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Oscillococcinum

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An open vial of Oscillococcinum tablets

Oscillococcinum /ˌɒsələˈkɒksɪnəm/ (or Oscillo)[1][2] is a homeopathic preparation marketed to relieve flu-like symptoms, although it does not provide any benefit beyond that of a placebo.

Oscillococcinum is promoted according to the disproven homeopathic principle that "like cures like", and that a disease can be cured by small amounts of the substance that cause similar symptoms. Boiron is its sole manufacturer. Oscillococcinum is used in more than 50 countries, being particularly popular in France, and has been in production for over 65 years.

Oscillococcinum was originally proposed by the French physician Joseph Roy, on the basis of his misidentification of a supposed oscillating bacterium he named oscillococcus in victims of the Spanish flu epidemic of 1917–1918. Roy said he had seen the same bacterium in cancer sufferers, and proposed a homeopathic preparation (which he claimed to have isolated in a duck) as a remedy for the Spanish flu. The microbes Roy said he saw have never been independently observed by any other researcher. In addition, it is now known that influenza is caused by a virus and not a bacterium.[3]

The preparation is derived from duck liver and heart, diluted to 200C—a ratio of one part duck offal to 10400 parts water.[4] Homeopaths claim that the molecules leave an "imprint" in the dilution that causes a healing effect on the body. There is no evidence that supports this mechanism or efficacy beyond placebo.[5][6][7]

Origin and history

The word Oscillococcinum was coined by the French physician Joseph Roy (1891–1978) in his 1925 book Towards Knowledge and the Cure of Cancer.[4][8] Roy wrote that while on military duty during the Spanish flu epidemic of 1917 he had observed an oscillating bacterium in the blood of flu victims, which he named Oscillococcus.[9]

Roy subsequently claimed to have observed the microbe in the blood of patients that had viral diseases like herpes, chicken pox, and shingles.[9] He thought it to be the causative agent of diseases as varied as eczema, rheumatism, tuberculosis, measles, and cancer. Roy searched for the "bacterium" in several animals until he felt that he had found it on the liver of a Long Island duckling.[9] Believing he had also detected it in the blood of cancer patients, he tried a vaccine-like therapy on them, which was unsuccessful.[9]

The microbe has never been independently observed by another researcher, and it remains unclear what, if anything, Roy actually saw.[10] Moreover, medical science has since disproved Roy's "universal germ" theory: rheumatism, for example, is not caused by bacteria, and measles is caused by a virus far too small for Roy to have observed in his optical microscope.[4]

The modern preparation is created from the heart and liver of Muscovy duck (see the preparation section for the details).[4]

In France, the selling of all products manufactured according to the Korsakovian principle of dilution was forbidden until 1992, with the exception of Oscillo, thanks to a special measure made for it.[9] As of 2000, Oscillococcinum was one of the top ten selling drugs in France, was publicised widely in the media, and was being prescribed for both flu and the common cold.[9] As of 2008, sales in the United States totalled US$15 million per year; Oscillo also sells widely in Europe.[11]

Preparation

The ingredients of a one-gram tube of Oscillococcinum are listed as follows:

  • Active ingredient: Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy duck liver and heart) 200CK HPUS 1×10−400 g[11] which is much less than the mass of a proton (1.67×10−24 g).[11]
  • Inactive ingredient: 0.85 g sucrose, 0.15 g lactose (100% sugar).[12]

The 200CK indicates that the preparation entails a series of 200 dilutions of the starting ingredient, an extract from the heart and liver of a Muscovy duck.[11] Each step entails a 1:100 dilution, where the first mixture contains 1% of the extract, the second contains 1% of the first mixture, etc.[11] The K indicates that it is prepared by the Korsakovian method, in which rather than 1% of the preparation being measured out at each stage and then diluted, a single vessel is repeatedly emptied, refilled, and vigorously shaken (in homeopathic terminology "succussed"), and it is assumed that 1% remains in the vessel each time.[13] The 200C dilution is so extreme that the final pill contains none of the original material.[11][14]

Oscillococcinum is generally considered harmless. When Boiron (the company that makes oscillococcinum) spokeswoman Gina Casey was asked if a product made from the heart and liver of a duck was safe, she replied: "Of course it is safe. There's nothing in it."[12]

Efficacy

There is no compelling scientific evidence that Oscillococcinum has any effect beyond placebo.[15] None of its active ingredient is present in a dose of the final product, nor is there any credible evidence that duck liver is effective in relieving (or causing) flu symptoms in the first place. Homeopaths claim the diluted molecules leave an "imprint" in the remedy, but there is no known mechanism for how this could occur.[11][16] Homeopathy as a whole is widely considered to be pseudoscience.[17]

As Robert L. Park, a critic of alternative medicine, explains, some of the characteristics of flu may suggest that Oscillococcinum works. Since the flu normally goes away on its own in a variable number of days, the natural course of the disease is a potential source of error in assessing the efficacy of any intervention: if one takes any medication, and then one's flu goes away, there is a tendency to attribute this to the medication even though the infection would have resolved anyway,[11] which is an example of the informal fallacy post hoc ergo propter hoc. Someone who gets over a mild strain of flu may attribute the mildness to the efficacy of the homeopathic preparation and not to the fact that it was a mild strain, and might recommend it to other people, spreading its popularity.[11] Also, the most likely explanation for its effectiveness with flu symptoms is that patients are misdiagnosing the symptoms of several rhinovirus diseases or of allergies to several hundred substances, and attributing them to a flu infection that they do not have.[11]

A 2005 review of flu treatments (vaccine, medicine, homeopathy) concluded that the popularity of Oscillococcinum in France was unsupported by any evidence of efficacy.[18] In a 2007 review, the effectiveness of non-mainstream remedies against seasonal flu could not be established beyond reasonable doubt, and the evidence was found to be sparse and limited by "small sample sizes, low methodological quality, or clinically irrelevant effect sizes", and that the results strengthened using conventional approaches for treating flu.[6]

A Cochrane review published in December 2015 found that there was insufficient evidence to make a conclusion about whether Oscillococcinum was useful for influenza.[15]

Lawsuits and criticisms

The non-profit educational organizations Center for Inquiry (CFI) and the associated Committee for Skeptical Inquiry (CSI) have petitioned the U.S. Food and Drug Administration (FDA), criticizing Boiron for misleading labeling and advertising of Oscillococcinum. "One petition complains that Boiron's packaging for Oscillococcinum lists the alleged active ingredient – duck liver and heart – in Latin only. Another petition complains that Boiron's web ad for this product implies that it has received FDA approval." Ronald Lindsay, CFI and CSI president and chief executive officer, contended that, "If Boiron is going to sell snake oil, the least they can do is use English on their labels."[19]

A class action lawsuit was filed against Boiron on behalf of "all California residents who purchased Oscillo at any time within the past four years". The lawsuit charged that Boiron "falsely advertises that Oscillo has the ability to cure the flu because it contains an active ingredient it claims is proven to get rid of flu symptoms in 48 hours". The lawsuit also stated that the listed active ingredient in Oscillococcinum (Oscillo) "is actually Muscovy Duck Liver and Heart ... and has no known medicinal quality."[20] A settlement was reached, with Boiron denying any wrongdoing and agreeing to make several changes to its marketing of the product.[21] These changes included adding to their packaging notices like "These 'Uses' have not been evaluated by the Food and Drug Administration" and "C, K, CK, and X are homeopathic dilutions."[22]

Since 2011, at least two class action lawsuits on behalf of customers who purchased Oscillococcinum have been filed against Boiron in the United States, alleging that Boiron falsely advertises that Oscillo has the ability to cure the flu.[23][24] A proposed settlement was reached in August 2012.[25] While the settlement was challenged in the U.S. Court of Appeals for the Ninth Circuit by one class member who opposed the settlement, on February 24, 2015, the Ninth Circuit issued a decision upholding approval of the class action settlement.[26]

Boiron's legal threats against Samuele Riva for writing criticisms on his website were rebuffed by his web hosting company, and the debacle was described as producing a Streisand effect against Boiron.[27]

References

  1. ^ "Oscillo may help, but not by much". Los Angeles Times. 2008-02-18.
  2. ^ "How is "Oscillococcinum" pronounced?". Oscillo.com. 2013-01-24. Retrieved 2013-11-08.
  3. ^ "Flu - NHS Choices". National Health Service. April 2015. Retrieved 2017-01-14.
  4. ^ a b c d Nienhuys, Jan Willem (2003-08-23). "The True Story of Oscillococcinum". Retrieved 2007-02-23.
  5. ^ E Ernst (December 2002). "A systematic review of systematic reviews of homeopathy". Br J Clin Pharmacol. 54 (6): 577–582. doi:10.1046/j.1365-2125.2002.01699.x. PMC 1874503. PMID 12492603.
  6. ^ a b 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.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  7. ^ "Questions and answers about homeopathy. 8. What has scientific research found out about whether homeopathy works?". US National Institute of Health (NCCAM research report). April 2003. Retrieved 2009-03-04. NCCAM Publication No. D183
  8. ^ Roy, Joseph (1925). Vers la connaissance et la guérison du cancer: vue nouvelle sur la constitution de la vie [Towards Knowledge and the Cure of Cancer: A New Vision About the Constitution of Life] (in French). Ed. du Raisin.
  9. ^ a b c d e f Abgrall, Jean-Marie (2000). Healing Or Stealing?: Medical Charlatans in the New Age. Algora. pp. 40–41. ISBN 978-1-892941-51-0.
  10. ^ "The Curious "Science" of Oscillococcinum". Office for Science and Society, McGill University. 2012-12-20. Archived from the original on 2013-10-23. Retrieved 2013-04-11.
  11. ^ a b c d e f g h i j Park, Robert L. (2008). Superstition: Belief in the Age of Science. Princeton University Press. pp. 143–147. ISBN 978-0-691-13355-3.
  12. ^ a b Dan McGraw. Flu Symptoms? Try Duck. U.S. News & World Report 2/9/97 page 2
  13. ^ Kayne SB, Caldwell IM (2006). Homeopathic pharmacy: theory and practice (2 ed.). Elsevier Health Sciences. p. 97. ISBN 978-0-443-10160-1.
  14. ^ Park, Robert L. (2002). Voodoo Science: The Road from Foolishness to Fraud (reprint ed.). Oxford University Press. p. 53. ISBN 978-0-19-860443-3.
  15. ^ a b Mathie, RT; Frye, J; Fisher, P (28 January 2015). "Homeopathic Oscillococcinum® for preventing and treating influenza and influenza-like illness". The Cochrane Database of Systematic Reviews. 1: CD001957. doi:10.1002/14651858.CD001957.pub6. PMC 6726585. PMID 25629583.
  16. ^ Toufexis Anastasia (25 September 1995). "Is homeopathy good medicine?". Time. p. 2. Archived from the original on May 1, 2008. Retrieved 2008-04-20.(page numbering given from online version)
  17. ^ National Science Board (April 2002). "Chapter 7 - Science and Technology: Public Attitudes and Public Understanding". Arlington, Virginia: National Science Foundation Directorate for Social, Behavioral and Economic Sciences.
  18. ^ Van; der Wouden, JC; Bueving, HJ; Poole, P. (Nov 2005). "Preventing influenza: an overview of systematic reviews". Respir. Med. 99 (11): 1341–9. doi:10.1016/j.rmed.2005.07.001. PMID 16112852.
  19. ^ "Citizen Petition calls on US FDA to review regulation of homeopathic drugs". The Pharma Letter. 18 September 2011. Retrieved 2011-09-20.
  20. ^ "Boiron Oscillococcinum Class Action Lawsuit". Top Class Actions. 8 August 2011. Retrieved 2011-09-24.
  21. ^ "The Law Office of Ronald A. Marron, APLC and Patton Boggs LLP Announce Preliminary Approval of Class Action Settlement". Retrieved 30 May 2012.
  22. ^ "Gallucci v. Boiron, Inc. et al Settlement Agreement" (PDF). Archived from the original (PDF) on 16 March 2013. Retrieved 30 May 2012.
  23. ^ Holter, Mike (8 August 2011). "Boiron Oscillococcinum Class Action Lawsuit". TopClassActions.com. Retrieved 2013-11-08. 'Unfortunately, Defendants fail to inform consumers of the truth regarding Oscillo and is purported active ingredient,' the Boiron class action lawsuit says. 'The truth is that the listed active ingredient in Oscillo, Anas Barbariae Hepatis et Cordis Extractum, is neither active in combating the flu nor is it actually an ingredient in Oscillo.'
  24. ^ "Henry Gonzales v. Boiron Inc. et al" (PDF). CourthouseMews.com. August 4, 2011.
  25. ^ "Gallucci v. Boiron, Inc., et al" (PDF). gilardi.com. August 13, 2012. Archived from the original (PDF) on April 16, 2016. Retrieved 2013-11-08. Pursuant to the Court's April 25, 2012 Order Granting Preliminary Approval ("PA Order", Dkt. 89), Plaintiffs Salvatore Gallucci, Amy Aronica, Kim Jones, Doris Petty, and Jeanne Prinzivalli respectfully submit this Memorandum in support of their Motion for Final Approval of the proposed classwide Settlement with Defendants Boiron, Inc. and Boiron USA, Inc.
  26. ^ Bucher, Anne (2015-02-25). "9th Circuit Upholds Boiron Homeopathic Remedy Settlement". TopClassActions.com. Retrieved 2015-05-20. On Tuesday, the 9th U.S. Circuit Court of Appeals upheld a Boiron homeopathic remedy class action settlement after disagreeing with an objector who had argued the 2012 deal was the result of collusion. In his appeal to the 9th Circuit, objector Henry Gonzales argued that the Boiron class action settlement was not fair, reasonable and adequate. He also argued that the $5 million false advertising settlement amount represents less than 1 percent of Boiron's retail sales and that Class Members would have had a better shot at a fair deal if the class action lawsuit had gone to trial. The three-judge appellate panel disagreed with Gonzales and found that U.S. District Judge John A. Houston did not abuse his discretion by approving the Boiron homeopathic remedy class action settlement back in 2012.
  27. ^ The Web's Backstroke. "In a classic case of "harm set, harm get", a French homeopathy giant earns public condemnation after threatening a private critic with legal action." Lab Times, May 2011
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