California, Here We Come

Long before the most recent showdown between the U.S. Congress and President George W. Bush over the use of embryonic stem cells, the administration’s intransigence drove proponents of the research to take their case to the states. California’s successful passage in 2004 of Proposition 71, which set aside $3 billion in tax dollars to fund stem cell research, quickened the pace of advocacy in various regions, with officials around the country kept awake by visions of the Golden State extending its lead in biotechnology.

By inadvertently creating a new grassroots movement to support embryonic stem cell research, the Bush administration actually may have fostered a model that will serve biomedical research more broadly in the future. It has also put many Republicans in a bind. In many parts of the country, biomedical research — and especially embryonic stem cell research — is seen as the next big hope for economic development. Thus, qualms about whether a cluster of approximately 100 cells barely visible to the naked eye is a human life stand in the way of potential job growth.

The depth of interest in this issue is reflected in the fact that, during the first half of 2007 alone, 39 state legislatures debated stem cell bills of one sort or another. Polling data makes it clear that a majority of Americans want this research to go forward, and politicians outside the beltway have gotten the message. Ten states now have established policies or funding programs for embryonic stem cell research: California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, Missouri, New Jersey, New York, and Wisconsin.

In April, the New York state legislature approved $100 million for stem cell research activities for this fiscal year, and it allocated $500 million over the next 10 years.

Massachusetts Governor Deval Patrick’s May 7 announcement of a $1.25-billion state life sciences initiative is typical in linking scientific advancement to economic development: “There is no place in the world with as much talent in life sciences and biotech as here in Massachusetts,” said Patrick, a Democrat. “Now is the time for us to invest in that talent and bring together the resources of our unparalleled research universities, teaching hospitals, and industry to work toward a common goal — to grow ideas into products to create cures and jobs.”

The Massachusetts plan includes grants for scientists, establishes research centers, and creates a stem cell bank that will be a repository of all the cell lines derived in the state. Over 10 years, the state will provide $1 billion, with the remaining $250 million coming from private sources.

Not to be outdone, in June, New Jersey Governor Jon Corzine (D) announced approval of $9.2 million in pre-construction costs furnished by the state’s Economic Development Authority to build a state stem cell research facility, calling it “an important first step in our growing partnership with private industry to fund this promising and potentially life-saving science.” He went on to say, “We can create the climate to facilitate this important research, while at the same time growing our economy with well-paying jobs.” The state has plans to build other facilities in different regions. Voters in New Jersey will also consider a ballot initiative this November that would allow the state to borrow $450 million over 10 years to fund stem cell research.

Typically more conservative, states in the heartland also have come down on the side of scientific investigation. In 2006, Missouri voters passed a statewide ballot initiative that changed the state’s constitution to guarantee that any stem cell research or therapy allowed by federal law would be legal in Missouri, thus removing the threat of more restrictive local measures.

It also created a set of ethical guidelines for the research, including requirements that the research be approved by a review board of scientists and institutional representatives, that written informed consent must be obtained from egg donors, and that no human blastocyst can be created by fertilization solely for the purposes of deriving stem cells. The proposal also specifically bans the use of cloning technology for reproductive purposes.

As in New Jersey and Massachusetts, economic competitiveness was a strong element in Missouri’s position. “By ensuring that Missouri’s medical institutions can compete on a level playing field with institutions in other states and countries, [the proposal] will attract millions of dollars in research investments to our state,” reads a document from supporters of the stem cell amendment.

In 2007, Iowa repealed a 2002 law banning somatic cell nuclear transfer (SCNT, or so-called “therapeutic cloning”). The process involves a technique whereby a researcher removes the nucleus of an egg cell and inserts the nucleus of a somatic cell, then triggers the process of cell division, which allows embryonic stem cells to be derived from the resulting blastocyst.

Support for embryonic stem cell research in the Corn Belt is significant because, until now, the region has not been a biotech hub for pharmaceutical applications. Moreover, Missouri has been a Republican stronghold in recent elections, and Iowa has shifted its support between the two major parties. The fact that, at least in this one regard, they have aligned themselves with such blue states as New York, New Jersey, and California suggests, perhaps, that the appeal of biomedical research — including the use of embryonic stem cells — may be sufficient to transcend partisan politics.

Further evidence came from the 2006 elections, as Republican and Democratic gubernatorial candidates — in both red and blue states — who promoted a pro-embryonic stem cell research platform were elected. These nowgovernors include: Arnold Schwarzenegger (R-CA); Eliot Spitzer (D-NY); James Doyle, Jr. (D-WI); Rod Blagojevich (D-IL); M. Jodi Rell (R-CT); John E. Baldacci (D-ME); Bill Richardson (D-NM); Charlie Crist (R-FL); and Martin O’Malley (D-MD).

Indeed, Michael N. Castle, a Republican Congressman from Delaware, and one of the sponsors of the 2007 bill vetoed by President Bush, summed up the situation in terms that sounded just like his Democratic colleagues. “We’re going to have to wait either for a change of mind at the White House, which seems unlikely,” he told the New York Times, “or the next president.”

However, opponents of embryonic stem cell research are not rolling over to play dead. In Missouri, lawmakers who opposed the constitutional amendment continue to oppose it, and uncertainty appears sufficient to impede progress. The state legislature blocked $85 million for a new research facility at the University of Missouri in Columbia, even though it was not specifically intended for stem cell work. The attitude now, one lawmaker told the New York Times, is that “if there’s a beaker or a Petri dish involved, we’re not going to fund it.” In June, the Stowers Institute for Medical Research in Kansas City suspended plans for a $300-million expansion, citing the negative atmosphere regarding stem cell research.

Elsewhere, opponents of stem cell research have simply reverted to more subtle tactics to continue the battle. Several bills, for example, have been introduced that would establish individual statewide umbilical cord blood banks — this despite the inefficiency of separate facilities in each state, a situation all the more cumbersome in light of the national cord blood donation program and banking system that already exits. Stem cells contained in a newborn’s umbilical cord blood have been used in regenerative and transplant medicine.

Although cord blood banks have been established in a few states, a close reading of some of the bills introduced this year suggests that effective policy may not be the objective. An early version of a cord blood banking law recently enacted in Georgia included this language: “Stem cells are widely available from sources other than the human embryo and by processes which do not result in the destruction of human embryonic life … the umbilical cord, placenta, and amniotic fluid are rich in stem cells … without destroying human life at any stage of development.”

The draft of the same bill also noted, perhaps prematurely, that “destructive stem cell research using embryonic stem cells has failed to yield any effective cures and treatment.”

Meanwhile, a Nevada proposal to create a statewide cord blood bank had a similar tenor, stating: “The safe and efficacious development of bioregenerative medical technologies requires respect for and preservation of human life; and … an embryo is understood to be the beginning of life.”

Neither of these propositions was enacted into law as written, but supporting umbilical cord donation and research was once again this year a priority for some states — primarily as an alternative to embryonic stem cell research. Arkansas, Georgia, and Oklahoma enacted laws creating statewide umbilical cord blood banks while North Dakota and Texas passed laws to provide information about cord blood donation to potential donors and physicians. None of these states has laws supporting embryonic stem cell research.

Similarly, a much-heralded breakthrough confirmed in reports published this June has become yet another debating point. The work in question shows that mouse skin cells can be “reprogrammed” into an undifferentiated state — the same pluripotent state that makes embryonic cells so valuable as potential building blocks for regeneration. Opponents of using embryonic stem cells have trumpeted this study as a rationale for bypassing the controversial technology. A statement in June from the U.S. Conference of Catholic Bishops argued, “Practically as well as ethically, these studies point the way toward enjoying any possible benefits of embryonic stem cells without some of their disadvantages.”

In an article published in June, the editor of anti-abortion site Lifenews.com, Steve Ertelt, noted, perhaps with some confusion, that the new technique, “If done in humans … could lead to obtaining the embryonic cells without killing days-old unborn children.”

These arguments will undoubtedly resonate in future state legislative battles. “The perception in the states, rightly or wrongly,” says Patrick Kelly, vice president for state government relations for the Biotechnology Industry Organization, “is that scientific advances are obviating the need to destroy embryos for research purposes.”

If Delaware Congressman Castle is right, and the federal ban on embryonic stem cell research ends with the next inaugural in Washington, the question may arise: Has all this work at the state level been wasted effort?

States can never replace the scientific leadership of federal agencies over the long term. California aside, state support for research on embryonic stem cells would be dwarfed by expanded funding from the U.S. National Institutes of Health. Moreover, competition among the states has the potential downside of parochialism and fragmentation. In Maryland, for example, state grants are restricted: “Organizations based outside the State of Maryland are not eligible to apply.” And state efforts could lead to a patchwork of regulations, intellectual property rules, and other issues making interstate collaboration difficult, hampering commercialization.

Even so, the state efforts inspired by the restrictive federal policy may have valuable and enduring implications. In 1932, Supreme Court Justice Louis Brandeis observed that states have the ability to try social policy ideas on a smaller scale to determine their worthiness. In one decision, he wrote, “It is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory, and try novel social and economic experiments without risk to the rest of the country.”

This concept was updated by David Osborne in his 1988 book Laboratories of Democracy, which examined state policies designed to promote economic growth by bringing together business, labor, and government. Many of these were a response to the federal policies of that era which emphasized tax cuts. They were, in Osborne’s view, innovative ideas that created a “new paradigm” with stakeholders working together.

State stem cell initiatives have spurred competition among jurisdictions. Life sciences companies and research universities benefit in this environment as state governments compete to “make the best deals” for research and commercialization enterprises within their borders. The result has been a net increase in state investment in biomedical research, according to a report prepared by Battelle Technology Partnership Practice, a company that analyzes life sciences research trends.

But the creation of a new paradigm of leadership and advocacy may be the most important legacy of this debate. State efforts in stem cell research have demonstrated the political power — at least in some places — of medical research as an issue and the ability of patient advocates, researchers, and industry to join together in support of a common goal. Embryonic stem cell research will remain controversial for the next few years. Efforts to expand embryonic stem cell research will continue to be opposed by groups such as the National Right to Life Committee and its state-based affiliates. For example, the language on Illinois Right to Life’s website shows that organization’s willingness to continue to fight state efforts to support embryonic stem cell research.

What’s more, stem cell research is not likely to be the last frontier of scientific innovation that will be seen as objectionable by some groups. Going forward, when opposition arises, those who support research can look to a newly established tradition of grassroots coalition building.

Thus, the impact of state battles on embryonic stem cell research will be felt long after it fades as a hot-button political issue. By demonstrating success in stem cell research, states will reinforce or even expand their role as laboratories for new policies and political decision-making. While biomedical research has long been considered almost exclusively within the federal government’s purview, the stem cell experience will empower states and advocates. The result will be grassroots political support for policies that continue to advance new areas of medical research.

Source: http://www.tjols.com/article-323.html