Respectful Insolence

Will wonders never cease? A recent story about how “homeopathic” Zicam managed to slide through a loophole in which the FDA doesn’t require evidence of efficacy or safety for medicines labeled as homeopathic has been percolating through the blogosphere based on a recent warning that the FDA issued. It turns out that the zinc in Zicam can mess up your sense of smell, causing a loss of the sense called anosmia. Steve Novella has already done an excellent job of discussing the issues involved with this loophole, which is big enough to pilot the proverbial Death Star through.

However, a followup story on the AP shows that the problem is likely more widespread than Zicam:

CAMBRIDGE, Mass. – The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal — until scores of consumers lost their sense of smell. One little word on Zicam’s label explains all this: “homeopathic.”

Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as treatments with explicit claims of medical benefit. Yet they don’t require federal checks for safety, effectiveness or even the right ingredients.

They’re somewhat similar to dietary supplements, which use many of the same natural ingredients and also aren’t federally tested for safety or benefit.

Many scientists view homeopathic remedies as modern snake oil — ineffective but mostly harmless because the drugs in them are present in such tiny amounts.

But an Associated Press analysis of the Food and Drug Administration’s side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.

The reason, it turns out, is because these “homeopathic” remedies have actual–gasp!–medicine in them:

In its review of homeopathy, the AP also found that:

  • Active homeopathic ingredients are typically diluted down to 1 part per million or less, but some are present in much higher concentrations. The active ingredient in Zicam is 2 parts per 100.
  • The FDA has set strict limits for alcohol in medicine, especially for small children, but they don’t apply to homeopathic remedies. The American Academy of Pediatrics has said no medicine should carry more than 5 percent alcohol. The FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.
  • The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. “The evidence is not there at this point,” says the center’s director, Dr. Josephine Briggs.
  • At least 20 ingredients used in conventional prescription drugs, like digitalis for heart trouble and morphine for pain, are also used in homeopathic remedies. Other homeopathic medicines are derived from cancerous or other diseased tissues. Many are formulated from powerful poisons like strychnine, arsenic or snake venom.

All of this is mostly correct, except that true homeopathic remedies are diluted to far, far below 1 ppm. In fact, even a 12C homeopathic dilution represents approximately a 1024-fold dilution. Get up to 20C or 30C, and there is, to a very good approximation, zero chance of even a single molecule of the active remedy remaining. It’s true that some homeopathic remedies have detectable compound in them (for instance, 6C potency), but the vast majority do not. However, thanks to an old law, homeopathic remedies can be marketed without having to demonstrate safety or efficacy to the FDA:

To this day, homeopaths put forth mystical-sounding explanations involving “vital force” and “healing energy.” And with arcane ingredients like “nux vomica” and “arsenicum album,” many homeopathic medicines sound like something brewed in a druid’s kettle.

In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law’s principal author was Sen. Royal Copeland of New York, a trained homeopath. “He did it in such a sneaky way that nobody really noticed or paid attention,” says medical author Natalie Robins.

And that law has remained in force ever since.

Basically, this law results in automatic approval of drugs that appear in the Homeopathic Pharmacopoeia are given automatic FDA approval, no science, evidence, or messy clinical trials needed. Talk about a double standard! True, most homeopathic remedies are mostly water or alcohol, but a lot of them are adulterated with real drugs–like Zicam, which contained enough zinc to fry the smell receptors of a number of people to the point where they lost their sense of smell.

Perhaps the revelation in this story that interested me the most was the news that NCCAM is no longer funding trials of homeopathy. You may recall that I went absolutely ballistic when I learned about clinical trials of homeopathy funded by NCCAM. If there were ever a bigger waste of money by the NIH than that, I’m not aware of it. It is good to see that a spark of rationality has pervaded NCCAM, at least for the moment. I don’t expect it to last (eventually the homeopaths will convince the powers that be at NCCAM that homeopathy deserves to be studied), but for now I’m glad to see no more money going for trials of homeopathy.

Of course, right now the homoepaths are–surprise! surprise!–claiming that Zicam is not “homeopathy”:

Dr. Iris R. Bell, a psychiatrist and homeopathy researcher at the University of Arizona, Tucson, says the suspended Zicam products deliver the homeopathic ingredient right into the nose — not an accepted homeopathic method. She says the FDA should act against such products.

She also acknowledged that “there are people preparing things homeopathically to try to get around FDA regulations of over-the-counter drugs.” But she says most homeopathic remedies are much safer than conventional pharmaceuticals, so no major regulatory changes are needed.

There’s no doubt that true homeopathic remedies are safer than conventional pharmaceuticals. They are, after all, water. Unfortunately, they are as effective as water against the diseases and conditions for which homeopaths recommend them; that is, not effective at all. Continuing Homeopathy Awareness Week, perhaps the most important “awareness” of homeopathy is that it is nothing more than pseudoscience. That fact can’t be emphasized or repeated enough.

Comments

  1. #1 Matthew Cline
    June 18, 2009

    But she says most homeopathic remedies are much safer than conventional pharmaceuticals, so no major regulatory changes are needed.

    So, would she consider a regulation to require that homeopathic remedies are proved to contain nothing but their substrate a small change? If homeopathic remedies aren’t tested at all right now, requiring all of them to undergo a test, even just a single one, would be a large change.

  2. #2 Bob O'H
    June 18, 2009

    I wonder how this bill defines a homeopathic remedy (I guess Tyler Hamilton does too): surely if there’s enough active ingredient to have an effect, it isn’t homeopathic.

  3. #3 Henry H
    June 18, 2009

    It pains me to continually see the phrase “homeopathic remedies.” My understanding of the word “remedy” was that in order to call something a remedy it actually has to, you know, remedy something. But in discussions of “alternative medicine” the word has become meaningless (through a process of dilution and succussion, no doubt) to the point where any group of charlatans can claim curative powers for their homeopathic fake plutonium and be rewarded in a sense with a “remedy” tag, even in an article as critical as the AP’s.

    While it’s not really an issue to either skeptics or die-hard homeopaths, it ought to be made more clear to the average reader of any such article that, when held to the proper experimental standards, homeopathy has never been found to be a remedy of anything.* Since the biggest danger of pseudoscience lies in its tendency to woo people away from efficacious medical treatments with magical sci-fi promises, I propose a challenge to you and your readers to come up with an appropriately neutral term (like “homeopathic mixtures”) and start changing the lexicon.

    *Except dehydration?

  4. #4 isles
    June 18, 2009

    This dovetails nicely with Marilynn Marchione’s recent article, within her excellent series on quackery, exposing the presence of undisclosed ingredients in supposedly all-natural, safe nutritional supplements.

    http://www.twincities.com/news/ci_12557123?source=rss

    Buying something from your friendly neighborhood naturopath doesn’t mean it’s safe OR effective. More like untested and potentially toxic.

  5. #5 Scooter
    June 18, 2009

    This reminds me of a report published in the BMJ in 1999.
    http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=27755
    They found high concentrations of dexamethasone in “Chinese Herbal” remedies for eczema. I wonder where the ancient Chinese got that from?
    All of this rubbish needs to be regulated and controlled. The potential for harm is real and undeniable.

  6. #6 Rogue Medic
    June 18, 2009

    The homeopaths are so full of it, even their extreme nothing is a lie. They are so full of deception, that no amount of dilution can cure them.

  7. #7 Michael Kingsford Gray
    June 18, 2009

    Homeopathic remedies, alternative to medicine, can cure (at least) the following ills:
    1) Mild Thirst
    2) Acutely distended gluteus maximus wallet
    3) Skepticism
    4) Honesty

    I know**, as I am as entitled to call myself an alternative to medicine practitioner, as are you.

    _________
    ** My Daddy’s instinct

  8. #8 jay
    June 18, 2009

    There was a quote on CNN by someone from the company complaining that there was ‘no causal mechanism’ for the tissue damage and there there was ‘no scientific evidence’

    Suddenly theese guys are interested in evidence?

  9. #9 Kimbo Jones
    June 18, 2009

    most homeopathic remedies are much safer than conventional pharmaceuticals, so no major regulatory changes are needed.

    Zicam isn’t homeopathy, but it was sold under that name. So yes, everything does have to be tested because how else are we supposed to know which are telling the truth about their wateriness and which are lying? What a moron.

  10. #10 notedscholar
    June 18, 2009

    It is sad that natural cures are falling victim to the dogmatism of medical science.

    I’m all for doctors, but we do need legitimate alternatives.

    NS

  11. #11 Scooter
    June 18, 2009

    It is sad that patients are falling victim to dishonesty of CAM practitioners.

    I’m all for natural cures, but we do need to have legitimate oversight.

    ST

  12. #12 Greg Laden
    June 18, 2009

    I think the deal is that it’s still homeopathic if the ‘medicine’ part has only side effects and no actual effects.

    After all, many homeopathic treatments are in water. Water is the Universal Solvent. That’s got to have some side effects… (Thirst quenching, etc.)

  13. #13 Scott
    June 18, 2009

    It is sad that natural cures are falling victim to the dogmatism of medical science.

    I’m all for doctors, but we do need legitimate alternatives.

    Got any? When examined closely, the only “alternative” treatment which has even the slightest claim to legitimacy is the use of herbal medicines. Which are quite exactly drugs, with the same (and more) risks as anything synthesized in a lab by Bayer. For public safety, they therefore need to be subject to the same regulation.

  14. #14 Rev. BigDumbChimp
    June 18, 2009

    It is sad that natural cures are falling victim to the dogmatism of medical science.

    I’m all for doctors, but we do need legitimate alternatives.

    NS

    this has been said before, but NS if the “alternatives” work, guess what. They are not longer alternatives. They are medicine.

    And being medicine they should be subjected to the same testing and regulation.

  15. #15 Robin Levett
    June 18, 2009

    @Henry H #3:

    *Except dehydration?

    You’re forgetting that the “solution” is generally administered as a (dried) sugar pill; so no, not even dehydration.

  16. #16 Cuttlefish
    June 18, 2009

    Is it Zinc or is it water
    That you’re giving to your daughter?
    If it’s water, then it’s safer, cos it doesn’t do a thing.
    Insufficiently diluting,
    Which is what they’re now disputing,
    Means the “remedy”‘s no longer pure as crystal mountain spring.
    I had thought that the expedience
    Of having no ingredients
    Was what they found attractive (and it’s cost-effective, too!)
    But now noticeable fractions
    Of a drug produce reactions
    Time to circle up the lawyers and avow that it’s not you!

  17. #17 Mu
    June 18, 2009

    Well, simple solution, allow only stuff at 6C or “better” to be marketed as homeopathic.

  18. #18 Agoraphobic Kleptomaniac
    June 18, 2009

    Well, simple solution, allow only stuff at 6C or “better” to be marketed as homeopathic.

    NO. I’m not taking their G*D* “word” that it’s a 6C+ solution. Regulation is Sorely needed for homeopathic garbage and Dietary supplements. Until then, Poisions and potentially dangerous substances will be able to be sold on the free market without any kind of oversight.

  19. #19 Stan P
    June 18, 2009

    I propose a labeling regulation that seems eminently reasonable: require homeopathic products to bear a label that lists all ingredients that are present in concentrations equal to or greater than that of the active ingredient. For a 12 C dilution (one molecule of active ingredient per bottle, give or take an order of magnitude or two) this would entail identifying and listing every compound present in the bottle in an amount of one molecule or more. I concede that it would take some time and a fairly large label to identify and list every organic and inorganic compound in the airborne dust that drifts into the product during the manufacturing process. It boggles to think how many bacterial spores, virus particles, and sloughed skin cells are floating around in any room occupied by people, not to mention all the sources of airborne dust: pollens, wind-blown soil, industrial emissions, volcanic aerosols, meteorite dust. Should keep the homeopaths busy for a while. I think it’s only fair (smile.)

  20. #20 EJS
    June 18, 2009

    So, let me get this straight. The ‘homeopathic’ drug Zicam is being pulled for its ability to effect a negative (ie damaging) consequence. Yet, the ranters and ravers take this as ‘evidence’ that CAM practitioners are scammers, since they advocate such ineffectual medicine? Can someone explain the logic behind this line of reasoning How can the same substance be powerful enough to cause such harm that the FDA would regulate it, and at the same time be ridiculed as so benign (according to scientific investigators) to qualify as quackery. Who are the pseudo-scientists here?

  21. #21 EJS
    June 18, 2009

    So, let me get this straight. The ‘homeopathic’ drug Zicam is being pulled for its ability to effect a negative (ie damaging) consequence. Yet, the ranters and ravers take this as ‘evidence’ that CAM practitioners are scammers, since they advocate such ineffectual medicine. Can someone explain the logic behind this line of reasoning? How can the same substance be powerful enough to cause such harm that the FDA would regulate it, and at the same time be ridiculed as so chemically benign (according to scientific investigators) to qualify as quackery? Who are the pseudo-scientists here?

  22. #22 Stan P
    June 18, 2009

    I propose a labeling regulation that seems eminently reasonable: require homeopathic products to bear a label that lists all ingredients that are present in concentrations equal to or greater than that of the active ingredient. For a 12 C dilution (one molecule of active ingredient per bottle, give or take an order of magnitude or two) this would entail identifying and listing every compound present in the bottle in an amount of one molecule or more. I concede that it would take some time and a fairly large label to identify and list every organic and inorganic compound in the airborne dust that drifts into the product during the manufacturing process. It boggles to think how many bacterial spores, virus particles, and sloughed skin cells are floating around in amy room occupied by people, not to mention all the sources of airborne dust: pollens, wind-blown soil, volcanic aerosols, meteorite dust. Should keep the homeopaths busy for a while.

  23. #23 Stan P
    June 18, 2009

    I propose a labeling regulation that seems eminently reasonable to me: require homeopathic products to bear a label that lists all the ingredients that are present in concentrations equal to or greater than that of the active ingredient. For a 12 C dilution (one molecule of active ingredient per bottle, give or take an order of magnitude or two) this would entail identifying and listing every compound present in the bottle in an amount of one molecule or more. I concede that it would take some time and a fairly large label to identify and list every organic and inorganic compound in the airborne dust that drifts into the product during the manufacturing process. It boggles to think how many bacterial spores, virus particles, and sloughed skin cells are floating around in any room occupied by people, not to mention all the sources of airborne dust: pollens, wind-blown soil, industrial emissions, volcanic aerosols, meteorite dust, etc. Should keep the homeopaths busy for a while. I think it’s only fair (smile.)

  24. #24 Stan P
    June 18, 2009

    EJS doesn’t understand how a homeopathic drug can be simultaneously criticized for being 1.) blandly ineffectual and 2.) harmfully toxic. EJS fails to pick up on the fact that the purveyors of Zicam are perpetrating a double scam. Zicam is potentially dangerous because it contains a substantial amount of zinc, than the innocuous concentration implied by the label, “homeopathic.”

  25. #25 Mu
    June 18, 2009

    EJS, Zicam is NOT homeopathic by any definition, other than what they print on the bottle. “True” homeopathic treatments require the material to be so dilute as to be no longer of physiological activity, if present at all (which is why they can be based on arsenic, plutonium and strychnine). That dilution leads to the inherent “safety” of homeopathic concoctions, and is why they were exempt from regulation. It’s also the reason scientist laugh about the claims of efficacy – it’s clean water (or alcohol, or powdered sugar).
    Zicam is simply a fraud, zinc solution nasal spray, labeled as homeopathic to bypass FDA rules. If it had gone through regular drug trials, the side effects would have been caught most likely. It’s like that herbal penis strength supplement that surprisingly worked – because of the powdered Viagra in it. Just because you claim it shouldn’t be regulated by the FDA under whatever exemption doesn’t mean you truly qualify for it.

  26. #26 Scott
    June 18, 2009

    Can someone explain the logic behind this line of reasoning How can the same substance be powerful enough to cause such harm that the FDA would regulate it, and at the same time be ridiculed as so benign (according to scientific investigators) to qualify as quackery.

    Certainly. Homeopathy (by the most common definition) qualifies as quackery because (among other reasons) it has no active ingredients. Zicam is NOT homeopathic by that definition, so there is no contradiction.

    If one uses a definition of homeopathy that includes Zicam, then it is indeed not correct to state that (all) homeopathic remedies are just water/alcohol/sugar and therefore ineffectual. But even the ones that aren’t are still quackery because there is no evidence that they work.

  27. #27 Pablo
    June 18, 2009

    Well, simple solution, allow only stuff at 6C or “better” to be marketed as homeopathic.

    The problem is that, for homeopathic claims, there is no quality assurance. In principle, you are correct, you could just say that anything that is actually XC (pick your X) or greater is homeopathic. However, that has to be ACTUALLY diluted, and not just claimed so. What we are seeing here is that things that are claimed to be homeopathic on the label in fact are not. It’s almost as if companies are using that label as an excuse to sell something without having to submit it to regulatory consideration.

    It’s a huge shell game. Companies are getting away with selling anything on the pretense that it is “homeopathic,” and all of a sudden there is no regulation at all, regardless of the fact that it isn’t “homeopathic” by any stretch of the imagination.

    Unfortunately, for most of the general public, “homeopathic” only means it is found in the “supplement” aisle in the grocery store. I really think if more people knew what “homeopathic” actually meant, they would be far more dismissive of it. Most people are smart enough to realize that it doesn’t make sense.

    Oh, and don’t think that the confusion is a mistake, either. It is clearly part of the campaign of the snake-peddlers, who use the “allopathic” moniker to imply the dichotomy of allopathic vs homeopathic. If allopathic is “doctor based medicine” then homeopathic is, apparently, everything else!!!!!

  28. #28 Marcus Ranum
    June 18, 2009

    I bet they wouldn’t let me get away with selling homeopathic LSD.

  29. #29 techskeptic
    June 18, 2009

    Who Knew?

    I knew

  30. #30 Richard
    June 18, 2009

    I’m ashamed to admit that I use a homeopathic preparation for external ear infections. But I’m a true believer! They work!

    Of course, inactive ingredients include glycerin as a vehicle and a quaternary ammonium compound as a preservative.

    (Actually, it pisses me off to pay 7 bucks for 2 ml of glycerin with antiseptic, so I now use 1X Iodine, which is a stronger and broader disinfectant, anyway.)

  31. #31 Pablo
    June 18, 2009

    Certainly. Homeopathy (by the most common definition) qualifies as quackery because (among other reasons) it has no active ingredients. Zicam is NOT homeopathic by that definition, so there is no contradiction.

    Be careful here. Homeopathic is not “defined” by having “no active ingredients.” Granted, it is usually that case in effect, but having no active ingredients is not a requirement for homeopathy. A 2C solution could still be homeopathic, and would have plenty of solute.

    On the other hand, there are definately problems in calling this stuff “homeopathic.” For example, recall that the principle of homeopathy is that you start with something that causes the same symptoms as those you are trying cure and then diluting it to the point where it doesn’t just “not cause” the symptoms, but makes them go away. In principle, how far it has to be diluted is an empirical determination.

    So what I am wondering. At what concentration does the active ingredient in Zicam actually cause the symptoms that is supposed to cure? Does it cause runny nose, coughs, and sneezing? Apparently at 2 parts in 100, it does not cause these symptoms (and just kills your olefactory – not quite a runny nose).

    So while “no active ingredients” is not really a definition of homeopathy, that is no consolation for Zicam, which doesn’t satisfy the actual one, either.

  32. #32 chris
    June 18, 2009

    Pablo wrote:

    It’s almost as if companies are using that label as an excuse to sell something without having to submit it to regulatory consideration.

    I don’t think that there is any question about it. This is exactly what is happening. What a perfect loophole to dump any garbage into a bottle and sell it as “medicine” — just call it homeopathic. Hell, you could put cat vomit in a bottle call it homeopathic and sell it as an emetic. Feed the cat fresh fish and you could label it as organic too!

  33. #33 Pablo
    June 18, 2009

    Chris – sorry, I’m not sure what emoticon would have been appropriate there. I was being a little disengenious with that comment.

  34. #34 John M 307
    June 18, 2009

    I am confused about the law exempting homeopathic remedies from FDA regulation. Does that mean that anything can be called homeopathic, and thereby be exempt? Or would labeling something homeopathic when it’s not be fraudulent?

    The notion of demanding every molecule be identified in a homeopathic liquid can’t be seriously entertained. Not only would it take probably the age of the universe to identify every molecule in a single small container, every container’s contents would be rather different.

  35. #35 chirs
    June 18, 2009

    No apology necessary Pablo. I missed the facetious tone. Is there a facetious or saracastic emoticon?
    Cheers.

  36. #36 Raging Bee
    June 18, 2009

    Was Zicam really “homeopathicallly prepared?” I never heard any claim to that effect in the ads I’ve seen. In fact, those ads (IIRC) portray it as the kind of reliable mainstream medicine you can get right alongside all the other cold, cough and allergy stuff at your local chain drugstore.

    My theory is, the word “homeopathic” was just stuck on so the drugmaker could get past the regs.

  37. #37 EJS
    June 18, 2009

    So Stan, then blame the makers of Zicam for 1) putting a harmful heavy metal based product on the market and 2)exploiting the public’s ignorance by calling it homeopathy. Do not however, use the Zicam kerfuffle as ‘evidence’ to debase homeopathy, since its not homeopathy in the first place. My point (again) is that its faulty logic to assign both a state of chemical intertness (based on dilution) *and* harm at the same time. If something doesn’t work at all, ever, for anything, then it can never hurt you or help you – right?

  38. #38 Stu
    June 18, 2009

    Do not however, use the Zicam kerfuffle as ‘evidence’ to debase homeopathy

    Of course, this is a gray area. Homeopaths see it as homeopathy, when in the concentrations Zircam was using it kind of flies in the face of their overarching principle.

    So do we believe what homeopaths say, or what homeopaths do?

    Or do we just split the difference and call it all for what it is: bullshit? (In the case of Zicam: dangerous crap that MIGHT help and also MIGHT cause permanent nerve damage for the common fucking cold, something that goes away by itself in less than a week?)

  39. #39 Adrienne
    June 18, 2009

    EJS asked If something doesn’t work at all, ever, for anything, then it can never hurt you or help you – right?

    It hurts you that you are believing in the efficacy of a method (homeopathy) that doesn’t work.

    It hurts you in that you are paying a lot of money for water or else a sugar pill..or worse, for some unregulated substance with harmful substances in it.

    It hurts you if it keeps you from pursuing real evidence-based medical treatment.

  40. #40 Scott
    June 18, 2009

    Be careful here. Homeopathic is not “defined” by having “no active ingredients.” Granted, it is usually that case in effect, but having no active ingredients is not a requirement for homeopathy. A 2C solution could still be homeopathic, and would have plenty of solute.

    Not what I meant. Having no active ingredients is not the definition, but a consequence of that common definition, which involves the *repeated* dilutions homeopaths so firmly insist are crucial to potentize the remedy. By everything I’ve heard and read from homeopaths themselves, 2C would usually be considered an exceedingly weak preparation not even worth considering using.

  41. #41 Pablo
    June 18, 2009

    Was Zicam really “homeopathicallly prepared?” I never heard any claim to that effect in the ads I’ve seen. In fact, those ads (IIRC) portray it as the kind of reliable mainstream medicine you can get right alongside all the other cold, cough and allergy stuff at your local chain drugstore.

    This is what I am wondering about as well. Zicam is supposedly a zinc product. But zinc, if you will recall, has been previously touted as a CURE for cold symptoms. As I noted above, in order to be homeopathic, full dosage zinc would need to cause cold symptoms, not cure them (I have heard some claim that apparently this has been shown, but I find it strange that the same thing that cures cold symptoms in full dosage also causes them).

    No, what the makers of Zicam are doing here is relying on the public’s vague notion that zinc is good for curing colds with their ignorance of what homeopathy is and putting them together into a fancy marketing scheme. This is ZINC, which is good for you, but it is homeopathic, so it is safe!

  42. #42 Adrienne
    June 18, 2009

    On a related note…it always bothered me that Cold-Eez zinc lozenges, which I habitually take whenever I start to get a cold, has always advertised itself as “homeopathic”.

    I figured they didn’t really mean it, they were just putting a buzzword on the box to appeal to the altie crowd.

  43. #43 trrll
    June 18, 2009

    So, let me get this straight. The ‘homeopathic’ drug Zicam is being pulled for its ability to effect a negative (ie damaging) consequence. Yet, the ranters and ravers take this as ‘evidence’ that CAM practitioners are scammers, since they advocate such ineffectual medicine?

    The problem is that true homeopathic (diluted to a concentration of effectively zero) preparations are reasonably assumed to be safe, and are exempted from the requirement of proof of safety, on the basis that they contain no active ingredients and thus are incapable of doing anything, good or bad. But the homeopathic label has here been used to exempt a real medication containing a pharmacological concentration of zinc, an active ingredient. There is in fact some evidence that zinc-containing medications can be effective in reducing the severity of colds. But real medications can also have real side effects, so the manufacturer thus should be required to produce evidence to establish safety, particularly in view of anecdotal reports of damage to the senses of smell.

  44. #44 Roland Branconnier
    June 18, 2009

    Quackery by any other name is still quackery. You might as well put your money in the trash. Who would have ever guessed that Americans would pay $1.59 for a bottle of H2O that can’t be distinguished from NY tap water! There is one born every minute!

  45. #45 Tsu Dho Nimh
    June 18, 2009

    I could make 1X solution of Ars Alba and market it to cure something.

    And the FDA couldn’t do anything about it, despite it being 10% arsenic.

  46. #46 cervantes
    June 18, 2009

    I’m not sure why you’re so down on the idea of NCCAM doing a clinical trial or two on homeopathic remedies — especially if, as you say, the homeopaths themselves are clamoring for it.

    Yes, it would cost some money that could be used to test actual promising treatments, but on the other hand, when the stuff is proven worthless, if that helps convince a few people not to waste their money and not to avoid legitimate medical services, will that not be worthwhile? I really don’t get your logic on this.

    The reason to do some RCTs is because, like it or not, a lot of people believe in this, the quacks are always flacking badly done studies that seem to show a benefit, and there is value to society in shutting them up. I don’t mind spending a little taxpayer money on that.

  47. #47 Tsu Dho Nimh
    June 18, 2009

    @45 – READ the article: “The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007″

    They are not going to test any more, because it’s a waste of money that could go towards testing reiki, kung-fu, the curative merits of unicorn poop and other equally implausible ways of curing people.

  48. #48 angela
    June 18, 2009

    Wonderful article, I always enjoy your writing :)

    In Canada we have Bill C-51 ‘on the table’ with the purpose of

    2.3 The purpose of this Act is to protect and promote the health and safety of the public and encourage accurate and consistent product representation by prohibiting and regulating certain activities in relation to foods, therapeutic products and cosmetics.”
    http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3398126&File=33#3

  49. #49 D. C. Sessions
    June 18, 2009

    They are not going to test any more, because it’s a waste of money that could go towards testing reiki, kung-fu, the curative merits of unicorn poop and other equally implausible ways of curing people.

    Correction: “other more plausible ways.” You can thank me later.

    Or was that “spank me later?” Whatever.

  50. #50 cervantes
    June 18, 2009

    $3.8 million spent on clinical research over 5 years is chump change. That’s less than the cost of a single study in environmental epidemiology and a fraction of the cost of a typical Phase3 clinical trial. You are missing the point — the reason to spend the money is not because you think the treatment is plausible, it’s because people are spending hundreds of millions of dollars a year on it, it’s being touted as scientifically proven, and it’s worth spending the dough to debunk it.

    Why is that so hard to understand?

  51. #51 Scott
    June 18, 2009

    Yes, it would cost some money that could be used to test actual promising treatments, but on the other hand, when the stuff is proven worthless, if that helps convince a few people not to waste their money and not to avoid legitimate medical services, will that not be worthwhile? I really don’t get your logic on this.

    What makes you think that people who aren’t convinced by the already-overwhelming mountain of evidence will be convinced by adding a few more nails to the coffin? (Yes, I’m mixing my metaphors. I think the point is clear, though.)

    The problem is that people who believe in homeopathy (or other forms of quackery) are either uninformed, or basing their belief on something other than the evidence. For the former, education is the answer, not more studies. The latter are impervious to logical argument, so more studies won’t convince them.

  52. #52 Stu
    June 18, 2009

    it’s being touted as scientifically proven, and it’s worth spending the dough to debunk it.

    No it’s not, because people won’t listen. Several studies have thoroughly debunked acupuncture, but it hasn’t made a dent in the magical needle-sticking business.

  53. #53 James Sweet
    June 18, 2009

    @Cervantes: I would really like to agree with you, but to echo what Scott said, there is a lot of reason to believe that firmer evidence of the inefficacy of homeopathy would not be very effective at convincing the already-convinced:

    http://www.timesonline.co.uk/tol/comment/columnists/daniel_finkelstein/article6485447.ece

    I think the money would be better spent getting the word out about the research that has already been done, and about what homeopathy really is. Those who have not yet been completely won over to the dark side can be convinced — but it’s not going to be on the basis of more and larger clinical studies, it’s going to be on the basis of them being equipped with the knowledge that is already out there before Big Woo gets to them.

    Okay, now all that being said, I agree with you that $4 million is chump change, and I’m not going to get my panties all up in a bunch if NCCAM keeps spending government money of that magnitude on homeopathy research. I honestly don’t really care either way, as long as the research gets reported honestly (which is maybe a bigger problem…)

  54. #54 D. C. Sessions
    June 18, 2009

    Okay, now all that being said, I agree with you that $4 million is chump change, and I’m not going to get my panties all up in a bunch if NCCAM keeps spending government money of that magnitude on homeopathy research. I honestly don’t really care either way, as long as the research gets reported honestly (which is maybe a bigger problem…)

    Well, that’s the other thing. All of those NCCAM homeopathy studies concluded that they were indeterminate and more study was needed. At best that makes them useless for educational purposes, but we’re not in an “at best” situation.

    Instead, we have people like Ullman and Panozzi who cherry-pick through the NCCAM papers and quote-mine them for what sounds like proof that homeopathy does work.

  55. #55 James Sweet
    June 18, 2009

    Well, that’s the other thing. All of those NCCAM homeopathy studies concluded that they were indeterminate and more study was needed. At best that makes them useless for educational purposes, but we’re not in an “at best” situation.

    Okay, now that’s something to be incensed about. Argh….

    I’ve been telling people all about the File Drawer Effect as soon as I learned about it. If the only studies you can find about some promising new treatment end with “more study is needed”, that probably doesn’t mean that scientists are too lazy to study it, it probably means they did and found bupkis.

  56. #56 Michael Simpson
    June 18, 2009

    You do realize that the point of this is not to debase homeopathy, which is completely useless, scientifically laughable, and pseudoscience at it’s best, it’s to criticize the fact that a company used a legal loophole to get around safety and efficacy standards of the FDA for prescription and OTC drugs. That homeopaths and real scientists think that Matrixx abused the system is kind of ironic, if not downright hysterical.

    By the way, the punishment of Matrixx’s abuse starts with the stock market. Their stock price is down about 70%.

  57. #57 D. C. Sessions
    June 18, 2009

    By the way, the punishment of Matrixx’s abuse starts with the stock market. Their stock price is down about 70%.

    Which means that there are some smokin’ deals on that stock, because their business isn’t down anywhere near that much and the fines are cheaper than doing actual studies.

    They’ll be back doing more of the same PDQ, profits will be up again, and those who bought in now will make out like bandits.

    Disclaimer: I’ve lost money on every stock trade I’ve ever made. Anyone who takes the above as financial advice is a fool and will soon discover what happens to fools’ money.

  58. #58 sailor
    June 18, 2009

    “I’m ashamed to admit that I use a homeopathic preparation for external ear infections. But I’m a true believer! They work!
    Of course, inactive ingredients include glycerin as a vehicle and a quaternary ammonium compound as a preservative.
    (Actually, it pisses me off to pay 7 bucks for 2 ml of glycerin with antiseptic, so I now use 1X Iodine, which is a stronger and broader disinfectant, anyway.)”
    You could try a very cheap remedy used by scuba divers. mix vinegar and denatured alcohol in equal proportions. Drop into the ear.

  59. #59 Prometheus
    June 18, 2009

    I’m a bit surprised that “Big Pharma” hasn’t capitalised on the “homeopathy” gambit. After all, you could just as easily say that each Lipitor tablet (10mg) is actually a 2X homeopathic dilution of atorvastatin.

    I bet that would be a lot cheaper than actually testing their next statin or “erectile dysfunction” cure. And think of the potential for direct-to-consumer sales (esp. for the ED cures)!

    There are a growing number of so-called “homeopathic” remedies that are nothing of the sort, unless you consider 2X and 1C “dilutions” as homeopathic. These are nothing more than oportunistic “small pharma” companies using the FDA’s homeopathy loophole to sell pharmaceuticals without the expensive and time-consuming (not to mention profit-consuming) safety and efficacy testing.

    There are also a number of “small pharma” companies exploiting the DSHEA “suuplement” loophole to market un-tested drugs as “supplements”. Eventually, people will get hurt and die from these practices. And since Congress has handcuffed the FDA, it will take hundreds of deaths – as it did with ephedra – to let the FDA move in and prevent these companies from lying to the public.

    There are people who see this as a “health freedom” issue, but where is the “freedom” to make your own choices when companies are allowed to lie to the consumer?

    Prometheus

    P.S. Sailor – try mixing vinegar with mineral oil (and a small amount of hair shampoo for emulsifier) for “swimmer’s ear”.

  60. #60 James Sweet
    June 18, 2009

    I’m a bit surprised that “Big Pharma” hasn’t capitalised on the “homeopathy” gambit. After all, you could just as easily say that each Lipitor tablet (10mg) is actually a 2X homeopathic dilution of atorvastatin.

    I bet that would be a lot cheaper than actually testing their next statin or “erectile dysfunction” cure. And think of the potential for direct-to-consumer sales (esp. for the ED cures)!

    I could be wrong, but I imagine the reason is because then it wouldn’t be covered by insurance.

    I have heard it said — and I have no credible source, so take this with a grain of salt — that a lot of the supplements and homeopathic remedies are manufactured and sold by subsidiaries of “Big Pharma”. If I may don my tinfoil hat for a bit, it almost makes one wonder if the pharmaceutical companies are already doing what you say for drugs that don’t work out the way they were hoping. “Damn, we can’t get FDA approval? Well, dilute it, market it as homeopathic, and we can at least recoup some of our losses.”….

    Meh, okay, conspiracy theory time over.

  61. #61 Knurl
    June 18, 2009

    I’m a bit surprised that “Big Pharma” hasn’t capitalised on the “homeopathy” gambit.

    I’ll bet all I own and all I know that they tried, but it didn’t work. Being a corporate accountant you can take my word that the bean counters would insist that such cost reduction possibilities are investigated.

  62. #62 Mike
    June 18, 2009

    If I recall correctly, zinc *is* effective, in small doses, in ameliorating a sore throat. So something cold-eeze can be good. There is no evidence that spraying it in your nose helps at all.

  63. #63 Cat
    June 19, 2009

    Based on scant evidence that zinc *may* reduce the severity and duration of a cold, I recently bought a bag of zinc lozenges. I felt that feeling in the back of my nose that indicated one might be coming on, and zinc is potentially more effective if you take it within 24 hours of first symptoms, assuming the stuff actually works.

    So! Imagine my surprise when the familiar bags of Cold-Eeze no longer have “zinc gluconate” as their active ingredient. Instead, it says “zinc gluconicum 2X (13.3mg) Homeopathic Cold Remedy”.

    Since when is 13.3mg of an active ingredient considered homeopathic? Especially an active ingredient that does not adhere to the “law of similars”?

    Insanity. Close this loophole now.

  64. #64 Rogue Medic
    June 19, 2009

    Homeopathy Warning!

    Don’t tell.

  65. #65 chris
    June 19, 2009

    James Sweet wrote:

    Meh, okay, conspiracy theory time over.

    That wasn’t really a conspiracy theory unless you add that ‘BigPharma’ worked with the government to get the homeopathy exemption so that they could then market useless or dangerous pharmaceuticals without oversight. Of course, that may be precisely what happened. Not all conspiracy theories are wrong.

  66. #66 zayzayem
    June 22, 2009

    One of the reasons I suspect that Big Pharma doesn’t regularly use this gambit is because they don’t have to. They already reap in heavy profits by selling regulated medicines that *gasp* actually work. They have far much to lose if/when they get caught out.

    Small-Mid Pharma however is probably a different story.

    Some of the pro-homeopathy people here are correct. This story is not really geared towards creating a stronger argument that homeopathic principles do not work (not that there isn’t enough of that material about) – this story quite rightly gives a great example to show what an awful industry is created when you bypass regulation and scrutiny by automatically assuming that all your chemicals are only safe, natural and positive (which is a central principle in homeopathy).

  67. #67 Phil
    June 22, 2009

    There’s no doubt that true homeopathic remedies are safer than conventional pharmaceuticals. They are, after all, water. Unfortunately, they are as effective as water against the diseases and conditions for which homeopaths recommend them; that is, not effective at all.

    Oh, I dunno. In that case I can think of one condition for which a homeopathic remedy might actually be effective: dehydration.

  68. #68 Hank Roberts
    June 24, 2009

    Here’s another one to watch:

    http://www.google.com/search?q=Nasal-Ease+“Hi-Tech+Pharmacal”+Zinc

  69. #69 Hank Roberts
    June 24, 2009

    > evidence

    Bogus.

    This site:
    http://kaoallergyasthma.blogspot.com/2009/02/what-is-zincum-aceticum-and-does-it.html

    Answers a question on the claim about zinc and colds, with comment:

    “… The first study has been completely discredited because the physician in charge neglected to mention to the Annals that he was a significant stockholder in the company. The second study had weak methodology and has influenced neither myself or any other physicians to recommend zinc. Note that this was done almost 20 years ago and with no other studies.”

    Anyone have a summary list of how many nasal zinc spray products are being sold under various names? I sure hope this gets action finally. I complained to the FDA more than a decade ago about this stuff and never got any response at all. I’m sure others must have.

    Where are the class action lawyers on this? Drafting, I hope.

  70. #70 Kismet
    June 25, 2009

    Rev. BigDumbChimp said: “this has been said before, but NS if the “alternatives” work, guess what. They are not longer alternatives. They are medicine.”
    This is true or wrong depending on your definition of “alternative”, do we call Vitamin D & K “alternative treatments” if healthy people take them? We know they’re promising – but not yet fully proven and studied, although, most probably safe and benefical. Evidence based medicine is studying both for various conditions but we’re only at the stage of “generally considered safe” + good epidemiology + animal data + early studies (รก la phase I/II trials if speaking in pharma terms).
    They’re definitely not (yet) recommended by many physicians e.g. for reasons of liability, but also because most physicians are ignorant of the literature. Personally, I call that sort of “evidence based speculation” “alternative [medicine]”, but that’s just me.

    Mike, I don’t think so. AFAIK it’s only zinc at high doses (we’re talking acetate or gluconate lozenges) that may be effective…

    See for instance:

    Duration and severity of symptoms and levels of plasma interleukin-1 receptor antagonist, soluble tumor necrosis factor receptor, and adhesion molecules in patients with common cold treated with zinc acetate.
    Prasad AS, Beck FW, Bao B, Snell D, Fitzgerald JT.
    J Infect Dis. 2008 Mar 15;197(6):795-802.

  71. #71 Dan
    January 7, 2010

    How can you call homeopathy pseudoscience if it is causing dangerous side-effects?

  72. #72 W. Kevin Vicklund
    April 5, 2011

    Aside from zinc anosmia, here’s what the AP found:

    But an Associated Press analysis of the Food and Drug Administration’s side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.

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