The promise that stem cells will lead to cures for today’s incurable diseases instills hope in millions of people who battle for their health every day. But stem cells also show promise in many other layers of society - potentially benefiting a country or state politically and economically, as scientific breakthroughs and the development of new technologies have long been a source of economic growth, new labor markets, and national pride.
In the struggle to maximize its share of this potential, the US has many natural advantages. The majority of the world’s stem cell scientists and companies are in the US, and the combined investment of federal and state governments, private foundations, and individual donors exceeds the investment made by other individual nations. However, this manpower and financial lead may not always translate into scientific results and can easily be squandered if not supported by policy.
In the June 2008 issue of Cell Stem Cell, researchers from Georgia Institute of Technology assessed various countries’ scientific “output”, as judged by the number of papers published peerreviewed journals, across different areas of molecular biology. The study showed that although the US produces the majority of the work in the field of human embryonic stem cells (hESCs), it is “under-performing” on a relative basis in comparison to other areas of molecular biology. In the study, scientific publications are grouped by the principal investigator’s country of origin and each country’s relative share of the papers in the areas of stem cell biology, RNAi technology, and molecular biology overall are compared.
While 46% of the molecular biology papers and 47% of the RNAi papers were published by US scientists, this was true for only 36% of the hESCs publications - suggesting the US is not reaching its full potential in this field. In contrast, the United Kingdom was shown to be “over-producing” in the area of hESC in comparison to molecular biology as a whole. Of the 16 countries examined in the study, there was an apparent correlation between “over-producing” and “under-producing” in the area of hESC and public policies that affect the field.
Historically, it has been the role of government to fund early stage research and bridge the gap between when scientists see potential discovery and when industry may see potential future profit.
Such policies can vary significantly. The combination of scientific attraction, economic incentive, and cultural beliefs associated with stem cell research has created a complex global dynamic, which has resulted in a spectrum of national regulatory and funding frameworks. For example, some countries such as the UK, China, and Singapore have supported the creation of new hESC lines and other techniques including somatic cell nuclear transfer, while others such as Italy and Germany prohibit the derivation of new hESC lines. The US is unique in its policies. Though research conducted with National Institutes of Health (NIH) funding (which accounts for 63% of all academic research overall) can only be used to work on the small number of stem cell lines created before August 9, 2001, there are no restrictions on research conducted with private funds. This has had a positive effect on the field in that individual states have jumped into the fray and actively funded stem cell research. But such funding is more precarious and the rules differ widely across states.
In challenging fiscal times states may pull back from prior plans to fund research programs and centers because they are more susceptible to economic swings than is the federal government. This was evidenced by New Jersey’s recent re-consideration of a planned $450M expenditure. And the variation in rules and regulations at the state level creates additional navigational challenges as scientists try to work together across institutions. Groups such as the Interstate Alliance for Stem Cell Research have arisen to help address these diseconomies because the interlocking funding and regulatory framework that the NIH normally provides is missing.
As in any early stage technology, the commercial life sciences sector cannot be expected to be a significant financial contributor when there is a need for developing fundamental scientific knowledge and training skilled scientists. Both of these basic needs are unlikely to be sufficiently funded by industry as the return on their investment is at best a springboard for future projects and downstream revenues. In the case of fundamental knowledge, much of this is disseminated to the wider world though publications - spreading know-how and potential profit across the field. Likewise, investing in the training of scientists benefits the industry as a whole by creating a skilled labor pool - benefits that again would not be entirely captured by the investing company. However, the stem cell field is now starting to see interest from the commercial sector in selected applications where stem cells are used as tools instead of therapies, which has more immediate market impact.
Historically, it has been the role of government to fund early stage research and bridge the gap between when scientists see potential discovery and when industry may see potential future profit. By investing in basic research and the next generation of skilled scientists, the NIH is able to distribute both the cost and benefit of such investments across the US. And yet, there is always the need for industry involvement and investment in order to move a treatment into the clinic and the marketplace. In addition to conducting and sponsoring research and development, pharmaceutical companies are critical to solving problems of scale and distribution. However the government is needed to distribute some of the risk associated with a new field of science across the nation. And this is not just a matter of dollars and cents. Equally important is the oversight provided by an integrated set of regulations and policies so that researchers can commit to the field, knowing that the government supports the work they do.
In the face of such obstacles, it is impressive that US still produces the majority of the world’s stem cell research. Such a lead is a testament to the investments made by industry, foundations, and organizations like HSCI. But when the real competition is with disease, and lives rather then profits are at stake, it is critical that federal policies support a field that holds so much potential.