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.

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Regulation of homeopathic ”remedies" as drugs would be wonderful. My patients' parents are always so disappointed when I tell them that the "cough medicine" they've shelled out $10-20 for is just sugar water or alcohol mixed with a lot of wishful thinking. What makes these products even more enticing is that the ”real" stuff (Robitussin, Triaminic, PediaCare, etc) is now (appropriately) labeled as only for children over 4 or 6 years old. So they think the Hylands crap is the only approved option.

By David Hoffman (not verified) on 18 Sep 2015 #permalink

BTW I'm from Indiana, not Indian. Oops.

By David Hoffman (not verified) on 18 Sep 2015 #permalink

Eisenhower wept. Homeopathy is religion, masquerading as medicine, perpetrating fraud. The only regulation it requires is the damned law courts. That the FDA and FTC are being made to perform this insane dog-n-pony act, shamelessly stacked with crooks and shills, instead of sending the whole shitshow straight back to congress to legislate correctly, just goes to show how ludicrously corrupted by big money industries and inchoate ideologues US politics has become.

David Hoffman@1:

Regulation of homeopathic ”remedies” as drugs would be wonderful.

The problem is that there is no way in Hell that Congress will ever actually allow them to DO this, not with big fat wads of cash and screeching true believers waving in their faces. Instead, they'll simply mandate regulatory agencies redefine "drug" to be "whatever includes homeopathy", and sack anyone left there who's still competent and courageous enough to point out they're absolutely full of it.

I've always considered Naturopathy as the "One Quackery To Rule Them All" !!!

Homeopathy is on the way out, because people want drug-free solutions to their problems.

I wonder about that. It seems to me that natural is ok to these types of people and homeopathy is seen as natural. I also wonder how many are trube natural cure believers and how many people are like the parents David Hoffman mentions in #1. They know that Robitussin, etc shouldn't be given to their kids but right next to it in the pharmacy is what looks like real medicine with no such restrictions.

By capnkrunch (not verified) on 18 Sep 2015 #permalink

Panel 2: Scientific Support for Homepathic Advertising Claims

In a sane world, this would be about as short as a panel discussion could be: there is none. Thank you for coming. Unfortunately, we don't live in that world.

IIRC, the process by which a homeopathic preparation comes to be listed in the HPUS is called "proving". Obviously this word is not used the same way that researchers running a clinical trial would use it, but it may be enough to satisfy the letter of the law. (IANAL. TINLA.) Pedantic, yes, but legal cases often turn on this kind of pedantry.

Speaking of legal details, Michigan statutes (specifically <a href="http://www.legislature.mi.gov/(S(jsr4cewskvaosspyacpvlq0z))/mileg.aspx?page=getObject&objectName=mcl-390-5"Section 390.5, Act 151 of 1851) require the flagship university of Orac's state to have a homeopath on the faculty:

The regents shall have power to enact ordinances, by-laws and regulations for the government of the university; to elect a president, to fix, increase and reduce the regular number of professors and tutors, and to appoint the same, and to determine the amount of their salaries: Provided, That there shall always be at least 1 professor of homeopathy in the department of medicine.

By Eric Lund (not verified) on 18 Sep 2015 #permalink

Sorry, botched link in my #8, here is the corrected version: Section 390.5

By Eric Lund (not verified) on 18 Sep 2015 #permalink

Has, you win the internet with your #3 comment!

Btw, I don't see homeopathy as on the way out either. The oddballs that lean towards it that I run across do think it's natural because it uses that 'like vs like' nonsense and it has no side-effects.

Then there's those like me who see a coupon for it and think it's a medicine only to have to make sure I read the label at the store so I don't accidentally buy what I think is a much cheaper generic version of NyQuil or something.

By Not a Troll (not verified) on 18 Sep 2015 #permalink

@ #1

Sleep deprivation and the misery of your tiny hacking human = "Maybe this will help, since I can't give her XYZ." It's been my experience to date that pharmacists are not slow in recommending said potions...

Efficacy claims aside, what about truth in ingredient labeling? Is there really Oscillococcinum 30X in that tablet? Prove it.

I also wonder if Hyland's poisonous teething tablets will be brought up. Probably not, since warning consumers that their product contains a potent poison isn't really involved in advertising claims.

Todd W.

Efficacy claims aside, what about truth in ingredient labeling? Is there really Oscillococcinum 30X in that tablet? Prove it.

I'd also be interested in seeing how they prove that the quantum water memory vibrations or whatever are there. Or at least that they started with something and did the whole shake and dilute deal. It's easy to imagine an unscrupulous manufacturer just using plain water; and given their business, it's easy to imagine that hemoepathic manufacturers are unscrupulous.

By capnkrunch (not verified) on 18 Sep 2015 #permalink

yes, nearly five days after my return, London still lingers in my choice of language

There are things the Brits say so much better than we do.

Is there really Oscillococcinum 30X in that tablet?

The Boiron site lists the ingredients as Anas barbariae 200CK*. So there is no Oscillococcinum in Oscillococcinum, and it's WAY more dilute stronger than a mere 30C!

*No indication of whether Anas barbariae 200CK is related to Louis CK

By Mephistopheles… (not verified) on 18 Sep 2015 #permalink

I don't understand Oscillococcinum's popularity in France Surely the French have much tastier duck products.

@MO'B

You caught me. I was just pulling numbers out of the air simply to prove a point. My bad. Sloppy on my part.

I’d also be interested in seeing how they prove that the quantum water memory vibrations or whatever are there.

They'll probably cite the infamous Nature[1] paper by Jacques Benveniste, the one that won him his first Ig Nobel Prize[2] in Chemistry in 1991. That's the one in which he claimed that water has memory. They may also cite Benveniste's later work, in which he claimed to find that this memory could be transmitted over telephone lines, for which he was awarded a second Ig Nobel Prize in Chemistry in 1998.[3]

[1] "Just because it's in Nature doesn't mean it's wrong." Although in this case, that's the way to bet.

[2] I happen to have the list of winners page open today because the 2015 awards were announced last night. A couple of prizes were awarded for biomedical research, but for offbeat evidence-based research rather than woo, so no new blog fodder for Orac there.

[3] Coincidentally, 1998 was the year Deepak Chopra was awarded the Ig Nobel Prize in Physics for "his unique interpretation of quantum physics as it applies to life, liberty, and the pursuit of economic happiness."

By Eric Lund (not verified) on 18 Sep 2015 #permalink

The FTC workshop is NOT about homeopathic remedies in general, but about the advertising "for OTC homeopathic products." There's quite a distinction there. The FTC frames the reason for the workshop thusly:

During the last few decades, the homeopathic drug industry in the United States has grown from a multimillion- to a multibillion-dollar market. In that same time, the homeopathic drug market has shifted: from one based primarily on formulations prescribed for an individual user, to mass-market formulations widely advertised and sold in major retail stores throughout the United States.

One possible interpretation of this:
'the "homeopathic" OTC business is different enough from the "homeopathy" the FDA has always given a pass that we can regulate it without stepping on the FDA's toes'.

Do remember, minions, that most of the sales volume for OTC products under the 'homeopathic' rubric in big box chains like CVS, Walgreens and Walmart comes from 'remedies' like Cold-Eeze that are not 30C dilutions, but actually have measurable (dubious) supposedly-active ingredients. That is, they aren't 'homeopathic' in the Hahnemann sense, as the word has become an advertising marker for 'natural' cures and/or folk remedies. Go to your local brick and mortar pharmacy, see what they have on the shelves with "homeopathic" on the box, and look at the ingredients.

Now, consider that the practice of professional homeopaths is economically dependent on the "individualization of care". The premise is that each individual condition of each individual patient will require a different sugar-water dilution, concocted specifically for the occasion out of the multiple available 'provings' listed in the homeopathic Materia Medica via some dadaist diagnostic process.

If mass-manufactured 'homeopathic' remedies can be mass-marketed at Walmart, then the principle has to be 'one-formula-works-for-everybody', so who needs to book an office visit with a homeopath? Thus, 'homeopathic' OTC, whatever is actually in it, is in competition with local homeopathy practitioners to the point it threatens to eliminate the basis on which they are able to generate an income.

The page at the American Association of Homeopathic Pharmacists website at Orac's “experts to represent our interests at the FTC event” link above is written as if the interests of the OTC manufacturers and individual homeopathy practitioners are the same, when in fact there's substantive conflict and contradiction between them. I'd interpret the spiel there as an attempt to bamboozle the practitioners into defending the OTC manufacturers in the name of 'the industry' as if they were all doing the same thing. Which they're not.

Since the 'homeopathic' label can refer to custom dilutions, and/or generic dilutions, and/or miscellaneous 'natural' remedies, the parties dispensing each of the above would benefit from regulations that impinged their competitors but not them, or impinged their competitors to a significantly greater degree. The composition of the different FTC workshop panels aligns with the split interests: the first panel is composed of folks associated with the OTC biz (Walmart and Boiron); the second including representatives of organizations invested in training/supporting/'integrating' professional CAM practitioners.

The differing groups appearing before the FTC might come out with a unified front, or they might take cuts at each other's throats (overt or subtle), with cohesive team play turning out to be nothing but a dream. It's not clear from the FTC's announcement how much the panelists just get to deliver prepared remarks, or whether they will be responding to questions from representatives of the FTC. What's the Director
of the New England School of Homeopathy going to say if he's asked whether Boiron's generic remedies are a valid substitute for the "individualization of care" taught at his school?

IMHO, the wildcards here are Adriene Fugh-Berman and
John Williamson, the nominally CAM-friendly experts who may well toss ALL forms of homeopathy – OTC and 'prescription' – "under the bus".

If I had to bet on one outcome though, it would be that the 'faux-homeopathy', 'natural' OTC remedies like Cold-Eeze that are actually stocked and sold at CVS, Walgreens etc. (with store-brand equivalents to the brand name products) will emerge unscathed – unless CVS is willing to sacrifice all use of the 'homeopathic' rubric in an effort to establish more legitimacy for its move to take over a big chunk of primary care in the US with its in-store clinics – which is what most insiders consider their reason for abandoning tobacco sales.
If CVS did that, Walgreens would probably go the other way for purposes of market positioning, offering even more stuff identified as 'homeopathic'. But CVS market position is so strong they're the 500 lb. gorilla here: if they really want something, it's all but Quixotic to attempt to get in their way.

The worst-case scenario here is pretty scary: CVS supports the "the homeopathic drug industry", expands its stock of 'homeopathic'-labeled products, and that big chunk of primary care they take over will be delivered by PAs functioning as pseudo-naturopaths – dispensing sbm remedies for some things, and directing patients to the 'homeopathic' OTC aisle for others. That could undercut 'prescription' homeopaths economically more than legitimate them ideologically, and it might even result in an overall reduction of 'pseudo-science' thought and practice (since the 'natural' versions of 'homeopathic' products actually contain something, and aren't premised on vitalistic voodoo), but I can't see it being good for public health...

Oops. Keep missing those slashes in the 'end' tags. Too old...

As I see it, there are no 4 dimensions about it: as OTC "drugs", they can not be sold with evidence of safety and efficacy. Having failed to exercise the law, the FDA is legally at fault and the FTC has every right to demand that any and all homeopathic preparations lacking such evidence are removed from the marketplace. Until such as time as independent clinical trials of sufficient power have demonstrated that any homeopathic preparation is effective for a given health condition, the FTC has also the right to prohibit their prescription and manufacture in the US.

Assuming that those actions are taken, one can only speculate about the fallout. A burgeoning black market or underground homeopaths concocting their wares with occasional raids by the FDA? Me thinks the former is more likely.

By Lighthorse (not verified) on 18 Sep 2015 #permalink

Given his reputation and title (Branch Chief, Basic and Mechanistic Research in Complementary and Integrative Health, National Center for Integrative Health), it will interesting to see how John Williamson responds. Like Fugh-Berman, he's no slouch when it comes to quality of evidence, so it won't be entirely a 'court of kangaroos'. A more difficult question, and one I may need to put to the nearest psychopharmacologist, will be how many grains of sale to sprinkle on my popcorn while watch the show.

By Lighthorse (not verified) on 18 Sep 2015 #permalink

Bible-Cure-Irrritable-Bowel-Syndrome/dp/0884198278

Ah, so that's what John was on about.

By herr doktor bimler (not verified) on 18 Sep 2015 #permalink
Is there really Oscillococcinum 30X in that tablet?

The Boiron site lists the ingredients as Anas barbariae 200CK*.

I think that that if there was some way to demonstrate, on the House or Senate floor, to the assembled congress critters, just exactly how Oscillococcinum is made, with a step by step demonstration of exactly what "200CK" means (that is, show somebody filling up a container with water, dumping it out, and refilling it 200 times, and then calling the water in the container 'medicine'), the we might be able to get a some new laws.

Of course, showing some one doing that might be too exciting for C-SPAN.

Johnny: "I think that that if there was some way to demonstrate,..."

Here you go:
http://www.merseysideskeptics.org.uk/2010/11/how-to-make-your-own-homeo…

And then anyone can send their congress critter this easy peasy recipe:

Recipe for Nat Mur or Natrum Mur or Natrium Mur or Natrum muriaticum:

1) Take ½ teaspoon of sea salt and dissolve into 1 cup of distilled water in a bottle.

2) Shake well.

3) This is a 1C solution (ratio 1/100).

4) Take ½ teaspoon of the 1C solution and put it a bottle with 1 cup of distilled water, throw out the 1C solution.

5) Shake well.

6) This is a 2C solution (ratio 1/10000).

7) Take ½ teaspoon of the 2C solution and put it a bottle with 1 cup of distilled water, throw out the 2C solution.

8) Shake well.

9) This is a 3C solution (ratio 1/1000000).

10) Take ½ teaspoon of the 3C solution and put it a bottle with 1 cup of distilled water, throw out the 3C solution.

11) Shake well.

12) This is a 4C solution (ratio 1/100000000).

13) Take ½ teaspoon of the 4C solution and put it a bottle with 1 cup of distilled water, throw out the 4C solution.

14) Shake well.

15) This is a 5C solution (ratio 1/10000000000).

16) Take ½ teaspoon of the 5C solution and put it a bottle with 1 cup of distilled water, throw out the 5C solution.

17) Shake well.

18) This is a 6C solution (ratio 1/1000000000000).

19) Take ½ teaspoon of the 6C solution and put it a bottle with 1 cup of distilled water, throw out the 6C solution.

20) Shake well.

21) This is a 7C solution (ratio 1/100000000000000).

22) Take ½ teaspoon of the 7C solution and put it a bottle with 1 cup of distilled water, throw out the 7C solution.

23) Shake well.

24) This is an 8C solution (ratio 1/10000000000000000).

25) Take ½ teaspoon of the 8C solution and put it a bottle with 1 cup of distilled water, throw out the 8C solution.

26) Shake well.

27) This is a 9C solution (ratio 1/1000000000000000000).

28) Take ½ teaspoon of the 9C solution and put it a bottle with 1 cup of distilled water, throw out the 9C solution.

29) Shake well.

30) This is a 10C solution (ratio 1/100000000000000000000).

31) Take ½ teaspoon of the 10C solution and put it a bottle with 1 cup of distilled water, throw out the 10C solution.

32) Shake well.

33) This is a 11C solution (ratio 1/10000000000000000000000).

34) Take ½ teaspoon of the 11C solution and put it a bottle with 1 cup of distilled water, throw out the 11C solution.

35) Shake well.

36) This is a 12C solution (ratio 1/1000000000000000000000000).

37) Take ½ teaspoon of the 12C solution and put it a bottle with 1 cup of distilled water, throw out the 12C solution.

38) Shake well.

39) This is a 13C solution (ratio 1/100000000000000000000000000).

40) Take ½ teaspoon of the 13C solution and put it a bottle with 1 cup of distilled water, throw out the 13C solution.

41) Shake well.

42) This is a 14C solution (ratio 1/10000000000000000000000000000).

43) Take ½ teaspoon of the 14C solution and put it a bottle with 1 cup of distilled water, throw out the 14C solution.

44) Shake well.

45) This is a 15C solution (ratio 1/1000000000000000000000000000000).

46) Take ½ teaspoon of the 15C solution and put it a bottle with 1 cup of distilled water, throw out the 15C solution.

47) Shake well.

48) This is a 16C solution (ratio 1/100000000000000000000000000000000).

49) Take ½ teaspoon of the 16C solution and put it a bottle with 1 cup of distilled water, throw out the 16C solution.

50) Shake well.

51) This is a 17C solution (ratio 1/10000000000000000000000000000000000).

52) Take ½ teaspoon of the 17C solution and put it a bottle with 1 cup of distilled water, throw out the 17C solution.

53) Shake well.

54) This is an 18C solution (ratio 1/1000000000000000000000000000000000000).

55) Take ½ teaspoon of the 18C solution and put it a bottle with 1 cup of distilled water, throw out the 18C solution.

56) Shake well.

57) This is a 19C solution (ratio 1/100000000000000000000000000000000000000).

58) Take ½ teaspoon of the 19C solution and put it a bottle with 1 cup of distilled water, throw out the 19C solution.

59) Shake well.

60) This is a 20C solution (ratio 1/10000000000000000000000000000000000000000).

61) Take ½ teaspoon of the 20C solution and put it a bottle with 1 cup of distilled water, throw out the 20C solution.

62) Shake well.

63) This is a 21C solution (ratio 1 in 10^42 or 1/1000000000000000000000000000000000000000000).

64) Take ½ teaspoon of the 21C solution and put it a bottle with 1 cup of distilled water, throw out the 21C solution.

65) Shake well.

66) This is a 22C solution (ratio 1 in 10^44 or 1/100000000000000000000000000000000000000000000).

67) Take ½ teaspoon of the 22C solution and put it a bottle with 1 cup of distilled water, throw out the 22C solution.

68) Shake well.

69) This is a 23C solution (ratio 1 in 10^46 or 1/10000000000000000000000000000000000000000000000).

70) Take ½ teaspoon of the 23C solution and put it a bottle with 1 cup of distilled water, throw out the 23C solution.

71) Shake well.

72) This is a 24C solution (ratio 1 in 10^48 or 1/1000000000000000000000000000000000000000000000000).

73) Take ½ teaspoon of the 24C solution and put it a bottle with 1 cup of distilled water, throw out the 24C solution.

74) Shake well.

75) This is a 25C solution (ratio 1 in 10^50 or 1/100000000000000000000000000000000000000000000000000).

76) Take ½ teaspoon of the 25C solution and put it a bottle with 1 cup of distilled water, throw out the 25C solution.

77) Shake well.

78) This is a 26C solution (ratio 1 in 10^52 or 1/10000000000000000000000000000000000000000000000000000).

79) Take ½ teaspoon of the 26C solution and put it a bottle with 1 cup of distilled water, throw out the 26C solution.

80) Shake well.

81) This is a 27C solution (ratio 1 in 10^54 or 1/1000000000000000000000000000000000000000000000000000000).
(the zeros are running off of the page!)

82) Take ½ teaspoon of the 27C solution and put it a bottle with 1 cup of distilled water, throw out the 27C solution.

83) Shake well.

84) This is a 28C solution (ratio 1 in 10^56 or 1/100000000000000000000000000000000000000000000000000000000).

85) Take ½ teaspoon of the 28C solution and put it a bottle with 1 cup of distilled water, throw out the 28C solution.

86) Shake well.

87) This is a 29C solution (ratio 1 in 10^58 or 1/10000000000000000000000000000000000000000000000000000000000).

88) Take ½ teaspoon of the 29C solution and put it a bottle with 1 cup of distilled water, throw out the 29C solution.

89) Shake well.

90) This is a 30C solution (ratio 1 in 10^60 or 1/1000000000000000000000000000000000000000000000000000000000000).

And then you are done! To make the pills, go to baking center of your grocery store and get some plain cake decorating sprinkles. You can try dropping some of the solution on the sprinkles, or just set the bottle next to the solution for it to absorb the energy (which is the typical method used for over the counter homeopathic remedies).

You can make up other remedies by knowing what the mother tincture is… For instance “Nux Vomica” (or Nux Vom) is from the Nux Vomica plant which contains the poison strychnine, Nux Sulph uses sulpher, and the stuff advertised on the radio for colds, Oscillococcinum is from duck liver.

I had to be away from my office most of this week. I check out the sample cabinet tonight and what do I find? Homeopathic teething gel. I'm hoping it's a joke being played and not reality that someone didn't check the label if it came in with other samples.

Regulation of this homeopathic nonsense can't come soon enough.

By Chris Hickie (not verified) on 18 Sep 2015 #permalink

And then anyone can send their congress critter this easy peasy recipe:

A fine recipe that goes to the heart of the matter (but I have to say I like Mark Crislip's words at http://www.pusware.com/quackcast/quackcast57.mp3, mostly because the world needs more Mark Crislip).

Sure, we can e-mail it, snail mail it, FAX it, send it to them in a dozen ways, and maybe their staff will even read it. The chances that the Congress(wo)man will even see it is unlikely, and most probably the staff will only scan it and drop it in the 'anti-homeopathy pile'. But if someone was to actually make, say, Oscillococcinum on the floor, or even in a committee meeting (bonus points if a homeopath could be there to say, with a straight face and under oath, 'yep, that's how we make make this powerful medicine'), I believe it may make a difference.

Well, I want to believe it would make a difference, but I may be wrong.

But if someone was to actually make, say, Oscillococcinum on the floor, or even in a committee meeting (bonus points if a homeopath could be there to say, with a straight face and under oath, ‘yep, that’s how we make make this powerful medicine’), I believe it may make a difference.

Someone of course could merely ask one of the Boiron representatives whether it's accurate. L-rd knows it's open to a leading construction that they'd see coming like a locomotive.

Chris Hickie,

I had to be away from my office most of this week. I check out the sample cabinet tonight and what do I find? Homeopathic teething gel.

You could hold onto it in case you encounter a case of fly agaric poisoning, I suppose....

By Krebiozen (not verified) on 19 Sep 2015 #permalink

I assume that everyone here knows that homeopathic preparations are currently manufactured by machines and have been for many years.

By Lighthorse (not verified) on 19 Sep 2015 #permalink

Lighthorse: "I assume that everyone here knows that homeopathic preparations are currently manufactured by machines and have been for many years."

Yes, we know. It was why the quality control falls to the side. Hyland had to shutdown production when they were actually putting enough belladonna in they teething remedy that kids actually got sick.

It is the kind of oversight you get from those who assume they are immune from regulation.

#28 I was at my state's health committee hearing on licensing naturopaths.
One of the naturopathic Not-a-Doctors who gave testimony in support of licensing is also a "a classically trained homeopath". She testified that homeopathy is completely safe because there is no physical substance in the medicine. Its an energy medicine.
Our legislators had made up their minds that they were going to license Nd's and no amount of ridiculous testimony was going to convince them otherwise.

She testified that homeopathy is completely safe because there is no physical substance in the medicine. Its an energy medicine.

The safety of a properly prepared homeopathic remedy was never in doubt, for exactly this reason. (Sometimes things do go wrong with the manufacturing process, as Chris notes above.) But they are also supposed to show efficacy. That one's harder to do.

It's nice to hear a "classically trained homeopath" admit in a legislative hearing that she's basically prescribing placebos, but trading that in for energy woo is even worse. There is a difference between honest ignorance and willful ignorance, and calling sugar pills "energy medicine" is definitely on the willful side of that line, whereas homeopaths who think their medicines contain the alleged active ingredient might be honestly ignorant--stupid, yes, but honestly ignorant.

By Eric Lund (not verified) on 20 Sep 2015 #permalink

The article seems to be gone. I get a diffent page, which only mentions the article in a list on the sideline. Other references in the sideline lead to the article, but this one not.

Having arrived in the US yesterday with a slight case of conjunctivitis, I wanted some eye drops that would soothe the irritation until the condition fixed itself (or got worse and sent me to the doctor for antibiotics). So down to Walgreens and in the eye drops section had to read all the packages to find some eye drops with actual ingredients in them (rather than magic water). Seriously, when you have to read all the fine print to turn up a product that is likely to do something, there is something wrong with labeling laws.

The article seems to be gone. I get a diffent page, which only mentions the article in a list on the sideline. Other references in the sideline lead to the article, but this one not.

This is a common outcome of visiting Natural News. Mikey has all these fancy redirects running that usually mean it is impossible to find the article you were after.

The article seems to be gone
Link works if you delete the short-term nonsense "#ixzz3mHjEL4YH" at the end.
Contents are as stupid as you'd think. Talks about the self-overdosed nimrods as "holistic doctors", "naturopaths", or just "doctors" when they were in fact Heilpraktikers, i.e. people who like to play dress-ups in a white coat and call themselves "healers" without the inconvenience of undergoing training.

Ms Weiland believes that they had been “experimenting” after finding the ground littered with blood-stained needles, mattresses, cushions and blankets.

By herr doktor bimler (not verified) on 20 Sep 2015 #permalink

How to kill off homeopathy for once and for all:

Produce a homeopathic "stop smoking" remedy that consists of a dilution of tobacco leaf that's just enough that a full dose of the product has an amount of bio-available nicotine that's equivalent to taking one drag on a cigarette.

Alternately, produce "homeopathic cigarettes" made with "a blend of natural herbs and extracts" that also include about one drag's worth of nicotine in an entire cigarette.

This will immediately be seen as a ploy to get smokers who have quit and are still dealing with "cravings," to fall off the wagon and start smoking again.

Boom! The full weight of regulation will fall on the industry like a 16-ton weight.

If that isn't enough to do it, then try homeopathic remedies for heroin and cocaine addiction, made with diluted extracts of opium poppy and coca leaf respectively.

The point of the exercise is to push the envelope of outrageousness so far that it finally provokes an unequivocal response.

By Gray Squirrel (not verified) on 20 Sep 2015 #permalink

Here's another link to the same story:
http://worldtoday.wikidot.com/naturalnews-com

"Initial reports of the incident implied that the 29 naturopathic doctors, who had been attending a homeopathic health conference, might have voluntarily taken the drug as part of an "experiment." However, follow-up reports reveal that none of the healers had willingly taken anything and that someone might have intentionally poisoned and/or tried to murder them."

Not to let the chance of a conspiracy go to waste, he added the following:

"By all appearances, it would seem as though these 29 enemies of the multi-billion dollar pharmaceutical cartel were victims of an attempted mass slaughter simply because their work involves healing people naturally rather than making them lifelong slaves to the medical-industrial complex and its high-profit "treatments" that never heal."

By Lighthorse (not verified) on 20 Sep 2015 #permalink

Should've gone for 2C-B, I suppose. Seriously, there are are only so many ways to simultaneously bomb 29 people, and there was no common event?

One take-home lesson: these people are apparently not good with the concept of "dosage." Or weighing things. I can imagine a desperate scramble for homeopathic antidotes as it was coming on.

@ Krebiozen (#30)--whoops, it's already gone in the trash. As homeopathic items have actually medicine in them, no special disposal rules apply.

By Chris Hickie (not verified) on 21 Sep 2015 #permalink

I think the way to kill homeopathy is to exempt the producers of homeopathic remedies from clinical trials, but to require all lots produced for sale meet the same pre-release quality control standards all other pharmaceuticals are required to meet.

If they can't design tests which will accurately measure concentration of active indicates, characterize potency, and demonstrate their 'drug' product can be distinguished from vehicle controls and appropriate negative controls (ifor exanple that they can demostrably tell the difference between 30C Oscillococcinum, pure solvent and 30C Nux Vomica) on some basis other than the container labels. if they can't, the lot fails and cannot be released for sale.

Of course, the assays they develop to accomplish these would all have to be validated. using blinded samples.

It's no tasking for much really--we're not asking them to prove homeopathy's works, just that they prove they can manufacture homeopathic remedies reliably before they're allowed to sell them.

Does anyone know of a live-blog for the FTC hearing?

^ Video doesn't work on Android, BTW.

Got it--I started listening about 1/2 hr ago. I was hoping to find a science based blog that has comments in real time to the presentations. Or even, if someone has recorded the presentation.
I hope the FTC eventually posts a transcript, but I'd love to read or what they said sooner, rather than later.

I hope the FTC eventually posts a transcript, but I’d love to read or what they said sooner, rather than later.

The only thing that was working for me was the closed captioning; a sensible pipeline would be cleaning that up as it comes in.

When I finally saw the note on the site that it was being broadcast via IOS, I hooked the phone into the computer, but the closed captioning didn't match the audio.
Orac's cast of characters was very helpful, but since I came in so late, it was still hard to tell who was who.
What I got out of it was that the Homeopathic industry thinks a disclaimer is enough info. for the consumer.

Ms Weiland believes that they had been “experimenting” after finding the ground littered with blood-stained needles, mattresses, cushions and blankets.

I laughed so hard reading this.

@#43 JGC

You fool! Don't you know that putting that requirement on homeopathic "medicine" will make them lower the dilution rate to actual detectable amounts, both weakening the effectiveness and even endangering the public?

[Obviously with no offense intended to JGC.]