This is a response to the document “Human Tissue Intended for Transplantation” [OMB control number 0910-0302, Docket ID FDA-2013-N-0797-0003].

The deadline for submissions is 3 January 2014.

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Response to “Human Tissue Intended for Transplantation” [OMB control number 0910-0302, Docket ID FDA-2013-N-0797-0003]

Thank you for the opportunity to provide feedback to “Human Tissue Intended for Transplantation” [OMB control number 0910-0302, Docket ID FDA-2013-N-0797-0003]. This response document will briefly address the ethical and safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products.

Ethical and safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products

Circumcision of male minors, in the absence of a clear and present immediate medical indication, is a controversial practice within the medical profession (KNMG 2010; Smith 2011; Svoboda & Van Howe 2013). Despite this, more than 1.14 million circumcision procedures were performed on male infants in U.S. hospitals in the year 2010 (AHRQ 2013). Foreskins excised from minors in the absence of a clear and present immediate medical indication, almost invariably present in a normal healthy state, and as such their excision and preservation contributes little to the study of the pathology of disease.

Products derived from foreskins excised en masse from minors in the absence of clear and present immediate medical indications, are frequently utilised in the commercial medical product, and more especially cosmetics industries (Advanced Healing 2011; Ballantyne 2009; Business Standard 2013; LifeCell 2012; Organogenesis 2011; Pitman 2008; SkinMedica 2011). As observed by the U.S. Department of Health and Human Services Office of Human Research Protections, “Changing technology in the field of genomics has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA” (OHRP 2011). Valid concerns therefore exist for the future privacy of children whose healthy tissues are likely to be acquired by commercial interests in the cosmetic and medical product industries - and may be retained indefinitely - due to presently unforeseeable technological advances in the field of genomics.

Doubts exist about the appropriateness of utilising products derived from foreskin and other healthy tissue excised from minors, in the cosmetic and medical product industries, on the basis of exculpatory consent forms signed by parents and legal guardians of minors, and whether it is appropriate for parents and legal guardians to give explicit consent for these purposes.

The provision of information to parents on circumcision consent forms about the storage, transfer, processing, sale or any other use of excised healthy foreskins is unstudied. However, a survey conducted by Schaefer et al (2011) of consent forms from U.S. in vitro fertilization clinics and the provision of information to egg donors of the potential for embryonic research using donated eggs, concluded that “egg donors in the United States, including some who may have a moral objection to research and stem cell research, are not being informed that embryos created with their donated eggs may in fact be used for these purposes”, suggesting the possibility that incomplete information is also being provided to parents about the use of foreskin and other healthy tissue excised from minors. Similarly, information about the original source of human skins cells used in cosmetic and medical products, has been ominously absent from the websites of some manufacturers who utilise foreskin-derived ingredients in their products (LifeCell 2012; SkinMedica 2011).

Cellulitis and osteomyelitis have been reported as complications in several studies drawn from the clinical literature for FDA regulated skin-substitute products incorporating foreskin-derived ingredients (AHRQ 2012). Further, as observed by Dr Ron Moy, a dermatologist at the David Geffen School of Medicine at the University of California, Los Angeles, foreskin cells can potentially carry viruses, and although foreskin fibroblasts may be screened for contamination, there is "no test that's perfect" (Ballantyne 2009).

Action Required

Future regulatory and policy decisions must address the ethical issues concerning the privacy of children whose healthy tissues are likely to be acquired by commercial interests in the cosmetic and medical product industries [due to presently unforeseeable technological advances in the field of genomics]; the extent to which parents and legal guardians can give consent for the use of foreskin and other healthy tissue excised from minors in the in the cosmetic and medical product industries; and the provision of information to parents and guardians in exculpatory consent forms. In the interim, safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products, mandate that full and complete disclosure in the proposed information collection activity take precedence over manufacturers professed concerns for increased regulatory and administrative 'burden'.

References

Advanced Healing (2011) Dermagraph Active Living Cells Overview Link http://www.dermagraft.com/about/overview/ Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jhakjim

AHRQ (2013) Most Frequent Procedures Performed in U.S. Hospitals, 2010 Statistical Brief #149 prepared by Pfuntner, A (Truven Health Analytics), Wier, LM (Truven Health Analytics), Stocks, C (AHRQ) February 2013 Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb149.jsp Accessed: 2013-07-10. Archived by WebCite at http://www.webcitation.org/6I0JloBRv

AHRQ (2012) Skin Substitutes for Treating Chronic Wounds Technology Assessment Report Project ID: HCPR0610 prepared by David L. Snyder, Ph.D. (ECRI Institute EPC), Nancy Sullivan, B.A. (ECRI Institute EPC), Karen M. Schoelles, M.D., S.M., F.A.C.P. (ECRI Institute EPC) 18 December 2012 Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf

Ballantyne, C (2009) A Cut above the Rest?: Wrinkle Treatment Uses Babies' Foreskins Scientific American 12 February 2009 [Epub] Full-text available at http://www.scientificamerican.com/article.cfm?id=a-cut-above-the-rest-wrin Accessed: 2012-01-18. Archived by WebCite at http://www.webcitation.org/64mLMhvCA

Business Standard (2013) Circumcised foreskins may provide new baldness treatment Business Standard website 21 October 2013 Full-text available at http://www.business-standard.com/article/pti-stories/circumcised-foreskins-may-provide-new-baldness-treatment-113102100652_1.html Accessed: 2013-12-27. Archived by WebCite at http://www.webcitation.org/6MAiVH64J

KNMG (2010) Non-theraputic circumcision of male minors Royal Dutch Medical Association Full-text available at http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976

LifeCell (2012) AlloDerm Tissue Matrix defined Full-text available at http://www.lifecell.com/alloderm-regenerative-tissue-matrix/95/ Accessed: 2012-01-18. Archived by WebCite at http://www.webcitation.org/64mqrqxmQ

OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered Office of Human Research Protections website Full-text available at http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jh4cWek

Organogenesis (2011) Apligraf: How Is It Made? Link http://www.apligraf.com/professional/what_is_apligraf/how_is_it_made/ Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jhpT91Q

Pitman, S (2008) Babies’ foreskin dubbed as new anti-aging treatment Cosmetic Design Full-text available at http://www.cosmeticsdesign.com/Formulation-Science/Babies-foreskin-dubbed-as-new-anti-aging-treatment Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64ji8mqbP

Schaefer GO, Sinaii N, Grady C (2011) Informing egg donors of the potential for embryonic research: a survey of consent forms from U.S. in vitro fertilization clinics Fertil Steril. 2011 Dec 22. [Epub ahead of print] Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22196714

SkinMedica (2011) Key Ingredients Link http://www.skinmedica.com/skin-care-products/skin-rejuvenation/tns-recovery-complex#tab2 Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jiK7Gdx

Smith JF (2011) The professional imperative for obstetrician-gynecologists to discontinue newborn male circumcision Am J Perinatol. 2011 Feb;28(2):125-8. Epub 2010 Aug 10 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=20700861

Svoboda JS, Van Howe RS (2013) Out of step: fatal flaws in the latest AAP policy report on neonatal circumcision J Med Ethics. 2013 Mar 18. [Epub ahead of print] Abstract available at https://www.ncbi.nlm.nih.gov/pubmed/23508208