Michael D. West, the head of Advanced Cell Technology, has placed himself where few of his colleagues want to be: smack in the eye of the raging political and ethical storm over human cloning. The 49-year-old scientist and entrepreneur is the biotech industry's self-appointed pitchman for cloning human embryos to help treat disease -- not to create people. He has testified on Capitol Hill and spoken often and at length with the media. He has also, perhaps recklessly, rushed to publish some of his lab's findings in the popular press rather than wait for scientific journals to review them.
Anything, it seems, to get the word out about what may be possibly achieved with cloned cells: treatments for debilitating diseases such as Parkinson's, diabetes, or Alzheimer's. "We're trying to save the lives of our fellow human beings who have no hope today," he says. "I really believe that I can convince [opponents] that this is the right thing to do."
But West's outspokenness has put the company he joined three years ago in jeopardy. Its financing is dubious, its credibility is strained. Nor has West won many over to his cause. Last year, President George W. Bush called for a ban on all human cloning and the House of Representatives passed such a bill. In the Senate, though, support is growing for a measure that would allow therapeutic cloning. That would put ACT in a much better position; it would have a crucial head start in what could be a multibillion dollar industry. But if the Senate leaves the issue unresolved, which is likely, ACT will continue to struggle.
Meanwhile, opponents of cloning are going after what meager resources ACT does have. In May, conservative members of Congress accused the company of fraud and demanded that the President rescind $1.9 million in federal grants to study animal cloning. The charges stem from an April finding by the Health & Human Services Dept. that ACT misused $150,000, mostly by buying equipment not included in its grant application. ACT says it had verbal approval for the purchases. West has agreed to pay back the $150,000, but expects to be able to draw down the rest of the funds. "The point is to portray ACT as unethical," says West. "It infuriates me."
WARY VENTURE CAPITALISTS. And it couldn't come at a worse time. The privately held company's coffers are nearly empty and its cloning experiments on hold as West scrounges to raise cash. "Notoriety does not usually attract institutional venture capital," says Michael Lytton, a general partner of Oxford Bioscience Partners, a Boston venture firm. Indeed, one major investor pulled out of a deal after Bush's pronouncement. Another, Anthem Venture Partners in Santa Monica, Calif., is mulling an investment, but has not come to terms with ACT. The only other U.S. company known to have experimented with human cloning is Geron Corp., which West founded in 1990, helped take public seven years later, and left in 1998.
ACT, which West controls through a majority stake in its holding company, is barely surviving. Based in Worcester, Mass., ACT brings in about $2 million a year from licensing patents and cloning prized cattle for farmers who hope the Food & Drug Administration will soon approve the sale of milk and meat from cloned animals. If that happens, West says ACT could receive "millions of dollars' worth of orders" from farmers.
While West, who holds a PhD in biology, has put his company at the vanguard of human- cloning research, his determination has alienated those who should be his natural allies. Mention West's name to fellow scientists and they either sigh, cringe, or ask, "What has he done now?" Their major complaint is with his company's science. If it were
stronger and he were more circumspect, West might be a better standard-bearer for cloning research, they argue. "I never saw any science that he did that was that interesting," says Carole Greider, professor of molecular biology and genetics at Johns Hopkins University and a former Geron adviser. "He was always just promoting ideas."
"CHIMERIC ORGANISM." The latest brouhaha over ACT's research occurred in November when the company published a paper in an online scientific journal claiming to have cloned the first human embryo. In fact, the experiment failed because the cells quickly died. Other scientists were outraged by what one called West's grandstanding: The paper, which might not have been approved for publication in a more established journal, received plenty of attention, most of it negative.
It wasn't the first time West has erred on the wrong side of caution. In 1999, he announced that the company had years earlier placed a human cell into a cow egg in an attempt to clone a human embryo. That experiment was also unsuccessful. Even so, "it raised the question of whether you were creating some kind of chimeric organism," says Steven Holtzman, CEO of Infinity Pharmaceuticals Inc. in Boston, who was then a member of President Bill Clinton's national bioethics advisory commission. West says he went public because "it would look awful if we were doing these things in secret."
While West admits stoking hype around his company, he insists it's for the right reasons. Since cloned embryonic stem cells might be able to develop into any kind of adult cell that an ailing person may need, "there's not an area of medicine that this won't potentially impact," he says. Many who know West describe him as overly optimistic. "I think some of the things he has done have been mistakes," says Vincent J. Cristofalo, a Thomas Jefferson University medical school professor and a member of Geron's scientific advisory board. "But I don't think he's trying to pull the wool over everyone's eyes."
EYES ON WASHINGTON. West has always been as much a businessman as a researcher. After two years in medical school, he dropped out to start Geron, a biotech firm that would study the aging of cells. Seven years later, in 1997, Geron went public and West became a millionaire. Then things got messy, and in 1998 he abruptly resigned and sold his stock for some $2 million. He used about half of that to buy ACT from Charoen Pokphand Group, a Thai conglomerate, in 1999. West admits that his departure from Geron was not amicable. And the company has since filed a claim with the U.S. Patent Office charging ACT with infringing the patents that West helped Geron win. Executives at Geron declined to comment.
It's the political battle that matters most. ACT's prospects will remain dim until lawmakers give their O.K. for therapeutic cloning and President Bush seconds it. In the meantime, West can only hope that the FDA will clear the way for him to turn his cattle-cloning business into a cash cow. By Faith Keenan in Worcester, Mass.