In the spring of 1997, scientists at Scotland's Roslin Institute successfully reproduced a sheep using DNA from a single adult sheep cell. It was a spectacular breakthrough. But the birth of Dolly, the first cloned mammal in history, provoked outrage among anti-abortion activists and many bioethicists, and triggered a debate on the dangers of human cloning.
In the United States, public interest groups and religious organizations clamored for the federal government to regulate any research that would lead to human cloning. A CNN/Time magazine poll taken after the announcement of Dolly indicated that 89 percent of Americans agreed that it was "morally unacceptable to clone humans." President Clinton responded promptly by issuing an executive order on March 4, 1997, prohibiting the use of federal funds for human cloning, citing what he termed "profound ethical issues."
But the presidential action did not affect privately funded research. Meanwhile, the Scottish company owned by the Roslin Institute was bought in May 1999 by an American biotechnology firm, Geron Corp., bringing the possibility of human cloning closer to home for Americans. Subsequently, Japan, India and most European countries banned cloning or imposed laws supervising such research, while the United Nations, the World Health Organization and the G-7, seven top industrialized nations, called for an outright ban.
Yet nearly three years after Dolly, there still is no federal legislation in place in the United States to regulate or even supervise human cloning, though some states have acted.
What is perhaps the most complex scientific and moral issue ever faced by Congress has become the object of traditional inside-the-Beltway maneuverings. Campaign contributions, revolving-door politics and old-fashioned lobbying by the biotechnology industry have helped keep any sort of cloning legislation from being enacted.
The new administration, meanwhile, has yet to state its position on the issue, though the Republican platform ratified last August praised GOP legislators who introduced bills against human cloning. A week after he was sworn in, President Bush said he was opposed to spending federal money on research on stem cells derived from aborted fetuses. Bush had said during the campaign that he was against any research that would destroy human embryos.
Human cloning is the process of creating a human from an embryo after transplanting the nucleus of a person's cell into a woman's egg after replacing the egg's original nucleus. To successfully clone a human being using currently available technology, several embryos are required, and all but one would be destroyed.
The position of Al Gore, Bush's Democratic rival in last November's presidential election, was unclear, although during the campaign the former vice president called for allocating more money for stem cell research.
Opposing factions lined up
Not surprisingly, the fight before Congress on cloning has pitted the biotechnology industry against anti-abortion organizations, several religious groups and some researchers and academics concerned with the moral implications.
"(Biotech) companies want to make sure that no legislation is passed that will hinder the sale of their products," said Sophia Kolehmainen, who directs the human genetics program at the Council for Responsible Genetics. The Council is a nonprofit group based in Cambridge, Mass., that advocates "socially responsible" use of new genetic technologies.
Kolehmainen and other bioethicists say the lack of a legal mechanism to govern cloning prevents mainstream researchers from responsibly tapping into new technologies such as genetic engineering. The failure on the public-policy front to address cloning in any significant way has turned the field into a Wild West that cultists, romantic researchers and profit-minded businesspersons have threatened to exploit.
For instance, the UFO-worshipping Raelian religion, founded by a former French sportswriter now known as Rael, has vowed to provide assistance to parents willing to have their child cloned. Fifty women have volunteered to carry cloned embryos in their wombs, and a wealthy American couple, whose 10-year-old daughter died in an accident and wants to clone the preserved cells of the girl, has promised financial support to the group. Chicago physicist and entrepreneur Richard Seed announced in January 1998 that he planned to open fertility clinics to clone humans. (So far there is no proof of the existence of any such clinic in the United States.) And in the scientific community, Princeton biologist Lee Silver and other influential academics have advocated the creation of a pool of gene-rich humans through cloning.
For its part, the biotech industry says it is opposed to human cloning, but does not favor any legislation, fearing that regulation would impose undue restrictions on research.
The Biotechnology Industry Organization, which represents nearly 850 biotech companies in the United States and 21 other countries, maintains that it is not necessary for Congress to enact legislation because a ban on federal funding is already in place. Human cloning can be prevented if the Food and Drug Administration enforces the existing laws, BIO contends.
The FDA said soon after the birth of Dolly that it had the authority to prevent human cloning. Then-Health and Human Services Secretary Donna Shalala told BIO President Carl Feldbaum in an April 9, 1998, letter that the FDA had jurisdiction over attempts to clone humans and that the agency was prepared to exercise that jurisdiction, according to BioWorld Today, an industry magazine. "FDA's authority does not address the larger question of whether or not creating a human being using cloning technology should be prohibited altogether, but this authority will help ensure that such experimentation does not proceed until basic questions about safety are answered," Shalala was quoted as writing.
But some disputed the agency's claim. "FDA viewed the cloning issue from a limited medical, therapeutic perspective, which it is not," said Mike MacDonald, a project coordinator for the International Center for Technology Assessment. "Cloning is a reproductive issue." The mission of his nonprofit organization is to provide the public with unbiased assessments and analyses of the impact of technological breakthroughs on society.
But the Biotechnology Industry Organization says legislation and the resultant restrictions would affect research in many areas unrelated to human cloning. "We oppose any legislation that would hinder the research," Charlie Craig, director of publications at the organization, told The Public i. "Cloning is the biotech industry's practice every day. Cloning technology is used all the time. In evaluating the legislation, we make sure that it doesn't disrupt research."
Anti-human-cloning activists call the industry's stand dubious.
"BIO's official position is they are against reproductive cloning. But by not pushing for a ban, they leave the door open," said Richard Hayes, coordinator of the San Francisco-based Exploratory Initiative on New Genetic Technologies, whose mission is to publicize the dangers posed by the "indiscriminate" use of genetic technology. Hayes added that the industry's position is a strategic one. "They say they are against human cloning, but they don't say that they won't do it."
Philip Bereano, a professor of technology and public policy at the University of Washington, agreed. "The industry, of course, wants the least legislation. They didn't want the federal order [which banned federal government funding]. But now that it is in place, they can't say anything against it." Bereano, who negotiated a 130-nation environmental treaty covering genetically modified organisms, asserted that "by saying that they oppose human cloning, they are just catering to the dominant morals of the society."
Anti-cloning bills introduced
Several bills surfaced in Congress shortly after the debate over cloning erupted. Seed's announcement that he planned to open fertility clinics to clone people caused a public outcry and pressed members of Congress into action.
However, the murkiness and divisiveness of Capitol Hill politics were in full display when two competing Senate bills banning human cloning were introduced in February 1998. The Democratic bill, sponsored by Sens. Dianne Feinstein of California and Edward Kennedy of Massachusetts, was introduced on Feb. 2; a Republican one appeared the next day from Sens. Christopher S. Bond of Missouri, Bill Frist of Tennessee and Trent Lott of Mississippi, the majority leader.
The Bond-Frist bill proposed an amendment to the federal criminal code that would have prohibited the use of a procedure called somatic cell nuclear transfer for the purpose of human cloning. The technique was employed for creating Dolly. Such a procedure involves transferring the nucleus of a cell from a somatic cell to an egg from which the nucleus has been removed. Somatic cells become the tissues, organs and other parts of the organism that are not germ cells.
The Feinstein-Kennedy bill, on the other hand, called for an amendment to the Public Health Service Act to prohibit human cloning — meaning cloning that leads to the birth of a child.
The biotech industry decried the Republican proposal, alleging that it would criminalize some types of unrelated stem cell research, and employed the BIO's formidable lobbying power to defeat the move. Joining the BIO in the crusade was its lobbying counterpart from the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America, along with corporations such as Genentech Inc., a biotech company that produces pharmaceuticals for treating genetic disorders.
Though it didn't explicitly back the Democratic bill, the BIO said it preferred it to the Republican version, and praised the "commendable efforts" by Feinstein and Kennedy in proposing an alternative, less stringent measure. "Their bill is very precisely worded with the powerful intent to avoid any collateral damage to legitimate research," BIO's Feldbaum said.
The biotech industry's main argument against the Bond-Frist bill was that it would criminalize stem cell and other embryonic-based research that could lead to breakthrough treatments for Alzheimer's disease, heart disease and cancer. It also argued that Congress was acting in haste to pass legislation on a "morally and scientifically complex" issue.
The Republican bill was also opposed by patients' rights groups, academics and abortion rights organizations that feared the legislation would be exploited by anti-abortion groups as a means to restrict abortion.
On the other hand, the Democratic version, which would have banned implanting cloned human embryos into a woman's uterus but allowed cloning of human embryos for research purposes, was met with stiff opposition from groups such as the National Right to Life Committee.
"Under the Kennedy-Feinstein proposal, it would be perfectly legal to create cloned human embryos and use them as subjects for harmful experimentation, so long as they are killed before being implanted in a woman's womb," the Committee's legislative director, Douglas Johnson, wrote in a letter urging senators to reject the bill.
In his enthusiasm to get the bill passed and under pressure from anti-abortion groups, Lott pushed Bond-Frist to a speedy vote, an effort countered by a filibuster from Feinstein.
Republican bill loses
The GOP bill was defeated on Feb. 11, 1998, getting just 42 of the 60 votes needed to break the filibuster. Among those voting against the bill were 12 Republicans, including Sens. Arlen Specter, R-Pa., Strom Thurmond, R-S.C., and Connie Mack, R-Fla.
Backers of the Republican bill cited a number of reasons for its failure, ranging from extraordinary lobbying efforts by its opponents to the poor quality of its drafting.
Former Bond legislative assistant Joe Pierle, who helped draft the legislation, said the biotech and pharmaceutical industries and the advocacy groups opposed to it lobbied intensely. "Basically, the other side was trying to scare the general public, saying that it would hamper the research," he told The Public i.
Others said it was rushed to the floor. "Ours wasn't a huge grass roots effort," said Richard Doerflinger, associate director for policy development at the Secretariat for Pro-Life Activities of the National Conference of Catholic Bishops. "The vote was ill-advised."
"The language (of the bill) was poorly drafted," said MacDonald of the International Center for Technology Assessment, who is now working on draft cloning legislation. "They had poor understanding of the problem," he said. But the Democratic bill, for all its ostensible support from the biotech industry, never came close to passing. In fact, it was never put to a vote and died in the Senate Labor and Human Resources Committee.
Anti-cloning activists involved in the legislative fight say the industry never wanted either bill to pass and supported the Democratic version only so far as it ensured that neither bill saw the light.
"The Kennedy-Feinstein bill was designed to help defeat the Republican bill," said Doerflinger. "The Labor-Human Resources committee never really reported anything [to the full Senate]."
But Feinstein's office blames "Capitol politics" for the measure's death. "We believe we had the requisite votes to pass the bill," said Scott Gerber, spokesman for Feinstein. "The committee leadership is responsible for the death of the bill. They did not bring it up for voting."
Pierle says it was apparent that the industry didn't want any sort of legislation to pass. "We asked for their advice on more than one occasion. But they were not willing to offer any constructive proposal. They gave the impression that they were going to oppose anything."
Parallel bills in House
There were bills in the House of Representatives, too. Soon after the Senate vote, Majority Leader Dick Armey, R-Texas, vowed to call a vote on a cloning bill before Memorial Day 1998, but it never happened.
Around the same period, a number of state legislatures were also debating human cloning legislation. By the third week of April 1998, 50 bills were pending in 25 state legislatures, according to BioWorld Today.
But the biotech and pharmaceutical industries were even more skeptical about these bills. The magazine reported that BIO, the Pharmaceutical Research and Manufacturers of America and the American Association of Medical Colleges had been monitoring state legislatures and lobbying there to prevent restrictive laws from going into place, and encouraging the states to send resolutions to Congress instead.
"Should the plethora of bills become state laws, biotechnology and pharmaceutical companies conducting research could be subject to a patchwork of bans and penalties across the country," the magazine wrote.
"We concede to the point that the American people may want legislation of some sort; but we think that if there is a law — and that is a big if — it should be a federal law extended uniformly to all 50 states centered around the authority of the FDA," BioWorld Today quoted spokesman Jeff Trewhitt of the Pharmaceutical Research and Manufacturers of America as saying.
In the end, Trewhitt's and other groups opposed to legislation scored a small victory. Only 10 states, among them Michigan and California, went on to enact bills on human cloning.
Lobbying defeated attempts at legislation
In Washington, the industry's lobbying was a major factor in defeating the Bond-Frist bill and in thwarting other attempts at legislation. Feldbaum told BioWorld Today that biomedical research employees worked overtime to convince lawmakers that the Senate leadership was being too hasty in its desire to ban cloning.
A review of lobbying records shows that between July 1997 and December 1998, BIO spent more than $1.6 million on lobbying. During that period, one of the main issues on the organization's lobbying agenda was human cloning. Besides using its own lobbyists, BIO spent an additional $40,000 with the lobbying firm of Bergner-Bockorny Inc. to help defeat congressional legislation.
Also lobbying against the cloning bill was Genentech, which is known for its powerful ties in Washington. The company's lobbying expenditures during the same period were more than $1 million. Genentech's CEO, Arthur Levinson, was a technology adviser to Gore's presidential campaign. In addition, Gore hired away Genentech's top Washington lobbyist, David W. Beier, in 1998 to become his top domestic policy adviser.
Doerflinger said his organization and other supporters of Bond-Frist were heavily outspent. "We didn't spend much money. In fact, we'll never be able to spend as much money as the industry."
The fact that the human cloning issue is inextricably linked to the highly divisive politics of abortion didn't help the various legislative efforts either. Both abortion rights and anti-abortion groups monitor Congress meticulously to keep tabs on how lawmakers vote on abortion issues.
Representatives of both sides of the abortion debate testified at the human cloning hearings. While the National Right to Life Committee and other anti-abortion groups supported the Bond-Frist bill, the influential abortion-rights National Abortion and Reproductive Rights League lobbied against it.
Other powerful forces opposed to anti-cloning legislation are academic groups that say such legislation would stymie their research programs. "There is a very strong pro-research lobby in the United States," said the University of Washington's Bereano. Influential academics from elite universities are the leaders of this constituency, the professor said. Many large universities hire lobbyists in the capital to ensure that federal research money continues to flow to their campuses.
BIO names four 'outstanding legislators'
In April 1999, BIO honored Feinstein and three other members of Congress — Sen. Mack and Reps. Calvin Dooley, D-Calif., and Jim Greenwood, R-Pa. — with its "Outstanding Legislator of the Year" award, honoring their "support of legislative issues critical to the continued growth and worldwide prominence of the biotech industry."
Presentations to "the champions" (as Chuck Ludlam, the group's vice president for government relations, put it) — all significant players in the anti-cloning legislation — were made during BIO's Legislative Day on Capitol Hill in April.
"These legislators exhibited leadership and courage on a broad range of issues: the defeat of hastily drafted anti-cloning legislation that would have impeded basic biomedical research; passage of the FDA Modernization Act to streamline development of new therapies and cures; and support for agricultural biotech products to improve foods and farming," Ludlam said.
Financial ties to industry
Like much of the legislative activity in Washington, the debate over human cloning and the two anti-cloning bills involved a mix of revolving-door politics and lawmakers with financial ties to the industry.
The biotechnology industry could draw on first-class access to many of the key Republican players in the cloning debate. Specter's chief of staff until 1993 was none other than BIO president Feldbaum. Frist's chief of staff Lee Rawls recently announced his resignation and went to join BIO as its vice president for government relations.
Frist, who co-sponsored the Republican bill, is a doctor who receives many of his campaign contributions from the medical and pharmaceutical industry. According to the non-partisan Center for Responsive Politics, over the past five years Frist's top supporting industry has been "health professionals," who have given him more than $800,000 in campaign contributions. "Hospitals/nursing homes" rank fourth, with "pharmaceuticals/health products" sixth. Combined, these two sectors have donated more than $500,000 to Frist. The Tennessee is also the Senate's top recipient of cash from the medical supplies manufacturing and sales industry.
Specter, one of the key Republicans to vote against the stringent GOP bill, has close ties to the biotechnology industry as chair of the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education. The top contributor to Specter's campaigns over the past five years has been Amgen Inc., one of the nation's leading biotechnology firms, which has given him more than $50,000. "Pharmaceuticals/health products" ranks fifth on the list of industries supporting Specter, according to the Center for Responsive Politics.
Focus shifts to stem cell research
The defeat of the Bond-Frist bill was seen as a big blow to anti-cloning groups and a huge victory for the industry. "That particular vote was devastating," said Doerflinger of the National Conference of Catholic Bishops.
The biotech industry, on the other hand, knew it had successfully resisted an attempt at regulation at a time when public opinion was overwhelmingly in favor of legislation. "This is a tremendous victory for biomedical research," Feldbaum said in a press release just after the Senate vote.
After the dust settled, the debate over human cloning became less intense. In the next two years, scientists succeeded in cloning more mammals. Oregon researchers cloned two Rhesus monkeys, and at the University of Hawaii, scientists cloned three generations of mice from nuclei of adult ovarian cumulus cells. Meanwhile, in Japan, eight identical calves were cloned using cells taken from a single adult cow. Though they were reported nationally, none of the incidents resulted in the kind of commotion Dolly triggered.
On the research front, the focus has shifted from human cloning to stem cell research. Stem cells, which form within the first eight days of an embryo's existence, can develop into almost any human tissue or organ. Theoretically, if the technique is perfected, scientists could someday generate replacement brain and heart cells for use in amazing breakthrough therapies for heart disease, Alzheimer's and a host of other devastating illnesses.
Anti-cloning activists see the industry's low-key position on cloning as part of an overall strategy. The industry's goal is "to get the embryonic stem cell research established first and then call for cloning. It is a two-step process," said Doerflinger.
"If stem cell research gets more accepted, it will take the steam out of the religious right's opposition to embryonic manipulation [which leads to cloning]," said Bereano of the University of Washington.
Hayes added that recent advances in stem cell research make it all the more necessary to have legislation to supervise genetic research. "Stem cell research is more defensible. It has beneficial aspects. But it would be better if some [anti-human cloning] laws are in place before the stem cell research goes forward."
Opponents are concerned that developments in animal cloning are refining the techniques needed for human cloning. They are also aware that breakthroughs in stem cell research might push scientists closer to human cloning.
Research by Geron and Massachusetts-based Advanced Cell Technologies, which involves cloning for the purposes of stem cell harvesting, is pushing the public toward the "threshold of human cloning," Hayes said. "ACT's ultimate goal is human cloning."
"Research on stem cells may produce knowledge, and the new technology may have applications in the area of cloning," said MacDonald of the International Center for Technology Assessment.
Repeated phone calls to Geron and Advanced Cell Technologies were not returned.
With human cloning completely off Beltway political radar screens, MacDonald fears that public opinion might change should some scientists such as Seed or groups like the Raelians succeed in cloning a human being, and that would make enactment of oversight legislation even more difficult.
A University of Kentucky professor, Panayiotis M. Zavos, said in late January 2001 that he and an Italian fertility specialist would produce babies through cloning for couples who cannot have children by other means. Also, if the U.K. or another foreign country makes progress in embryonic research, the American biotech industry and government would be under enormous pressure to "compete," in a regulatory sense. Britain's House of Lords voted Jan. 22, 2001, to allow scientists to investigate the potential medical benefits of embryonic stem cell research.
The move, which would allow scientists to clone embryos and keep them alive for up to two weeks in order to extract stem cells, was welcomed by the country's research community and the biotech industry, but was decried by opponents as a step toward allowing human cloning.
The British measure might embolden the American biotech industry and academic community to demand a relaxation of rules in the U.S.
Meanwhile, a 36-member committee of the European Parliament opened hearings in the last week of January 2001 on human cloning. The committee expects to come up with proposals that are to be placed before the EU assembly later in 2001.
For all the legislative movement abroad, there seems little chance of cloning bills being passed on Capitol Hill. Republican lawmakers are walking a tightrope, trying to appease both their anti-abortion and pro-business constituents. "Republicans are also favoring the biotech industry," MacDonald said. For them, "there is no politically pressing need to ban human cloning now." They don't want to be seen as suppressing free enterprise, he said.