This was quite a year for reproductive and genetic technologies, and many of the biggest stories will certainly have sequels. Among the most significant topics were:
- Artificial gametes and cloning
- Inheritable genetic modification
- Prenatal, newborn and other genetic testing
- The fertility industry
- Commercial surrogacy
- Egg “donation” / egg freezing
- Eugenics as policy
- Forensic DNA / DNA databases
- Stem cells: therapies and scandals
- Synthetic biology and the bioeconomy
Artificial gametes and cloning
The Nobel Prize in Physiology or Medicine went to John Gurdon and Shinya Yamanaka, for cloning a frog and discovering how to reprogram adult cells into induced pluripotent stem (iPS) cells, respectively. Scientists are still expanding on these breakthroughs.
Mitinori Saitou and colleagues in Kyoto created mice by using sperm and eggs grown from iPS cells, though supplied ovaries were also needed, at least for the time being. This sparked immediate speculation about human applications, as did an earlier Chinese technique of generating sperm. In Korea, there was a push to remove restrictions on human research cloning, and eventually reproductive cloning. Korean animal cloning also garnered free publicity via reality TV.
Inheritable genetic modification
Scientists at the Oregon Health and Science University combined sperm with the nuclear DNA from one egg and the mitochondrial DNA from another to generate blastocysts (and embryonic stem cells). If carried to term, these would be “3-parent babies” and, the scientists acknowledge, constitute human germline modification, also known as inheritable genetic modification (IGM). The team produced live monkeys using this method in 2009, and are pushing the US Food and Drug Administration to approve human clinical trials, although all human germline interventions have previously been considered off limits by scientists around the world and more than 40 countries have passed laws against it. In the UK, the HFEA has started a public consultation about allowing similar mitochondrial replacement techniques.
General advocacy of IGM was on the rise this year: various proponents advocated it as an alternative to geoengineering, a military technique, a routine application for making better children, or even a moral duty to create “designer babies.” Critical discussion of the “eugenic impulse” also broadened, while some (particularly several proponents of synthetic biology) tried perversely to reclaim it as a positive, even ethical, desire.
Prenatal, newborn and other genetic testing
The direct-to-consumer (DTC) gene testing industry attracted some new investment, and controversially began considering whole-genome sequencing, particularly for babies. The development of private databases that can be sold for research use began to draw more attention, especially since promises of anonymity seemed increasingly implausible.
Non-invasive prenatal diagnostic (NIPD) testing, which analyzes fetal DNA circulating in the mother's blood, was shown to be feasible, raising eugenic concerns and complex ethical issues. The marketing of such tests, and the ideology behind them, was questioned in detail on this blog (1, 2, 3).
The fertility industry
In vitro fertilization (IVF) was linked to birth defects (though there may be less than there used to be), and to later cardiac problems. Women who use fertility treatments have been found to have significantly higher rates of PTSD disorder. There has also been concern that the US fertility industry ignores minorities and that many providers flout “best practice” guidelines established by the sector’s professional organization. Despite this, the number of IVF babies worldwide reached the five million mark this year, with lenders finding it to be good business, and several different contests for free IVF treatment springing up.
India continued to be in the news as an ever-growing destination for commercial surrogacy, with reports of exploitative practices and of the tragic deaths of two women working as surrogates. A law to regulate India’s assisted reproduction industry made some progress, and increased attention was paid to the ethical dimensions of hiring an overseas surrogate.
Surrogacy agreements and complications were news in many countries, including Australia, the UK, Canada, and China. In the United States, class issues gained more attention; some women are pressured into being a surrogate in order to make ends meet. There have been messy legal battles over custody; and the lack of regulation has led states such as Oregon and California to attract international customers, though California has been at the forefront of several surrogacy scandals this year.
Egg “donation” / egg freezing
The American Society for Reproductive Medicine (ASRM) removed its experimental label from egg freezing this year, though only for women at risk of losing their fertility due to medical treatments such as chemotherapy. Despite this clear caveat, news accounts and fertility industry figures used the ASRM shift to encourage more women to consider it as a viable option for preserving their own fertility. Some clinics began promoting frozen “egg banks” as a way to find and control egg donors more easily. Personal accounts from several US egg donors have surfaced, elucidating various concerns.
The appropriate amount to pay egg donors has continued to garner attention, with Denmark considering increasing payments, but worried about commodification, and the UK seeing the waiting time for recipients cut in half after they did increase payments to donors. One California clinic has begun creating embryos not for specific intended parents but by using “desirable” donor sperm and eggs and then splitting the “batches” among several people, causing an uproar from many critics about commodification and baby-selling.
Eugenics as policy
North Carolina’s Senate blocked payments to victims of forced sterilizations that the House had approved (and has recently decided to consider again next year). A Virginia lawmaker considered symbolic reparations. A woman who was forcibly sterilized spoke out about her experience; so too did the daughter of a woman who was forcibly sterilized, which prompted the generous funding of an organization to outlaw forced sterilizations.
CGS, working with a network of advocates and scholars, , helped to publicize California’s legacies of eugenics with a conference (available on video) at the University of California at Berkeley School of Law. The sterilization of disabled women and drug addicts also gained some media attention, as did revelations of the sterilization of hundreds of women in California prisons without their consent or knowledge. Internationally, several eugenic practices were revealed, such as the forced removal of Indian women’s wombs, government-led forced sterilizations in Uzbekistan, and coercion of Ethiopian women in Israel to agree to long-term birth control methods. German doctors finally apologized for their complicity in the Holocaust, and Australia is finally considering criminalizing the involuntary sterilization of disabled people.
Forensic DNA / DNA databases
There has been a continuation of the trend towards larger national DNA databases around the world this year, including in the UK, Denmark, and India. Many US states have also greatly expanded their DNA police databases, by taking DNA from everyone who is arrested even if they’re not convicted, or by taking DNA from all who are convicted, even for misdemeanors.
However, the infallibility of DNA evidence has been largely discredited this year with one story after another of people wrongly accused by supposedly fool-proof DNA evidence (1, 2, 3, 4, 5, 6).
The legality and privacy concerns of requiring DNA from so many innocent people have also been called into question and the issue has been in and out of the court system. Maryland ruled that DNA collection upon arrest was unconstitutional, but the ruling has been appealed to the Supreme Court.
Stem cells: therapies and scandals
The first tentative positive results of a clinical trial of treatment derived from human embryonic stem cells were published. Geron’s trial remains suspended, though the company’s estranged founder and another former CEO are bidding to take it over. The California Institute for Regenerative Medicine ended the year under significant criticism after a report by the Institute of Medicine agreed with longstanding concerns by CGS and other public interest organizations about conflicts of interest built into the agency’s governance structure.
Stem cell scams made headlines, and drew the attention of 60 Minutes and Harvard Law School, as well as the FDA. In Texas, a huge (potentially tragic and occasionally hilarious) controversy arose around Celltex, a stem-cell company with connections to Governor Perry. The FDA intervened, and Celltex is entangled in lawsuits with its Korean partner RNLBio and its Texas subsidiary Human Biostar, itself the target of a lawsuit by former patients.
Synthetic biology and the bioeconomy
The White House unveiled a “National Bioeconomy Blueprint” that relied heavily on synthetic biology. Craig Venter and George Church kept the publicity mills humming. Regulation, however, lagged, though a broad coalition of over 100 civil society organizations developed Principles for the Oversight of Synthetic Biology, and international discussion continues.
South Korea’s government boosted investment in stem cells and regenerative medicine, despite several inconvenient scandals. Some American political observers raised concerns when China’s BGI Shenzhen made a bid to acquire California-based Complete Genomics.
Watch this space
It is already clear that 2013 will include many significant decisions on the legal and regulatory fronts: By June, the U.S. Supreme Court will hand down decisions about Myriad’s gene patents and the Maryland forensic DNA case (which may be definitive or may fudge the issues). The FDA will or will not allow trials on mitochondrial germline replacement to proceed (as may the UK’s HFEA), and may develop detailed regulations about DTC testing, in addition to legalizing or banning GM salmon and other foods.
Some scientists and entrepreneurs will continue to push the technical and ethical envelopes. Discussion of prenatal testing seems sure to grow, and likely to raise controversial issues involving not only abortion but definitions of disability and attitudes to eugenics. An international conference has been announced for early February, in Hong Kong, with the lead highlight of the scientific program being a presentation on “producing sperms and eggs from iPSC.” Those of us who are concerned about such issues need to be forewarned.
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