Apr 05 2012
There is a disturbing lack of protection for the consumer of “complementary and alternative” products and services. I can think of no other area of commerce where misleading, as well as out and out false, information is so regularly employed, without consequence, to entice the consumer into forking over his hard-earned cash. Nor do I know of any other manner of goods or services where giving consumers patently false information is protected by law.
Consider first the fact that nonsensical gibberish is enshrined in state law in the form of “CAM” practice acts, which give practitioners of implausible, if not wholly discredited, diagnostic methods and treatments carte blanche to ply their trades. For example, as has been discussed before on SBM, state law defines chiropractic as the detection and correction of subluxations, which, as many chiropractors themselves admit, do not exist. State practice acts define acupuncture in such pseudoscientific terms as “modulation and restoration of normal function in and between the body’s energetic and organ systems and biomechanical, metabolic and circulation functions using stimulation of selected points.”
As well, naturopathy practice acts allow “mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine.” State practice acts also permit the indiscriminate use of the term “doctor” and “physician.” Scope of practice is broadly defined as “primary care.”
To add insult to injury, state law generally gives the Boards governing these practices exclusive authority to regulate their “professions.” This has resulted in rules which incorporate even more pseudoscientific nonsense into the scope of practice. In Florida, for example, a Board of Acupuncture rule allows aromatherapy, electric moxibustion, color therapy, homeopathy, ion pumping cords, iridology, kirlian photography, magnet therapy, photonic stimulation and sonopuncture.
These Boards usually have exclusive jurisdiction to adjudicate complaints against practitioners. Thus, the unfortunate consumer who complains to a “CAM” provider Board that a practitioner failed to disclose the scientific implausibility and lack of evidence of effectiveness of a particular therapy is likely to get a frosty reception. Unfortunately, even the Medical Boards may turn a deaf ear to consumer complaints about the use of “CAM” due to the squishy double standard for “CAM” versus “conventional” medicine adopted by the Federation of State Medical Boards.
And then, there’s the feds
All those problems and we haven’t even scratched the surface of federal law yet.
Although the U.S. Food and Drug Administration is charged with regulating dietary supplements, a 2009 Government Accountability Office report found
surveys and experts indicate that consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products. Without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers may be exposed to greater health risks associated with the uninformed use of these products.
And pity the poor consumer lulled into complacency by the knowledge that the FDA has regulatory authority over homeopathic products. As a federal district court recently concluded:
- “Unlike non-homeopathic OTC drugs, homeopathic OTC drugs . . . are not evaluated by the FDA at all.”
- “The Court is unaware of what standards, if any, exists to ensure that homeopathic OTC drugs are safe and effective.”
- “[T]he FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental . . . .”
- “[T]he FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs . . . .”
Lessons from the financial meltdown
The 2008 financial debacle highlighted the need for enhanced protection for consumers of financial products and services. This resulted in the passage of the Dodd-Frank Wall Street Reform and Consumer Protection Act in 2010. The law created the Consumer Financial Protection Bureau (CFPB), operating under the auspices of the Federal Reserve and responsible for regulating consumer financial products. The CFPB will consolidate existing consumer protection programs now scattered across several agencies, which were widely criticized for doing a poor job in the past.
The Bureau has the power to make and enforce rules for banks and other financial services providers which aim to protect consumers from deceptive and abusive loans and other financial products and services. According to the CFPB website, part of this responsibility will be to ensure that “consumers are provided with timely and understandable information to make responsible decisions about transactions involving consumer financial products and services.”
The Bureau also has the authority to conduct examinations of financial services providers and collect and tract consumer complaints about them. For example, if you have a gripe with your credit card company, you can go on the CFPB website right now and file a complaint.
Perhaps it is time to grant similar protections for consumers in the “CAM” marketplace. In spite of the fact that many people would rank their health as more important than their financial condition, their purchase of financial services and products now appears to be far more protected from unfair, deceptive, or abusive practices than their purchase of “CAM” products and services.
Despite considerable political wrangling over the CFPB’s start up, last fall the Bureau published a Supervision and Examination Manual on its website detailing how the CFPB will oversee consumer financial service providers. This includes guidance on unfair and deceptive acts and practices.
In some respects these guidelines are similar to those already in place at the Federal Trade Commission. Yet Congress, in creating an agency specifically overseeing the consumer financial industry, obviously saw a need not met by current FTC regulation - as well as other existing regulatory protections - in the consumer financial markets.
One could come to the same conclusion regarding CAM – that even though some state and federal regulation is already in place (such as the FDA’s authority to regulate dietary supplements) it is inadequate to address the specific abuses of CAM practices and products in the consumer marketplace. In fact, as we have seen, in some instances these abuses are actually facilitated.
How it works
Let’s take a closer look at how consumer financial regulation might inform consumer CAM regulation. According to the CFPB’s Manual, an unfair act or practice is one that
- Causes or is likely to cause substantial injury to consumers,
- Is not reasonably avoidable by consumers, and
- Is not outweighed by countervailing benefits to consumers or to competition.
Significantly, an act or practice causing a small amount of harm to a large number of people (think of, for example, a purchase of a homeopathic product) can meet the test for “substantial injury.” Actual injury is not required in all cases – a significant risk of concrete harm is sometimes sufficient.
According to the CFPB, a representation, omission of information, act or practice is deceptive when
- It misleads or is likely to mislead the consumer,
- The consumer’s interpretation of the misrepresentation (etc.) is reasonable under the circumstances, and
- It is likely to affect the consumer’s choice or conduct (in legal parlance, it is “material”).
“Materiality” is presumed in some cases. Express claims about a product or service are presumed material, as is information about their basic characteristics, like costs or benefits.
The CFPB can also go after “abusive” practices and products. While the agency has yet to issue guidance on how it will enforce this authority, the Dodd-Frank Act defines an “abusive” act or practice as, among other things, one that takes advantage of the consumer’s reasonable reliance on the seller of financial products or services to act in the consumer’s interest.
Could it work for “CAM” consumers?
If federal law protected consumers of CAM products and services as it now protects consumers of financial products and services, and created a Consumer CAM Protection Bureau (“CCPB”), how might consumers benefit? (I don’t know what our new law would be called, although we can be fairly certain it won’t be the Hatch-Burton-Harkin CAM Reform and Consumer Protection Act of 2012.)
For one thing, instead of being spread among numerous federal and state agencies, we would have a single agency focused solely on looking over the collective shoulder of CAM product and service providers, a group that sorely needs some additional supervision.
For another, I imagine mere knowledge that one is being watched might jump start the Herculean task of shoveling all the crap out of CAM practices and products. (Of course, whether anything might be left at the end of the clean – up is subject to speculation. As has been noted on this blog before, if it is plausible and works, it’s plain old science-based medicine, not “complementary and alternative” or “integrative” medicine.)
CAM consumers would have access to accurate and reliable information about CAM products and practices, including the meaning of terms (to the extent they have any meaning) used in selling them to the public. Financial consumers can find out answers to questions such as “What is a ‘daily periodic rate’?” and “What is the difference between a fixed APR and a variable APR?” Why shouldn’t CAM consumers be entitled to similar accurate and unbiased information presented in an easily understood manner, such as:
Q: What is a chiropractic subluxation?
A: The chiropractic subluxation is allegedly a misalignment of the spinal vertebrae purported to interfere with “nerve flow” between the brain and other organs, thereby causing disease. However, in reality it doesn’t exist and the detection and correction of subluxations will not do you any good.
Q: Does acupuncture work?
A: No. It is highly implausible and many studies show that it is no more effective than placebo.
If this seems somewhat silly, I ask you: why shouldn’t consumers have this information prior to purchasing CAM products and services? If a consumer needs to know what a variable APR is before deciding to borrow money, is it any less important to know whether acupuncture is beneficial before spending money on acupuncture services?
A prohibition against unfair and deceptive acts or practices, if defined in same manner as the Dodd-Frank Act, and given its own dedicated oversight and enforcement bureau, would go a long way toward halting the sale of nonsense. For example, I think there is little doubt the CAM Bureau would take a dim view of a reiki practitioner telling a consumer that reiki will relieve pain (or that reiki can do anything, for that matter) because, as we know, this would mislead the consumer into thinking that reiki is effective, when we in fact know that it is both highly implausible that it would work and that it does not in fact work.
If reiki were offered by an M.D. we might well find ourselves spilling over into the category of “abusive” practices, as, of course, any consumer would reasonably believe that her M.D. is acting in her best interest.
In fact, over time, I imagine these measures would leave few CAM products or practices standing. Given access to accurate and unbiased information about CAM, I’ll wager that not many consumers who reviewed that information would choose to purchase it. For those who do seek it out, sellers would be prohibited from misleading folks about what exactly it is they are selling, which, we might guess, would lead to severely diminished sales.
The financial services industry is far larger than the business of CAM and creating a whole federal bureau to fight its abuse of consumers is likely overkill. But the fact remains that the patchwork of state and federal regulation now in place is inadequate to the task. Perhaps a smaller unit within a federal agency (the FTC might be a candidate) would be sufficient if it were solely dedicated to protection of CAM consumers and given adequate authority by Congress to make and enforce rules governing unfair and abusive practices and handle consumer complaints.
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