Legislative Alchemy

In Legislative Alchemy I: Naturopathy, II: Chiropractic and III: Acupuncture, we learned how state legislatures transform scientifically implausible and unproven diagnostic methods and treatments into legal health care practices. Examples typical of the sheer nonsense found in both proposed and actual legislation include:

Naturopathic health care [is] a system of health care practices for the prevention, diagnosis, evaluation and treatment of illnesses, injuries and conditions of the human body through the use of education, nutrition, natural medicines and therapies and other modalities which are designed to support, stimulate or supplement the human body’s own natural self-healing processes.

[Chiropractic is] the science of adjustment, manipulation and treatment of the human body in which vertebral subluxations and other malpositioned articulations and structures that may interfere with the normal generation, transmission and expression of nerve impulse between the brain, organs and tissue cells of the body, which may be a cause of the disease, are adjusted, manipulated or treated.

[Acupuncture is] a form of health care that is based on a theory of energetic physiology that describes and explains the interrelationship of bodily organs or functions with an associated acupuncture point or combination of points that are stimulated in order to restore the normal function of the bodily organ or function.

This is gobbledygook, tarted up with a few scientific-sounding terms — “physiology,” “tissue cells,” “diagnosis.”

We know in fact that:

• Naturopathy’s basic premise is simply a restatement of long-discredited vitalism.
• The chiropractic “vertebral subluxation” does not exist, so it can’t “interfere” with anything,
  nor can it be “adjusted.”
• There is no “energetic physiology,” theoretical or otherwise.

The legalization of nonsense as health care has a deleterious effect on the public. Each year, millions in the U.S. visit state-licensed naturopaths, chiropractors and acupuncturists, exposing themselves to diagnoses of conditions that do not exist and treatments for these non-existent conditions, as well as treatment of real diseases with implausible and ineffective therapies. They will spend millions of dollars on these visits, paying with either their money or yours.

Although it is reasonable to assume that correct diagnosis of a real disease or condition will be at times foregone and effective treatment delayed in these visits, we don’t really know the full extent because no one appears to be looking at this issue in a systematic way, although we do have anecdotal reports. As well, it is reasonable to assume that these unnecessary treatments for imagined conditions will be injurious in and of themselves in some cases. Again, all we have are anecdotal reports, as no one is collecting the data in any systematic way.

Which brings us to . . .

The Cure

One possible solution is that states stop further licensing of “CAM” providers. Although I have not researched the issue, I do know of one instance in which this occurred. In 1959, the Florida legislature abolished the licensing authority for naturopaths, although anyone who had a license at that time was allowed to continue practicing. Anyone else holding himself out as a naturopath in Florida can be prosecuted for the unlicensed practice of a health care profession. Attempts to re-established naturopathy licensing in Florida have failed.

As you can well imagine, it would be a long, contentious, expensive and laborious process to halt the licensing of chiropractors in all 50 states, acupuncturists in 43 states and naturopaths in the 16 states where they are currently licensed.

A second, simpler solution presents itself in the form of curtailing the use of implausible and unproven practices via legislation without directly repealing the “CAM” provider practice acts. The basic premise is that scientifically plausible health care practices can be used unless and until they are shown not to work. Implausible practices, however, must meet a higher standard. In other words, it is in essence “extraordinary claims require extraordinary evidence” fashioned into health care consumer protection law.

Before looking at how this might be achieved, let’s begin with proposed legislative findings. These are typically recited at the beginning of a bill and become part of the bill’s legislative history. In turn, should a court need to interpret particular language in the bill once it is enacted into law, the legislative history can be used in determining what the legislature meant, referred to as “legislative intent.”

We will call our proposed state legislation

The Science-Based Healthcare Practices Act

Legislative Findings:

Whereas, the Legislature finds that those healthcare practices not based on generally accepted scientific principles and those healthcare practices which have been proven ineffective:

cause unnecessary expenditure of time and money by the public for ineffective treatments; and

expose the public to the risk of delay of appropriate and timely diagnosis and treatment; and

violate nationally and internationally accepted ethical norms; and

pose an unnecessary risk to the public health by exposing the public to treatments that carry risk of harm without a sufficient benefit to justify that risk.

Whereas, the Legislature finds that healthcare practices not based on generally accepted scientific principles misrepresent the sciences of biology, physiology, anatomy, physics and chemistry to the public, which undermines the legitimate public interest in a scientifically literate citizenry.

Therefore, the Legislature finds that it is in the best interest of the public health, safety and welfare to protect the public from healthcare practices which are not based on generally accepted scientific principles or have proven ineffective.

“Extraordinary claims require extraordinary evidence”

The proposed statute would read, in part, as follows:

Sec. XXX.xxx, (Your State’s Name Here) Statutes

(1) Notwithstanding any other provision of (Your State) law, no healthcare practitioner licensed by this state shall engage in the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition if such diagnosis, treatment, operation, or prescription is implausible because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology, and it is either

(i) not supported, to a reasonable degree of scientific certainty, by good quality randomized, placebo-controlled trials, or

(ii) not supported, to a reasonable degree of scientific certainty, by a Cochrane Collaboration Systematic Review or a systematic review or meta-analysis of like quality.

The standard “is implausible because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology” was taken from “Illinois Department of Professional Regulation Medical Disciplinary Board (MDB). Board Policy Statement: Complementary and Alternative Therapies. November 1999,” quoted in an SBM post by Dr. Kimball Atwood. While the Illinois Department of Professional Regulation’s policy was, as a whole, disappointing, its definition of “implausible” is useful.

The level of evidence required in for implausible practices is based on R. Barker Bausell, Snake Oil Science: The Truth About Complementary and Alternative Medicine (New York: Oxford University Press 2007), Chapter 11 (“What High-Quality Trails Reveal About CAM”) and Chapter 12 (“What High Quality Systematic Reviews Reveal About CAM”).

Why, you may ask, if a practice is implausible, would we allow it at all? Why the provision regarding studies?

This is a perfectly reasonable criticism and if you wish to go ahead with the process of eliminating such practices altogether from state law, please do. I simply offer this as a solution which might be politically achievable, as the proposed legislation does not actually do away with any “CAM” provider type.

In opposition to this legislation, “CAM” providers would be put in the position of arguing that their diagnostic methods and practices are not implausible, which is fairly easily defeated per the legislation’s definition. Alternatively, they would have to argue that, even if implausible, their diagnostic methods and therapies should be permitted anyway. This is, of course, what is already happening — they are used despite implausibility and lack of evidence,a position “CAM” providers currently need not defend once they achieve licensed health care provider status.

I also agree that it is not a good idea to spend considerable resources testing biologically implausible claims and this post is not an argument that even more resources should be expended doing so. But, while the U.S. government is at it, we might as well put the results to some good use.

The proposed legislation’s “out” based on high-quality trials also helps avoid a claim of direct conflict between the “CAM” practice acts and the new law, a conflict that would invariably wind up in the courts. For example, the proposed law does not prevent a chiropractor from claiming he can detect “subluxations” in a patient and proceeding to “adjust” them for the purpose of, say, treating the patient’s asthma. But because detection and adjustment of subluxations in general and its effectiveness in treating asthma in particular are highly implausible, a chiropractor will need an high level of evidence to legally make this claim. That evidence does not currently exist — and let me just go out on a limb here and predict it never will.

Likewise, an acupuncturist is not prevented from recommending acupuncture to treat infertility but, again, because of the implausibility of the proposed underlying mechanism of acupuncture and its putative effect on infertility, he must meet a high level of evidence to make that recommendation and commence treatment. Again, the evidence isn’t there and, again, I’ll predict it won’t be in the future.

Ordinary claims require ordinary evidence

But, what about those diagnostic methods and therapies, like chelation, which, at least initially, seemed plausible, but, even though disproved, continue in use?

For them, we have this:

(2) Notwithstanding any other provision of (Your State) law, no health care practitioner licensed by this state, shall engage in the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition even if such diagnosis, treatment, operation, or prescription is plausible because its implied mechanisms or putative effects are in accordance with well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology, if

(i) good quality randomized, placebo-controlled trials, or

(ii) a Cochrane Collaboration Systematic Review or a systematic review or meta-analysis of like quality,

demonstrate, within a reasonable degree of scientific certainty, that said diagnosis, treatment, operation or prescription is not effective for said human disease, pain, injury, deformity, or other physical or mental condition.

The Science-Based Healthcare Practices Act would not eliminate all implausible and unproven healthcare. For example, a diagnostic method like thermography for breast cancer detection might slip by the implausibility test and remain on the market, not because it’s a reliable diagnostic tool, but because no trial meeting our statutory standard says it isn’t reliable.

And just to be sure

I propose a few other provisions to avoid attempted end-runs around the legislation’s purpose.

To help forestall any fudging on the science, the following would be included:

“Each term in this section shall be interpreted according to its generally accepted meaning
in the scientific community.”

To make clear that “subluxations,” “qi,” vitalism and the like do not get a pass on science simply by virtue of their inclusion in the practice acts:

“It shall not be a defense to prosecution for a violation of this section that a diagnosis, treatment, operation, or prescription is within the scope of practice, as defined in Chapter X, (Your State) Statutes, of a healthcare practitioner accused of said violation.”

And, to help ensure that poor quality trials cannot be used to buoy scientifically implausible health care practices (with thanks again to R. Barker Bausell, Ph.D.),

“Good quality, randomized placebo controlled trial,” shall mean a trial meeting the following minimum criteria:

(i) involving the random assignment of participants to a credible placebo control group; and

(ii) employing at least fifty participants per group; and

(iii) losing no more than 25 per cent of its participants over the course of the study; and

(iv) published in a high-impact, peer-reviewed research journal.”

Enforcement

Now that we’ve created a prohibition against implausible practices without really good evidence that they actually work, as well as plausible ones that don’t work, how to enforce it?

That authority could be given to the various boards which currently oversee health care practitioners but this seems inconsistent with the purpose of the act. If the legislature is trying to erect a barrier of scientific evidence (both basic and clinical) between the practitioner who employs implausible diagnostic methods and therapies and the patient, then the very practitioners who ignore science would not seem best suited to the task.

The medicine and osteopathic boards might be suitable to enforce our proposed legislation as against M.D.s and D.O.s, but even medical boards have proven reluctant to discipline physicians whose practice includes implausible and unproven therapies. In fairness, perhaps they were hamstrung by lack of statutory firepower sufficient to specifically address implausible, unproven and disproven practices.

One solution is to give enforcement authority to the state agency overseeing the unlicensed practice of a health care profession. This agency would already have the investigational and prosecutorial bureaucracy in place to proceed. Here, our proposed statute adopts its enforcement procedures from Florida’s “Unlicensed practice of a health care profession” statute, which gives the Department of Health (DOH) the authority to investigate and prosecute.

Briefly, if the DOH has probable cause to believe the Science-Based Healthcare Practices Act has been violated, it can issue a cease and desist order and impose a civil penalty. If the violator is recalcitrant, DOH can go to court seeking an injunction and the consequences escalate from there. Of course, the alleged violator can dispute the charges and have his day in court.

Conclusion

The Science-Based Healthcare Practices Act is an imperfect solution to the problem of legislative alchemy. It is preferable to avoid licensing practitioners whose tenets violate basic science. Given the impracticability of repealing over 100 separate state practice acts, imposing an evidence requirement for implausible practices offers — if I may — an alternative solution. The Act would also have the beneficial effect of curtailing the use of diagnostic methods and therapies which, although not implausible, have proven ineffective.

Suggestions for improvement are welcome.

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