The late medical ethicist and pediatrician William G. Bartholome included in his talk at the 1988 National Health Fraud Conference in Kansas City a discussion of the concentric circles of Hell described in Dante’s Inferno. Thinking about those circles reminds me of the importance of combating health fraud and quackery.
The first (outermost) circle, called Limbo, is reserved for the otherwise virtuous who failed to accept Christ. If your idea of Heaven is the RMS Titanic in all its glory, Limbo would be the steerage deck.
But as you go deeper into Hell, accommodations get increasingly dreadful. Within the seventh circle of Hell, immersion in a river of boiling blood and fire is a relatively tame fate. Supposedly it’s even worse in the region where inhabitants are forever stuck in scorching sand and showered with flakes of fire.
The seventh circle is designated for violent people. But there are even deeper circles for supposedly worse people. Yes, even worse!
I’ll spare you a description of the eighth and ninth circles, but their inhabitants might regard the seventh circle as a realm of luxury.
Dante envisioned the eighth circle for the conscious frauds (sorcerers, astrologers, false prophets, alchemists, thieves, corrupt politicians, perjurers, impostors, and other intentional deceivers) and the ninth circle for the treacherous: those who betray others in social relationships.
I’m not sure I have a solid grasp of Dante’s distinction between the fraudulent and the treacherous, but I agree with this point Dr. Bartholome made about Dante: He took fraud seriously.
So do I. However, I’m not sure I think about fraud quite the way Dante did.
First, I don’t see fraud as categorically worse than violence (although it’s clear that some frauds cause more harm than some violent acts).
Second, I don’t see fraud as limited to intentional deceit—even though legal dictionary definitions of fraud such as the definition at law.com refer to intentional deceit or perversion of truth.
When Bernie Madoff intentionally deceived his clients and made off with their money, it’s clear that he defrauded them.
When health care providers intentionally bill third-party payers for services that they know they didn’t provide, that’s fraud. (It’s called health insurance fraud or health care fraud and, as I’ll explain, it’s not the same as health fraud.)
But what about people who strongly believe in their own false or misleading promotional claims for health-related uses of products or services? Is it fraud—or the equivalent of fraud—when promoters truly believe the baloney they promote?
I suggest that being a well-meaning dupe is no excuse for deceptively promoting health products and services. Indeed, being a true believer in your cherished nonsense gives you an advantage in projecting sincerity, which enhances the illusion of credibility and therefore makes you more effective at misleading unsuspecting people.
It’s relatively easy for honest sellers of televisions, kitchen appliances, musical instruments, and ceiling fans to accurately present the operational features of their products to prospective customers. However, the consumer protection challenges related to products and services marketed for health-related purposes are much greater. There is more at stake when people address health concerns than other concerns of daily living.
Consumers and health care practitioners often don’t recognize how problematic personal or clinical experience can be for judging the safety and effectiveness of health products and services. As noted by the late Barry Beyerstein, bogus therapies often seem to work for various reasons.
It’s easy to jump to incorrect conclusions about the risks and benefits of a health product or service by failing to take account of the following:
- the natural variation in the course of diseases
- the potential for diagnostic errors
- the potential for prognostic errors
- erroneous health outcome measures
- errors in interpreting health outcomes
- distortions in reporting health outcomes
- previous or concurrent activities or therapies that can influence health status
Rigorous testing with appropriate cases under appropriate conditions is required to validate health products and services. Making promotional claims without validation is health fraud and quackery.
Definitions of Health Fraud and Quackery
In June 1986, the New York State Assembly Republican Task Force on Health Fraud and the Elderly released a special report that included this definition:
Health fraud is the promotion, for financial gain, of fraudulent or unproven devices, treatments, services, plans or products (including, but not limited to, diets and nutritional supplements) that alter or claim to alter the human condition. Those who promote such medical remedies that do not work or have not been proven to work are called 'quacks'.
The U.S. Food and Drug Administration (FDA) uses this definition to guide regulatory action:
HEALTH FRAUD: The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article.
Neither of these definitions refers to activities performed for profit. The first definition refers to financial gain, but that’s not the same as profit. The phony faith healers who were famously described by James Randi accumulated fortunes by soliciting donations for their ministries, but their ministries weren’t for-profit enterprises. That should not stop us from referring to phony faith healing as health fraud.
Neither definition equates fraud with intentional deceit. The FDA definition clearly indicates that health fraud may or may not involve intent to deceive.
The Assembly Republican Task Force definition refers to “devices, treatments, services, plans or products” while the FDA definition refers only to “articles,” which can be interpreted to mean products regulated by FDA including drugs, medical devices, dietary supplements, etc. The more restricted focus of the FDA’s definition reflects limitations in its regulatory authority: for example, FDA does not regulate health professions. (In the U.S., professions are regulated at the state level).
The expression “scientifically proven” is the language of regulatory policy, not science. Scientific testing offers validation, confirmation, or verification of claims made for health products and services, but not the certainty implied by the word proof. But the expression “scientifically proven” is helpful because it indicates that the burden of “proof” should always be placed on those wishing to make promotional claims, not on doubters.
The definitions of health fraud are very similar to some definitions of quackery.
In 1984, the Subcommittee on Health and Long-Term Care of the U.S. House of Representatives Select Committee on Aging issued its report Quackery: A $10 Billion Scandal. The report defined quackery as “the practice or pretensions of a quack” and used this definition of a quack:
…anyone who promotes medical schemes or remedies known to be false, or which are unproven, for a profit.
In 1986, the now defunct National Council Against Health Fraud (NCAHF) defined quackery as:
Promoting health products, services, or practices of questionable safety, effectiveness, or validity for an intended purpose.
William Jarvis, president of NCAHF and its precursor organizations for more than 20 years wrote:
Quackery's paramount characteristic is promotion ("Quacks quack!") rather than fraud, greed, or misinformation.
I noted in a talk I gave in 2000:
My dictionary of English word origins states that there are two words 'quack.' One, of course, denotes the call of a duck ("quack, quack") and originated as an imitation of the sound of itself. The other word 'quack' helps me to focus my feelings of outrage and I hope it does the same for you. My dictionary says it was borrowed from the early modern Dutch word quacksalver, a compound formed from quacken meaning 'chatter' or 'prattle' and salf, the Dutch relative of the English salve. The dictionary says that quacksalver etymologically denoted 'someone who prattles on or boasts about the efficacy of his remedies.'
I prefer the term quackery to health fraud because quackery doesn’t have the false connotation of intentional deception. The major disadvantage of referring to quackery instead of health fraud is that many people think it sounds like something too silly to take seriously. As Dr. Jarvis wrote:
Why should a critter as cute and harmless-looking as a duck be used to symbolize the vicious social menace of quackery? A vulture would seem to be more appropriate. But vultures actually wait until death occurs before engaging their targets. Thus their conduct is too benign to symbolize quackery, which preys on the weak, the helpless, and the desperate.
Other birds of prey behave more like that of quacks, but the bald eagle, which is a national symbol, would not be suitable for derision. An ostrich might be appropriate, because of its reputation for hiding its head in the sand, thus symbolizing the denial so often seen in both quacks and their victims.
Perhaps, an ostrich would be a good symbol, but Dr. Jarvis concluded:
The duck personifies quackery because it makes a lot of noise about nothing.
Unfortunately, insufficient noise is made about quackery as a social and public health scourge. In 2011, George Lundberg, former editor of the Journal of the American Medical Association (JAMA) and of Medscape bemoaned the finding that “alternative medicine” delivers many more hits than does “quackery” in Google searches even though controlled tests consistently fail to show that [so-called] alternative therapies work.
Dr. Lundberg didn’t help matters when he wrote one of the forewords to the textbook Fundamentals of Complementary and Alternative Medicine, Fourth Edition. The textbook whitewashes the problem of quackery; regards any analysis of superstition in traditional medical systems as 19th century thinking; and includes laudatory chapters by practitioners of homeopathy, “energy medicine,” reflexology, qi gong, and other forms of pseudomedical mysticism. As I pointed out in my review of the textbook, Dr. Lundberg praised the book for its objectivity and accuracy.
Non-Validated Therapies in Modern Medicine
It isn’t health fraud/quackery to administer non-validated therapies of biologically plausible value when consenting patients seeking help are given accurate, relevant information about potential benefits and harms. Non-validated treatments can be ethically administered in properly designed clinical trials and even outside of clinical trials.
Validated treatments don’t exist for every health problem in every patient population. And just because a treatment is validated does not mean it is guaranteed to work for all relevant patients.
Responsible health care professionals judiciously use non-validated treatments of plausible value to respond to the needs of their patients. But they offer such innovation honestly and as part of the art of healing.
In my testimony to the White House Commission on Complementary and Alternative Medicine Policy in 2001, I argued:
It is unavoidable for responsible healthcare professionals to use unproven methods in caring for patients. We will never have all the answers to address the complexities of human health problems. Clinical judgment and innovation will always be an essential part of the art of delivering healthcare. However, responsible healthcare professionals do not promote the use of unproven methods. The promotion of unproven methods through…advertising and publicity is objectionable because it is deceptive. It violates the ethical principles of veracity and nonmaleficence (the general duty of "first do no harm").
Medical care needs to be evidence-based. But some of modern medicine’s most hostile critics insist that little in medicine is based on evidence. Many doctor-bashers are advocates for so-called complementary and alternative medicine, a euphemistic label for health care based on superstition, revelation, pseudoscience, tradition, anecdote, and/or wishful thinking rather than evidence.
The late Robert Imrie and David W. Ramey explained that medical care is based on much stronger evidence than doctor-bashers claim. Steven Novella, an assistant professor of neurology at Yale School of Medicine, also rejected the notion that mainstream medicine is not science-based. He wrote:
My personal experience is that nearly 100% of the clinical decisions I make are based upon the best available evidence combined with plausible and rational extension of what is known. I can’t think of any time when I use treatments that are based upon nothing, or even nothing but anecdote. At the very least there is a biologically plausible mechanism of action and adequate evidence for lack of harm.
Principles of Consumer Protection
The good intentions of some promoters of unproven health care methods do not keep them off the metaphorical road to Hell’s eighth circle. But the road doesn’t even come close to Limbo when good intentions are linked to principles of consumer protection.
NCAHF was a nonprofit, tax-exempt voluntary health agency founded in 1984 with a mission based on consumer protection principles. According to its statement of beliefs:
“Consumer" is not a special class but a role played by all; everyone in a free enterprise society has a stake in maintaining high standards for health products and services.
Professionals in the health sciences, academia, law and business as well as government agencies share a responsibility to help consumers protect themselves from deception and exploitation in health-related matters.
The scientific process is essential for discovering truths and validating health claims and information.
Health products and services should be:
- proved safe and effective before marketing with proponents bearing the burden of such proof
- accurately labeled or fully described
- truthfully advertised.
As noted in the Consumer Bill of Rights, consumers have:
- The right to free and informed choice
- The right to accurate information
- The right to safety
- The right to be heard
- The right to consumer education
Quacks, their apologists, and their devoted customers often participate in “health freedom” advocacy organizations. They insist that consumers should have “freedom of choice” in the consumer marketplace and that the free enterprise system is based on the principle of caveat emptor (let the buyer beware).
NCAHF had several answers to the health freedom pitch. Consumers have only the illusion of free choice when they are led to make decisions based on false or misleading information that comes with quackery. There is no health freedom in what is based upon misinformed consent. When you’re being deceived, you’re not free to choose. And when your health is threatened, it’s especially difficult to be wary of quackery. “Health freedom” advocates expect health consumers to beware despite their disadvantageous bargaining position, but they don’t expect those offering products and services to be fully accountable to consumers. Caveat emptor is an important educational message for the James Randi Educational Foundation to offer, but it’s unreasonable to rely on caveat emptor without public policy based on the notion of caveat venditor (or caveat vendor): let the seller beware.
The NCAHF motto was: Freedom of choice through reliable information.
The Harmful Impact of Quackery
Quackery has been a population health scourge for centuries. Dr. Jarvis called it a national scandal.
The prospects for a quackery-free society are no more realistic than the prospects for drug-free society that some “War on Drugs” advocates have as their goal. The goal for opponents of quackery should be harm reduction: reduction of the harmful public health and societal impact of quackery (just as opponents of drug-abuse should strive for drug-related harm reduction).
Education is part of the solution, but we also need improved public policy to strengthen consumer protections and make quackery less rewarding. We need to promote a social environment that supports healthy skepticism and truth-seeking rather than credulity and wishful thinking.
Unfortunately, few of us are active opponents against quackery. Scientists and health professionals tend to have other priorities. Some take an empty-minded approach in their efforts to be open-minded. Some tend to fit the definition of shruggies proposed by Val Jones.
...a person who doesn’t care about the science versus pseudoscience debate. When presented with descriptions of exaggerated or fraudulent health claims or practices, their response is to shrug. Shruggies are fairly inert, they will not argue the merits (or lack thereof) of complementary and alternative medicine (CAM) or pseudoscience in general. They simply aren’t all that interested in the discussion, and are somewhat puzzled by those who are.
Dr. Jones suggested that she used to be one of the shruggies, until she came to appreciate the insidious harm of snake-oil practices. There is an urgent need for efforts to overcome shruggie tendencies. (One such effort is Tim Farley’s focus on the harmful impact of misinformation ).
Dr. Jarvis emphasized awareness of several types of harm from quackery:
- Economic harm refers to the financial impact of pursuing fruitless quackery.
- Direct harm refers to toxic and lethal effects of quack treatments. (I’m more concerned about the risk of direct harm from the nostrums offered by dumb and deluded quacks than the nostrums offered by dishonest quacks who are smart enough to avoid poisoning or killing the people they rip off.)
- Indirect harm refers to delay or failure to use effective treatment because of diversion by quackery.
- Psychological harm includes irrational fears, guilt, antisocial behavior, and distraction away from resolving issues with loved ones.
- Societal harm includes misallocation of resources. The proliferation of quackery-promoting integrative medicine centers is a recent example.
I will be discussing more about the nature of quackery and specific examples of quackery-related harms in future submissions to Swift. And I look forward to being a less lonely opponent of quackery.
Jarvis WT. How quackery is promoted. In Barrett S, Cassileth BR, editors. Dubious Cancer Treatment: A Report on “Alternative” Methods and the Practitioners and Patients Who Use Them. Tampa, 1991, Florida Division of the American Cancer Society.