The Lyme Wars: Debate Rages About Treatment

Who knew a little tick could cause so much trouble? When Lyme disease was first described in 1977, did anyone suspect that three decades later, a battle would be raging between two professional organizations about how to treat it? Today, the “war” between the Infectious Diseases Society of America (IDSA) and the International Lyme and Associated Diseases Society (ILADS) leaves clinicians wondering whose guidelines they should follow.

Is it a case of David versus Goliath—the “upstart” ILADS challenging the established IDSA—or evidence-based medicine versus questionable practice? The more you listen to the parties involved, the more difficult it can be to determine the answer.

Chronic Problem
The crux of the Lyme disease treatment debate is whether the condition exists in a chronic form. ILADS practitioners insist that it does; how else to explain the lingering symptoms many patients experience, which they say resolve only with long-term, high-dose antibiotic therapy? IDSA, however, takes the viewpoint that these patients—whose symptoms of fatigue, cognitive dysfunction, and musculoskeletal pain are subjective and vague (belonging on the symptom list for chronic fatigue syndrome and fibromyalgia as well)—never had Lyme disease in the first place, and this is why standard therapy for the condition appears not to work for them.

“It’s true that those kinds of symptoms can occur in Lyme disease,” says Gary P. Wormser, MD, Chief of the Division of Infectious Diseases at New York Medical College in Valhalla, and lead author of IDSA’s guidelines. “But where the disconnect occurs is when people want to ascribe everybody with those symptoms as having Lyme disease, when they have no bona fide evidence [ie, validated laboratory results] of the disease.”

ILADS clinicians counter that the IDSA underestimates Borrelia burgdorferi (Bb), the spirochete that causes Lyme disease. “What we’re dealing with is way more sophisticated bacteria than any other bacteria we know,” says Ginger R. Savely, RN, FNP-C, a Lyme disease specialist at Union Square Medical Associates in San Francisco. “The more you really study the bacteria and how it works, the more you become incredibly impressed by how many mechanisms this bacteria has for survival and how difficult it is to get rid of it.”

Furthermore, Lyme disease specialists contend that the currently available diagnostic tools, the ELISA and the Western blot test, do not have sufficient sensitivity to reliably detect the presence of Bb (see Savely GR. Update on Lyme disease. Clinician Reviews. 2006;16[4]:44-51). This, they say, is why it can be difficult to validate the diagnosis.

Bottom line: If you can’t agree on what you’re treating, you certainly won’t agree on how to treat it.

Prolonged Antibiotic Therapy
IDSA’s guidelines on the treatment of Lyme disease recommend, in general, 14-day courses of oral antibiotics, with the option of a longer course (28 days) or retreatment where deemed appropriate. “We don’t treat bacterial infections with prolonged antibiotics,” Wormser points out, citing as examples cystitis, strep throat, and sinusitis. “So when you see 14 days recommended, that’s a long course relative to many bacterial infections.”

At issue in the Lyme “war” is the fact that ILADS, in the words of President Daniel Cameron, MD, MPH, “likes to offer options to patients who find themselves still sick after 30 days of treatment”—specifically, long-term (sometimes indefinite) high-dose antibiotic therapy.

Wormser is quick to point out that “our guidelines don’t really discuss how any individual patient is to be treated. They just tell you a general approach that we think is scientifically based and makes sense, based on all other infectious diseases.” In the IDSA’s estimation, the research does not support the efficacy of long-term antibiotic therapy for Lyme disease—and in the absence of that support, the risks involved are just too great.

Those risks include the growing problem of antibiotic-resistant bacteria, the possibility of coinfection with an organism such as Clostridium difficile, and the potential for sepsis and other complications associated with prolonged IV therapy. “Would you really dialyze somebody who didn’t need dialysis?” Wormser asks. “That’s an extreme example. But we say to ourselves every time we use them, ‘Do we really need antibiotics here, and what’s the shortest period of time we can give them, not the longest?’”

“The IDSA loves to say that what we’re doing is harmful or dangerous,” says Savely, who has treated more than 1,000 patients according to the ILADS recommendations. “The data have not shown that to be true. We have not had problems or complications—certainly not mortality—from the kind of treatment that we do.”

Furthermore, ILADS clinicians say they restore hope to patients whom “mainstream” medicine has failed. “People were coming to me with just terrible, terrible conditions, where they had been to so many specialists and every one had told them, ‘There’s no hope. We can’t do anything for you,’” Savely says. “And then I’d start treating them with high-dose long-term antibiotics, and they would get their lives back.”

Wormser understands that many patients feel let down by practitioners who can’t provide definitive answers about their condition. “And I know people will turn to whoever says they think they can help—I can’t blame them for that,” he says. Nonetheless, “it is remarkable the difference that patients with real Lyme have, in terms of their experience with antibiotics, compared to people who probably don’t have Lyme but feel they do.”

Risky Business?
So, how should clinicians handle patient inquiries about Lyme disease treatment? ILADS President Cameron believes that all options should be presented. “The patient should be involved in the decision, rather than just offered only one answer,” he says, although he respects every clinician’s right to say, “There are other options, but I choose this one.”

Clinician Reviews Editorial Board member Julia Pallentino, MSN, JD, ARNP, sees patients in her gastroenterology practice in Tallahassee, Florida, who are being treated by other clinicians with long-term antibiotic therapy for Lyme disease. “I respect their right to seek care from where they wish to seek it, and if they feel it has been helpful, I support that,” she says. Even so, if she were the one treating them for Lyme disease, “I certainly would not take on a different way of treatment because they want it. I would say, ‘I understand that you think this will help you, and I certainly respect your opinion. However, that’s not the method I use. If you want to use a different method, then I would recommend you find a practitioner who does that.’”

Of course, in this day and age, the specter of malpractice hangs over everyone. “As an attorney, I can tell you I’d much rather my client had been using IDSA guidelines than ILADS,” Pallentino says. “If you treat a patient according to CDC guidelines [which are the IDSA guidelines, in this case], then it would be very difficult to say that you weren’t doing what was accepted, appropriate treatment.”

Savely understands all too well how risky treating Lyme disease can be. In 2004, she was voted Texas NP of the Year. Two years later, she says, her supervising physician was more or less intimidated by the medical board into terminating their collaborative agreement. Finding another supervising physician proved so difficult that she accepted an offer from an ILADS doctor to work with him, requiring her to relocate her practice to San Francisco. The changes impacted every area of her life—and yet, she persists in caring for Lyme disease patients according to the ILADS guidelines.

Why? “Somebody’s got to take care of these people,” she says. “Every time I have a patient saying ‘I cannot even tell you how grateful I am to you for listening to me when no one else would, and for treating me when nobody else would, and for letting me live again,’ I just go, ‘Gosh, I have to do this. I have to.’”

Whether other clinicians will feel they have to treat Lyme disease using one of the competing regimens is for them alone to decide.

Who knew a little tick could cause so much trouble? When Lyme disease was first described in 1977, did anyone suspect that three decades later, a battle would be raging between two professional organizations about how to treat it? Today, the “war” between the Infectious Diseases Society of America (IDSA) and the International Lyme and Associated Diseases Society (ILADS) leaves clinicians wondering whose guidelines they should follow.

Is it a case of David versus Goliath—the “upstart” ILADS challenging the established IDSA—or evidence-based medicine versus questionable practice? The more you listen to the parties involved, the more difficult it can be to determine the answer.

Chronic Problem
The crux of the Lyme disease treatment debate is whether the condition exists in a chronic form. ILADS practitioners insist that it does; how else to explain the lingering symptoms many patients experience, which they say resolve only with long-term, high-dose antibiotic therapy? IDSA, however, takes the viewpoint that these patients—whose symptoms of fatigue, cognitive dysfunction, and musculoskeletal pain are subjective and vague (belonging on the symptom list for chronic fatigue syndrome and fibromyalgia as well)—never had Lyme disease in the first place, and this is why standard therapy for the condition appears not to work for them.

“It’s true that those kinds of symptoms can occur in Lyme disease,” says Gary P. Wormser, MD, Chief of the Division of Infectious Diseases at New York Medical College in Valhalla, and lead author of IDSA’s guidelines. “But where the disconnect occurs is when people want to ascribe everybody with those symptoms as having Lyme disease, when they have no bona fide evidence [ie, validated laboratory results] of the disease.”

ILADS clinicians counter that the IDSA underestimates Borrelia burgdorferi (Bb), the spirochete that causes Lyme disease. “What we’re dealing with is way more sophisticated bacteria than any other bacteria we know,” says Ginger R. Savely, RN, FNP-C, a Lyme disease specialist at Union Square Medical Associates in San Francisco. “The more you really study the bacteria and how it works, the more you become incredibly impressed by how many mechanisms this bacteria has for survival and how difficult it is to get rid of it.”

Furthermore, Lyme disease specialists contend that the currently available diagnostic tools, the ELISA and the Western blot test, do not have sufficient sensitivity to reliably detect the presence of Bb (see Savely GR. Update on Lyme disease. Clinician Reviews. 2006;16[4]:44-51). This, they say, is why it can be difficult to validate the diagnosis.

Bottom line: If you can’t agree on what you’re treating, you certainly won’t agree on how to treat it.

Prolonged Antibiotic Therapy
IDSA’s guidelines on the treatment of Lyme disease recommend, in general, 14-day courses of oral antibiotics, with the option of a longer course (28 days) or retreatment where deemed appropriate. “We don’t treat bacterial infections with prolonged antibiotics,” Wormser points out, citing as examples cystitis, strep throat, and sinusitis. “So when you see 14 days recommended, that’s a long course relative to many bacterial infections.”

At issue in the Lyme “war” is the fact that ILADS, in the words of President Daniel Cameron, MD, MPH, “likes to offer options to patients who find themselves still sick after 30 days of treatment”—specifically, long-term (sometimes indefinite) high-dose antibiotic therapy.

Wormser is quick to point out that “our guidelines don’t really discuss how any individual patient is to be treated. They just tell you a general approach that we think is scientifically based and makes sense, based on all other infectious diseases.” In the IDSA’s estimation, the research does not support the efficacy of long-term antibiotic therapy for Lyme disease—and in the absence of that support, the risks involved are just too great.

Those risks include the growing problem of antibiotic-resistant bacteria, the possibility of coinfection with an organism such as Clostridium difficile, and the potential for sepsis and other complications associated with prolonged IV therapy. “Would you really dialyze somebody who didn’t need dialysis?” Wormser asks. “That’s an extreme example. But we say to ourselves every time we use them, ‘Do we really need antibiotics here, and what’s the shortest period of time we can give them, not the longest?’”

“The IDSA loves to say that what we’re doing is harmful or dangerous,” says Savely, who has treated more than 1,000 patients according to the ILADS recommendations. “The data have not shown that to be true. We have not had problems or complications—certainly not mortality—from the kind of treatment that we do.”

Furthermore, ILADS clinicians say they restore hope to patients whom “mainstream” medicine has failed. “People were coming to me with just terrible, terrible conditions, where they had been to so many specialists and every one had told them, ‘There’s no hope. We can’t do anything for you,’” Savely says. “And then I’d start treating them with high-dose long-term antibiotics, and they would get their lives back.”

Wormser understands that many patients feel let down by practitioners who can’t provide definitive answers about their condition. “And I know people will turn to whoever says they think they can help—I can’t blame them for that,” he says. Nonetheless, “it is remarkable the difference that patients with real Lyme have, in terms of their experience with antibiotics, compared to people who probably don’t have Lyme but feel they do.”

Risky Business?
So, how should clinicians handle patient inquiries about Lyme disease treatment? ILADS President Cameron believes that all options should be presented. “The patient should be involved in the decision, rather than just offered only one answer,” he says, although he respects every clinician’s right to say, “There are other options, but I choose this one.”

Clinician Reviews Editorial Board member Julia Pallentino, MSN, JD, ARNP, sees patients in her gastroenterology practice in Tallahassee, Florida, who are being treated by other clinicians with long-term antibiotic therapy for Lyme disease. “I respect their right to seek care from where they wish to seek it, and if they feel it has been helpful, I support that,” she says. Even so, if she were the one treating them for Lyme disease, “I certainly would not take on a different way of treatment because they want it. I would say, ‘I understand that you think this will help you, and I certainly respect your opinion. However, that’s not the method I use. If you want to use a different method, then I would recommend you find a practitioner who does that.’”

Of course, in this day and age, the specter of malpractice hangs over everyone. “As an attorney, I can tell you I’d much rather my client had been using IDSA guidelines than ILADS,” Pallentino says. “If you treat a patient according to CDC guidelines [which are the IDSA guidelines, in this case], then it would be very difficult to say that you weren’t doing what was accepted, appropriate treatment.”

Savely understands all too well how risky treating Lyme disease can be. In 2004, she was voted Texas NP of the Year. Two years later, she says, her supervising physician was more or less intimidated by the medical board into terminating their collaborative agreement. Finding another supervising physician proved so difficult that she accepted an offer from an ILADS doctor to work with him, requiring her to relocate her practice to San Francisco. The changes impacted every area of her life—and yet, she persists in caring for Lyme disease patients according to the ILADS guidelines.

Why? “Somebody’s got to take care of these people,” she says. “Every time I have a patient saying ‘I cannot even tell you how grateful I am to you for listening to me when no one else would, and for treating me when nobody else would, and for letting me live again,’ I just go, ‘Gosh, I have to do this. I have to.’”

Whether other clinicians will feel they have to treat Lyme disease using one of the competing regimens is for them alone to decide.

Who knew a little tick could cause so much trouble? When Lyme disease was first described in 1977, did anyone suspect that three decades later, a battle would be raging between two professional organizations about how to treat it? Today, the “war” between the Infectious Diseases Society of America (IDSA) and the International Lyme and Associated Diseases Society (ILADS) leaves clinicians wondering whose guidelines they should follow.

Is it a case of David versus Goliath—the “upstart” ILADS challenging the established IDSA—or evidence-based medicine versus questionable practice? The more you listen to the parties involved, the more difficult it can be to determine the answer.

Chronic Problem
The crux of the Lyme disease treatment debate is whether the condition exists in a chronic form. ILADS practitioners insist that it does; how else to explain the lingering symptoms many patients experience, which they say resolve only with long-term, high-dose antibiotic therapy? IDSA, however, takes the viewpoint that these patients—whose symptoms of fatigue, cognitive dysfunction, and musculoskeletal pain are subjective and vague (belonging on the symptom list for chronic fatigue syndrome and fibromyalgia as well)—never had Lyme disease in the first place, and this is why standard therapy for the condition appears not to work for them.

“It’s true that those kinds of symptoms can occur in Lyme disease,” says Gary P. Wormser, MD, Chief of the Division of Infectious Diseases at New York Medical College in Valhalla, and lead author of IDSA’s guidelines. “But where the disconnect occurs is when people want to ascribe everybody with those symptoms as having Lyme disease, when they have no bona fide evidence [ie, validated laboratory results] of the disease.”

ILADS clinicians counter that the IDSA underestimates Borrelia burgdorferi (Bb), the spirochete that causes Lyme disease. “What we’re dealing with is way more sophisticated bacteria than any other bacteria we know,” says Ginger R. Savely, RN, FNP-C, a Lyme disease specialist at Union Square Medical Associates in San Francisco. “The more you really study the bacteria and how it works, the more you become incredibly impressed by how many mechanisms this bacteria has for survival and how difficult it is to get rid of it.”

Furthermore, Lyme disease specialists contend that the currently available diagnostic tools, the ELISA and the Western blot test, do not have sufficient sensitivity to reliably detect the presence of Bb (see Savely GR. Update on Lyme disease. Clinician Reviews. 2006;16[4]:44-51). This, they say, is why it can be difficult to validate the diagnosis.

Bottom line: If you can’t agree on what you’re treating, you certainly won’t agree on how to treat it.

Prolonged Antibiotic Therapy
IDSA’s guidelines on the treatment of Lyme disease recommend, in general, 14-day courses of oral antibiotics, with the option of a longer course (28 days) or retreatment where deemed appropriate. “We don’t treat bacterial infections with prolonged antibiotics,” Wormser points out, citing as examples cystitis, strep throat, and sinusitis. “So when you see 14 days recommended, that’s a long course relative to many bacterial infections.”

At issue in the Lyme “war” is the fact that ILADS, in the words of President Daniel Cameron, MD, MPH, “likes to offer options to patients who find themselves still sick after 30 days of treatment”—specifically, long-term (sometimes indefinite) high-dose antibiotic therapy.

Wormser is quick to point out that “our guidelines don’t really discuss how any individual patient is to be treated. They just tell you a general approach that we think is scientifically based and makes sense, based on all other infectious diseases.” In the IDSA’s estimation, the research does not support the efficacy of long-term antibiotic therapy for Lyme disease—and in the absence of that support, the risks involved are just too great.

Those risks include the growing problem of antibiotic-resistant bacteria, the possibility of coinfection with an organism such as Clostridium difficile, and the potential for sepsis and other complications associated with prolonged IV therapy. “Would you really dialyze somebody who didn’t need dialysis?” Wormser asks. “That’s an extreme example. But we say to ourselves every time we use them, ‘Do we really need antibiotics here, and what’s the shortest period of time we can give them, not the longest?’”

“The IDSA loves to say that what we’re doing is harmful or dangerous,” says Savely, who has treated more than 1,000 patients according to the ILADS recommendations. “The data have not shown that to be true. We have not had problems or complications—certainly not mortality—from the kind of treatment that we do.”

Furthermore, ILADS clinicians say they restore hope to patients whom “mainstream” medicine has failed. “People were coming to me with just terrible, terrible conditions, where they had been to so many specialists and every one had told them, ‘There’s no hope. We can’t do anything for you,’” Savely says. “And then I’d start treating them with high-dose long-term antibiotics, and they would get their lives back.”

Wormser understands that many patients feel let down by practitioners who can’t provide definitive answers about their condition. “And I know people will turn to whoever says they think they can help—I can’t blame them for that,” he says. Nonetheless, “it is remarkable the difference that patients with real Lyme have, in terms of their experience with antibiotics, compared to people who probably don’t have Lyme but feel they do.”

Risky Business?
So, how should clinicians handle patient inquiries about Lyme disease treatment? ILADS President Cameron believes that all options should be presented. “The patient should be involved in the decision, rather than just offered only one answer,” he says, although he respects every clinician’s right to say, “There are other options, but I choose this one.”

Clinician Reviews Editorial Board member Julia Pallentino, MSN, JD, ARNP, sees patients in her gastroenterology practice in Tallahassee, Florida, who are being treated by other clinicians with long-term antibiotic therapy for Lyme disease. “I respect their right to seek care from where they wish to seek it, and if they feel it has been helpful, I support that,” she says. Even so, if she were the one treating them for Lyme disease, “I certainly would not take on a different way of treatment because they want it. I would say, ‘I understand that you think this will help you, and I certainly respect your opinion. However, that’s not the method I use. If you want to use a different method, then I would recommend you find a practitioner who does that.’”

Of course, in this day and age, the specter of malpractice hangs over everyone. “As an attorney, I can tell you I’d much rather my client had been using IDSA guidelines than ILADS,” Pallentino says. “If you treat a patient according to CDC guidelines [which are the IDSA guidelines, in this case], then it would be very difficult to say that you weren’t doing what was accepted, appropriate treatment.”

Savely understands all too well how risky treating Lyme disease can be. In 2004, she was voted Texas NP of the Year. Two years later, she says, her supervising physician was more or less intimidated by the medical board into terminating their collaborative agreement. Finding another supervising physician proved so difficult that she accepted an offer from an ILADS doctor to work with him, requiring her to relocate her practice to San Francisco. The changes impacted every area of her life—and yet, she persists in caring for Lyme disease patients according to the ILADS guidelines.

Why? “Somebody’s got to take care of these people,” she says. “Every time I have a patient saying ‘I cannot even tell you how grateful I am to you for listening to me when no one else would, and for treating me when nobody else would, and for letting me live again,’ I just go, ‘Gosh, I have to do this. I have to.’”

Whether other clinicians will feel they have to treat Lyme disease using one of the competing regimens is for them alone to decide.