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.

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.

Tomorrow I will discuss the scientific questions at hand – is long term antibiotic use appropriate for  chronic Lyme infection, and does chronic Lyme infection exist and how is it diagnosed?