US sperm banks are adamantly opposed to the removal of donor anonymity, despite the risks of genetic disease and unintentional incest, reports LA Weekly, in a fascinating look into the US$75 million industry. The article focuses on California Cryogenics, in Los Angeles, which is run by Dr Cappy Rothman. As the biggest player in the largely unregulated industry, his company's policies set the pace for his competitors.
At the moment, all records of sperm donors are destroyed after their samples are sold. So it is impossible for mothers or children to become familiar with the father's medical histories or to know how many siblings they have. The industry fears that if donor anonymity is abolished, no one will donate sperm. Currently, qualified men can earn between US$11,000 to $17,000 by signing up for an 18-month contract. One company, Northwest Andrology, even displays bundles of $100 bills on its website.
In the face of growing pressure to allow donor-conceived children to know who their fathers are, Dr Rothman is prepared to make some concessions. He says that he is trying to coordinate an "industry- wide donor tracking system" which would stop the destruction of records. He still would refuse to release the names of donors. But other companies fear that even these concessions would devastate the industry.
Sperm banks dismiss the danger of accidental incest. "We don't talk about it," says Dr Rothman, "because it's not an issue. Not only is it statistically improbable, but go back 300 years and just about all of us lived in tiny villages. There was no public transit. Everyone was related to everyone else because there was no one else around to marry. We're all descendants of incest. Secondly, from a medical perspective, you're talking about the danger of one generation of incest - even if that happens, the chances of something going wrong are minute."
What the sperm banking industry fears most is government regulation. At the moment, the US Food and Drug Administration requires sperm banks to screen donors for sexually transmitted diseases every three months. But Dr Rothman complains that this is unreasonable, as there is no record of anyone contracting HIV from purchased sperm. The FDA also effectively stopped Dr Rothman from expanding overseas to Denmark. The sperm of blond, blue-eyed Danes might be contaminated with mad cow disease -- which Rothman says is utter nonsense. "Every time the FDA passes another law," says Rothman, all they're doing is restricting women's reproductive freedom".
Rothman insists that he is also protecting consumer freedom: "By letting the FDA tell you whose sperm you can't use, they're in essence telling you whose sperm you have to use. And I don't think we want the federal government deciding what kinds of kids the American public should be allowed to have." ~ LA Weekly, Sept 26
JAMA endorses pro-choice critics of partial-birth abortion
The prestigious Journal of the American Medical Association has endorsed the pro-choice critique of the US Supreme Court's recent decision on partial-birth abortion. In a commentary article, Lawrence O. Gostin, of the Georgetown University Law Centre, says that the Court's decision in Gonzalez v Carhart "erodes trust in the Supreme Court as an institution, undermines clinical freedom and the patient-physician relationship, and degrades public discourse on reproductive rights particularly and the role of women in society generally."
Mr Goston argues that the Partial-Birth Abortion Ban Act, which was allowed by the Court, has a "chilling effect" on doctors' freedom to practice in accordance with "sincere exercise" of clinical judgement. For the first time, he contends, the Supreme Court has validated the strategy of the "right to life" movement: that abortion is not in the best interests of women, that women are often misled about the its risks, and that the welfare of women and foetuses are the same. The Court, he says, is promoting a "new paternalism" by assuming that women are confused when seeking an abortion and that it will "cause feelings of guilt, shame, and sadness". ~ JAMA, Oct 3
Frozen ovaries could end egg shortage
Whether for IVF, therapeutic cloning or medical research, the biggest hurdle in reproductive technology at the moment is a shortage of women's eggs. However, two of the biggest IVF clinics in the UK are working on a solution without resorting to animal eggs or complicated manipulations of scarce cells. The Bridge Clinic and Care Fertility are developing techniques of maturing immature eggs taken from slivers of ovarian tissue. These are removed using keyhole surgery and then frozen. A tiny slice of the tissue contains thousands of immature eggs.
Although most IVF clinics downplay the risks of fertility treatment, the two British clinics are now highlighting them to illustrate the potential benefits of their new technique. No longer will women require daily injection of potentially dangerous hormones and uncomfortable and invasive operations. Dr Alan Thornhill, of the Bridge Clinic, told the London Telegraph: "It would mean we have got a pool of thousands of eggs at very little risk to the woman and relatively low cost because you avoid the huge drug costs. Instead of having up to 10 eggs to work with, with this you can have lots of eggs without the risk of over-stimulation."
Although there are some promising precedents for the clinics' ambitions, the new technique is still five years away from implementation. If successful, it could allow women to defer motherhood for years, or women about to undergo cancer treatment to retain their fertility.
But it could also lead to mass production of genetically selected embryos, as highlighted by economist James Miller on the US website TCS Daily. With its enormous population, China could force high-IQ women to donate ovarian tissue, cultivate their eggs, combine them with sperm from high-IQ men, screen the embryos with cheap genomics technology, and hope for armies of Einsteins. ~ London Telegraph, Sept 23; TCS Daily, Oct 2
US elections could affect British stem cell science
British stem cell scientists could lose their lead if a supporter of embryonic stem cell research wins the US presidential election, says the new head of the Medical Research Council, the UK's largest public science funding agency. Generous funding and liberal regulation have attracted a number of talented people to the UK who were impatient with restrictions imposed by the Bush administration, says Dr Leszek Borysiewicz. "This is an area that Britain could very quickly be overtaken in, particularly if the sort of big bucks that California is throwing into the system were suddenly thrown in across the whole of the United States," he observed. ~ Guardian, Sept 28
IRS in sex-change surgery debate
The American tax office has been dragged into the debate over whether sex-changes are genuine medical treatment or an inappropriate response to a psychological problem. Rhianon O'Donnabhain, a construction engineer from Boston, decided to become a woman in 2001 after having fathered three children. He claimed a US$5,000 tax deduction for the surgery, which the Internal Revenue Service initially allowed. However, the IRS quickly reversed its decision because the operation had been merely cosmetic, and therefore not deductible. O'Donnabhain refused and sued the IRS. The case is now making its way through the courts.
O'Donnabhain, now 64, is supported by the Boston-based Gay and Lesbian Advocates and Defenders as a test case. A psychiatrist at Harvard Medical School, Marshall Forstein, says that an operation is clearly medically necessary. "When did the IRS suddenly become physicians? It's absolutely clear that transgender identity is a condition discussed in diagnostic manuals. It seems the IRS is now in the business of practicing medicine without a licence." ~ Washington Post, Oct 1
Foetal brain tissue again mooted for cures
A report in Nature Neuroscience has once again sparked interest in the use of foetal brain tissue to cure Parkinson's and other diseases. Dr Afsaneh Gaillard, of the University of Poitiers, in France, transplanted neurons from 14-day-old mice into mature mice with brain lesions. Two months later the grafts were well integrated into the host's brain tissue. If validated, according to a commentary by Mark Tuszynski in the journal, "the biology of this observation is stunning and the implications are important". "Attempts to repopulate the nervous system with fetal tissue or stem cells would merit very close examination".
Echoing Alan Greenspan's critique of stock market hype, however, Tuszynski warns against "unbridled and irrational exuberance". Other promising techniques have failed in the past, he points out. ~ Nature Neuroscience, October
FDA blasted over clinical trials
The US Food and Drug Administration can't keep out of the limelight. It was heavily criticised for not providing adequate supervision of processed food and medicines imported from China, resulting in gigantic recalls and public health warnings. And now a report into its supervision of clinical trials suggests that it is disorganised, under-financed and often negligent. "In some ways, rats and mice get greater protection as research subjects in the United States than do humans," Dr Arthur Caplan, of the University of Pennsylvania told the New York Times. Animal research centres have to register with the federal government, keep track of the number of subjects, are subject to unannounced spot inspections and dispatch problems quickly. None of this is true in human research.
A report from the Department of Health and Human Services says that the FDA is unable to identify all ongoing clinical trials or institutional review boards. It relies on voluntary compliance to correct violations. In addition, its guidance and regulations are behind the times.
The Times cited two disturbing examples of lack of oversight. In one, a woman checked into an Oklahoma clinic to participate in a drug trial for bipolar disorder. She was forced to stay against her will, even though her lawyer appeared at the doorstep with a writ of habeas corpus. The clinic had a number of other problems, but it took the FDA two years to send a warning letter. Last November the psychiatrist who owned the clinic was suspended for having sex with two patients. Apparently he continues to participate in drug trials and to do research.
The importance of government oversight is highlighted by a report in the Wall Street Journal about the growing use of dying hospice patients as participants in clinical trials. There is growing interest in these people because of their unique medical needs. However, clinical trials in this environment present serious ethical issues. "People are really vulnerable when they're coming to the end of their life," says Porter Storey, of the American Academy of Hospice and Palliative Medicine. "They're willing to sign up for anything," he says. They may put too much hope in an experimental cure or they may agree just to please their doctor. ~ New York Times, Sept 28; Wall Street Journal, Sept 27
"Therapeutic misconception" over therapeutic cloning
Stem cell scientists eager to obtain women's eggs must guard against the temptation to overplay the benefits of their research, say two Stanford bioethicists. Mildred Cho and David Magnus argue that there is a danger of "therapeutic misconception" -- especially in California, where research is building up -- because egg donors are likely to be women with relatives afflicted with some disease. They may be donating in the belief that their loved one may somehow benefit from their efforts. However, this is unlikely, say Cho and Magnus.
"Pursuing oocyte donors from families who are afflicted with disease that are potential targets of future or present stem cell research is likely to be a more successful strategy than attempting to procure them from among healthy young women who typically are paid thousands of dollars to "donate" oocytes for infertile couples. But it will be imperative that these donors comprehend the well- understood risks of being an oocyte donor and also understand that human ESC research is in its infancy. Even CIRM's [California Institute for Regenerative Medicine's] strategic plan recognises that it is unlikely that there will be any treatments within the next decade. Women's voluntary donation of oocytes may be critical to research, but it is far too early for women to do so with the expectation that their donation is going to lead to cures anytime soon." ~ Nature Reports Stem Cells, Sept 27
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