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The CAM Docket: Boiron II

Five consumer lawsuits are pending in the U.S. against Boiron, the world’s largest manufacturer of homeopathic products. One lawsuit is also pending in Canada. As reported in a previous post, the U.S. plaintiffs claim they purchased homeopathic products, such as Coldcalm, Oscillo, Arnicare and Chestal Cough Syrup, based on Boiron’s misleading and false statements that they are effective for various ailments. Therefore, these plaintiffs allege, Boiron has defrauded consumers, as well as violated various consumer protection laws. Boiron denies these claims.

The plaintiffs’ allegations in each of the five U.S. lawsuits are based in part on the same fallacies underlying homeopathy discussed many times before here at SBM:

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

Which raises an interesting question: how does one defend a product that appears to be indefensible? Let’s take a look.

Delarosa v. Boiron

In Delarosa v. Boiron, Inc., the first lawsuit filed and now certified as a class action by the court, there are cross-motions for summary judgment pending. I won’t make you suffer through an explanation of Rule 56 of the Federal Rules of Civil Procedure, which governs summary judgment motions. Suffice it to say that at this point each side apparently feels it has enough uncontroverted evidence to win, at least on some of the issues, without having to go to trial and is asking the judge to rule accordingly.

The plaintiff in Delarosa has the burden of proving Coldcalm does not work as advertised and that Boiron knew or should have known this. Conversely, Boiron, as the defendant, does not have to prove that Coldcalm does work as advertised or that it was unaware that Coldcalm does not work. However, in order to refute the plaintiff’s claims, Boiron has, as one would expect, offered its own evidence that Coldcalm is effective to relieve cold symptoms and that it believes in those claims. And although Boiron argues that the plaintiff cannot prevail simply by attacking homeopathy in general, the plaintiff has submitted evidence that homeopathy does not, and cannot, work. Thus, Boiron has, again as might be expected, submitted evidence on that issue.

Boiron has not yet filed a response to the plaintiff’s summary judgment motion, apparently because of a dispute over information it requested from the plaintiff in discovery. For this and other reasons, we cannot conclude that the evidence presented to this point by Boiron is all that Boiron may possess in support of homeopathy in general and Coldcalm in particular. But we do know that, in filing its own motion for summary judgment, it argues that the evidence is sufficient for the court to decide in its favor. Specifically, Boiron argues that the plaintiff cannot meet her burden of proof in showing Boiron believed its statements were false. “To the contrary,” Boiron argues, it “can provide extensive support regarding the efficacy of both homeopathic drugs generally and Children’s Coldcalm specifically.”

Plaintiff’s expert witness

One of the plaintiff’s experts, Lynn R. Willis, Ph.D, currently holds the position of Professor Emeritus at the Department of Pharmacology and Toxicology at the Indiana University School of Medicine, where he was the director of the medical pharmacology course for 23 years.  [Another expert witness for the plaintiff is SBM's own Harriet Hall, M.D.]

Dr. Willis’s sworn statement in support of the plaintiff’s motion offers this devastating, and unsurprising, analysis of homeopathy in general and Coldcalm in particular:

27. Homeopathy is based upon the ‘Law of Similars.’ Homeopaths assert that ‘like cures like’ or more precisely that one substance that causes symptoms when it is given in large doses will cure illnesses that have the same symptoms if that substance is given in an extremely small dose. There is no credible scientific evidence to support the Law of Similars. In fact, scientific evidence is contrary to the Law of Similars.

28. The dosages of homeopathic drugs are prepared through serial dilution. Serial dilution is done by taking the homeopathic drug and mixing it with water or alcohol at a specific ratio of 1:10 (X) or 1:100 (C). At each dilution the homeopathic drug is shaken in a process called succussion (also referred to as “potentizing”). Succussion is believed to activate the “vital energy” of the diluted substance. No evidence of this “vital energy” has ever been detected by modern science; nor can it be. The serial dilutions are repeated until the desired dilution is reached.

29. The ingredients in Coldcalm, the product at issue in this action, are diluted either to 3C (1:1,000,000) or 6C (1:1,000,000,000,000). There is no scientific evidence that homeopathic drugs, such as the ones found in Coldcalm, have any biological effect on the human body at such extreme dilutions. The dose-response relationship established and proven by modern medicine is contrary to the idea that such extreme dilutions of a medicinal agent can have biological effects on the human body.

30. There is no credible scientific evidence that homeopathy results in anything more than a placebo effect. Indeed, homeopathy theory and practice are contrary to modern scientific research.

. . .

44.The notion that the extreme dilutions found in Cold Calm and other homeopathic remedies should be associated with observable biologic effects and actions is wholly contrary to the proven dose-response relationships of modern pharmacology and medicine in which the intensity of drug action is directly proportional, not inversely proportional, to dose.

45. As outlined in paragraphs 33 through 41, the concentrations of the ingredients in ColdCalm have no detectable effects on the human body; however, as mentioned above, where there is no likelihood of a medicinal agent producing a tangible health benefit to a patient, any risk at all is unacceptable.

Dr. Willis goes through each ingredient in Coldcalm, which includes honeybees, poisonous plants and potassium dichromate (“a powerful oxidizing agent”), finding that, although some are dangerous (even deadly) to humans, at the dilutions stated on the label, none could possibly have any discernible effect on the human body. Dr. Willis opines not only that Coldcalm does not, and could not, have any effect on the common cold, the product itself violates homeopathy’s own precept that each treatment must be individualized, making “one size fits all” remedies inappropriate.

Boiron’s expert

To support its claims of plausibility and effectiveness, Boiron relies on Robert Charles Dumont, M.D. Dr. Dumont trained as, and practiced as, a pediatric gastroenterologist. However, he now describes himself as a “pediatric integrative specialist” with the Raby Institute for Integrative Medicine at Northwestern in Chicago, Illinois.

On its website, the Raby Institute for Integrative Medicine serves up this insult to thousands of dedicated, caring physicians who, poor slugs, practice the obviously inferior “traditional” medicine:

Our approach to healing is unlike what you might experience in a traditional medical setting. Rather than focusing solely on treating the symptoms of a disease or curing an illness, we focus on the whole patient as a unique individual – taking into account each element of a person’s health, environment, and lifestyle. We seek to restore our patients’ unique, natural balance that defines optimal health, and support them to develop health habits that maintain wellness and prevent disease.

“Unique, natural balance that defines optimal health?” What does that even mean?

In pursuit of this lofty goal, the Raby Institute offers a smorgasbord of “CAM” practices previously debunked on SBM and elsewhere, including acupuncture, reflexology, cranial sacral therapy, magnets (“Treatments include shoe inserts, knee wraps, and other bandages, to relieve soreness in joints and muscles from sports injuries”), reiki, the “HCG Longevity Diet,” detoxification, energy medicine, and, our topic here, homeopathy (“based on natural ingredients that work with your immune system rather than suppressing it”).  Well, they’ve got me there.  No one could argue that honeybees aren’t “natural.”

If you will permit me a digression, I cannot resist sharing this lyrical gibberish from the Raby Institute’s website describing a form of CAM with which I was heretofore unfamiliar:

Vibrational Medicine

Nearly everything around us that we touch and see carries a unique vibrational energy signature—a living pulse that connects all things. Vibrational medicine incorporates the use of this chi energy within living organisms such as plants, gemstones and crystals, water, sunlight, and even the foods we eat, to help us balance the energies in our own bodies. Vibrational medicine therapies include color therapy, crystal therapy, flower essence therapies, grounding, and herbal therapies.

If you make it up, they will come.

Turning back to Dr. Dumont and his statement filed in support of Boiron’s motion, Dr. Dumont says that he “received training in integrative medicine to include training in acupuncture, medical hypnosis, functional medicine, and mind-body medicine.” As well, he has trained in homeopathy and is currently instructor and on the board of the U.S. chapter of the Center for Education and Development of Clinical Homeopathy. In this and additional homeopathy-related training and other activities, he appears well-qualified to speak on the subject.

Dr. Dumont seems to be in agreement with Dr. Willis on the putative principles underlying homeopathic remedies and on the manner in which they are prepared. He does not specifically agree or disagree with the Dr. Willis’s conclusion, based on these principles, that homeopathic theory is contrary to current scientific research. In documents filed with the court, the only statement Dr. Dumont makes at all in this regard is that “basic laboratory research is confirming the biological activity of highly diluted substances and helping the scientific community better understand their mechanism of action.” He attaches two exhibits listing studies of homeopathy but does not indicate which specifically support this statement. Nor does he explain how “the biological activity of highly diluted substances” supports any of the highly implausible assumptions underlying homeopathy.

In answer to deposition questions as to whether there was any scientific evidence indicating how Coldcalm’s ingredients (honeybees, etc.) could relieve cold symptoms, he consistently answered to the effect that “the mechanism is not known.” The plaintiff’s attorney finally asked:

Q. do you have any idea how these things [Coldcalm’s ingredients] are supposed work to accomplish these purposes?

A. No one has any hypothesis within the scientific community how they work.

Q. And that includes you?

A. That includes me. I would have the Nobel prize if I knew.

This did not stop Dr. Dumont from opining that Coldcalm is effective as advertised. He says that there are studies supporting “the efficacy of several of the homeopathic medicines present in Children’s Coldcalm,” but does not know of any studies supporting the efficacy of Coldcalm itself. Rather, he relies on the fact that

patients who have used Coldcalm and children’s Coldcalm to relieve symptoms associated with the common cold have had success with these products. . . . My experience treating patients with Coldcalm and Children’s Coldcalm is extremely positive and I continue to regularly recommend both products to patients who are suffering from symptoms associated with the common cold.

When asked in his deposition whether the basis for his belief that Children’s Coldcalm has been effective for his patients “is just spontaneous statements by mothers indicating that it has worked for their children or them, right?” he replied, “Exactly.”  [Homeopaths and their reliance on anecdotes as evidence of effectiveness is the subject of recent blog posts by Dr. Novella.]

In addition, Christophe Merville, Boiron’s director for education and pharmacy development, testified in his deposition that he was unaware of any scientific testing, research or evidence supporting the effectiveness of Coldcalm or Children’s Coldcalm.

In support of its position that Boiron did not defraud consumers because it “believes in the efficacy of both homeopathic drugs generally and Children’s Coldcalm specifically,” Boiron cites Dr. Dumont’s statement and the testimony of one of its employees, Ludovic G. Rassat. It is not clear how Dr. Dumont’s testimony is relevant to this point, as it occurred only after the suit was filed, long after Boiron made its claims for Coldcalm. Mr. Rassat testified in his deposition as follows:

A.  . . . homeopathic medicine is believed to basically stimulate the body’s own ability to – to rebalance itself and get better, so this is all the concept of homeopathic medicine, and this is basically what doctors using homeopathic medicines are doing.

Q. Do you know how Children’s Coldcalm would work to stimulate the body’s ability to rebalance itself and get better?

A. Well, you see, in the back of the product, you have a list of homeopathic active ingredients.

Q. Right.

A. Each homeopathic active ingredients are basically – has been reviewed – have been – are listed in the Materia Medica as being – went through, you know, hundred (phonetic) years of clinical observations by homeopathic doctors, and that’s – all those ingredients are participating to the . . . the action of the product.

Q. Okay. Are you aware of any scientific support indicating that these active ingredients on the back of the Children’s Coldcalm label will be effective in accomplishing the purposes stated [on the packaging]?

A. Again you’re – again, the base of those – those ingredients is the Materia Medica and 200 years of clinical observations by doctors, so that’s the scientific base of those product – those ingredients.

Summation, for now

So, let’s sum up the evidence at this point:

  • Boiron has not come up with any reliable evidence that the basic principles upon which homeopathy depends are scientifically valid, and does not directly contradict plaintiffs’ experts’ statements that those principles are, in fact, scientifically invalid.
  • There are no studies, by Boiron or anyone else, demonstrating the effectiveness of Coldcalm or Children’s Coldcalm for the purposes stated on its own packaging, that is, the relief of cold symptoms.
  • Boiron’s only evidence that Coldcalm and Children’s Coldcalm are effective is anecdotal.

Does this mean that the plaintiff and the class of Coldcalm purchasers she represents will win their summary judgment motion? Not necessarily. Boiron has not filed its response to the plaintiff’s motion and may provide additional evidence when it does. Boiron could prevail on other factual issues, such as the plaintiff’s alleged lack of proof that she or her family members actually had colds when they took Coldcalm (as opposed to, for example, allergies). There are other legal issues to be decided, such as what burden of proof the plaintiff must carry to win her motion. To this point, Boiron argues that the plaintiff cannot rely solely on the implausibility and ineffectiveness of homeopathy generally, but must prove specifically that Coldcalm does not work and that Boiron knew or should have known this. It may also be that the court finds material questions of fact prevent a decision on the merits at this point.

But no matter what the ultimate outcome, this case highlights (as reported in the last post) the almost total lack of regulation of homeopathic products sold in the U.S. It also reveals that, given the need to come up with evidence sufficient to support its argument that the plaintiff cannot prove Coldcalm is ineffective or that Boiron knew that to be the case, Boiron utterly fails to overcome the overwhelming scientific evidence that homeopathy is nothing but pseudoscience.

The court has yet to rule on the parties’ cross-motions for summary judgment. I’ll keep you posted.

Posted in: Health Fraud, Homeopathy, Legal, Politics and Regulation

Leave a Comment (26) ↓

26 thoughts on “The CAM Docket: Boiron II

  1. Jan Willem Nienhuys says:

    I don’t know about rules of evidence in a court of law, but it seems to me that the general statement that homeopathy doesn’t work is not a very effective plea.

    Suppose someone accused of a serious crime (OK that’s criminal law, and we are delaing now with civil law) would argue that humans generally are quite nice to each other, hence …

    No. Here is a specific product, and it is quite OK to explain that the ingredients (see http://boironusa.com/products/coldcalm.php ) cannot have any action. As Boiron is offering it as a medicine, the burden of proof falls on them, at least when it is judged by medical norms. There is no such proof. But the plaintiff also has no proof (a double blind placebo controlled RCT) that precisely this stuff doesn’t work.

    There is of course one point that can be made. The founder of homeopathy, Samuel Hahnemann, whose instructions for the preparation of homeopathic remedies still are followed almost to the letter, wrote in section 273 of his Organon

    In no case under treatment is it necessary and therefore not permissible to administer to a patient more than one single, simple medicinal substance at one time. It is inconceivable how the slightest doubt could exist as to whether it was more consistent with nature and more rational to prescribe a single, simple1 medicine at one time in a disease or a mixture of several differently acting drugs. It is absolutely not allowed in homœopathy, the one true, simple and natural art of healing, to give the patient at one time two different medicinal substance.

    See also http://www.homeopathyhome.com/reference/organon/organon.html

    In section 274 he explains why, even quoting Ockham’s maxim: ‘it is wrong to attempt to employ complex means when simple means suffice’. He argues that one cannot know how two or more remedies interact, even if one knows a lot about the single remedy. One of Hahnemann’s objections to 18th century medicine was that the doctors then prescribed crazy mixtures of all kinds of herbs, and made patients take these frequently and in large amounts. In homeopathy the doctor gives (ideally) a single small pill, prepared by his own hand from pure substances.

    Anyway the founder of homeopathy himself has said that combining different (nine in fact) remedies in one pill is just nonsense.

    A second point that might be made is that the purported effects of these individual remedies derive (partly) from tests with highly diluted substances. These tests have never been checked properly (double blind, randomized) and the few times people tried it, the tests failed. A substance like Apis mellifica (honeybee) has ‘symptoms’ based on medical case descriptions of anaphylactic reactions after a bee sting.

    In the Netherlands there was a similar case. The chairman of the Antiquackery Association said that a certain homeopathic remedy was worthless. The company making the stuff sued. And won in a way. The outcome of the legal wrangling was that it was perfectly allowed to say that homeopathy in general doesn’t work, that this ointment contained carcinogenic substances (it was partly mother tincture) and that it is a shame it is sold, but one thing was not permissible: claiming that this specific ointment did not work when you don’t have experimental data to support this specific claim. Of course the situation is slightly different with Coldcalm, because the ointment contained not only highly diluted stuff, but quite a lot of mother tincture of Symphytum officinale if I remember correctly.

  2. Wrigs13 says:

    I’m no legal expert, but if they are using the ‘Materia Medica’, a homeopathic resource, as evidence, because homeopathy works, that the active ingredients in coldcalm work as stated, then attacking homeopathy is valid. If homeopathy is proved in a court of law to not work and its scientific basis is invalid, then the evidence for coldcalm must also be invalid. In any logical argument if the premises or logic are incorrect then any conclusion drawn from them cannot be considered to be correct.

    I admit this is not the same thing as proving it does not work, but without any plausible and compelling evidence and a discredited premise for the belief it does work, then at that point must not coldcalm actually prove it does work?

    What I find most disturbing is the ‘I don’t know’ answers, as if this is a basis for a defense against knowingly deceiving the public, ignorance and antiquity are being invoked as a shield against being held accountable. I hope that the laws definition of ‘should have known’ rather than the harder to prove ‘did know’ is enough to bring this case to a close.

    After Simon Singhs success, a very public case and the total discrediting of homeopathy would push all of CAM onto the back foot.

  3. DugganSC says:

    As somewhat as a sidetrek on this, I’ve been encountering my own frustration in dealing with people claiming homeopathic cures in my life, namely that the term “homeopathic” seems to be moving to apply to all of CAM and in most of the cases, they’re taking herbal remedies (supplements in most cases) which are being advertised as “homeopathic medicine” and, at least in some of the cases, I recognize the herbs in question as ones appropriate for the treatment. So we may eventually see these companies start to dodge or raise false targets by introducing medicines called “homeopathic” but actually based on medicinal efficacy of the components.

    Then again, this could just be a social phenomena where the meaning of the word is shifting in the general populace, much the same way that “insects” includes spiders and scorpions for many common people.

  4. Epinephrine says:

    But the plaintiff also has no proof (a double blind placebo controlled RCT) that precisely this stuff doesn’t work.

    You can’t have proof that something doesn’t work. You can fail to show a difference, but that may simply mean a poor sample, or that the effect is present but smaller than you can detect, etc.

    I disagree with your statement that a general plea about homeopathy is a bad idea; I think that it is in fact essential to bring this point up – in my mind this is part of distinguishing between SBM and EBM, that the result of an RCT by itself shouldn’t be convincing, the science must be reasonable as well. For example, oscillococcinum has a successful placebo controlled randomised clinical trial. Even if an experiment were to generate data that is unlikely under the null hypothesis, how unlikely is the alternative? The larger picture of how homeopathy tends to fail in testing makes a point about the likelihood of the alternate hypothesis.

    If you run enough of these tests (RCTs), you will get a positive result, and since negative results aren’t tracked and published there is nothing stopping a manufacturer from getting positive results, if they are willing to run enough studies. Of course, actual drugs need to register their clinical trials. The general claim that homeopathy has generally shown itself not to work throws doubt on the result of an RCT showing that a particular homeopathic treatment does work. Until there is a system tracking clinical trials for non-pharmaceuticals (correct me if I am wrong, but I don’t believe that any requirement to report negative results exists) we face the problem that eventually any sufficiently investigated therapy will have positive results. The existence of positive results does not imply effectiveness.

  5. Jan Willem Nienhuys says:

    You can’t have proof that something doesn’t work.

    Scientifically that’s hard. But given a strong claim, one can design a test that can reject the claim with great certainty. For example, if you would claim that you can make a brick float in mid-air by using mind power only, and that you succeed in doing that 99 out of 100 times, it is not so difficult to design a test to show that your mind power cannot do that.

    oscillococcinum has a successful placebo controlled randomised clinical trial

    Actually more than one.
    There is one by Ferley, Zmirou and others (1989) that is clearly fraudulent. Their test population consisted of 478 people going to their family doctors with flu-like symptoms during a time when there was a flu epidemic. But they considered only the 63 people that recovered within 48 hours. Their article displays a graph from which it is clear that you get a ‘significant’ result only with that choice and no other choice of the 14 possibilities. If one calculates the chi-squared correctly, one finds p=0.0494 . Now Ferley et al. say that their criterion was pre-specified, but that is hard to believe, as it would mean an enormous risk of getting not enough patients to ‘reach significance’ even if the hypothesis that oscillococcinum works were true.
    Ferley J.P., Zmirou D., D’Adhemar D., Balducci F. (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenza like syndromes. British Journal of Clinical Pharmacology 27:329-335

    It is a best an exploratory result. Then, beginning 1991, other researchers among which the boss of Boiron Clinical Research Lab, repeated the test. In their paper you have to look carefully to find how the Ferley hypothesis fared. Notwithstanding that they changed the definitions of sick and cured they got only p=0.44 for the Ferley hypothesis. Next they concocted out of 17 variables a ‘trend’ which was ‘significant’. It is hard to believe that they already had precisely this trend in mind before the test. Then it took them about 7 years to find a journal willing to publish their stuff.
    Papp R., Schuback G., Beck E., Burkard G., Bengel J., Lehrl S., Belon P. (1998). Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation. British Homeopathic Journal 87:69-76.

    There are two other trials that even Boiron doesn’t advertise much, namely
    Casanova P. (1984) Homeopathie, syndrome grippal et double insu. Tonus 25-26
    Casanova P, Gerard R. (1992) Bilan de 3 années d’études randomisées multicentriques oscillococcinum/placebo. Laboratoires Boiron, 11-16 (but also published as
    Casanova P, Gerard R. (1988) Bilan de 3 années d’études randomisées multicentriques Oscillococcinum/placebo. Proposta Omeopatica 6:14-17.)

    A summary of oscillococcinum research can be found in
    Luigi Alberto Marrari, Laurence Terzan and Gilles Chaufferin (2012) Oscillococcinum for influenza treatment. Ann Ist Super Sanità Vol. 48, No. 1: 105-109.

    In my opinion all this research is rather clearly fraudulent (namely by trying to find proof in the data after they have been collected), and it is quite possible that this type of fraud (also called ‘fishing expedition’) is widespread in various sciences.
    I don’t think many large negative RCT’s are hidden from view. But one particular kind of ‘fishing’ is quite effective.

    In a trial patients often enter one by one, and are treated for a short time. One can after, say, 20 or 30 patients break the code for the patients that one has seen already. If the result is ‘significant’ (with at least one outcome variable), one publishes. ‘Hurray, we have reached significance.’ If not, there are two possibilities: the results are very poor and it is unlikely that collecting another bunch will get a positive result. Then one aborts the investigation. If the results are not really poor, one collects another bunch, and so on. The result will be a large number of small positive trials, and of course no trials where the verum performs ‘significantly’ worse than the placebo.

  6. Harriet Hall says:

    I thought the lawyers were going to avoid making this a trial about homeopathy and were only going to accuse Boiron of false advertising and misleading labeling for the specific product. They were making efficacy claims for Coldcalm without even having tested it, there was no rationale for the particular mixture of ingredients, and their labeling was not adequate for the average consumer to understand how dilute the ingredients were.

  7. Epinephrine says:

    It is a best an exploratory result. Then, beginning 1991, other researchers among which the boss of Boiron Clinical Research Lab, repeated the test. In their paper you have to look carefully to find how the Ferley hypothesis fared. Notwithstanding that they changed the definitions of sick and cured they got only p=0.44 for the Ferley hypothesis. Next they concocted out of 17 variables a ‘trend’ which was ‘significant’. It is hard to believe that they already had precisely this trend in mind before the test. Then it took them about 7 years to find a journal willing to publish their stuff.
    Papp R., Schuback G., Beck E., Burkard G., Bengel J., Lehrl S., Belon P. (1998). Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation. British Homeopathic Journal 87:69-76.

    Yes, I’ve read this one. They claim that they randomised the participants to the two conditions (with 184 and 188 subjects); they then had compliance issues resulting in a loss of 21 from one group and 17 from the other, ending up with (conveniently!) exactly equal numbers in each group. Their description suggests that the two null hypotheses they chose to focus on were determined prior to the test. The two groups were very similar in age, body temperature, and “severity of symptoms.”

    If the researchers are being honest, superficially it isn’t a bad study, having ensured that the two groups are similar on important variables. The null hypothesis that equal numbers of patients would have no symptoms after 48 hours is easily defined and tested.

    I do wonder about the results, I’m not familiar with the test they chose (Krauth test), I would think that it would be pretty easy to use a test like a Chi-square test to see if the frequency of being without symptoms was affected by being in either the placebo group or not – the p for this test is ~0.39, so that Krauth test must be really specific to be able to reduce the p value so much…

    Anyway, I’m not sure where in the paper is says anything about getting only a p=0.44 for the Ferley hypothesis – it states,

    According to the Krauth test, the null hypothesis (the number of patients free of symptoms after 48 hours is equal in both treatment groups) was contradicted at a statistically significant level. The data show a clear improvement in health in the verum group.
    Probability by the Krauth test: P=0.0028.

    Now, if the test is a bad test, or isn’t used properly, that’s a problem. If they’ve misrepresented what they are analyzing, that’s an issue. They’re making a pretty specific claim that they have tested the hypothesis that the number of patients free of symptoms after 48 hours is equal in the two groups, and rejected it with a p=0.0028. I don’t believe them, as the data doesn’t look very convincing to me. It’s not the most convincing data.

    But this is really a bit off topic anyway. If they are willing to lie or misrepresent the data or methodologies, we can ignore all of it, and you suggest that they are fraudulent.

    As a really quick check, I bootstrapped the data with 1000 runs, and the 95% confidence intervals for the #of patients symptom free after 48 hours overlap substantially (22-42, 16-34). I don’t think that there is sufficient evidence of a difference between the two. Verum was better than placebo 836 times, which is not 95% confidence.

  8. DugganSC says:

    FWIW, this looks like the most likely candidate for the “Krauth test”. I’m not a mathematician enough to say if it’s a good form of analysis or not.

  9. fledarmus1 says:

    The problem with fraud and misrepresentation is that you have to prove that the person you are accusing either a) knew that what he was saying about the product was false and said it anyway to get you to buy it (fraud) or b) made a false statement OF FACT to convince you to buy the product and had no reasonable basis to believe it to be true (misrepresentation). The best defense for Boirons is that they honestly believed their product worked. My guess is the only way this suit will hold up is if you could find a smoking gun – an email where the owner of the company is asking his chief financial officer how they will sell a product which is actually just plain water, for example. As long as the sellers reasonably believed in their product (or at least as long as the plaintiffs can’t prove otherwise), this is not a case of fraud or misrepresentation.

  10. Scott says:

    @ fledarmus1:

    The word “reasonable” in your argument is what makes your conclusion incorrect. Borion did NOT have a reasonable basis to believe their claims to be true, and the sellers could NOT reasonably believe in the product. The fact that they may have actually held such a belief does not render it reasonable. Ergo, misrepresentation according to your own argument.

  11. Jan Willem Nienhuys says:

    I’m not sure where in the paper it says anything about getting only a p=0.44 for the Ferley hypothesis

    It doesn’t. Remember, the Ferley hypothesis was ‘cured after 48 hours’. In Table 2 of the Papp et al. paper it says clearly:
    total cured in 48 hours: 57, being 32 verum and 25 placebo.

    One doesn’t need advanced statistics to see that this doesn’t amount to much. With that kind of numbers (around 30 out of much more) the standard deviation of the difference is about the square root of the sum, so the difference 7 (between 25 and 32) isn’t even a full standard deviation, which means that p must be over 1/3. The exact computation is as follows:

    not cured in 48 hours: verum 156 placebo 159 total 315
    cured in 48 hours: verum 32 placebo 25 total 57
    total verum 188 placebo 184 total 472

    Fisher’s exact test one tailed 0.2192 (times 2 = 0.44, this was my original calculation)
    same, two tailed 0.3898
    chi-squared with continuity correction: 0.4381

    Papp et al. seem to like to take n=167 for both the placebo and verum group, but that doesn’t make a big difference.
    Rounded to 1 decimal it all amounts to p=0.4

    I have no idea what the Krauth test is, but the above test (actually chi-squared without continuity correction) is how Ferley et al.
    did it. I only can find that Krauth is associated with something called configural frequency analysis. I doubt that any of the referees of the British Homeopathic Journal know what it is. They probably just took Belon’s word for it (note the address for correspondence).

  12. pmoran says:

    Who is funding these cases, and why, considering the chequered outcome of such challenges in the past?

    As a judge I might wonder why these cases are being brought by consumers, rather than government agencies responsible for regulating health care claims. Why also are they picking on this rather harmless product costing a few measly dollars, which the simplest personal inquiry might reveal to any who really want to know is of doubtful efficacy. Doctors don’t recommend this treatment of influenza or colds, isn’t that a sufficient signal for most that there is something dubious about it?

    So judges might be inclined to think along the following lines:- “these people have an agenda — a well-meaning one, but one that means that should I give the judgment they desire to the effect that “homeopathy is bunkum”, they will move on to challenge other forms of CAM, hoping that the precedent will enable the suppression of all forms of CAM. Is that an end-point I wish to facilitate? Do I want ALL of medicine to be held to the admirable-in-native-context but highly error-averse, often arbitrary in application, and occasionally misleading standards of mainstream medicine? Is that what the public would want me to do? Some would, but many wouldn’t.”

    So, what should we realistically expect — at most a slap on the wrist, with an admonition to moderate or obfuscate the medical claims?

  13. Jann Bellamy says:

    @Dr. Hall:

    The problem with attacking homeopathy in general is that Boiron is arguing California law does not allow the plaintiff to rely soley on the implausibility and ineffectiveness of homeopathy in proving that Coldcalm in particular is ineffective. However, that doesn’t mean that implausibility and ineffectiveness of homeopathy in genereal isn’t relevant to the question of the effectiveness of Coldcalm in particular. In other words, it is certainly an important part of their case, but (according to Boiron’s interpretation of California law) they cannot rely solely on this. I don’t agree with Boiron’s interpretation, but the plaintiff has to be prepared in case Boiron prevails on this point of law. I imagine the judge will speak to this issue in her ruling on the summary judgment motions.

    @pmoran
    “As a judge I might wonder why these cases are being brought by consumers, rather than government agencies responsible for regulating health care claims.”

    No you wouldn’t. Consumers have every right to bring their claims for fraud and violation of consumer protection laws in court and the fact that government regulators aren’t bringing these claims is wholly irrelevant. That is why common law fraud and consumer protection laws exist in the first place — so consumers can bring such claims.

    “Why also are they picking on this rather harmless product costing a few measly dollars”

    Because they believe they have been defrauded. The amount of each individual claim is irrelevant. “A few measly dollars” adds up to billions in dollars in sales for Boiron. I don’t think you’d argue that a single multi-billion dollar defrauding of one person isn’t worthy of bringing suit — so why is an alleged multi-billion dollar fraud spread out over numerous victims not worthy of the court’s time? If the individual claim amounts were the deciding factor, companies could defraud consumers with impunity, so long as each claim was small.

    “which the simplest personal inquiry might reveal to any who really want to know is of doubtful efficacy.”

    So consumers should bear the burden of checking out all claims on all products they purchase, rather than putting the burden on the seller to tell the truth? For one thing, that’s not a very efficient way to run an economy. Consumers would spend vast amounts of time researching each product they think they might want to purchase: Does reasearch show that this toothpaste really makes my teeth whiter? Does research show that this car actually get this gas mileage? Should I test this milk to see if it really contain the amount of vitamin D it says? What is the evidence that this lotion relieves dry skin? Is this crochet needle really a size “H” — should I measure it to make sure? Is this pencil really a No. 2, or should I have it tested?

    “Doctors don’t recommend this treatment of influenza or colds, isn’t that a sufficient signal for most that there is something dubious about it?”

    You should review the post, in which the reader is informed that an M.D.(Boiron’s expert witness) prescribes Coldcalm, that the Institute at which he works employs homeopathy, that he trains other M.D.s in homeopathy, and is part of an organization that promotes the use of homeopathy in medical practice.

    “So judges might be inclined to think along the following lines (etc.)”

    No they wouldn’t. That’s not how the legal system works. You might try “the simplest personal inquiry” into the operations of the this branch of government before you make such statements.

  14. pmoran says:

    I was not expressing an opinion on the law or its workings or how it will formulate its final judgment, Jann, and I still don’t buy that these actions are a guileless reaction to a single fraudulent act.

    I am predicting that the outcome will be disappointing for those who hope to get some more nails into a homeopathy’s coffin. I don’t mind if I am wrong, but I do predict that something equally dubious will take its place.

    I also suggest that these person’s resources and complaints might be better directed if the concern merely is that homeopathic products be subjected to more accurate labelling.

  15. Harriet Hall says:

    @pmoran

    “these person’s resources and complaints might be better directed if the concern merely is that homeopathic products be subjected to more accurate labelling.”

    I disagree. Laws are slow to change and poorly enforced. Class action lawsuits are arguably the most effective means for individual consumers to band together and get results. I don’t know of any other efforts that could have achieved this:
    http://www.law360.com/health/articles/316955/boiron-to-pay-up-to-12m-to-end-false-advertising-suits
    Boiron has not only agreed to pay out money but has agreed to more accurate labeling.

    No one is naively suggesting that these lawsuits could put homeopathy in a coffin. They can, however, increase public awareness and help reduce the worse abuses.

  16. Scott says:

    As a judge I might wonder why these cases are being brought by consumers, rather than government agencies responsible for regulating health care claims.

    Only if you somehow managed to be unaware that no government agency has such responsibility. This was discussed at some length in the prior post on this subject. Fundamentally, homeopaths can make whatever claims they like without any kind of oversight or regulation by any government agency.

    The closest one could come would be the FTC’s role in false advertising. But they don’t have the expertise to realize that the advertising is indeed false.

  17. rork says:

    I wasn’t sure whether believing (perhaps with evidence, perhaps not) that it had some placebo effect was good enough to say “it works” and not be lying.
    I sorta figured all intelligent homeopaths (I assume they exist) knew they were just peddling placebo.

  18. fledarmus1 says:

    @Scott – no, the use of the word reasonable (and the word fact) are exactly what makes my argument. “Reasonable” is a legal term in this context, not a scientific one. The way you prove that there was no reasonable basis for belief is to get twelve people (or a judge) to listen to experts on both sides talk about every study that’s ever been done, and then ask them if the defendants might actually have believed something that one of the experts on the CAM side presented. Fortunately it is only a civil suit, so the jury decision doesn’t have to be unanimous, but I think it’s a little naive to try to argue that homeopathy has never been presented in such a way that a reasonable person might actually believe that it works, and sell a product based on that belief.

    And for this level of rigor, I don’t even think you would have to show that the product worked better than a placebo, because there are already enough people believing that the very existence of a placebo effect proves that placebos work in some instances. The argument is only that your product shows a positive effect – the fact that a placebo shows the same positive effect just proves that the placebo works too.

    All you would really need to show to convince most jurors that the plaintiff had a reasonable basis for belief is that the plaintiff read one published work written by someone qualified to put Dr. in front of his name that said it was good stuff. That’s the entire defense, and the only thing a plaintiff could do at that point is to prove through the defendant’s own words that he is lying about whether he believes in the product.

    “Fact” is a far worse issue, especially in science. If the representation cannot be designated as a fact, and therefore demonstrably true or false, then legally it is an opinion. The laws of fraud and misrepresentation apply only to facts. Expect to hear “it’s just a theory” and “you can’t prove that it doesn’t work” repeated over and over.

    Lawyers, feel free to chime in about any of this. I’ve been taking a few shortcuts with the explanations, and any rigor you could add to the argument would be a good thing.

  19. Scott says:

    IANAL, but my understanding is that the legal “reasonable” standard includes a presumption that the hypothetical reasonable person is in fact well-informed of the facts. And hence that the examples you give would not qualify.

  20. Jann Bellamy says:

    @fledarmus1:

    “The laws of fraud and misrepresentation apply only to facts.”

    Not according to the Restatement of the Law of Torts, Second, Sec. 525, which says that if A:

    1.fraudulently makes a misrepresentation of fact, opinion, intention or law to B
    2.for the purpose of inducing B to act (or refrain from acting),
    3.A is liable to B for B’s monetary loss
    4.caused by B’s justifiable reliance on the misrepresentation.

    According to the Restatement, Sec. 526, A misrepresentation is fraudulent if the maker

    a.knows or believes that the matter is not as he represents it to be,
    b.does not have the confidence in the accuracy of his representation that he states or implies, or
    c.knows that he does not have the basis for his representation that he states or implies.

    Even if the plaintiff can’t prove (a.), she can certainly show that homeopathy is so implausible a reasonable person could not have confidence in the accuracy of his representation as to effectiveness (b.) or that he knew he was overstating his case (c.) Courts have found defendant’s representations so scientifically implausible that their beliefs could not be reasonable. I discussed this in a previous post: “Is CAM Fraud?”

    http://www.sciencebasedmedicine.org/index.php/is-cam-fraud/

    “The argument is only that your product shows a positive effect – the fact that a placebo shows the same positive effect just proves that the placebo works too. ”

    But that doesn’t appear to be what Boiron is arguing — it is arguing that homeopathy actually works because the products’ ingredients work based on principles of homeopathy.

  21. norrisL says:

    Vibrational medicine incorporates the use of this chi energy within living organisms such as plants, gemstones and crystals, water, sunlight, and even the foods we eat

    So “gemstones and crystals, water, sunlight, and even the foods we eat” are living organisms????? (Assuming here that the foods we eat were living but by the time we eat them, they are not)

    How can we hope to debate against brainless fools who are capable of writing rot like that?

    All I can hope for is Boiron defeated, shamed and fined massively by the court for deceiving innocent half-wits foolish enough to believe this homeopathy garbage.

  22. BillyJoe says:

    norrisL: “So “gemstones and crystals, water, sunlight, and even the foods we eat” are living organisms?????”

    I also read this sentence like that the first time around.
    Then I figured it must mean:
    Vibrational medicine incorporates the use of this chi energy within
    - living organisms such as plants
    - gemstones and crystals
    - water
    - sunlight
    - food
    But, then, who knows. :D

  23. Mojo says:

    @Jan Willem Nienhuys

    Their test population consisted of 478 people going to their family doctors with flu-like symptoms during a time when there was a flu epidemic. But they considered only the 63 people that recovered within 48 hours.

    That suggests to me that they may have considered only the patients who had “flu-like” symptoms but didn’t actually have flu.

  24. Jan Willem Nienhuys says:

    only the patients who had “flu-like” symptoms but didn’t actually have flu.

    There is something esle which is deeply irrational. Soppose you are suffering form ‘flu-like symptoms’.

    You get recommended a kind of pills that you have to take three times per day until your cold or flu or whatever is over, at a cost of a dollar each time.

    You: Will this ward of the real flu, make the symptoms less or the disease shorter?

    Salesperson: Nothing like that is proved in a scientific test.

    You: What did the scientific test show?

    Salesperson: People that were sick for only 48 hours or less turned out to have taken the real stuff more often than the fake
    stuff.

    You: Aha! But how do I know that I will be in this group? If the whole thing lasts only 48 hours, I am not going to take any pills.

    Salesperson: Well, you have maybe 85% or 88% chance of feeling sick more than 48 hours depending on the kind of flu doing the rounds, but if you pay the eighteen bucks, that chance drops by about 2% or 3%.

    You: How do they know that?

    Salesperson: Well the company that earns billions from this stuff organized a test, and that was the result.

    You: I’d like to take a quick look at Pubmed, where did you say they published this?

    Salesperson: It’s not in Pubmed. The company managed to get it published in the Journal for the Preservation of Eighteenth Century Medical Fantasies. Took them them seven years to persuade the JPECMF to print it. But the JPECMF is not covered by Pubmed.

    You: Ah well that settles it. Seven is a holey number. Goodbye.

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