WASHINGTON, D.C.—President Barack Obama on March 9 signed an executive order to lift federal funding restrictions on embryonic stem cell research, reversing limitations on the controversial research efforts placed in August 2001 by former President George W. Bush.
The executive order signed by the president allows the National Institutes of Health (NIH) to fund research using embryonic stem cells and issue new guidelines consistent with the order within 120 days. The NIH was previously able to fund research only on a very limited number of stem cell lines.
The order could have a wide-reaching impact on drug researchers and manufacturers, who have been quick to sort out just what it means for the industry.
Kenneth Aldrich, chairman of International Stem Cell Corp., sees two significant developments arising from the executive order.
"I think it is going to be a huge help for two reasons," Aldrich says. "It will make some direct funding available that was not there before, but I think there is a secondary reason that has been largely overlooked but is as equally important. Up until now, academic institutions that did not have money for separate facilities for stem cell research were terrified to do any stem cell research for fear that they would run afoul of the restrictions and lose all of their federal funding."
As a result, Aldrich says he believes the executive order will open the door much more wider than initially believed for new research to develop new drugs and other forms of treatment.
Others, like Biotechnology Industry Organization (BIO) CEO Jim Greenwood, are enthusiastic about the decision to permit NIH funding of embryonic stem cell research.
"BIO believes that research on both adult and embryonic stem cells holds great promise to produce new therapies and possibly cures for the millions of patients in the U.S. and around the world suffering from cancer, diabetes, Alzheimers's, Parkinson's, spinal cord injuries and other life-threatening diseases and conditions," says Greenwood.
Embryonic stem cell research will also further the development of cell-based therapies by leading to greater scientific understanding of cell differentiation and proliferation, Greenwood adds, pointing out that the action is a first step in what will prove to be a long and complex process to move from the promise of research to the reality of new therapies and cures for patients.
Josephine Johnston, director of research operations at The Hastings Center, agrees, arguing that the real impact of Obama's executive order won't be fully known until the NIH reveals guidelines for research.
"Obama didn't create any new guidelines," Johnston stresses. "That is up to the NIH to determine the guidelines for how the research will be conducted and which research will be eligible for funding. The devil is going to be in the details of what the NIH develops. Currently, there are no new dollars dedicated to stem cell research."
The executive order also does not earmark any additional funding toward stem cell research, as Johnston points out.
"It is likely that more money will be directed to research, but that has not been determined," she says.
While taking a wait-and-see approach, Johnston still remains optimistic about the future of stem cell research in the United States.
"I think it is possible that they (NIH) would allow a broader array of research," she points out. "I am curious now to see what kind of guidelines they do come up with. They don't have the power to direct more federal funding to the research, though, so whether that will happen remains to be seen."
For some companies, however, the benefits will be more immediate.
According to David Chiang, chairman and CEO of Sage-N Research Inc., the first companies that will benefit as the field enters its research phase will be tool companies such as his, which focuses on profiling protein modifications for cell signaling.
"Realistically, the direct outcome of stem cell-based therapeutics, such as repairing spinal injuries, will be 15 or 20 years or more, says Chiang. "After all, traditional drug discovery is far more mature, and novel drugs still maybe 10 years from a promising target to FDA approval. For the next 10 years, people are going to be hiding in their labs using new tools to discover new things. Seeing the actual results will come down the road. It will be very exciting."
Chiang also notes that the real impact from the efforts of research over the next 20 years will likely come from the deeper understanding of diseases related to cell biology, such as solid cancers, and the acceleration of cancer drugs and cancer biomarkers.
"The stem cell will be the Rosetta Stone that allows someone to compare the protein profile of, say, a kidney cell with the stem cell as a standard," he says. "Scientists can then compare the proteins and their 'post-translational modifications' (the on/off switches of proteins) between a diseased and a normal kidney cell, to better figure out which are relevant."
Companies like Millipore Corp., which supply cell lines, specialty media and sample preparation devices for stem cell research, will likely be among the chief beneficiaries of Obama's executive order. Millipore President, Chairman and CEO Martin Madaus says he views it as a new chapter in stem cell research.
"The potential to treat and even cure disease is enormous," Madaus says. "This executive order will broaden and expand stem cell based life science research that holds the promise to develop therapies for today's incurable diseases. Millipore is deeply committed to enabling the advancement of ethical stem cell research and being a scientific partner in the stem cell research community."
Obama's order also comes at a time when the sagging U.S. economy has slowed the flow of investment into biotechnology companies to a mere trickle. It's been even worse for companies whose main technology centers around embryonic stem cell research because of the government restrictions put in place by former President Bush.
David Smoller, president of Sigma-Aldrich's research biotech business unit, says that while the executive order gives researchers access to cells to move their research forward, the change will not create a financial windfall for companies.
"I expect it to help, but I don't think it is going to double the revenue or anything like that," he says. "It is a great tool that companies may now have access to."
Chiang adds that the change may put U.S. researchers on a level playing field with scientists abroad who have already been engaging in stem cell research efforts.
"Internationally, it will remove some of the barriers that prevent the U.S. from falling behind other countries in this critical field," he says. "There have already been high-profile stem cell successes in other countries."
Aldrich agrees that the executive order will level the playing field for U.S. companies to compete against international counterparts.
"There is no question that it levels the playing field," he says. "I don't believe that we have lost our advantage in the stem cell area. The lifting of the ban has come soon enough that we can reassert our historical dominance in stem cell research. Had the ban lasted another couple of years, I think you would have seen a huge outflow of talent from this country."
State proposals could limit stem cell research
It didn't take long for Obama's executive order to begin having an impact on research efforts. On the day Obama signed the stem cell order, a University of Michigan consortium announced it will create new embryonic stem cell lines that will aid the search for disease treatments and cures. The A. Alfred Taubman Medical Research Institute Consortium for Stem Cell Therapies is the first major embryonic stem cell research program launched in Michigan since the Nov. 4 passage of a state constitutional amendment allowing scientists to create new stem cell lines using surplus embryos from fertility clinics.
"The Consortium for Stem Cell Therapies will catalyze efforts by world-class scientists at the University of Michigan who are devoting their full talents to the search for new treatments and cures," says Mary Sue Coleman, president of the University of Michigan. "At the University of Michigan, we believe stem cell research offers one of our best hopes for finding new treatments and cures for a wide variety of diseases."
However, some state legislatures are considering measures to limit stem cell research.
Just three days after Obama signed the order, lawmakers in Georgia kicked off a push to limit embryonic stem cell research in the Peach State. The Georgia bill sought to put a ban on therapeutic cloning and the creation of embryos for any purpose other than procreation. Critics of the proposal said the bill, which was opposed by the state university system, patient groups and fertility clinics, would hamper the bioscience sector, one of the brighter spots in Georgia's faltering economy. Georgia has put an emphasis on attracting biotechnology companies to the state, and in May, Atlanta will host the Biotechnology Industry Organization's BIO 2009 Annual International Convention, which could attract more than 20,000 professionals from 70 nations.
At press time, DDN learned that the bill will not pass this session. Gov. Sonny Perdue, a Republican who has pushed the state's efforts to attract science and technology businesses, indicated he would support the bill.
But even if it does not become law, its recent passage by the Senate makes recruitment more difficult, says Charles Craig, president of Georgia Bio, which promotes the state's interests in life sciences.
"It's sending a signal that Georgia is anti-science," Craig says.
In Mississippi, House lawmakers gave their approval to a bill prohibiting the University of Mississippi from using state money "for research that kills or destroys an existing human embryo," and some states are considering legislation that would define an embryo as a person.
And in Oklahoma, legislators introduced a bill that would make virtually any stem cell research work illegal in that state. Texas lawmakers are also considering a measure that would ban the use of state funds for stem cell research.
California is one of the few states in the U.S. that have state funding for human embryonic stem cell research in addition to Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin.
Arizona already has a law on the books that says university researchers cannot use state funds to manipulate embryonic stem cells in pursuit of treatment or potential cures.
Another Arizona law prohibits Arizona scientists from experimenting with any type of human embryo or fetus. Similarly, Louisiana prohibits research on embryos made in vitro fertilization or IVF clinics.
Iowa, Massachusetts and Missouri have made stem cell research legal, but do not fund it. Arkansas, Indiana, Louisiana, North Dakota, and South Dakota ban embryonic stem cell research all together.
