When I write or talk about the scientific evidence against particular alternative medical approaches, I am frequently asked the question, “So, if it doesn’t work, why is it legal?” Believers in CAM ask this to show that there must be something to what they are promoting or, presumably, the government wouldn’t let them sell it. And skeptics raise the question often out of sheer incredulity that anyone would be allowed to make money selling a medical therapy that doesn’t work. It turns out that the answer to this question is a complex, multilayered story involving science, history, politics, religion, and culture.
While we science types tend to be primarily interested in what is true and what isn’t, that is a sometimes surprisingly minor factor in the process of constructing laws and regulations concerning medicine. What I hope to do in this series of essays is look at some of the major themes involved in the regulation of medical practice, particularly as they relate to alternative medicine. I will begin by touching on some of the general philosophical and legal issues that have defined the debate among the politicians and lawyers responsible for shaping the legal environment in which medicine is practiced. The I will review some of the specific domains within this environment, including: medical licensure and scope-of-practice laws; malpractice law; FDA regulation of drugs, homeopathic remedies, and dietary supplements; truth-in-advertising law; and anti-trust law.
But first…
The Disclaimer
Obviously, an exhaustive and comprehensive look at the Byzantine and unstable landscape of medical law is beyond the scope of both this blog and my own knowledge and expertise. I am no lawyer, and for the details of the laws and judicial opinions concerning this subject I must rely on sources whose accuracy I am not qualified to verify independently. Much of the published material I have found on CAM and the law seems written from a political and ideological perspective sympathetic to the postmodernist notion of multiple equally legitimate “ways of knowing,” and also to a laissez-faire approach to regulation generally. So clearly the details provided and the interpretations given in such writings may not fairly represent the legal or regulatory environment. In any case, while I hope to provide some useful insight into how CAM fits into the system of medical law and regulation in the United States, nothing I say should be taken as the definitive word on the law or as legal advice.
Caveat Emptor v. Caveat Venditor
There is a deep ideological divide in America on the subject of who is responsible for ensuring that the products we buy are safe and perform as advertised, and the area of medicine is not exempt from this political debate. On one extreme is the self-identified “health freedom” lobby, which argues that the consumer and the market should be the only forces to regulate healthcare products and services. As an example, economist Randall Holcombe has written:
An auto mechanic does not have to be a medical expert to use market information to find good health care, any more than a doctor has to be an automobile expert to find a good car…Deregulation not only provides incentives for patients to look for, and physicians to offer, better care, it permits all parties concerned the freedom to decide what better care is. For instance, in the debate over alternative medicine, such as herbal treatments, chiropractors, acupuncture, and so on, the question is not only whether alternative medicine is effective, but whether people should be allowed to use these alternatives even if their physical health may not improve or may even suffer….In a free country, people should be free to choose whatever health care options they want for whatever purpose…even if healthcare professionals believe that care is substandard.1
Those more sympathetic to laws and regulations intended to protect consumers from unsafe and ineffective therapies argue against this concept of “medical anarchism:”
Why not let the market decide? Why not trust the citizenry to sort out what works from what doesn’t work in medicine as we do in other aspects of life?
The answer has to do with knowledge and risk. People do let the market decide with regard to goods like ice cream cones and baseball bats, and services like travel booking. If the ice cream is not good, people won’t buy it; if the service is defective, people will go elsewhere. However, in such situations, people are easily able to evaluate the quality and value of the goods and services they receive…Nor are such services administered under duress, nor are they represented as necessary for one’s health or well-being…
But in the area of medicine, too much is at stake. If one chooses the wrong therapeutic modality, once can lose health, life, and limb. Furthermore, few individuals are sufficiently wealthy, educated, or possessed of the resources to test putative medical therapies. In fact, there are so many putative therapies, that it is impossible for an individual to try them all. When people are ill, they do not have time to test even a handful.2
These arguments tend to run in parallel, and to be only tenuously connected, with the usual focus of this blog; the question of how one evaluates medical therapies and what the evaluation indicates about safety and efficacy. Of course, many proponents of CAM who invoke the “health freedom” position do actually believe the therapies they promote are beneficial. But the fundamental position itself does not hinge on this, since from a perspective such as Dr. Holcombe’s people should be free to choose even therapies that are ineffective or harmful without “burdensome” government regulatory interference. The self-evident notion that it is the role of government to protect the public from quackery turns out not to be self-evident to many Americans, and thus demonstrating that a given approach is quackery may not be sufficient to convince them that it should be prohibited or even officially discouraged.
The Right to Privacy v. State Police Powers
In the legal arena, the political conflict between those favoring or opposing aggressive consumer protection regulations in the area of healthcare takes the form of statutes and judicial opinions balancing the competing constitutional principles of an individual right to privacy and a governmental authority, or even mandate, to protect the public health. Neither a right to privacy or absolute authority over one’s own body nor a government role in regulating healthcare are specifically mentioned in the U.S. Constitution, but both are held to exist by long-standing interpretation. A right to privacy, including control over one’s own body and the care of it, is generally believed to be established by a broad reading of the 14th Amendment, though there is some controversy about this as about most areas of constitutional law. The authority of the state to abrogate this right in the process of protecting the public health is usually understood to be based in the “police powers” established by the 10th Amendment.
In 1824, the Supreme Court made reference to “health laws of every description” as encompassed within the “state police powers,” those powers not specifically delegated to the federal government nor prohibited to the States which are thus held, under the Tenth Amendment, to be the prerogative of the individual states.3 The court cited and expanded this opinion in a subsequent case in 1905, in which a state mandate to protect the public health was held to override, at least in some circumstances, the individual right to control one’s own body. The case involved a man prosecuted for refusing a mandatory smallpox vaccination. The opinion stated:
The authority of the state to enact this statute is to be referred to what is commonly called the police power…this court …distinctly recognized the authority of a state to enact quarantine laws and “health laws of every description…”
The defendant insists that his liberty is invaded when the state subjects him to fine or imprisonment for neglecting or refusing to submit to vaccination…and that the execution of such a law…is nothing short of an assault upon his person. But the liberty secured by the Constitution of the United States…does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good.4
The court went on to specifically balance the “liberty secured by the 14th Amendment,” including “the control of one’s body” against “the power of the public to guard itself against imminent danger” and concluded that under at least some circumstances the authority to protect the public health trumps he right of an individual to control his or her own body.
This precedent was further developed and expanded in subsequent cases to validate the state’s authority to define and regulate medical practices, to control what practices could be offered and by whom via licensing and scope-of-practice laws, and to prohibit individual’s from choosing specific medical treatments if these were considered to be ineffective or dangerous. I will discuss the specifics of these cases in subsequent posts. But for now I simply want to illustrate that the legal basis for the regulations of medical practice which today pertain to CAM, as well as scientific medicine, is generally seen by the courts as a balance between the individual right to privacy and the state authority to protect public health.1,5
Just the Facts, Ma’am?*
I feel it is important to emphasize again that the question of the medical facts in such cases, and how these are established, are not always seen by the courts to be as relevant as the legal or political issues. For example, in Jacobson v. Massachusetts the court specifically addressed the factual claims by the defendant that the vaccine was ineffective and unsafe. The court’s reasoning will seem familiar, and disturbing, to those of us dealing with the anti-vaccination movement today:
The appellant claims that vaccination does not tend to prevent smallpox, but tends to bring about other diseases, and that it does much harm, with no good. It must be conceded that some laymen, both learned and unlearned, and some physicians of great skill and repute, do not believe that vaccination is a preventative of smallpox. The common belief, however, is that it has a decided tendency to prevent the spread of this fearful disease…While not accepted by all, it is accepted by the mass of the people, as well as by most members of the medical profession…A common belief, like common knowledge, does not require evidence to establish its existence, but may be acted upon without proof by the legislature and the courts…The fact that the belief may be wrong, and that science may yet show it to be wrong, is not conclusive; for the legislature has the right to pass laws which, according to the common belief of the people, are adapted to prevent the spread of contagious diseases. In a free country, where the government is by the people, through their chosen representatives, practical legislation admits of no other standard of action, for what the people believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact or not. Any other basis would conflict with the spirit of the Constitution, and would sanction measures opposed to a Republican form of government.4
While the decision in this case, to support the authority of the state to enforce mandatory vaccination as a public health measure, might be welcomed by supporters of science-based public health policy, the decision itself was by no means based in science or scientific reasoning.
The laws and judicial opinions which govern the practice of medicine may sometimes support and sometimes oppose legitimate, science and evidence-based medicine. But the legislators, lawyers, and judges responsible for these laws and opinions are not scientists, and their reasoning about scientific and medical issues often has a philosophical and epistemological basis often incompatible with the scientific approach. Such policy mistakes as DSHEA and NCCAM are much easier to understand, and hopefully prevent, if we clearly understand this.
If we are to be effective at promoting scientific medicine and containing unscientific approaches and ineffective or unsafe therapies, we must be aware of the limitations of scientific and fact-based arguments in persuading legislators and judges, as well as the general public. Though science and facts derived from scientific knowledge and investigation must be the foundation of our medical approach, they are not always the most effective means of making the case for this approach, even with our colleagues much less with the citizens, politicians, and legal professionals who ultimately control what sort of influence and oversight government has on medicine. Non-scientists tend to view debates about regulation of CAM in terms of individual rights, consumer protection, truth-in-advertising, fair competition in the marketplace, and other such political and philosophical frames which are as important, or even more important, to them as the issue of what is factually true about CAM and whether particular therapies help or harm.
In this series of essays, I will look at laws and regulations concerning CAM primarily from these perspectives. The kinds of questions that arise in this process may initially seem odd to those of us accustomed to a straightforward emphasis on the relevant facts and evidence. Are doctors allowed to offer unproven or even clearly bogus therapies? Are they required to offer them if a patient wants them? Can a mainstream doctor, be sued for providing or failing to provide an alternative therapy? Can an alternative practitioner be sued for providing, or failing to provide, mainstream scientific medical care? Can and should patients have whatever care they want regardless of whether science supports it? And from my perspective as a veterinarian, since pets are legally property not persons, is there any legal or regulatory control over alternative veterinary medicine at all? Such questions and the reasoning behind asking and answering them, shapes the landscape within which we operate as healthcare providers and advocates for science-based medicine, so I hope an examination of them will be interesting and useful.
* Our friends at snopes.com tell me that Joe Friday never actually said this, but due to its cultural resonance I choose to invoke the phrase anyway. Oh, I hope all this exposure to legal argument and reasoning hasn’t damaged my respect for actual facts! Return to text.
References
- Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 279. Return to text.
- Ramey DW, Rollin BE. Untested therapies and medical anarchism. In: Complementary and alternative veterinary medicine considered. Ames (IA), USA: Iowa State Press, 2004. p.168-9. Return to text.
- Gibbons v. Ogden, 22 U.S. 1, 78 (1824). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 26. Return to text.
- Jacobson v. Massachusetts, 197 U.S. 11 (1905). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 26-29. Return to text.
- Cohen MH. Legal issues in alternative medicine: A guide for clinicians, hospitals, and patients. Victoria (BC), Canada: Trafford Publishing, 2003. Return to text.