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"Should the possibility of inadvertent gene transfer to the germline be considered a benefit or risk?"

Posted by Jesse Reynolds on March 21st, 2007


W. French Anderson

Researchers in the UK are working towards gene "therapy" on human fetuses. Although the technique holds potential for treatments of serious genetic conditions, it raises both ethical and safety concerns.

The still-experimental procedure, more accurately called medical gene transfer, modifies the genes of human body cells, while trying to avoid the reproductive cells. This is done in order to treat a genetic condition while preventing the genetic modification from being inheritable. But the likelihood of modifying the reproductive cells is much greater when working with a fetus.

This debate played out in the US almost ten years ago , when W. French Anderson, one of the leading researchers in the area at the time, proposed the in utero technique to the NIH's Recombinant DNA Advisory Committee (RAC) . He explicitly acknowledged the possibility of crossing the germline barrier: "Should the possibility of inadvertent gene transfer to the germline be considered a benefit or risk?" He was clearly trying to force the hand of RAC, and in his words - to "push the envelope." Would the RAC approve inheritable genetic modification, if it came in a disguise? And even if the reproductive cells are not inadvertently modified, the approval of genetic modification to earlier and earlier stages of development sets the stage for the acceptance of inheritable genetic modification by both regulatory agencies and the public.

At the time, Paul Billings of the Council for Responsible Genetics offered a strong argument against Anderson's proposal:

So far, human gene therapy has failed, and it seems paradoxical that this failure should be used as a justification to extend genetic manipulation in humans to less-differentiated cells and the germline (particularly given that the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) only allowed consideration of somatic intervention if germline tampering was banned)....

It would be a poor public policy decision if full patienthood was conferred on the more than 85% of conceptuses and fetuses that do not survive the normal gestation period or experience early neonatal death. Treatment of generally non-viable fetuses, even with powerful genetic methods and parental permission, should be avoided. Making young fetuses into patients only serves to confuse compassion with eugenics.
And given how little success there's been in the field since, this argument still holds up.



Genetic justice, industry style

Posted by Marcy Darnovsky on March 19th, 2007


The issues raised by the intertwining of law and human biotechnologies are often technically and socially complex. What's a busy jurist to do?

If the Biotechnology Industry Organization has its way, she'll click on to biojudiciary.org: A Jurist's Guide to 21st Century Biotechnology. In an introductory statement, former BIO president Carl Feldbaum writes that the project aims to give judges and legal professionals a "neutral" and "objective educational resource."

This goal is unlikely to be attained. The project's founders, board of directors, and working group members are drawn from BIO itself, biotech companies, or their law firms (with the single exception of an analyst from the Congressional Research Service). Not one public interest organization is represented; not one academic figure is included.

Feldbaum points out that "the biotechnology industry did not take off until the 1980 Supreme Court decision in Diamond v. Chakrabarty upheld the right to patent organisms." BIO knows how to follow the money.




Can’t discard them as embryos, abort them as fetuses, or cast them out? Try hormone patches.

Posted by Marcy Darnovsky on March 16th, 2007


The Associated Press reported yesterday that a leading evangelical would support hormonal "treatments" for fetuses if genetic tests that can identify them as predisposed to be gay are developed. In a March 2 blog post, the Reverend R. Albert Mohler, Jr. concluded, "If such knowledge should ever be discovered, we should embrace it and use it for the greater good of humanity and for the greater glory of God."

His remarks set both red and blue bloggers abuzz, with charges of "eugenics" and "designer babies" flying.

Mohler's stance is carefully consistent with his theological commitments. He opposes abortion. He calls pre-implantation genetic diagnosis "one of the greatest threats to human dignity in our times." He affirms "the basic sinfulness of all homosexual behavior," while simultaneously arguing emphatically that "all persons-whether identified as heterosexual, homosexual, lesbian, transsexual, transgendered, bisexual, or whatever-are equally made in the image of God."

Unfortunately, Mohler's desire to "do something about" embryos identified as gay is not confined to religious conservatives. For a proposal from the liberal end of the political spectrum, see bioethicist Edgar Dahl's 2003 article in Human Reproduction, which argues that "parents should be permitted to use PGD to choose the sexual orientation of their children." 




Prisons: Rehabilitation or Repository?

Posted by Osagie K. Obasogie on March 15th, 2007


On the heels of the IOM's suggestion to relax restrictions on using prisoners in clinical trials, South Carolina is looking to push the envelope a bit further: incentivizing prisoners to "donate" organs by skimming 180 days off their sentence. No, this isn't Beijing. We're talking about Charleston which, despite General Lee's efforts, is still subject to federal law that forbids any "valuable consideration" to be given in exchange for organs. This hasn't dismayed a bipartisan state Senate panel, which hopes to find a loophole to permit the proposed program. What's going on here? First the federal government wants to use prisoners to test drugs, now states want to harvest prisoners for their organs. What's next? 200 days shaved from women's prison sentences for donating eggs for stem cell research? This shift from prisons as rehabilitative institutions to profitable biomedical repositories is more than troubling.




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