The Rise of Stem Cell Research
Did George Bush inadvertently jumpstart a stem cell revolution?
Democrats in the House of Representatives passed legislation last week that would lift President Bush's restrictions on federal funding of embryonic stem cell research. Bush issued his only veto against the same legislation last year. The legislation would allow federal funding for developing new embryonic stem cell lines derived from donated embryos leftover from fertility treatments.
When Bush first restricted federal funding to embryonic stem lines derived before his nationally televised speech on the subject in 2001, researchers feared that such limits would send a signal that would strongly "chill" research in the field. For example, many researchers worried that Sen. Sam Brownback's (R-Kan.) bill to ban both publicly and privately financed therapeutic cloning research was just the first step toward outlawing all human embryonic stem cell research. But that didn't happen.
Instead, the research restrictions—real and proposed—provoked a strong pushback by researchers and eventually the public. States began big time funding of embryonic stem cell research, e.g., $3 billion in California and $270 million in New Jersey. And the floodgates of private funding opened, showering hundreds of millions on stem cell researchers. It is highly probable that far more embryos have been used for stem cell research than would have been the case had President Bush not imposed his restrictions. How's that for irony!
Although we'll never know for sure, it is also probable that the fear that further limits might be imposed on human embryonic stem cell research intensified the hunt for other sources of stem cells. And the very good news is that these searches have been very successful. Stem cells have been found in fat, testicles, umbilical cord blood and tissue, bone marrow, and, most recently, amniotic fluid. More therapies using adult stem cell should be soon available in the medical marketplace. In fact, stem cell research may be enhanced as states compete to fund the most promising work. Maybe.
Instead of being modeled on drug development, perhaps embryonic stem cell research will follow a development path more like that blazed by researchers in assisted reproduction. Rather than being hampered by a paucity of federal research funding perhaps embryonic stem cell research will flourish just as research on assisted reproduction techniques (ART) has. Arguably in vitro fertilization research has proceeded rapidly because of, not in spite of, essentially no federal funding. So far more than 3 million babies have been born by means of ART. Without intrusive federal oversight and regulation IVF researchers have been able to deploy new techniques such as intracytoplasmic sperm injection, pre-implantation genetic diagnosis, and sperm sorting for sex selection very shortly after they have been developed.
Research has stopped in promising areas of ART only when the Feds decide to get involved. For example, New Jersey Institute of Reproductive Medicine and Science researchers pioneered cytoplasmic transfer from donor eggs into the eggs of women that suffered from a defect in their cytoplasm. Revitalized, the eggs were fertilized, inserted into their mothers' wombs, and brought to term. Twenty children were born by means of the procedure, and then the FDA banned it. Cytoplasmic transfer is now available at fertility clinics in other countries. The latest breakthrough is in vitro maturation of eggs. Immature eggs are removed from a woman's ovaries and matured in a laboratory outside her body. This means that women no longer have to undergo uncomfortable hormone treatments to produce superovulation in order to obtain the number of eggs suitable for IVF procedures.
Meanwhile where federal research funding is most lavish and regulation is most onerous, that is where progress in getting treatments to patients is slowing down. The FDA approved only 18 new drugs in 2006, down from an average of 26 per year over the past six years. As the costs for getting through the regulatory gauntlet go up, pharmaceutical companies are narrowing their product lines and bringing fewer treatments to patients.
It is a truism among academic researchers and many economists that Federal funding is necessary for basic research and that such funding is perpetually inadequate. However, a 2001 study by Organization for Economic Co-operation and Development researchers found that in fact that higher spending by industry on R&D correlates nicely with higher economic growth rates. In contrast to the academic truisms about the need for Federal funding, the study found that "business?performed R&D … drives the positive association between total R&D intensity and output growth."
The OECD researchers noted that publicly funded defense research actually crowded out private research, "while civilian public research is neutral with respect to business?performed R&D." In other words, government funded civilian research didn't hurt private sector but there wasn't much evidence that it helped, at least in the short term. The report concluded, "Research and development (R&D) activities undertaken by the business sector seem to have high social returns, while no clear?cut relationship could be established between non-business-oriented R&D activities and growth." In other words, economic growth was associated almost entirely with private sector research funding. The OECD report did allow that perhaps publicly funded research might eventually result in long-term technology spillovers, but that contention was hard to evaluate.
As private donors and states continue to shovel tens of millions at stem cell researchers, it may just be that President Bush did embryonic stem cell research a huge favor when he imposed restrictions on federal funding of it.
Ronald Bailey is reason's science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is now available from Prometheus Books.
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