Oscillococcinum

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One dose (one gram) of Oscillococcinum

Oscillococcinum (or Oscillo[1][2]) is a homeopathic preparation originally claimed to be made from the (non-existent) "oscillococcus" bacterium, which is marketed to relieve influenza-like symptoms. It is a popular preparation, particularly in France. Oscillococcinum is manufactured by a French company, Boiron, its sole manufacturer. There are, however, other manufacturers who make similar preparations. Oscillococcinum is used in more than 50 countries. In France, it has been in production for over 65 years.

The preparation is derived from duck liver and heart, diluted to 200C—a ratio of one part duck offal to 10400 parts water.[3] This is such a high dilution that the final product likely contains not a single molecule of the original liver (there are around 1080 molecules in the entire known universe[4]). 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.[5][6][7]

It was originally proposed by the French physician Joseph Roy, based on his misidentification of an oscillating bacterium he named oscillococcus in victims of the Spanish flu epidemic of 1917-1918; he then claimed to have 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 many diseases, of which flu is the best known. The oscillococcus bacterium does not exist, and is therefore not the cause of any disease. The most likely explanation is air bubbles or some other error in preparing his microscope slides.

Lawsuits[edit]

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.[8][9] A proposed settlement was reached in August 2012,[10] but as of September 2013, that settlement has been challenged in the U.S. Court of Appeals for the Ninth Circuit by class members who opposed the settlement.[11]

Origin and history[edit]

The word Oscillococcinum was coined in 1925 by the French physician Joseph Roy (1891–1978) who saw military duty during the Spanish Flu epidemic of 1917.[3] Roy wrote that on examining the blood of flu victims, he had observed what he thought to have been an oscillating bacterium which he named Oscillococcus.[12]

Roy claimed he had also detected the bacterium in the blood of patients that had viral diseases like herpes, chicken pox and shingles.[12] He thought it to be the causative agent of diseases as varied as eczema, rheumatism, tuberculosis, measles, and cancer. The microbes have never been independently observed by another researcher, and it remains unclear what, if anything, Roy actually saw.[13]

Believing he had detected it in the blood of cancer patients, he tried a vaccine-like therapy on them, which was unsuccessful.[12] 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.[3]

Roy searched for the "bacterium" in several animals until he felt that he had found it on the liver of the Long Island duckling.[12] The modern preparation is created from the heart and liver of Muscovy Duck (see the preparation section for the details).

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.[12] 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 cold.[12] As of 2008 it sells US$15 million per year in the U.S., and it also sells widely in Europe.[14]

Preparation[edit]

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

  • Active ingredient: Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy Duck liver and heart) 200CK HPUS 1×10−400 g[14]
  • Inactive ingredient: 0.85 g sucrose, 0.15 g lactose (100% sugar.[15])

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.[14] 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.[14] 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.[16] The 200C dilution is so extreme that the final pill contains none of the original material.[14][4] Mathematically, in order to have a reasonable chance to obtain one molecule of the original extract, the patient would have to consume an amount of the remedy roughly 10321 times the number of atoms in the observable universe.

In the United States, under the 1938 Federal Food, Drug, and Cosmetic Act, only those substances listed in the Homeopathic Pharmacopeia of the United States (HPUS) and prepared according to the guidelines therein may be marketed as homeopathic. Only preparations of Oscillococcinum made according to those guidelines may be thus labeled. "A product's compliance with the requirements of the HPUS, USP, or NF does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."[17]

Oscillococcinum is generally considered harmless. When Boiron's 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."[15]

Efficacy[edit]

There is no compelling scientific evidence that Oscillococcinum has any effect beyond placebo.[18] 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 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.[14][19] Homeopathy as a whole is considered to be pseudoscience.[20]

Oscillo is used for the relief of symptoms of flu, which is normally a self-limiting disease (i.e. one that goes away on its own in a variable number of days); this natural course of the disease is a potential source of error in assessing the efficacy of any intervention - if one takes any medication and one's flu goes away, then there is a tendency to attribute this to the medication even though the infection would have resolved anyway.[14] Someone who gets over a mild strain of flu will attribute the mildness to the efficacy of the homeopathic preparation and not to the fact that it was a mild strain, and will recommend it to other people, spreading its popularity.[14] 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.[14]

A 2002 review concludes that no homeopathic preparation is relevantly different from placebo or superior to other treatments.[5] A 2003 review from the U.S.'s National Institutes of Health found that, in general, systematic reviews of homeopathic preparations find little evidence to support homeopathy as an effective treatment for any specific condition.[7]

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.[21]

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.[6]

A Cochrane review published in December 2012 found that there was insufficient evidence to make a robust conclusion about whether Oscillococcinum is effective for the prevention or treatment of influenza.[18]

Criticisms of marketing[edit]

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, contends, "If Boiron is going to sell snake oil, the least they can do is use English on their labels.”[22]

A class action lawsuit has been filed against Boiron on behalf of "all California residents who purchased Oscillo at any time within the past four years." The lawsuit charges 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 states that the listed active ingredient in Oscillococcinum (Oscillo) "is actually Muscovy Duck Liver and Heart...and has no known medicinal quality."[23] A settlement was reached, with Boiron denying any wrongdoing. As part of the settlement, Boiron has agreed to make specific changes to its marketing.[24] These changes include 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."[25]

References[edit]

  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. ^ a b c Nienhuys, Jan Willem (2003-08-23). "The True Story of Oscillococcinum". Retrieved 2007-02-23. 
  4. ^ a b Robert L. Park (2002). Oxford University Press, ed. Voodoo Science: The Road from Foolishness to Fraud (reprint ed.). p. 53. ISBN 0-19-860443-2. 
  5. ^ a b 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. 
  7. ^ a b "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. ^ 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.'" 
  9. ^ "Henry Gonzales v. Boiron Inc. et al" (PDF). CourthouseMews.com. August 4, 2011. 
  10. ^ "Gallucci v. Boiron, Inc., et al." (PDF). gilardi.com. August 13, 2012. 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." 
  11. ^ Bucher, Anne. "Boiron Hit with New Class Action Lawsuit Over Oscillo". TopClassActions.com. Retrieved 2013-11-08. "In December 2011, Jovel had filed a similar class action lawsuit against Boiron, but his lawsuit was dismissed due to lack of standing. He opted out of the recent Boiron class action settlement (Gallucci v. Boiron) that was granted final approval in October 2012 but is being challenged in the Ninth Circuit Court of Appeals by Class Members who opposed the settlement. He claims that the labeling changes approved in the class action settlement, which require Boiron to put a disclaimer on its packaging stating that the product’s uses have not been evaluated by the U.S. Food & Drug Administration and that the product is a 'homeopathic dilution,' are insufficient." 
  12. ^ a b c d e f Jean-Marie Abgrall (2000). Algora Publishing, ed. Healing Or Stealing?: Medical Charlatans in the New Age. pp. 40–41. ISBN 1-892941-51-1. 
  13. ^ "The Curious “Science” of Oscillococcinum". Office for Science and Society, McGill University. 2012-12-20. Retrieved 2013-04-11. 
  14. ^ a b c d e f g h i Robert L. Park (2008). Princeton University Press, ed. Superstition: Belief in the Age of Science. pp. 143–147. ISBN 0-691-13355-7. 
  15. ^ a b Dan McGraw. Flu Symptoms? Try Duck. U.S. News & World Report 2/9/97 page 2
  16. ^ Kayne SB, Caldwell IM (2006). "Homeopathic pharmacy: theory and practice" (2 ed.). Elsevier Health Sciences. p. 97. ISBN 978-0-443-10160-1. 
  17. ^ Strauss, Steven (2000). CRC Press, ed. Strauss's federal drug laws and examination review (5, illustrated ed.). CRC Press. ISBN 1-56676-978-7. 
  18. ^ a b Mathie RT, Frye J, Fisher P. (December 2012). "Homeopathic Oscillococcinum(®) for preventing and treating influenza and influenza-like illness". Cochrane database of systematic reviews (12). doi:10.1002/14651858.CD001957.pub5. PMID 23235586. 
  19. ^ Toufexis Anastasia (25 September 1995). "Is homeopathy good medicine?". Time. p. 2. Retrieved 2008-04-20. (subscription required (help)). (page numbering given from online version)
  20. ^ 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. 
  21. ^ 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
  22. ^ "Citizen Petition calls on US FDA to review regulation of homeopathic drugs". The Pharma Letter. 18 September 2011. Retrieved 2011-09-20. 
  23. ^ "Boiron Oscillococcinum Class Action Lawsuit". Top Class Actions. 8 August 2011. Retrieved 2011-09-24. 
  24. ^ "The Law Office of Ronald A. Marron, APLC and Patton Boggs LLP Announce Preliminary Approval of Class Action Settlement". Retrieved 30 May 2012. 
  25. ^ "Gallucci v. Boiron, Inc. et al Settlement Agreement". Retrieved 30 May 2012. 

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