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In 2012, Kim Allen and other consumers filed suit against Hyland’s, a wholly owned subsidiary of Standard Homeopathic Co., for false advertising in a California federal district court. (Allen v. Hylands Inc., Case No. 2:12-cv-01150-DMG(MANx), U.S. District Court for the Central District of California) The judge certified a plaintiff class of purchasers of ten Hyland’s homeopathic remedies including Calms Forte, Teething Tablets (the subject of an FDA warning, also here) ClearAc (for acne), Migraine Headache Relief, Poison Ivy/Oak Tablets, Cough and Seasonal Allergy Relief and Colic Tablets. At the 2015 trial, plaintiffs’ counsel argued to the jury that Hyland’s misled tens of thousands of purchasers and sought $255 million in refunds.
Experts with impeccable credentials testified on plaintiffs’ behalf that the principles of homeopathy are biologically impossible, that the overwhelming preponderance of the evidence from clinical trials is that it does not work, and, specifically, the Hyland’s products in question do not provide any effective relief beyond placebo. There was testimony that the FDA, the federal agency charged with regulating homeopathic remedies (however lightly) takes the position that there are little to no active ingredients in these products. Plaintiffs put into evidence the government reports from the U.K. and Australia finding there are no health conditions for which there is reliable evidence that homeopathy is effective. They also put into evidence the NCCIH’s statement that the most rigorous clinical trials and systematic analyses of the research on homeopathy have concluded that there is little evidence to support homeopathy for any specific condition.
And they lost. The jury came back with a verdict in Hyland’s favor, after a 13-day trial held in 2015. (The case only recently came to my attention in a news report on pending motion, which we’ll get to shortly.) Based on the jury’s verdict, the judge ruled in favor of Hyland’s on claims that remained to be resolved after trial. In other words, it was a complete victory for Hyland’s.
Plaintiffs have moved for a new trial, arguing that the judge erroneously instructed the jury that they had to prove that Hyland’s products “cannot” work. While the plaintiffs did argue that homeopathic remedies, indeed, cannot work, because of biological implausibility, they say that was not their only theory of the case. They argue they merely had to prove the products were ineffective, i.e., that they “do not” work, but that the judge’s instructions to the jury failed to include this theory of the case. Hyland’s, in its response to the motion for a new trial, argues that this is merely semantics; that there is no difference between the two standards.
In their motion for a new trial, Plaintiffs also say they were entitled to a jury instruction that, if a product’s “effectiveness” is solely the result of a placebo effect, an advertisement that the product is “effective” is false even though some consumers may experience positive results. (This argument is based on a decision in a case brought by the FTC against a manufacturer of cure for baldness. The court held that where evidence developed under accepted standards of scientific research demonstrates that the product has no force beyond its placebo effect, advertising it as “effective” is indeed false.) Hyland’s was allowed to introduce evidence of customer satisfaction surveys — in other words, anecdotal evidence of effectiveness – which plaintiffs argue, correctly, could simply indicate the placebo effect at work. Thus, they say, they were entitled to this particular jury instruction on placebo effects.
Finally, the plaintiffs argue that a new trial should be granted because the verdict was against the clear weight of the evidence. The court has taken the motion under consideration.
The trial consumed two weeks and several thousand pages of transcripts and documentary evidence. The case was filed in 2012, finally went to trial in 2015, and is still under consideration on the plaintiffs’ pending motion. A complete summary of the case and discussion of the evidence is far beyond the scope of this post. However, two figures we’ve met before on SBM figured prominently in the trial and I felt their testimony worthy of discussion, for the record, so to speak. (If you have a Pacer account, you can read all 483 docket entries and their associated documents. Otherwise, I have downloaded selected documents and provide links to them.)
The evidence
And what was the evidence in Hyland’s favor, proving to the jury that their product claims were true? A whopping load of junk science, hauled into the courtroom by two of homeopathy’s biggest advocates: Iris Bell, MD, PhD, and Peter Fisher, the British homeopath and physician who treats the Queen.
In testimony at trial (also here), and by affidavit, Dr. Bell, who has been a paid consultant to Standard Homeopathic Co. since 2006, held forth on homeopathy. She said that homeopathy is based on two principles: “like cures like” and “remedies will retain their biological activity if they are repeatedly diluted and agitated or shaken between each dilution.” This is hogwash, of course, but lest the jury doubt that there is “modern” science behind homeopathy, she continues:
Modern homeopathy is premised upon a non-linear dose response for these natural substances. The non-linear dose response phenomenon is explained by a well-documented observation in the research literature known as hormesis, whereby the same substance can produces effects in different or opposite directions, depends on the dose of the substance and the state or condition of the organism at the time it receives the dose. Low doses tend to produce beneficial effects, whereas high doses of the same substance tend to produce adverse or toxic effects. . . . to take advantage hormesis, homeopathic drugs are prepared at the lowest subtoxic observed level sufficient to trigger the secondary symptoms without causing the primary symptom.
And, nanoparticles! If a juror might think the whole idea of diluting a substance until there is nothing left is crazy talk, Dr. Bell says
The method by which many homeopathic medicines are made involves grinding the source material before it is further diluted and succussed. This grinding process is similar to one of two major ways in which nanoparticles of plants, mineral, or drugs are made. . .
But do we know that nanoparticles of active ingredients actually remain in homeopathic remedies so they can work their magic via hormesis? Oh, yes, we do, as Dr. Bell testified at trial:
There was a paper published by investigators at the Indian Institute of Technology stating — studying six different homeopathic medicines using electromicriscopy and other techniques of that type where they actually showed that there were nanoparticles of the source material in the verum medicines.
In her view, this answered criticisms that
there’s nothing there if you keep diluting it enough. At that point there is something there. Based on that original study, there were nanoparticles of course material present even at those high potencies . . .
which she testified were up to 200C. (A dilution of one molecule in the entire observable universe would be about 40C.)
She also testified:
The literature suggests that many nanoparticles are capable of having some very interesting properties that could overlap with some of the finds that have been reported in homeopathic literature on the electromagnetic signals and the optical signals.
Faced with the testimony of plaintiffs’ expert that all of this violated the laws of physics, Dr. Bell testified that she did not agree. Why?
Because the materials were there.
Except that they weren’t. And hormesis doesn’t “explain” how homeopathy “works,” either. Dr. Bell’s testimony, which is basically a rehash of stuff she’s said before, has been thoroughly debunked by David Gorski and our good friend Orac, with an assist from Harriet Hall in deconstructing the Indian lab experiment supposedly demonstrating the presence of nanoparticles in homeopathic remedies.
I won’t go into the technical details here, but suffice to say that the “nanoparticles” the Indian researchers “saw” were almost surely contaminants and that the “signaling” from the nanoparticles is based on a roundly criticized paper by Luc Montainger et al. Per the latest “explanation” from homeopaths, once you have nanoparticles (even if you don’t), then (insert lots of handwaving) hormesis. Hormesis is a hypothesis that some substances toxic at high doses might be benign or beneficial at low doses. Of course, no nanoparticles, no hormesis, but even if these magical nanoparticles existed, trying to invoke hormeis as an explanation is, as David Gorski says, “wishful thinking on the part of homeopaths, representing extreme over-extrapolation.”
Or, more colorfully, as Dr. Gorski put it when Dr. Bell set out her nanoparticles (existence + signals) = hormesis = homeopathy works “theory” in a journal article:
I started to wonder whether I was the victim of a Sokal-style hoax here or whether Bell wrote her paper the way that David Bowie used to like to write songs: By cutting up newspaper and magazine articles and randomly splicing the words back together. In this case, it seems as though Bell cut up a bunch of nanoparticle papers and some homeopathy literature and then threw them together to produce much of this paper.
Dr. Bell also testified (by affidavit) that each of the Hyland’s products
[c]ontrary to the assertion [by plaintiffs] that the dilutions result in ‘very little, if any, of the advertised ‘active ingredients’ are present in the Products’ the dilutions of each of the triturated and/or succussed ingredients in the products at issue in this case are sufficient to provide the relief of symptoms for which they are indicated.
All of which pleased the homeopathy crowd to no end.
Dr. Bell was not the only homeopath to testify, nor the most famous. None other than Peter Fisher, the Queen’s physician, also testified on Hyland’s behalf at trial and by affidavit. (For unknown reasons, one volume of his testimony does not appear to have been filed with the court.) Dr. Fisher is a well-known defender of homeopathy and the subject of several SBM posts debunking those defenses:
Should physicians and managed care organizations offer homeopathy?
False balance for homeopathy in the BMJ
Homeopathy for fibromyalgia: The Huffington Post bombs again
He cherry-picked his way through homeopathy studies and even “explained” slides to the jury supposedly showing nanoparticles in homeopathic remedies. He also tried to attack Shang et al. for their “beautiful demonstration,” as Dr. Gorski called it, that
whatever effects due to homeopathy ‘detected’ in clinical trials are nonspecific and not detectably different from placebo effects, exactly as one would anticipate based on the basic science showing that homeopathy cannot work unless huge swaths of our current understanding of physics and chemistry are seriously in error.
I read a good portion of his testimony and I have to admit, if you didn’t know anything about science in general or homeopathy in particular, he sounds convincing, partly for reasons we’ll return to in a moment.
At this point, you might well be asking yourself: why were Bell and Fisher allowed to put their pseudoscientific “theories” into evidence in the first place? The answer is: I don’t know. When I first looked at the docket, I was expecting to see a pre-trial motion to exclude their testimony based on federal evidentiary rules and Daubert, which require the judge to act as a “gatekeeper,” insuring that expert testimony is scientifically reliable. However, while plaintiffs sought to exclude their testimony on other grounds, they never explicitly attacked it as pseudoscience in a pre-trial motion to exclude it. In fairness, I cannot question that decision because I have no idea why they made it.
The larger issues
What is striking to me about this case is how it is an exemplar of everything that is wrong with “integrative” medicine and tolerance for pseudoscience. If Iris Bell was credible as a witness, and I have to presume she was if Hyland’s won, it is at least in part because she held a faculty position at the University of Arizona, was an NIH-funded researcher, and is a licensed homeopath and physician (she trained as a psychiatrist) in Arizona. In fact, she testified that one NCCAM grant paid half her salary for ten years.
The same is true of Peter Fisher. To burnish his credibility, he testified is on the National Institute for Health and Care Excellence, a UK governmental body that advises the National Health Service on what treatments it should and shouldn’t use, WHO’s expert advisory panel on complementary medicine, registered in homeopathy by the General Medical Council, and was for 17 years in a position of authority with the Royal London College of Integrated Medicine, which is part of the University College London Hospital NHS Trusts, “one of the leading academic medical centers in the U.K.” (his words) as well as the Queen’s physician. He also testified he is the editor-in-chief of the journal Homeopathy, which, he said, is indexed in PubMed, a service of the National Library of Medicine, and published by Elsevier, “a leading international publisher of scientific medical and technical literature.”
This veneer of respectability and scientific veritas bestowed by quackademic medicine, government entities, state licensing authorities (via state legislatures who pass licensing acts), PubMed’s indexing of dubious journals, and companies that publish these “peer-reviewed” journals, allows companies like Hyland’s to rip off the public with its worthless products, and, for good measure, keeps consumers from recovering their money when they complain, no matter how scientifically air-tight their false advertising claims may be.
I have to fault the FDA here too. Had it done its job, and required homeopathic remedy manufacturers to comply with the law, manufacturers would have to prove safety and efficacy before their products went on the market. In fact, while we’re at it, we can blame Congress as well, for incorporating the entire Homeopathic Pharmacoepia into U.S. law in 1938.
I am pleased with the FTC’s announcement that it will clamp down on labeling homeopathic remedies by requiring that companies have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.
It remains to be seen how much effect this will have. According to testimony at this trial, most people take homeopathic remedies based on their own past experience or recommendations from friends and family, not what they read on the labels. The FTC will still allow manufacturers to make unsubstantiated claims as long as the label says there is no scientific evidence that the product works and that the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. Given the fact that they jury in this case was essentially told the same thing by plaintiffs’ experts, I have my concerns. And, again, “modern medical experts” must overcome the positive PR homeopathy gets from its use at “modern medical” centers.
I don’t know how many homeopathic remedy class actions are pending in federal courts now. Perhaps it is time to set up an expert panel to review the scientific issues involved in these suits, as was done in the breast implant cases. Jurors may be confused, but there is no controversy among scientists that homeopathy does not, and cannot, work.
from Science-Based Medicine http://ift.tt/2jzXr9I
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