoms clouds conference.

The symptoms of Lyme disease, spread by ticks, can persist even after treatment with antibiotics. EYE OF SCIENCE/SPL

Doctors and researchers in the United States have spoken out about the lack of support provided by the Institute of Medicine (IOM) and the National Institutes of Health (NIH) when it comes to treating patients with chronic Lyme disease.

The remarks were made at a workshop organized by the IOM in Washington DC on 11 and 12 October.

"Our session wasn't supposed to talk about treating chronic Lyme," says Sam Donta, an infectious disease specialist at Falmouth Hospital in Massachusetts who spoke at the workshop. "But when we had our pre-session conference call and they said this is supposed to be about diagnosis and management, I said how can you talk about management without talking about treatment?"

"The IOM overly restrict the definition of chronic Lyme disease," says Donta. "I hope now the IOM is finally listening."

The IOM will issue a report on gaps in the prevention, amelioration and resolution of Lyme disease and other tick-borne diseases, which will help to guide agencies such as the NIH.

Although the treatment of chronic Lyme disease has been controversial for decades, the IOM excluded the issue from their agenda at the request of the NIH.

There is widespread disagreement over what constitutes and causes the chronic disease, in which a range of symptoms persist after a patient has been treated for the initial bacterial infection. Names for the condition differ, but whether it's called chronic Lyme disease, post-Lyme disease syndrome (PLDS) or something else, patients can suffer from fatigue, pain, temporary paralysis, heart conditions and severe cognitive problems.

"Our patients with PLDS feel terrible, their lives have been disrupted immeasurably and they deserve answers," says Afton Hassett of the University of Michigan Medical School at Ann Arbor who spoke about biomarkers, which could be used to diagnose patients with chronic Lyme disease.

Shut door

Many patients who have been diagnosed with chronic Lyme by their doctors do not meet the criteria set out by the Center for Disease Control and Prevention (CDC) for the disease.

Paul Mead, a medical epidemiologist at the CDC, says that he would welcome new insight that might contribute to better diagnoses and treatments for patients who don't meet the centre's current criteria. "There's no point in debating whether or not this is a real entity," he says. "The point is what is the best treatment."

“Our patients with PLDS feel terrible, their lives have been disrupted immeasurably and they deserve answers.”



But his words have not been met with financial backing. Controlled clinical trials testing long-term antibiotic therapy previously found that the antibiotic was no better than a placebo1, and that intravenous antibiotic treatment might even be dangerous for some patients2,3.

The Infectious Diseases Society of America recommends against treating chronic Lyme disease with antibiotics and some worry that the door to new trials has now been shut.

In his presentation, Brian Fallon of Columbia University in New York pointed out that, in the trial he led, patients in severe pain benefited from intravenous antibiotics. But, he added, those with low levels of pain fared no better than those given the placebo3.

"This study has been significantly downplayed, and I think to the detriment of science because although it showed that IV antibiotics can cause significant risk, there was a greater improvement with the drug than with the placebo," he says. He added that more trials should focus on using safer antibiotics and non-antibiotic treatments.

Persistent pest

The NIH does not fund trials on treating chronic Lyme disease and the IOM are hesitant to push for further studies on antibiotic treatments, says Fallon, because the jury is still out on whether chronic Lyme disease results from an extended inflammatory reaction to the Lyme bacteria — Borrelia burgdorferi in the United States — after it has been eradicated by a short course of antibiotics.

Yet Borrelia infections often persist in animals, say researchers at the workshop. Linda Bockenstedt of Yale School of Medicine in Connecticut presented images of non-mobile bacteria remaining in the tissues of mice long after they had been treated with antibiotics.

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In March, the NIH, and specifically the National Institute of Allergy and Infectious Diseases (NIAID), charged the IOM with establishing a committee to analyse the state of science for tick-borne diseases. "The charges to this committee specifically request that we do not consider or discuss treatment guidelines and we will hold to that," says Lonnie King, chair of the IOM committee on Lyme disease and other tick-borne diseases.

"NIAID viewed this meeting as providing a unique opportunity to bring diverse perspectives on the state of the science on Lyme and tick-borne diseases," said Jill Harper, chief of correspondence management at NIAID, in a statement to Nature. "Adding a complicated issue such as clinical treatment guidelines to the agenda might have diluted the scientific focus of the meeting."

Nonetheless, Monte Skall, executive director of the National Capital Lyme and Tick-Borne Disease Association, was pleasantly surprised that the IOM acknowledged chronic Lyme disease at the workshop. Three advocacy groups withdrew from the workshop before it started, accusing the IOM of bias against claims of chronic Lyme disease and the possibility that it can be treated with antibiotics. "It goes to show you, it's best to come to a conference like this with an open mind," Skall says. "We are hoping that out of this workshop comes a second workshop where we can talk about treatment."