Stem Cell Ruling Could Focus Funding on Treatments

U.S. District Court Chief Judge Royce C. Lamberth agreed on August 23 with two adult stem cell scientists, Drs. James Deisher and Theresa Sherley, who filed suit to block federal taxpayer funding of human embryonic stem cell (hESC) research, which they argued violated current federal law and caused them irreparable harm by restricting funding for adult stem cell research.

Judge Lamberth’s preliminary injunction halts federal taxpayer funding of hESC research. While the mainstream press and scientific elite have responded with horror, the ruling actually benefits patients seeking treatments. If the decision stands, it should free up millions more dollars for the types of stem cell research—adult stem cells—that are increasingly treating diseases previously thought untreatable, including diabetes and spinal cord injury.

How is it that the federal government funded something illegal? The judge ruled that in funding hESC research, the National Institutes of Health (NIH) violated a 1996 law named (after the congressional sponsors) the Dickey-Wicker amendment. The amendment, first passed during the Clinton Administration, prohibits research funding that involves destroying or harming human embryos.

In 1975, the federal government actually recognized that human embryos in the womb are to be protected as “human subjects” in federally funded research. The Dickey-Wicker amendment was passed to offer the same protections for embryos outside the womb. Since 1996 it has been included in every annual appropriations bill funding many federal health programs, including NIH.

It states that no federal funds may be used for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.”

At the time Dickey-Wicker passed, scientists were focused on fetal tissue research. After a disastrous trial that harmed many Parkinson’s patients, this research fell out of favor.

In 1998 researchers successfully grew hESC in the lab and brought on a new debate. How could the government fund research on hESC when obtaining such stem cells necessarily destroys the embryo, given the Dickey-Wicker restriction?

The Clinton Administration was in a pickle. In 1999, Harriet Raab, Health and Human Services general counsel, wrote a memo which argued that the Dickey-Wicker amendment only prohibited federal funds for actually killing or harming a human embryo, but federal funds could be used for research on the embryonic stem cells obtained after the embryos were destroyed with private funds.

As a result, in January 2000, new rules promulgated by then-NIH Director Harold Varmus allowed federal funding for hESC research so long as private funds were used to destroy the embryos. In response, several entities filed a lawsuit arguing that these guidelines were illegal because they violated the Dickey-Wicker amendment.

The lawsuit was never ruled on since the NIH funds did not go out the door. After stopping implementation of the Clinton guidelines, President Bush announced in August 2001 that he would allow limited funding on hESC obtained from embryos destroyed prior to that date. The Bush position differed from the Clinton guidelines by not creating a federally funded financial incentive to destroy more embryos.

Proponents of hESC research objected to the limitations, whereas a few groups, including the Family Research Council, opposed the Bush policy. Upon taking office, President Obama overturned the Bush policy with an executive order allowing hESC research funding so long as private dollars were used to destroy the embryos. It is the current policy that relied on the Raab memo and began funding hESC research beyond that approved under Bush.

It is to these new guidelines that Drs. Deisher and Sherley brought suit, and the judge agreed to enjoin.

Judge Lamberth’s opinion is clear and concise: “ESC research is clearly research in which an embryo is destroyed.” And he concluded, “Accordingly, the court concludes that, by allowing federal funding of ESC research, the guidelines are in violation of the Dickey-Wicker Amendment.”

He dismissed NIH’s argument that the law’s phrase “research in which” only applied to that part of research involved directly with the destruction of the embryo. He said that Dickey-Wicker clearly means that “all ‘research in which'” embryos are destroyed may not be funded. He therefore rejected the fundamental claim made in the Raab memo. The Obama Administration has said it will appeal.

But what does the ruling mean for patients if it remains and NIH must stop funding all hESC research? Since only adult stem cells are being used to treat patients, it clearly frees up millions more dollars for such adult stem cell treatments. These stem cells, including cord blood stem cells, are uncontroversial and currently treating thousands of patients.

Other kinds of novel stem cells, such as the Induced Pluripotent Stem Cells (iPSCs) act just like embryonic stem cells but are generated by reprogramming the genes of body cells. No embryos are involved, and government funding is allowed. For examples of the many diseases treated by adult stem cells, visit Stem Cell Research Facts.

In contrast, hESC have been used to treat no one, have controllability problems leading to tumors, and have the ethical baggage of coming from destroyed embryos.

It is true that the federal government is funding adult stem cell research. But it could do much more. It may require legislation to push the government, still bent on funding embryonic stem cell research, to put patient treatments first. The bipartisan legislation called the Patients First Act (H.R. 877), sponsored by Rep. Randy Forbes (R.-Va.) and Rep. Dan Lipinski (D.-Ill.), would do just that.

A Rasmussen poll released Friday found that 57% of Americans do not think the federal government should fund embryonic stem cell research, while only 33% think it should. Regardless of what is done with private funds, should not the federal government put patient treatments first? After all, lives are at stake, not just money