What prompted the recent headlines about genetically-modified human embryos? Why did a brief account of an experiment at Cornell University, presented last fall at an American Society for Reproductive Medicine conference and then published without fanfare in its journal Fertility and Sterility, suddenly make news around the world?

 

The work in question involved transferring a gene that codes for a fluorescing protein into a non-viable human embryo, and showing that all the cells in the embryo glowed after three days of cell division. As one of the research team’s members later acknowledged, it was the first time that scientists are known to have created a genetically-modified human embryo.

 

Strangely, the study stayed beneath the public and media radar for months. It was brought to the attention of the UK’s Sunday Times by Dr. David King, director of the British organization Human Genetics Alert, who came across it recently while reading a document prepared by the Human Fertilization and Embryology Authority. The story ran in the May 11 Sunday Times and was then picked up by the Associated Press and The New York Times, among others.

 

Human Genetics Alert, the Center for Genetics and Society (my organization), and other public interest groups pointed out that the work crossed an ethical boundary that until now has been observed by scientists around the world. Intentions and motivations aside, the development of techniques for altering the genetics of human embryos represents a step that could lead to inheritable genetic modification of human beings, also known as “germline” engineering.

 

The prospect of altering the human germline – and thus opening the door to engineering novel and irreversible human physical, cognitive, and other traits – has long beset genetic and reproductive research. Because of its likely profound social harms, human germline modification has been definitively rejected by dozens of countries that have adopted policies prohibiting it. Unfortunately, no federal legislation in the United States addresses it.

 

In the recent round of media accounts, members of the Cornell research team downplayed the significance of the embryo modification study. In a narrow technical sense, they’re right. Genetic alterations in animal embryos are routine, as is the production of genetically-modified mammals. Scientists at the Oregon Regional Primate Research Center created a rhesus monkey whose cells contained a fluorescence gene derived from a jellyfish in 2001. In short, producing genetically-modified human embryos has been technically feasible for the past couple decades. But no previous attempts to do so have been reported.

 

Why? Most of the explanation lies in two considerations. First, as the Cornell researchers were surely aware, producing a genetically-modified human embryo would raise lots of eyebrows and serious concerns, and is not a matter for routine approval by an institutional review board. Yet they proceeded without any effort at wider public consultation or discussion.

 

Second, the scientific rationale for such experiments (other than to refine germline modification) is tenuous. Though The New York Times reported one member of the Cornell group saying “the purpose of the work was stem cell research,” this is not convincing. It does not seem to be a point of view shared by others in the stem cell field, as demonstrated when the topic of genetically-modified human embryos was considered by the Scientific and Medical Accountability Standards Working Group of the California Institute for Regenerative Medicine. That committee easily agreed that no such studies would be eligible for funding by the institute.

 

Speaking to the Associated Press on behalf of the research team, Zev Rosenwaks, director of the Center for Reproductive Medicine and Infertility at New York-Presbyterian / Weill Cornell Medical Center, said the experimenters are not interested in using genetically-modified embryos for reproduction. "None of us wants to make designer babies," Rosenwaks said.

 

Important Lessons
It’s clear that this particular experiment wasn’t meant as an effort to produce a genetically-modified child. As the original report noted and as the researchers took pains to reiterate in the recent media accounts, the work was done with a triploid embryo that could not have developed past a certain stage. And Rosenwaks' disavowal of interest in human germline modification is certainly welcome.

 

The controversy surrounding the Cornell study holds an important lesson for the biotech field: Failing to appreciate public concerns can easily undermine public trust. In opinion polls, large majorities consistently reject the prospect of modifying the traits of future children and generations. This sentiment holds across demographic groups, political lines, and national boundaries; it has been enacted as law in nearly every country with a biotechnology research sector.

 

In recent years, researchers understandably have been reluctant to voice their support for any limits on technological and scientific work, for fear of abetting restrictions like the ones that the Bush administration imposed on funding for embryonic stem cell research. But this stance can be costly if it leads to the perception – or the reality – that scientists are unwilling to support the establishment of basic rules of the road.

 

Drawing a clear line that puts inheritable genetic modification on the unacceptable side would bring the United States in line with policies already in place in more than 40 countries. There’s no need to reinvent the policy wheel; we can learn a great deal from the experiences of others.

 

The reaction to the Cornell experiment comes in the waning days of the Bush era, as shifts in the U.S. political climate become facts on the ground. This would be a good time for U.S. scientists to begin speaking up in support of policies to ensure that beneficial human biotech research can proceed with robust public support, while prohibiting applications widely judged to be unacceptable.