Mar 24 2014

Homeopathic Products Recalled for Containing Actual Drugs

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20 responses so far

20 Responses to “Homeopathic Products Recalled for Containing Actual Drugs”

  1. killerbeeeon 24 Mar 2014 at 11:17 am

    Zicam isn’t actually homeopathy as zinc acetate and zinc gluconate are present in the solution, a fact the label clearly stated. Given that you defined homeopathy and then incorrectly ascribed it to Zicam seriously calls into question your credibility.

  2. carbonUniton 24 Mar 2014 at 1:18 pm

    http://donotlinkl.com/www.drz.org/asp/store/DetailPage.asp

    “European practitioners report that Pleo™ Fort apparently promotes normal bowel flora in the gastro-intestinal tract (especially after antibiotic therapy)…”

    Oh, the irony!

    http://donotlinke.com/www.evitamins4u.com/pleofortdrops

    “PRODUCT DESCRIPTION: Fortakehl is obtained from the mold fungus Penicillium roquefortii; it is not an antibiotic and does not produce antibiotic substances. Therefore, there is no occurrence of side effects that may occur during an antibiotic treatment, such as allergies, liver damage, destruction of the intestinal flora, and the formation of penicillin-resistant strains.

    INGREDIENTS: Penicillium roquefortii”

    Whoops!

  3. carbonUniton 24 Mar 2014 at 1:23 pm

    Stupid gremlins got into both above links. (Is there any way to edit comments after posting?)
    http://donotlink.com/www.drz.org/asp/store/DetailPage.asp
    http://donotlink.com/www.evitamins4u.com/pleofortdrops

    I’m (poorly!) prefixing these urls with donotlink.com to avoid contributing search ranking to those pages.

  4. palwadoron 24 Mar 2014 at 3:34 pm

    I don’t understand this. Why homeopathy still being sold legally? How is it not fraud to sell Homeopathic remedies? This doesn’t make any sense to me.

    I mean, they must be claiming that their “medicine” have some valid effect, right? And since it has been proven beyond all possible doubt that it does not, why is it still okay to sell it?

  5. Draalon 24 Mar 2014 at 10:10 pm

    There’s got to be something more to this that what meets the eye. A cursory lit search revealed that Penicillium roquefortii (blue cheese mold) and Penicillium glabrum (common food spoiler) are not known to produces beta-lactams. Since the FDA warning does not say that beta-lactams were actually found (I interpret that to mean the fermentation process has the potential but was unproven to have made beta-lactams), I am guessing there are three most likely possibilities,
    1) An FDA employee thought that strain with the genus Penicillium sounded like it could be dangerous
    2) The fermentation process was actually contamination by a strain of Penicillium chrysogenum, Penicillium notatum, Aspergillus nidulans or Penicillium nalgiovense which do produce beta-lactams.
    3) The P. glabrum and P. roquefortii genomes were sequenced and open reading frame were annotated as homologs of pcbAB, pcbC and penDE. (oh, wait, I can test this! …. BLAST results:
    P. roquefortii and P. glabrum genomes have no protein of DNA homology for pcbAB, pcbC or penDE.) So… how are strains that ‘should’ not make beta-lactams are suspected of making beta-lactams?

  6. Steven Novellaon 25 Mar 2014 at 8:37 am

    killerbee – you completely missed the point. Zicam is marketed as homeopathic, but it isn’t really because it contains active ingredients.

    I wrote above: “However, some specific products have been found to have functional levels of active ingredients, so they are not truly homeopathic.”

    You must have missed that.

  7. Kawarthajonon 25 Mar 2014 at 9:52 am

    @killerbee:

    from the Zicam website:

    “Is Zicam® regulated by the FDA?
    The active ingredients in all Zicam® Cold Remedy products – zinc gluconate and zinc acetate – are listed as drugs in the Homoeopathic Pharmacopoeia of the United States (HPUS) which is a compendium recognized in the Federal Food, Drug, Cosmetic Act [FD&C Act]); as such, these products are classified by the FDA as OTC homeopathic drugs. All Zicam® products are sold over-the-counter in accord with FDA’s guidelines.” http://www.zicam.com/faqs_zicam/

    Funny that one perceived mistake that Steve makes (which turns out not to be a mistake at all) calls into question his whole credibility.

  8. Bruceon 25 Mar 2014 at 10:21 am

    I have a few mainland European friends who will call herbal remedies “homeopathic” despite them containing active ingredients. I often wonder if it is an error in translation, an intentional misrepresentation of homeopathy by sCAMmers on the mainland or a completely unintentional misunderstanding of what homeopathy is by my friends (though it seems to be widespread).

    If I were one to believe in conspiracy theories I would almost think homeopathic sCAMmers are trying to grab on to the coat tails of the one area of CAM that does have some (debateable) efficacy.

  9. ccbowerson 25 Mar 2014 at 10:23 am

    To elborate what Steve wrote when he corrected killerbee, the problem is more than just one of “marketing.”

    Once categorized as a homeopathic product by inclusion of the ingredient(s) in the Homoeopathic Pharmacopoeia of the United States, homeopathic products bypass any requirements that are normally necessary for new drugs, as they are automatically exempt from having to demonstrate efficacy or safety prior to marketing and selling those products. Of course if there weren’t such an exemption, this would not be an issue, because there would be no homeopathic products approved for use.

    If there was a problem with calling those Zicam products homeopathic when they really weren’t, that is the fault of the makers of Zicam, not the person who points out this inconsistency. Unfortunately there doesn’t seem to be specific requirements for dose for a product to be called homeoopathy. In other words, specific dilutions are not required, which can lead to problems such as this. The main recourse is for the FDA to demand safety data when problems arise, which is a poor way to regulate something that is claiming to be a medication.

  10. Remi_Gauon 25 Mar 2014 at 11:29 am

    On a tangeant: that reminds me of the time when I was doing my PhD in a neuropharmacology lab in Paris and we received samples from Boiron to run HPLC on to confirm they only contained water… They were afraid that some of their products had been “contaminated”.

  11. Bronze Dogon 25 Mar 2014 at 11:31 am

    Real drugs have to go through a series of clinical trials so that the pharmaceutical companies can demonstrate safety and efficacy. They do this in order to get approval by the FDA, which is necessary for them to market the drug in the US. This process is expensive and it often turns out negative, with a drug that won’t work as they hoped and can’t be sold for that intended purpose.

    Homeopathic remedies get a rubber stamp by default, and for a homeopathic product to get taken off the market, someone else has to demonstrate something’s wrong with it.

    How exactly is this fair?

    Which of the two methods would you find more trustworthy?

    I have the feeling Killer Bee just scanned the article for key words and noticed Zicam. Without reading, xe presumed you didn’t have anything to say about it beyond using it as an example of homeopathy, triggering a comment script. I’ve seen my share of trolls who seem to think like primitive search bots, rather than perform the complex human task known as “reading for comprehension.”

  12. Draalon 25 Mar 2014 at 12:10 pm

    We know that homeopathic remedies are bunk.
    But what is the FDA doing here?
    There are no reported cases of adverse side effects and no report of actually finding penicillin or derivatives. The company reports to use two Penicillium strains (one being a strain of blue cheese mold), both of which are known not to produce beta-lactams. The genomes for both of these strains are publically available. Neither genomes contain DNA or protein sequences that share any homology to the well characterized penicillin biosynthetic pathway. IF they detected penicillin, the presence would be caused by either a second mold strain that can make penicillin contaminating their fermenter (fairly likely as many home brewers know) or the strains they are using actually picked up the biosynthetic gene cluster through horizontal gene transfer (a common feature of secondary metabolite pathways), akin to a strain obtaining antibiotic resistance through gene transfer from another strain. This is less likely, IMO.

    As I see it, the recall is not based on sound evidence. Yes, I would love to see the removal of all homeopathic remedies but there’s something that does not add up in this case of potential contamination.

  13. Steven Novellaon 25 Mar 2014 at 1:04 pm

    Draal,

    As far as I know the FDA has not disclosed the details behind their warning. I will keep looking.

    The only justification they have for regulating homeopathic products is if they contain regulated drugs. So they do keep an eye on that. The company appears to have gone along with the FDAs concerns and are not challenging it, again, as far as I can see.

    Your hypotheses seem reasonable as explanations for the FDAs actions – perhaps it is a contaminant. Quality control within the homeopathy industry is pretty poor, so they may just be erring on the side of caution here.

  14. carbonUniton 25 Mar 2014 at 1:07 pm

    I’ve considered staging a homeopathic overdose in front of the management of a local high end grocery store which carries homeopathic products. Problem is, it would seem to be an unsafe thing to do! How do you know that what you are consuming is “real” pure homeopathic drugs (i.e. water or harmless filler) instead of something that is contaminated or has some extra “natural” ingredients to help it along.

    I often get the feeling that “homeopathic” is being used as a synonym for “home remedy”.

  15. pdeboeron 25 Mar 2014 at 1:17 pm

    Thanks Killerbee, you gave me an excuse to look up Zicam. The preparation of Zicam is homeopathic in that they use the 1X and 2X dilutions which are 1/10 and 1/100.

    According to wikipedia this would still be a homeopathic preparation. I know that common dilutions are 30C or in the range above 12C where it is likely to contain no molecules of the active ingredient.

    So Steve, despite it not being the normal practice of homeopathy, isn’t it still homeopathy?

    However, since in homeopathy, the strength of the potion correlates to the dilution, then Zicam should be a very weak homeopathic preparation.

    As an aside, Zicam trademarks Pre-Cold! They have trademarked the condition that they claim you have before a cold! I’m going to trademark Flu and Cold and sue the pants off of everyone!

  16. carbonUniton 27 Mar 2014 at 12:23 pm

    How the hell can a 1x or 2x dilution be called homeopathic? In homeopathic terms, that’s really weak stuff! In real world terms, it has meaningful quantities of the ingredient. From what concentration of the ingredient did they start? If you dilute the ingredients by small powers of ten, do you get to call resulting concoction homeopathic?

    With respect to a homeopathic overdose, it would be a really bad idea for stuff at low dilutions!

  17. Bronze Dogon 27 Mar 2014 at 1:57 pm

    The fact that they’re using 1X and 2X dilutions has me wondering if the ones in charge know it’s bunk at higher dilutions, but are testing the limits of their loopholes to find out just how much active ingredient they can have. If they can add a proven drug, they get to compete with pharmaceutical companies by continuing to cut corners on quality standards. If they get to add other chemicals that have noticeable side effects, they can point to those side effects as evidence it’s doing something and hope that skeptics don’t notice it’s not the usual ridiculous 30C.

    …What’s the typical homeopathic starting point before the dilutions, again? I know in normal chemistry, you express it in moles per liter of solvent or how many parts per million/billion. The math would be simple from there if the active ingredient is a simple chemical, but I’ve heard of ingredients in the form of whole herbs and animal parts like duck liver. I’ve also heard of zanier homeopaths who claimed to have used ingredients like “Berlin Wall” and tachyons.

  18. OpenMindedNotCredulouson 29 Mar 2014 at 9:53 pm

    @killerbeee you say

    “Zicam isn’t actually homeopathy….

    Yet their own FAQ states quite clearly (at least as of this message) that they consider their product to be homeopathic: http://www.zicam.com/faqs_zicam/

    Will you change your assertion given the facts?

  19. Draalon 30 Mar 2014 at 7:28 pm

    The dilutions used by Zicam do no follow the original process designed by Samuel Christian Hahnemann; a 10 fold or 100 fold dilution does not make it homeopathic as it was the original conceived. I believe the mother tincture is 1 gram/part of substance and 99 grams/parts of water or ethanol.
    So is Zicam homeopathic or not?
    Yes and no, IMO. No because it does not adhere to the process as describe by Hahnemann way back when. Yes because definitions of words in a language are allowed to change. It is a fallacy to insist on historical definitions over contemporary ones; also multiple definitions are often given for the same word. Basically, Zicam is attempting to redefine what is homeopathic is intentionally. Since homeopathic is not a scientific term, its definition does not require it to be strictly defined as in actual medicine. That being said, with respect to discussing a word, it helps if all parties involved in a discussion use the same definition for any given word depending on context.

  20. Draalon 02 Apr 2014 at 5:05 pm

    I called the company Terra Medica and talked to the customer service representative. I was told the following:
    1) the company and FDA tested samples and there were no positive tests for penicillin
    2) there are no reports of adverse side affects reported either to the FDA or Terra Medica due to beta-lactam sensitivity from their products
    3) without any more information provided by the FDA, the representative suggested it was the name of the strains that alarmed the FDA

    So lets set aside the issue of homeopathic medicine. The FDA has asked a company to voluntarily recall their products based on a claim (see the FDA warning) that these stains MAY produce beta-lactam. This claim has virtually no supporting evidence from what we know from microbiology (the genomes are available, the beta-lactam genes and pathways are well know, no homology is in either genome, these strains have never been reported to produce beta-lactam, the strains are very common to find in our food and environment).
    The FDA is saying that Penicillium roqueforti (aka blue cheese mold) has the ‘potential’ to make beta-lactams … So therefore by extension… the FDA should be requesting that any product made with blue cheese should be recalled. (it’s obviously absurd to think this would happen but that’s not my point)

    Lets assume that the FDA is acting under the precautionary principle. But they have put forth a claim that is, given all available information that an arm chair google scholar can dig up, is false.
    Is the FDA acting appropriately or not? – I can see this being viewed on the side of a business being harassed by the FDA on unproven grounds.

    Was this an appropriate blog posting given there is no evidence of harm (for this case only)? Why not turn it around and blog on how the FDA is making a claim not based on evidence (dare you!)? Look, I’m not trying to pick a fight but rather say, “hey, I think this post needs another skeptical look.”

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