A team of US scientists has set off a flurry of news stories with the claim that they and others have created "genetically engineered children." The researchers report in the March issue of the journal  Human Reproduction on the creation of "nearly 30 babies worldwide"  who, they say, represent "the first case of human germline genetic  modification resulting in normal healthy children." <www.humrep.oupjournals.org/cgi/content/abstract/16/3/513>.

These events raise a red flag signaling the urgency of working toward bans on the manipulation of the genes we pass on to our children--the technology known as "human germline engineering."

The gene transfer procedure in question is not germline modification in the usual sense: It cannot lead to the controlled alteration of traits that most disturbs those working to prohibit human germline engineering. But the procedure has put the future health of these children--and their descendants--at possible risk of an extremely serious medical condition that often develops later in life.

In addition, the procedure flouts the widespread conviction among scientists, political leaders, and the general public that tampering with the human germline is medically unnecessary and unsafe, and that it could open the door to a "techno-eugenic" human future, with  potentially disastrous outcomes. In an increasing number of countries  world-wide, human germline engineering is being declared a criminal act.  

How the Procedure Works

The researchers--Jason Barritt, Carol Brenner, Henry Malter and Jacques Cohen of the Institute for Reproductive Medicine and Science at the St. Barnabas Medical Center in New Jersey--were using a technique known as  cytoplasmic transfer. They injected cytoplasm (cellular material outside  the nucleus) from eggs of fertile women into "potentially compromised"  eggs of women whose difficulty in establishing pregnancies they presumed  to be due to defects in the cytoplasm of their eggs.

Cytoplasm contains structures called mitochondria, which produce energy for the cell and which have a small number of their own genes. So when cytoplasm is transferred, some mitochondria and their genes are likely  to be transferred as well.

Some of the babies born after the cytoplasmic transfers have been tested and found, unsurprisingly, to have mitochondrial genes from both the donor and recipient eggs. Since mitochondrial DNA is passed from mothers to their children, the introduced mixed-mitochondria condition can be  considered a germline alteration.  

The Medical Risks

A mixture of mitochondrial types is known to occur naturally, and  sometimes to cause life-threatening illness. The often debilitating  symptoms of "mitochondrial heteroplasmy," as it is called, can begin  at any point in life including well into adulthood. (See United  Mitochondrial Disease Foundation, <www.umdf.org>.) So the claim by  the St. Barnabas researchers that they have produced "normal healthy  children" may, tragically, be premature.

The St. Barnabas report in Human Reproduction asserts that naturally occurring "pathological" heteroplasmy associated with disease differs  from the kind produced by cytoplasmic transfer, which it calls "benign  heteroplasmy [that occurs] after mixing two potentially normal  populations of mitochondria." But it offers no evidence for the  assertion that the mitochondrial heteroplasmy they have produced in  these children is, in fact, benign.

We do not know how much the parents seeking treatment for infertility  were told about the likelihood of mitochondrial heteroplasmy in their  babies, or about its association with mitochondrial disease. The St.  Barnabas website, <www.sbivf.com/cytpqa.htm>, continues to offer the  procedure without mentioning these risks.   

"Inadvertent" Germline Engineering

Cytoplasmic transfers have been done for several years at a number of infertility centers, and the mixed mitochondrial condition of the children born after the procedures has been reported in the past. It has also been recognized for some time that a form of germline modification is therefore produced by cytoplasmic transfer. The real  news at this juncture is the St. Barnabas researchers' provocative  assertion that they have produced genetically altered children.

The St. Barnabas claim began drawing attention after the publication of an editorial about it in the April 20 issue of the journal Science. In "Inadvertently Crossing the Germ Line," bioethicists Erik Parens of the Hastings Center and Eric Juengst of Case Western Reserve wrote, "This news should gladden all who welcome new children into the world. And it should trouble those committed to transparent public conversation about the prospect of using `reprogenetic' technologies to shape future children."  (See <www.sciencemag.org/cgi/content/summary/292/5516/397>.)

Parens and Juengst go on to speculate why the researchers might have  felt justified in ignoring the NIH Recombinant DNA Advisory Committee's  de facto ban on germline interventions. One of their suggestions, later confirmed by Cohen, was that the work was privately funded, and the NIH committee technically has jurisdiction only when federal moneys are involved. In many countries, the experiments would be illegal whether or not government money was spent.

Parens and Juengst, who consider the act "unfortunate" but "perfectly legitimate," conclude with the "hope that before any other inadvertent steps are taken toward making IGMs [inheritable genetic modifications], those interventions will receive the public discussion they deserve"--a formulation that unfortunately can be read as assuming that such other steps will ultimately be taken.  

Controlling the New Genetic and Reproductive Technologies

There is little doubt that the St. Barnabas researchers understood the medical risks and intensely controversial nature of the procedures, as well as the legal technicalities of their situation. Yet they decided to cross one of the most politically and ethically consequential technological thresholds human beings have ever confronted. Their disregard starkly demonstrates the urgency of bringing human genetic and reproductive technologies--whether privately or publicly funded-- under effective societal control.

Some media coverage of the situation, notably by Gina Kolata in the New York Times accepted the claim that cytoplasmic transfer is simply a fertility treatment ("Babies Born in Experiments Have Genes From 3  People," May 5, 2001). Most articles featured headlines about "genetically altered" or "genetically engineered" babies. Only the  non-profit group Institute for Science in Society considered the  babies' risk of future mitochondrial disease. (Joe Cummins and  Mae-Wan Ho, May 2 ISIS Report, <www.i-sis.org/first_gm_humans.shtml>.)

It would be unfortunate if headlines about "GE babies" and claims that "the germ line has already been crossed" were used to demoralize opponents of a techno-eugenic future. We need to begin immediately to put in place global accords that ban human genetic manipulation and establish participatory procedures for deciding about the acceptability of other new genetic and reproductive technologies.

In the meantime, the St. Barnabas Medical Center and all other institutions should suspend use of cytoplasmic transfer immediately. In addition, the US Congress should determine how such a medically and politically dangerous procedure was permitted in the first place.

The genetic redesign of human beings can and must be prevented.

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For samples of media coverage, see "Genetically altered babies born," BBC News Online, May 4, <news6.thdo.bbc.co.uk/hi/english/sci/tech/newsid%5F1312000/1312708.stm>,

"Gene-altered babies spark debate," <www.msnbc.com/modules/exports/ct_email.asp?/news/569043.asp>, and "Bio-Babies Spawn Ethics Question," Wired, May 5, <www.wirednews.com/news/print/0,1294,43579,00.html>.

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