Dec 11 2014

Another Terrible Anti-Consumer Health Bill

On the desk of New York Governor Andrew Cuomo is a bill that would protect doctors practicing substandard medicine from being investigated by the Office of Professional Medical Conduct. The bill is similar to one unfortunately passed in Connecticut a few years ago – it is meant to protect doctors who prescribe long and recurring courses of IV antibiotics for alleged chronic Lyme disease.

This would be a terrible law on many levels, and I urge Governor Cuomo to veto the bill.

Bad Law

The standard of care in medicine is determined by the consensus of medical opinion and practice, which in turn is based upon the best available evidence. Often this is informed by panels of experts and professional societies who review the evidence and publish practice guidelines or standards.

The standard of care cannot be written in stone because it is a moving target. Scientific evidence is a living changing thing, and so you cannot simply write into law what the standard of care is. Rather the law simply sets up a process by which the standard of care can be determined when necessary.

Further, the standard includes a great deal of wiggle room, especially when evidence is less than definitive or there is a range of opinions as to what constitutes optimal care. Physicians only run afoul of the standard when they practice substantially below the standard in such a way that is unethical, negligent, incompetent, fraudulent and/or harmful to patients.

A state legislature has no business enshrining into law specific details as to what constitutes the standard of care. They lack the expertise as legislators, and such a law would lock into place a specific decision that would then not be able to adapt to evolving evidence.

This bill, however, goes beyond a single issue. While it is being promoted by chronic Lyme advocacy groups, and may have been drafted for that purpose, it is worded as an all-purpose “healthcare freedom” law – shielding all quacks and dubious practitioners from being investigated for practicing substandard care.

The law states that the Office of Professional Medical Conduct cannot investigate a practitioner “based solely on treatment that is not universally accepted by the medical profession.” This is sloppy wording, but it essentially says that doctors cannot be investigated simply for practicing below the standard of care (which is what “accepted by the medical profession” means). This raises the bar for investigation significantly and can be effectively used to shield all manner of quackery. I have encountered this directly myself.

Bad Science

There is no controversy over the existence of Lyme disease – it is an infection caused by the spirochete bacteria, Borrelia burgdorferi. This tick-borne bacteria causes three stages of disease: an acute infectious illness marked by a target-shaped rash around the tick bite, then a disseminated infection, and finally a tertiary infection that can affect the joints, heart, nervous system, and other organs.

The infection can be diagnosed by blood tests (or spinal fluid tests for neurological disease) testing for the antibodies to the spirochete (a Lyme titer) and also for proteins associated with the bacteria itself (the Western Blot). No test is perfect, but the titer followed as needed by the Western Blot is a highly sensitive and specific test. Like all antibody tests, they can be negative initially and may take a number of weeks to become positive.

The controversy comes from those who believe (practitioners and patients) that you can have a chronic Lyme infection even with negative tests for Lyme titer and Western Blot, even without the typical features diagnostic of Lyme disease, and without the usual response to antibiotics. In other words, they are proposing an antibody negative Lyme disease with atypical clinical features and resistant to standard treatment. This is a trifecta of special pleading, explaining away all negative evidence.

Occam’s razor would prefer the explanation for the persistent lack of evidence for Lyme that Lyme is simply the wrong diagnosis.

As a medical hypothesis the idea is not impossible or crazy. Each individual component of the special pleading may be improbable but not impossible. Tests can be false negative, diseases can present atypically, and sometimes they can resist standard treatment. The problem is – there is simply no evidence for any of these claims.

Further, the idea of atypical chronic Lyme has been tested and the hypothesis rejected by the evidence. Most damning are studies looking at the response of patients diagnosed with chronic Lyme to IV antibiotics – showing no benefit. So even if you hold onto a belief in chronic Lyme, the IV antibiotics being used to treat this questionable condition don’t work.

I wrote about the evidence against chronic Lyme disease here. I wrote that in 2009. The evidence has not changed since. Trying to save the Chronic Lyme concept, proponents have proposed that coinfections are the real cause. However, a 2014 systematic review concluded:

The medical literature does not support the diagnosis of chronic, atypical tick-borne coinfections in patients with chronic, nonspecific illnesses.

What about Lyme variants being missed by the test?

In the context of the broader medical literature, it is not currently possible to ascribe a pathogenic role to morphologic variants of B. burgdorferi in either typical manifestations of Lyme disease or in other chronic disease states that are often labeled chronic Lyme disease. There is no clinical literature to justify specific treatment of B. burgdorferi morphologic variants.

The false diagnosis of chronic Lyme and treatment with IV antibiotics is also anything but benign. Chronic antibiotics cause resistance and have side effects and risks. Further, the incorrect diagnosis of chronic Lyme may cause another serious illness to be missed, such as cancer, other infections, or other chronic illness.

Conspiracy Theories

When the science is lacking, enter the conspiracy theories. In this case the conspiracy theories are particularly bizarre. The notion that some patients with chronic symptoms have treatment resistant Lyme disease and need recurrent bouts of IV antibiotics, while wrong, is completely within the standard paradigm of mainstream medicine. There is no East vs West, no life energy or mysterious forces at work, and no threat to “big pharma.”

In fact, if chronic Lyme disease were real it would be a win-win for mainstream medicine. It is, in fact, exactly what proponents of unscientific theories often accuse mainstream medicine of – preferring chronic treatments to keep illness at bay. IV antibiotics are a lucrative procedure. Chronic Lyme disease, in other words, is a money-making machine for mainstream physicians, and would meet an unmet need. So what’s the problem?

The only barrier to accepting and treating alleged chronic Lyme is the scientific evidence coupled with professional ethics. Therefore, proponents have to invent a new conspiracy – led by the insurance companies. Now doctors have a new master cracking their whip, the insurance companies who don’t want to pay for treatment.  Why doctors, the ones who stand to make the money, would side with the insurance companies is never explained. How the insurance companies managed to win this one battle (while otherwise having to pay for evidence-based treatment) is never explained.

This narrative, with the insurance companies cast as the new villain, is simply a made-up fiction. In their pockets, apparently, is the Infectious Diseases Society of America, who have reviewed the evidence and concluded that chronic Lyme is not real and treatment with IV antibiotics not warranted.


This is a clear cut case of a fake controversy being promoted by a special interest group, invoking improbable conspiracy theories to explain why the science does not support their position. The science here is very clear – there is no evidence that chronic Lyme infection is real or that treatment with IV antibiotics is warranted.

Practitioners who prescribe IV antibiotics for this alleged condition do so against the standard of care. They have been unable to defend themselves with scientific evidence or legitimate medical arguments. They have therefore resorted to getting laws passed simply protecting themselves from the evidence and the regulatory bodies whose job it is to defend the standard of care.

It is disappointing that state legislators are so easily duped by such conspiracy theories, and so easily coaxed into stepping way beyond their proper role. It is frightening that such unscientific nonsense can be passed unanimously in both houses of New York’s congress (as it was in CT).

Governor Cuomo seems to be taking his time reviewing the issue. I can only hope that someone who knows what they are talking about got to him. I can only hope that his people are reading the thoughts of doctors and scientists, such as this post, and taking another look as this issue. We will see.

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