Judge Deals Biotech Blow Over Stem Cells

A federal district judge has once again thrown into question one of the most promising, potentially lucrative, and politically divisive areas of biotech research.

Chief Judge Royce C. Lamberth of the Federal District Court for the District of Columbia on Monday put a halt to federal funding of embryonic stem cell research. The judge reversed, at least temporarily, a policy put in place by President Barack Obama allowing the National Institutes of Health to funnel money to research on stem cells harvested by embryos created for in vitro fertilization, but then not used.

The judge found that a group of researchers working with adult stem cells, represented by the Alliance Defense Fund, had a good chance of winning their suit challenging the Obama administration’s policy. That suit was based on a 1996 Congressional ban on destroying embryos to create embryonic stem cell lines.

Lamberth’s ruling throws into question embryonic stem cell research, and renews the political and social battle over the research and its promise as a business and a potential cure for numerous diseases.

“I have had to tell everyone in my lab that when they feed their cells tomorrow morning, they better use media that has not been funded by the federal government,” Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, told the New York Times. “This ruling means an immediate disruption of dozens of labs doing this work since the Obama administration made its order.”

During the administration of President George W. Bush, federal funding for research into new lines of embryonic stem cells was halted, opening the way for states like California to fill that funding gap. California’s San Francisco Bay area is the heart of biotech research companies and the venture capitalists who fund them.

Stem cells have the potential to become any specialized cell in the body, making them an attractive option for those trying to create biologically based cures for diseases. Embryonic stem cell cures are still very much in the early research stage, which is why government funding plays such a large role in the research.

Still, one company has begun tests using the cells for research that could go beyond the lab and into the market. The FDA has agreed to allow a study by Geron Corp., a Menlo Park, California, biotech firm, into whether embryonic stem cells can be used to help cure those with spinal cord injuries.

Even getting to the point of allowing human studies has proved hugely expensive and time consuming, taking 15 years and $150 million. And the research has proved politically and morally divisive.

Proponents of the research say it has huge promise to bring cures for diseases from diabetes to Alzheimer’s, and the Obama administration in its order backed that premise.

But embryonic stem cell research has drawn powerful opposition from those who say the embryos destroyed are budding humans. Among the opposition, count many religious conservatives, including the hierarchy of the Roman Catholic Church.

Research dollars should be directed to adult stem cell lines, many argue, a form of research that doesn’t carry with it the moral questions of embryonic stem cell research, since embryos aren’t destroyed in the extraction of those lines.

There are, however, many researchers who say embryonic cells are more adaptable than adult cells, and therefore more promising when it comes to finding uses for them in fighting disease.

So where does Lamberth’s ruling leave business?

In many ways, the industry is at least temporarily back where it was before Obama took office in January 2009. That means researchers in California and other areas who have backed the research themselves have an edge over competitors in other areas of the country. And it also could give the edge to researchers in other nations including the United Kingdom, where doctors say they have created red blood cells using embryonic stem cells.

During the Bush ban on funding, in 2004, California voters allowed the state to sell $3 billion in bonds to fund the California Institute for Regenerative Medicine (CIRM), which since has earmarked more than $1 billion for 364 projects, including construction of stem cell research facilities and research programs, the San Francisco Business Times reports.

“The decision leaves CIRM as the most significant source of funding for human embryonic stem cells in the U.S.,” CIRM president Alan Trounson said in a press release.

And CIRM officials, condemning Monday’s ruling, vowed to move forward with the stem cell work they have begun. And while those opposed to embryonic stem cell research have invoked moral arguments, so do those who advocate for it.

“It would be immoral to unnecessarily delay the critical medical research that is vital for human embryonic stem cell therapies to reach patients suffering from chronic disease and injury,” said Robert Klein, chairman of the CIRM governing board. “We must remember that the microscopic cells used for this research would otherwise be thrown away by in vitro fertilization clinics, by couples that had finished their family planning.”

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Kent Bernhard Jr. is News Editor of Portfolio.com