Stephen Kintz
Apr 29, 2012

The effects of regulation on stem cell research

In 2009, Barack Obama issued Executive Order 13505, which allowed the National Institutes of Health (NIH) to develop guidelines for the funding and development of embryonic stem cell research. The guidelines give the government authority to begin funding research on embryonic stems developed from surplus cells donated by couples during in vitro fertilization. The guidelines also provide the government with the framework to approve or disapprove older lines of embryonic stem cells, such as the 21 lines of embryonic stem cells approved by the Bush administration in 2001, which might not fully meet the new regulations. NIH has also developed a national registry of available lines of embryonic stem cells. For many scientists, this was a small step in the right direction because it creates a process for allowing access to as many as 700 new lines of embryonic stem cells.

Rather predictably, two researchers, James Sherley and Theresa Diesher, have filed a lawsuit claiming the new guidelines violate an older law, called the Dickey-Wicker amendment, that prevents the United States government from supporting research that puts embryonic stems cells at risk of being destroyed. The plaintiffs believe that destroying of embryonic stem cells is immoral. The case is currently being heard in the US Court of Appeals for the District of Columbia Circuit, and there is a strong possibility that it will make its way to the Supreme Court.

Because of the uncertainty of the outcome, I don't know the effects that the court case will have on future stem cell research. However, I do wonder if the current regulations and on-going legal battle over stem cell research is hurting scientific progress.

Unfortunately, it does appear that this is the case. For example, the original 2009 guidelines did not allow the federal government to fund stem cell research using stem cells created from somatic nuclear transfer (cloning) or another technique in which is single cell (called a blastomere) is taken from an embryo. Moreover, the continued court battle has prevented NIH from making changes to the guidelines that would allow stem cells developed from these techniques. Both of these methods are considered highly productive in producing new lines of stem cells. The ban on the single blastomere technique is particularly frustrating for many scientists because this technique does not destroy the human embryo.

This reduces the supply of stem cells available for public funding and drives up cost. It also leaves research companies (like ACT) that are trying to conduct clinical trials using stem cells from a non-approved line with little recourse but to fund the research entirely themselves. Therefore, it is no wonder that companies, like Geron Inc., have discontinued many research projects using stem cells.

The problem is exacerbated when one realizes that adult stem cells, touted as an alternative to embryonic stem cells, have some limitations. Researchers have determined that adult stem cells retain the properties of the cells they were derived from. This suggests that adult stem cells could be limited to only producing a few types of tissues. Our over-reliance on less-flexible adult stem cells could slow down progress and limit innovation.

Another problem is that many researchers use both adult and embryonic stem cells in their research. In 2010, the Mayo Clinic determined 26 percent of research papers using adult stem cell also used embryonic stem cells. Research that compares adult stem cells and embryonic stem cells allows for scientists to develop a better understanding of adult stem cells, because adult stem cell research is still in its infancy. Without the ability for scientists to compare various lines of stem cells, progress in adult stem cell work will be slow.

Of course, the real problem about government regulations limiting access to embryonic stem cells and funding is that it limits our global competitiveness. China is one of the fastest developers of stem cell research, so not everyone in the world has so many regulations and limits. This puts US scientists at a distinct disadvantage. America’s true scientific might lays in the fact that the US attracts so many scientists to its shores. Yet, if funding and materials are not present, scientists will go elsewhere. The United States will lose our scientific edge in stem cell research if we continue to limit the funding and resources for scientists.

So government regulations and legal battles are hurting scientific progress. Hopefully, the court will not overturn Barack Obama’s 2009 executive order because stem cell researchers and research companies are already struggling.