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Animal products in pharmaceuticals

From Wikipedia, the free encyclopedia

Animal products in pharmaceuticals play a role as both active and inactive ingredients, the latter including binders, carriers, stabilizers, fillers, and colorants.[1] Animals and their products may also be used in pharmaceutical production without being included in the product itself.

The religious, cultural, and ethical concerns of patients and the disclosure of animal ingredients in pharmaceuticals are a growing area of concern for some people.[2][3][4] These would include people who abide by veganism ("vegans"), the practice of abstaining from the use of animal products. Vegan medicines are medications and dietary supplements that do not have any ingredients of animal origin. The vegan status can be determined either through self-proclamation of the company or certification from a third-party organization, such as The Vegan Society or PETA.[5][6]

Desire for ingredient information

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There is public interest in knowing whether medications and supplements contain animal-sourced ingredients.[7][8] In a study of 100 people, 84% reported not knowing that several medications contained ingredients derived from animal sources. Nearly 63% of the people wanted their physicians, and 35% of the people wanted other healthcare providers (pharmacists, nurses), to notify them when using such medications.[9] Alternatives exist for many animal-derived ingredients, and healthcare providers are increasingly incorporating awareness around animal-free drugs in their medical practice.[9][4]

A 2013 study in the BMC Medical Ethics contacted branches of six of the world's largest religions. Of the six religions contacted, respondents from three did not accept or approve of the use of animal products in pharmaceuticals. The authors concluded that:

...religious codes conflict with some treatment regimens. It is crucial to obtain informed consent from patients for the use of drugs and implants with animal or human derived content. However, information on the origin of ingredients in drugs is not always available to health practitioners.[2]

Similarly, a 2014 BMJ analysis on the topic discussed the lack of information about ingredients available to doctors. According to the article, "Most medications prescribed in primary care contain animal derived products" and "Disclosure of animal content and excipients would help patients make an informed personal choice"[4]

Active ingredients in drugs and dietary supplements

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Biomedicine

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  • Insulin from cattle and pigs has been used since the 1920s, and was the predominant form of insulin used for decades. The first synthetic human insulin was created using bacteria in 1978.[10] In the United States, the manufacture of beef insulin was discontinued in 1998, and the manufacture of pork insulin was discontinued in 2006.[11]
  • Premarin, a hormone replacement therapy, is a conjugated estrogen. It was first available in the form of a preparation manufactured from the urine of pregnant mares - hence "Premarin" from "PREgnant MARe's urINe". It is now also made as a fully synthetic product.[12][13]

Dietary supplements

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  • Glucosamine, used in dietary supplements marketed for osteoarthritis, is extracted from chitin from shellfish.[14] Non-animal sourced glucosamine is also available.[15]
  • Cartilage as a dietary supplement is by definition animal-sourced. Shark cartilage is marketed explicitly or implicitly as a treatment or preventive for various illnesses, including cancer. There is no consensus that shark cartilage is useful in treating or preventing cancer or other diseases.[16]

Traditional Chinese Medicine

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Traditional Chinese Medicine (TCM) utilizes approximately 1,000 plant species and 36 animal species.[17] Animal ingredients in TCM include animal parts such as tiger bones, rhino horns, deer antlers, and snake bile.[18] The use of animal parts in TCM have been definitively linked to the extinction of wildlife.[19] One example of this link is the pangolin trade, which has led the pangolin to be called the world's "most trafficked mammal."[20] In 2020, pangolin scales were removed from the Chinese list of ingredients approved for use in Traditional Chinese Medicine.[21]

Homeopathic medicine

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Blatta Orientalis

Homeopathic medicine is made of plants, minerals, or animal parts.[22] Oscillococcinum, a remedy purported to reduce cold and flu like symptoms, is made of duck heart and liver.[23] There is also use of insects in homeopathic medicine, such as Blatta orientalis, a type of cockroach which has been studied by homeopaths for anti-asthmatic effects.[24]

Inactive ingredients

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  • Gelatin is derived from animal skin, bone, and tissue most often from pigs or beef.[25] There is no practical way of determining if the gelatin used in pharmaceuticals is derived from beef or pork. It is used primarily for gel capsules and as stabilizers for vaccines.[26] Non-animal derived alternatives to gelatin include pectin as a gelling agent or cellulose for creating capsules.[27]
  • Lactose is derived from cow's milk and is a frequently used filler or binder in tablets and capsules.[28]
  • Magnesium stearate is the most commonly used emulsifier, binder, thickener, or lubricant. It can be derived from animal- or plant-sourced stearic acid,[29] although it is most commonly sourced from cottonseed oil or palm oil.[30]
  • Sodium tallowate is a common soap ingredient derived from tallow—the fat of animals such as cattle and sheep.[31] A popular alternative to this ingredient is sodium palmate, which is derived from palm oil.[32] Soap is a pharmaceutical according to the United States Food and Drug Administration.[33]
  • Shellac is a resin excreted by female insects of the species Kerria lacca. It is used as a glazing agent on pills.[34]
  • Carmine, derived from crushed cochineal beetles, is a red or purple substance commonly used in pharmaceutical products. Evidence shows that it can be allergenic.[35][36] Carmine is an allergen according to the US Food and Drug Administration (FDA).[37] The FDA requires this ingredient to be declared in food and cosmetics, but not pharmaceuticals.[38][39]

Animal use during product development or production

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Main articles: Animal testing and Alternatives to animal testing

A separate issue is the use of testing on animals as a means of initial testing during drug development, or actual production.[40] Guiding principles for more ethical use of animals in testing are the Three Rs first described by Russell and Burch in 1959.[41] These principles are now followed in many testing establishments worldwide.

  1. Replacement refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aim.
  2. Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.
  3. Refinement refers to methods that alleviate or minimize potential pain, suffering, or distress, and enhance animal welfare for the animals used.

Cow blood is used in vaccine manufacture. Microorganisms for vaccine manufacture are grown under controlled conditions in liquid solutions ("media") which provide the nutrients necessary for growth. These can include cow plasma.[42] Chicken eggs are used in the production process of some vaccines. For influenza vaccination there are non-egg alternatives.[43]

See also

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Further reading

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References

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  1. ^ Barclay, Eliza (15 March 2013). "Is Your Medicine Vegan? Probably Not". NPR. Retrieved 2020-03-04.
  2. ^ a b Eriksson, Axelina; Burcharth, Jakob; Rosenberg, Jacob (2013-12-01). "Animal derived products may conflict with religious patients' beliefs". BMC Medical Ethics. 14 (1): 48. doi:10.1186/1472-6939-14-48. ISSN 1472-6939. PMC 4220589. PMID 24289542.
  3. ^ Rodger, Daniel; Blackshaw, Bruce P. (2019-02-18). "Using animal-derived constituents in anaesthesia and surgery: the case for disclosing to patients". BMC Medical Ethics. 20 (1): 14. doi:10.1186/s12910-019-0351-4. ISSN 1472-6939. PMC 6379939. PMID 30777063.
  4. ^ a b c Tatham KC, Patel KP (February 2014). "Suitability of common drugs for patients who avoid animal products" (PDF). BMJ. 348: g401. doi:10.1136/bmj.g401. PMID 24496281. S2CID 42628750.
  5. ^ Vegan Trend in Consumer Buying Behaviour, Theseus, 2019
  6. ^ "Vegan Trademark Standards". The Vegan Society. Retrieved 2024-03-22.
  7. ^ People have a right to know if their medicines contain animal ingredients Archived 2020-10-24 at the Wayback Machine, The Pharmaceutical Journal, July 27, 2007
  8. ^ Many drugs 'non-vegetarian and need better labelling, BBC, February 28, 2012
  9. ^ a b Sattar SP, Ahmed MS, Madison J, Olsen DR, Bhatia SC, Ellahi S, Majeed F, Ramaswamy S, Petty F, Wilson DR (November 2004). "Patient and physician attitudes to using medications with religiously forbidden ingredients". Ann Pharmacother. 38 (11): 1830–5. doi:10.1345/aph.1E001. PMID 15479773. S2CID 20902192.
  10. ^ "The History of a Wonderful Thing We Call Insulin | ADA". www.diabetes.org. Retrieved 2020-05-26.
  11. ^ Research, Center for Drug Evaluation and (2019-07-10). "Questions and Answers on Importing Beef or Pork Insulin for Personal Use". FDA.
  12. ^ Morrison, Keith (2004-01-18). "The HRT horses". NBC News. Retrieved 2022-12-01.
  13. ^ IARC Working Group on the Evaluation of Carcinogenic Risks to Humans; World Health Organization; International Agency for Research on Cancer (2007). Combined Estrogen-progestogen Contraceptives and Combined Estrogen-progestogen Menopausal Therapy. World Health Organization. pp. 378–. ISBN 978-92-832-1291-1.
  14. ^ Murray, Michael T. (2012). "Chapter 94: Glucosamine". In Pizzorno, Joseph E. Jr.; Murray, Michael T. (eds.). Textbook of natural medicine (4th ed.). Edinburgh: Churchill Livingstone. p. 790. ISBN 9781437723335.
  15. ^ "Another vegetarian glucosamine launched in US". NutraIngredients-USA.com. January 25, 2008. Archived from the original on April 17, 2009.
  16. ^ PDQ® Integrative, Alternative, and Complementary Therapies Editorial Board (23 August 2018). "Cartilage (Bovine and Shark) (PDQ®): Health Professional Version". PDQ Cancer Information Summaries, Bethesda (MD). Bethesda, MD: National Cancer Institute (US). PMID 26389205.
  17. ^ "Traditional Chinese Medicine and Endangered Animals". Saving Earth | Encyclopedia Britannica. 2008-04-05. Retrieved 2020-10-13.
  18. ^ Still, J. (2003-06-01). "Use of animal products in traditional Chinese medicine: environmental impact and health hazards". Complementary Therapies in Medicine. 11 (2): 118–122. doi:10.1016/S0965-2299(03)00055-4. ISSN 0965-2299. PMID 12801499.
  19. ^ "Traditional Chinese medicine and wildlife". Animals. 2019-02-27. Archived from the original on March 2, 2019. Retrieved 2020-10-13.
  20. ^ "The most trafficked creature you've never heard of". www.cnn.com. Retrieved 2020-10-13.
  21. ^ "China removes pangolin scale from list of official medicines". www.nhm.ac.uk. Retrieved 2020-10-13.
  22. ^ "Homeopathy". NCCIH. Retrieved 2020-09-10.
  23. ^ "The True Story of Oscillococcinum | Quackwatch". 27 August 2003. Retrieved 2020-09-10.
  24. ^ Chandrakant Nimgulkar, Chetan; Dattatray Patil, Savita; Dinesh Kumar, B. (July 2011). "Anti-asthmatic and anti-anaphylactic activities of Blatta orientalis mother tincture". Homeopathy. 100 (3): 138–143. doi:10.1016/j.homp.2010.08.006. ISSN 1476-4245. PMID 21784330.
  25. ^ Gelatin at the Encyclopædia Britannica
  26. ^ "Medicines/Pharmaceuticals of Animal Origin" (PDF). Queensland Health. January 4, 2019. Retrieved March 9, 2020.
  27. ^ Prakash, Ajay; Soni, Hariom; Mishra, Abhishek; Sarma, Phulen (2017). "Are your capsules vegetarian or nonvegetarian: An ethical and scientific justification". Indian Journal of Pharmacology. 49 (5): 401–404. doi:10.4103/ijp.IJP_409_17. PMC 5830853. PMID 29515283.
  28. ^ Westhoff, Gerrit M.; Kuster, Ben F.M.; Heslinga, Michiel C.; Pluim, Hendrik; Verhage, Marinus. "Lactose and Derivatives". Ullmann's Encyclopedia of Industrial Chemistry. Weinheim: Wiley-VCH. doi:10.1002/14356007.a15_107.pub2. ISBN 978-3527306732.
  29. ^ Nora, Angelo; Szczepanek, Alfred; Koenen, Gunther. "Metallic Soaps". Ullmann's Encyclopedia of Industrial Chemistry. Weinheim: Wiley-VCH. doi:10.1002/14356007.a16_361. ISBN 978-3527306732.
  30. ^ Myatt, Dana (6 November 2013). "Magnesium Stearate: A Safe and Effective Filler – Setting the Record Straight". NutritionReview.org. Retrieved 11 August 2020.
  31. ^ Tallow at the Encyclopædia Britannica
  32. ^ "About Sodium Palmate - Tom's of Maine". www.tomsofmaine.com. Retrieved 2020-03-27.
  33. ^ Nutrition, Center for Food Safety and Applied (2020-02-04). "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)". FDA.
  34. ^ US Patent 6620431, "Shellac film coatings providing release at selected pH and method" 
  35. ^ Taylor SL, Hefle SL (2001). "Ingredient and labeling issues associated with allergenic foods". Allergy. 56 (Suppl 67): 64–9. doi:10.1034/j.1398-9995.2001.00920.x. PMID 11298013. S2CID 35810034.
  36. ^ Takeo N, Nakamura M, Nakayama S, Okamoto O, Sugimoto N, Sugiura S, Sato N, Harada S, Yamaguchi M, Mitsui N, Kubota Y (October 2018). "Cochineal dye-induced immediate allergy: Review of Japanese cases and proposed new diagnostic chart". Allergology International. 67 (4): 496–505. doi:10.1016/j.alit.2018.02.012. ISSN 1440-1592. PMID 29705083.
  37. ^ "Why You Should Never, Ever Give Red Candies To Your Valentine". HuffPost. 2014-02-13. Retrieved 2020-09-03.
  38. ^ Nutrition, Center for Food Safety and Applied (2020-01-14). "Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain Cochineal Extract and Carmine". U.S. Food and Drug Administration. Retrieved 2020-09-05.
  39. ^ "Cochineal (Inactive Ingredient)". Drugs.com. Retrieved 2020-09-05.
  40. ^ "Safety Testing". Science, Medicine, and Animals. Safety Testing. Washington (DC): National Academies Press (US): National Research Council (US) Committee to Update Science, Medicine, and Animals. 2004.
  41. ^ Russell, W.M.S. and Burch, R.L., (1959). The Principles of Humane Experimental Technique, Methuen, London. ISBN 0-900767-78-2 [1] Archived 2011-09-27 at the Wayback Machine
  42. ^ Research, Center for Biologics Evaluation and (2019-03-20). "Bovine Derived Materials Used in Vaccine Manufacturing Questions and Answers". FDA.
  43. ^ "Flublok Seasonal Influenza (Flu) Vaccine". Centers for Disease Control and Prevention. 14 December 2017. Archived from the original on 14 March 2018. Retrieved 13 March 2018.
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