Legislative Alchemy
Three decades ago, our elected representatives thought quackery a sufficient threat to physical, mental and financial health to warrant an exhaustive four-year study of its deleterious effects and a 250-page Congressional subcommittee report condemning the assault of pseudoscience on the American healthcare system. The report defined “quackery” as:
The promotion of medical remedies known to be false or which are unproven for a profit, usually by means of false representations that they will “cure” or aid in the cure of various diseases and problems. Quackery is pseudoscience at its best.
Acupuncture, subluxation-based chiropractic, Gerson therapy, fad diets, herbs, glandulars, hydrotherapy, and energy healing, among others, were condemned as pseudoscience harmful to the public. As a remedy, the report made several suggestions to alleviate victimization of the public by quacks: increased government enforcement efforts, increased criminal penalties, more consumer education, strengthening medical licensing statutes to make practice of medicine without a license a felony, and more patient protection when non-standard therapies are offered.
So much for that idea. Via the magic of Legislative Alchemy, the last 30 years have seen Congress and the state legislatures weaken consumer protections against quackery and incorporate the very pseudoscience Congress itself warned against into state and federal law.
Even when legislators aren’t directly incorporating pseudoscience into the law, they fail to realize how other laws (such as the Medical Device Amendments, which we’ll get to in a moment) don’t include proper controls to prohibit their use by quacks for pseudoscientific diagnoses and treatment.
I’ve written about Legislative Alchemy many times on SBM. But individual instances cannot properly convey the magnitude of the problem. In this post, I attempt to collect the various laws which legalize pseudo-medicine, describe how they operate to the detriment of our health care system and patients, and offer solutions. Altogether, they paint a grim portrait of the extent to which pseudoscience is baked into our healthcare system by clueless legislators. (Feel free to add your own examples.)
Federal laws
Dietary Supplement Health and Education Act of 1994 (DSHEA)
What it does:
DSHEA was written by the dietary supplement industry and it shows. It allows vitamins, minerals, herbs, enzymes and desiccated animal organs (glandulars) to be sold based on vague claims of benefit to body “structure” and “function,” terms no one seems to understand but often misinterpreted as meaning supplements can prevent or treat disease. Sellers are supposed to have evidence to back up their claims but are not required share it with the FDA or the public. Premarket regulation is limited to minimal registration requirements, labeling standards and good manufacturing practices. The FDA must wait until it learns of contamination or adverse events before acting and burden is on the FDA to prove product is unsafe. The FDA has a $5 million budget and about two dozen staffers to police the entire industry.
What this means:
Dietary supplements are a $41 billion a year industry in the U.S. Yet, supplements have failed to live up to the hype that they are effective in preventing or treating disease and some actually increase the risk of disease. Adulteration with undisclosed ingredients, including prescription drugs, poses health risks. In addition to over-the-counter sales, supplements serve as an economic engine for “integrative medicine” and “functional medicine” practitioners, naturopaths, and chiropractors, who prescribe them both for prevention and treatment of disease without adequate evidence of safety or effectiveness. These practitioners then sell the prescribed supplements to their patients at a profit.
What needs to happen:
DSHEA should be scrapped and a new regulatory scheme put in place. Vitamins and minerals should be sold in reasonable doses with adequate evidence supplied to buyers of the need for dietary supplementation. Herbs and desiccated animal organs are simply unpurified drugs and should be required to meet pre-market safety and efficacy standards based on well-conducted clinical trials before health claims can be made. Good manufacturing standards and post-market surveillance should be beefed up.
Food, Drug, & Cosmetic Act of 1938: Homeopathic Drugs
What it does:
All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription (most homeopathic remedies are OTC), fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. Instead, both prescription and OTC homeopathic drugs have been manufactured and sold without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed.”
What this means:
The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet homeopathic remedies are a $3 billion a year business in the U.S., sold widely in drugstores and other retail locations, online, and by naturopaths and other health care practitioners who prescribe them. (Homeopathy is an integral part of naturopathy.)
What needs to happen:
This one is easy. The FDA should simply follow the law and require all homeopathic drugs to comply with the same statutes and regulations as all other OTC and prescription drugs. Two years ago, the FDA sought public comment on homeopathic remedy regulation but, so far, has done nothing. Fortunately, the FTC, on the other hand, has announced it will do its job and follow the law:
The FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is, companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.
Medical Device Amendments of 1976 to the Food, Drug & Cosmetics Act: Laboratory-Developed Tests
What it does:
The FDA regulates most in vitro diagnostic devices (IVDs) as medical devices. (A limited number are regulated as biological products, a topic we won’t get into here.) IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it focused on commercial tests kits, which are broadly marketed to laboratories or the public. The latter had to undergo the same pre-market approval process as other medical devices regulated by the FDA, including, in some cases, clinical studies demonstrating that the device is safe and effective for its intended use.
Historically, LDTs were developed by hospitals, researchers and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. The FDA now estimates that there are about 11,000 LDTs offered by 2,000 laboratories. A federal law, The Clinical Laboratories Improvement Act (CLIA), requires assessment of whether a lab can test according to instructions and detect what is intended to be detected, that is, the test’s analytical validity. However, a key element is missing in that evaluation: clinical validity. Does the test accurately diagnose or predict the risk of a particular clinical outcome? While the FDA announced its intent to revisit the issue of LDTs several years ago, it has not done so, although it issued draft guidance and a discussion paper on the subject. There is also a discussion draft of a bill circulating in Congress to address LDTs.
What this means:
While the majority of LDTs are developed by legitimate, mainstream medical organizations, the lack of regulation has allowed the creation of bogus tests to detect supposed “nutritional deficiencies” and “chronic Lyme” among others. There’s also a problem with bastardizing legitimate tests for quack purposes, as has happened with MTHFR genetic testing. These tests are used by practitioners like naturopaths and “Lyme literate” doctors to sell patients dietary supplements and other unnecessary treatments.
What needs to happen:
Whether a legislative solution is crafted by Congress or the FDA uses its existing authority to regulate LDTs, any test that is used to diagnose a disease or condition that is not supported by sufficient evidence that it actually exists (such as “nutritional deficiencies” that have no scientifically recognized effect on human health) or is not recognized as a valid medical diagnosis should require pre-market approval. This would eliminate at least some of the bogus testing used by pseudoscientific practitioners who prey on unsuspecting patients.
Compounded drug regulation
What it does:
Compounded drugs are created by health care practitioners and pharmacists without going through the tough FDA pre-market approval process or having to meet the same good manufacturing practices as other pharmaceutical products. Their manufacture is regulated by a combination of federal drug law and state health care practitioner regulation. After a meningitis outbreak caused by a compounded medication, Congress beefed up the requirements for compounded drugs and the FDA issued draft guidance implementing the new law. This upset naturopaths and physicians who employ dubious compounded drugs in their practices and they are lobbying their representatives in Congress to weaken the law’s consumer protections.
What this means:
While there are many legitimate uses of compounded drugs, naturopaths and some physicians abuse the process by concocting quack remedies, sometimes with tragic results. The new law and draft guidance are a step in the right direction, but naturopaths and their allies could be successful in weakening these improvements. Much of the problem, however, may be out of the federal government’s control as long as states continue to license practitioners of pseudoscience and fail to discipline physicians who use dubious compounded remedies.
What needs to happen:
In addition to resisting efforts to weaken the new law or the FDA’s interpretation of it, see the recommended solutions for dealing with the naturopathic practice acts and physicians who practice pseudoscience under the so-called “health freedom” laws, below.
Affordable Care Act “non-discrimination” provision
What it does:
Section 2706 of the Patient Protection and Affordable Care Act (the “ACA” or “Obamacare”) prohibits “discrimination” by health insurers against state-regulated health care practitioners acting within their scope of practice as defined by state law.
What this means:
Exactly what would constitute “discrimination” was never defined and the law seems to have done little (if anything) to assist naturopaths, chiropractors and acupuncturists in gaining coverage for their practices, perhaps because health insurers are not prohibited from refusing to cover diagnoses and treatments they consider “experimental,” that is, lacking in evidence.
What needs to be happen:
Health insurers should not be forced to cover practitioners who achieved their scope of practice through political means rather than appropriate education and training and adherence to evidence-based practices. Section 2706 should be repealed.
State laws
Chiropractic Practice Acts
What they do:
All 50 states license chiropractors. All states permit chiropractors to claim that they can detect non-existent “subluxations” and that the correction of these phantom lesions improves health and can prevent or treat disease. State practice acts are not uniform and vary widely in scope of practice. All states allow chiropractors to perform or order diagnostic testing and give nutritional advice. In some states, chiropractors can, for example, perform physicals for school athletics and gynecological exams and administer oral and IV chelation therapy. Other states allow the term “chiropractic physician.”
Licensure is granted based on graduation from chiropractic college, where clinical education takes place in small school clinics offering a very limited range of experience and passing an examination, both of which are controlled entirely by chiropractors. In most states, boards made up of a majority of chiropractors regulate their practice, including discipline, continuing education requirements and specialty practice, such as “chiropractic neurology,” “chiropractic pediatrics,” and “chiropractic internist.” Specialty practice is permitted based on post-grad courses which may take place in hotel conference rooms and require no clinical experience. Practice expansion efforts have resulted in limited prescription privileges, the authority to give patients IV vitamin and mineral infusions, and to enter into direct primary care agreements with patients (also here).
What this means:
Claiming a variety of health benefits, including (among many others) turning breach babies and improvements in asthma, allergies, bedwetting, ear infections, and “wellness,” chiropractors have been detecting “subluxations” for over a century without ever having shown that subluxations exist, that they have a deleterious effect on human health, that they can be detected, or that “subluxation correction” via “adjustments” is effective for anything. (These practices are to be distinguished from the evidence-based use of spinal manipulation for certain types of back pain, to which some chiropractors limit themselves, although they are hard to find.) Given the right to use diagnostic testing (both real and bogus) and give “nutritional advice,” which translates into prescribing and selling dietary supplements, allows chiropractors to practice an ersatz version of primary care. (The American Chiropractic Association, the largest chiropractic professional association, vigorously promotes “the DC as PCP.”) This includes a plethora of quack diagnoses and treatments.
What needs to happen:
Detection and correction of subluxations should be eliminated from the chiropractic practice acts. (And not by creatively renaming subluxations.) Chiropractors should be limited to the diagnosis and treatment of musculoskeletal problems, without prescription privileges. They should be prohibited from using bogus diagnostic tests and devices, although, as mentioned above, this needs to be addressed at the national level so that it applies to all health care practitioners. While they should be allowed to advise patients on proper diet, they should be prohibited from selling dietary supplements they prescribe to their patients, a huge conflict of interest. School physicals, pelvic exams, obstetrics and all the other practices for which they are inadequately educated and trained should be eliminated from the practice acts and, because of their anti-vaccination philosophy, they should be specifically prohibited from giving immunization advice as outside their scope of practice.
Naturopathic Practice Acts
What they do:
Naturopathic “doctors,” those with degrees from naturopathic “medical” schools, are currently regulated (through licensing or registration) in 19 states and Washington, D.C., with scopes of practice varying widely from full-range primary care scope (although only Oregon does this) to practice acts which specifically refute the notion that naturopaths are capable of practicing as primary care doctors (as in Maryland and Rhode Island). Like chiropractors, naturopaths have set up their own educational and testing system, controlled completely by naturopaths and operating wholly outside the mainstream U.S. university system. States default to these “credentials” as sufficient to ensure public safety.
More than any other type of health care practitioner, the naturopathic practice acts legalize a wide range of quackery. These acts recognize vitalism as the source of naturopathic practice and allow naturopaths to treat patients with (depending on the state) homeopathy, colonic irrigation, herbs, and energy healing, and IV infusions of vitamins, and minerals, among many others. The authority to do diagnostic testing allows naturopaths to use the sort of unvalidated testing discussed earlier in the post. Most states give naturopaths their own regulatory board.
What this means:
At best, naturopaths sell patients dubious remedies, like homeopathic drugs and dietary supplements, for self-limiting conditions that may well have gotten better on their own, or for made-up conditions like “chronic candidiasis.” At worst, they treat patients with dangerous remedies like IV hydrogen peroxide and IV curcumin, sometimes killing them. If you want a peek inside how they operate, read Britt Hermes blog, Naturopathic Diaries, David Gorski’s and Orac’s posts on “What naturopaths say when they think no one is listening” (actually, Orac titled his posts more colorfully) and Scott Gavura’s “Naturopathy vs. Science” series. To boot, naturopaths are also anti-vaccination.
What needs to happen:
Repeal the naturopathic practice acts. There’s not a shred of reliable evidence that naturopathic practice benefits patients, and it has the potential to do great financial and physical harm.
Homeopathic Practice Acts
What they do:
Only three states specifically license medical and osteopathic doctors as “homeopathic physicians,” although naturopaths, chiropractors, acupuncturists and unlicensed CAM practitioners can legally prescribe, administer and sell homeopathic remedies to patients in some states.
What this means:
Physicians could possibly be prosecuted for falling below the medical standard of care for employing homeopathic remedies without specific authority to do so, since homeopathy is so obviously devoid of any scientific basis or evidence of effectiveness. Homeopathic practice acts eliminate that possibility.
What to do:
This is another no-brainer. No MD or DO should be allowed by the state to prescribe bogus remedies. Homeopathic practice acts should be repealed.
Acupuncture, Traditional Chinese Medicine, East Asian Medicine and Oriental Medicine Practice Acts and Auricular Acupuncture
What they do:
State acupuncture practice acts vary widely, with some, like Mississippi, allowing a very narrow scope of practice (in Mississippi’s case, requiring that the patient have been evaluated by a physician in most instances and limiting practitioners to needle acupuncture). Others are far more expansive, allowing the practice of what is variously called Traditional Chinese Medicine, East Asian Medicine and Oriental Medicine. Some, like Kansas, specifically incorporate a proposed mechanism of action unknown to science:
assessment, evaluation, prevention treatment or correction of any abnormal physiology or pain by means of controlling and regulating the flow and balance of energy . . . and stimulating the body to restore itself.
These laws incorporate all manner of pseudoscientific diagnoses as well as treatments, such as moxibustion, herbalism, and cupping. Several states also permit the practice of auricular acupuncture for limited conditions, like substance abuse, by those without formal training in acupuncture. Like chiropractors and naturopaths, acupuncturists have created and control their own educational and testing system, to which the state legislatures default in licensing decisions. Most states give acupuncturists their own regulatory board.
What this means:
Acupuncture is a theatrical placebo, leading some patients to believe that acupuncture “works.” In addition to ineffectiveness, acupuncture has its risks (also here), as does the use of herbs (or, unrefined drugs), which are too often contaminated. Even if one were to concede (and we don’t) that needle acupuncture is effective for a handful of conditions, the practice acts allow acupuncturists to diagnose and treat virtually any disease or condition with methods that are both biologically implausible and have no reliable evidence of safety or efficacy.
What needs to happen:
At best, repeal the acupuncture practice acts. A less drastic solution would be to allow acupuncturists to see only those patients with a physician referral for a limited course of treatment, eliminating the authority to diagnose according to principles that are no better than magic tricks and treat with unproven remedies like herbs, cupping and moxibustion.
State “health freedom” laws: Quack version
What they do:
While the provisions vary by state, and not all states have them, so-called “health freedom” laws (or, as I prefer, the “Quack Full Employment Acts“) allow people with no health care education or training to sell bogus treatments to the public without fear of being prosecuted for the unlicensed practice of a health care profession as long as certain minimal requirements are made. For example, in Nevada, practitioners of Gerson Therapy, reiki, reflexology, herbalism, “detoxification,” and iridology are protected from prosecution for the unlicensed practice of medicine, for which the penalty is reduced from a felony to a misdemeanor. Even then, the state must meet an almost impossible burden of proof in prosecuting them. In Colorado, unlicensed practitioners offering energy healing, dietary supplements, homeopathic remedies and colonic irrigation are shielded.
What this means:
The state cannot prosecute even the most egregious quackery, in some cases even if it causes physical harm.
What needs to happen:
This is another simple one: eliminate these unwarranted protections of quacks and repeal and restore the authorities’ ability to prosecute.
State “health freedom” laws: Physician version
What they do:
Either via statute or regulation, some states have adopted a double standard for physicians using “complementary and alternative” diagnoses and treatments. The Federation of State Medical Boards has provided a template for implementing this double standard. Basically, these laws permit a physician to practice in a manner that would normally fall below the standard of care without fear of prosecution from the state medical board if certain requirements are met. (See, e.g., this Texas regulation and this Florida statute.) Provisions vary from state to state, but generally require that the diagnosis or treatment not pose an undue risk or actually cause harm.
What this means:
Physicians are free to discard evidence-based medicine in favor of pseudoscience.
What needs to happen:
Physicians should be held to a single standard of care, with no exceptions for pseudoscience, of all things. These statutes and regulations should be repealed.
Conclusion: We’re moving in the wrong direction
While changes (or, at least, proposed changes) in the regulation of laboratory-developed tests and compounded drugs are a step in the right direction, the legalization of quackery is actually expanding via the enactment, for example, of scope of practice liberalization for chiropractors and naturopathic practice acts. Over 30 years ago, a Congressional subcommittee concluded:
As this report details, quackery has traveled far from the day of the pitchman and covered wagon to emerge as big business. Those who orchestrate and profit from the sale and promotion of these useless and often harmful “health” products are no longer quaint and comical figures. They are well organized, sophisticated and persistent. [We estimate] the cost of quackery – the promotion and sale of useless remedies promising relief from chronic and critical health conditions – exceeds $10 billion a year [a figure that has greatly increased; dietary supplements alone are a $41 billion a year business.] The costs of quackery in human terms, measured in disillusion, pain, relief forsaken or postponed because of reliance on unproven methods, is more difficult to measure, but nonetheless real. All too frequently, the purchaser has paid with his life. While the impact of quackery on our lives has been increasing and growing in sophistication, public and private efforts designed to address and control this problem have diminished, been redirected or disbanded.
I would argue that a concerted public effort to protect consumers from quackery is virtually non-existent today. As far as I know, a legislative solution to the victimization of consumers is not even a topic of conversation in the halls of Congress or the state legislatures. It should be.
