American Association for Cancer Research

AACR Cancer Policy Monitor

CPM

                                                                                                  SEPTEMBER 2010

UNCERTAINTY SURROUNDING STEM CELL RESEARCH PERSISTS                 

Legal battle far from over as Congress hears from NIH, researchers

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Longtime congressional champions for biomedical research brought the reignited debate over federal funding for human embryonic stem cell research to Capitol Hill last week, calling on the director of the National Institutes of Health (NIH), leading stem cell researchers, and a patient to testify before a Senate panel on the potential of this research to deliver cures and novel therapies to millions of people suffering from cancer, Alzheimer’s, Lou Gehrig’s disease, spinal cord injuries and other ailments.

Sen. Tom Harkin (D-Iowa), chairman of the Senate appropriations subcommittee that funds NIH, praised NIH Director Francis Collins, M.D., Ph.D., for his clear account of the exciting science surrounding embryonic stem cell research. Collins explained that embryonic stem cells offer the ability to investigate the molecular basis of normal development and disease, have the potential to provide regenerative therapy for injury or debilitating disease, and are already being used as a tool for high-throughput screening for novel therapeutics. He said that “patients stand to benefit the most and lose the most” from the decision to fund or not fund this research.

The future of this area of research became clouded on August 23 when Chief Judge Royce C. Lamberth of the Federal District Court for the District of Columbia granted a preliminary injunction that barred all federal funding for embryonic stem cell research while he considers a controversial case before him that questions the legality of NIH guidelines on stem cell research. At the heart of the legal battle is whether the guidelines, which were developed last year to implement President Obama’s executive order expanding the number of lines eligible for research, violate the 1996 Dickey-Wicker amendment that prohibits federal funds from being used for research that destroys or harms embryos.

Consequently, the NIH was forced to suspend review of all grants, contracts and applications involving the use of human embryonic stem cells.

An appeals court temporarily lifted the injunction on Sept. 9 and federally-funded embryonic stem cell research activities resumed, however, uncertainty persists as scientists await another decision, expected as early as Sept. 24, from the appeals court as to whether or not to extend the stay. If extended, the government will be able to continue funding such research until Lamberth rules on the legality of the guidelines. If the appeals court rules to discontinue the stay, federal financing would come to a standstill for an unforeseeable length of time.

Opponents of embryonic stem cell research often cite successes with the less controversial forms of stem cells—adult stem cells and induced pluripotent stem cells (iPSCs), which are adult stem cells reprogrammed to a state more like an embryonic stem cell—as justification to discontinue research using embryonic stem cells. Several witnesses at the Senate hearing disagreed, however, stating that all three types of stem cells needed to be studied in order to truly understand the potential for any one of the types. One witness, a researcher working with adult stem cells, avidly urged increased funding for adult stem cell studies, but dodged Sen. Harkin’s pointed question as to whether embryonic stem cell research should also be funded.

Prominent stem cell researchers George Daley, M.D., Ph.D., and Sean Morrison, Ph.D., told the Senate panel that the volatility in funding was threatening the preeminence of America in this area and was jeopardizing the careers of scientists in their labs.

Advocates for embryonic stem cell research are calling on Congress to provide a more permanent fix and restore stability to this promising area of research. House Members Rep. Diana DeGette (D-Colo.) and Rep. Mike Castle (R-Del.) have sponsored legislative proposals and have been vocal about their support. In the Senate, Sen. Arlen Specter (D-Penn.) has introduced a bill that would codify the NIH guidelines and sidestep Lamberth’s ruling.

Although Sens. Harkin and Specter expressed support for legislative proposals, the upcoming midterm elections make it unlikely that either chamber will take action on the controversial issue.

  • Take Action! Urge Congress to Support and Protect Stem Cell Research

Resource:

Review of stem cell federal policy and timeline of court proceedings

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