West Coast Editor

In the collective mind of the lesser-educated sector of the populace, the genomics revolution means a chance for power-crazed scientists to deploy new DNA data plus cloning technology to manufacture (among other things) improved human beings: disease-resistant humans, surely, but also those with perhaps more intelligence, stronger humans, maybe even “super” beings.

Science fiction dies hard. What’s more, religious and moral leaders can be reluctant to let go of their constant remembrances of history lest, as the philosopher Santayana warned, society be condemned to repeat it this time, with a more sophisticated arsenal of scientific weaponry.

In the real world, of course, the issues are different. With biotechnology companies focused mainly on making money through curing disease, and with watchdogs at every turn, ethics are a strong concern. Ordinary people, and investors, are growing more and more sophisticated about the details, and by the start of 2002, the battle lines were growing more clear.

And the battle itself was expanding. Companies learned ever more innovative ways to explore and manipulate genetic data, until the question became: What, exactly, comprises a genomics-based debate over ethics? If “genomics” means “structural and functional information about genes,” the controversy grows almost astonishingly wide.

Michael Werner, vice president of bioethics for the Biotechnology Industry Organization, which lobbies in Washington on behalf of the industry, said it’s “going to be harder and harder to draw a bright line around genomics and non-genomics issues. The pure issues like gene patenting, privacy and discrimination may still be around, but more and more, it will be a broad debate about technology and society.”

In 2001, it seemed all eyes were on stem-cell research at least, those eyes that were not on war, and on the threat of further terrorist attacks. Giving a boost to the debate late in the year was news from Advanced Cell Technology Inc., which published a paper in the Journal of Regenerative Medicine disclosing that the firm had created the world’s first human embryos through therapeutic cloning, or somatic cell nuclear transfer.

The paper reported privately held ACT’s work with parthenogenesis (that is, activating an egg cell without fertilizing it with a sperm cell) and somatic cell nuclear transfer to form pre-implantation embryos. Human egg cells were prepared by removing their DNA and adding the DNA from a human somatic cell, according to the company.

Amid the frantic media coverage that followed, ACT officials explained they were more interested in making sick people better than creating copies of humans. But the uproar had begun, even to an extent that somehow displaced if only for a while the worry over more anti-American strikes.

Earlier in the year, President Bush had declared the federal government would pay for research on 64 existing stem cell lines (which since has become 72) located within 10 labs across the world. That sparked the first round of noise regarding stem cells, which was drowned out by the September 11 terrorist attacks. In November, ACT revealed its progress with stem cells.

“I don’t want to say the politics around stem cells is over, but we’ve had the big debate,” Werner said early in 2002, as Congress re-convened and prepared to take up consideration of a number of cloning measures.

He stopped short of calling the brouhaha over federal funding of stem cell research a “red herring,” but noted that private companies such as ACT will go ahead with whatever they have planned.

“[Federal funding] is not insignificant, in terms of accelerating projects,” Werner said. “It’s a red herring in the sense of, if you’re a company, you just do a private round of financing.”

Although the government stance toward such research sets the tone, in the case of stem cells, “the companies just went out and did it. But it does mean there was only a small number of companies that could do that frankly, ones that are energetic and not risk averse. Geron is going to do just fine, regardless.”

Geron Inc. is the company that funded work at the Wisconsin Alumni Research Foundation that resulted in the derivation of stem cells in 1998. WARF was issued the patent on human pluripotent embryonic stem cells, and licensed a limited number of cell types to Geron.

In mid-January 2002, Bush’s 18-member council on bioethics met for the first time to survey the issues in a bid to become what Bush called the “conscience of the country.” The previous summer, the House had approved a bill by Rep. Dave Weldon (R-Fla.) that would ban both therapeutic and reproductive cloning, and Bush was said to support the measure.

Werner was cautious about the panel.

“It’s so early, and it’s so hard to tell,” he said. “This is clearly a group with an academic bent, and it doesn’t have patient representatives, for example. It’s clearly got folks who are outspoken against stem cells, and some against nuclear transfer. All we can hope is that, as they take these issues under advisement, they keep the patients in mind.”

Purely genomics-related controversy is likely to take any of a number of forms, Werner said. “Certainly, the privacy issue will be one for sure, and all of the issues about genomics research. What do you do with tissue samples? There are consent issues, and issues of discrimination [based on genetic findings], and the protection of human subjects.”

The privacy matter is “part of a larger societal debate about the role of technology and of government,” he said. “What are the limits of information technology, for example?” Proposed bills to keep genetic information private is primarily directed toward insurance companies and employers.

“They’re out there, and they’ve got a lot of support,” Werner said. Mainly, they are designed to block insurers from adjusting premiums, based on discovered predisposition toward disease.

The whole issue of genetic discrimination, which is larger, is even more distinctly genomics related, Werner said.

“I just don’t know what’s going to happen with that,” he said. “It’s getting harder to identify what’s a genomics company and it’s going to get harder to identify what’s a genetic test. I would suspect, given advances in genomics and technology, some are clear cut and others will be blurry,” incorporating genetic data but not relying solely upon it.

As the skirmishing over ethics continues, conflicting parties are found to have their own interests that may keep them from arguing from a standpoint that would benefit the most people. Even BIO is not immune to charges that it will take the position most beneficial to the industry.

“I don’t think that’s quite fair,” Werner said. “We’ve demonstrated that we try to look at biotechnology in the context of the society as a whole, and we have a statement of ethical principles. You don’t want to get into a, It’s good for General Motors, so it’s good for America’ kind of thing, but our companies aren’t making widgets, and they should get credit for that. We always try to keep the patients first.”

He was loath to predict the next likely area where opponents may clash over genomics.

“The next debate will be about another technology that some people object to, for whatever reason,” he said. “There’s always going to be a stem cell.’ We just don’t know what it is.”

For all of its benefits, the genomics field seems to have brought strife aplenty.

“I don’t think it has created a monster,” Werner said. “As with all technological advances, [genomics] raises new questions. This is worth it. You regulate what you can.”