Homeopathy Under Attack in California

April 9, 2013
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Homeopathic medicationBecause homeopathic medicines are protected at the federal level, the attempt to eliminate them is coming at the state level.

Homeopathic medicines are protected as legal drugs under the Food, Drug, and Cosmetic Act (FD&C)—which means homeopathic manufacturers can make disease claims. We can thank a brave legislator for insisting on this when the Act was enacted many decades ago. However, unlike conventional drugs, homeopathic medicines do not have to undergo the FDA new drug approval process. Pre-market approval for homeopathic drugs comes from the Homeopathic Pharmacopoeia of the United States (HPUS) monograph, which involves clinical verification of the efficacy of the substance.

Despite federal law, the presence of an HPUS monograph has not protected homeopathic products from a lawsuit under California’s consumer protection law. This is creating an uncertain and expensive business environment for the homeopathic industry and could threaten the marketing of these products in California and other states.

In the 2012 lawsuit of Delarosa v. Boiron, Inc., the plaintiffs alleged that Boiron, the world’s leading homeopathic manufacturer, falsely claimed that its Children’s Coldcalm product would provide relief from cold symptoms, in violation of California consumer protection laws. Boiron argued that the case should not go to trial because the plaintiff’s claims are precluded by federal preemption: the federal definition of a drug, as defined by the FD&C, includes homeopathic remedies like Coldcalm, which are recognized in the HPUS.

The judge denied the preemption. He ruled that Boiron was not protected because the FD&C also contains a preemption exemption for products that aren’t marketed pursuant to FDA approval or final FDA regulation. Trial is set for later this month.

The ruling is significant in that these two sections of the FD&C seem to be contradicting one another. As a result, it creates an opening to claim that the presence of a homeopathic drug in the HPUS is not sufficient under California consumer protection law to prove that the drug is effective.

This isn’t the only California lawsuit attacking homeopathy. Here are some others.

In Galluci v. Boiron, the plaintiffs alleged that Boiron made false claims regarding over twenty-four homeopathic products, that they could effectively treat ailments such as flu, arthritis, sore joints, joint pain, aches, fever, coughs, insomnia, or sleeplessness—again, in alleged violation of California consumer protection laws. Ignoring the principles of homeopathy, the plaintiffs also argued that Boiron’s products are so diluted that they are “effectively nonexistent” and are thus akin to placebo or sugar pills. This is akin to saying that because homeopathic preparations are not like standard drugs, they are fraudulent, exactly the kind of claim that federal protection under the FD&C Act was designed to prevent.

Boiron settled the case for $5 million. It also agreed to place a warning on all its products that “Uses have not been evaluated by the Food and Drug Administration,” and to provide additional data on homeopathic dilution to consumers on their website.

In Allen v. Hyland’s, the plaintiffs alleged that the defendants (Hyland’s and Standard Homeopathy) marketed their homeopathic products as having health benefits while knowing the products had no active ingredients in amounts sufficient enough to cause any beneficial actions, in alleged violation of consumer protection laws. The defendants were unsuccessful in getting the case dismissed, though they did manage to limit the suit to the seven products which plaintiffs actually purchased. The case is still pending.

A couple of things to note here. In none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not treat them as they stated they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you get to sue the company!)

Also, the plaintiff in two of these lawsuits is represented by the same attorneys, the Newport Trial Group. The law firm involved in the third case, Marron and Associates, has been accused by the Newport Trial Group of tracking their homeopathic class action suits and plagiarizing them, in an effort to attract clients to their own potential class actions against homeopathic companies.

Did these law firms recruit the plaintiffs? Are they doing this in hopes of getting multi-million dollar settlements, much of which will go to lawyers? Is this just another chapter in the predatory California lawsuits linked to Proposition 65 that we have written about before? Those lawsuits are about supplements, and these lawsuits are about homeopathic medicines, but the pattern seems similar.

The basic premise of the suits—that in the successive dilutions that homeopathic medicines go through to achieve their final potency, there may be no molecules of the original substance left at those concentrations— is not just an attack on these companies. It is an attack on homeopathy itself. Homeopathic researchers have always struggled to explain why their preparations seem to work, even though clinical evidence says it does.

New scientific research may help. Using a laboratory technique called spectroscopy, researchers have found that different homeopathic medicines and different dilutions of the same medicine can be distinguished from each other, even though all should logically contain nothing but water. One explanation for this is that the repeated dilution and succussion (the forceful agitation of the liquid) during classical remedy preparation may break the substance into immeasurably small nanoparticles, that is, “top-down” nanostructures. A novel model for how homeopathic medicines work on living systems has been proposed by researchers Iris Bell, MD, PhD, and Mary Koithan, PhD, RN, CNS. The traditional theory, that some presence remains without actual particles, is of course more controversial. We will return to the scientific questions underlying homeopathy in another article soon.

While homeopathic medicines do not go through the FDA drug approval process, they are absolutely reviewed for safety and effectiveness. The FDA recognizes the monograph published in the HPUS and administered by the Homeopathic Pharmacopia Convention of the United States, a nonprofit standard-setting organization. Currently, 1,286 official homeopathic drug products are recognized by the HPUS. Moreover, homeopathic drugs are subject to FD&C misbranding provisions, and must comply with Good Manufacturing Practice requirements. If homeopathic substance is “new” (that is, used after 1962), manufacturers most commonly gather evidence for safety and effectiveness through a method specifically designed for homeopathics called “proving.”

What is happening in California is a real threat to homeopathy. As these cases proceed, we’ll keep you informed and also work to develop strategies to protect it from predatory lawyers and a hostile court environment.

135 Responses to “Homeopathy Under Attack in California”

  1. concerned person says:

    I would like to mention Semyon Kirlian who tested his own hand in his machine and was unable to get his usual pattern of emanations no matter how hard he tried. He shortly after became ill and soon realized that he had seen the change in his electrodynamic field prior to the onset of the illness.His work has shown that as a leaf dies its self emissions decrease until there is none. The self emission of living things seems to be a measure of the life force occurring within their system. Here is your proof of life force.

       0 likes

  2. R. Munn says:

    It is obvious to me that there are people out to get an easy buck by these fake law suits. I am a lay practitioner of homeopathy and have been for many years. If you do not follow the exact treatment it will not work. Many things counteract the remedies and people do not listen to the instructions. I have personally observed many successful results on my self from using this science. Big business is doing their thing again and again and we know who they are. AMA, FDA, pharmaceuticals, drug companies, lawyers, and people who live off of law suits ete.,etc.,etc.

       3 likes

  3. maria muldaur says:

    All people should be entitled to choose their own medical care, do their own research and
    take responsibility for their own bodies. I just don’t get the big threat posed to the pharmaceutical companies. All people should be responsible for deciding on their own course of healing and have at their disposal everything that is currently available.

       5 likes

  4. Cranston says:

    To protect homeopathy, become a member on NCH. Go to http://www.nationalcenterforhomeopathy.org

       3 likes

  5. Cranston says:

    Hundreds of studies have been done including double blind to prove homeopathic medicines work. Two have even been published in Pediatrics, one about diahrea and another about ear aches. With the ear ache study, the day after the homeopathic medicines had been given, the objective observations were the same but the subjective symptoms were different. The patients said they felt fine, no more pain.
    I, a layman can divise studies to prove homeopatic medicines work. I would use Arnica to prove it can prevent bruising and Rhus tox as an immunization against poison ivy. Each would only take about three days. I hope the judge will allow such things in the court room. I would also challenge the attorneys bringing this suit to do a proving of Glynonin. This would only take 8 hours. I also challenge Guy Chapman to do this. If he can take ten doses spread out over 8 hours, I will give him $1000.

       1 likes

    • Guy Chapman says:

      It is easy to contact me, if you wish to offer challenges you should do that. I am happy to try a “proving” as long as the substance under proof is independently assayed and proven to be not lower than 12C potency. In practice this means sending the product to a UK laboratory and having a sample tested and shown to be chemically indistinguishable from pure lactose (as per assays of commercially available homeopathic remedies in Canada when tested by CBC Marketplace), then forwarded directly to me not via any intermediary. I don’t think that should be an issue for you other than the cost of the assay.

      It is going to cost you some money to establish confidence that the product is homeopathic, since unlike most users of “natural woo” I tend to be a bit careful what I put in my mouth and have this odd thing about wanting to ensure that any drugs (or even non-drugs) I consume are provably safe or at least have a known and quantifiable risk which I find acceptable.

         2 likes

  6. concerned individual says:

    I keep reading about clinical tests and double blind study, but here is one overlooked fact: Studies are often funded by special interests, and tweaked to the desired outcome. Why is this considered the credible way to go? In fact, hundreds or thousands of years of anecdotal evidence speak much louder than studies or words. Even decades are very reliable measures by which one can see whether or not a therapy is working.
    All this talk about placebo and double blind studies are based on imaginery ideas that these are valid proof. When patients that are tested on BigPharma’s drugs and have side effects, are thereafter lumped into the pre-existing conditions category and therefore the side effects are dismissed, is that a reliable study with a trustworthy outcome?
    As the offspring of a pharmaceutical salesman—that’s right, people with no medical degree peddle drugs to doctors, and the docs get their information from those with gains to be made—I will tell you that my parent quit the field based on ethical concerns, that the studies were often so faked that to get behind such legalized drug-peddling, would not be to society’s best interest. Whence then, the trust in such “studies” as are being demanded all across this forum? Why the doubt in “mere anecdotes” ? In fact, these may be the most reliable indicator of all. Something to think about.

       5 likes

    • Lori Lamb says:

      I have even heard and read that they don’t bother to give all the facts on some drugs that would be very beneficial for the Dr.’s to know. I’ve always had a problem with pharmaceutical reps, they are just well dressed glorified drug pushers. Too much money changing hands and too many scripts being written for perks instead of the best interest of the patient. It’s like the flavor of the month club. I’m glad to hear that your Dad had the integrity to pull himself out.

         1 likes

  7. Mark says:

    The Medical “industry” is a scam and treats and cures nothing. In fact most of it makes people sick. These meidical quacks and con artists including the criminal pharm industry want to protect their right to profit from making people sick. It’s illegal for these quacks to say they cure anything, that should give you a clue.

       1 likes

  8. Pietje Sligcher says:

    Dear readers, what worries me the most is that we as poeple who know that homeopathy works wan’t be able to use it for our grandchildren only because we dont’t have the power and the money that the big industries have to influence politics. Why can’t Ihave the possibility to do with my health what I want??? Why want other poeple take my choice from me???? Here in Holland a new law is coming and in that law is prescribed what seeds we have to use in our garden. Montsana and the bose from Windows are taken over the world and our freedom. We have to join all over the world to stop this.

       8 likes

  9. Guy Chapman says:

    If there was credible evidence, there would be no threat.

    There is no credible evidence.

    The solution is not to fight the threat, but to work on getting some credible evidence.

    Sadly (for you)this is unlikely as it would violate multiple laws of physics.

    In short, you are busted. Bad luck.

       3 likes

  10. Jn Radzik, MD says:

    Homeopathic medicines are highly diluted, and so are immunizations. Sometimes it takes trace or minute amount of inactivated virus, inactivated viral element or of other micro-element to do the job. Homeopathic products and immunizations thus look very similar in this aspect. What one has to pay attention is safety. The statistics from 27 European Union countries that were compiled recently indicated one death from natural product, 21 or so from being hit by lightning, and over 200,000 from prescription drugs. I hope that our agencies that protect us from bad drugs and bad things know this.

       6 likes

  11. Guy Chapman says:

    There are only three problems with homeopathy: there’s no reason to think it should work, no way it can work, and no proof it does work, beyond placebo.

    Homeopaths need to drop the pretence that it’s a system of medicine and be honest about the reality: it’s a religion. It’s authority is drawn from holy writ, the books of Hahnemann and his prophets (people like Kent and Vithoulkas). Life energy has no objectively provable physical existence, but fits nicely with religious mysticism.

    Drop the pretence, admit it’s faith healing, and get the protection that religions routinely claim. You know it makes sense.

       2 likes

    • alek says:

      Mr. Chapman you seem to be ‘mistraknowitall’ and thank you for being the perfect eample of the ultimate Ignorance that tries to rule the world through the big pharma .
      Truth will protect itself if not in courts then in the real world.
      Keep Calm and Use Homeopathy , Guy.

         2 likes

  12. Elisa Orozco says:

    Some years ago, I tried CLARITIN at my doctor’s recommendation. It did NOT work on my allergies. I guess I should have sued the manufacturer! Since then, I have learned to use several homeopathic and natural allergy medications and they work fine. I have used many of the HYLAND products for various reasons, all to my satisfaction. My point is, different remedies work on different people as we are all different. If one thing doesn’t work, try something else. I, personally, will always opt for the natural remedy as first choice!

       9 likes

  13. “Homeopathy Under Attack in California”, I wonder why? Could it be that homeopathy is scientifically implausible or that any high quality double blinded, placebo controlled study has shown it to be no better than placebo? Nah, couldn’t be that.

       2 likes

    • concerned individual says:

      science is based on facts, not assumptions and images in one’s head. Always check out assumptions with facts.

         2 likes

    • concerned individual says:

      Science is based on facts, not assumptions and images in one’s head. Always check out your assumptions with facts, especially if you claim to be science-based.

         0 likes

  14. Homeopathy has NOTHING to do with molecules. It is all about “Life Energy”. I agree with Athanasios that the manufacturers of these wonderful remedies are to blame for misrepresenting their products in a conventional medicall paradigm. There are numerous books and other information sources lauding the value of matching these plant-derived remedies with the human body micro-voltage disruptions due to lifestyle, nutrition and other incongrueties with the homeostasis of the body, human or animal. It is also about PHOTONS as part of the creation of these microvoltages. Photons carry the Universal messages of an optimum health environment.
    Dr, Hanneman is likely turning over in his grave about the abuse of his wonderful discovery of how the living body functions. These companies have dug their own grave and cause us users of remedies to carry the burden of higher costs for their useage.

       4 likes

    • Guy Chapman says:

      It’s true that homeopathy has nothing to do with molecules. It has nothing to do with anything that can be objectively shown to exist, other than the placebo effect.

      “Life energy” has never been observed by any scientific measurement, however sensitive, and there are no anatomical structures associated with it. It also appears to violate the law of conservation of energy and the laws of thermodynamics. Whatever it is, it is a remarkable thing that has such profound effects but cannot be detected by any scientific instrument or quantified in equations or found within even the deepest mysteries of atomic physics.

         1 likes

  15. Malissa McCain says:

    I have an auto immune illness and cannot take most medications. If it were not for homeopathic preparations I don’t know what I would have done while experiencing severe pain from extensive dental work. Homeopathics were the only thing that helped me with the pain while not causing the problems that regular medications cause me.

    Please do not restrict the use and distribution of homeopathic remedies in any way.

    Sincerely,

    Malissa McCain

       11 likes

  16. Jeffrey Langlois says:

    Homeopathic medicines provide a very low cost and very safe natural alternative to synthetic drugs.

       7 likes

    • Guy Chapman says:

      Not really, no. Oscillococcinum, for example, costs as much as other proprietary cold and flu medications but contains no active ingredient and has never had to pass a clinical trial (nor could it: it’s based on a non-existent bacterium).

         1 likes

  17. Jeanne Zinser-Mandala says:

    I have used homeopathic remedies for years. When I was first prescribed a remedy I was skeptical, but was incredibly impressed at how successfully the remedy worked. I have learned that homeopathy was the main medical treatment before the AMA came into being, which was a PR entity formed because people were suspicious of the “new medicine”. We have fallen hook, line and sinker for this PR. There are other healing methods and one should be able to use the one that works best for you. Whether homeopathic, ayurvedic, acupuncture, Chinese medicine, osteopathic, or whatever you have found helps you most, you should be able to use it without worrying about the finances of allopathic doctors. If you are drug sensitve, as many people are, alternatives should be readily available. These other methods certainly should not be considered Alternative Medicines. If this effort suceeds, other methods will be in the sigits of greedy lawyers too.

       5 likes

  18. Donalie Sheldan says:

    I have used homeopathic remedies with astonishingly effective results for over 35 years. I have enjoyed these results without any side effects. However, when I have used pharmaceutical products, I almost always end up not using them because of an unpleasant side effect. Not everyone has as much success as I with homeopathy but I have never heard of anyone suffering any side effects from it.

       7 likes

  19. CAMILLE ANGILERI says:

    IS Homeopathy that much of a threat to Pharm companies? yes because they actually work with no side effects.It is our right to have a say concerning our choice about medication. We should be allowed to use what we feel is right for us not what is profitable for you.

       11 likes

  20. Athanasios says:

    The problem rises from the companies themselves and the claims they make…. Many of the old respected homeopaths, including Hahneman himself, warned about the tendency to treat homeopathic remedies in a way similar to conventional medicine… The way i see it people did not suit individual practitioners, or the homeopathic remedies in general. Just companies that misuse and pervert homeopathy to make a profit.

    Homeopathy is for the treatment of the individual and companies that produce products over the counter making specific healing claims are doing more damage to homeopathy than all the negativity coming from it’s opponents….

       1 likes

  21. Will foster says:

    Ok, so give us something to DO about it, link to register a protest with some gobment official or something!

       3 likes

  22. Placebo, coincidence, power of suggestion, self-limiting conditions and anecdotal testimony provide the “proof” that Homeopathic compounds are effective until double-blind RCTs say otherwise.

       0 likes

  23. Beverly Harris says:

    If you have ever been told by the medical community that they cannot help you or your symptoms, then you know how apathetic and frightening that can be. Be forewarned! I have been there. If it were not for homeopathic therapy, I may not be alive today to tell you this. No one is exempt. Please do everything you can to inform people and negate this dangerous precedent-setting action. People need access to all options on the table to protect their health. The Constitution supposedly protects our rights to treat ourselves medically. But lately, in case you haven’t noticed, our Constitutional rights have been systematically dismantled (privacy rights, habeas corpus, etc. to name a few). Now, is not the time to be complacent regarding our health choices.

       26 likes

    • Edith says:

      I agree with the woman above. I had migraines for 35 years, rating an 8 or 9 out of 10. Had one headache that had rated a 25 relative to the 1 to 10 scale. By the time I began homeopathic treatment I was incapacitated 9 days a month minimum. Prior to that I tried a list of treatments as long as both your arms, and the drugs did not work (take one when the pain starts and one an hour until it goes away–I gave up once after 8 another time after 12 pills doing nothing. Once it stopped the headache after 8 pills, for 4 hours. But the pain was usually gone by 4 pm on the 3rd day. That time the pain stopped at 8 pm instead. It gave me a mediocre pause to the pain). On the right chronic remedy for me, gradually the migraines became milder and eventually stopped completely. The last one was about 4 years ago.

         6 likes

    • Shawn Sargent says:

      You are 1000% right Beverly: America needs to wake up and fight for our rights, before they are all gone.
      I maintain my right to my own medical care, and it is infuriating, when natural medicine is attacked and pharmacuetical medicine gets a free pass.
      Natural, medicine is the way of the future, and it has been practiced for thousands of years.
      We can’t afford to let our guard down!

         3 likes

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