Boiron, oscillococcinum and homeopathy: Why courts do not decide science

Let me just start by saying that. In fact, I’ll repeat it. Science is not decided by laws, courts, judges, or juries. The accuracy of this statement should be so incredibly obvious that it shouldn’t have to be stated, much less repeated over and over and over again. That being said, all too often it’s impossible to avoid having legislators legislate and courts rule on issues involving science and medicine. Sometimes it’s even desirable to try. The risk in doing so, however, is that the result will be a travesty of a verdict, such as the recent jury award of $289 million to a man who claimed that glyphosate caused his cancer when in fact the evidence is overwhelming that glyphosate is not associated with cancer, the erroneous conclusions of the World Health Organization’s International Agency for Research on Cancer’s (IARC) notwithstanding. Other examples abound, such as the class action lawsuits against Dow Corning in the 1990s claiming that silicone breast implants cause a variety of autoimmune and connective tissue diseases when they do not. Even the Vaccine Court, which usually gets the science right, screws up from time to time, such as when it ruled for a complainant who claimed that vaccines resulted in their child’s death from sudden infant death syndrome (SIDS). Then there’s this ruling favoring Boiron and its homeopathic flu remedy Oscillococcinum that I learned about from Jonathan Jarry a couple of days ago:

California's 9th Circuit says, "Yeah, Boiron can continue marketing Oscillocconum [a sugar pill] against flu-like symptoms because Boiron was very convincing!" That's why science isn't decided by judges, juries, and lawyers. https://t.co/vyFc2ItM5a @CaulfieldTim @ryarmst pic.twitter.com/TEKV7HhBBB

— Jonathan Jarry (@crackedscience) December 5, 2018

Before I discuss the ruling, let’s recap just what homeopathy and Boiron’s homeopathic flu remedy Oscillococcinum actually are. (Apologies to longtime readers who already know.) I frequently refer to homeopathy as “The One Quackery To Rule Them All.” There’s a good reason for that. For homeopathy to work, multiple well-established laws of physics and chemistry that have been demonstrated with incredible planet-sized masses of evidence would have to be not just wrong, but spectacularly wrong. Just look at its two major Laws. First is the Law of Similars, which states that, to relieve symptoms, you should pick a substance that causes those same symptoms in healthy humans. Not only is there no medical or physical basis for this law, but the jokes about it write themselves—or would, if homeopaths hadn’t already written them. Homeopathic Ebola virus to treat Ebola, for instance? Or homeopathic saliva from a rabid dog to treat growling in a child? The list of ridiculousness goes on. (I’m not even going to get into homeopathic “provings,” which is how homeopaths claim to determine which remedy is good for which symptoms.) Basically, homeopathy is based on the principles of sympathetic magic.

Fortunately, for most homeopathic remedies, there’s actually nothing there. In the case of homeopathic saliva from a rabid dog or homeopathic Ebola, that would make the only danger existing to be a danger to the homeopath trying to prepare such compounds without killing himself. (Actually, that’s not true. Homeopaths are so incompetent that they might allow a little of the active substance to remain, thus endangering anyone who might use it.) In any event, the Second Law of Homeopathy is the Law of Infinitesimals. This law states that, to make a remedy stronger, you dilute the remedy. And, wow, do homeopaths ever do that! A typical homeopathic remedy is 30C, with “C” signifying a 100-fold dilution. So a 30 C homeopathic dilution is equal to thirty 100-fold dilutions or (10^-2)³⁰, or a 10⁶⁰-fold dilution. Those of you with a chemistry background will notice right away that this is an incredibly large number compared to Avogadro’s number, which is 6.022 x 10²³ and is the number of molecules in a mole of a chemical. So, even if one starts with a mole of a substance (whose weight equals its molecular weight in grams), the resulting 30C dilution will dilute it over 10³⁶-fold beyond the number of starting molecules. In other words, it’s incredibly unlikely that there will be a single molecule of starting substance left, other than potentially any that might “carry over” between serial dilutions sticking to the glassware. As Richard Dawkins put it, the numbers just don’t add up:

Also, 30C is by no means the most “potent” homeopathic dilution there is. Some remedies go up to hundreds of C or even “M,” which signifies a thousand. Basically, any homeopathic dilution above around 12C is water, and dilutions “weaker” than that are generally still so dilute that it is unlikely that the compound included is unlikely to have an effect, although, sadly, that is not always the case, such as with belladonna in homeopathic teething rings.

This brings us to Boiron and Oscillococcinum, or, as Mark Crislip likes to call it, “o-so-silly-o-coccinum.” Why is that? Well, first the starting compound is an extract from duck liver and heart known as Anas barbariae:

Since 1925, Oscillococcinum has been prepared as follows. Into a one litre bottle, a mixture of pancreatic juice and glucose is poured. Next a Canard de Barbarie is decapitated and 35 grams of its liver and 15 grams of its heart are put into the bottle. Why liver? Doctor Roy writes: “The Ancients considered the liver as the seat of suffering, even more important than the heart, which is a very profound insight, because it is on the level of the liver that the pathological modifications of the blood happen, and also there the quality of the energy of our heart muscle changes in a durable manner.” Maybe the French tendency to call any form of not well-being a “crise de foie” (“bilious attack”) had also something to do with it. After 40 days in the sterile bottle, liver and heart autolyse (disintegrate) into a kind of goo, which is then “potentized” with the Korsakov method.

The Korsakov method is a quicker and dirtier method of doing the serial dilutions. Prior to Semyon Nicolaevich Korsakov’s “discovery,” homeopaths used clean glassware for each new 100-fold dilution. Korsakov’s “insight” was to reuse the same glassware for each step, which saved a lot of money and effort when hundreds of dilutions had to be made. He also used distilled water instead of ethanol.

No, I’m not kidding about any of this. This is what Oscillococcinum is. This is how it’s prepared, except that Boiron has industrialized the process so that it can make huge quantities. Boiron’s Oscillococcinum is nothing more than a 200C (or 200 CK, if you want to specify Korsakov dilution) of ground up duck liver and heart that’s been allowed to stew for several weeks until it turns into a disgusting goo. As you might imagine, there is no rigorous evidence that Oscillococcinum has any therapeutic properties (as opposed to a lot of really crappy evidence from poorly designed and controlled clinical trials that homeopaths like to cite). Then, if you go back to the original rationale for this remedy, you’ll see Dr. Joseph Roy, who was serving as a French military physician when the Spanish flu pandemic hit in 1918, examined the blood of victims and claimed to have found a new and strange microorganism that consisted of two unequal balls that performed a quick vibratory motion. Roy dubbed them “oscillococci.” He also found these strange “organisms” in syphilitic ulcers, the blood of cancer patients, the tubercles of tuberculosis patients, and the pus of gonorrhea sufferers. Today, no one is sure just what Roy saw. (Maybe it was dust.) In any case, using homeopathic principles, Roy took a source of these “oscillococci,” and, for whatever reason, that source turned out to be the muscovy duck. Thus was born what is now the homeopathic remedy known as Oscillococcinum.

And finally, we get back to the case I’m talking about:

On November 8, 2018, the Ninth Circuit affirmed a jury verdict in a consumer class action deceptive advertising case in favor of Defendants Boiron Inc. and Boiron USA, Inc. (together, “Boiron”), the sellers of a homeopathic treatment for flu-like symptoms called Oscillococcinum (“Oscillo”). Although the Ninth Circuit’s memorandum decision is marked “Not for Publication” and therefore is non-precedential under Ninth Circuit rules, the decision is still worth noting, as jury verdicts in class action false advertising cases are rare.According to the appellate briefs, Oscillo’s active ingredient is a compound (extracted from the heart and liver of the Muscovy duck for those foodies in our readership) that is subjected to a homeopathic dilution process. The diluted compound is then sprayed onto specially-manufactured granules. Plaintiff argued that, due to the homeopathic dilution process, Oscillo was essentially “water sprayed on sugar,” which could not provide the relief from flu-like symptoms that Boiron advertised. Plaintiff claimed that Boiron had therefore violated two California deceptive advertising statutes, the Unfair Competition Law (“UCL”) and Consumers Legal Remedies Act (“CLRA”).

At the conclusion of a one-week trial in the Central District of California, the jury found in Boiron’s favor that its representations that Oscillo relieves flu-like symptoms were not false. On appeal, the Ninth Circuit affirmed, finding that the jury verdict did not constitute plain error because Boiron presented sufficient evidence from which the jury could have concluded that Oscillo actually works against flu-like symptoms. This was a “battle of the experts” for the jury, the court wrote, that could not be relitigated on appeal. And the jury appeared to have believed Boiron’s expert, clinical studies, and anecdotal evidence more than it believed the plaintiff’s expert, according to the court.

This is, of course, frequently the problem with jury trials involving medicine and science. They often boil down to which party’s expert witnesses are more convincing. On the one side, the side defending science will likely have scientists who lay down the science, but that’s boring. Then, on the pseudoscience side, the witnesses are almost always quacks or pseudoscientists, and quacks and pseudoscientists are frequently convincing.

So what was this case? Well, it was a class action suit against Boiron as described above, and the jury ruled for Boiron, leading homeopathy supporters to rejoice:

So how did this ruling come about? First, we have to go back to 2012, when there was a settlement of a class action suit against Boiron in which Boiron agreed to provide up to $5 million in refunds to consumers who purchased certain Boiron homeopathic products, including Oscillo, Arnicare, Chestal and Coldcalm. Steve Novella wrote about the settlement at the time, noting that Boiron used as its primary expert witness a homeopath who is also a physician who basically admitted there is no scientific evidence to support the claims made by Boiron, but then added the nonsensical argument that there is 200 years of anecdotal experience by homeopaths for the ingredients used. (Never mind that, for instance, in the case of Oscillococcinum, the remedy is only 100 years old.) The products themselves have never been shown in a valid scientific study to be effective for anything, although I note that Boiron still uses two 20 year old placebo-controlled studies that claim to have found that Oscillococcinum decreases the severity and duration of flu-related symptoms. (Placebo vs. placebo, eh?) A 2015 Cochrane review, however, concluded:

There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum in the prevention or treatment of influenza and influenza‐like illness.

Given the extreme implausibility that duck heart and liver diluted to nothing will have any effect on the course or symptoms of influenza, my take on this is that it should basically be translated as saying that Oscillococcinum does not work. And, no, no further research is needed to conclude that, in my not-so-humble opinion.

But, wait! I hear you saying, “There was a settlement in 2012.” Why did this case go to trial in 2016? Here you go:

One was a nationwide settlement that included all Boiron homeopathic products over a 12-year period of time.

That settlement, in Gallucci v. Boiron, Inc., S.D. Cal., No. 11-2039, provided a $5 million fund to reimburse class members and called for label changes to make clear that the products’ advertised uses hadn’t been evaluated by the Food and Drug Administration (16 CLASS 200, 2/27/15).

The other settlement, in DeLaRosa v. Boiron, Inc., C.D. Cal. No. 10-1569, involved one Boiron product, Childrens’ Coldcalm. The DeLaRosa settlement also provided monetary relief to class members and a similar label change.

But suits persisted, even with the settlements, she said.

In the case that went to trial, Christopher Lewert, representing a California class, alleged the company’s Oscillococcinum (Oscillo) flu remedy was no more effective than a sugar pill.

So:

“What was unique about us is that we had settled before, and it’s like the plaintiffs left us no choice,” Christina G. Sarchio, who represented Boiron, told Bloomberg BNA.

“The company said, ‘you know what, we feel good about our facts, we feel good about our evidence, we don’t feel we’ve done anything wrong, and we’ll leave it to the jury system to make that decision for us,’” Sarchio, with Orrick Herrington and Sutcliffe in Washington, D.C., said.

“It’s otherwise going to be death by a thousand paper cuts. Let’s just pull the band-aid off and see what happens,” she said.

And now here is the truly risible part:

The flu product case was tried to seven jurors, one of whom spoke to the parties afterward, Sarchio said.

That juror said he felt the plaintiffs hadn’t met their burden of proof, she said. “For them to allege the product didn’t work as advertised, they should have demonstrated that it didn’t actually work, and they hadn’t done that.”

Cue the sound of Orac exploding from the illogical nonsense. Hopefully, Avon can reconstruct him. (Blakes 7 fans, as rare as they are in the US, will understand that reference.)

No, no, no, no! In the case of a product purported to be a medicine that will treat a medical condition, the burden of evidence in science is not on the person claiming that the medication doesn’t work. It’s on the company sells it claiming that it does work. If that’s not enough, read this mind-numbingly stupid passage (from a scientific standpoint) from the actual affirmation of the original 2016 ruling:

Fourth, Lewert’s sole theory why Boiron’s packaging was misleading or deceptive was that Oscillo was a sugar pill and ergo could not treat flu symptoms. When the jury found explicitly that Boiron’s representations were not false, it must have implicitly rejected Lewert’s argument that Oscillo was just sugar. The district court did not err in treating that factual finding as having preclusive effect on the UCL claims.

Because Lewert offered no theory as to how Oscillo’s packaging might be misleading if indeed it treats flu symptoms—regardless of the mechanism by which it does so—he presented no evidence that would allow him to prevail under the UCL after the jury rejected his CLRA claims. See Cal. Bus. & Prof. Code § 17200. The district court’s factual finding that Boiron’s claims were not misleading or deceptive was therefore supported by sufficient evidence and not clearly erroneous.

I was left shaking my head in disbelief at the scientific ignorance and outright idiocy. It was one of the rare times when Orac was rendered speechless about support of pseudoscience.

Yes, I know that this ruling is non-precedential, but it is nonetheless a prime example of why scientists and doctors take a dim view of court rulings on science and medicine and why science and medicine are not decided by laws, courts, judges, or juries. Unfortunately, science and medicine policy all too frequently are.