The CAM Docket: Boiron II

The CAM Docket: Boiron II
by Jann Bellamy
via Science-Based Medicine

Excerpted:

«

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.

[...]

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?

[...]

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.

[...]

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.

[...]

»

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…

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