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Time to Put Research Cloning on the Back Burner

Posted by Marcy Darnovsky on December 10th, 2008


[Cross-posted from "What's New in Life Science Research" at ScienceBlogs]

I agree with Mike's first point: By now - more than 12 years since the birth of the first cloned mammal, and 10 years since stem cells were first extracted from human embryos - most people understand the difference between cloning for reproduction and cloning for research purposes.

But I think his suggestion that people are wary of SCNT because creating replacement organs seems like magic is way off base. There is a lot of magical thinking going on about SCNT, but most of it has originated with advocates of cloning-based stem cell research who have irresponsibly hyped SCNT as an imminent miracle cure.

In fact, there's been very little progress in cloning-based stem cell research in more than a decade. And even if its considerable technical and logistical challenges were ever overcome, SCNT would be an ethically problematic approach to regenerative medicine - for several reasons that have nothing to do with the moral status of human embryos.

Over the past year, some of the world's top cloning scientists - including Ian Wilmut of Dolly-the-cloned-sheep fame - have announced that they're abandoning their SCNT work. The scientific and medical justifications for SCNT are getting weaker, and the social and ethical problems it raises aren't going away. It's time to put SCNT on the back burner.

Here's why.

It's worth stressing - since so many news stories (not to mention blog posts) are misleading on this point - that SCNT has produced not one human stem cell. And work on it is a very small part of the stem cell world: Only a small number of labs remain interested in trying it, and that number has diminished over the past year as work with cell reprogramming techniques has advanced.

Cell reprogramming looks likely to achieve the very thing that made SCNT so hypothetically compelling: disease-specific and patient-specific stem cells that can do all the tricks "ordinary" embryonic stem cells can do. It raises other concerns, but at least it uses ordinary body cells instead of embryos and eggs.

The scenario in which research cloning would produce "personal repair kits" for each of us was always extraordinarily unlikely. By their nature, SCNT-based treatments would be so expensive that they'd constitute a kind of "designer medicine," out of reach except for the extremely wealthy.

Is it possible that SCNT, along with cell reprogramming, could still be useful as a research tool for studying early disease development or testing drugs? Yes, but SCNT poses other problems.

The Ethics of Eggs

Here's a big one: SCNT requires very large numbers of human eggs. And procuring eggs is an invasive and time-consuming process that puts women at risk of adverse reactions, some of which can be quite serious, even life-threatening.

Remember Hwang Woo-suk, the Korean cloning scientist whose published claims of producing stem cells with SCNT turned out to be fraudulent? Hwang also lied about having found a way to reduce the number of eggs required for SCNT. When a real count was made, it turned out that he'd used over 2200 eggs collected from 119 women. He'd neglected to properly inform many of them about the risks. He'd coerced some of them - including junior researchers in his own lab - to have their eggs extracted. And in violation of Korean law, he'd paid more than half of them - several said they'd agreed because they desperately needed money. Twenty percent of the women whose eggs he'd used experienced serious adverse reactions, and 16 were hospitalized.

The prospect of an increased demand for eggs raised concerns early on about exploiting economically vulnerable women - and that was before the current economic collapse. That's why a number of countries (including Canada, France, China), states (including California), and scientific bodies (including the National Academies of Sciences) have ruled or recommended that women who provide eggs for cloning-based research be reimbursed for their expenses, but not paid more than that.

But the U.S. still doesn't have a federal law that limits payments or establishes other rules to protect women who provide eggs for SCNT research. For that matter, the U.S. - unlike dozens of other countries, including all of those in which SCNT research is known to be taking place - still hasn't passed a law against reproductive cloning.

For these reasons and more, I think it's both too early and too late to continue SCNT research: too early because the regulations that would be required to ensure it could be done responsibly aren't in place, and too late because SCNT is an idea whose time has passed.

Hotline for Eugenics Victims

Posted by Pete Shanks on December 10th, 2008

Eugenics logo

North Carolina has set up a toll-free number (800-662-7030) for survivors of the state's eugenic program, which ran from 1929 to 1974. More than 7,600 people were sterilized under the law, which was finally repealed in 2003. Presumably most of them are no longer alive, but state legislators are trying to decide how to compensate the surviving victims.

Kudos are due once again to the Winston-Salem Journal, for its prize-winning 2002 series "Against Their Will," which played a pivotal role in bringing this history to modern attention, and for continuing to follow the story.

Over the last several years, there have also been apologies from Virginia, Indiana (on the occasion of the 100th anniversary of the first state sterilization law), Oregon, California and South Carolina. (A resolution was introduced in Georgia, but it seems to have stalled.) There have also been conferences in Sacramento and Indianapolis, focusing on their respective local histories, and in Washington, D.C., looking to avoid a eugenic future.

These efforts are important, even if to date North Carolina is the only jurisdiction to offer anything more than words of regret. Shouldn't other states follow their lead? Is it time for national consideration of the issue? There are regular reports of people proposing to revive eugenic sterilization. And technically, the Supreme Court ruling in Buck v. Bell, which confirmed the legality of state sterilization, still stands. (Skinner v. Oklahoma raised questions about the use of sterilization as punishment but did not overturn the Buck decision.) Should we find a way of over-riding it?

Previously on Biopolitical Times:

DNA Databases: Another Human Rights Violation in the U.S. Criminal Justice System?

Posted by Osagie K. Obasogie on December 9th, 2008

One of the more dubious aspects of the United States criminal justice system is the long list of practices that others in the Western World consider to be blatant human rights violations. This includes the death penalty, the so-called “prison industrial complex,” and the disproportionate policing, prosecution, and imprisonment of racial minorities. But a ruling last week out of the European Court of Human Rights suggests that the US can now add another one to the list: the collection and retention of DNA profiles from arrestees never convicted of a crime.

While the expansion of DNA databases in the United States has been well documented, the latest trend has been the permanent retention of DNA samples from those arrested but never convicted. Proponents of this move argue that expanding the collection of DNA samples to arrestees will improve law enforcement; opponents point out that these materials are highly sensitive and implicate family members other than the individual arrestee. This privacy concern is what largely persuaded the European Court of Human Rights to rule against the UK policy of retaining arrestees’ samples.

The case was brought by two men: a then 12 year old accused of armed robbery and a 45 year old charged with harassing his partner. Neither was ever convicted, yet their DNA remained in the UK database after several requests to remove them. The Court did not mince words in describing the human rights impact of this practice:

the blanket and indiscriminate nature of the powers of retention of the fingerprints, cellular samples and DNA profiles of persons suspected but not convicted of offences, as applied in the case of the present applicants, fails to strike a fair balance between the competing public and private interests and that the respondent State has overstepped any acceptable margin of appreciation in this regard. Accordingly, the retention at issue constitutes a disproportionate interference with the applicants' right to respect for private life and cannot be regarded as necessary in a democratic society. 

Women's health group launches campaign on risks of drug used in egg retrieval

Posted by Marcy Darnovsky on December 8th, 2008

An article in the December newsletter of the National Women's Health Network sounds an alarm about significant problems caused by the drug Lupron. Despite thousands of reports to the FDA of serious adverse reactions, Lupron is still being prescribed both for FDA-approved uses - prostate cancer in men and endometriosis and fibroids in women - and for "off-label" uses - shutting down the ovaries of women whose eggs are being retrieved either for their own or someone else's fertility treatment.

The article by Susan K. Flinn includes the stories of women who have contacted NWHN asking it to investigate the drug. Their stories are similar, Flinn reports: These women were healthy before using Lupron, but after using it they had serious symptoms that persisted for months or years. And despite thousands of adverse reactions reported to the FDA, neither the agency nor Lupron's manufacturer have indicated any interest in investigating the drug.

The NWHN is calling for

a concerted effort of women, physicians, health officials, researchers and media. The people who are considering taking Lupron are the ones who have the right to know that they are risking a lifetime of symptoms that may cost them their jobs, spouses, savings and quality of life.
Toward those ends, NWHN is initiating an educational and policy campaign "to get the word out about the misuse and dangers of Lupron® and other drugs," and together with Our Bodies Ourselves, the Center for Medical Consumers, and the Endometriosis Association, is about to launch The Informed Rx Decision-Making Consortium.

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