Animal products in pharmaceuticals

Animal product additives in pharmaceuticals play a role as both active and inactive ingredients. Animal products in pharmaceuticals are inactive ingredients when used as binders, carriers, stabilizers, fillers, and colorants.[1] Biologics and some vitamins are use cases for animal products as active ingredients in pharmaceuticals. A pharmaceutical is a medium used to diagnose, treat, and prevent disease and to correct bodily functions.[2] The religious, cultural, and ethical concerns of patients and the disclosure of animal ingredients in pharmaceuticals are a growing area of concern.[3][4][5]

Controversy

A 2007 article in The Pharmaceutical Journal argues that people have a right to know if there are animal products in their pharmaceuticals. The author suggests that just as with food in the U.K., a "suitable for vegetarians" stamp on pharmaceuticals without animal products would be a suitable solution. The article then goes on to detail how in May of the same year, the Association of the British Pharmaceutical Industry, the Medicines and Healthcare products Regulatory Agency, and various drug companies met to discuss the issue[6]

In a 2013 study in the BMC Medical Ethics contacted 18 branches of 6 of the world's largest religions to assess the lack of available information on ingredients given the presence of animal products in pharmaceuticals. Of the 6 religions contacts, 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.[3]

Similarly a 2014 article in the BMJ discusses the lack of information about ingredients available to doctors. According to the article, the factors that make this knowledge gap an issue include: "religion, culture, economic status, environmental concern, food intolerances, and personal preferences."[5]

Active Ingredients

Insulin

Insulin from cattles and pigs have been used since 1920's, and was the predominant form of insulin used for decades. The first synthetic human insulin was created using bacteria in 1978.[7] In the United States, the manufacture of beef insulin was discontinued in 1998, and the manufacture of pork insulin was discontinued in 2006.[8] Just normally.

Biologics

Xenotransplantation is the transplantation of non-human animal tissues, cells, and organs into a human recipient.[9] Xenotransplantation is often seen as a solution to the unavailability of human organs for allotransplantation.[10] According to the Food and Drug Administration, xenotransplantation presents public health risks, including transmitting viruses, bacteria, or other organisms to humans that may not be pathogenic or detectable in the source animal.[11] A 2017 article in Molecular Biotechnology argues that genetically modified pigs are the solution to reducing the infection rate of porcine endogenous retroviruses (PERV) in humans with xenotransplantation from pigs.[12]

Premarin

The drug Premarin is a conjugated estrogen which is commonly used as a hormone replacement therapy. The drug is derived from the urine of pregnant horses.[13]

Inactive Ingredients

Gelatin

One of the most common animal products in medicine is Gelatin.[1] Gelatin is derived from animal skin, bone, and tissue most often from pigs or beef.[14] 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.[15] A non-animal derived alternative to gelatin is Pectin as a gelling agent or Cellulose for creating vegetable capsules.[16]

Stearic Acid
Gelatin, stearic acid, sodium tallowate, and vaccine ingredients are commonly derived from cows.

Another common animal-derived additive is Stearic acid. Stearic acid can be derived from vegetables or animals such as cows, sheep, dogs, or cats.[15] There is no practical method for determining the source of stearic acid in pharmaceuticals. Stearic acid is far more abundant in animal rather than vegetable sources. Lard and tallow, for example, contain up to 30% stearic acid.[17]

Sodium Tallowate

Sodium tallowate is a common soap ingredient derived from tallow—the fat of animals such as cattle and sheep.[18] Soaps which include the use of sodium tallowate include Dove, Dial, and Ivory. A popular alternative to this ingredient is sodium palmate, which is derived from palm oil.[19] Soap is a pharmaceutical according to the United States Food and Drug Administration.[20]

Vaccines

According to the American Food and Drug Administration, "Cow components are often used simply because cows are very large animals, commonly used for food, and thus much material is available." Although cows are most commonly used, animal products in vaccines can be from a variety of animals. Within the vaccine, the inactive components from animal sources can include amino acids, glycerol, detergents, gelatin, enzymes and blood.[21]

See also

References
  1. "Is Your Medicine Vegan? Probably Not". NPR.org. Retrieved 2020-03-04.
  2. "Pharmaceutical | therapeutic substance". Encyclopedia Britannica. Retrieved 2020-05-26.
  3. 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.
  4. 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.
  5. Tatham, Kate C.; Patel, Kinesh P. (2014-02-04). "Suitability of common drugs for patients who avoid animal products". BMJ. 348: g401. doi:10.1136/bmj.g401. ISSN 1756-1833. PMID 24496281. S2CID 42628750.
  6. JUL 2007, The Pharmaceutical Journal27. "People have a right to know if their medicines contain animal ingredients". Pharmaceutical Journal. Retrieved 2020-07-17.
  7. "The History of a Wonderful Thing We Call Insulin | ADA". www.diabetes.org. Retrieved 2020-05-26.
  8. Research, Center for Drug Evaluation and (2019-07-10). "Questions and Answers on Importing Beef or Pork Insulin for Personal Use". FDA.
  9. "U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation". Morbidity and Mortality Weekly Report: Recommendations and Reports. 50 (RR-15): i–46. 2001. ISSN 1057-5987. JSTOR 42000864.
  10. Anderson, M (April 2006). "Xenotransplantation: a bioethical evaluation". Journal of Medical Ethics. 32 (4): 205–208. doi:10.1136/jme.2005.012914. ISSN 0306-6800. PMC 2565783. PMID 16574873.
  11. "Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for Industry". fda.gov. US Food and Drug Administration. December 2016. p. 2. Retrieved 11 April 2020. This article incorporates text from this source, which is in the public domain.
  12. Hryhorowicz, Magdalena; Zeyland, Joanna; Słomski, Ryszard; Lipiński, Daniel (2017). "Genetically Modified Pigs as Organ Donors for Xenotransplantation". Molecular Biotechnology. 59 (9): 435–444. doi:10.1007/s12033-017-0024-9. ISSN 1073-6085. PMC 5617878. PMID 28698981.
  13. News, Keith Morrison NBC (2004-01-19). "The HRT horses". msnbc.com. Retrieved 2020-05-26.
  14. "Gelatin | animal protein". Encyclopedia Britannica. Retrieved 2020-03-04.
  15. "Medicines/Pharmaceuticals of Animal Origin" (PDF). Queensland Health. January 4, 2019. Retrieved March 9, 2020.
  16. 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 (inactive 2020-07-23). ISSN 0253-7613. PMC 5830853. PMID 29515283.
  17. "Stearic acid | chemical compound". Encyclopedia Britannica. Retrieved 2020-03-09.
  18. "Tallow | biochemistry". Encyclopedia Britannica. Retrieved 2020-03-29.
  19. "About Sodium Palmate - Tom's of Maine". www.tomsofmaine.com. Retrieved 2020-03-27.
  20. Nutrition, Center for Food Safety and Applied (2020-02-04). "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)". FDA.
  21. Research, Center for Biologics Evaluation and (2019-03-20). "Bovine Derived Materials Used in Vaccine Manufacturing Questions and Answers". FDA.
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