FDA, foreskin-derived products & ICCR-6

[Minuteman]

( Continued from http://www.foreskin-restoration.net/...?t=7399&page=2 )

A thread for collating official statements, medical article abstracts and the like, regarding the use of foreskin-derived products (both as an ingredient and as a testing medium), with a focus on helping readers prepare arguments to present to the FDA in the lead up to, and to participants at the ICCR-6 conference itself (to be held in the United States sometime around June 2012), about why it is ethically unsound and medically unnecessary to use neonatal foreskin derived products in the cosmetic and medical industries.

Summary of outcome of ICCR-5 conference held in 2011:

"International Cooperation on Cosmetic Regulation (ICCR) Outcome of the Meeting Held June 28 to July 1, 2011"

http://www.fda.gov/Cosmetics/Interna.../ucm262211.htm

Readers from ICCR member nations may want to try and elicit more information from their national regulatory agencies about what is meant by "alternative test methods" to animal testing.

International Cooperation on Cosmetic Regulation (ICCR) Outcome of the Meeting Held June 28 to July 1, 2011


Paris, France

The International Cooperation on Cosmetics Regulation (ICCR) held its fifth annual meeting (ICCR-5) June 28 –July 1st, 2011 in Paris, France, to discuss issues related to cosmetics and cosmetic-like drug/quasi-drug products. ICCR is an international group of cosmetic regulatory authorities from Canada, the European Union, Japan, and the United States. This multilateral framework maintains the highest level of global consumer protection, while minimizing barriers to international trade. As part of this meeting, the regulators entered into a dialogue with cosmetics industry trade associations from each region, and other interested parties.

The meeting focused on the following topics:

* Alternative Test Methods
* Nanotechnologies
* Safety Assessment Principles
* Trace Contaminants
* Involvement of Interested Parties in ICCR

On June 30, the ICCR Regulators hosted an open stakeholder meeting. Participants in this session included members of consumer organizations, industry associations, and academia, with an interest in regulatory issues involving cosmetics. Information on the ICCR process, as well as current work items such as nanotechnology, alternatives to animal testing, trace contaminants and safety of cosmetics was shared. Several proposals for new work items were presented for future consideration. There are plans to have a similar session at ICCR-6.

ICCR-6 will be held in the United States in 2012.

Outcomes of the Meeting

1. Alternative Test Methods
Regulators received an update from International Cooperation on Alternative Test Methods (ICATM)[1].
The report Applicability of Animal Testing Alternatives in Regulatory Frameworks within ICCR Regions was accepted.

2. Nanotechnologies

* Regulators accepted the report of the ICCR Ad Hoc Working Group on Characterization of Nanomaterials which describes the characterization methods listed in the annex to the Report of the ICCR Joint Ad Hoc Working Group on Nanotechnology in Cosmetic Products : Criteria and Methods of Detection – ICCR-4.
* A new Working Group will be formed to examine methods to characterize insolubility, biopersistance, measurement of size in the realm of 1 to 100 nm in final formulations.
* Regulators and industry received an update on the progress of the Ad Hoc Working Group on Safety Assessment of Nanomaterials.
* Industry presented the results of a 2011 Associations Survey of Nanomaterials Used in Cosmetics prepared for ICCR.

3. Safety Assessment Principles

* Regulators accepted a report on Principles of Cosmetic Product Safety Assessment.

4. Trace Contaminants

* ICCR Ad Hoc Traces Working Group provided a report on Principles for Handling Trace materials was accepted.
* Discussions continue for recommendations on maximum lead contamination levels.
* Work has already begun on a new document regarding maximum levels of 1,4-dioxane.


5. Involvement of Interested Parties in ICCR

* Interested parties were invited to submit detailed proposals for work items for discussion and ICCR members' consideration.
* Proposals were presented at the open stakeholder meeting on nanotechnologies, endocrine disruptors, cosmetic product safety, and alternatives to animal testing including the formation of an ad hoc working group on this topic.
* ICCR will review the proposals for consistency with the objectives and scope of ICCR.
* New work items can be submitted at any time to the ICCR.


[1] The International Cooperation on Alternative Test Methods (ICATM) was established by ICCR as a framework for validation organizations of Canada, the EU, Japan, and the US to enhance cooperation in replacing, reducing, and refining animal testing.

[Minuteman]

"Interest in circumcision more than foreskin deep" ( originally linked by brutus, here: http://www.timeslive.co.za/ilive/201...-foreskin-deep )

Article links to many good sources.

http://www.timeslive.co.za/ilive/201...-foreskin-deep

' I recently saw both your articles regarding the sale of infant foreskins to pharmaceutical companies. Africa must be informed that western "humanitarian aid" organisations may be interested in a little more than just "public health."

The following products are also derrived from infant foreskins:

Dermagraft-TC
Dermagraft-TC which is an artifical skin created from harvested foreskins from infant circumcision.[1] It is made and sold by Advanced Tissue Sciences (ATS), which is a corporation based in La Jolla, CA. Dermagraft-TC is FDA approved,[2][3] and it sells for about $3,000 per square foot; one foreskin contains enough genetic material to grow 250,000 square feet of skin.[4]
References
1.↑ "Dermagraft-TC: Overview". Advanced Biohealing, Inc.. http://www.dermagraft.com/about/overview/. Retrieved 2011-03-06. "Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue."
2.↑ "Dermagraft-TC". MediLexicon. http://www.medilexicon.com/drugs/der...ralInformation. Retrieved 2011-03-06. "...fibroblast-derived temporary skin substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA."
3.↑ "Advanced Tissue Sciences' temporary wound covering Dermagraft-TC approved for marketing by FDA". Transplant News. 2007-03-28. http://www.highbeam.com/doc/1G1-47248437.html. Retrieved 2011-03-06. "...the Food and Drug Administration has approved Dermagraft-TC for marketing, making it the first human fibroblast-derived temporary skin substitute to be approved."
4.↑ Circumcision. Daecher M. Icon 1998;2(2):70-3.

Apligraf
Apligraf is a synthetic skin created from harvested foreskins.[1] It is FDA approved,[2] and it is made and sold by Organogenesis, which a corporation based in Canton, MA. Novartis Pharmaceuticals Corp. has global marketing rights to Apligraf.
References
1.↑ "Apligraf: How Is It Made?". Organogenesis. http://www.apligraf.com/professional...ow_is_it_made/. Retrieved 2011-03-06. "Human keratinocytes and fibroblasts are derived from neonatal foreskins"
2.↑ "Apligraf". Organogenesis. http://www.organogenesis.com/product.../apligraf.html. Retrieved 2011-03-06. "Apligraf® is the first bio-engineered cell based product to receive FDA approval (in 1998)."

AlloDerm
AlloDerm(R) which is a skin graft created from harvested infant foreskins.[1] It is approved by the FDA[2] and it is made and sold by LifeCell Corporation (Nasdaq:LIFC), which is a corporation based in Branchburg, NJ.[3]
References
1.↑ "LifeCell Research Demonstrates Potential". Business Wire. 1995-05-16. http://www.highbeam.com/doc/1G1-16828845.html. Retrieved 2011-03-06. "...the culturing of human neonatal foreskin keratinocytes..."
2.↑ "AlloDerm®Tissue Matrix defined". LifeCell Corporation. http://www.lifecell.com/alloderm-reg...sue-matrix/95/. Retrieved 2011-03-06. "...screened and tested according to FDA regulations..."
3.↑ "Index". LifeCell Corporation. http://www.lifecell.com. Retrieved 2011-03-06.


The following corporations stand to gain from the acquisition of infant foreskins, and the public needs to be informed about them.

Advanced Tissue Sciences
Advanced Tissue Sciences is a corporation based in La Jolla, CA. They are the makers of Dermagraft-TC, which is an artifical skin created from harvested foreskins from infant circumcision.[1] They are also the makers of NouriCel, another product made from harvested foreskins,[2] and one of the main ingredients of SkinMedica's TNS Recovery Complex product.[3]
Earnings
Dermagraft-TC is FDA approved,[4][5] and it sells for about $3,000 per square foot and one foreskin contains enough genetic material to grow 250,000 square feet of skin.[6]
Advanced Tissue Sciences has sold about $1 million worth of cultured dermis to Proctor & Gamble, Helene Curtis, and other such businesses for pre-market testing. Advanced Tissue Science's foreskin-derived merchandise held a $32 million stock offering in the beginning of 1992.[7]
In 1996 alone, Advanced Tissue Sciences could boast of a healthy $663.9 million market capitalization performance.[8]
References
↑ "Dermagraft-TC: Overview". Advanced Biohealing, Inc.. http://www.dermagraft.com/about/overview/. Retrieved 2011-03-06. "Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue."
↑ "The Foreskin Mafia". Acroposthion.com. http://www.acroposthion.com/acroposthion_019.htm. Retrieved 2011-03-06. "TNS contains... NouriCel-MD which is... a combination of Natural Growth Factors, matrix proteins, and soluble collagen. Human Growth Factors extracted from cultured cells of foreskin..."
↑ "SkinMedica Introduces TNS Recovery Complex". SkinMedica. 2002-02-12. http://www.corporate.skinmedica.com/...covery-complex. Retrieved 2011-03-06. "TNS Recovery Complex is the only product containing a professional concentration of NouriCel®, a new cosmetic ingredient from leading tissue-engineering company Advanced Tissue Sciences."
↑ "Dermagraft-TC: General Information". Advanced Tissue Sciences. MediLexicon International Ltd. 2011. http://www.medilexicon.com/drugs/der...ralInformation. Retrieved 2011-05-07. "Dermagraft-TC is the first human, fibroblast-derived temporary skin substitute for the treatment of partial-thickness burns that has been approved for marketing by the FDA."
↑ "Advanced Tissue Sciences' temporary wound covering Dermagraft-TC approved for marketing by FDA". Transplant News. HighBeam Research. 1997-03-28. http://www.highbeam.com/doc/1G1-47248437.html. Retrieved 2011-05-07. "the Food and Drug Administration has approved Dermagraft-TC"
↑ Circumcision. Daecher M. Icon 1998;2(2):70-3.
↑ Julie Pitta. Biosynthetics. Forbes 10 May 1993: 170-171 Note: The 32-page Advanced Tissue Sciences, Inc. 1997 Annual Report refers to "fibroblasts" but does not contain the word "foreskin."
↑ Biotech's Big Discovery. Hall CT. San Francisco Chronicle. October 25, 1996: E1, E4.

Organogenesis
Organogenesis is a corporation based in Canton, MA.[1] They profit from Apligraf, which is a synthetic skin created from harvested foreskins.[1] Novartis Pharmaceuticals Corp. has global marketing rights to Apligraf.
Call for increase of foreskin harvesting
WE MUST BE ABLE TO OBTAIN ADEQUATE SOURCES OF SUPPLY
"We manufacture Apligraf for commercial sale, as well as for use in clinical trials, at our Canton, Massachusetts facility. Among the fundamental raw materials needed to manufacture Apligraf are keratinocyte and fibroblast cells. Because these cells are derived from donated infant foreskin, they may contain human-borne pathogens. We perform extensive testing of the cells for pathogens, including the HIV or "AIDS" virus. Our inability to obtain cells of adequate purity, or cells that are pathogen-free, would limit our ability to manufacture sufficient quantities of our products."
-- Organogensis, 2001 Annual Report (Delaware: Organogenesis, 2001), p.8.
References
↑ 1.0 1.1 "Headquarters". Organogenesis. http://www.organogenesis.com/about_us/headquarters.html. Retrieved 2011-03-06. "The corporate headquarters and manufacturing facility are located in Canton, Massachusetts."

LifeCell Corporation
LifeCell Corporation (Nasdaq:LIFC) is a corporation based in Branchburg, NJ.[1] The profit from the creation and sale of AlloDerm(R) which is a skin graft created from harvested infant foreskins.[2]
References
↑ "Index". LifeCell Corporation. http://www.lifecell.com. Retrieved 2011-03-06.
↑ "LifeCell Research Demonstrates Potential". Business Wire. 1995-05-16. http://www.highbeam.com/doc/1G1-16828845.html. Retrieved 2011-03-06. "...the culturing of human neonatal foreskin keratinocytes..." '

[Minuteman]

"Uterine stem cells used to treat diabetes in mice"

http://www.nih.gov/news/health/aug2011/nichd-30.htm

For Immediate Release
Tuesday, August 30, 2011
Contact:
Robert Bock
Marianne Glass Miller
301-496-5133
Uterine stem cells used to treat diabetes in mice
NIH-funded researchers convert cells from uterine lining into insulin-producing cells

Researchers funded by the National Institutes of Health have converted stem cells from the human endometrium into insulin-producing cells and transplanted them into mice to control the animals’ diabetes.

The endometrium, or uterine lining, is a source of adult stem cells. Normally, these cells generate uterine tissue each month as part of the menstrual cycle. Like other stem cells, however, they can divide to form other kinds of cells.

The study’s findings suggest the possibility that endometrial stem cells could be used to develop insulin-producing islet cells. These islet cells could then be used to advance the study of islet cells transplantation as a treatment for people with diabetes. If the transplantation of islet cells derived from endometrial cells is perfected, the study authors write that women with diabetes could provide their own endometrial tissue for such a transplant, sidestepping the chance of rejection posed by tissue from another person. Endometrial stem cells are readily available and can be collected easily during a simple outpatient procedure. Endometrial tissue could also be collected after hysterectomy, the surgical removal of the uterus.

“The study findings are encouraging,” said Louis V. DePaolo, Ph.D., chief of the Reproductive Sciences Branch at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study. “Research to transplant insulin-producing cells into patients with diabetes could proceed at a much faster pace with a relatively accessible source of donor tissue.”

The study authors note that such a treatment would be more useful for people with Type 1 diabetes, in which no insulin is produced. The treatment would be less useful for Type 2 diabetes, in which insulin is usually produced, but in which cells have difficulty using the insulin that is available.

The findings appear in Molecular Therapy. The study was conducted by Xavier Santamaria, Efi E. Massasa, Yuzhe Feng, Erin Wolff and Hugh Taylor, M.D., all of Yale University, New Haven, Conn.

The study authors write that endometrial tissue samples could be warehoused in a tissue bank. A large number of samples would make it comparatively easy to find compatible tissue for transplant to women who no longer have a uterus and to men. According to the Centers for Disease Control and Prevention, roughly 600,000 hysterectomies are performed each year in the United States as treatment for a number of disorders and conditions.

In their study, the researchers bathed endometrial stem cells in cultures containing special nutrients and growth factors. Responding to these substances, the endometrial stem cells adopted the characteristics of beta cells, cells of the pancreas that produce insulin.

The incubation process took about three weeks. During this time, the endometrial stem cells took on the shape of beta cells and began making proteins typically made by beta cells. The researchers found that some of these cells also produced insulin.

After a meal, the body breaks food down into components like the sugar, glucose. Glucose then circulates in the blood. In response, beta cells release insulin, which allows the body’s cells to take in the circulating glucose. In their study, the researchers exposed the mature stem cells to glucose and found that, like typical beta cells, the cultured cells responded by producing insulin.

Next, the researchers injected the mature, insulin-making cells into the kidney capsule (membrane surrounding the kidney) of mice having a laboratory-induced form of diabetes. The mice had few working beta cells and very high levels of blood glucose. In mice that did not receive the stem cell therapy, blood sugar levels remained high. Additionally, the mice became lethargic and developed cataracts—both signs of untreated diabetes.

In contrast, mice receiving the cell therapy were active and did not develop cataracts. However, the treatment was not entirely effective, as the animals’ blood sugar remained higher than normal. Still, the animals continued to produce some insulin for six weeks, until the researchers ended the study.

“Verifying how long this treatment stays effective is one of our next research priorities,” said Dr. Taylor, the study’s senior author. “We also will investigate how changing the nutrient bath or increasing the dose of injected cells could make this treatment more effective.”

Dr. Taylor explained that culture and transplantation of endometrial stem cells might prove useful principally for Type 1 diabetes. In this form of the disorder, the immune system destroys the body’s own insulin-producing cells. As a result, insulin is not available to bring blood glucose levels under control. Although a diabetic woman’s immune system would be unlikely to reject islet cells developed from her own endometrial stem cells, it is still possible that her immune system would eventually target the new islet cells in the same way it targeted her original islet cells in the pancreas. For this reason, studies using endometrial stem cells to treat diabetes might first need to find ways to quell the immune attack against the islet cells.

Dr. Taylor added that endometrial stem cell therapy also might one day prove most useful for patients with Type 2 diabetes. In this form of diabetes, islet cells still produce insulin, but cells have trouble using insulin. In some patients with Type 2 diabetes, beta cells eventually die off. Dr. Taylor suggested that the stem cell approach might be helpful for patients at this later stage of the disease.

This study was conducted as part of the NICHD funded nationwide Specialized Cooperative Centers Program in Reproduction and Infertility Research.

In 2010, the researchers published a study which showed that endometrial stem cells could replace brain cells lost in mice having a laboratory-induced form of Parkinson’s disease.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov

Edit 17 January 2012 - Citation and link to the full-text of the source article:

Santamaria X, Massasa EE, Feng Y, Wolff E, Taylor HS (2011) Derivation of insulin producing cells from human endometrial stromal stem cells and use in the treatment of murine diabetes Mol Ther. 2011 Nov;19(11):2065-71. doi: 10.1038/mt.2011.173. Epub 2011 Aug 30 Full-text available at http://www.nature.com/mt/journal/v19/n11/full/mt2011173a.html Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64kMxgXLG

Abstract:

Pancreatic islet cell transplantation is an effective approach to treat type 1 diabetes, however the shortage of cadaveric donors and limitations due to rejection require alternative solutions. Multipotent cells derived from the uterine endometrium have the ability to differentiate into mesodermal and ectodermal cellular lineages, suggesting the existence of mesenchymal stem cells in this tissue. We differentiated human endometrial stromal stem cells (ESSC) into insulin secreting cells using a simple and nontransfection protocol. An in vitro protocol was developed and evaluated by assessing the expression of pan β-cell markers, followed by confirmation of insulin secretion. PAX4, PDX1, GLUT2, and insulin, were all increased in differentiated cells compared to controls. Differentiated cells secreted insulin in a glucose responsive manner. In a murine model, differentiated cells were injected into the kidney capsules of diabetic mice and human insulin identified in serum. Within 5 weeks blood glucose levels were stabilized in animals transplanted with differentiated cells, however those treated with undifferentiated cells developed progressive hyperglycemia. Mice transplanted with control cells lost weight and developed cataracts while those receiving insulin producing cells did not. Endometrium provides an easily accessible, renewable, and immunologically identical source of stem cells with potential therapeutic applications in diabetes.

[Minuteman]

"Adult human dental pulp stem cells differentiate toward functionally active neurons under appropriate environmental cues"

Full-text link:

http://onlinelibrary.wiley.com/doi/1...2007-0979/full

PubMed Abstract (Emphasis added):

Adult human dental pulp stem cells differentiate toward functionally active neurons under appropriate environmental cues.
Arthur A, Rychkov G, Shi S, Koblar SA, Gronthos S.
Source

The Australian Research Council, Centre for the Molecular Genetics of Development, University of Adelaide, Adelaide, Australia.
Abstract

Human adult dental pulp stem cells (DPSCs) reside within the perivascular niche of dental pulp and are thought to originate from migrating cranial neural crest (CNC) cells. During embryonic development, CNC cells differentiate into a wide variety of cell types, including neurons of the peripheral nervous system. Previously, we have demonstrated that DPSCs derived from adult human third molar teeth differentiate into cell types reminiscent of CNC embryonic ontology. We hypothesized that DPSCs exposed to the appropriate environmental cues would differentiate into functionally active neurons. The data demonstrated that ex vivo-expanded human adult DPSCs responded to neuronal inductive conditions both in vitro and in vivo. Human adult DPSCs, but not human foreskin fibroblasts (HFFs), acquired a neuronal morphology, and expressed neuronal-specific markers at both the gene and protein levels. Culture-expanded DPSCs also exhibited the capacity to produce a sodium current consistent with functional neuronal cells when exposed to neuronal inductive media. Furthermore, the response of human DPSCs and HFFs to endogenous neuronal environmental cues was determined in vivo using an avian xenotransplantation assay. DPSCs expressed neuronal markers and acquired a neuronal morphology following transplantation into the mesencephalon of embryonic day-2 chicken embryo, whereas HFFs maintained a thin spindle fibroblastic morphology. We propose that adult human DPSCs provide a readily accessible source of exogenous stem/precursor cells that have the potential for use in cell-therapeutic paradigms to treat neurological disease.

PMID:
18499892
[PubMed - indexed for MEDLINE]

PubMed citation / link:

Stem Cells. 2008 Jul;26(7):1787-95. Epub 2008 May 22 / http://www.ncbi.nlm.nih.gov/pubmed/18499892

[Minuteman]

"Babies’ foreskin dubbed as new anti-aging treatment" Cosmeticsdesign.com 18 November 2008.

http://liveweb.archive.org/http://ww...ging-treatment

The reference to burn victims towards the end sounds rather tacked on:

A British biomedical company, InterCytex, says it is aiming to bring its anti-aging and scar repairing product Vavelta to the US market.

The product is already available from accredited clinics in the UK through an injection process, but the company says it is now well under way with the process of getting it approved by the US FDA.
...
Like Botox, the treatment is targeted as the injections are concentrated in areas where the most damage has occurred: around the eyes, forehead and mouth in the case of photoaging damage, and anywhere on the face or body in the case of scar or burn damage.
...
However, the company says that the treatment is not likely to be made available in the US any time soon, as the US FDA validation process could take up to four years to be finalized.

Possibly introduced in the UK because of for these reasons:

"Botox comes under tighter regulation in UK" Cosmeticsdesign.com 12 December 2008.

http://liveweb.archive.org/http://ww...gulation-in-UK

The General Medical Council has announced new regulations governing Botox aimed at tightening up the administration of the popular anti-ageing treatment.

The new recommendations mean that consumers seeking out dermal fillers such as Botox will now have to go to qualified doctors before having the injections to ascertain if they are healthy enough and are not susceptible to an allergic reaction.
...
However, the treatment has not been without controversy and in April of this year it was cited in a study as being potentially hazardous as toxins were shown to have travelled to the brains of lab rats.

The study, which was headed up by Matteo Caleo of the Italian National Research Council's Institute of Neuroscience, is said to show for the first time that the botulinum toxin may affect the brain.

Edit 18 Jan 2012 Vavelta is also mentioned here:

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/ar...-the-rest-wrin Accessed: 2012-01-18. Archived by WebCite at http://www.webcitation.org/64mLMhvCA

The fibroblasts in Vavelta are isolated from the foreskins taken from baby boys, given several months to grow and multiply in the lab, and then packaged into treatment vials that are shipped to a select group of U.K. physicians. Each vial costs approximately 750 pounds, or $1,000], according to the company spokesperson.
...
Ron Moy, a dermatologist at the David Geffen School of Medicine at the University of California, Los Angeles, says that foreskin cells could potentially carry viruses. And although the company screens all the fibroblasts for contamination, he cautions there is "no test that's perfect."

[Minuteman]

"Draft Guidance Document on Exculpatory Language in Informed Consent" FDA mailing list email dated 8 September 2011.

Emphasis added:

On September 7, 2011, the Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) announced in the Federal Register the availability of a joint draft document entitled, "Guidance on Exculpatory Language in Informed Consent," and are inviting public comments on that document. The joint draft document, among other things, does the following:

1. Provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent.

2. Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory.

3. Clarifies that OHRP and FDA have concluded that language in informed consent is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens. This represents a change from OHRP's November 15, 1996 guidance on point, "Exculpatory Language in Informed Consent," which identified as "exculpatory" certain informed consent statements in which subjects gave up any rights they might have in their biospecimens.

OHRP and FDA now consider these statements to be acceptable for inclusion in informed consent, and they are restated as examples of acceptable language in the draft guidance. Thus, for example, it would now be acceptable to include language in a consent form such as "I give up any property rights I may have" in biospecimens, or "I voluntarily and freely donate" the biospecimens to a particular institution.

When finalized, the draft document will supersede OHRP's November 15, 1996 guidance entitled, "Exculpatory Language in Informed Consent" and question number 52 in FDA's January 1998 guidance entitled, "Institutional Review Boards Frequently Asked Questions - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators."

The Federal Register notice of availability, the joint draft guidance document, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/. The joint draft document can also be accessed on the FDA website at http://www.fda.gov/ScienceResearch/S...es/default.htm.

[Minuteman]

"Cosmetics Regulatory Gap Closed" Australian Parliamentary Secretary for Health and Ageing press release, 15 September 2011.

From an Australian Department of Health and Ageing mailing list email. Probably not immediately relevant, but information I might want to be able to retrieve later.

http://liveweb.archive.org/http://ww...1-ck-ck039.htm

The Parliamentary Secretary for Health and Ageing, Catherine King, has welcomed new laws to regulate ingredients in cosmetics which passed the Senate today.

“The new legislation will cut red tape, eliminate overlapping regulation between agencies and better protect public health,” Ms King said.

The regulation of ingredients in cosmetics has been split between the Therapeutic Goods Administration (TGA) and the National Industrial Chemicals Scheme (NICNAS) which has been confusing for consumers and a burden on industry

“This new legislation finalises the transfer of the regulation of these ingredients to NICNAS while also allowing any conditions which have been put on their use by TGA, to be transferred to NICNAS.

“For industry this new law will mean that the ingredients in their products will automatically be included in the Australian Inventory of Chemical Substances (AICS) without requiring further assessment by NICNAS

“This both addresses a public health gap and will reduce the regulatory burden on industry. The passing of the new laws completes the government's cosmetics regulatory reforms which we began in 2007.” Ms King said.

Ms King said the new laws also mean that consumers can find information in one place about the regulation of cosmetic ingredients, including the assessment of ultra-violet filters in secondary sunscreen products, which are one group of the cosmetic ingredients transferred to NICNAS under the cosmetic reforms.

“It also removes the need for NICNAS to prepare and publish a summary report for each chemical assessment as NICNAS now publishes the full public report for each assessment on the NICNAS website.”

The legislation also makes minor technical amendments to the Schedule to the Act to clarify certain data requirements for new chemicals and to maintain consistency with other national chemical notification schemes.

"The passing of the new Industrial Chemicals Bill is another example of the Gillard government delivering on its commitment for greater transparency in regulation, for decreased burden for industry while maintaining public health" Ms King said.

[Minuteman]

"Australia Continues to Build on Increased Organ Donation and Transplantation"

http://liveweb.archive.org/http://ww...1-ck-ck044.htm

Another link that may prove useful, possibly as a case study that education of properly informed and consenting adults can help fulfill biospecimen requirements for genuinely worthy areas of research and application.

May also have some relevance to a possible reply to this CDC "solid organ transplantation" community consultation - http://www.foreskin-restoration.net/...ead.php?t=9318

[Minuteman]

Readers from ICCR member nations may want to try and elicit more information from their national regulatory agencies about what is meant by "alternative test methods" to animal testing.

This site would appear to be a good source of information:

http://alttox.org/

What is AltTox?

AltTox.org is a website dedicated to advancing non-animal methods of toxicity testing through online discussion and information exchange.

The AltTox forum is a message board intended to encourage information exchange, commentary and discussion of science and policy issues related to non-animal methods of toxicity testing.

The Toxicity Testing Resource Center is the informational section of AltTox.org. It provides a comprehensive source of information on toxicity testing, non-animal alternatives, relevant stakeholders, government oversight, validation and regulatory acceptance of testing methods, and challenges to and opportunities for progress.

The direct link to the "Framework for International Cooperation on Alternative Test Methods (ICATM)" on the FDA site is here:

http://www.fda.gov/InternationalProg.../ucm114518.htm

[Minuteman]

"Scientists Rejuvenate Cells From Elderly" Health Highlights 1 November 2011.

http://www.healthfinder.gov/news/new...ce=govdelivery

Age-worn cells in people over 90 were rejuvenated into stem cells that were identical to those found in embryos, a new study says.

The achievement could lead to new opportunities in regenerative medicine, especially for seniors, according to scientists, Agence France-Presse reported.

The research is reported in the journal Genes & Development.

"This is a new paradigm for cell rejuvenation," Jean-Marc Lemaitre, a researcher at the Institute of Functional Genomics at the University of Montpellier in France, told AFP. "The age of cells is definitely not a barrier to reprogramming."