CALIFORNIA: Class action against foreskin product for cancer risk

Foreskin product poses health risk

The Wall Street Journal
March 19, 2014

Hagens Berman: Pharmaceutical Company SkinMedica Selling Misbranded Drug Products as Cosmeceuticals

Consumers today filed a proposed class-action lawsuit against Allergan Inc. (NYSE:AGN) and its pharmaceutical company subsidiary, SkinMedica, claiming that the companies have misbranded and unlawfully marketed Tissue Nutrient Solution (TNS), a skin-care product line containing human growth factors obtained from human foreskin tissue which could increase the risk of cancer and pose other health risks, according to the complaint filed by Hagens Berman Sobol Shapiro LLC.

The lawsuit, filed by consumer-rights law firm Hagens Berman in the U.S. District Court for the Central District of California, claims that for at least the past four years, SkinMedica has failed to disclose significant safety concerns associated with TNS products while marketing the products without appropriate government approval, proper labeling, or adequate safety studies.

"A healthcare company's primary obligation must be to deliver products that are properly tested for safety, and meet all the appropriate regulatory requirements," said Steve Berman, attorney for the plaintiffs and managing partner of Seattle-based Hagens Berman. "In this case, we intend to show that SkinMedica and Allergan skirted laws that required them to disclose the significant safety concerns at issue and the lack of regulatory approval."

"We believe that in SkinMedica's zeal to market its skin care products, it created a serious health risk for those who used TNS products," Berman added.

According to the firm's investigation, SkinMedica's TNS products, which have been sold nationally through doctors' offices and retailers, contain a proprietary mix of "human growth factors" derived from human foreskin tissue. Human growth factors are intended to mobilize, stimulate, or otherwise alter the production of cells, including the ability to initiate cell division, which could stimulate growth of cancerous tumor cells, according to the complaint.

The suit alleges that in marketing their TNS products, Allergan and its subsidiary SkinMedica did not adequately disclose the health risks associated with these growth factors.

SkinMedica's TNS products -- which the company calls "cosmeceuticals" -- did not have government approval and could not be sold lawfully in the U.S. without such approval, something else the company did not disclose to consumers, according to the complaint. The suit alleges that because neither the U.S. Food and Drug Administration nor the California Department of Public Health found TNS products to be safe for their intended use, and because TNS products omit required disclosures relating to safety concerns, the products have been misbranded under both federal laws and parallel state laws.

The lawsuit is a proposed class action based upon California's consumer protection laws, and seeks to represent a class of all persons in the U.S. who purchased SkinMedica's TNS products during the last four years.

Concerned consumers are encouraged to contact Hagens Berman by emailing SkinMedica@hbsslaw.com or calling 206-623-7292.
...

VANCOUVER: CAN-FAP to protest at Gates talk

Metro News (Vancouver)
March 17, 2014

Vancouver activists to protest 'foreskin enemy #1' Bill Gates at TED

by Emily Jackson
Foreskin advocates plan to protest Bill Gates for funding circumcision programs in Africa when the Microsoft founder speaks at the Ted Talks conference in Vancouver on Tuesday.

The Canadian Foreskin Awareness Project hopes to label Gates as “foreskin enemy #1” for donating millions to circumcision programs in 14 countries to reduce the risk of HIV transmission, according to an event posting on Facebook.

Project founder Glen Callender calls into question the research that claims male circumcision reduces transmission of the virus. (There is “compelling evidence” it reduces heterosexual infections in men by about 60 per cent, according to the World Health Organization.)

“Soon it will be obvious that circumcision gave these men false confidence, not effective protection,” Callender said in the event posting. “Bill Gates is an intelligent man who certainly means well, but he really blew it this time.”

This isn’t Callender’s first time protesting the rich and famous over foreskin. He made headlines across North America last year when he protested Oprah for promoting face cream with ingredients derived from foreskin. (That particular product, SkinMedica, was derived from growth factors from a single donation [theft] of foreskin more than a decade ago.)

“If my foreskin and I don’t publicly challenge at least one world-famous pro-circumcision billionaire philanthropist each year, then we’re not doing our job as Canada’s premier man-foreskin circumcision-fighting team,” Callender said.

The Bill and Melinda Gates Foundation donates millions annually to help the 33 million people around the world living with HIV. They fund research on an HIV vaccine, the delivery of anti-retroviral treatment and the development of ways to reduce transmission, including contraception and circumcision.

The protesters will gather around the Vancouver Convention Centre before Bill and Melinda Gates take the stage at 6 p.m.

OTTAWA: Demonstration against Oprah's foreskin facecream

Ottawa Citizen
April 9, 2013

Foreskin Crusaders to protest against Oprah event

[The term "crusader" is as unfortunate as it was in the second Gulf War. Most infant circumcision in Canada is not religious.]

by Zev Singer

OTTAWA — While an expected 14,000 people stream into Scotiabank Place on Wednesday night to hear Oprah Winfrey speak, they will be greeted by a group of protesting foreskin activists looking to take the media mogul to task.

This will take a bit of explaining.

The group, the Canadian Foreskin Awareness Project, or CAN-FAP, opposes the circumcision of baby boys. Oprah has become their target because, they say, she has endorsed an anti-aging skin product that was developed using skin cells harvested from a baby’s foreskin.

The product, made by SkinMedica, sells for around $250 per ounce.

The company could not be reached for comment Tuesday, but has previously explained that it does not use foreskins in the production of the cream, and has not since the original one was used to develop the line of cells nearly two decades ago. (There was actually nothing special about the foreskin — any baby skin would have worked, but foreskins were the available source).

[That is disingenous. There were issues of informed consent (and from the foreskin's owner, not just his parents) and medical ethics in the sale and re-use of human tissue even then. A man is walking round somewhere unaware that the cellular descendents of his foreskin are now adorning Oprah's face. There have been other notorious cases of the non-consented use of human tissue where availability was precisely what made its use so despicable. ]

However, CAN-FAP founder Glen Callender, a Vancouver resident who also staged a protest outside the Oprah event there in January, said Tuesday that in his eyes non-consensual male circumcision is a human rights violation that he equates with female genital mutilation.

“If you were to do that to me right now, today, as an adult, it would be aggravated sexual assault. You’d go to prison for 14 or 15 years,” Callender said. “I can’t see how that would be any different if you did that to me as a defenceless baby.”

Callender, a 39-year-old freelance writer and editor, said his main issue is the sexual pleasure that’s being taken away from men.

Oprah has had no comment.

Earlier story

VANCOUVER: Intactivists protest Oprah's foreskin facecream

Brandford Expositor (Canada)
January 23, 2013

Oprah protested for endorsing face cream made from foreskins

by Jim Morris

Picture by James Loewen

VANCOUVER – Her advice may be followed by hordes of people, but a Vancouver group wants Oprah Winfrey to explain why she has endorsed an anti-wrinkle cream made with human foreskins.

Winfrey makes her first appearance in Vancouver on Thursday before a sold-out crowd at Rogers Arena.

But as crowds pack into the stadium, Glen Callender, founder of the Canadian Foreskin Awareness Project, will be outside with his supporters protesting Winfrey's support of SkinMedica.

Callender says it’s hypocritical of Winfrey to speak out against female genital mutilation, while saying it’s all right to use a face cream made from foreskins from circumcised infant males.

“Imagine how Oprah would respond if a skin cream for men went on the market that was made from parts of the genitalia of little girls,” Callender said. “That would be an outrage and rightly so.”

Callender expects “a dozen to two dozen people” to attend the protest.

Advertisements for SkinMedica say Winfrey has described the product as her “magic fountain of youth and miracle wrinkle solution.” Winfrey didn’t immediately respond to an email asking for comment.

The makers of SkinMedica have said they use foreskin fibroblast — a piece of human skin used as a culture to grow other skin or cells.

“I would like Oprah to come to her senses and realize that all children have a fundamental human right to keep all their genitalia and to decide for themselves if anything gets cut off,” Callender said Wednesday.

Callender describes the Foreskin Awareness Project as Canada's “feistiest pro-foreskin advocacy group” with the goal of “foreskin education and appreciation.”