The black-legged tick, responsible for spreading Borrelia burgdorgeri, the bacteria that causes Lyme disease

The black-legged tick, responsible for spreading Borrelia burgdorgeri, the bacteria that causes Lyme disease

The tick borne spirochete infection known as Lyme disease was named after Lyme, CT – a part of the country where the disease remains endemic. It is therefore especially poignant that the Connecticut state senate unanimously passed Public Act No. 09-128: AN ACT CONCERNING THE USE OF LONG-TERM ANTIBIOTICS FOR THE TREATMENT OF LYME DISEASE.The bill had previously passed the state House, also unanimously.

This is a terrible bill that is both anti-science and anti-consumer protection. How it passed both houses without dissent reflects exactly why such micro-management decisions should not be made by politicians.  It is the result of lobbying by a narrow interest group and does not reflect either the state of the science on Lyme disease nor the proper role of regulation to ensure standards of care within medicine.

This is also not an isolated case. There is already a similar law in Rhode Island, and there have been similar bills proposed in Pennsylvania, Massachusetts, and New York, and a bill in Maryland that would compel insurance companies to pay for antibiotic treatment for chronic Lyme disease (CLD).   This is part of a coordinated effort by individuals and organizations who hold an ideological opinion regarding the cause and treatment of CLD. They wish to use the political process to win a victory for their view that they have been unable to win in the arena of science (which should sound familiar).

The bill now awaits Governor Rell’s signature, which given the heavy political support for this bill seems almost certain.

This bill represents much which is wrong with the state of science and medicine in the US.

Standard of care vs health freedom

In the US each state is responsible for the regulation of medical practice, through each state’s board of health. They license physicians, nurses, and other health care practitioners, and they are also responsible for protecting the public by maintaining an appropriate standard of care.  They primarily do this by disciplining practitioners – suspending or even revoking their license or restricting the scope of their practice.

Generally there are two legal standards at work. The lower or easier standard is for the state to investigate the practice of a licensed professional to determine if their actions are substantially below the standard of care, and if they determine that it is, discipline is appropriate.

The higher standard is for the state to act against a health care provider based upon harm that has already been done to one or more specific patients/clients based upon the complaints brought by those clients. This higher standard is not at issue – there is general support for the rights of patients to bring complaints against health care providers. And of course, this is parallel to and separate from the civil system of malpractice.

Incidentally, there are also ethical standards that can be enforced by the state. Some of these have nothing to do with the standard of care (like not sleeping with your patients), but rather with professionalism. But some do have implications for actual practice, for example not practicing outside of your area of training.

What is at issue here is the capacity of state licensing boards to monitor and maintain a minimal standard of care and to discipline providers who violate this standard of care. This standard has been under continuous assault to weaken and even eliminate it, in the name of health care freedom.

It is important to note that the state boards of health do not determine what the standard of care is – they just enforce it. The standard of care, by definition, is the consensus of practice among recognized experts. The standard is based largely upon the published evidence as incorporated into practice based also on experience and a basic scientific understanding of physiology. Often there are published guidelines by professional organizations – essentially saying, “this is the standard of care.”

State regulators turn to the experts to tell them if what a licensed professional is doing is acceptable within the standard of care or if it falls unacceptably below. The standard of care is a rapidly moving target, as new evidence is published, technology evolves, and practices change.

What the CT state legislature has done with their recent decision is to intrude on the process of determining what the standard of care is. It is the role of politicians and government to determine what to regulate, what the goals of regulation are, and to set up a mechanism for determining the details and enforcement of regulation. But it is not their role to determine those details themselves. As I described above, that is best left to experts.

CT state representatives and senators have unanimously decided to carve out an exception in the standard of care for the use of antibiotics for the treatment of chronic Lyme disease. The bill essentially says that the state cannot discipline a health care practitioner solely for using long term antibiotics to treat chronic Lyme disease – a controversial topic. In so doing they have decided to impose the political process and their imperfect understanding of a complex scientific issue above the consensus of scientific opinion. While I believe they probably thought they were doing good, they have done harm, even malfeasance, by displaying astounding arrogance and naivete.

The political process is simply not capable of tracking the standard of medical care. It is too slow a process and too subject to political bias. Will the state change this law as new scientific evidence is published? I highly doubt it. This is one of those laws that will linger on the books for decades, regardless of scientific opinion and new evidence.

Do these legislators really believe that the information they received was complete and representative? Rather – they were lobbied by narrow interest groups (Lyme Disease Association, Inc., Newtown Lyme Disease Task Force, Ridgefield Lyme Disease Task Force,Time For Lyme, Inc., Eastern Connecticut Chapter, Lyme Disease Association) who are dedicated to a specific minority scientific conclusion regardless of the evidence. It is always the case that those with a vested interest in a political outcome are the ones with the attention and endurance to push for their cause.

This is why the legislative process is simply not designed to micromanage the standard of care. The legislators should have had the wisdom to simply acknowledge that determining a specific, complex, and evolving scientific question is simply not within their purview or the capability of the legislature.

This bill is a specific application of a more global effort to weaken enforcement of the standard of care. Many states have so-called health care freedom laws which carve out exceptions for “alternative” practices. Essentially they say that the state cannot act against the license of a practitioner for any practice (no matter how outrageous) if that practice is “alternative.” Some states require that patients be informed that a specific practice is “alternative”, but that’s about it. I doubt that the average patient would understand by “alternative” they mean not subject to any standard of care and beyond the reach of regulation, unless the burden of proving harm is met after the fact.

Chronic Lyme disease

The current scientific and medical issues surrounding the concept of CLD highlights the folly of trying to capture this complex and rapidly evolving scientific question with a snapshot of political opinion.

The problem begins with the fact that Chronic Lyme Disease is not a discrete entity. The term has been used to refer to at least four different clinical situations, as outlined by Adriana Marques in her recent review:

Category 1 – symptoms of unknown cause, with no evidence of Borrelia burgdorferi infection
Category 2 – a well-defined illness unrelated to B. burgdorferi infection
Category 3 – symptoms of unknown cause, with antibodies against B. burgdorferi but no history of objective clinical findings that are consistent with Lyme disease
Category 4 – post-Lyme disease syndrome

In all of these types of cases there are patients who believe they are chronically infected with the Lyme spirochete, but they do not meet proven and accepted criteria for such a diagnosis. But it increases confusion to lump all four categories together, as the CT bill does.

What is not controversial is that Lyme disease is a tick-born infection with the spirochete bacteria Borrelia burgdorferi (in the US, while two other Borrelia species are common in Europe). The infection has an early  phase, characterized by a rash, often referred to as a targeted rash called erythema migrans, as well as fever, headache, and fatigue.There is also a late phase with arthritis, carditis (inflammation of the heart), and meningoencephalitis (inflammation of the brain and meninges). A common manifestation of the latter is Bell’s Palsy or facial weakness.

It is also not controversial that the spirochete usually responds to antibiotics. Rapid treatment in the early phase with doxycycline or other antibiotics know to be active against B. burgdorferi usually prevents development of late stage symptoms, and the late stage can also be treated, although usually IV antibiotics, such as ceftriaxone need to be used for 4-6 weeks.

The controversy lies with those who believe they have chronic infection with Lyme spirochetes despite adequate antibiotic therapy, or who never had clear evidence of Lyme infection in the first place.

The current consensus of scientific opinion on this matter is reflected by two recent reviews, that of Marques cited above and another by Phillip Baker:

Marques concludes:

At this point, the overwhelming evidence shows that prolonged antibiotic therapy, as tested in the clinical trials, does not offer lasting or substantive benefit in treating patients who have post-Lyme disease syndrome. Therefore, it is time to move forward to test other approaches that may help these patients. Unfortunately, no prospective studies of other treatment modalitiesfor patients who have post-Lyme disease syndrome have been performed.

And Baker:

The results of NIH-supported studies acknowledge that some patients with “chronic Lyme  disease/ posttreatment Lyme disease syndrome” indeed have deficits with respect to their physical health status. No doubt such patients experience significant pain and therefore require appropriate medical attention and care. However, because there is no evidence to indicate that their symptoms are caused by a persistent Borrelia burgdorferi infection, other options must be considered to determine their cause and how such patients might be treated to relieve their symptoms. Without direct evidence for a persistent infection, it is clear that extended antibiotic therapy is not the answer; it remains an unproven and unsafe therapeutic approach that is neither justified nor in the best interest of the public health. This is in accord with the views expressed by many outstanding experts in infectious disease.

To summarize these points, and emphasize my own experience and interpretation – at present there is insufficient evidence to support the conclusion that patients in any of the four categories above have chronic Lyme infection. The clinical evidence that we have for category 4 – CLD, is, on the balance, negative. There are significant risks to using long term antibiotics, and these risks far outweigh the unproven benefits – even if we accept the mild and equivocal improvements in some trials.

Further, the political and popular controversy surrounding the question of antibiotics has distracted Lyme care and research away from other avenues that may be more fruitful.

It is interesting that in response to the opinions expressed above, the typical response (I give as evidence various comments to my blog entry from yesterday) is to accuse doctors and scientists of not believing or not caring for patient who believe they have CLD. But read the opinions above – these researchers accept that this population of patient is suffering with symptoms. Their only goal is to understand their true medical situation so as to effectively treat it. They are against the use of antibiotics not because of some defect of empathy, but because the science simply does not support it.

But as we have seen with many grassroots popular campaigns against the scientific medical consensus – having a meaningful conversation between the public and the medical community is all but impossible as the voices that dominate in the public are accusatory bordering on paranoid, distort the scientific opinion, and demonize the medical profession and all who oppose their views.

This replicates the situation seen with the anti-vaccination movement, as well as chelation doctors who claim, despite decades of evidence to the contrary, that chelation therapy can treat heart disease and a long list of other conditions.

In addition to the science being strongly against the belief that there are large numbers of patients suffering from chronic Lyme infection despite antibiotic use, we can begin to see the true complexity of this medical question. The four categories of patients above do not even capture the full range of individual patients that fit into this broad syndrome.

For example, there are patients who come to believe they have CLD because of misinformation they have received on the internet or by others. This then becomes the focus of their attention and their efforts to find help for their symptoms. Meanwhile, the true underlying diagnosis is being missed. Some of these patients may have multiple sclerosis, some other autoimmune disease, a primary sleep disorder, chronic fatigue syndrome, infection with some other agent such as a virus – the list of alternatives is long. Focusing on Lyme disease, in an atmosphere of distrust for the medical profession, is counterproductive in these cases to say the least.

At the other end of the spectrum are the category 4 patients who actually had Lyme disease, maybe even late stage Lyme disease, and now have chronic symptoms (such as fatigue and difficulty concentrating) after being treated. This is a genuine medical mystery at the moment – we do not know why such symptoms persist in a small percentage (maybe 5%) of Lyme patients. It is possible that these are symptoms of cellular damage done by the infection. It is also possible that the infection has triggered a post-infectious immune disorder. It is also possible that a secondary infection that is not sensitive to the antibiotics may be at work.

And there is the possibility that a minority of cases are infected with resistant Lyme. This possibility has not been dismissed or ignored, as is often charged. Rather it has been studied – the results were just negative. Therefore it is prudent to move onto the other hypothesis and study them.

What about patients who believe they have been helped by antibiotics? Most readers will guess my first answer – the well known placebo effect. Also, many of the symptoms of CLD tend to have a natural variation over time in some patients, who will then seek treatment when their symptoms are at their greatest and then credit the inevitable decrease in symptoms on the treatment.

But there are other intriguing possibilities. Baker points out that many antibiotics used to treat Lyme disease also have pharmacological effects, such as anti-inflammatory effects or effects similar to drugs used to treat chronic neurological conditions. This may produce an actual symptomatic benefit in some patients. If this is true, then we can more effectively target CLD symptoms with better and safer anti-inflammatory and neuropathic medications. So far, trials have not been done with these approaches.

There are many other points to be made, but this is sufficient to capture the meat of the issue, and to set up my next point. Individual physicians treating patients with CLD with chronic antibiotics could fall along a very long spectrum. They could have different criteria for who qualifies for treatment. Some may only treat category 3, and only continue treatment if there is an objective response. While others may treatment anybody who thinks they may have CLD with no criteria for monitoring treatment.

With the current system of regulation, each individual practitioner could be judged according to their practice, and individual decisions could be rendered. Having a minority opinion is not sufficient to be disciplined for substandard care, and so some physicians may have looser criteria for prescribing antibiotics and not be targeted for discipline. While there may also be those physicians who are recklessly and dangerously prescribing antibiotics for patients who likely have another specific diagnosis, and truly deserve to have their practice restricted.

Under the proposed law, all such distinctions are wiped away, and there will be blanket protection for anyone prescribing antibiotics for CLD, not matter how they define it and what criteria they use. This is the core absurdity of imposing a simple law upon a complex scientific medical issue.

And as I stated yesterday – this is a rapidly moving target. There are questions that are still being asked, and further research is likely to clarify the situation even further. If the science moves farther and farther away from the use of antibiotics, there is unlikely to be a grassroots lobby to reverse this unwise law. We will be stuck with it, and the state will have lost an important mechanism to protect the public against possibly dangerous quacks who can then exploit this special exemption.

Conclusion: Putting laws before science is a mistake

The new CT bill, when passed into law as it almost certainly will be, is a grave mistake. It is legislative arrogance and naivete at the same time. Yet there is likely to be similar efforts in other states. Advocates of ideology tend to be more relentless and motivated than the defenders of reason.

This also reflects a broader syndrome – minority or discredited medical ideas that persist in a cult-like fashion after they have failed the test of scientific evidence. The emotions and thought processes that sustain these movements are remarkably similar across a wide range of issues. What is also distressingly similar is the use (I would argue abuse) of the political process to rig the game of science – to secure political victories to rectify scientific failures. This represents a harmful intrusion of politics into science, and the public suffers.

Posted by Steven Novella

Founder and currently Executive Editor of Science-Based Medicine Steven Novella, MD is an academic clinical neurologist at the Yale University School of Medicine. He is also the president and co-founder of the New England Skeptical Society, the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe, and the author of the NeuroLogicaBlog, a daily blog that covers news and issues in neuroscience, but also general science, scientific skepticism, philosophy of science, critical thinking, and the intersection of science with the media and society. Dr. Novella also contributes every Sunday to The Rogues Gallery, the official blog of the SGU.