Sunday, September 18, 2011

The Rights To Treat and Be Treated

There’s a real possibility that recent events in British Columbia signal the beginning of change in Canada’s suppressive approach to Lyme disease. So far in 2011:
  • A report on chronic Lyme disease by a senior public health official found the Lyme test ‘inadequate’, acknowledged that chronic Lyme can be treated to improve quality of life, and recommended doctors be empowered to adopt ‘realistic but flexible’ approaches to treatment in consultation with their patients.
  • For the first time, a provincial health minister acknowledged the presence of undiagnosed and untreated chronic Lyme disease in BC and confirmed that doctors have the right to prescribe longer courses of antibiotics than set out in the Lyme guidelines.
  • BC announced a new initiative to set up a complex chronic disease clinic to gain experience treating chronic Lyme and to initiate research on a reliable Lyme test.
It’s clear that something changed in the BCgovernment’s approach in 2011. Asked pointedly in Estimates debate by MLA LanaPopham whether BC doctors have the right to prescribe antibiotics for Lyme disease beyond current guidelines, Health Minister Mike de Jong responded:

“There are no constraints on the part of a physician in the circumstances the member has described from prescribing alonger course of antibiotics. That remains the exclusive domain of the physician.”

This frank statement gives primacy to a physician’s judgment in prescribing a remedy for disease. It means that if a doctor diagnoses a patient with Lyme and believes that antibiotics should be given until symptoms resolve,s/he has that right. Unfortunately, it’s also a right not exercised by many doctors today.

In Minister de Jong’s words: “there is, admittedly, a reluctance to do so because the physicians in general terms will follow the guidelines they are presented with by the College in Canada and by international bodies.” That’s the reality in BC and across Canada, and it’s why the guidelines and messaging to docs about the threat and incidence of Lyme need desperately to change.

Most GPs feel pressed to conform to what’sapproved by their licensing body, the public health apparatus, and specialist doctors. Most won’t exercise a right to treat more comprehensively when those holding their license uniformly repeat that a one-size-fits-all formula is best. This is especially true for a disease that few have wittingly dealt with, onethey’re insistently told is ‘rare’ and unlikely to be seen.

Fact is, BC docs are actively discouragedfrom diagnosing Lyme. It’s not too much to say there’s a stigma attached to it,nor that a dim view is taken of any doctor who breaks ranks. The message is,let the test tell you the answer. Fear of being outed for treating Lyme is why Dr. Brian Schmidt, author of a high-level report on chronic Lyme disease for the DM of Health, recommended BC“satisfy itself that a doctor may prescribe therapy to a patient that departs from prevailing medical practise”; and that “a doctor will not be investigated solely on the grounds that the registrant practices complementary medicine oruses non-traditional therapies”. I take him to mean that BC should remind doctorsthey have this latitude, should they in their professional judgment determine a therapy is advantageous to patient health.

These are rights and obligations set out in BC medical law that both doctors and regulatory bodies are insufficiently aware of – especially with respect to diagnosis and treatment of chronic Lymedisease. A longer course of antibiotics for chronic Lyme departs from prevailing practise, yet would qualify as complementary or non-traditional therapy for an illness the physician believes exists.

In Dr. Schmidt’s words: “Concerns continue about the rights of physicians to provide treatment advice to their patients,and the patients’ rights to receive care. Despite the advice of regulating bodies to the contrary, many physicians are fearful of retribution”. In other words, behind the scenes in medicine, there’s a chill on prescribing practises that depart from guidelines for Lyme patients. For infected patients looking to access needed medical care, this chill combines perversely with the Infectious Diseases Society of America’s denial of a chronic form of Lyme.

Dr. Schmidt’s recommendations reflect the urgency of reminding doctors that they are to make the choices in concert with their patients, and that the CPS’s role isn’t to penalize them for supplying a higher standard of care. There is after all a body of research supporting the existence of chronic Lyme and the possibility of symptom-relief and return of function using longer-course antibiotic therapies.

Dr. Schmidt determined that scientific opinion, rather than denying a chronic form of Lyme,supports the idea that it’s a bona fide disease for which ‘no effective test currently exists’. And clinical experience (ie. what physicians have learned from repeated courses of treatment) – if allowed to weigh in the balance – shows definitively that many can return to normal function with antibiotic therapy.

Patients with chronic lyme know thedifficulties of getting such therapy in BC. Inevitably, for an infectious disease that’s bacterial, antibiotics are needed, and when chronic, certainlyfor longer than a month. Absurdly, that’s just what the IDSA guidelines aredesigned to rule out. This works very well for US private insurance companies seeking to close off reponsibility for ongoing therapy, but it deals Canadian patients right out of their care benefits.

Treatment may, for some very sick people,involve taking antibiotics intravenously (many cannot take sustained oral ingestion without reaction). This option is effectively policed out in Canada,via quiet collaboration between Infectious Disease doctors and the hospitalistswho would install the PICC lines for IV therapy. If an IDD won’t authorize theinstallation – and none in BC will so far as I know – IV therapy simply can’t happen.

The BC guidelines are all about confiningantibiotic use to the narrowest circumstance, only where a flawed test ‘finds’Lyme, and then for only the shortest period of time – sometimes as little asten days. And never more than once, whether a patient has had Lyme for a weekor for years.

Dr. Schmidt’s review of the literature concluded what every Lyme victim sadly comes to realize – the test is inadequate and cannot be relied on – yet it’s being used to rule it out definitively. No positive test result, no diagnosis, and no antibiotics – now or ever.

Reliance on a test that doesn’t work keep sick people from accessing medically needed care. Denial of treatment for chronic Lyme keeps disabled people from any relief of pain and return of function. The IDSA guidelines are also used by private insurance companies inCanada (and the infectious disease doctors working privately for them) to deny sick patients care-benefits under their extended healthcare plans (drugs, homecare and nursing, LTD).

Dr. Schmidt notes that “the current state of diagnostic methods for Chronic Lyme and other related infections is inadequate”. He recommends “urgent attention” be given to creating betterdiagnostics and that testing for co-infections become “a component of thestandard diagnostic panel”. Improving diagnostics “is the first and highest priority for BC”.

Compare this to the BC CDC’s Dr. Henry,whose faith abides in the two-tiered test regime – despite strong evidence to the contrary; and in the ability of BC doctors’ to diagnose Lyme – despite 63%of them not recognizing the sole physical symptom (a bulls-eye rash) theguidelines allow as diagnostic.

This I believe is why Dr. Schmidt warned againstthe ‘risk of complacency’: passive surveillance of the population based on confidence in a test whose poor design is fixed like an insect in amber means no clear picture of the actual number of Lyme cases. And refusal to treat those with chronic Lyme means a sentence in hell and/or personal bankruptcy for manyinnocent people.

Just as Schmidt’s confidential report was being released by Lyme advocate Gwen Barlee, BC announced a significant newinitiative: a $2-million specialty clinic to develop experience in diagnosing and treating chronic forms of resistant illness, including Lyme disease. The new clinic is also to have a research component aimed at contributing to development of new diagnostic technologies.

Back to Minister de Jong: “We are obviouslydealing with an area where there are some differing views among clinicians…I and the government and the ministry are satisfied that there are people whose Lyme disease was not diagnosed or treated, and they went on to have real longer term chronic complications.”

This is a giant step forward for government and the ministry of health, placing them beyond the ruling orthodoxy. Minister de Jong acknowledges that Lyme is sometimes missed in BC, goes on to become chronic, and that this has consequences for the lives of patients. These peoplehave been mostly abandoned to their own devices to this point. The new clinicis intended to create a base of experience that might begin to remedy that situation by contributing to new standards of care.

Sustained denial of all problems with Lyme policy has been government’s typical reaction, so this marks a major turning point. The new position is consistent with Schmidt’s reading of the scientific literature, which found the test unreliable but affirmed the efficacy of antibiotic and anti-microbial strategies in treating chronic Lyme – a disease that places “a significant burden on patients who are sometimes given few options or hope.”

“In the face of existing diagnostic knowledge, which is ambiguous at best, it is understandable that a significant proportion of the medical profession is hesitant to move away from the strong and appropriate tradition of only practicing within established standards of care. Hopefully, standards of care and better diagnostics will change with more evidence, but in the face of no treatment at all patients are in the middle of the issue.”

The current ‘standard of care’ results in most physicians providing no treatment at all for chronic Lyme. Enter the clinic: “The good news is that the government recognizes that….we’re probably in a position where we want to get some reliable information and data of our own, which is why the $2-million has beenallocated to fund the diagnosis study.”

It’s fair to infer from this that the clinic is intended to create a space wheretreatment experience can accumulate and be documented and openly discussed. By extension, it implies the high fence the IDSA has built to isolate chronic Lyme from obligations to treat may now have an escape hatch. It will be necessary to ensure no IDSA ideologues invade the treatment space, if learning is actually to occur.

Minister de Jong refers to the “uncertaintyor debate about what… best practises on the diagnostic side actually are”. The$2-million clinic-study is intended to “add to the body of evidence that will help resolve that”. “…until those best practises change, we’re unlikely to seethe response from medical practioners change”.

It’s still early days for the BC Lyme clinic. Negotiations are under way with a potential host and there’s work being done on a clinical delivery model. Therehave been initial discussions with CanLyme about how the clinic might work and on the technical matter of a working definition of chronic Lyme. An advisory group with advocates included is part of the design, but hasn’t been convened. We’re still a long way fromanyone with chronic Lyme actually getting treated. But in the design phase at least, the door appears open to more patient-focused model of care.

Research is to be a second thrust for the clinic: CanLyme is encouraging work towards a reliable test that will bring the kind of ‘certainty’ that enables clear identification and prompt treatment. The potential involvement of Genome BC in the initiative is intriguing. B.C. has donestellar work in developing an HIV test that is now used worldwide – perhaps a reliable test for Lyme could emerge from this collaboration.

All of this is good as far as it goes. But the IDSA guidelines remain in place and doctors, most of whom are kept Lyme-ignorant by design, will continue to rely on ELISA results to rule Lyme out definitively. This means that an unknown but growing number of British Columbians will be condemned each year to develop a life-ruining illness for which they’re unlikely to receive any treatment (unless they self-diagnose without-of-country testing and can somehow find their way into the new clinic).

As advocates, we obviously can’t put all our eggs in the clinic basket. Enough is already known about Lyme to detect it clinically and treat it pre-emptively. It’s not hard to get Lyme, but it can be easy to cure if the intervention follows soon after the bite. Schmidt put the Lyme test’s accuracy in the first five weeks of infection at as low as 20% -that’s the window in which you can treat it most easily and avoid dissemination.Many would put the test’s efficacy far lower still.

With appropriate signals from the Minister of Health and the College, more doctors would feel confident in using their judgment to detect new Lyme infection. The cost of treating it with a month of antibioticsas early as possible is negligible. Think of all the suffering (and expense) that would be spared if the system erred on the side of treating early, rather than on the side of delaying and denying it.

While developing our own treatment experience here is vital, there’s vast experience in treating chronic Lyme in the USA. It would be an excellent idea to find ways to transfer some of the strategicknowledge of doctors like Sam Donta and Raphael Stricker to BC, in order to accelerate our learning.

Dr. Schmidt characterizes Lyme as a stealth pathogen that takes multiple forms and is resistant to extirpation. He refers to the huge potential to aim therapy more strategically at the hiding forms borrelia assumes when it’s chronic. Doctors with broad treatment experience may have useful ideas about how to do that, and how best to deal with the complications of co-infections like Babesia. Conveningopen symposia on pattern recognition and treatment modalities would beconsistent with his recommendation for “more professional education on atypical symptoms and presentations related to B.b. and related coinfections”.

Minister de Jong’s responses to MLA Popham’s questions were encouraging to hear. It’s a giant step beyond his predecessor’s one liner that ‘ BC treats Lyme to international standards’. The fly in theointment is the Minister’s belief that the BC CDC has renewed efforts to raise awareness among B.C. doctors. While he sees this as a sign that Lyme detection is improving, these efforts unfortunately are firmly rooted in reinforcing the status quo. The CDC’s communications with doctors,such as they are, aim to pull them back into the IDSA straightjacket, and into continuing reliance on theflawed test regime to rule Lyme out.

BC has over 5,000 doctors that need to hear that most of BC is endemic for Lyme disease and that people can be exposed to infected ticks in their backyard orin the local park. They need to be educated to recognize variable symptom patterns and warned not to rely on the test. Lyme disease in BC is overwhelmingly neurological, not arthritic. Coinfections are becoming the norm. There should be a clear message to doctors that a negative ELISA should never be used to rule out Lyme disease.

Certainly no one with a bulls-eye rash should ever be told it’s just a ‘spider bite’ or that ‘we don’t have Lyme in BC’. These last two responses – both frequently heard – represent deep ignorance rather than medical insight. They instantly create new Lyme victims and deal sick people out of care-benefits they’re entitled to. They would be immediately addressed if public health were actually seized of its mission to protect the public’s health.

I think many doctors would benefit just from seeing the Minister’s statement that they retain the right to prescribe according to their professional medical judgement. Some know it already, butmost have been captured by the group think that is the IDSA guidelines. I think they would also benefit from seeing Schmidt’s conclusion that ‘antibiotics are inexpensive and generally considered safe…if carefully chosen, delivered, and medically overseen.”

Access to IV antibiotics, which may be necessary for some patients with complex infections that are chronic, is another matter. Currently infectious disease doctors are mobilized to refusesuch therapy for tick-borne infections – somehow this monopoly has to be broken up, as the refusal to recognize chronic Lyme and the blanket prohibition on IV therapy stands between sick people and their health.

Doctors have rights to treat infectious disease with antibiotics, and patients have public health rights to receive medically necessary care as needed. Current circumstances conspire to removeboth sets of rights using rigid formulas where more open approaches are required. We need to keep the Schmidt report in front of the government, the public, and especially our corps of doctors.

That said, we also need to hope we don’t lose Minister de Jong to a cabinet shuffle, and that he continues to move along the Lyme disease learning curve. Openness to change is very welcome. And long overdue.

This blog is about the rise of Lyme disease and other tick borne infections, in British Columbia and across Canada, and the failure of public health agencies to adequately warn and protect the public from this debilitating disease. Its purpose is to alert people to a danger that increasingly surrounds them, in the outdoors and in their backyards, and to pressure government, opinion leaders and public health officials to reform the medical framework for Lyme disease diagnosis and treatment. Today, due to faulty tests, lack of physician knowledge and inadequate treatment protocols, many patients are being forced to live with a devastating chronic illness rather than being given medically necessary care. Most have to travel to the United States to purchase healthcare they are entitled to under law in Canada, but currently denied. Many people are living in poverty as a result of personally financing antibiotics, which are the sole control and cure for chronic Lyme disease. This blog discusses issues and offers resources relating to Lyme disease diagnosis and cure. It aspires to be an instrument of change.