Editor’s note: This is the first installment in a three-part series exploring the debate over Lyme disease diagnosis and treatment, and how it has affected Rhode Island and those with the disease locally.
North Kingstown resident Joe Russo used to be a healthy, active man.
Along with providing for himself through full-time employment, Russo was an avid hunter, always searching for game during his downtime. He also rode bicycles up and down his neighborhood.
Then, more than a decade ago, things began to change. He continued his normal daily routine but had “weird symptoms that would come and go, or just didn’t feel right.” He would seek medical treatment to find out what was wrong, but the doctors only said he was either anxious, depressed or had allergies.
“So, you try all the things they tell you and you keep trucking,” he said.
The symptoms would subside, he added, but months later he would experience “these other flares and weird stuff,” like vertigo, dizzy spells or sweats.
As the years passed, Russo did not get better. He sought testing for “everything under the sun” – cancer and heart issues, among others – to get an answer for why his condition was deteriorating. However, the doctors at the time failed to test for another possibility – Lyme disease.
Russo ultimately saw another doctor and received a confirmed diagnosis of the tick-borne disease. Relieved at finally having an answer, he went back to his primary care physician to plan a course of action.
But the response he got was unexpected.
“When I went back to [my physician] with the positive lab [results], telling her, ‘OK, we have an answer,’ she dismissed me,” he said. “Our relationship was very good. She was always caring. She tested me for everything, but once she found out I had Lyme, she wanted nothing to do with me.”
Russo said he inquired in writing to seek an explanation for the dismissal, but received no response.
“She left me with no reason,” he said.
He added, “That was humbling and it actually hurt. A doctor can dismiss you with this and there’s nothing you can do about it.”
Lyme disease is an extremely complex illness with no known cure. It can produce an array of symptoms, such as fatigue, joint pain, arthritis, muscle aches, palsy, tingling and twitching muscles and other neurological symptoms. The most common symptom is a rash, often in a bulls-eye pattern.
Dr. Jim Gloor, a North Kingstown-based physician who has specialized in Lyme disease treatment for more than three decades, said Lyme-causing bacteria is “one of the most complex eukaryotic cells.” Typically, he said, a person’s immune system is supposed to “sort out” what is foreign and what is not inside a person’s body. But Lyme-causing bacteria is so effective in evading the immune system that it “overheats the immune engine,” causing a sufferer’s health to go haywire.
“It’s like when you race an old Chevy down the highway at 100 mph over a bumpy road, something’s going to break,” he said. “The immune system goes haywire and we have fallout from it that ends up being other conditions that are autoimmune, which is a nice way of saying, ‘We don’t know exactly why the immune system went sour.’”
Gloor said the medical community has yet to fully understand the immune system and autoimmunity. Because of that, he said, “a lot more research” needs to be done, particularly because Lyme disease is “so sophisticated.”
“It confuses and confounds the immune system, and it confounds the body in general,” he said.
The complexity has caused confusion over how Lyme disease is diagnosed, and led to intense debate locally and nationally about treatments and whether the disease can be designated as chronic.
Dr. Utpala Bandy, a state epidemiologist and medical director for the Rhode Island Department of Health’s Division of Preparedness, Infectious Disease and Emergency Medical Services, said July 26 while the state does not develop, produce, approve or endorse any guidelines on treating Lyme disease, “two main sets” of guidelines are in place nationally for physicians to follow.
One comes from the Infectious Diseases Society of America, or IDSA, in conjunction with the Centers for Disease Control and Prevention, and the other from the International Lyme and Associated Diseases Society, or ILADS.
The organizations have conflicting views of Lyme disease treatment and diagnoses of long-term Lyme disease.
According to the state Department of Health’s Jan. 31, 2016, report on Lyme disease, the IDSA/CDC guidelines indicate patients should take the antibiotic doxycycline for several Lyme disease symptoms, including the “bulls-eye” rash, palsy, cardiac disease, arthritis without neurological involvement and recurrent arthritis after a single course of antibiotics.
IDSA, according to its 2006 report “Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines,” also maintains there is “no convincing evidence for the existence” of a chronic borrelia burgdorferi infection – the bacteria that causes Lyme disease – in patients who have received the recommended treatments. The report states antibiotic therapy “is not recommended” for patients with chronic Lyme disease lasting longer than six months.
In June, CDC published in its “Morbidity and Mortality Weekly Report” an article that also warns of “serious risks” for Lyme patients receiving antibiotic and intravenous treatment, even resulting in “serious harm, including death.”
The introduction to the article, titled “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States,” reads: “The term ‘chronic Lyme disease’ is used by some health care providers as a diagnosis for various constitutional, musculoskeletal, and neuropsychiatric symptoms. Patients with a diagnosis of chronic Lyme disease have been provided a wide range of medications as treatment, including long courses of intravenous (IV) antibiotics. Studies have not shown that such treatments lead to substantial long-term improvement for patients, and they can be harmful. This report describes cases of septic shock, osteomyelitis, Clostridium difficile colitis, and paraspinal abscess resulting from treatments for chronic Lyme disease. Patients, clinicians, and public health practitioners should be aware that treatments for chronic Lyme disease can carry serious risks.”
Other treatments, including “IV infusions of hydrogen peroxide, immunoglobulin therapy, hyperbaric oxygen therapy, electromagnetic frequency treatments, garlic supplements, colloidal silver, and stem cell transplants,” are also presented as being risky and not shown to produce favorable results.
The article further states, “At least five randomized, placebo-controlled studies have shown that prolonged courses of IV antibiotics in particular do not substantially improve long-term outcome for patients with a diagnosis of chronic Lyme disease and can result in serious harm, including death.” Five specific cases are cited to support the article’s assertions.
In contrast, ILADS states on its website that “it is impossible to state a meaningful success rate for the prevention of Lyme disease by a single 200 mg dose of doxycycline,” and advises clinicians should not use a single doxycycline dose for treatment due to “very-low quality evidence.”
An “optimal treatment regimen has not yet been determined,” ILADS states, adding that it is “too early to standardize restrictive protocols.” ILADS recommends patient goals and values regarding treatment options be identified and strongly considered during a shared decision-making process.
ILADS President Dr. Samuel Shor pushed back against the CDC’s June 16 report in a June 23 post on the National Center for Biotechnology Information’s website. He notes one National Institutes of Health-supported study, in which 37 patients suspected of having active neuroborrelliosis – a central nervous system disorder caused by Lyme disease – received 10 weeks of IV Ceftriaxone, or two grams a day of the antibiotic. Pain and physical functioning “improved at 12 [weeks] and was sustained at 24 weeks,” Shor states.
Shor also points to another NIH-supported study in which 55 patients who felt they had an active infection of the main Lyme disease bacteria and experienced severe fatigue for longer than six months received 28 days of IV Ceftriaxone. According to Shor, a “significant improvement in fatigue was sustained at 6 months.”
While there are conflicting viewpoints regarding how Lyme disease should be approached and treated, one local advocate believes the state sides with the IDSA/CDC guidelines – which, he believes, are outdated.
Lane Poor, a North Kingstown resident, was first diagnosed with Lyme disease in 1983 and still feels the effects of the disease. He has traveled around the state for years making residents aware of the disease and its harmful effects – especially if it goes undetected.
In an interview in June, he said he believes the state “can’t accept the fact” that Lyme disease is a major problem in Rhode Island, mainly because it is “complicated,” “messy” and there is “no silver bullet” in terms of treatment. He said the disease can result in multiple infections following the initial infection from a tick bite, and doctors are “not used to it being multiple infections.”
“They’re used to it as, ‘It’s one disease and you have that one thing that will kill the one disease.’ That doesn’t happen with Lyme,” he said. “Lyme disease, you can get other infections. It is so hard for doctors to identify what’s going on because you’ve got three, four different infections. It’s a compound disease, and we’re not used to treating compound diseases.”
Poor also believes there are many more Lyme disease cases in Rhode Island than the Department of Health has reported. In 2014, Rhode Island, at 86 cases per 100,000 people, had the fourth-highest Lyme disease rate in the U.S. Bandy said the department processes approximately 3,000 test reports for surveillance every summer, and of that amount, approximately 900 new Lyme disease cases are determined annually.
Poor, though, thinks Rhode Island’s rate may be 10 times higher than the official figure.
“Massachusetts has got an infection rate of about 800 people per 100,000, and RIDOH says we have 80,” he said. “We’re neighbors with Massachusetts.”
Both Poor and Gloor are critical of the CDC’s recommended two-tier testing regimen. CDC suggests doctors first order a test known as an enzyme-linked immunosorbent assay, or ELISA, to screen for Lyme disease and then confirm it with a western blot, a procedure used to detect specific proteins.
However, according to the advocacy group LymeDisease.org, a 2002 study by Massachusetts Dr. Samuel Donta revealed 52 percent of patients with chronic Lyme disease are considered “negative” by the ELISA test, but the western blot shows a positive result. The College of American Pathologists, according to a 1997 study, found that ELISA tests “do not have adequate sensitivity to be used for screening purposes.”
Gloor said in about half of his cases, the tests are negative “across the board.”
LymeDisease.org states a quality test can help a doctor assess the disease’s severity, estimate a patient’s prognosis, monitor the disease’s progression, detect relapses or adjust therapies.
“Unfortunately, a test with this capability does not exist for Lyme disease,” according to LymeDisease.org.
Donta also said the tests are “indirect” and do not indicate whether or not the Lyme disease bacteria is still present. Until a proven test is developed, he said, “clinical judgment and observations ... should be how one proceeds to treat such patients.”
Bandy said physicians and patients “can do whatever they want” as long as it is a “shared decision-making process.”
But Lyme disease specialists in Rhode Island and beyond have had their methods questioned by health officials.
Over more than five years, Gloor was called to appear before the Department of Health’s Board of Medical Licensure and Discipline multiple times to answer allegations from several complainants regarding his regimens for treating long-term Lyme disease, mostly with antibiotics and intravenous medicines.
The complaints, according to a 2014 consent decree filed with the health department, which was obtained by The Independent, were received by the board in 2012 and 2013, and the panel “questioned the reasonableness of the diagnosis and treatment plans.”
While the board found no wrongdoing regarding Gloor’s regimens in 2014, the decree indicates he was penalized for “failing to properly document diagnoses in the assessment and plan sections of certain medical charts and with respect to the legibility of patient records.” He was ordered to pay a $1,935 administrative fee to the health department and was placed on a monitoring period for one year.
In December 2016, Gloor was again cited by the Board of Medical Licensure and Discipline for poor record keeping, according to a second consent decree filed with the health department, which also indicated Gloor’s handwriting was “barely legible and his script was so large there is only room for the barest information.”
Gloor agreed to a reprimand and paid an administrative fee of $500. He additionally agreed to complete eight hours of continuing education regarding record keeping, health department spokeswoman Annemarie Beardsworth said in an email July 24.
Poor was sharply critical of the health department’s dealings with Gloor, and indicated other local physicians had been treated similarly. He said the consent decrees amount to health officials serving as “judge, jury and executioner all in one thing.”
“Doctors are scared stiff they’re going to be brought before the board for treating Lyme disease, so they don’t [treat it],” he added. “A lot of doctors have refused to have anything to do with it.”
Gloor said the issues with the health department have taken a toll emotionally and mentally, and have had a significant negative impact on his practice. He was forced to move from his former office at Wickford Junction to a new space on Post Road.
“This tied me up for years,” he said. “My practice went to hell.”