President Obama must heed calls for stem cell research

Wednesday, November 05, 2008

On 20th January 2009, the climate for embryonic stem cell research in the United States will change for the better. Obama will be inaugurated. Both he and McCain supported the Stem Cell Research Enhancement Act, a piece of legislation twice vetoed by President Bush. It is widely expected that the new president will support the lifting of the arbitrary funding restrictions imposed by George W Bush on the National Institute of Health (NIH) funding embryonic stem cell research.

President Bush restricted federal funding to only those embryonic stem cell lines, approximately 21 in number, in existence on 9th August 2001, the date he announced his policy, his rationale being that funding on embryonic stem cell lines created after that date would somehow make the government complicit in the future destruction of human life.

The numbers from the NIH detail the sad tale evidencing the United States' failure to exploit the breakthroughs of Dr James Thomson and Dr James Gearhart, who, in separate experiments a decade ago, first derived human pluripotent stem cells.

Since 2001, NIH has funded approximately $3bn for combined adult, umbilical cord and non-human embryonic stem cell research, while a relatively paltry $160m (estimated) has gone into researching the approved 'presidential' lines. Those lines have been supplanted by hundreds of more recently derived lines better suited for research and most free of animal proteins. These new lines remain off limits to US researchers and their laboratories utilising NIH funding grants for their research.

The consequences of using NIH funded facilities, equipment and personnel is quite serious for researchers trespassing on unapproved embryonic stem cell lines. Indeed, should even a single pipette funded by a federal grant be misused in that fashion, that institution's entire NIH funding could be jeopardised.

With its annual budget exceeding $25bn, the NIH has largely been on the sidelines. That and other federal constraints have opened competitive opportunities for other nations with strong life sciences infrastructures to pour resources into this promising field, and thereby securing potential advantages over US researchers.

Historically, the America's policy debates, the so-called 'stem cell wars', parallels the rise of the social-conservative tide that placed George W Bush in power. The opposition sought to elevate the legal standing of tiny, microscopic clumps of frozen cells, in effect, dragging embryonic stem cells and medical science into the forefront of the intractable abortion debate in America.

The leadership of the 'right to life' movement, comprised of fundamentalist evangelical Christians and Catholics, strategised that they could undermine support for abortion rights if they could convince the public that blastocysts in a petri dish are equal to living, breathing persons.

Many social-conservative think-tanks created specific bioethics agendas opposed to embryonic stem cell research. Organisations such as the American Enterprise Institute, Family Research Council and Discovery Institute, with combined budgets of millions of dollars, are the architects of endless legal gambits. They are authors of the media 'talking points' used by the social conservative politicos and allied cable news pundits. All are geared towards delay and obfuscation, not illumination.

A favourite tactic of the opposition is to fan the flame of anti-cloning hysteria, by blurring the bright line between reproductive cloning and nuclear transfer (so-called therapeutic cloning), which could be used to develop patient matched stem cells and cell lines burdened by disease for study.

Raising the spectre of a 'Brave New World', opponents have proposed Draconian legislation criminalising all cloning, unethical reproductive cloning of babies, and nuclear transfer. The proposed federal legislation would threaten scientists and even patients with potential prison terms and heavy fines. Similarly, the cloning issue played out on a world stage in the United Nations, where the Bush Administration and the Vatican strongly supported a world treaty that would have halted nuclear transfer.

The opposition badly underestimated the public's appetite for this paradigm shifting research. This research promises to attack debilitating medical conditions, not by drugs or surgery, but by replacing damaged tissues and organs through cell therapies, as well as determine root causes for disease, and serves as a useful tool for drug discovery.

Their heavy-handedness in messaging and outrageous proposals has spectacularly backfired in ways they could never have imagined.

The push-back to this onslaught came from grassroots countermovement, global in scope, defending nuclear transfer and stem cell research. Deny hope to people facing a lifetime of suffering and debilitating disease, and there is likely to be a strong reaction. An upswell of enlightened public support, buoyed by the hope for cures and frustrated by opposition that made little sense to those wracked by chronic disease, became engaged, motivated and empowered. More powerful than a political movement, what has emerged is a global consumer movement, the 'Pro-Cures Movement', where the ordinary citizens see promising research not as an obscure public health issue, but as a personal health issue. Ordinary men and women, who may have forgotten their 10th grade biology, nevertheless recognise that stem cell research may some day deliver treatments for themselves, a friend or a loved one. A powerful force indeed.

This movement gained its bearings, even as many politicians in the US discovered that being pro-research won elections. They bombarded the television airwaves with pro-stem cell messaging. Strong patient advocacy organisations, such as the Juvenile Diabetes Research Foundation, and the Parkinson's Action Network, and popular public figures such as Christopher Reeve and Michael J Fox all weighed into the debate.

The stakeholders include more than 100 patient advocacy organisations, scientific societies and universities lobbying in Washington comprising the Coalition for Advancement of Medical Research. Their mission is to open the federal floodgates for funding and derail unreasonable restrictions.

On the international front, a global coalition of NGOs eventually prevailed in 2005 in their campaign to block the proposed United Nations treaty seeking to outlaw nuclear transfer.

The consumer movement has spawned massive new outside investment through state funding and private philanthropy for constructing new facilities, dedicated to fully explore and exploit the full promise of human embryonic stem cells beyond the 'presidential' lines.

Most impressively, in the US, this movement propels state initiatives advancing stem cell research. The principal organisers of Proposition 71 in California were private citizens, parents with children afflicted with diabetes. These efforts resulted in a successful ballot initiative, approved overwhelmingly by the electorate, creating the California Institute for Regenerative Medicine, which provides for $3bn towards stem cell research over a 10 year period.

Hundreds of thousands of American citizens have signed petitions and gone to the polls to fight for stem cell research. In the socially conservative state of Missouri, the bellwether state, stem cell research is now a protected fundamental right in the state constitution. A similar battle will be played out on the November 2008 ballot in Michigan.

A new American president will not dissolve opposition. Expect the foes of the research to continue to seek restrictions through lawsuits, delaying actions and state by state fights.

Each year, hundreds of bills are filed in almost every state seeking to elevate the status of in vitro blastocysts, defining 'personhood' as beginning at conception, thus raising the prospect of halting access to surplus embryos donated by their progenitors for medical research. The opposition seemingly prefer that embryos remain perpetually frozen or be discarded as medical waste, rather than used in potentially life-saving research.

Beyond January 2009, many obstacles will remain. Without broad public support and impetus, there is concern that regulatory approval for the first embryonic stem cell clinical trials might be unreasonably delayed. Funding restrictions might be lifted through executive order or legislation, but will the money be there to advance the research? The NIH budget remains stagnant. With inflationary pressures on the economy, the movement remains mobilised to make sure stem cells are a priority.

Globally, the advent of US federal funding for hESCR will galvanise the field in new ways. The political climate in the United States will certainly change for the better. But the consumer movement must be vigilant, lest the determined foes devise new strategies and tactics to delay the promise and hope for cures.