Please lodge anti-circumcision submissions with Medicaid / CMS (Deadline 17 Feb. 2012) - Mothering Forums

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#1 of 4 Old 02-13-2012, 06:03 AM - Thread Starter
 
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This is a response to the document “Medicare, Medicaid, Children's Health Insurance Programs: Transparency Reports and Reporting of Physician Ownership or Investment Interests” [regulations.gov Docket No. CMS-2011-0191, FR Doc No: 2011-32244] ( http://www.regulations.gov/#!documentDetail;D=CMS-2011-0191-0001 ).

The deadline for submissions is 17 February 2012.

This submission can be made by anybody from any country around the world.

Instructions:

Download and save the document from the following link (Click 'Download Now', Wait for the counter to reach zero and then click 'Download file now'):

http://www.4shared.com/office/eVb3mSuY/CMS-2011-0191_17February2012.html

Go to the following regulations.gov submission page:

http://www.regulations.gov/#!submitComment;D=CMS-2011-0191-0001

Complete the required fields ("Country", "State or Province", "Postal Code" and "Category") and as many optional fields you would like to. Click browse under '3. UPLOAD FILE(S)' to upload the saved document from your harddisk. Click 'Submit'.
 

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#2 of 4 Old 02-13-2012, 06:05 AM - Thread Starter
 
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In case anyone experiences problems with the above 4shared link, the full-text of the response document is below, which you can copy and paste into the text editor or word processor of your choice, save to your harddisk and upload to regulations.gov:



Response to “Medicare, Medicaid, Children's Health Insurance Programs: Transparency Reports and Reporting of Physician Ownership or Investment Interests” [regulations.gov Docket No. CMS-2011-0191, FR Doc No: 2011-32244]

Thank you for the opportunity to provide feedback to “Medicare, Medicaid, Children's Health Insurance Programs: Transparency Reports and Reporting of Physician Ownership or Investment Interests” [regulations.gov Docket No. CMS-2011-0191, FR Doc No: 2011-32244]. This response document shall briefly address the important role that increased transparency and public awareness of financial relationships between drug and device manufacturers and certain health care providers has to play in safeguarding patients against government agencies regulatory failures; in filling information gaps on exculpatory consent forms regarding the use of foreskin and other healthy tissue excised from minors; and the need for greater transparency to help safeguard patients from the potential clinical bias of physicians and teaching hospitals in receipt of NIH research funding.

Medicaid and circumcision

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), with doubts having been raised in the professional literature about whether it is even lawful to circumcise, and to allow the circumcision, of healthy boys at the expense of Medicaid (Adler 2011). Despite this, more than 1.14 million circumcision procedures were performed on male infants in U.S. hospitals in the year 2009 (AHRQ 2011), with hospitals in states in which Medicaid continues to cover circumcision of male minors in the absence of a clear and present immediate medical indication, having circumcision rates higher than states where it does not (CDC 2011). Thus at the outset, a stipend from the state acts as an incentive for physicians to subject minors to a controversial medical procedure, in the absence of a clear and present immediate medical indication, and one that will continue to dilute other government expenditures and initiatives aimed at improving child and infant health (HHS 2011a).

FDA, circumcision devices and regulatory failure

In 2000, the Food and Drug Administration [FDA] issued a public health notice about safety concerns regarding Gomco [and Gomco-type] circumcision clamps and Mogen [and Mogen-type] circumcision clamps, having received approximately 20 injury reports a year between 1996-2000 including lacerations, hemorrhaging, penile amputation and urethral damage (FDA 2000).

As of September 2011, the FDA has received a further 139 reports of problems related to circumcision clamps, including 51 injuries, twenty-one of those which were related to Mogen-type clamps, all but one of which involved injuries (Hennessy-Fiske 2011).

Despite this, the FDA has yet to issue a recall on any circumcision devices, and many physicians and teaching hospitals continue to use Gomco- and Mogen-type circumcision clamps (Hennessy-Fiske 2011).

On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee states inspections of food facilities (OIG 2011a), suggesting the possibility that more systemic problems exist within the agency, impacting it's ability to perform it's basic regulatory functions.

Increased transparency and public awareness of financial relationships between drug and device manufacturers and certain health care providers thus has an important role to play in safeguarding patients against government agencies regulatory failure, and one that must take precedence over drug and device manufacturers professed concern for increased regulatory and administrative 'burden'.

Foreskin-derived medical and cosmetic products and the informed consent of donors

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. Further, the most promising advances in the field of cellular regeneration research, are to be found in cell lines derived from adult sources including dental pulp cells (Authur et al 2008), uterine cells (Bock 2011) and bone marrow cells (Wada et al 2011); and diagnostic and therapeutic application of patient-derived cells (HHS 2011b; Pasca et al 2011), rather than cell lines derived from the excised healthy foreskins of minors.

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; 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, is ominously absent from the websites of some manufacturers who utilise foreskin-derived ingredients in their products (LifeCell 2012; SkinMedica 2011).

Increased transparency and public awareness of financial relationships between drug and device manufacturers and certain health care providers thus has an important role to play in filling information gaps on exculpatory consent forms regarding the use of foreskin and other healthy tissue excised from minors, and one that must take precedence over drug and device manufacturers professed concern for increased regulatory and administrative 'burden'.

Safeguarding patients from the potential for clinic bias resulting from NIH research funding

In 2011, the Department of Health and Human Services Office of Inspector General [OIG] published a series of audit reports revealing that throughout the fiscal years 2000-2010, institutes under the aegis of the National Institutes of Health [NIH], did not comply with the time and amount requirements specified in appropriations statutes, in awarding federal contracts to commercial partners, committing the federal government to tens of millions of dollars of expenditure ahead of appropriation of funds from Congress. Specific examples involving the National Institute of Allergy and Infectious Diseases [NIAID] include Contract N01-AI-15416 with the University of California at San Francisco (OIG 2011b), Contract N01-AI-3-0052 with Avecia Biologics Limited (OIG 2011c), Contract HHSN266-2006-00015C with NexBio, Inc. (OIG 2011d) and Contract HHSN272-2008-00013C with the EMMES Corporation (OIG 2011e).

During this time, federal agencies also funded and sponsored research conducted abroad, that would be unlikely to receive ethical approval to be conducted in the United States, incorporating the excision of healthy tissue from subjects in the absence of a clear and present immediate medical indication . Specific examples include NIAIDs sponsorship and funding of ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 (Bailey et al 2007; Gray et al 2007). Consent forms for these trials failed to include then known information, from the professional medical literature, about the importance to mens sexual health of the foreskin and other tissues removed by circumcision (Taylor et al 1996).

Of concern, is that the results of the above trials are increasingly being used to justify the en masse circumcision of male minors in the absence of clear and present immediate medical indications, both in the United States and abroad, and in the former instance, at the expense of Medicaid (CDC 2011; Kim 2011).

To help inform patients of potential clinical bias of physicians in receipt of NIH research funding, it is imperative that the proposed publicly accessible, centralised website be expanded to include NIH grants awarded to physicians and teaching hospitals. This could be accomplished with minimal burden by cross-referencing the names of physicians and teaching hospitals with grant information already available through sources such as ClinicalTrials.gov.

Conclusion and Action Required

Increased transparency and public awareness of financial relationships between drug and device manufacturers and certain health care providers has an important role to play in safeguarding patients against government agencies regulatory failure, and one that must take precedence over drug and device manufacturers professed concern for increased regulatory and administrative 'burden'.

Increased transparency and public awareness of financial relationships between drug and device manufacturers and certain health care providers has an important role to play in filling information gaps on exculpatory consents forms regarding the use of foreskin and other healthy tissue excised from minors, and one that must take precedence over drug and device manufacturers professed concern for increased regulatory and administrative 'burden'.

To help inform patients of potential clinical bias of physicians in receipt of NIH research funding, it is imperative that the proposed publicly accessible, centralised website be expanded to include NIH grants awarded to physicians and teaching hospitals. This could be accomplished with minimal burden by cross-referencing the names of physicians and teaching hospitals with grant information already available through sources such as ClinicalTrials.gov.

References

Adler P W (2011) Is it lawful to use Medicaid to pay for circumcision? J Law Med. 2011;19(2):335-53 Abstract available at http://sites.thomsonreuters.com.au/journals/2011/11/28/journal-of-law-and-medicine-update-december-2011/ Accessed: 2012-01-08 Archived by WebCite at http://www.webcitation.org/64YPGfMLo

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 (2011) Hospital Stays for Children, 2009. HCUP Statistical Brief #118 prepared by Yu, H. (RAND Corporation), Wier, L.M. (Thomson Reuters), and Elixhauser, A. (AHRQ) August 2011. Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb118.jsp

Arthur A, Rychkov G, Shi S, Koblar SA, Gronthos S (2008) Adult human dental pulp stem cells differentiate toward functionally active neurons under appropriate environmental cues in Stem Cells. 2008 Jul;26(7):1787-95. Epub 2008 May 22 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18499892

Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO (2007) Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet369(9562),643–656 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17321310

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

Bock, R (2011) Uterine stem cells used to treat diabetes in mice NIH News Full-text available at http://www.nih.gov/news/health/aug2011/nichd-30.htm Archived by WebCite at http://www.webcitation.org/64jhMI7v9

CDC (2011) Trends in In-Hospital Newborn Male Circumcision - United States 1999-2010 Prepared by Xinjian Zhang, PhD, Sanjyot Shinde, PhD, Peter H Kilmarx, MD, Robert T Chen, MD, Div of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Shanna Cox, MSPH, Lee Warner, PhD, Div of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion; Maria Owings, PhD, Div of Healthcare Statistics, National Center for Health Statistics; Charbel El Bcheraoui, PhD, EIS Officer, CDC. Morbidity and Mortality Weekly Report (MMWR) Full-text available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_w

FDA (2000) Potential for Injury from Circumcision Clamps Food and Drug Administration Full-text available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062279.htm

Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ (2007) Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet369(9562),657–666 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17321311

Hennessy-Fiske, Molly (2011) Injuries linked to circumcision clamps. Los Angeles Times 26 October 2011 http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story Accessed: 2012-02-12. Archived by WebCite at http://www.webcitation.org/65PYUIZ0D

HHS (2011a) Obama Administration awards nearly $300 million to states for enrolling eligible children in health coverage HHS Newsroom December 28, 2011 Full-text available at http://www.hhs.gov/news/press/2011pres/12/20111228a.html

HHS (2011b) Scientists Rejuvenate Cells From Elderly Department of Health and Human Services Health Highlights 1 November 2011 Full-text available at http://www.healthfinder.gov/news/newsstory.aspx?Docid=658486

Kim, A (2011) Botswana’s Infant Circumcision Campaign in PRI's The World Article archived at http://liveweb.archive.org/http://www.theworld.org/2011/10/botswana-infant-circumcision-campaign/ Retrieved 11 October 2011

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

OIG (2011a) Vulnerabilities in FDA's Oversight of State Food Facility Inspections (OEI-02-09-00430) Health and Human Services Office of Inspector General website 13 December 2011 Full-text available at http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf

OIG (2011b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-15416 With the University of California at San Francisco Audit (A-03-10-03120) on the Health and Human Services Office of Inspector General website 10 July 2011 Available at http://oig.hhs.gov/oas/reports/region3/31003120.pdf

OIG (2011c)Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-3-0052 With Avecia Biologics Limited (A-03-10-03117) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003117.pdf

OIG (2011d) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2006-00015C With NexBio, Inc. (A-03-10-03119) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003119.pdf

OIG (2011e) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN272-2008-00013C with the EMMES Corporation (A-03-10-03115) Health and Human Services Office of Inspector General website 31 October 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003115.pdf

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

Pasca SP, Portmann T, Voineagu I, Yazawa M, Shcheglovitov A, Pasca AM, Cord B, Palmer TD, Chikahisa S, Nishino S, Bernstein JA, Hallmayer J, Geschwind DH, Dolmetsch RE (2011) Using iPSC-derived neurons to uncover cellular phenotypes associated with Timothy syndrome Nat Med. 2011 Nov 27;17(12):1657-62. doi: 10.1038/nm.2576 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22120178

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

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

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

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

Taylor, J.P., A.P. Lockwood and A.J.Taylor The prepuce: Specialized mucosa of the penis and its loss to circumcision Journal of Urology (1996), 77, 291-295 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=8800902

Wada N, Bartold PM, Gronthos S (2011) Human foreskin fibroblasts exert immunomodulatory properties by a different mechanism to bone marrow stromal/stem cells Stem Cells Dev. 2011 Apr;20(4):647-59. Epub 2010 Oct 12 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=20712449

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#3 of 4 Old 02-17-2012, 06:45 AM - Thread Starter
 
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Last day for lodging replies.

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#4 of 4 Old 02-01-2013, 06:38 PM - Thread Starter
 
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The CMS has now published a Final Rule on reporting of Physician Ownership or Investment Interests. For further details please see the following link (scroll down to comment #6):

 

http://www.foreskin-restoration.net/forum/showthread.php?t=10452

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