Pluripotent Politics: The Uphill Struggle for Federally Funded Stem Cell Research

Daniel Arias | daniel.arias@yale.edu November 4, 2012

Pluripotent Politics: The Uphill Struggle for Federally Funded Stem Cell Research

The field of stem cell research is rife with both opportunity and controversy. Scientists, politicians, and everyday civilians have significant stakes in these two areas. Although stem cell research holds promises of great advancement in therapeutic medicines, it presents challenging questions about the morality of embryonic research. These areas of contention are evidenced, however, not in the discussion of U.S. stem cell research itself but in discussions of funding: should the government support grants for stem cell research?

“We are in a strange situation in the United States [where] our only public issue has been about funding,” says Professor Stephen Latham, Director of the Yale Interdisciplinary Center for Bioethics. “In contrast with other places, stem cell research has always been legal in the U.S. The only question has been ‘Has tax money been used to pay for it?’”

A Field is Born

Human embryonic stem cell research can largely trace its roots to 1998. In November of that year, a professor at the University of Wisconsin by the name of James Thomson published an article in the journal Science that announced the creation of the first line of human embryonic stem cells (hESCs). Back in 1995, Thomson had already perfected the techniques to grow stem cells from a primate in the laboratory, a process that had taken four years of trial and error. Using these same techniques, he then tried to create the first hESC line, using leftover embryos from a local in vitro fertilization clinic. His first try was a success, leading to the creation of the first human stem cell line ever.

Thomson’s stem cell breakthrough held much promise for medicine because of the very nature of stem cells themselves. A stem cell is an undifferentiated cell, capable of becoming, with limited exception, any fetal or adult cell type in the body (a trait known as “pluripotency”). A stem cell can become part of the skin, the nervous system, the lungs, or any other part of the body. Naturally, this makes stem cell researchers eager to translate the properties of stem cells to tissue and organ transplantation, where one’s own stem cells could be used to regrow one’s own damaged tissue.

What makes Thomson’s research all the more interesting is that it was accomplished with private funds, free from government expense. But Thomson had no choice but to use private dollars. In 1974, Congress banned government funding to embryonic research. In the aftermath of the 1973 Supreme Court decision in Roe v. Wade, some groups felt deeply concerned about embryonic research, insisting that Roe v. Wade would lead to unregulated use of fetal tissue leftover from abortions. Congress acted swiftly and banned federal funding for embryonic research altogether, allowing the ban to be lifted only with the establishment of guidelines to regulate research.

Restriction and Resistance

Shortly after Congress enacted the ban, the scientific community pressured the Department of Health and Human Services (HHS) and its primary research organization, the National Institutes of Health (NIH), to lift the Congressional ban. The wording of the ban gave the HHS Secretary discretion to lift the ban, with the NIH pressuring HHS in 1979 and 1986 to do so; both these efforts failed. In fact, HHS decided in 1987 to end the debate and issued an outright ban of all fetal tissue research, regardless of the source of funding.

While researchers in the United States received no federal financial support for fetal cell research, researchers in other parts of the world were advancing the field in their stead. As advances in fetal cell research progressed internationally (as in the case of Anders Björklund’s Parkinson cell therapy studies in Sweden), the NIH strengthened its advocacy for embryonic research. Nevertheless, the 1988 NIH recommendation to fund embryonic and fetal research was shot down by then HHS Secretary, Louis Sullivan, and the moratorium persisted. The United States would continue to lag behind the world in the fields of embryonic and fetal research.

At this point, Congress was prompted by patient advocacy groups and attempted to act to overturn the ban on embryonic research. In 1990, a bill overturning the ban on human embryonic research passed the House and Senate but was vetoed by President George H. W. Bush. Following the 1992 election, President Clinton issued an executive order commanding the HHS Secretary to lift the ban; after his order drew heavy criticism from the pro-life movement, Clinton reversed his position and allowed the ban to stay in place. It would not be until the end of his second term in office that the issue of the ban would be revived.

Human embryonic stem cells. Image courtesy of Diane Krause from ESCRO (Embryonic Stem Cell Research Oversight at Yale).

The New Millennium and the Stem Cell Détente

The first significant event towards loosened funding restrictions occurred in 2000, when the Clinton administration announced that the NIH would accept applications for federally funded embryonic stem cell research provided that the embryos used for research were obtained from fertility clinics who would otherwise discard them. Though the order prohibited funding that would facilitate the destruction of an embryo, researchers could apply for grants to work on new cell lines if the establishment of the cell line was conducted using private funds.

Though this represented a significant milestone in the uphill struggle for federally funded hESC research, the implementation of this order was cut short by the 2000 presidential election. The election of President George W. Bush created a de facto freeze on the issue, for Bush had announced during his campaign that, if elected, he would reverse Clinton’s policy on hESC funding. As the debates over hESC research were reignited, Bush directed HHS to conduct a second study on the issue while the President formulated a decision.

On August 9, 2001, President Bush announced his decision: the Administration would be the first in U.S. history to provide federal funds for hESC research. Rather than reverse Clinton’s policy, Bush tailored it by attaching a caveat: federal funds could only be obtained for research using pre-existing cell lines (pre-existing being defined as existing before his address) which were obtained as discarded material from fertility clinics by the informed consent of the donors. A total of 21 cell lines would be now available for federal funding in the United States.

With the election of President Obama (who, during his inaugural address, pledged to “restore science to its rightful place”) came a renewed push for expanded hESC funding. On March 9, 2009, President Obama removed the federal funding restrictions for novel stem cell lines, provided that the development of these stem cell lines did not involve public funds.

While this history suggests a long and arduous path to victory for embryonic stem cell research, it is important to consider that the U.S. spends a relatively minor amount of funding towards human embryonic stem cell studies. In 2011, the NIH directed $123 million to hESC research; non-embryonic non-human stem cell research, in the same year, received over five times that amount. As a portion of the total 2011 NIH budget, hESC research received 0.39% of NIH funding.
To address this gap, states have established their own funds for stem cell research. Latham explains that, during the Bush years, there were researchers at Yale and the University of Connecticut who took advantage of the Connecticut funding program, most receiving small seed grants that got their research started. Yale received about half of the Connecticut funding and continues to do so; the state of Connecticut has spent $59 million in the last five years on grants-in-aid for stem cell researchers.

A Course for the Future

As states attempt to supplement federal funding, the research focus in the field of stem cells has been shifting. “We see people shifting their interests towards induced pluripotent cells,” says Latham. “Induced pluripotent cells are specialized cells, such as skin cells and red blood cells, which undergo forced de-specialization. You can generate tissue using induced pluripotent cells that come from the person who will be receiving the tissue, so genetic matching isn’t an issue,” explains Latham. “Furthermore, there aren’t the ethical problems of human embryonic stem cells, since you don’t need an embryo to make these cells.”

The shift to induced pluripotent cell research, however, does not mean a death knell for embryonic stem cell research. “We can’t shift completely,” says Latham. “The gold standard for pluripotency [remains] the embryonic cell… We can’t completely stop, but there has been a shift.”

As science and politics develop around the shifting focus of stem cell research, undoubtedly the issue of funding will continue to constitute a significant factor in the direction of research. Each presidential administration in the last quarter of the century has refocused the course of stem cell research through the power of the purse. As November looms nearer and nearer, researchers and patients around the world will be holding their breaths to see how the upcoming election will attempt to answer the perpetual question: Who pays?