NIH guidelines will work for federally funded stem cells, but some say protocols are needed for all cell lines.
Yesterday President Obama signed an executive order that opened the door to billions of dollars in federal funding for human embryonic stem cells (hESCs). “It’s the big day everyone’s been waiting for, for about a decade, when science triumphs politics,” says Michael Werner, a partner in the Washington law firm of Holland & Knight and long-time advocate for hESC research.
“There’s certainly more to do from a scientific, political, and legal perspective, if you’re talking about turning this research into therapies for patients, but it’s a dramatic step forward and has been a long time coming.”
The executive order reverses a policy that has limited federal funding of hESC research to the handful of cell lines in existence as of August 9, 2001. The restriction reflected former President Bush’s belief that it was wrong to destroy human embryos to derive stem cells. His first use of veto power was to reject legislation that would have overturned the executive order. At the time he established his policy, Bush said funding research with the then-existing lines was justified since those embryos had already been destroyed.
President Obama likewise has cast his policy partly in terms of religious belief: “As a person of faith, I believe we are called to care for each other and work to ease human suffering,” he said at the signing ceremony. He allows people of faith may disagree with the new policy, but said, “The proper course has become clear,” given the consensus in favor of the research.
What Happens Next?
The new policy will help biotech companies interested in hESC research in three ways: It will provide funding for academic research through the NIH’s internal programs and its billions of dollars in external grant funding; it will provide money directly to entrepreneurial biotech firms through SBIR grants; and it will provide validation and assurance that the federal government will support the technology going forward.
“For years an enormous cloud has hung over this field,” Michael West, Ph.D., CEO of BioTime, a company with hESC research programs. “The large pharmaceutical companies have been very reluctant to get into this field simply because of the controversy.”
Dr. West is also a founder and former executive of Geron, which earlier this year became the first company to take an hESC product into clinical testing. It is being investigated as a therapy for spinal cord injury.
Dr. West and other supporters of hESC research are calling for legislation to codify the executive order, which will make it impossible for another president to reverse policy. In the meantime, the executive order calls on the NIH to develop guidelines for federally funded stem cell research.
Voluntary guidelines put forth in 2005 from the National Academies are expected to be a starting point, according to Josephine Johnston, a resident scholar at The Hastings Center, an independent bioethics research institution in New York. Under those guidelines, couples who have undergone in vitro fertilization procedures may donate their unused embryos to research under an informed-consent process. Scientists may then use those embryos to derive embryonic stem cells.
A legislative amendment passed in the mid-1990s prohibits the federal government from funding any part of this process or indeed any procedure that destroys embryos. Johnston notes that the U.S. is unique in its lack of regulation for hESC research that is not federally funded. Other countries regulate “regardless of the funding source. This differentiation between federal and private funding doesn’t make much sense.”
Other bioethicists agree. “The rules should be enforceable rather than voluntary guidelines and should apply to all stem cell research, whether it is publicly or privately funded,” says Marcy Darnovsky, Ph.D., associate executive director of the Center for Genetics and Society.
Concerns about hESCs
Besides the ethical concerns, some critics of federal funding for hESC research say adult stem cells have more potential to treat disease and that they make embryonic cells obsolete. “Embryonic stem cells were only cultured 10 years ago, so it’s a relatively young technology versus adult stem cells, which have been used for 40 years,” explains Frost & Sullivan research analyst Katheryn Symank.
“It’s way too early to discount hESC technology at this point,” she points out. The new federal policy, she says, could make this nascent technology very attractive to investors.
Dr. West agrees, noting that back in the 1970s recombinant DNA was highly controversial, for both safety and ethical reasons. But once safety was assured and the technology began to generate FDA-approved drugs such as insulin and growth hormone, “the cloud went away, and the industry just bloomed.”
Debbie Strickland is a GEN freelance writer.