Gene Therapy Called Too Risky
Caltech president David Baltimore this week voiced one of the most ringing condemnations by a prominent scientist of human gene therapy, suggesting that it was premature to be testing the experimental technique in people.
“I disagree we’ve had value from gene therapy trials so far . . . “ Baltimore said, referring to the roughly 300 human studies since 1990. No research has yet reported an entirely successful treatment, and an experiment last fall killed an 18-year-old volunteer, touching off a national debate.
“A number of us are asking, ‘What the hell are we doing putting these things in people?’ ” said Baltimore, a Nobel laureate.
Fittingly, he made his remarks at a symposium here commemorating the 25th anniversary of a legendary gathering where genetic scientists postponed some types of recombinant DNA experiments as too risky. Baltimore was a prime mover behind the 1975 meeting and a coauthor of the influential research guidelines that grew out of it.
“There was definitely a resonance to having David be the one to say that,” said Alexander Capron, a legal scholar and co-director of USC’s Pacific Center for Health Policy and Ethics, which organized the invitation-only, three-day symposium that ended Thursday.
More than 60 scientists and scholars from the United States, England and five European nations attended six often-contentious sessions on controversial subjects such as genetically modified foods and gene therapy. They also grappled with the legacy of the meeting 25 years ago at the same place: the state-owned Asilomar Conference Grounds, a seaside retreat near Monterey.
Though a scholarly meeting about a meeting may seem hopelessly esoteric, the significance of the 1975 Asilomar Conference on Recombinant DNA Molecules is hard to overestimate. It was the first time that leading scientists agreed to restrict their research because they could not rule out dangers to lab workers and the public.
The guidelines that the 140 scientists drew up back then soon became government policy. Among other things, they deferred genetic engineering experiments on disease-causing microbes until they found that their experiments were not likely to produce super bugs that could escape the lab and infect the public. Moreover, the publicity surrounding the meeting and guidelines sparked public concern, triggering the recombinant DNA controversy that raged throughout the 1970s and early 1980s.
To this day, “Asilomar” echoes with larger meaning in the history of science, much as “Potsdam” does in political history. Science historians and regulators even refer to the “Asilomar” process, meaning an effort by scientists to limit research before the government does it for them.
Maxine Singer, president of the Carnegie Institution of Washington and a co-organizer of the 1975 meeting, argued that genetically modified foods would be more likely to receive public acceptance if agricultural scientists had held an Asilomar-style conference to forge a unified view on the perceived risks of those products.
The question of whether such an approach is ultimately in the public’s best interest provoked much debate this week. The scientists generally argued that such self-governance was appropriate, but other scholars countered that it skirted open public dialogue.
No one disputed that genetics has changed dramatically in the last two and a half decades. Indeed, high school students now perform the basic recombinant DNA experiments that once aroused fear.
But perhaps the most profound change, most of the disparate conferees seemed to agree, was the rise of commercial biotechnology, a business made possible by genetic engineering. Although it has been a boon to science and even the economy, it also threatens the cherished scientific ideals of openness and independence, many presentations asserted.
Dr. Alan Schechter, a research physician at the National Institutes of Health, argued that clinical scientists should not be allowed to have financial stakes in companies that sponsor studies they conduct. Many biotech companies compensate outside clinical researchers with stock shares, which can rise or fall in value depending on a large study’s outcome, creating a potential conflict between the scientists’ financial interests and the need to care for patients dispassionately.
Patients’ rights was a recurring theme. LeRoy Walters, an ethics specialist at Georgetown University, argued for tougher federal oversight of gene therapy experiments and full disclosure of “adverse events.”
Harold Shapiro, president of Princeton University and chairman of the National Bioethics Advisory Commission, argued that federal regulations for protecting research subjects should be both expanded and simplified.
