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National Academies Revise Stem Cell Research Guidelines

Posted by Jesse Reynolds on September 9th, 2008

The United States lacks federal oversight of stem cell research, and instead relies on a patchwork of regulations and guidelines from states, funders, and nonprofit organizations. Most influential have been the National Academies' Guidelines for Human Embryonic Stem Cell Research, which were just revised for the second time since their debut in 2005. Although the guidelines are nonbinding, they have served as the model for others, particularly California's $3 billion program, and will likely do so for policy under the new presidential administration.

The press release from the National Academies highlights changes in two key areas, one encouraging, and one less so. First, the committee revisited the question of payments to women who provide eggs for cloning-based stem cell research, and maintained their position that these women should not be compensated. The amendments, though, clarify the types of reimbursements that are allowed. Taking a cue from California's regulations, they aim to make the egg donor neither better nor worse off.

Women who undergo hormonal induction to generate oocytes  specifically for research purposes (such as for NT [nuclear transfer, or cloning-based  stem cell research]) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. Direct expenses may include costs associated with travel, housing, child care, medical care, health insurance, and  actual lost wages. No payments beyond  reimbursements, cash or in-kind, should be provided for donating  oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research  purposes or of somatic cells for use in  NT.

Second, the committee now recommends that the institutionally-affiliated boards that approve the stem cell research projects, ESCROs, undergo audits whose results are publicly available. We've long maintained that leaving this oversight to boards that are essentially part-and-parcel of the research institutions themselves is tantamount to letting the fox guard the henhouse. However, the National Academies is an independent nonprofit organization, and cannot impose mandates or real regulation. While this change is certainly an improvement, let's hope that any legislation under a new administration does not merely mimic the Academies' Guidelines, but instead recognizes that they were drafted by an agency with limitations.

An institution that maintains its own ESCRO committee should conduct periodic audits of the committee to verify that it is carrying out its responsibilities appropriately. Auditable records include documentation of decisions regarding the acceptability of research proposals and verification that cell lines in use at the institution were acceptably derived (see Section 1.6). Institutions should make the results of the audits available to the public.

An institution that uses an external ESCRO committee should nevertheless ensure that the registry and educational functions of an internal ESCRO committee are carried out by the external ESCRO committee on its behalf or internally by other administrative units. Those institutions that use external ESCRO committees are also responsible for ensuring that these committees are likewise carrying out their responsibilities appropriately.

Previously on Biopolitical Times:

Enhancement: Of breasts and bottom lines

Posted by Marcy Darnovsky on September 8th, 2008

Over at Our Bodies, Our Blog, Christine Cupaiuolo takes on the global pharmaceutical company that makes Botox and breast implants. The post, titled "Re-Framing Empowerment: Allergan, Breast Implants and a New, Improved You," looks first at Allergan's new marketing campaign.

The company is busy trying to portray "plastic bags filled with silicone or saline solution" as "sources of power, freedom, individuality and self-confidence." Its approach: Make "injecting, slicing and rearranging body parts" sound like treating yourself to a day at the spa. "Nearly 400,000 women did something fabulous for themselves last year," Allergan rhapsodizes in ads for its "Natrelle collection of breast implants."

Many women with breast implants have found them distinctly not fabulous. But studies on their risks somehow don't reflect the growing number of horror stories documented by the blogs, websites, and documentaries to which OBOB links. Could part of the explanation lie in the financial connections to the breast implant industry enjoyed by the authors of key studies on breast implant safety?

A review of previous studies recently published in the journal Annals of Plastic Surgery concluded that breast implants are safe. But the National Research Center for Women & Families notes that all four of the review's authors have financial ties to the breast implant industry, and that studies by the National Cancer Institute and the FDA "found significant increases in several illnesses among women with implants."

Previously on Biopolitical Times:

India in the News

Posted by Jesse Reynolds on September 3rd, 2008

In the last couple weeks, India's booming fertility industry has been in the news frequently:

Activists have petitioned the Supreme Court to stop major internet sites from running ads for sex selection. The activists, including Sabu George, previously have been successful ending similar ads in print publications. But now they are taking on Google, Microsoft, and Yahoo.

Surrogacy in India is almost a half-billion dollar industry.

Paying for eggs is on the rise. Economically vulnerable women are more likely to provide eggs, and according to one expert, "desirable physical attributes such as fair skin and good features" result in higher payments. The report ended with:

Another donor pointed out that the agents typically try to locate prospective donors among the poor.

"As their husban­ds are easy to convince, they are approached first. However, with financial dealings involved in the process, husbands often force their will on their wives," she said­.

Another investigative report concluded that egg providers are often cheated and misled. Prospective parents are becoming more selective about the traits of potential sperm and egg providers. Yet India has no law regulating the assisted reproduction industry.

Eggs on ice: New profit center for the baby business

Posted by Marcy Darnovsky on August 31st, 2008

A growing number of assisted reproduction companies are now promoting egg freezing and banking for women who are - or can be encouraged to become - nervous about their biological clocks. The Washington Post said in May 2007 that "at least 138" fertility clinics offer this service; a more recent estimate put the number at "more than 220."

This despite the fact that American Society for Reproductive Medicine, the fertility industry's own trade organization, put out a press release last fall titled "ASRM Urges Caution, Strong Counseling for Women Seeking Egg Freezing." ASRM says the technique is experimental - success rates are tiny, effects on the resulting children uncertain - and warns that for now it's appropriate only for women with cancer or other illnesses who may become infertile as a result of treatments for such as chemotherapy.

"Social egg freezing" has also been widely covered by media from women's magazines (Marie Claire, Cosmopolitan) to the business press (Wall Street Journal, Forbes) to the most mainstream of newspapers and broadcast outlets (New York Times, NPR, Newsweek, NBC Nightly News, ABC News). Much of the coverage could easily be mistaken for an infomercial - which explains why it's helpfully collected on the website of the egg freezing company Extend Fertility, whose tagline is "Fertility. Freedom. Finally."

An article this week in the Washington Post falls squarely into the infomercial genre - it fails even to mention the ASRM's cautions. For a far different treatment (not included on Extend Fertility's website), see the July-August newsletter of the National Women's Health Network. That article's title asks whether egg freezing is an example of "Marketing Ploys for Career-oriented Women." Unlike other coverage of social egg freezing, it observes that egg retrieval is invasive and risky for women. And it notes that

advocates of egg freezing use alarming statistics in a misleading fashion to encourage women to create unnecessary back-up plans based on an ineffective, expensive, and unproven technology.

Previously on Biopolitcial Times:

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