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 Orac and 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

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