Will 2016 be the year when the FDA and FTC finally crack down on homeopathy?

I like to say that homeopathy is The One Quackery To Rule Them All (although of late I've debated whether homeopathy or reiki is the most properly referred to as that). It's a strange beast, homeopathy. Its two main "Laws" are so clearly pseudoscience that you'd think that no one could ever fall for something that dumb, but, well over 200 years after Samuel Hahnemann pulled those two Laws out of his nether regions, not only is homeopathy still popular in large swaths of the developed world, but there are actual physicians who use it.

Just consider homeopathy's laws. The first is the Law of Similars, which states that to relieve a symptom you must use a substance that causes that symptom. Not only does this law make no sense on an intuitive level, but there is no biological or medical basis for it. Of course, the Law of Similars doesn't really matter, because the second law of homeopathy renders it completely irrelevant. That law, the Law of Infinitesimals, states that diluting a remedy makes it stronger. That's not nearly enough pseudoscience, though. Because of this law, homeopaths often dilute remedies to, in essence, nonexistence. For example, a typical 30C dilution (where C=100) means thirty 100-fold dilutions, which, if you do the math, you'll find to be a 10-60 dilution. Avogadro's number is only on the order of 6 x 1023, which means that a 30C dilution is at least 1036-fold higher than a dilution where we'd expect to see a single molecule of the original substance; that is, if you start with what chemists call a mole of starting compound. No wonder homeopathy is considered the king of pseudoscience, and that's not even considering that some homeopathic remedies (like Oscillococcinum, the infamous homeopathic flu remedy) use starting ingredients like extract of duck liver and heart—and at 200C (10-400), yet!

So it's been with a great deal of interest that I and other skeptics followed the developments in homeopathy last year, which have now been recapped in an article in the New England Journal of Medicine. Actually, the developments weren't so much in homeopathy, which basically never changes, other than sometimes in the extravagant imagination of homeopaths trying to justify their quackery with everything from quantum mechanics to "nanoparticles." Rather, the developments concerned the regulation of homeopathy in the US. Basically, the FDA announced that it would hold hearings on revamping its regulation of homeopathy, which were held in April. Then, in September, the Federal Trade Commission (FTC) held a workshop to consider its regulation of advertising homeopathic products. For the first time in a very long time, it looks as though there might be real change in the way homeopathy is regulated in this country.

It's really good to see the NEJM publish an article, Regulating Homeopathic Products — A Century of Dilute Interest by Scott H. Podolsky, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H., on the potential for real regulatory reform when it comes to homeopathy. (The only thing that made me sad about the article is that I should have thought of pitching an article on this topic to the NEJM first!) It's a clear description of how we've gotten where we are with respect to homeopathy.

Noting that there have been over a century of missed opportunities to regulate homeopathy, Podolsky and Kesselheim provide a little historical lesson:

Founded by Samuel Hahnemann in Germany around the turn of the 19th century and introduced into the United States shortly thereafter, homeopathy was predicated on such notions as “like cures like” and the “law of infinitesimals,” whereby extraordinarily diluted products that in their original form might have caused symptoms resembling those of the illness in question are administered to patients in a highly individualized fashion.

In the competitive U.S. medical marketplace of the 1830s and 1840s, orthodox physicians took notice and drew attention to the biologic implausibility of homeopathic remedies. The most caustic critique was voiced by Oliver Wendell Holmes, who declared homeopathy a “mingled mass of perverse ingenuity, of tinsel erudition, or imbecile credulity, and of artful misrepresentation,” while noting the potential therapeutic effect on patients of “the strong impression made upon their minds by this novel and marvelous method of treatment.” But Holmes similarly criticized the orthodox “heroic” medicine of his day (which was grounded in bleeding and emetics), and homeopathy continued to attract adherents, including some conventional physicians.

People often ask me: How could homeopathy have ever caught on, even in the 1800s? The reasons are simple. First, Hahnemann thought it up before Avogadro's number had been deduced. Second, "conventional" medicine of the time was so poor, rife with bleedings, purges, the use of heavy metals like mercury and cadmium, and a lot of treatments that likely did more harm than good in many cases. Given that homeopathy, at its core, is nothing more than either water or ethanol (depending on what was used as the diluent) or sugar pills (homeopaths often put their remedies into sugar pills and dry them out), it's the equivalent of doing nothing. In the world of 1800s medicine, not infrequently doing nothing with homeopathy and letting a disease run its course, produced better results than "conventional" medicine. As medicine advanced and became more scientific, particularly from the late 1800s on, that changed. Medicine became more and more effective, while homeopathy remained water. Yet for some reason it persisted.

The first missed opportunity to regulate homeopathy was, of course, the Pure Food and Drug Act of 1906. This regulation largely didn't happen:

The Pure Food and Drug Act of 1906, which had endowed the agency with its initial regulatory power and mandated that drug products actually contain the ingredients on their labels, governed drugs recognized in the U.S. Pharmacopeia and the National Formulary, as well as any product intended to cure, mitigate, or prevent disease. This scope would clearly have covered homeopathic remedies, which were largely administered by clinicians at the time, but regulators had been focused on stemming the tide of truly dangerous quack products containing cocaine, heroin, and chloroform, among other harmful substances.

The next missed opportunity came in 1938, when in the wake of the 1937 elixir sulfanilamide tragedy resulted in at least 100 deaths due to the use of diethylene glycol as a solvent for the medicine, the 1938 Food, Drug, and Cosmetic Act was passed. The act mandated pre-market review of the safety of all new drugs, banned false therapeutic claims, and authorized factory inspections. What it did not do is to regulate homeopathy in any meaningful way:

The next major piece of legislation that could have restricted homeopathic products was the 1938 Food, Drug, and Cosmetic Act. That law, however, focused on the safety, rather than efficacy, of new drugs, and remedies listed in the Homeopathic Pharmacopeia were considered to have met the new quality standards. The inclusion in the Act of a reference to the Homeopathic Pharmacopoeia appears to have resulted not only from the efforts of Senator Royal Copeland (D-NY), a homeopathic practitioner and sponsor of the bill, to differentiate homeopathy from quackery, but also from the belief among such prominent leaders of academic medicine as Morris Fishbein (editor of JAMA) that the distinctions between conventional medicine and homeopathy would continue to dissolve in the crucible of scientific investigation.

The Homeopathic Pharmacopeia still determines what homeopathic products can and can't be sold in the US today. In essence, homeopathic remedies are not regulated in any meaningful way in the US.

The last missed opportunity was over 50 years ago, when in the wake of the thalidomide tragedy, Congress passed the 1962 Kefauver–Harris Amendments, which I've discussed on multiple occasions. The big difference that these amendments made is that for the first time they mandated that the FDA not only perform pre-market assessment of new drugs and medical devices for safety but that it also assess them for efficacy. Yet somehow homeopathic products fell through the cracks again:

When the 1962 Kefauver–Harris Amendments mandated that the efficacy of conventional drugs be proven through “well-controlled investigations,” homeopathic remedies remained under the regulatory radar, protected by the amendments’ failure to change the status of products in the Homeopathic Pharmacopeia. Moreover, both the subsequent Drug Efficacy Study Implementation (DESI) process, by which all drugs approved between 1938 and 1962 were retrospectively evaluated, and the FDA’s review of over-the-counter remedies, excluded homeopathic products, in the latter case with the intention that they would be reviewed “at a later time” (they weren’t).

Same as it ever was—and is. At least, I hope, same as it ever was and is until now. Noting drolly that unlike dietary supplements "homeopathic products can actually be substantially regulated by the FDA, since the Food, Drug, and Cosmetic Act allows them to be sold as 'therapeutic,'" Podolsky and Kesselheim note that perhaps now is the time that the end of homeopathic remedies' century-long evasion of regulatory scrutiny is at an end. I certainly hope so, but practical and political considerations might limit what can be done:

We believe that, at minimum, regulators should reconsider the way homeopathic drugs are marketed, so that consumers who are seeking conventional medicines at pharmacies don’t become confused. In August, the FTC submitted comments to the FDA recommending that the agencies better harmonize their approaches to regulating homeopathic products and their advertising. Reconsidering the over-the-counter sale of homeopathic remedies entirely would be an even more drastic step and would require the FDA to take on the entire industry for propagating remedies that don’t meet the same standards of scientific proof applied to conventional medicines.

This is exactly what the FDA should do, but I have little faith that it will. Homeopathy is pure quackery, one of the purest quackeries that exist. It is water. (Really, how many times does this need to be said?) The history of its regulation in the US has been a sordid one. Particularly disappointing is how for nearly 80 years the FDA has been hamstrung from applying the same sort of regulatory framework to homeopathy as it does to any other drugs. One could understand how, even if Sen. Copeland hadn't sabotaged the 1938 revision of the Pure Food and Drug Act, that law only mandated that the FDA review safety. Since most homeopathic remedies are, in essence, water, most of them would have had no problem meeting that standard.

However, after 1962, there is less of an excuse. Even despite Copeland's sabotage of the FDA's regulatory authority through carving out an exception for homeopathic remedies, there is no reason the FDA couldn't have regulated homeopathic remedies based on the Kefauver–Harris Amendments, given that homeopathic remedies make therapeutic claims. Yet for 50 years the FDA did nothing or, at best, very little. That's why, even as I hope that this time the FDA and FTC are finally going to do something to substantively regulate homeopathic remedies, even if only to require manufacturers to let consumers know that remedies more dilute than 12C almost certainly have nothing in them, I can't help but counter my hopefulness with my knowledge of history.

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Rhetorically - no.

Homeopathy isn't science, biochemistry or medicine, it is a faith (or economics). Non-maleficence and beneficence are not the same thing.

I do find it interesting that one of the few truely immiscible subjects are medicine and economics.

It wasn't just Avagadro's number Hahneman didn't know, atomic theory as a whole, genes, proteins, molecules in general, hormones, germ theory, cell theory (though cells were known) the causes of virtually all diseases and probably the function of many of the major organs were all unknown.

By G. Shelley (not verified) on 21 Jan 2016 #permalink

Well yes, homeopathy is consistent with what was then known about medical science. Likewise, phlogiston and luminiferous aether were consistent with what was known of science at the time they were proposed. Subsequent scientific discoveries have falsified all three of these theories. This is why phlogiston and luminiferous aether are only seriously discussed in the context of history of science, and have been otherwise completely absent from chemistry and physics classes for the last hundred years or more. Homeopathy ought to have suffered a similar fate, but its practice, unlike its scientific basis, is alive and well.

By Eric Lund (not verified) on 21 Jan 2016 #permalink

I now openly slag homeopathy when brought up by parents in clinic--typically for "cold remedies" for infants and "teething tablets". Parents will ask why this stuff is sold next to real medicine. It's so frustrating to tell them it's sold because it's allowed and profitable--even though it doesn't do a thing for the patient.

By Chris Hickie (not verified) on 21 Jan 2016 #permalink

I picked up a prescription at a pharmacy (one run by a large HMO, not a commercial chain) and noticed a well known homeopathic cold remedy (the duck liver stuff which I can’t spell off the top of my head) prominently displayed. I took it to the counter and asked the person (a pharmacy technician, not just an innocent cashier) if she knew what this was. I received only a blank stare. I then asked the pharmacist who had approached at that time. No response there either. When I tried to briefly explain, I was met with pained expressions of, “why are you doing this to us?”.

Both of these people are educated and should be aware of homeopathy and even more aware of what is on the shelves of their workplace.

Much work remains.

By darwinslapdog (not verified) on 21 Jan 2016 #permalink

Here's to Oliver Wendell Holmes and his wonderful powers of expression.

Happy the days when you could express yourself robustly like that without being arraigned for hate speech.

By Peter Dugdale (not verified) on 21 Jan 2016 #permalink

A local chain grocery store's pharmacy video screen has a slide asking patients to check with the pharmacist to make sure their prescription medication won't interact with their homeopathic meds. My hope is at least some of the pharmacists would say "None of your prescription medication gives a damn about homeopathy".

By Chris Hickie (not verified) on 21 Jan 2016 #permalink

it’s allowed and profitable

The latter is reason in the current political environment to be pessimistic about anything actually happening. In addition to the usual alt-med suspects screaming about interference with their Medical Freedumb(TM), you'll get the usual libertarian economist suspects screaming about regulation preventing Job Creators(TM) from creating jobs. I don't know if Samuel Hahnemann and Ayn Rand would have hit it off in real life, but their disciples certainly seem to do so.

By Eric Lund (not verified) on 21 Jan 2016 #permalink

My DIL recently lamented that she couldn't find any cough medicine for he sick kids. She was opting for some homeopathic (non)remedy that was on the shelf at the local pharmacy. She is intelligent enough to have gotten a masters in social work but when I tried to explain the worthless nature of the remedy she bought, including the math, she kept saying I want to give them something.
.
Could not make any headway on dissuading from using or buying homeopathic crap.

@Chris Hickie #7

Maybe not but I hope customers ask. Some of the homeopathic solutions contain alcohol in quantities that should be checked for that alone.

By Not a Troll (not verified) on 21 Jan 2016 #permalink

Let's hope the FDA does something. In Canada it is not too difficult to get a 'natural' drug registered http://www.cbc.ca/news/health/health-canada-licensing-of-natural-remedi…

Note that the evidence used as to efficacy seems to have been homeopathic :

To get a licence, Marketplace submitted an application in May, 2014, to Health Canada, and included photocopied pages from A Dictionary of Practical Materia Medica by Dr. John Henry Clarke, a 1902 homeopathic reference book of ingredients, as evidence for its effectiveness.

By jrkrideau (not verified) on 21 Jan 2016 #permalink

#9 MikeMa
Hot water and honey: Just stick a decent label on it. Or perhaps Indian chai? Again label and instructions to microwave before giving it to children?

By jrkrideau (not verified) on 21 Jan 2016 #permalink

@jrkrideau (#12): ah, the good old days. I remember well when my brother (born in the late 1950s) had walking pneumonia, and our grandfather, a no-nonsense guy from the old school, prescribed Brown's Mixture (tincture of opium) for his cough and whiskey, lemon, honey and hot water to help him feel better. Those, along with mandated bedrest (we were never allowed out of bed until 24 hours after a fever broke) and APC tablets, were our normal medications.

Yes, he strongly believed in vaccines. Antibiotics were for bacterial illnesses only, and you had to be plenty sick before he'd give them to you.

A cold? Bah. Go to bed, lots of fluid and rest.

Because of the "rest" decree - which meant no TV or other amusements - we never played sick in order to stay home from school. Why stay home and be bored? OTOH, if you were really sick, amusements were allowed. Smart man, my grandfather.

Meant to add: nowadays, Grandfather (and my parents, for allowing it!) would be up on charges of child abuse for allowing my tween brother to have alcohol...

@ MI Dawn:

In the mid-1980s, I was a graduate student and on New Year's I became really ill with bronchitis- an old school doctor gave me codeine(!!!!!) which made me incredibly high but nauseous so I couldn't take continue ( unfortunately)-
I was then given something that looked like a vitamin capsule but remained miserable.
The second doctor gave me antibiotics. Guess what? I recovered quickly.

By Denice Walter (not verified) on 21 Jan 2016 #permalink

Opiates generally are effective for things like pain and cough. That's why, in any film with a WWII setting and a need to break out the first aid kit, you will find morphine[1] in the kit. The problem with opiates is the high risk of addiction. That's why they are controlled substances.

[1]The exception is Catch-22, in which during one of the flashback scenes Yossarian opens the first aid kit to find shares of Milo's syndicate where the morphine should have been. Of course morphine would have been valuable on the black market.

By Eric Lund (not verified) on 21 Jan 2016 #permalink

As a pediatrician I often have parents come in with a bottle of homeopathic cold medicine in hand and when I ask them why they bought it they say it is because it was on the shelf next to "other" cold medicines and says it is safe for kids and the "other" cough medicine says don't use for kids under 5 without consulting a physician.

So, the medical community finally recognize that cough medicines are generally ineffective and hold some risk for children and appropriately begin to discourage their use and the result is that homeopathic cold medicines are mixed in on the shelf with traditional cold medicines and their use skyrockets. The Law of Unintended Consequences strikes again ...

By D. Chapman (not verified) on 21 Jan 2016 #permalink

@Not a Troll

Some of the homeopathic solutions contain alcohol in quantities that should be checked for that alone.

That is a good point. Orally ingested homeopathic remedies are currently exempt from limitations and labeling requirements on the amount of alcohol in the product, whereas real medicine cannot contain more than a specific amount (a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?f…">21 CFR 328.10) and must have a warning if more than 5% or 0.5%, depending on age (21 CFR 328.50).

@ Todd W. and Not a Troll, there is also the problem of homeopathic remedies containing wildly variable amounts of active ingredients, e.g. Hyland's Teething Tablets with Belladonna. And since homeopathy isn't regulated per se, they can contain contaminants such as actual prescription medications.

By Science Mom (not verified) on 21 Jan 2016 #permalink

@Science Mom

Indeed. I wrote about the recall of Hyland's Teething Tablets. It doesn't help that labeling of homeopathic products is not in any measurement standard used by anyone outside of homeopathy (e.g., grams, mg, etc.).

Homeopathy makes me crazy! I've often asked pharmacy staff if they know what homeopathy really is... Most of the time I get a sheepish look and a response something like "People ask for it" - Appeal to popularity logical fallacy, of course. I object to the the very prevalent practice of pharmacy chains stocking homeopathic preparations on the same shelf next to real OTC meds. I think regs should mandate a disclaimer prominently displayed as to the nature of homeopathic items and they should all be stocked grouped together separate from legitimate meds.

@jrkrideau
I seem to recall the hot water and honey from my childhood now that you mention it. No recollection of effectiveness but it cannot possibly be worse than the homeopathic crud.

@MI Dawn
I remember APC tablets also. My mom had a HUGE plastic tub filled with them in the linen closet.

@D. Chapman
I too am disgusted by the intermixing of real medicine with the homeopathic waste at most modern pharmacies.

Since 2012, here in the Netherlands, OTC homeopathic 'remedies' cannot be sold with any indication, unless the efficacy for treating a particular condition has been proven in a scientific manner. This has had two results:
- Homeopathic con art... erm, companies such as Boiron and Vogel expressed their 'concern' about 'consumer choice and education' (read: their bottom line); quite a few homeopaths went rather further in their criticism (to put it mildly), and
- Sales of OTC homeopathic 'remedies' dropped by 40% in the subsequent two years. (Hooray!)

And to this date, not a single homeopathic manufacturer has produced evidence of efficacy of even one 'remedy' for even one condition. Even their original indignation has subsided into nothing more than a background rumble and some lamentations on their respective Web sites. And, of course, they now rely on other, somewhat less direct methods of getting their indications across, e.g. through patients' forums and social media.

Now I really hope they're waiting for the second shoe to drop: the fact that they blatantly violate consumer law by putting 'active ingredients' on their label that are most definitely not present in their 'remedies'. And yes, work is being done to address this issue as well.

Perhaps an example for you guys (and gals, of course) across the pond

jkrideau left out a key ingredient -- it's hot water, honey, and a squirt of fresh lemon juice.

Without the fresh lemon juice, the treatment is worthless. It's the vitamin C, dontcherknow.

By shay simmons (not verified) on 21 Jan 2016 #permalink

I still propose what I believe to be a fair working compromise: require the FDA to continue to recognize preparations in the HPUS as drugs but hold producers of homeopathic treatments to the same manufacturing standards for release and sale of their products as are all other non-homeopathic drug manufacturers.

Citing the Hyland belladonna incident, the FDA should insist makers of homeopathic products conduct quality control testing on random samples of each ‘drug’ lot before its released for sale, demonstrating that the active ingredient is present at the desired final concentration.

What’s that you say? It’s impossible to detect the presence of the starting materials diluted far in excess Avogadro’s number in your final product? That’s one hell of a sensitivity issue with your assays–come back to us when you’ve solved it and we can talk about approving lots for release.

It would of course be absolutely mandatory that the QC assays include all appropriate controls as well to avoid false positives and negatives–for example, an assay would need proven capable of reliably distinguishing between a final drug product and matched vehicle controls containing everything but the active ingredient, as well as distinguish one final product and another (for example, tell a 100C preparation of aconite from a 100C preparation of Pulsatilla).

Honey has been proven at least moderately effective for cough in children. I remember reading about a study. They do sell some honey cough syrups for children but sometimes it is hard to find them. They also had honey lollipops that boy child liked when he had a cough. Probably because they were sweet. Of course the honey is not appropriate for an infant due to risk of botulism, but for a toddler it would be useful. I really think it is more because parents want to do something (read that as anything and I do mean anything) that might make a fussy, crying, whining, won't sleep child calm for even five minutes. A cold in an infant or toddler is a terrifying and grueling experience particularly for new parents.

Another problem (that also occurs with "natural products and supplements"), is the actual content of the pill/liquid. Without no oversight, you never what's in there. Homeopathic remedies are just water or sugar....in theory. My mom once gave me some homeopathic drops for a cold: I de-congested instantly (and my sister did too...somehow, subsequent colds were not responsive, so the placebo effect is null as I was expecting results the subsequent times). What was in that first lot? I recall an old (around 2003) study on isoflavone pills (as supplement...in a biochemistry class in a pharmacology undergrad program, we had to present papers on natural supplements....probably their way of showing us the ludicrouness of it all). That lab took 25 different brands of isoflavones, measured their isoflavone content and compared to what was on the label. Only 5 had the same amount as the label. Most were way under the label, or even non-detectable.

So @7 Chris Hickie
There might be an actual interaction, if the homeopathic product is laced with something...Nobody knows for sure until someone reports an effect...

Back in the '80s I treated HIV/AIDS patients.When they needed an expectorant I often fell back on potassium iodide but the only one that the Medicaid pharmacy would allow was terpin hydrate. For you lucky Orac-Minions young enough never to have encountered it, it was a nasty liquid in which the awful oil of turpentine taste was poorly disguised by a harsh orange peel flavoring. It was also about 25 proof - it was like a bad Grand Marnier knockoff. I called at least once a week to explain that it was a highly inappropriate medication for patients with either esophageal ulcers or a substance abuse history. They didn't seem to care, "That's it, take it or leave it".
I got a little vindication later; the FDA looked into meds that had been grandfathered in - the old reliables, their effectiveness had always been taken on faith. As I suspected they would, they took that devil's piss off the market, but too late to help my former patients.

By Old Rockin' Dave (not verified) on 21 Jan 2016 #permalink

Maybe, if the FDA wusses out again, the FTC can do something. I'd like to see all homeopathic stuff be prominently labeled "HOMEOPATHIC", in 2 in letters. Like they do with the health warnings on cigarettes in Australia.

I remember my parents calling our pediatrician about what to give my younger brother for a cough, and then making up a lemon juice-honey mixture. Way better tasting than any cough syrup they stuffed in my face!

By JustaTech (not verified) on 21 Jan 2016 #permalink

@shay:

hot water, honey, and a squirt of fresh lemon juice

Around here they call that lemonade.

By justthestats (not verified) on 21 Jan 2016 #permalink

Over at Orac's not-so-secret other blog, one of his cobloggers did a piece on cough remedies for children.

If the child is at least 18 months old, give them a spoonful of honey. And yes, specifically honey: someone did an RCT of honey versus other syrup, and the honey worked better.

Unfortunately, nobody seems to have tested this in adults, but I sometimes use it on myself anyway, on the theory that it won't do me any harm.

ORD@#28: I also treated HIV back in the 80's - but in Oz, where we had a civilised health care system and pharmaceutical benefits scheme. Turpin hydrate was one of those things we read about in Ellroy novels - we never had to use it. If I recall, the alcohol content made turpin hydrate a prohibition-era magnet for alcoholics - hence the term "on the terps". In Oz (which never had much truck with prohibition until it joined the US "War on Drugs" lurk) the equivalent was vanilla essence, which was essentially 50-80% ethanol. Army & Shearer's cooks were notorious for ordering litres of the stuff, then selling it on.

@Vicki,
I will see if I can convince my DIL to stop wasting money and try something that works. I can even look up the link!

rhwombat, I didn't know about the Prohibition uses, but it had to have been that way. We also know about the vanilla extract here. It's favorite of kids too young to drink legally and have no one to buy booze for them. The peppermint and almond extracts I have in my kitchen are pretty strong too. There also used to be a mouthwash that was about 60 proof (The name escapes me.). It made for some almost-got-sent-home events at summer camp one year.
By the way, I'm trying to figure out your handle. Are you right-handed, or do you have an extremely rare blood type?

By Old Rockin' Dave (not verified) on 22 Jan 2016 #permalink

@MikeMa #33: Other than plain honey, black elderberry syrup is an old European remedy for coughs in children and adults. Evidence that it works for cough in children is still limited to a small clinical study in adults and children, the majority of whom were diagnosed with type B influenza. The number of children was too small to derive any indication of efficacy versus placebo. The placebo group received a syrup containing honey and glucose while the verum group received a syrup formulated with the same ingredients plus an extract of the berries. Since the study was conducted in the early 1990s, the old remedy has yet to be tested in clinical trials in children. Regardless of the absence of scientific evidence of safety and efficacy in children, elderberry syrups are promoted and sold for use in children in the treatment of colds.

By Lighthorse (not verified) on 22 Jan 2016 #permalink

There also used to be a mouthwash that was about 60 proof (The name escapes me.).

The "blue" Listerine that I have is 43 proof. There was a radio documentary I heard some years back about rural U.S. wet houses (I can't find it offhand; it's not one of the ready G—le hits) in which it was mentioned that some of the residents prefer mouthwash over other choices even when money is not an obstacle.

The "Frontline " episode on PBS recently about supplements was pretty informative except for not mentioning ever the one quackery to rule them all. Glaring omission.

By Mike Callahan (not verified) on 22 Jan 2016 #permalink

I am not a doctor, but I'd be a careful about administering honey to young children because of the possible choking hazard. Give it in small amounts at a time.

Peanut butter is especially notorious for this -- NEVER try to eat a spoonful of peanut butter.

In other life-saving advice, NEVER get out of a car on a road after an accident, until you are CERTAIN it is safe. I've known several people who have been killed this way.

By palindrom (not verified) on 22 Jan 2016 #permalink

ORD@#34: I am right-handed and Rhesus negative, but the handle is merely my initials suffixed by my favourite cubic-droppinged marsupial. Wombats are remarkably dextrous for small tanks.

@Mike Callahan #37. That would be due to the fact that homeopathic preparations are not classified or regulated as dietary supplements.

By Lighthorse (not verified) on 22 Jan 2016 #permalink

"... be a careful about administering honey to young children ..."

Honey that hasn't been essentially sterilized frequently harbors viable Clostridium botulinum. In older kids and adults, this normally isn't a problem because it doesn't multiply in the gut and there isn't enough toxin in the honey to be a problem. With infants, it can cause an "infection" and produce enough toxin to be a serious risk.

I once saw a mouse trying to cope with peanut butter that had apparently stuck to the roof of its mouth. I felt sorry for the little critter, but it was kind of funny (and the mouse was OK; the event only lasted two or three seconds).

[Homeopathy] is water. (Really, how many times does this need to be said?)

How many times does it need to said that 'homeopathic products' sold OTC are NOT water, i.e. not based on the Laws of Similars and Infinitesimals. As Science Mom #19 notes, lots of these things have labeled active ingredients, and many actually contain various crap that's not supposed to be in there. This last, IIRC, is what the Feds are on about.

How many times does it need to said that people don't know what 'homeopathic' means, because in practice it's just a marketing buzzword for Big OTC. Wikipedia says a 1997 survey found that less than 17% of respondents who said they used homeopathic remedies had seen a homeopathy practitioner in the previous year. There are about 10 times as many chain pharmacy outlets in the US with 'homeopathic' OTC on the shelves than there are homepaths, and doubtless many, many times more customers.

What CVS/Walgreens/Walmart sell and what homeopaths do are very different beasts. Talking about them as if they're one unified thing isn't helping anything or anybody. Especially when the focus keeps going back to the relatively trivial number of hosers dispensing mystified H2O. Which is hardly a comparable heath concern to ubiquitous big box stores having totally unregulated pills containing belladonna and/or who-knows-what prominently displayed on their shelves.

sadmar: Spare me. No, seriously, spare me.

We know all of this in far more detail than you do or likely ever will. We were discussing these very things since long before you ever discovered this blog or my not-so-super-secret other blog. I've pointed out more times than I can remember that the public doesn't know what homeopathic products are, thinking that they are just herbal remedies.

Yes, adulteration was one concern of the FDA's, but if you actually read the transcripts of the FDA and FTC hearings, you'd find that one of the largest parts of discussion was whether homeopathic remedies should be required to prove efficacy or not in light of the laws of homeopathy and how technically most homeopathic remedies, if prepared according to the principles of homeopathy, can't contain active ingredient. In light of that the FTC was unhappy with claims of efficacy with no evidence. As for adulteration, in actuality, the FDA already has the power to ban adulterated products, yes, even supplements. The DSHEA of 1994 doesn't take that power away for supplements. Rather, it requires the FDA to treat supplements as "food" not medicine for purposes of regulating purity and making sure that the supplement contains what the label says it does.

As for the water thing, seriously, you of all people should understand why I repeat the principles of homeopathy every time I write anything about it, even at the risk of being repetitive. It's for that very reason: I know that most people don't know what homeopathy is! So I make sure that any newbie who stumbles across a post by me about homeopathy is informed what the true principles of homeopathy are, why the vast majority of homeopathic remedies, if constituted according to the principles of homeopathy, are water, and why homeopathic remedies beyond 12C are incredibly unlikely to contain detectable remedy. It's intentional. It's so that any reader who ever comes across a homeopathy post on this blog doesn't have to click a link to find an explanation of why homeopathy is pseudoscience.

As for "big homeo," like Boiron, basically these companies have actually mechanized the production of homeopathic dilutions and actually do prepare their quack wares according to the law of infinitesimals, if not following the "personalization" aspect of classical homeopathy. It tends to be the smaller companies that adulterate their remedies with potential active ingredient.

Whenever I'm in CVS I make a point of asking the pharmacists how they feel working in a store that sells homeopathic products. Most say they have nothing to do with the decision to carry them, or nothing at all. A few have said it was embarrassing and they would take them off the shelves if they could.

By Old Rockin' Dave (not verified) on 23 Jan 2016 #permalink

As left brained as I am, an aptitude for numbers, worked in the financial industry for 20 years, skeptical as can be, Homeopathy worked on and still works on my 4 children. Stunned so much so that I undertook a formal education, passed the national certification exam and opened a practice. Still skeptic but it's helped a Grave's disease woman's level normal so that her dr had her come off her medication. Couple kids off their asthma and allergy medications. Another child no longer has facial tics. Another child is no longer a disruption in school and is no longer agoraphobic. A few Lyme cases no longer have residual effects. A couple "cured" pneumonia cases with months later chronic coughs gone. I continue to see people helped by it. Say what you want, think what you want. Homeopathy works. God Forbid you open your minds and try it. "Don't knock 'til you've tried it"

Couple kids off their asthma and allergy medications.

Beg pardon?

^ And...

A couple “cured” pneumonia cases with months later chronic coughs gone.

I do appreciate the use of quotes around cured here, though. It is far too often that defenders of homeopathy (Roslyn Ross springs to mind) utterly "forget" Organon Aphorism 7, which makes clear that homeopathy – by design – addresses nothing but symptoms (footnotes omitted):

"Now, as in a disease, from which no manifest exciting or maintaining cause (causa occasionalis) has to be removed, we can perceive nothing but the morbid symptoms, it must (regard being had to the possibility of a miasm, and attention paid to the accessory circumstances, § 5) be the symptoms alone by which the disease demands and points to the remedy suited to relieve it – and, moreover, the totality of these its symptoms, of this outwardly reflected picture of the internal essence of the disease, that is, of the affection of the vital force, must be the principal, or the sole means, whereby the disease can make known what remedy it requires – the only thing that can determine the choice of the most appropriate remedy – and thus, in a word, the totality of the symptoms must be the principal, indeed the only thing the physician has to take note of in every case of disease and to remove by means of his art, in order that it shall be cured[*] and transformed into health.

[*] Oops.

jibjab@#45:
Time works. Homeopathy is just the excuse you use to charge for filling in time with a placebo effect.

A few Lyme cases no longer have residual effects.

Dare I ask about the source of the Lyme-Disease diagnosis?

By herr doktor bimler (not verified) on 23 Jan 2016 #permalink

Orac:

You are not spared. So you're explaining Hahnemannian dilution again for the noobs, but it's supposed to be OK that you don't tell them that's NOT what's in most of the boxes labeled "homeopathic" on the shelf at Walgreens, because you wrote about that at some time in the past? Talk about low-hanging fruit...

Go to the damn store, see what's on the shelf labeled 'homeopathic', see what people buy, find out what most of them think the word means... and that's WHAT IT MEANS. Semiotics is a meaning market, the market has spoken, and good luck trying to tell the makers and users of Cold-Eeze and Zicam that zinc lozenges aren't 'homeopathic' or that homeopathy is just water.

Look, you I and Steve Salzberg know that the makers of Cold-Eeze, Zicam and a bunch of other stuff are using the homeopathic label (first word on the Cold-Eeze web page as crawled by Google) to try to dodge FDA regulation, but apparently zinc gluconate in the measure Salzberg describes as "quite a lot of [zinc]" IS in the HPUS. When the FDA tried to rein in Zicam in '09, their position was they could regulate any drug, 'homeopathic' or not, that posed a safety risk to the public, and they only demanded action on the Zicam nasal swabs, which had been associated with ansonia (loss of smell), not the lozenges. And what did the FDA get? Nada. Zicam still sells the swabs, still has zinc in 'em, still calls 'em homeopathic.

But hey, it's just water! No worries! So never mind me thinking the noobs might want to know about that what are probably the biggest selling 'homeopathic' cold remedies contain "quite a lot of zinc" and that if they put that crap up their nose they could lose their sense of smell.

the vast majority of homeopathic remedies, if constituted according to the principles of homeopathy, are water, and why homeopathic remedies beyond 12C are incredibly unlikely to contain detectable remedy.

OK, you didn't mean 'remedy' you meant detectable anything. But your counting species, when you ought to be counting populations. Do the vast majority of purchases of 'homeopathic' products involve J. Q. Public taking home a dilution beyond 12C, or stuff like 'zincum gluconium 2X'?

No, doc, you spare me. And try to avoid blatant self-contradiction the next time you presume to lecture me on how much you know, and what value that supposedly has, when you don't put that knowledge in the damn posts, and frame the knowledge you do drop in a way that's going to confuse the (bleep) out of some poor J. Q. consumer who knows less science than you do and wanders in here wondering what the (bleep) is in all those boxes down in the cold and flu aisle at the CVS...

[sadmar exits, still babbling uncontrollably... did you know that JP has a bump under her nose?}

@sadmar:

First, what makes you think I haven't looked at the sort of stuff on the shelves of Walgreen's, CVS, etc.? Again, I was doing this sort of stuff probably long before it ever caught your attention.

Second, I note that you appear not to actually know what happened at the FTC and FDA hearings on regulating homeopathy, as you completely ignored that point. Again, adulteration was a concern, but far more time was spent on efficacy given what homeopathy is.

As for which homeopathic remedies sell the most, that's harder information to get. Certainly, you've provided no more than anecdotal evidence to support your contention about "2X" remedies, while criticizing me for not backing up my statements. (Irony abounds, as always, when sadmar wanders into fields in which he's not an expert, just as he accuses me when I do so.) One of the most popular homeopathic remedies, if not the most popular I'm aware of, Oscillococcinum for Flu is manufactured by Boron. It's sold in more than 50 countries and can be found on the shelves of every major chain drugstore in the US. Guess what its potency is?

200C!

Yes, it's a 200C preparation of Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy duck liver and heart). Oh, there's sucrose and lactose in the pill as binders as well. Other than the lack of individualization, it's as pure homeopathy as you can imagine.

Oh, and Boiron also sells Arnica montana 30C, Nux Vomica 30C Pellets, etc. I would also point out that even a 6C homeopathic dilution is 10-12. If you start with a mole of substance (whatever remedy we're talking about), you'll be left with a picomolar concentration in your remedy. Take the amount of the in a pill (likely 1 ml or less), and you're talking about a femtomole (10-15 mole) of material. Dilute that in the 42 L of water (or even just the 5 L blood volume) of the prototypical 70 kg man, and you're well into concentration ranges that have no effect for the vast majority of people. Such remedies are, practically speaking, indistinguishable from water.

sadmar,

Do the vast majority of purchases of ‘homeopathic’ products involve J. Q. Public taking home a dilution beyond 12C, or stuff like ‘zincum gluconium 2X’?

I have never shopped at WalMart, but it does look to me as if the vast majority of the homeopathic medicines on offer at WalMart are prepared using Hahnemannian dilutions beyond 12C, though whether the majority sold are is another matter. I agree that "homeopathic" is being used as a buzz word to sell some non-homeopathic products, but the amount of zinc in Cold-Eze lozenges (not nasal swabs or sprays) is 13.3 mg, less than you would find in a steak or a bowl of breakfast cereal, and anosmia is only (as far as I am aware) caused by zinc if it is topically applied to the olfactory paraphenalia it is not going to cause anosmia (not "ansonia"), even in the unlikely event of someone managing to squeeze a lozenge up their nose. However, since zinc doesn't affect the duration of colds except in doses exceeding 75 mg (PMID 21769305), one might, more or less accurately, characterize a dose of 13.3 mg as homeopathic, if homeopathic is taken to mean a dose far too low to do any good.

By Krebiozen (not verified) on 24 Jan 2016 #permalink

Kreb:

Big web retailers will sell anything on their sites. They all have 'marketplace' arrangements with other vendors, wherein they don't have to actually buy inventory and stock the products in their warehouses, but just take a cut on orders placed through them, which are then shipped to the customer directly from the 'marketplace' seller.

What really counts for Walmart, then, is only the tiny portion of that very long list you linked that they stock in store, give prominent shelf space, promote in ads with 'on sale' pricing, etc. Shelf space is a big deal in retail. Soft drink makers pay big bucks to chains to have 'X' amount of space devoted to their products, and prime placement at the ends of aisles, with certain items at eye level. OTC producers may or may not be paying for prime display, but the principle remains that shelf position and area correlate with sales volume.

I'm going to check my local CVS, Walgreens, and Target this weekend, and see what they stock, where, how much, etc. Maybe I'll find water-memory homeopathic stuff more in evidence than I recall from prior casual trips through the remedies aisles. (Yes, I know some stores do stock Oscillococcinum, and that it's 200C duck organs.)

I was just quoting Steve Salzberg on there being "quite a lot" of zinc in Zicam. If that's not worth discussing in comparison to a bowl of Product 19, you can quarrel with Salzberg for being alarmist over a 'nothing'.

I mean, the point (yes?) is that false promises are being made about products that mainly don't do anything, with a few in there that might even do some bad in some (albeit rare) circumstances. I don't see how the dose of stuff-that-doesn't-work-beyond-placebo-anyway matters. It just clouds what DOES matter to attack the whole spectrum of 'homeopathic products' on the basis of dilution, when so many of the boxes people take home with 'homeopathic' on the label have stuff in them, 'active' or not. (Alcohol is not water.*)

See, here you are, backtracking and shifting the goalposts by comparing zinc-based cold remedies with a breakfast cereal that has zinc ADDED as an essential nutrient carrying an RDA. 13.3 mg of zinc may be "a dose far too low to do any good" for colds, but (according to NIH) it's enough to ward off trouble seeing in the dark, loss of hair, frequent infections, skin sores, and (ahem) "hypogonadism in males". So I'll assume you had your RDA of zinc (11 mg) when you had the cojones to write that 13.3 mg is "a dose far too low to do any good", period. ;-)

Shouldn't a science advocate survey the actual phenomenon at hand (consumption of products labeled 'homeopathic') and describe it as accurately as possible? Why not just say 'Popular homeopathic products mostly contain stuff that has no effect whatsoever as the promised remedy, and some of them are nothing but water that has gone through a ridiculous psuedo-scientific ritual of infinitesimal dilution of stuff that would have no effect whatsoever as the promised remedy, even it was still actually present, which it's not.'?

I don't get the agita. Is it just because 'sadmar' brought up the point in a 'sadmarian' way? 'sadmar' is, after all, just another 'nothing'' spitting trace atoms of text into the vast cosmos of Web-wordage. Unless there's some good reason NOT to frame 'homeopathic remedies' as I've suggested, perhaps the point is worth considering on merit, sans the butt-hurt rejoinders.
_______
* So, if you added some infinitesimal thing listed in the HPUS to booze up to (what potency?), you could sell the relabeled hooch 24/7 at any store, circumventing all liquor laws? Maybe I should try to get an ® for 'All-natural homeopathic Sloshicoccinum'.

Since we at RI are all indebted to PharmaCom ( joyously hell-bent on world domination), younger minions should be aware that there is an international alliance known as Walgreens Boots ( 2014) which is trying its best to take over: with meds, OTCs, homeopathy, greeting cards, digital photography kiosks, packaged foods.
Seems like something Draconis had a hand in.

By Denice Walter (not verified) on 31 Jan 2016 #permalink

^ Of course they are trying to take over the world. Over at the corner of happy & healthy, they are buying out their competition and offering healthcare clinics. In addition they seem to be on every corner.

By Not a Troll (not verified) on 31 Jan 2016 #permalink

Sadmar writes (#55),

Maybe I should try to get an ® for ‘All-natural homeopathic

MJD says,

There'd be more interest in "Supernatural homopathic" :-)

Your always an entertaining read Sadmar. Thx

By Michael J. Dochniak (not verified) on 31 Jan 2016 #permalink

Of course they are trying to take over the world. Over at the corner of happy & healthy, they are buying out their competition and offering healthcare clinics.

CVS Caremark is a much greater force in my neck of the woods. The local university's in-house HMO plan long ago made them a preferred provider. Even worse, they further refused to reimburse prescriptions filled at the local independent pharmacy.

I would also point out that even a 6C homeopathic dilution is 10-12.

I'm pretty sure it's possible to enable <sup> tags for the commentariat, BTW, given that one of the SBs turned on the LaTeX option at some point (not Ethan, despite a request).