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No, sugar pills won’t repel insects, and other consequences of regulating nonsense

As a group blog, Science-Based Medicine brings a variety of perspectives to issues of science in medicine. However we align around a few core principles which define what science-based medicine is, and how it should be practiced. One principle we emphasize is the importance of subjecting the evaluation of all health interventions and treatments to a single, science-based standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently. I started reading, took the red pill, and here I am today.

As a Canadian, one of perspectives I hope that I can bring to the blog is the opportunity to compare how different countries address similar health challenges. While the FDA and Health Canada share similar drug approval processes, they differ dramatically in their approach to homeopathy.  The American Dietary Supplement Health and Education Act of 1994 (DSHEA) is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. Given the criticism of DSHEA that is regularly dished out by SBM bloggers, I assumed that it also applied to homeopathy. I was wrong. The National Center for Complementary and Alternative Medicine (NCCAM) points out,

Homeopathic remedies are regulated as drugs under the Federal Food, Drug and Cosmetic Act (FDCA). However, under current Agency policy, FDA does not evaluate the remedies for safety or effectiveness. FDA enforcement policies for homeopathic drugs are described in FDA’s Compliance Policy Guide entitled Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15).

FDA allows homeopathic remedies that meet certain conditions to be marketed without agency preapproval. For example, homeopathic remedies must contain active ingredients that are listed in the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS lists active ingredients that may be legally included in homeopathic products and standards for strength, quality, and purity of that ingredient. In addition, the FDA requires that the label on the product, outer container, or accompanying leaflet include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the number of times the active ingredient was diluted, and directions for use. If a homeopathic remedy claims to treat a serious disease such as cancer, it must be sold by prescription. Only products for minor health problems, like a cold or headache, which go away on their own, can be sold without a prescription.

What NCCAM doesn’t mention is that homeopathy is an elaborate placebo system, where the “remedies” lack active ingredients. As would be expected with inert products, clinical trials confirm what basic science predicts: homeopathy’s effects are placebo effects. Yet these placebos, because they’re labelled “homeopathy” are regulated as drugs.  Amazingly, the the regulations delineate some homeopathy products as “prescription” and some as “non-prescription” based on what they’re being used for — not based on what they contain. Which is odd, because homeopathic remedies are chemically and therapeutically indistinguishably – they are inert.

Nonsensical? Yes. But that’s homeopathy.  To the FDA’s credit, they don’t waste resources reviewing products before they’re sold, and they explicitly don’t vouch for safety and effectiveness. Now let me introduce you to Health Canada’s Natural Health Products Directorate.

The Natural Health Product regulations, under Canada’s Food and Drugs Act, regulate homeopathic products as well as many of the products Americans regulate under DSHEA: nutritional supplements, probiotics, traditional Chinese medicine, vitamins, and herbal remedies. They are a deliberate shadow of the regulations that govern drug products — requiring some manufacturing quality and safety standards, while effectively removing the standards for product efficacy claims. Yet Health Canada insists that this doesn’t compromise quality, safety, or efficacy:

Through the Natural Health Products Directorate, Health Canada ensures that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

The consequence? Regulation of the absurd. Health Canada reviews every remedy, and explicitly attests their safety and effectiveness. In Canada you can purchase Health Canada approved (Search each product by number here):

  • homeopathic sea water — DIN-HM 80017767
  • homeopathic insulin — DIN-HM 80016480
  • homeopathic granite — DIN-HM 80012752
  • homeopathic roasted sponge “Spongia Tosta” — DIN-HM 80011377
  • homeopathic chloroform DIN-HM 80010524
  • homeopathic table salt DIN-HM 80005389

There are hundreds more, including more well known products like Oscillococcinum and Traumeel, all deemed safe and effective.

It’s easy to laugh at the irony of homeopathic water, and the while the sale of these products is certainly unethical, when used for self-limiting conditions, the risk of harm may be slight. But a framework that gives even a veneer of credibility to sugar pills increases the perception that homeopathy has legitimate medical uses. We’ve seen this worldwide with homeopaths descending on Haiti or treating HIV in Africa, illustrating that proponents lack any insight into the lack of objective effects. More recently, the government of Madhya Pradesh, a state in India, announced a plan to use homeopathy to prevent malaria outbreaks. When homeopathy is used as a substitute for real medical treatments, the risk of harms are real, not theoretical. So I was concerned to to see the following in the Calgary Herald:

A Calgary business that aims to bring traditional homeopathic remedies to the mainstream public has received Health Canada approval for its first locally developed product. Mozi-Q is a natural mosquito repellent created by Calgary-based Xerion Dispensary. The product, made from a plant-derived substance called staphysagria, is taken orally and is advertised not only as a bug repellent, but as a product that will also lessen the stinging and itching associated with insect bites.

which also noted

All natural health products — including homeopathic remedies — sold in Canada are subject to the Natural Health Products Regulations, which came into force on Jan. 1, 2004. Only after Health Canada has assessed a product and decided it is safe, effective and of high quality, will a product be approved.

Effective. There it is. Yes, homeopathic insect repellent, approved by Health Canada with licence number 80031902, with the following “Recommended Use or Purpose”:

Homeopathic rememdy [sic] used for reducing the severity and frequency of insect bites.

And what’s in this product? Like most homeopathy, the labeling obscures the actual lack of ingredients. I converted the homeopathic labeling to English, and looked for evidence to support any of the ingredients – diluted or otherwise.

  • “cedron 4C:” This is Simaruba Ferroginea, commonly called Rattlesnake Bean in a 10−8 dilution (i.e., 0.000001%) — This product is related to the pinto bean. It is likely nontoxic, especially at this dilution.
  • “grindelia 6C”: Grindelia Robusta or Gumweed in a 10−12 dilution (i.e., 0.0000000001%) — This ingredient is considered “Possibly Safe” at non-homeopathic doses by the Natural Medicines Comprehensive Database
  • “ledum palustre 3X” : Marsh Tea in a 10−3 dilution (i.e., 0.1%) — This ingredient is considered “Likely Unsafe” at non-homeopathic doses by the Natural Medicines Comprehensive Database, causing kidney and urinary tract damage as well as central nervous system excitation.
  • “staphysagria 4X”: Delphinium staphisagria or Stavesacre in  10−4 dilution  (i.e., 0.01%) — This ingredient is considered “Likely Unsafe” at non-homeopathic doses by the Natural Medicines Comprehensive Database, as it is poisonous.
  • “urtica urens 6X” : Stinging nettle in a 10−6  dilution (i.e., 0.0001%) — This ingredient is considered “Possibly Safe” at non-homeopathic doses by the Natural Medicines Comprehensive Database.

Interestingly, some of the ingredients aren’t diluted past the “12C” level, the point at which Avogadro’s constant establishes that there isn’t likely to be a single molecule of the original ingredient. The 3X dilution of Marsh Tea is only a 1:1000 dilution, which depending on the original preparation, could deliver detectable traces of the source plant. Should we be concerned? The amount is so minute that it’s unlikely to have any meaningful effects, toxic or otherwise. But does it work? Not surprisingly there is no published evidence suggesting that any component of Mozi-Q, either alone or in combination, have any effect on either reducing the frequency of insect bites” or “reducing the severity of insect bites”. The manufacturer states the following:

Has it been studied?
In the ’60s a homeopath by the name of HR. Trexler studied Staphysagria for its effectiveness at preventing mosquito bites. In a study of 421 subjects over a 4 year period, he found this remedy to be 90% effective.

Tried and True!
We have tested this remedy in our clinic over four mosquito seasons and found the response from the public confirmatory of Trexler’s findings.

And that’s the sum total of the evidence — which appeared to be adequate for Health Canada, who granted the “safe and effective” imprimatur of legitimacy. A published report from Trexler does date back to 1965, and it’s not available. There are no other published reports with the product. I did find Trexler’s US patent registration from 1956 claiming that staphsagria is an effective insect repellent. No evidence of a formal evaluation is described. A patent, of course, doesn’t establish efficacy. Given the totality of evidence, has failed to show that homeopathy has any meaningful clinical effects, I am skeptical that a homeopath identified an effective homeopathic oral insect repellent in 1956, and subjected it to a rigorous evaluation in the 1960′s. In any case, it would be easy to prove if it does work – it could be evaluated like every other insect repellent on the market.

How Real Insect Repellents work

For many of us, insect bites are an occasional annoyance that we can largely avoid. Yet insects can transmit over 100 diseases, including malaria, West Nile virus, yellow fever, Dengue fever, Lyme disease and even plague. Malaria alone kills 1.2 million people, mainly African children, annually. And now that we have West Nile and Lyme disease throughout North America, there is a bigger impetus to minimize bites. Given the importance of repelling insects effectively, validated methods have been created to test new products.

While it’s not definitively established what attracts insects to bite, carbon dioxide and lactic acid from our skin and breath seem to act as attractants. In light of this, it’s not surprising that no oral product has ever been demonstrated to effectively work as an insect repellent. What does work, beyond physical barriers, are chemical products that we apply to our skin.  The most common ingredient in repellents is N, N- diethyl-3-methylbenzamide, more commonly known as DEET, although there are several other chemicals that have been approved for use in consumer products.

How do you know if an insect repellent works? You offer your forearm up as a meal. Consumer Reports illustrates the testing nicely. The US Environmental Protection Agency specifies these testing requirements in detail. Its approval outlines the duration of effectiveness as well as detailed descriptions of the efficacy and safety evaluations. In Canada, similar regulation rests with the Pest Management Regulatory Agency. When I asked the PMRA by email how a homeopathic remedy could be possibly be approved as an insect repellent, they replied with the following:

Please be advised that, according to the Pest Control Products Regulations (PCPR), pest control products that are used for the control of arthropods on or in humans or animals can be exempted from the Pest Control Products Act (PCPA), and made subject to the Food and Drugs Act (FDA), if the control product is to be administered directly and not by topical application. If the action of the product is not due to the simple presence of the active ingredient on the skin (the intent of topical application under the PCPA) but rather that the active ingredient has to be absorbed first before it can exert its effect, this is not considered to be a topical mode of action. This would be the case for mosquito repellent patch products. Even though the patch is to be applied to the surface of the skin, the PMRA does not register any pesticide that’s to be taken orally. Based on this systemic mode of action, as per a previous agreement between PMRA and Health Products and Food Branch (HPFB), the type of product you describe in your email would fall under the jurisdiction of HPFB.

Is there a facepalm emoticon? There is no “systemic mode of action” that has been demonstrated for homeopathy. There is no evidence that any oral products are effective as insect repellents. In the US, a product like Mozi-Q which lacks evidence of efficacy would not likely be permitted, (homeopathy or not) as there is a  federal regulation on oral insect repellents in place, which notes:

Labeling claims for OTC orally administered insect repellent drug products are either false, misleading, or unsupported by scientific data.

Any OTC drug product that is labeled, represented, or promoted for oral use as an insect repellent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug and Cosmetic Act for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act.

Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted OTC for oral use as an insect repellent is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

Yet these products are being deliberately exempted from testing in Canada, and Health Canada is approving them in the absence of any good evidence.

Conclusion

When a regulator clears away scientific barriers to product approvals, we should not be surprised by what emerges.  Homeopathic insect repellent that is deemed “safe and effective” illustrates the consequences of regulating nonsense. Consumers who rely on regulators to test and approve products don’t care how a product is licensed – they want assurance that it works. Because while insect bites can be a nuisance, they can also be deadly. Who will be responsible if a consumer contracts a insect-borne disease if they use homeopathy instead of proven insect repellents: The manufacturer, or the regulator? In the absence of effective regulation, the science in this case is very clear: if you want to reduce your risk of insect bites and their consequences, use real insect repellents — not homeopathy.

 

 

Posted in: Homeopathy, Science and Medicine

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25 thoughts on “No, sugar pills won’t repel insects, and other consequences of regulating nonsense

  1. Jan Willem Nienhuys says:

    Many homeopathic remedies are in the form of lactose/sucrose globuli, i.e. small pills of about 5 mg. There are also larger sizes, I believe about 60 mg.

    Now what does the ingredient Ledum Palustre 3X mean in the case that the product is sold in sugar form? First the plant is cut up and then pressed. The juice is then mixed with equal parts of alcohol. Another method is that the chopped plants are first mixed with alcohol, let to stand for some time, and then it is pressed. The result is called the mother tincture. A third possibility is that the dried plant is used. Anyway, the mother tincture usually is at least 50% alcohol and the remainder is plant juice or chemicals extracted from the plant.

    The mother tincture is then ritually diluted with alcohol (usually 70% alcohol), and the final product (1X, 3C or whatever) is sprayed over the lactose pellets, and then left to dry. Never mind hifalutin tales about memory of water or alcohol or even quantum mechanical entanglement, it’s the memory of lactose that counts. It is assumed that 1 gram of alcohol can be used to moisturize 500 gram of pellets. So if you want to convert 3X in the case of lactose pellets, then another factor 1000 (2 for the mother tincture, and 500 for the moisturizing step) must be taken into account.

    This might sound a bit esoteric, but in the case of remedies with mercury or cadmium compounds it just makes the difference beween officially poisonous and harmless.

  2. nybgrus says:

    Great piece Scott. I love contrasting differences between health systems – especially when demonstrating that basically everyone has inane legislation to some degree. Makes me feel a bit better about us in ‘Murrica.

    I also think it is absolutely ridiculous to give this sort of false legitimacy and engender a spirit wherein a homeopath can go to a developing nation and give people fake treatments when they desperately need real medicine. This is an excellent example (looking at you pmoran) of why it matters not how genuinely the practitioner thinks they are helping their patients. Do you really think that those “Homeopaths Without Borders” didn’t genuinely believe they were out there helping the Haitians? So how does one separate the mild mannered “useful” stuff that homeopaths do and this? Whenever pmoran argues about those that “genuinely believe” they are helping patients and thus we shouldn’t be so “strident” against them this is exactly what I think about. How can a legislative body – or any body – say “This over here, when you give ground up and diluted to nothing duck liver pills for the flu is ok but this stuff over here when you give diluted to nothing cholera vaccine to disaster victims in developing nations is not, even though it is exactly the same thing”

    Anyways, I digress. You also commented:

    While it’s not definitively established what attracts insects to bite, carbon dioxide and lactic acid from our skin and breath seem to act as attractants.

    Actually there have been a few papers written on the topic. PLoS has a couple of them, the most recent demonstrating that human odor, as influenced by skin flora have a large role to play in attraction and repulsion of mosquitos. This same group has an earlier article which also demonstrates similar findings.

    In other words, it seems that the reason some people (like my girlfriend) are instantly ravaged by mosquitos while some people (like myself) are mostly left alone is because our bacteria make us smell different to the l’il buggers. And some people just smell tastier. Interestingly the study also cites a few species of bacteria that seem to actively repulse mosquitos leading me to wonder if altering the skin flora of people might be a possible way to help populations have long term mosquito protection. The ability to maintain this changed flora and its consequences in the long term would need to be explored, of course, but it seems like an interesting avenue of thought to me.

    And of course, even that does not give us a way to utilize systemic oral therapy as insect repellent.

  3. Jan Willem Nienhuys says:

    PS. the Mozi-Q is tablets, so I think that the tablets are prepared by putting together lactose pellets of the five kinds as described above, each making up 1/10 of the weight of the tablet, and adding lactose etc. for the total weight. If what I surmise is correct, then this means that actually 1/10 x 1/1000 x 1/1000 of the weight of the tablet is the weight of the original Ledum palustreplant juice in it. It’s even nothinger than you think.

  4. BillyJoe says:

    “some people (like my girlfriend) are instantly ravaged….”
    That must be difficult for you. :(

    “some people just smell tastier”
    Hmmm…:)

  5. rork says:

    Nice article. I officially declare myself an admirer, cause Gavura has written interesting stuff regularly.
    On with the digression:
    I live and play in mosquito infested lands, and can distinguish fairly many. We had 2 species last year that even old-timers had never experienced before (we had big floods in late July). I know the black fly and no-see-um too. I and my friends have hypotheses:
    1) smoking tobacco, even if you aren’t doing it this second, might help. That’s a systemic hypothesis. Hard to disentangle it from surface stink though. Smoking at the moment does seem to matter for mosquitoes.
    2) the color of your clothes. Light is right.
    3) The twitchy people get more attention. Stop swatting like crazy and calling them to you. Repeat the mantra: smooth, smooth… Hard to tell if it’s just correlation though – the tastier people might swat more due to greater molestation. The less molested then get to come up with theories that flatter themselves.
    4) Our Ontario brothers advise not bathing. It’s a greasy skin thing we think. Apply deer fat (we don’t have the traditional bear fat). This and #1 repels some humans, of this we are certain. I rationalize that real side effects are a hallmark of real medicine.
    5) knowledge of time of day by landscape interactions are very important, but it gets species specific. To give simple examples: pick the windiest spot, islands are good, know what excellent black fly habitat looks like.

  6. Janet Camp says:

    Being “tastier” than most–and allergic to most living things–I have tried all of Rork’s folklore (and more) to little avail. I hate DEET, but alas, it works. Between the DEET and the sunscreen though, I am just a mess on a hot day. I won’t even mention the “ravaging” that occured the time in Ontario when my car broke down on a very hot day in the middle of nowhere and I was stupid enough to actually get out of the car without DEET!

    Great post and interesting to see the very tolerant way Canada sacrifices scientific integrity on the altar of cultural “respect”. I’ve always admired Canada in so many ways, but this policy is horribly misguided–just as is the DSHEA.

  7. WilliamLawrenceUtridge says:

    The thought of an oral insect repellent is rather terrifying to me. Either:

    - the dose would have to be massive, or
    - the original compound incredibly potent, or
    - the compound would have to be selectively toxic to insects but harmless to humans

    You would have to dose the body such that, despite being dissolved in a large volume container, adequate amounts of the repellent accumulate on the exterior of the skin.

    No wonder there’s no effective oral treatments.

    Also, Way to go Canada! Doot doot doot, doot doot do-doot, doot doot doot do-doot!

    The Canadians will get it.

  8. If a particular homeopathic product is sufficiently diluted to the point that it does not contain any detectable amounts of active substances from the HPUS, how can one determine if it is actually a homeopathic product and prepared as claimed?

    With a pharmaceutical drug, it can be tested to see if it contains the active substance in the amount claimed. For a homeopathic product of, say, a 200C dilution/concentration, the manufacturer could just bottle distilled water or package sugar pills on which they claimed they had applied a drops of a homeopathic preparation and there would be no way to tell the difference since they end results are the same.

    Let’s say you believe in the efficacy of homeopathy, but suspect a manufacturer may be cheating (that is cheating beyond the normal practice of homeopathy) and just bottling distilled water, doing only 100 instead of 200 serial dilutions, or skipping the succession. How would you be able to prove fraud without being able to observe and document the production methods?

  9. fledarmus1 says:

    K-9 Advantix (Bayer) is supposed to repel mosquitos and ticks, as well as killing them. When does the human version come out?

  10. dchamney1 says:

    Now, if I take the Mozi-Q and still get bitten , can I sue for false advertising?

  11. qetzal says:

    Does Health Canada describe their basis for judging such products “effective,” either for homeopathy as a class, or for specific products?

    With drugs in the US, FDA is pretty clear about what evidence is typically needed to show efficacy. They also publish specific approval info online for each individual drug, including a discussion of the clinical data that demonstrate efficacy. They don’t do that for homeopathic ‘drugs’ of course, but neither do they vouch for their efficacy.

  12. Jan Willem Nienhuys says:

    Karl Whithakay

    how can one determine if it is actually a homeopathic product and prepared as claimed?

    Basically the company has to provide documentation about their production process. That documentation is necessary anyway, because there must be guarantees that the production process is sufficiently hygienic. That’s my guess.

    dchamney1

    Now, if I take the Mozi-Q and still get bitten

    This is what homeopaths call the initial aggravation. In classical homeopathy one gets one (1) globule after an interview of about 90 minutes and then the healer waits a week to determine whether the preparation chosen matches the subjective symptoms (becomes worse in the morning, subject sleep on the right side, is afraid of thunderstorms etc. etc.). If the patient gets worse, that’s the initial aggravation. This trick has been borrowed by other healers, but they say “you are feeling miserable, but that’s good, it means the toxins finally are coming out”.

    But the Mozi-Q is supposed to work within 30 minutes….

  13. @Jan Willem Nienhuys,

    “Basically the company has to provide documentation about their production process. That documentation is necessary anyway, because there must be guarantees that the production process is sufficiently hygienic. That’s my guess. ”

    But if that documentation is on the honor system, and there’s no regulatory inspection to certify not only hygienic operation, but also to certify accurate, authentic production methods, what is there to stop a dishonest producer (or one more dishonest than the others) from lying about the number of dilutions performed, whether succession was done, or what, if any, original ingredients were used?

    For any homeopathic remedy 30C or higher, what safeguard is there to keep a producer honest?

    Nobody would be able to tell the difference in the end product if:

    You stopped serial diluting after 30C and labeled it any higher dilution that you wanted.
    You did not due the succession.
    You used the same starting ingredients for all your remedies > 30C.
    You just used unprocessed, unadulterated distilled water.

    It would be interesting to see if, in any kind of lawsuit against a manufacturer of homeopathic remedies over 30C, plaintiff’s counsel could get the manufacturer to go on record under oath as saying the listed ingredients are not present in their product in any detectable quantities and their product is scientifically indistinguishable from water.

  14. “what safeguard is there to keep a producer honest?”

    That is, honest about the preparation and production methods of the product they are selling, of course.

    We already know that there is nothing to keep them honest about the nature of homeopathic products themselves.

  15. BillyJoe says:

    Karl, it’s ‘succussion’.

  16. DevoutCatalyst says:

    As in ringing their necks?

  17. Jan Willem Nienhuys says:

    But if that documentation is on the honor system, and there’s no regulatory inspection

    I had hoped someone to provide more information about that. The whole food and medicines industry is hopefully inspected regularly. A homeopathic factory has many employees (the large ones at least). It would require a major conspiracy to cheat at the preparation in any systematic (and cost saving) way.

    Can you see the articles in the newspaper?

    Homeopathic horror shock fraud

    Noirob factory skips succussions. An anonymous source, code named
    ‘Suckusser’, had revealed that all pelletized homeopathic remedies sold
    by Noirob are just ordinary sugar pellets. It all started when it was accidentally
    discovered that a spraying machine had been defect for over a year
    without anybody noticing it. Management then decided to skip the spraying
    altogether, saving annually $ 10,000,000 in production costs. The liquid
    homeopathy is still produced in the classical way.

    The personnel in the super secret spraying section of the factory had all been
    laid off and replaced by two people who merely transferred the pellets from
    the ‘untreated’ bins into the ‘treated’ bins. This was discovered when the FDA
    raided the Noirob premises on the tip of ‘Suckusser’. They found only one
    functioning spraying machine that occasionally was used for making promotional
    movies.

    The Noirob top has been charged with ‘conspiracy to defraud the
    public’. They plead ‘not guilty’. They claim it was all a decision made
    by the lower management. But ‘Suckussion’ claims to have secret tapes
    made during board meetings that show otherwise.

    The discoveries sent shock waves through the homeopathic world, and
    Noirob and other homeopathic stocks plummeted so far that another
    financial crisis threatens, as many banks are using these stocks as a
    collateral for loans.

    A psychological help desk has been opened for the millions of homeopathy
    users that fear that they haven’t been cured at all of their ailments. ‘I might
    have had the flu for the past ten years, without knowing it,’ one of these
    users complains.

    I am afraid you’ll see such stories only in The Onion. Apart from being
    staffed by ardent believers, homeopathic companies can’t organise
    conspiracies. Just an occasional individual ‘researcher’ twisting the
    results of an ‘RCT’ is about all they can manage.

  18. @BillyJoe

    “Karl, it’s ‘succussion’.”

    Yes, I know, and I failed to notice my spell checker was changing it since succussion is not in its dictionary.

  19. Jan Willem Nienhuys,

    “I had hoped someone to provide more information about that. The whole food and medicines industry is hopefully inspected regularly. A homeopathic factory has many employees (the large ones at least). It would require a major conspiracy to cheat at the preparation in any systematic (and cost saving) way. ”

    Having worked for a materials manufacturer, I don’t think the conspiracy would need to be quite as big as you suspect, and the more automated the production, the easier it is to cheat. There often can be a lot of people involved in a production process that only really have a good knowledge of what’s going on in their specialized area.

    Also, in regards to inspection, I would think that if there are any inspections, they would be mostly limited to concerns like compliance with Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, and not with complying with homeopathic production methods.

    However, upon doing a tiny bit of research, it would appear that an inspection of a manufacturer of homeopathic products may include them complying with their own documentation for production methods as seen in the “CGMP Deviations” section in this FDA letter: http://www.casewatch.org/fdawarning/prod/2011/standard.shtml

    “For example, your firm’s mixing times in the approved records for Belladonna, Chamomilla, Calcarea Phos., and Coffea Cruda 1X dilutions, and the approved record for Hyland’s Teething Tablets, are not supported by adequate process validation. ”

    The thing I don’t know is if that letter is a result of a regular inspection or an inspection triggered by something like problems with the products on the consumer end.

  20. rork says:

    Jan, that was so funny. Thanks. And for your more informative writings too, which are common.

  21. Quill says:

    I think this a very good article and really enjoyed the comments, especially Jan’s take on a “scandal” in the world of Noirob. In some ways it is comforting to know that naturohomeowackiness isn’t confined to the US but also lurks in Canada. If it was just the Americans that believed all this crud I’d be very worried. But since it seems to be an affliction of civilization at large it seems a cure anyplace will serve the world. I hope some country gets around to calling this quackery for what it is and not what it claims to be.

  22. gretemike says:

    Daydreaming . . .

    I wonder how far the regulatory agency would go with this charade? Suppose the company wanted to donate a whole lot of their product to Africa where the battle against mosquitos is a matter of life and death? Would they be allowed to do it?

  23. gretemike says:

    I was doing some surfing and came across this depressing link. The depressing part is the last paragraph.

    http://articles.timesofindia.indiatimes.com/2012-06-17/kozhikode/32282560_1_fever-cases-waste-disposal-jaundice

  24. Burstaholic says:

    One note – you mentioned that a study (of indeterminate quality) was done on the main “ingredient” of this preparation, but I wonder if you know whether or not that the study was done on a homeopathic preparation of that ingredient.

    After all, just because something doesn’t work when diluted 1 million to 1 doesn’t necessarily mean an appropriate dose would not be effective.

    The essential fallacy of homeopathy could conceivably conceal (and render ineffective) a genuine treatment; even though it is unlikely, the possibility should given due consideration – which here means a scientifically valid test.

    It would be a shame if homeopaths caused a genuine treatment to be lost simply by becoming associated with it.

  25. Scott says:

    @ Burstaholic:

    A notable issue with your suggestion is that there isn’t any reason to believe something used to make a homeopathic remedy has any greater likelihood of being an actual treatment than picking something at random. So unless you’re prepared to suggest that every single substance should be tested as a treatment for every single condition, there is no scientific reason to look at homeopathic remedies in particular.

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