This week on the SGU we interviewed Maureen Ohlhausen, Acting Chairman of the Federal Trade Commission (FTC). We had an interesting discussion about how that agency should best regulate health care products in the marketplace. The areas of our agreement and disagreement were extremely interesting, and illuminate some of the challenges we face in promoting science-based medicine.
The interview was partly inspired by a recent FTC decision regarding the regulation of homeopathic products. We were generally pleased with the decision, which essentially would tighten up the labeling on homeopathic products, requiring evidence to support efficacy claims. Here is a key component of the decision that we discussed during the interview:
However, the policy statement also notes that “the FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. Accordingly, it recognizes that an OTC homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
During the interview Ohlhausen explained her basic philosophy, which is evident in the decision. First, one of the basic missions of the FTC is to protect the consumer from fraud and deception in the marketplace. She feels this goal should be accomplished first through market forces, and that regulation should avoid as much as possible reducing consumer choice. She does not want to take choices away from consumers, just give them all the information they need to make informed choices. If they still choose to purchase nonsense, then it’s on them.
She also pointed out that the FTC is not the only actor in this space, and that its mandate is limited. The FTC cannot remove products from the market, for example. Obviously the FDA has more authority in this area (which is why we anxiously await the FDA’s decision about its own regulation of homeopathy).
The SBM view
This is more my personal view, but it is the one that has been consistently articulated on SBM by me and others. I completely understand the FTC position, given their mandate and limitations. Some of my concerns also may be more appropriate for the FDA. Further, some changes to regulation would need to happen at the level of Congress passing new laws (such as removing or amending the Dietary Supplement Health and Education Act).
The major premise of Ohlhausen’s position is that more choice is always better for the consumer. Tied to this is the notion of free speech as far as it extends to commercial speech. Therefore, marketers have the right to put out information as long as that information is not misleading, and consumers should have the right to make their own decisions based on that information. That is a perfectly reasonable position, but it has limits. The real question is – what are or should be those limits?
Ohlhausen believes that of primary concern are the inherent safety of the products in question, and the seriousness of the illness they are intended to treat. These are reasonable factors to consider when prioritizing limited resources. What this means, however, is that if the product itself is inherently safe (not directly harmful) and it is marketed to symptoms or self-limited illness, then regulatory agencies should err on the side of “regulatory humility” and let the free market sort it out. Their role is limited to making sure no fraudulent or misleading claims are made.
Further, she says, in areas where the scientific evidence is limited or preliminary, marketers should be given some leeway to base claims on preliminary evidence. If we require too much evidence then we effectively make it impossible for the sellers of unpatentable products to fund the research.
I disagree on three major points: that the only important way to deceive the consumer is through packaging or direct marketing claims, that the only harm worth considering is direct toxic harm, and that we should give leeway to preliminary scientific findings.
Let me start with the point about giving leeway to products that are not inherently unsafe or intended for very serious illness. There is a tremendous amount of indirect harm from health products that are not directly toxic but are essentially worthless. There is financial harm (which the FTC recognizes as sufficient to trigger regulation), there is psychological harm (such as false hope), and there is downstream harm.
The downstream harm is difficult to quantify, but we see it all the time. One common scenario is this – a consumer purchases a homeopathic product for a self-limiting illness, like a cold. There is no possible benefit from the product, but the consumer is convinced it worked because of placebo effects and other psychological effects (such as wanting to believe they did not waste their money, or convincing their skeptical relatives who thought their purchase was silly). The consumer is now convinced that homeopathy works. That, in my opinion, is harm.
They are partly convinced because society allows homeopathic products to be packaged as if they are real medicine, with names and claims that imply that they are real medicine. They are sold in pharmacies alongside real medicine. The products are afforded the trappings of legitimacy. This also contributes to placebo effects.
Because of all this, when the hypothetical consumer eventually develops a serious illness, they will be more inclined to seek treatment from a practitioner of homeopathy. That is a choice that may cost them their life. That is harm that was contributed to by the lax regulation of homeopathic products. I don’t think that this connection is too tenuous to influence our regulatory policy.
If we look at the big picture, society is being harmed by increasing acceptance of loose scientific standards in health care specifically designed to allow for dubious products and practices. The consumer is being harmed by this, and each piece of lax regulation contributes to the overall phenomenon. This phenomenon includes convincing the public (and even many scientists and practitioners) that placebo effects alone justify a treatment, that anecdotes are useful, that unblinded studies can determine efficacy, and that certain special magical kinds of treatments cannot be tested by standard scientific methods. The alternative medicine phenomenon is playing off of and contributing to public scientific illiteracy. There is therefore also societal harm, which further includes wasting tremendous resources researching, regulating, and purchasing treatments that cannot possibly work.
This brings me to the next point, that the consumer is only deceived through direct claims made on packaging or advertising. Ohlhausen claims that if the consumer truly understands what homeopathy is, that it is based on 18th century science and its claims are not accepted by modern scientists, then they are not being deceived. I think very few consumers would fit into this category.
Every single patient and member of the public I have ever spoken to on the topic of homeopathy (excluding people I meet at skeptical events) does not have a functional understanding of what homeopathy is. Most think it is herbal medicine, or make a vague reference to “natural” medicine. Many are surprised and even disbelieving when I explain to them what the ingredients are and that it doesn’t matter because they are usually diluted out of existence. “That can’t be right,” is a common response, “because they sell it in the pharmacy.”
The point here is that homeopathic products do not exist in isolation. They have to be put into context. This may be a tall order for an agency like the FTC, but I think it should inform their regulatory decisions (again, maybe this needs to be fixed at the Congressional level). This context includes homeopaths who, as we speak, are promoting homeopathic potions to HIV patients in Africa, and recommending homeopathic nosodes instead of vaccines. Some homeopaths do treat serious illnesses, and products sold for cold symptoms are their foot in the door.
It is no coincidence that the public is massively misinformed about the true nature of homeopathy. Often they are described as using “small” doses, which is not true – they typically use nonexistent doses. There is a big difference between a small dose and zero dose.
Therefore, should the OTC homeopathic product industry be responsible for the overall homeopathy industry, including the misleading claims and deceptions that produce a public who generally does not know what homeopathy is? Is this cultural deception going to be fixed by a brief disclaimer on homeopathic product packaging?
Generally regulatory agencies recognize that if a company or industry creates a demand for their product through misleading claims, they are not entitled to benefit from the demand they fraudulently created, even if they are no longer making misleading claims on their packaging. I think this principle applies here. I don’t think we can tease apart all the various elements that contributed to common misconceptions about homeopathy. The entire industry is based on deception.
I would further argue that there is no possible benefit to the public from the availability of homeopathic products. There is no scenario in which the consumer is not harmed (even just by financial harm). Shouldn’t agencies like the FTC be able to consider these meta-questions – is the industry itself even legitimate? I don’t see the harm to consumers by taking this choice away from them. “Regulatory humility” is not relevant here, because there is no scientific doubt about this question. We are as certain as we can be that homeopathy cannot possibly work, and that it in fact does not work.
The final point is more nuance – how should we deal with preliminary evidence? Ohlhausen’s view is that, since there may be benefit to a product, the public has the right to know about that benefit, even before we have rock solid scientific evidence. Specifically, we should not use the same threshold we have for prescription drugs for things like food or supplements.
That latter point is valid, but more context is required here. For me an important question to ask is this – what are the odds that the preliminary evidence will turn out to be true? We can further look at it this way – what is the net harm vs benefit to the consumer by allowing marketing based on preliminary scientific evidence? There is also the smaller related point, should the marketers be the ones to make those claims to the public?
There is no easy answer to the question of how many preliminary health claims will turn out to be true, but we have spent years here at SBM examining that question. It is one of the core questions for SBM – where should the threshold for scientific evidence be placed so that we can be reasonably sure that claims are reliable? What is sufficient evidence to recommend a treatment?
The full answer is complex, but the simple summary is this – a lot higher than it currently is. There is no one article I can link you to that does a sufficient job of summarizing this topic, there are dozens of articles spread throughout SBM that address different aspects of this question. We know that most preliminary scientific studies will turn out to be wrong. There is a huge problem in science with p-hacking and with lack of reproducibility. There is a bias towards false positives, which is significantly higher in industry-funded studies.
If you combine all these factors together you come to the conclusion that any given health claim based on preliminary industry-funded research is almost certainly biased toward the industry and likely will not pan out. Those are precisely the claims that Ohlhausen thinks should be given leeway.
The net effect to the consumer, therefore, seems to be massively negative. I suspect that the net health effect of the entire OTC supplement industry (so I am not including supplements prescribed by doctors based upon valid evidence) on the public is negative. We are spending billions of dollars for no benefit, or a net negative health effect.
There is a proper balance somewhere, but I don’t think we are even close right now on supplements. We worry too much about delaying the marketing of a product that will eventually be vindicated, and not enough about the many, many more products that are worthless or even a little harmful that are being prematurely marketed to the public.
At the very least we need to come up with a much better way to communicate the current status of the science to the public. Maybe we need to have an easy-to-understand grading system for scientific evidence. Something like – based upon current scientific evidence there is a very low probability that this claim will turn out to be true.
Right now the regulation is binary – we either allow the claim or we don’t. We are therefore stuck forever in the false-positive vs false-negative debate. While I think it is clear right now we need to shift massively toward avoiding false positives, and perhaps we also need to get away from this binary system.
I think overall the FTC is moving in the right direction. I would simply go a lot further. We need a vigorous and evidence-based national discussion on this issue.