The FTC vs. homeopathy: Substantive change in the regulation of magic or window dressing for the status quo?

Homeopathy is a frequent topic on this blog, for reasons that regular readers no doubt understand all too well by now. Homeopathy is, as I like to call it, again borrowing from Tolkien, The One Quackery To Rule Them All. When it comes to quackery, few can even come close to homeopathy for the sheer ridiculousness of its precepts. Whether it is the Law of Similars, which claims that to cure a disease you need to use a substance that cause’s that diseases symptoms in healthy people, a “law” that has no basis in science, or the Law of Infinitesimals, which postulates that serially diluting a substance to nonexistence in the solution—with vigorous shaking (succussion) to “potentize” the mixture between each dilution step, of course—makes it stronger, few quackeries bring the pseudoscience to such a high level as homeopathy. Indeed, as I frequently like to say, for homeopathy to work, not only would much of what we know about physics and chemistry have to be wrong, but spectacularly wrong. Sure, reiki is nothing but faith healing that substitutes Eastern mystical beliefs for Christian beliefs in identifying the source of the “healing power” used, but that’s just pure magical thinking, little or no reference to science required. Few quacks can create a self-contained, self-sustaining world of pseudoscience the way homeopaths can.

Given just how utterly barmy (yes, nearly five days after my return, London still lingers in my choice of language) homeopathy is, it is often puzzling to supporters of science-based medicine how it can be legal, not only in the UK, where the last time I visited England I made it a point to have my photo taken in front of the Royal London Homeopathic Hospital (which has “evolved” into the Royal London Hospital for Integrated Medicine) but right here in the US. As Jann Bellamy explained a few months ago, thanks to a quirk in the Food, Drug and Cosmetics Act (FD&C Act), passed in 1938 and history in which the FDA basically abdicated its responsibility to regulate homeopathic remedies as drugs, anything included within a publication known as the Homoeopathic Pharmacopoeia of the United States (HPUS) are, in practice, allowed to be sold. Jann makes a compelling case that, because under the FD&C Act of 1938, substances in the HPUS are defined as drugs, the FDA should have authority to regulate them as such, but, even in the wake of the Kefauver-Harris Amendments of 1962 that required manufacturers to prove safety and efficacy rather just safety before a drug could be approved, homeopathy remained largely unregulated. If it was in the HPUS, basically, it was okay.

This year, however, there have been indications in Washington that, from a regulatory standpoint, the status quo might be about to change. The most recent indication of that is an workshop being hosted by the Federal Trade Commission (FTC) on Monday to examine whether changes should be made in how manufacturers are allowed to advertise homeopathic remedies. The FTC, of course, is charged with investigating fraudulent business practices and prosecuting the perpetrators of such practices, and what bigger fraud is there in medicine than claiming that magic water can cure disease? Unfortunately, as we were reminded earlier this year when the Food and Drug Administration (FDA) held a similar workshop to discuss modernizing how it regulates homeopathy, homeopathy is a fraud that is seemingly quite legal in the US, at least for the moment.

Earlier this year, the FDA announced that it was considering modernizing how it regulates homeopathic remedies and held a hearing for public input. As I noted at the time, there were few skeptics and plenty of industry representatives and homeopaths who testified. Written comments were also solicited, and the Society for Science-Based Medicine (SfSBM) submitted one, arguing that the FDA has, without legal authority, exempted homeopathic remedies from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). (In the interests of full disclosure, I am on the board of directors of SfSBM.) The SfSBM further argued that lax regulation of homeopathy has resulted in consumer confusion, and consumers do not understand how the FDA regulates (or, more accurately, does not regulate) homeopathic drugs and the lack of scientific evidence for homeopathy.

It turns out that the Federal Trade Commission (FTC), the federal agency responsible for preventing, identifying, and prosecuting fraudulent business practices, also submitted a comment to the FDA making the very same points, as Jann Bellamy pointed out earlier this month, referring to it as the “battle of the feds” and noting:

The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation.

Jann also noted:

I don’t know how often (if ever) one governmental agency recommends that another government agency “reconsider its regulatory framework” because its current policies cause consumer confusion, potential harm, and inhibit the former’s ability to do its job, which happens to be preventing that very same consumer confusion and harm.

Neither do I, but I do know that the FTC workshop is scheduled for next Monday and will be webcast. It is instructive to look at who has been asked to participate in the workshop. The workshop’s agenda is divided into three sessions:

• Panel 1: Homeopathic Industry & Advertising
• Panel 2: Scientific Support for Homepathic Advertising Claims
• Panel 3: Legal/Regulatory Issues Presented by Homeopathic Advertising

Panel 1: The homeopathic Dream Team

Not surprisingly, the homeopathy industry mobilized to defend its ability to make huge profits selling water and sugar pills at massive markup, assembling a “homeopathic dream team” of “experts to represent our interests at the FTC event.”

For panel 1, the panelists include just some of those “dream team” members. Here is the panel:

• John P. Borneman, Chairman and Chief Executive Officer, Standard Homeopathic Company and Hyland’s, Inc.
• Candace Corlett, President, WSL Strategic Retail
• Mark Land, Vice President, Operations & Regulatory Affairs, Boiron, Inc.
• Yale Martin, Independent Retail Consultant
• Duffy McKay, Senior Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition

On the surface, it looks like it’s four to one, quack-apologists versus a science advocate (Duffy McKay). John Borneman and Mark Land represent manufacturers of homeopathic remedies and can predictably be expected to defend the current system, from which their companies have profited so magnificently selling quackery. Also on the surface, Yale Martin seemed like an interesting choice:

Yale Martin is an independent retail consultant residing in Bentonville, Arkansas. He retired in November 2014 from Walmart Stores, Inc. after 18 years in Walmart’s buying office. Mr. Martin spent much of his career as a buyer and for the last five years supervised Walmart’s over-the-counter (OTC) buying office, responsible for more than 4,000 OTC items retailed in Walmart’s 5,000 US stores. Previously, Mr. Martin held buying positions in Baby, Pet, Health and Beauty Aids/Cosmetics, and OTC. Mr. Martin holds a bachelor’s degree from the University of California and serves on the Board of Directors of Angie’s Artisan Treats, an organic snack food company owned by a private equity firm.

My guess (and it’s a blindingly obvious guess) is that Martin will also be on the side of the current system, given how profitable over-the-counter homeopathic remedies are, perhaps with mild tweaks. Maybe he’ll recommend some minor changes in labeling or something like that, but I highly doubt he’ll say anything substantive. Don’t believe me? Check out his testimony at the FDA hearing:

The homeopathic products sold in typical mass retailers are successfully used by tens of thousands of consumers each day. The free market system has a tendency to quickly eliminate items which do not meet consumer expectations since they are not repurchased. Items that fail to meet a retailer’s “minimum sales threshold” are quickly replaced by other items. Shelf space is the most valuable commodity a retailer has and items that disappoint consumers do not last long in any retailer.

Many, if not most, of the manufacturers of homeopathic products are conservative, long-established companies. Some of these companies are nearing 100 years old. These companies have a history of producing quality products that address health issues of importance to consumers. Any additional restrictive regulations of these homeopathic drug products would hinder the public’s access to these products and would significantly limit consumer choice.

Yes, he’ll argue that the free market will take care of all those pesky problems of determining efficacy of homeopathic products. If they don’t work, people won’t buy them! Never mind that the advertising goes out of its way to give the impression that they work. And we wouldn’t want to “limit consumer choice” by requiring that companies be able to back up their claims of efficacy and safety, now would we? Again, the free market will take care of all that, at least, if you believe Mr. Martin. Expect the same drivel at the FTC panel. Of course, he’s on the “dream team” too; so of course he’s going to defend the industry.

But what about Duffy McKay? When I read the list, I must admit that the Council for Responsible Nutrition sounded as though it might be science-based. However, I was quickly disabused of that notion when I read his bio, which reveals that he is a “licensed Naturopathic Doctor who still sees patients on a part-time basis in an integrative medical practice, and previously was co-owner and practitioner in a family-owned New Hampshire complementary and alternative medicine private practice.” Basically, the CRN is, according to its website, the “leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers,” and its member companies “manufacture popular national brands as well as the store brands marketed by major supermarkets, drug stores and discount chains.”

So, in the first panel, it’s four quacks and a marketing flack (Candace Corlett). This does not look promising at all.

Panel 2: Evidence for hope, or hope for evidence?

In panel 2, the participants include:

• Adriene Fugh-Berman, Associate Professor, Department of Pharmacology and Physiology, Georgetown University Medical Center
• Paul Herscu, Naturopathic Physician, Director, New England School of Homeopathy
• Wayne B. Jonas, President & CEO, Samueli Institute
• Richard (Rik) Lostritto, Division Director and Acting Associate Office Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ), Food and Drug Administration
• David Riley, Academy of Integrative Health and Medicine, Integrative Medicine Institute
• John Williamson, Branch Chief, Basic and Mechanistic Research in Complementary and Integrative Health, National Center for Integrative Health

This list is a little better. Yes, it’s stacked with advocates of “integrative medicine” (the Samueli Institute is one of the big players in this field and has been discussed here before on multiple occasions). On the other hand, Adrienne Fugh-Berman, even though she is an advocate of “complementary and alternative medicine” (CAM), is no friend of homeopathy. At the FDA hearing, she said that the evidence for homeopathy is “between scant and nil” and expressed concern about stocking homeopathic remedies right next to real medicine on pharmacy shelves because, in her view, most consumers and medical professionals have no idea what homeopathic remedies are (which is undoubtedly true), don’t know they aren’t reviewed for safety and efficacy (also undoubtedly true), and likely think they are dietary supplements or conventional OTC drugs Then, of course, it’ll be interesting to see Richard Lostritto try to defend the current FDA policy regarding homeopathy.

Finally, although it might seem unpromising that there is a Branch Chief from the NCCIH there, I do note that the NCCIH of late hasn’t exactly been that friendly to homeopathy. The last time I checked, there hasn’t been a grant from NCCIH to fund research into homeopathy since 2008. Indeed, when I paid a visit, with Steve Novella and Kimball Atwood,” to the National Center for Complementary and Alternative Medicine (NCCAM, as it was called back then) for a discussion with Josephine Briggs in 2010, although she didn’t explicitly rule out ever funding a homeopathy grant again (probably because she couldn’t do that) she definitely seemed to agree that homeopathy was not particularly plausible and didn’t express much enthusiasm for it. At the time she was likely heavily involved in developing the 2011-2015 strategic plan, that I like to refer to as “let’s do some real science for a change.” So it made sense that she would want to throw homeopathy under the bus to some extent, even as she met with homeopaths around the same time to provide “balance.”

Still, overall, the second panel is packed with homeopathy advocates.

Panel 3: Legal niceties

Finally, there is panel 3:

• Kathleen Dunnigan, Senior Staff Attorney, National Advertising Division, Council of Better Business Bureaus
• Elaine Lippmann, Regulatory Counsel, Food and Drug Administration
• Al Lorman, Partner, Law Office of Alvin J. Lorman
• Paul D. Rubin, Esq., Partner, Ropes & Gray, LLP
• Michelle Rusk, Senior Staff Attorney, Division of Advertising Practices, Federal Trade Commission
• Christina Guerola Sarchio, Partner, Orrick, Herrington & Sutcliffe, LLP
• David C. Spangler, Senior Vice President, Policy, and General Counsel and Secretary, Consumer Healthcare Products Association
• Anthony Vozzolo, Partner, Faruqi and Faruqi, LLP

Not surprisingly, given that this last panel is to discuss legal and regulatory issues, it composed of all lawyers. Unfortunately, most are flacks for the homeopathy industry, with Sarchio and Rubin being arguably two of the heaviest hitting of the homeopathic flacks. They’re both part of the AHRP homeopathic dream team, and both represent Boiron, the French manufacturer responsible for the homeopathic flu remedy known as Oscillococcinum, which is a 200C dilution of Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy Duck liver and heart, respectively). I kid you not. Then there’s David Spangler, director of Consumer Healthcare Products Association’s (CHPA) legal affairs and international affairs. He is also on the AHRP’s homeopathic dream team. (The CHPA testified at the FDA hearing in April in favor of the current regulatory system.) Let’s just put it this way, the CHPA says homeopathic medicines work and refers people to the websites of manufacturers of homeopathic remedies like Boiron and Hylands for more information.

Still, all is not lost. Elaine Lippman acquitted herself well in the FDA hearing, asking hard questions of the advocates trotted out by the homeopathy industry, such as why they couldn’t do the same kinds of studies that drug companies had to do to provide evidence that their products are effective, e.g., RCTs. She even got one to admit there wasn’t any reason they couldn’t do this, and got the Consumer Healthcare Products Association (CHPA) representative to admit that they had no evidence that consumers understood the labels of homeopathic drugs. Next, Kathleen Dunnigan represents the National Advertising Division for the Council of Better Business Bureaus. She has a degree in engineering, so she might be expected to understand why homeopathy is so completely implausible from a scientific standpoint. If that is true, she could be a valuable member of the committee. In addition, Anthony Vozzolo has handled a class action suit against Hyland’s (Forcellati v. Hyland’s, Inc.), a major manufacturer of homeopathic remedies; so that’s promising.

Finally, Michelle Rusk could be very good indeed, if this presentation she gave on the FTC’s substantiation policy for dietary supplements is any indication. As Jann noted to me in an e-mail, if this policy were applied to homeopathic remedies, the industry would take a major hit.

Conclusion: Hopes and ropes

I realize that any regulatory agency considering major changes in how it regulates an industry needs to hear from advocates of that industry. That’s just politics and policy. However, it is still depressing how heavily stacked the first two panels are in favor of homeopathy and CAM advocates. The last panel is less blatantly stacked that way, but still leans towards the advocates. I happen to know, for instance, that the Center for Inquiry tried to get a representative at the workshop. As the final makeup of the workshop shows, it was unable to do so. (At least at the FDA hearing in April, Michael De Dora and other critics of homeopathy made statements.)

I realize that there is an argument to be made that the FTC has already decided that homeopathic products need to be treated, for purposes of advertising, like every other drug and are simply giving advocates every opportunity to make their case; i.e., that they are giving industry advocates enough rope to hang themselves, but even in that event one would expect that the workshop wouldn’t be quite so unbalanced in favor of homeopathy advocates.