Cloning Trevor

Granted rare access to the labs of Advanced Cell Technology, the only U.S. group openly pursuing human cloning research for medical purposes, our correspondent spent six months tracking highly experimental work on the cells of a young boy with a life-threatening genetic disorder
A Public-Relations Disaster

A few weeks later ACT took a risk that could have put the company out of business—and, worse, could have closed the door on the budding field of therapeutic-cloning research. On November 9 the company e-mailed a hastily written scientific paper to e-biomed: The Journal of Regenerative Medicine, an online publication known for its quick turnaround time. The paper announced dryly that in ACT's lab "three somatic cell-derived embryos developed beyond the pronuclear stage." Robert Lanza, ACT's vice-president of medical and scientific development, called before the report came out to give me a translation. "The news is going to be that we have the world's first cloned human embryos," he said. "I just want to give you a heads-up—because when we make this announcement, it might bump the war [on terrorism] off the front page."

On almost every level the announcement was premature. ACT's original goal had been to publish in a prestigious journal like Science or Nature, when the company had what it is really after: human embryonic stem cells derived from a cloned embryo. ACT had nothing like that—it had managed only to sustain a cloned embryo to the six-cell stage of development.

At first, ACT's scientists say, they were uncertain whether they should publish such preliminary data. But given that they were working in an ethically fraught area of science, they decided to be as open as possible about their progress.

After Lanza called me about the imminent publication of ACT's cloning paper, I traveled to his house, on an island in a pond in central Massachusetts, to discuss the announcement. Lanza is in his mid-forties, animated and boyish, with graying brown hair that sticks straight up from his head. He, West, and Cibelli form ACT's core triumvirate. As we sat at his kitchen table, Lanza told me that rumors in the scientific community were starting to make him nervous. Apparently the mavericks of the cloning world—those trying to produce a baby—were possibly on the verge of getting some preliminary results. "If they should come out and make some sort of an announcement first," Lanza said, "it could do severe damage. Because when it breaks, if their goal is reproductive cloning, all of the research will be banned. It will be killed—and it won't matter what we say, because no one's going to listen anymore." Last year, in fact, the outrage surrounding the mavericks' activities had directly contributed to the passage of the House anti-cloning bill.

But ACT itself also bore responsibility. On July 12, just weeks prior to the bill's passage, The Washington Post had broken the news that ACT was trying to create cloned human embryos as a source of stem cells—making it the only group in the country to acknowledge such plans publicly. The uproar that followed was still fresh in congressional minds at the time of the vote. Congressman Bart Stupak, of Michigan, one of the bill's co-sponsors, alluded on the day of the vote not only to the renegades but also to ACT. "The need for action is clear," he told his colleagues. "Research firms have announced their intentions to clone embryos for research purposes and then discard what is not needed."

A week before the publication of ACT's paper in The Journal of Regenerative Medicine, I called Thomas Okarma, the current chief executive officer of Geron, to get his views on ACT and its reputation. Despite his commitment to stem-cell and therapeutic-cloning research, Okarma was harshly critical of ACT. "They've done more harm to the field than good, I'm afraid," he told me. The most glaring example, he said, was ACT's announcement, just after Mike West joined the company, in the fall of 1998, that it was attempting to fuse human skin cells with cow eggs whose nuclear DNA had been removed. The motivation was sound: ACT was essentially hoping to do therapeutic cloning without the difficulty and expense of using human eggs—reviving experiments Jose Cibelli had started as a graduate student, in 1996, with his own cells. But, in the interest of "transparency" West released details to The New York Times and 48 Hours, and two days after the news broke, President Bill Clinton, "deeply troubled" by the work, asked the head of his National Bioethics Advisory Commission to investigate. By an unfortunate coincidence, one week before the 48 Hours broadcast, scientists had announced that they had derived human embryonic stem cells for the first time—news that made ACT's announcement seem like me-too publicity.

The cow-human embryos turned out to be "just plain duds," according to West, and ACT has never generated enough data for a significant scientific paper. (Members of the scientific community had predicted this outcome, although researchers in China have recently claimed success using rabbit eggs.) But the damage was done, because the public entirely misinterpreted the experiments. "Religious fundamentalists who, you know, are against reproductive and therapeutic cloning anyway, are using this example," Okarma told me. "'My God,' they say, 'these people are going to make chimeric creatures—mixing cows and humans.' It creates a fantasied negative scenario that casts an umbra on all of us working in the field, and makes it harder for the field to advance. And it's well documented in the scientific literature that fusing cells from two such distantly related species will not work." Okarma was not alone in dismissing ACT: the company's "publication by press release" was widely attacked by other scientists as irresponsible and insubstantial.

He added, "It's not in the same category as the Raëlians"—a religious group, inspired by "revelations" from extraterrestrials, that is working on reproductive cloning—"because there are certainly legitimate scientists at ACT trying to do this work, okay? But from the perspective of the regulatory bodies, they are in the same spaceship."

Backlash

When Bob Lanza joined ACT, in March of 1999,not long after the cow-human cloning fiasco, it was a company bruised and embarrassed by recent events, and in need of building its scientific reputation. Lanza was a strong addition to the team.

He had gotten started young. When Lanza was just eighteen, he published his first research paper—in Nature, a journal many scientists strive a lifetime to publish in. The paper involved the results of biology experiments he had started in his parents' basement, in the Boston area, at the age of twelve. As a thirteen-year-old Lanza had gone to Harvard seeking advice and had stumbled on Stephen Kuffler, the chairman of the department of neurobiology. Kuffler (whom the boy initially mistook for a janitor) helped Lanza to finish his experiments and work toward publication. From then on Lanza bootstrapped his way along, invoking the name of one scientist to gain access to the next. He ended up accumulating an astonishing list of apprenticeships. He worked with Jonas Salk, the engineer of the polio vaccine; with the renowned behavioral psychologist B. F. Skinner; and with the Nobel laureates Gerald Edelman and Rodney Porter, who uncovered the structure of antibodies. Lanza did surgeries in South Africa with the pioneer of heart transplantation, Christiaan Barnard, and while he was still in medical school he co-wrote the first textbook on heart transplantation, with Barnard and David Cooper.

One of the first things Lanza did after he joined ACT was to recruit sixty-seven Nobel laureates to sign a letter urging the Clinton Administration to support federal funding for human embryonic-stem-cell research. He tracked them down one by one, calling them and enlisting them in the cause. He sent a similar letter, carrying eighty signatures, to President Bush in February of last year. Lanza's efforts were part of a snowball effect. A month later the presidents of more than a hundred universities and colleges sent their own petition to the Secretary of Health and Human Services. By last summer even some pro-life conservatives, such as Senator Orrin Hatch, of Utah, had come out in favor of the research, as had former First Lady Nancy Reagan.

Lanza and his colleagues hoped to generate a similar effect with their cloning announcement. The press release that they prepared also referred readers to feature stories about their cloning "milestone" that would be appearing on the covers of Scientific American and U.S. News & World Report. The stories were written by journalists who had a long association with ACT, and the Scientific American article was in fact co-authored by the ACT scientists and written in their own voices. These articles ended up being scheduled to go online at exactly 9:00 A.M. EST on November 25—the precise moment that the Journal of Regenerative Medicine article itself was to appear online. Mike West was also scheduled for a 10:00 A.M. appearance on NBC's Meet the Press that day.

"You can see how things are lined up," Lanza told me about the articles. "We're getting our ammunition all in the barrel. At least people will understand that there is a legitimate medical use for this technology. And even though we may get beat up, I hope there's minimal damage."

When ACT's paper became public, on the Sunday of Thanksgiving weekend, the backlash was swift. The White House made it clear immediately that President Bush was "100 percent opposed to any type of cloning of human embryos." The following day, in a Rose Garden appearance, the President called ACT's work "morally wrong," and added, "We should not, as a society, grow life to destroy it. And that's exactly what's taking place." The Vatican issued a statement expressing "unequivocal condemnation" of therapeutic cloning, which it portrayed as tantamount to murder. Conservative members of both houses of Congress, backed by anti-abortion and religious groups, joined the President in calling for immediate Senate action, warning that the "mad scientists" doing this "ghoulish work" must be stopped. When I spoke with Bob Lanza on the Friday after the announcement, protesters from pro-life groups were outside ACT's office building, which was being guarded by police cruisers. Its front doors—usually left open—were locked.

Earlier in the month Sam Brownback, of Kansas, the Senate's most vocal advocate of a total ban on cloning research, had struck a deal with the Senate's Democratic leadership, agreeing to delay action on human cloning legislation until February or March of this year. All had been quiet on the legislative front, with a thoughtful debate planned on the merits of the technology. But after ACT's announcement, that agreement went out the window. Brownback immediately resumed attempts to force a vote on a ban—or, failing that, to impose a six-month moratorium on all human cloning research. "I have been warning this body for months that this day was going to be here. Now it's here," he said in the Senate. "We now have the first human clone."

"I was frankly horrified," Tom Okarma told me the week after the announcement. "This is precisely what the opposition has been waiting for. They can now mount a renewed offensive to proscribe or outlaw this technology, and there won't be any credible scientists who push back, because no value has been demonstrated by the experiment ACT published. It hasn't moved the field one millimeter. It's essentially negative results. And no legitimate scientist will stand behind that."

None did. Instead they pointed out that ACT's experiment didn't actually make clear whether creating a healthy cloned human embryo was even possible, since the researchers hadn't succeeded in nurturing an embryo beyond the six-cell stage. Human eggs are packed with factors that control the first few rounds of cell division, which meant that the cloned embryos created by ACT may simply have been cruising on autopilot, without the donor cells' DNA ever having taken over the controls. "It's a complete failure," George Seidel, a cloning expert at Colorado State University, in Fort Collins, told The New York Times about the experiment. Ian Wilmut, one of the researchers who cloned Dolly, told London's Independent newspaper, "In terms of what this says for human cloning, it is pretty irrelevant." John Gearhart, of the Johns Hopkins University School of Medicine, said in an interview aired on ABC that the research was so preliminary that "it should not have been published."

But it wasn't the preliminary nature of the research that had raised scientists' ire so much as the fanfare with which it had been published. In the 1960s and 70s, when Robert Edwards and Patrick Steptoe were attempting to create the first baby through in vitro fertilization, they similarly published the results of a number of steps along the way. Before they had even created a blastocyst, much less a pregnancy, they published reports in Nature of the first time human sperm cells penetrated human eggs in the lab dish, and of the first time such embryos faltered along to just sixteen cells. ACT's paper had done essentially the same thing.

The scientific consensus, though, was that ACT's public-relations campaign had raced far ahead of its data. "Important Milestone in Therapeutic Cloning," ACT had headlined its press release, which claimed in the opening paragraph that the experiment provided "the first proof that reprogrammed human cells can supply tissue for transplantation." Given that there were no human embryonic stem cells and no transplantable tissue in evidence, it had done no such thing. Although ACT did go on to qualify its results as "preliminary"—the first halting steps in an ongoing effort—it was clear that the company was trying to engineer front-page news out of what could be construed as a scientific non-event.

The announcement did indeed make headlines, but even the mainstream media quickly turned sour. "As pure business hype, the announcement of human cloning by a small biotech startup was a masterpiece," the San Francisco Chronicle editorialized. "In reality, the achievements ... are skimpy." The Washington Post concurred, calling the work "less than meets the eye." An article in the Los Angeles Times dismissed the "big breakthrough" as "a yawn." The New York Times was no less critical. "Unfortunately," an editorial in the paper read, "by rushing into print with such preliminary results, and orchestrating a media blitz to accompany the announcement, Advanced Cell Technology has invited legislative retaliation that could cripple the very research it is attempting to pioneer." In terms of ACT's credibility, it seemed to be the cow-human-embryo fiasco all over again.

One of the more bruising assessments came from Harold Varmus, a Nobel laureate and a former director of the National Institutes of Health. "So why did the company make its announcement?" Varmus wrote in The New York Times. "Although its executives claimed to be excited about the findings and said the information would promote educational debate, the actual reasons may be more self-serving. Biotechnology companies are dependent on investors, and investors like publicity."

In January, I asked Cibelli if he had any regrets about the announcement. "No," he said. "It brought the issue back to the table, and that's what we wanted. We predicted that we would be criticized by our peers. We took a calculated risk. Would I rather have had blastocysts? Sure. Was it thrilling to see at least six cells? Yeah." He paused, and then continued. "Now that the storm has died down, we've got to finish what we started. Mike has gotta get the money, and the rest of us have to finish the work."

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