Stem Cell Ruling Will Slow Research--But Not Stop It

U.S. District Judge Royce C. Lamberth issued a ruling that undoubtedly stunned many boomers who've been hoping that treatments based on embryonic stem cells might eventually spare them from Alzheimer's, Parkinson's and other age-related diseases.

Lamberth's ruling (here's the full text) essentially blocks the Obama Administration from providing federal funding for research involving embryonic stem cells.

As this Milwaukee Journal Sentinel article details, the court ruling abruptly halts $70 million in federally funded embryonic stem cell research. At the University of Wisconsin-Madison, where embryonic stem cells were first isolated and grown back in 1998, 20 such projects are on hold.

"There's huge uncertainty," Stephen A. Duncan, director of UW-M's Program in Regenerative Medicine and Stem Cell Biology, told the Journal Sentinel. "I've got Ph.D. candidates who are working with embryonic stem cells who have to stop working with them. Everything will die."

Lamberth put up this roadblock by granting an injunction sought by two researchers who are ethically opposed to the use of embryonic stem cells, which are obtained from unused embryos donated by clients from in-vitro fertilization clinics. The plaintiffs contend that federal funding for such research reduced the amount of money available for their own research into the use of an alternative approach involving induced pluripotent stem cells (iPSCs), also known as adult stem cells.

Lamberth found that the Obama decision to fund research utilizing new embryonic stem cell lines violated an amendment passed by Congress in 1996--and subsequently added to budget bills ever since--that bans federal funding for research that involves any destruction of embryos. As this New York Times article points out, Lamberth's recent ruling has sweeping implications because it seems to ban any federal funding for embryonic stem cell research, including projects that would have been allowed under the Bush Administration's policy of allowing use of embryonic stem cell lines created before 2001.

Lamberth's decision comes at a particularly ironic time. As we explained in this blog post, the U.S. Food and Drug Administration has given the go-ahead to Northern California biotechnology firm Geron to begin human trials of GRNOPC1, an embryonic stem cell treatment for paralysis. Geron says GRNOPC1 may also have the potential to treat Alzheimer's disease and other neurological ailments for which there presently are no effective treatments. The trial isn't federally funded, so Lamberth's ruling doesn't affect it.

The court ruling, however, will wreak havoc on many other currently planned studies. But it won't stop embryonic stem cell research from moving ahead. Because of a Bush-era ban on federal funding for research from new embryonic stem cell lines, other players stepped in to support the work. The most notable example is the state of California. In 2004, voters there passed Proposition 71, which resulted in the state providing $300 million a year to underwrite embryonic stem cell research--more than four times the amount that was coming from the federal government under the Obama Administration. Wisconsin, Connecticut, Maryland, New Jersey and others are following suit on a smaller scale.

Beyond that, private sector funding is now flowing into the labs that are working on embryonic stem cell therapies. Geron, the company testing the first embryonic stem-cell treatment approved by the FDA, has invested more than $200 million in its stem cell program. As this Fortune article notes, pharmaceutical giant Pfizer announced last November that it is investing $100 million in both embryonic and adult stem cell research over the next three to five years. If Geron's new treatment does well in trials, look for the spigot to open even further.