Saturday, October 25th, 2014

The Obameter

Ensure that stem cell research is conducted ethically and with vigorous oversight


"I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations. As president ... I will ensure that all research on stem cells is conducted ethically and with rigorous oversight."


Sources:
Subjects: Health Care, Science

Updates

2009 guidelines on embryonic stem cell research provide detailed oversight

Can embryonic stem cell research ever be conducted ethically?

That was the pledge President Barack Obama made when he lifted the restrictions placed on the use of embryonic stem cells by his predecessor. But a look at the battle that has played out over the last three years illustrates how contentious this area of biomedical research is.

Embryonic stem cell research involves the destruction of human embryos, an unambiguously immoral act to many in the right to life movement. But scientists say the cells, which are derived from an early developing embryo and can become any kind of human cell, are invaluable in the search for cures to many diseases.

While acknowledging that impasse, we'll take a look at the actions of the Obama administration in this area.

In 2001, President George W. Bush signed an order allowing research only on the 21 stem cell lines already in existence at the time, or on stem cells not derived from embryos. During the 2008 campaign, Obama vowed to end those restrictions.

He did so with an executive order of his own on March 9, 2009 (we rated that a Promise Kept), although he did not allow federal funds to pay for unlimited research on human embryos. Federal law still bans federal funding for research in which scientists directly destroy human embryos. Under Obama's order, scientists were allowed to study stem cell lines created by others, such as private fertility clinics, but not create their own lines.

His order also directed the secretary of health and human services to issue new guidelines for the research within 120 days through the National Institutes of Health, or NIH. The guidelines were to include "provisions establishing appropriate safeguards," and the guidance should be updated "periodically, as appropriate."

NIH released a draft of those guidelines in April 2009, detailing meticulous restrictions on the origin of cells that could be studied and how the cells could be obtained. For example, the guidelines:

• prohibited federal funding for work on stem cells taken from cloned embryos, or from embryos that were created expressly for research;
• permitted federal funding for research on cells derived from human embryos that were created solely for reproduction, that no longer were needed and had been donated;
• prohibited any form of payment to the donors of the cells.

The final rules were released in July 2009.

Richard Doerflinger, of the U.S. Conference of Catholic Bishops, told the Washington Post, "For the first time in history, the federal government will encourage the destruction of human life at a very early stage for federally funded research. These guidelines encourage researchers to go out and destroy embryos for taxpayer-funded research."

NIH, under the new guidelines, began approving additional lines of cells in December that year. At its disposal was $10 billion in economic stimulus money. A few months later, some researchers complained that the new rules -- specifically the provision requiring embryo donors to sign a consent form -- were inhibiting them from using the old lines approved under the Bush administration. And in July 2010, NIH for the first time rejected dozens of colonies of cells that contained genetic mutations (potentially valuable in studying diseases) because the consent forms were deemed too broad.

But beyond those incidents, the entire initiative was thrown into doubt when a federal judge blocked government funding of the research, ruling that the support violated a 1996 federal law barring the use of taxpayer money for experiments that destroy human embryos. NIH temporarily suspended funding because of the injunction, which was soon lifted while the case was on appeal. In August 2012, an appeals court threw out the legal challenge. Under a longstanding interpretation of the federal law -- that embryos are destroyed when stem cells are extracted in private labs and clinics, not by the federally financed researchers -- Obama's guidelines were allowed to stand.

Which brings us to this: Obama vowed to put protocols in place to ensure that federally funded embryonic stem cell research adheres to ethical guidelines and strict oversight. Knowing that many people object to the research in any form, we find that the rules put in place live up to Obama's pledge, which explicitly allowed for the research to go forward. From preventing payments for cell donation to prohibiting the creation of new lines solely for research, those guidelines meet the threshold for a Promise Kept.

Sources:

PolitiFact, "Obama signs executive order on stem cells,” March 9, 2009

National Institutes of Health, "Guidelines on Human Stem Cell Research,” April 2009

St. Petersburg Times, "NIH issues draft of stem cell rules,” April 18, 2009, via Nexis

New York Times, "Obama Plans To Retain Some Limits On Stem Cells,” April 18, 2009, via Nexis

New York Times, "Rules Will Allow Financing for Old Stem Cell Lines,” July 7, 2009, via Nexis

Washington Post, "U.S. set to fund more stem cell study,”

Washington Post, "Stem cell research waiting on 'lines'; Fate of Bush's 21 cell lines hampers Obama's attempt to lift funding restrictions,” March 15, 2010, via Nexis

Washington Post, "NIH rejects stem cell request; Director says use of dozens of colonies would break new rules,” June 22, 2010

Washington Post, "Judge blocks stem cell rules,” Aug. 24, 2010

Los Angeles Times, "Appeals court extends stem cell research,” Sept. 29, 2010, via Nexis

New York Times, "Funding For Stem Cell Research Is Upheld,” Aug. 24, 2012

Obama calls for stem cell guidelines

Editor's note: This is a promise we missed when we first created out database. We added it as promise No. 514 on March 9, 2009.

President Obama said during the presidential campaign that he opposed restrictions on the use of human embryonic stem cells in scientific research funded by the federal government.

"Rather than restrict the funding of such research, I favor responsible oversight of it, in accord with recent reports from the National Research Council," Obama wrote in response to a questionnaire from a consortium of scientific groups.

Obama signed an executive order on March 9, 2009, reversing President George W. Bush's orders limiting the research. As a result, we rated Promise No. 513 ("Reverse restrictions on stem cell research") a Promise Kept. The order also directs the secretary of health and human services to issue new guidelines for the research within 120 days through the National Institutes of Health. The guidelines should include "provisions establishing appropriate safeguards," and the guidance should be updated "periodically, as appropriate."

This is fairly vague, and Obama's nominee for secretary of health and human services, Gov. Kathleen Sebelius of Kansas, has yet to be confirmed. Still, it's enough for us to move this promise to In the Works.

Sources:

White House Web site, Executive order on stem cell research , March 9, 2009

White House Web site, Memorandum on scientific integrity , March 9, 2009

George W. Bush White House archive, Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways , June 20, 2007 

St. Petersburg Times, Stem cells partition labs , July 5, 2007

Nova, The Politics of Stem Cells , April 13, 2005

St. Petersburg Times, In stem cell debate, truth lies between the slogans , Aug. 4, 2004

George W. Bush White House archive, President discusses stem cell research , Aug. 9, 2001