Oscillococcinum, Boiron

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Posted 21 August 2011

Oscillococcinum is a homeopathic alternative medicine marketed to relieve influenza-like symptoms. It is one of the most popular homeopathic preparations, particularly in France. Oscillococcinum is manufactured by a French company, Boiron, its sole manufacturer.[1]

It is being extensively advertised in South Africa, in particularly in television advertisements.

The burning questions are:

  1. Does it work?
  2. Does the way it works make scientific sense?
  3. What would happen if one publicly states that this product’s claims are baloney?

The preparation is derived from duck liver and heart, diluted to 200C—a ratio of one part duck liver to 100200 parts water. This is such a high dilution that the final product likely contains not a single molecule of the original liver. Homeopaths claim that the molecules leave an “imprint” in the dilution that causes a healing effect on the body, although there is no evidence that supports this mechanism or efficacy beyond placebo. [1]

Boiron claims on their South African site that there is proof that the product works: “Clinical studies show that Oscillococcinum reduce the severity and duration of flu symptoms”[2][3].

A  Cochrane review in 2009 concluded that the product does NOT work for prevention and needs further studies on whether it would work for treatment, but does NOT recommend it:
Though promising, the data were not strong enough to make a general recommendation to use Oscillococcinum for first-line treatment of influenza and influenza-like syndromes. Further research is warranted but the required sample sizes are large. Current evidence does not support a preventative effect of Oscillococcinum-like homeopathic medicines in influenza and influenza-like syndromes.

This review was later withdrawn, and a 2015 updated version published. This update states:

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. Our findings do not rule out the possibility that Oscillococcinum® could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum®.

The Key Results in the plain language summary: The findings from the two prevention trials did not show that Oscillococcinum® can prevent the onset of flu. Although the results from the four other clinical trials suggested that Oscillococcinum® relieved flu symptoms at 48 hours, this might be due to bias in the trial methods. One patient reported headache after taking Oscillococcinum®. The evidence is current to September 2014.

The update also states:

The overall standard of research reporting was poor, and thus many aspects of the trials’ methods and results were at unclear risk of bias. We therefore judged the evidence overall as low quality, preventing clear conclusions from being made about Oscillococcinum® in the prevention or treatment of flu and flu-like illness.

Extract from WikiPedia[1]:
A 2005 review of flu treatments (vaccine, medicine, homeopathy) has concluded that the popularity of Oscillococcinum in France was unsupported by the current evidence as to its efficacy.[14] A 2006 Cochrane meta-analysis covered three prevention trials (number of participants (n) = 2265) and four treatment trials (n = 1194). In another Cochrane review, the authors conclude “Current evidence does not support a preventative effect of Oscillococcinum-like homeopathic medicines in influenza and influenza-like syndromes.”[15] In a 2007 review, the effectiveness of non-mainstream remedies against seasonal flu could not be established beyond reasonable doubt, and the evidence is found to be sparse and limited by “small sample sizes, low methodological quality, or clinically irrelevant effect sizes”, and that the results strengthen using conventional approaches for flu.[4]

What happens if a blogger points out that this product has no robust evidence that it works?

Don’t! Boiron may sue you.

Don’t believe me? Read on!

Homeopathy multinational sues blogger over statements that its mythological curative had “no active ingredient”

Posted by Cory Doctorow on Wednesday, Aug 17th at 6:12am

Samuele Riva, an Italian blogger, is being sued by Boiron, a France-based homeopathic “remedy” multinational. Riva dared to mock the company’s claim that its Ooscillococcinum has no “active ingredient.” The company claims that the product has been made by diluting “oscillococcinum” (a mythological substance said to be present in duck liver, though no evidence supports this claim) at 1:100 dilution 200 times, which “is the equivalent of diluting 1ml of original ingredient into a volume of water that is the size of the known universe.”

Writing at ScienceBasedMedicine.org, Steven Novella calls this “a pseudoscience trifecta”: Boiron claims that its imaginary element is present in its solution which has been diluted at farcical levels, and that the imaginary ingredient in question is effective at treating flu symptoms. “Essentially Boiron takes fairy dust and then dilutes it out of (non)existence.”

I hope Boiron does draw a line in the sand over their oscillococcinum product, and that it becomes the center piece of a broader public discussion about homeopathy. Most of the public does not understand what homeopathy actually is. They think it means “natural” or “herbal” medicine. They have no idea that homeopathy is about taking fanciful ingredients with a dubious connection to the symptoms in the first place, and then diluting them into oblivion, then placing a drop of the pure water that remains and placing it on a sugar pill. The resultant pill is then supposed to contain the magic vibrations of the original substance.

This rank pseudoscience, which has no place in 21st century medicine, is the business of Boiron. Let’s see them try to defend themselves and their products. Let’s see them harass bloggers and those who are just trying to expose the public to the truth. Let’s see them argue in public how air bubbles in duck liver fantastically diluted can treat the flu.

 

The blog, Science-Based Medicine, also has a good overview of this “Homeopathic Thuggery“.

An extract:

For example, Riva suggested that Boiron’s oscillococcinum has no active ingredient. Well, let’s see- the company lists the active ingredient in this product as “Anas barbariae hepatis et cordis extractum 200CK HPUS.” The “200C” means that the listed ingredient was diluted with a 1:100 dilution 200 times. Serial dilution is a funny thing – a 200c dilution is the equivalent of diluting 1ml of original ingredient into a volume of water that is the size of the known universe. This is far far beyond the point where there is any reasonable chance of there being even a single molecule of original ingredient left.

So Riva was completely justified (as have many other critics) in saying that Boiron’s 200c product has no active ingredient. In fact it is deceptive to list something that has been diluted 200C as an “active ingredient.”

Not that it matters in this case, because the original ingredient is a pseudoscience unto itself. Mark Crislip gives the full details, here is his summary:

In the 1919 flu epidemic a physician who did not understand that artifacts on the slide, probably bubbles, move randomly due to Brownian motion. Looking at the tissues of flu patients with a microscope, he found what he thought was not only the cause of influenza, but the cause of all diseases: small cocci (round balls) that oscillated under the microscope. He found these wiggling bubbles in all the tissues of all the ill people he examined and thought he discovered the true cause of all disease. Sigh. Yet another cause of all illness. He is the only person, before or since, to see these oscillating cocci. Hence the name.

That’s right, oscillococcinum does not even exist – essentially Boiron takes fairy dust and then dilutes it out of (non)existence. The “anas barbariea hepatis” is basically duck liver, which is supposed to contain the most concentrated nonexistent oscillococcinum. It’s a pseudoscience trifecta.

 

This is far more than just a matter of whether this product works or not: it is about how a commercial entity threatens an individual simply for assessing the same evidence that the company uses for commercial gain, and without malice, argues that that evidence is inadequate in support of the products claims.

[Some of the references listed below are numbered as in the original articles.]

 

[1] http://en.wikipedia.org/wiki/Oscillococcinum

[2] Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like syndrome: a placebo-controlled, double-blind evaluation. Br Homeopath J. 1998; 87: 69 – 76.
[3] Ferly JP, Amirou D, D” Adhemar D, Balducci F. A controlled evaluation of a homeopathic preparation in the treatment of influenza-like syndromes. Br J Clin Pharmacol. 1989; 27: 329-335

[4] Ruoling Guo, Max H. Pittler, E Ernst (November 2007). “Complementary Medicine for Treating or Preventing Influenza or Influenza-like Illness”. The American Journal of Medicine 120 (11): 923–929.e3. doi:10.1016/j.amjmed.2007.06.031. PMID 17976414

[14] van der Wouden JC, Bueving HJ, Poole P. Preventing influenza: an overview of systematic reviews. Respir Med. 2005 Nov;99(11):1341-9. Epub 2005 Aug 19. PMID 16112852

[15] Vickers AJ, Smith C (2006). “Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes”. Cochrane Database Syst Rev 3: CD001957. doi:10.1002/14651858.CD001957.pub3. PMID 16855981. Retrieved 2011-03-30.

Breaking news: 21 August 2011

 

From: Consumer Health Digest #11-26, August 18, 2011

Major homeopathic manufacturer facing class-action suits 

A class-action complaint has been filed against the manufacturers of Oscillococcinum, a homeopathic product widely claimed to be a flu remedy. The complaint charges that the product (a) is nothing more than a sugar pill, (b) has no impact on the flu or any symptoms that accompany it, and (c) contains no molecules of its allegedly active ingredient.

http://www.casewatch.org/civil/boiron/oscillococcinum/complaint.shtml

The suit, filed in California against Boiron, Inc., Boiron USA, Inc., and Laboratories Boiron, asks the court to halt the challenged claims and award damages for violating consumer protections laws. The “active ingredient” in Oscillococcinum is prepared by incubating small amounts of a freshly killed duck’s liver and heart for 40 days.

The resultant solution is then filtered, freeze-dried, rehydrated, diluted 1/100 200 times (shaking it inbetween each dilution), and impregnated into sugar granules. If a single molecule of the original substance could survive the dilution, its concentration would be 1 in 100200-a number vastly greater than the estimated number of molecules in the universe. http://www.homeowatch.org/o

Last year the FDA and FTC jointly warned a distributor that it was illegal to advertise Oscillococcinum “for fast relief of flu infection symptoms.”

http://www.casewatch.org/fdawarning/prod/2010 /homeopathy_for_health.shtml 

The Newport Trial Group (http://trialnewport. com
), which filed this suit, is pursuing a similar one against Boiron USA in connection with its marketing of Children’s ColdCalm, a homeopathic product claimed to relieve sneezing, runny nose, nasal congestion, sinus pain, headaches, and sore throat.

http://www.casewatch.org/civil/boiron/coldca lm/complaint.pdf In July, a federal court judge denied a motion to dismiss that case on grounds that the FDA has primary jurisdiction and the court should defer to the government’s enforcement powers.

http://www.casewatch.org/civil/boiron/coldcalm/dismissal_order_rulin g.pdf

After noting that the FDA has not required that homeopathic products meet efficacy standards, the judge ruled that jurisdiction is proper because the agency has largely abdicated any role it might have had in creating such standards.

The Committee for Skeptical Inquiry and the Center for Inquiry have urged Walmart to stop marketing Oscillicoccinum.

http://www.homeowat ch.org/news/cfi.html

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