I'm a bit confused. Normally, Lyme activists spend a lot of time and ink complaining that there is not enough research being done on chronic Lyme disease and better diagnostics. So NIH sets up a clinical trial using xenodiagnosis to look for the presence of persisting B. burgdorferi bacteria in Lyme disease patients. Here’s summary of the trial objectives from clinicialtrials.gov:
In this proposal, the utility of xenodiagnosis for identifying persistence of B. burgdorferi in treated human Lyme disease will be tested in up to 120 subjects with various stages of Lyme disease with 30 healthy adults to serve as controls. Subjects will be followed for approximately 3 months.
In Objective #1, subjects who have the characteristic erythema migrans (EM) rash and have been treated with antibiotics early (within 3 weeks of infection) in the course of Lyme disease will be tested. After completion of antibiotic therapy, 25-30 larval Ixodes ticks will be allowed to feed on the subject and biopsies of the EM site will be performed. Repleted ticks will be collected, allowed to molt to their nymphal stage and then fed on severe combined immunodeficiency (SCID) mice. The repleted nymphal ticks and the immunodeficient mice will be tested for the presence of B. burgdorferi by PCR and culture.
In Objective #2, similar studies will be performed, but enrollment will target subjects with elevated C6 (region 6 of the VlsE surface protein of B. burgdorferi) antibody levels.
In Objective #3, patients with persistent symptoms after antibiotic therapy will be evaluated. As an attempt to increase the chances of a positive xenodiagnosis in humans, patients with EM who are in the first 2 days of antibiotic therapy and patients with untreated Lyme arthritis will also be evaluated.
In Objective #4 we will assess the safety of the planned xenodiagnostic procedure in humans. All individuals who underwent xenodiagnosis under the study will be assessed for adverse events.
Evidence that B. burgdorferi can be recovered by xenodiagnosis after antibiotic therapy in subjects with continued symptoms would change the current paradigm for potential mechanisms of disease and provide researchers and clinicians a tool for identifying patients with persistent infection.
But these wacky Lymees want to stop this particular line of research. Why? Well, according to the California group and Dr. Lorraine Johnson, the Lyme expert and medico-ethical-legal expert, it’s "because of the safety risks to patients, CALDA believes this study is unethical.” Basically, they are (allegedly) worried that some unknown pathogen might be lurking in these laboratory-raised ticks and be transmitted to the patients enrolled in the trial. Dr. Johnson writes, “Researchers recently discovered that Borrelia miyamotoi, a species of Borelia that occurs in Asia, Europe and North America, causes human illness. This discovery highlights the risk to patients in a current NIH study from exposure to unidentified pathogens that may not have been screened for by the researchers.”
Those are legitimate concerns…to a degree. However, B. miyamotoi is found in only about 2 percent of the deer ticks in the Northeast and Upper Midwest and are even less likely to be found in lab-raised and lab-screened ticks. Second, informed consent and a standard IRB review exist to ensure patient safety. Third, just because there is, by definition, some risk in a clinical trial does not make that trial “unethical.” Such a stance would end all clinical research, and all vaccine and drug trials. Fourth, it’s likely the investigators will let some of their ticks feed directly on SCID mice instead of on patients as a control for indigenous, unknown pathogens and other adverse reactions to the ticks themselves. Some thought has gone into this trial.
Some thought also has gone into the complaints from activists. Here’s an experiment that could, as the investigators note, “change the current paradigm for potential mechanisms of disease and provide researchers and clinicians a tool for identifying patients with persistent infection.” That’s what the activists have insisted they want: confirmation that they really are persistently infected with B. burgdorferi and in need of long-term antibiotic therapies. Of course, if the trial finds no evidence of persistent infection it’s another huge nail in the coffin of chronic Lyme disease.
And that’s why they want the trial stopped. The risk that this line of research might shatter the central dogma of Lyme activism and undermine the financial well-being of Lyme activists, Lyme literate doctors, and Lyme i.v. infusion companies is just too great a risk to take. Better to stick with belief than to take a chance on reality. It’s an unreasonable and unethical stance, but it’s better than having to admit error and defeat.