The value of federal funds
Most basic biomedical science in this country—the early, exploratory research—is funded by federal dollars, with the National Institutes of Health taking the lead (to the tune of $20 billion in research-related funding a year). Scientists say that no field of research can flourish without access to this kind of government support. Yet the Harvard scientists you'll meet in our NOVA scienceNOW segment are barred from using federal funds for the research we describe. If they already head government-funded labs, none of the equipment they've purchased can be used to create brand new human embryonic stem cells, to work with any such cells created after 2001, or to create cloned human embryos for stem cell research. That means not a microscope, not a petri dish, not one glass beaker. Scientist Doug Melton, who receives private funds from the Howard Hughes Medical Institute, has gone so far as to equip an entirely separate lab, at an undisclosed location, for this work.
The short version is this. It is currently illegal, because of Congress, to use federal funds for any experiment that creates or destroys a human embryo. Creating new embryos through cloning falls squarely under that ban. So does destroying an embryo to create stem cells. It's legal to do both of these things (clone and create human embryonic stem cells) but only with private funds. Meanwhile, Congress remains in a pitched battle over how much of cloning to outlaw. Some federal lawmakers want to ban all forms of cloning, while others want to ban making babies while allowing promising biomedical research that is done exclusively in the lab dish. The House has twice passed legislation that would outlaw all forms of cloning—in 2001 and again in 2003. That legislation stalled in the Senate.
Since human embryonic stem cells are not themselves embryos, however, different rules apply. The accepted view is that research with the cells doesn't fall under Congress' federal funding ban. In 2001, however, President Bush extended the ban to cover all human embryonic stem cells—making an exception only for certain cells (currently estimated at 22 stem cell lines) that had already been created by the time of his announcement. A "line," if you're wondering, is any group of cells that all come from the same original embryo.
Where states stand
Confusing matters even more, individual states have passed a patchwork of legislation—with more bills still being debated at the state level. Some states have banned all forms of cloning or human embryonic stem cell research outright. In 2002, by contrast, California became the first state to officially endorse human embryonic stem cell research, including experiments that involve cloned embryos (while banning creating a cloned baby). In 2004, New Jersey followed suit—and established the nation's first state-supported stem cell research facility. Later in 2004, California voters approved Proposition 71, a bond measure that will provide $3 billion over 10 years to stem cell research, including work with cloned human embryos and the stem cells they produce. Stars like Brad Pitt, Michael J. Fox, and the late Christopher Reeve helped convince voters to embrace the measure.
Recently, the most high-profile fight has been in Massachusetts, home to Harvard and the several Harvard faculty members currently pursuing cloning for stem cell research. In March of 2005, under a veto threat by Republican Governor Mitt Romney, state lawmakers voted in favor of allowing such work to continue in their state. Romney, however, supports deriving stem cells only from embryos left over at fertility clinics, and strongly opposes creating cloned embryos for research. He called the proposed legislation a "radical cloning bill" in an ad campaign designed to defeat it. Although the state's endorsement of human embryonic stem cell research and research cloning passed by a veto-proof margin, Romney has said that he will veto it all the same.
The Clinton legacy
President Bush's stem cell decision, like the many state measures, is part of a long history of lawmakers grappling with the ethics of human embryo research. In fact, since the advent of in vitro fertilization, which produced the first "test-tube" baby in 1978, the federal government has avoided funding any work with human embryos. Many scientists say that this has hobbled research into infertility, birth defects, cancer, and methods for diagnosing genetic disease in embryos.
In one sense, Bush's administration is a turning point. He has presided over the first flow of federal funds to a promising area of research that relies on destroying human embryos. And yet Bush's repeated claims to be "the first president ever to allow funding" for human embryonic stem cell research (made, for instance, during the second nationally televised presidential debate in fall 2004) are not accurate. Here, he lays claim to a stem cell legacy that isn't his. Truth is, Bush's immediate predecessor, Bill Clinton, was a far greater supporter of human embryonic stem cell research.
Recall the political context. In 1993, with something called the National Institutes of Health Revitalization Act, Congress and President Clinton gave the NIH direct authority to fund human embryo research for the first time—ushering in what seemed like a new era. In response, the NIH established a panel of scientists, ethicists, public policy experts, and patients' advocates to consider the moral and ethical issues involved and to determine which types of experiments should be eligible for federal funding. In 1994, this NIH Human Embryo Research Panel made its recommendations—among them, that the destruction of spare embryos from fertility clinics, with the goal of obtaining stem cells, should receive federal funding. Embryos at the required stage are round balls no bigger than a grain of sand.
The Dickey-Wicker Amendment
President Clinton rejected part of these recommendations and directed the NIH not to allocate funds to experiments that would create new embryos specifically for research. But for the Gingrich-era Congress that took up the matter in 1995, funding any work with human embryos was going too far, and the recommendations created an uproar. Within a year, Congress had banned the use of federal funds for any experiment in which a human embryo is either created or destroyed. Known as the Dickey-Wicker Amendment for its authors, Representative Jay Dickey, Republican of Arkansas, and Representative Roger Wicker, Republican of Mississippi, the ban passed as a rider attached to the appropriations bill for the Department of Health and Human Services. Congress has actively renewed that ban each year since, thus relegating all human embryo research to the private sector.
Such was the state of affairs when, in 1998, using—by necessity—private funds, James Thomson of the University of Wisconsin successfully created the first human embryonic stem cell lines. Clinton's NIH knew the historic nature of that achievement. "This research has the potential to revolutionize the practice of medicine," Harold Varmus, director of the NIH, testified at a Senate hearing that year. New treatments for conditions like Parkinson's, heart disease, diabetes, and spinal cord injury now appeared possible. But the research needed years of federal support in order to flourish—and the Dickey-Wicker Amendment stood squarely in the way.
Or did it? In January of 1999, Harriet Rabb, the top lawyer at the Department of Health and Human Services, released a legal opinion that would set the course for Clinton Administration policy. Federal funds, obviously, could not be used to derive stem cell lines (because derivation involves embryo destruction). However, she concluded that because human embryonic stem cells "are not a human embryo within the statutory definition," the Dickey-Wicker Amendment does not apply to them. The NIH was therefore free to give federal funding to experiments involving the cells themselves (what Republican Senator Sam Brownback, of Kansas, called a bit of "legal sophistry.")
The NIH, with input from the National Bioethics Advisory Commission and others, went on to develop guidelines outlining the types of human embryonic stem cell research that would be eligible for federal funding. These Clinton Administration guidelines, published in August of 2000, forbid the use of federal funds to destroy human embryos to derive stem cells (because of the Dickey-Wicker Amendment), but permitted research with stem cells that other, privately funded scientists had already derived from spare embryos slated for destruction at fertility clinics.
President Clinton strongly endorsed the new guidelines, noting that human embryonic stem cell research promised "potentially staggering benefits." And with the guidelines in place, the NIH began accepting grant proposals from scientists. Thus, it was the Clinton Administration that first opened the door to federal funding.
When President Bush took office in January of 2001, by contrast, he began to shut that door. First, his HHS Secretary Tommy Thompson ordered a review of Rabb's legal decision. Then, the Bush Administration told the NIH to cancel its plans to review grant applications—pending completion of the HHS review. If the Bush Administration had done nothing, the NIH would have proceeded to review the applications and to finance those that were successful. Instead, that process was halted, a decision that saddened, angered, and frustrated supporters of human embryonic stem cell research.
On August 9, 2001, Bush went further. He announced that federal funding would now be restricted to a limited number of stem cell lines already created by that date—a decision that denied support to many promising avenues of biomedical research in an effort not to "sanction or encourage further destruction of human embryos." Three months later, his administration ordered an official withdrawal of funding guidelines that Clinton had authorized. And with that withdrawal, Bush became the first president to reduce—below what his predecessor had authorized—the amount of human embryonic stem cell research eligible for federal funding. (Reports issued by Bush's own President's Council on Bioethics, which he established by executive order before appointing all of its members, confirm these events in detail.)
Loosening Bush's restrictions on stem cell research, then, would not be venturing into uncharted territory. It would simply be returning toward where we were before, under Clinton.
Where things stand now
The arguments currently being made for removing the Bush restrictions are, by now, familiar. The President's policy limits federal funding to research on some 22 cell lines that existed over three years ago. As scientists note, dozens of other stem cell lines have since been created with private funds, some of which are easier to access, easier to maintain in the lab, easier to turn into cell types of interest—and more likely to contribute to actual human cell therapies, since they have not been in contact with mouse cells (as have all of the Presidentially approved lines).
In June of 2004, 58 U.S. Senators sent a letter to President Bush urging him to expand the number of stem cell lines eligible for federally funded research. Among the signatories were 14 Republicans, including abortion opponents Trent Lott and Orrin Hatch. That April, 206 members of the U.S. House of Representatives had signed a similar letter. Also in June, 48 Nobel laureates, including Clinton's NIH director Harold Varmus, endorsed John Kerry's presidential candidacy, citing, among other things, the "unwarranted restrictions on stem cell research" imposed by President Bush. Those restrictions, the laureates believe, are impeding medical advances. In April of 2005, in Congressional testimony, Bush's NIH director Elias Zerhouni acknowledged that there is "mounting evidence" that a policy change would benefit science. Other top NIH officials agreed.
What does the public think? In a February 2005 poll by Results for America, a project of the Civil Society Institute, 70 percent of Americans favored loosening the Bush restrictions. This included more than half of conservatives (56 percent), 80 percent of moderates, and 84 percent of liberals.
Of course, not everyone agrees that more federal funding for stem cell research is a good thing—especially not those who, like President Bush, champion the very early human embryo. But change may be in the air. In March of 2005, the House Republican leadership agreed to a vote on a key bill: one that would relax Bush's restrictions on human embryonic stem cell research. The vote will be the first of its kind since Bush declared much of this research off-limits to federal funding in 2001, and will reopen a contentious debate over when a human life begins. A similar bill has been introduced in the Senate, but as of this writing Majority Leader Bill Frist has not yet indicated plans to bring it to a vote. A White House spokeswoman has said that Bush himself has not changed his position.