Visit the webpage of the Stem Cell Action Coalition for national legislative updates.

The following summary is provided by Wisconsin Stem Cell Now:

A. Is embryonic stem cell research eligible for federal funding?

The National Institutes of Health (NIH) funds research using adult stem cells, embryonic stem cells, stem cells obtained from umbilical cord blood, and stem cells derived from non-human tissue.

The policy of the Bush administration was to limit the use of federal dollars to research using embryonic stem cell lines created prior to August 9, 2001. While at the time of this decision President Bush claimed that approximately 64 stem cell lines would be eligible for federal funding, it soon became apparent that far fewer stem cell lines were actually viable and available to researchers. During the Bush Administration, 21 stem cell lines derived from human embryos were available to researchers who wished to obtain federal funding of their work.

The National Stem Cell Bank was formed as the national repository of these embryonic stem cell lines (and also three iPS stem cell lines). Established by WiCell, a private, not-for-profit supporting organization to the University of Wisconsin-Madison, the National Stem Cell Bank is funded through a federal grant.

Meanwhile, during the Bush Administration, researchers were continuing to produce hundreds if not thousands of new embryonic stem cell lines after August 9, 2001. In most cases, these post-2001 stem cell lines were derived with embryos that were created during the process of in vitro fertilization and that were subsequently donated to researchers in lieu of destruction. As laboratory techniques improved after 2001, and as researchers learned more about cell biology, the quality of these newer embryonic stem cell lines exceeded the quality of the lines created earlier.

During the Bush Administration, Congress twice passed legislation seeking to extend federal funding to these post-2001 embryonic stem cell lines. In both cases, President Bush vetoed the bill and supporters failed to override the veto.

Therefore, the Bush era restrictions on federal funding for embryonic stem cell research placed significant limits on researchers. The embryonic stem cell lines eligible to receive federal funding were of a lesser quality, and are therefore less useful to researchers. Research institutions that wished to conduct research using both pre-2001 and post-2001 embryonic stem cell lines had to either set up elaborate accounting systems or else construct completely separate facilities in order to assure that no federal dollars were indirectly used to support research outside of National Institutes of Health (NIH) guidelines. In addition, collaboration between institutions, which often leads to faster progress, became more difficult becasue different funding rules applied to different institutions.

Several states moved to fill this funding gap by directly funding research using embryonic stem cell lines created after 2001. Wisconsin was not one of these states.  While privately funded research has long been underway in Wisconsin using these types of stem cell lines, no Wisconsin tax dollars are currently used to support this research. 

This situation improved on March 9, 2009, when the Obama Administration issued an Executive Order lifting the restrictions on using federal fundings to support embryonic stem cell research on stem cell lines created after the year 2001. The National Institutes for Health subsequently proposed rules to govern which stem cell lines created after 2001 would be eligible for federal funding. The NIH issued Draft Guidelines for Human Stem Cell Research, and solicited and received public comment in anticipation of adopting final rules.

There was significant concern expressed in many of the comments that the proposed guidelines would have imposed unnecessarily strict rules regarding the documentation of donor consent before federal dollars could have been used to support research on stem cell lines created after 2001.  The final guidelines, as adopted by NIH, dropped these documentation provisions. The stimulus funding bill passed by Congress included over $10 billion in additional funding for NIH, a portion of which will be devoted to support all forms of stem cell research.

B. Does the National Institutes of Health provide adequate funding for stem cell research?

Medical research is extremely costly. While private fundraising will always be essential, public dollars have made up an increasing proportion of the funds devoted to supporting medical research. The budget of the National Institutes of Health (NIH), which funds basic medical research, grew at a 15% annual rate in the latter half of the 1990s but it has entered a decline in recent years. Tight budgets at both the federal and state level have worked to create more competition among interest groups for government dollars. The total level of public funding currently devoted to medical research does not reflect the priority that should be placed on curing disease and reducing human suffering.

Within the NIH budget, the current levels of federal funding for stem cell research in general is extremely low in comparison to the amount devoted to funding for other types of medical research. For fiscal year 2008, the NIH estimates a total of $656 million will be awarded to fund all forms of stem cell research. This compares to over $1 billion to study the human genome. In addition, within the entire 2008 NIH budget for stem cell research, only $42 million is available to fund human embryonic stem cell research (less than 6.5% of the total).

Stem cell researchers in Wisconsin do receive a fair proportion of the NIH grants available for stem-cell research. This is undoubtedly because Wisconsin researchers created many of the pre-2001 stem-cell lines that are eligible for federal funding. One doctor engaged in stem cell research in Wisconsin describes efforts in our state as “overly reliant” on federal funding, which he described as too small to support the research agenda that many feel is necessary in order to advance the science.

C. Does the State of Wisconsin currently provide funding for stem cell research?

Stem cell researchers in Wisconsin currently get their financial support from NIH grants, from charitable foundations, from money donated by patient advocacy groups, and from the general University of Wisconsin budget (in which they compete with other faculty and researchers for resources). Even embryonic stem cell research eligible for NIH funding under the guidelines adopted by the Bush Administration does not receive any direct financial support from the state budget.

The Wisconsin Alumni Research Foundation (WARF) is the primary funder of stem cell research in Wisconsin. WARF is a private, non-profit organization. A WARF subsidiary, the WiCell Research Institute, has also contributed funding. Other private sources of research funding include the UW Foundation and patient advocacy organizations dedicated to curing specific diseases.

In contrast, the Wisconsin state government has not budgeted any public dollars to support stem cell research. The state currently funds a venture capital tax credit that is available to private companies engaged in stem cell research efforts as an incentive for conducting such research in our state. The state has made a total of $10.4 million in competitive grants and loans to stem-cell companies, which private sources matched by contributing an additional $50 million.

The primary focus of financial support for stem cell research using Wisconsin tax dollars has been the Wisconsin Institute for Discovery, a new research facility being built on the University of Wisconsin campus. The WID, announced by Governor Jim Doyle in 2004, is a complex designed to house biotechnology researchers across several fields in one location, including stem cell researchers. The multi-year $750 million building budget is comprised of a combination of state and private funds. So far, the State of Wisconsin has contributed $50 million, WARF has contributed $50 million, private donors contributed $50 million, and some of the proceeds from the sale of Wisconsin BlueCross-Blue Shield to the public have been allocated to construction. It is true that an improved physical environment will eventually benefit researchers. However, while “bricks and mortar” are helpful, it is what happens inside the Wisconsin Institute for Discovery building that truly matters. None of the seed grants to researchers that have been announced so far in connection with the WID has been directed towards stem cell research.

Wisconsin currently does not award any grants directly funding research by any of the researchers engaged in stem cell research at the University of Wisconsin or at the Medical College of Wisconsin. Other than the general University of Wisconsin budget, the state awards no money to directly pay the costs of research assistant salaries or specialized mechanical equipment. As one Wisconsin researcher put it: “there is simply no state money available.” Researchers could particularly use “seed money” grants that allow them to perform smaller demonstration projects that can subsequently be used as the basis for larger grant proposals to NIH, the Juvenile Diabetes Research Foundation, or other private funders.

D. Are other states funding stem cell research?

Ten states currently have in place structures for the direct funding of stem cell research. In 2004, California voters approved a bond measure that promises to eventually provide $3 billion for stem cell research in their state through a grant application process. Litigation delayed the onset of funding, but a $151 million grants program was finally announced this past summer and the first $30 plus million was recently awarded.

New York has pledged to make $600 million in grants over the next ten years. The Massachusetts legislature created a Life Sciences Investment Fund and allocated money to be used for grants to researchers. Maryland recently approved the funding of stem cell research taking place at the University of Maryland. Connecticut and New Jersey have also passed laws allocating money from their state budgets to directly support stem cell research. The Illinois Governor used an executive order to make grants totaling $5 million out of its 2007 state budget to stem cell researchers. Arizona, North Carolina, and Virginia have formed groups to study the issue.

As long as a comprehensive federal policy to support all forms of stem cell research is lacking, the devolution of funding for medical research from the federal to the state level will continue. However, there are significant downsides to this process. States will compete against one another to attract top researchers and to attract private business development. The legal and funding rules applicable to research will become increasingly balkanized. This patchwork of inconsistent regulation will preclude collaboration across state lines. Research results may not be fully shared. States may seek to limit out-of-state access to therapies developed using state dollars, or alternatively might seek to prevent their residents from traveling elsewhere to seek therapies that are prohibited at home. Progress towards achieving the promise of stem cell research will be far slower than it should be.

E. Why isn’t private funding of stem cell research the answer?

Fundamental principles of economics tell us that not every good or service will be optimized by reliance on the “free market.” The optimal amount of basic medical research will not take place without government subsidy. Most major medical advances over the last century have taken place as a result of government-funded efforts. Indeed, the private sector spends more than $59 billion on biomedical research each year, but only 10-15 % of that total is devoted to basic research that doesn’t immediately translate into marketable products. In contrast, the publicly funded NIH devotes 55-60 % of its budget to basic research.

The high risk involved in medical research means that many private companies will either forgo many promising avenues of research or else face financial failure. Basic medical research is extremely expensive in the near term, has a low probability of resulting in a marketable drug or therapy, and even then will not generate a profit on the up-front investment until many years in the future. In addition, many diseases and chronic health conditions do not afflict sufficient numbers of people to create a viable “market” for any cure.

It is right and appropriate for government to use the tax dollars of all citizens to help subsidize basic research into cures, and to compensate for the less than optimal free market incentives to conduct medical research. The primary function of government is to provide every citizen with the essentials of health and safety, especially where private sector alternatives are too expensive for most people.

Government funded research is better coordinated and subject to better oversight than privately funded research. Publicly funded research grants can be awarded so as to avoid duplication of efforts, to encourage collaboration, to promote the publication of results, and to condition the receipt of public funds on the observance of ethical guidelines. In contrast, private research is conducted out of the public eye, where research methods may not be publicly shared, intellectual property rights are zealously guarded, government oversight and accountability is limited, and pursuit of a comprehensive research strategy is impossible. This is why government leadership has historically been critical to rapid advances in medical knowledge (i.e., the swift development of AIDS drugs).

F. Why is it important for Wisconsin to fund stem cell research?

The State of Wisconsin should provide additional financial support to researchers conducting all forms of stem cell research because: 1) the state is currently a leader in the field; 2) the lack of adequate federal funding means that state funding is necessary to accelerate the pace of progress; 3) the failure to adequately support researchers will increase the likelihood that other states will attract researchers away from Wisconsin; and 4) the emerging field of regenerative medicine will provide an economic boost to a Wisconsin economy that still remains heavily reliant on manufacturing and agriculture.

Wisconsin is a leading pioneer in stem cell research. A University of Wisconsin scientist, Dr. James Thomson, was the first researcher to isolate and culture human embryonic stem cells and also made the initial breakthrough in the creation of iPS cell lines. As a result, the Wisconsin Alumni Research Foundation holds several key patents related to stem cell research. These patents have been licensed to biotech companies. Access to stem cell lines and trained researchers has attracted start-up companies to locate in Wisconsin. It is estimated that Wisconsin’s biotechnology industry employs some 30,000 people and contributes over $7 billion to the state’s economy.

Since implementing its ambitious stem cell research initiative, the State of California has lured 24 leading scientists to relocate, along with 33 younger researchers. California has announced that its new regenerative medicine laboratories will eventually employ 2,200 researchers. In a decade, there will be only a handful of world class centers for economic activity associated with stem cell research. Thanks to a group of talented and dedicated researchers, Wisconsin has a head start in this process. Wisconsin needs to do all that it can so that in ten years our state is one of those economic centers.

G. Stem Cell Research Has Broad Based Public Support

Widespread support for use of embryonic stem cells in research exists. The August 2004 poll by the Pew Research Center and the Pew Forum on Religion & Public Life found:
* 52% of those surveyed said that it was important to conduct stem cell research.
* The level of support for stem cell research was increasing among all groups, whether considered by age, education, income, race, religion, or political outlook.

A 2005 poll conducted by Cures for Tomorrow, a pro-stem cell organization in Wisconsin, showed that of 500 polled Wisconsinites:
* 69% support stem-cell research,
* 59% want more state funding, and
* 41% strongly support continued research.
Prestigious organizations supporting stem cell research include:

* American Medical Association,
* American Association for the Advancement of Science,
* American Diabetes Association,
* Association of American Medical Colleges,
* National Health Council,
* The National Coalition for Cancer Research, and
* Christopher Reeve Paralysis Foundation.