On and Off and On Again: Human Embryonic Stem Cell Research

The ethical and legal issues of human embryonic stem cell (hESC) research seldom fail to stir public debate. Recent events, however, have (in addition to producing a deluge of news items on the topic) resulted in weekly changes in the prognosis for the future of federally funded hESC research. Here is a summary, by date, of what has transpired in response to the case of Dr. James L. Sherley, et al., Plaintiffs, v. Kathleen Sebelius, et al., Defendants. Civ. No. 1:09-cv-1575 (RCL).

August 23, 2010: Judge Royce Lamberth, of the Federal District Court of the District of Columbia, granted an injunction preventing the NIH from using federal funds for hESC research. The plantiffs in the case (James L. Sherley and Theresa Deisher) argue that funds from the NIH are supporting research with does not conform with the Dickey-Wicker Amendment. Although interpretations vary, the Amendment prohibits the NIH from creating or harming human embryos for research purposes. The injunction sought to stop hESC research until the case of Sherley v. Sebelius is resolved in the courts. (See: Sherley v. Sebelius, Dist. Court, Dist. of Columbia 2010.)

August 31, 2010: The U.S. Department of Justice (DOJ) filed a motion to stop the injunction on the behalf of the NIH, the Defendants’ Emergency Motion to Stay Preliminary Injunction Pending Appeal and for Expedited Briefing and Consideration. In the Motion to Stay the defendants (NIH) disagree with Judge Lamberth’s interpretation of the Dickey-Wicker Amendment. The NIH insists that the Amendment does not prohibit research involving pre-existing hESCs. The NIH also argues that research using hESCs can be distinguished from research to create new hESC lines.

Francis Collins, in a declaration attached to the Motion, also pointed to the public costs of the ruling. According to Collins, the injunction would “result in [the] immeasurable loss of valuable and one-of-a-kind research resources”. Part of this “immeasurable loss” includes the waste of “over $546 million dollars of public funds” already spent on hESC related research. (See Motion to Stay, available from: http://www.nih.gov/about/director/stemcell/stay_08312010.pdf.)

September 8, 2010: Judge Lamberth rejected the DOJ’s request to temporarily lift the injunction. In his response to the Motion to Stay, the Judge wrote: “a stay would flout the will of Congress, as this Court understands what Congress has enacted in the Dickey-Wicker Amendment … Congress has mandated that the public interest is served by preventing taxpayer funding of research that entails the destruction of human embryos.” The DOJ continued its appeal in the Court of Appeals for the District of Columbia. (See: Rob Stein. Judge declines to lift stem cell funding ban. The Washington Post. September 8, 2010.)

September 9, 2010: The U.S. Court of Appeals for the District of Columbia granted the Motion to Stay. The temporary order allows federally funded research using hESCs to continue while the court hears the appeal to Lamberth’s decision. The Court requested additional information from the parties by September 20, 2010. Afterwards, the Court will determine whether the order to stay the injunction will remain in place for the duration of the case before the District Court. (See: Gardiner Harris. Stem cell financing ban ends, for now. The New York Times. September 9, 2010.)

September 9, 2010: Plaintiffs filed a Motion for Summary Judgment in the District Court. (See Motion for Summary Judgment, available from: http://docs.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2009cv01575/138107/55/.)

September 10, 2010: In addition to generating media coverage and frustrating researchers, the legal dispute has spurred other public developments. While the temporary stay is in place, the NIH is “rushing” to fund hESC research. According to Science Insider, the NIH hopes to expedite funding for 24 ongoing grants (due for renewal in September and October). The funding, however, comes with a caution to exercise “prudence in resuming experiments.” (See: Gretchen Vogel and Jocelyn Kaiser. NIH rushes to hand out stem cell grants during temporary stay. ScienceInsider. September 10, 2010.)

September 13, 2010: Reacting with similar urgency, legislators have renewed the push to legalize hESC research. In the Senate, Arlen Specter introduced S. 3766: A bill to amend the Public Health Service Act to provide for human stem cell research, including human embryonic stem cell research, and for other purposes. Meanwhile, Diana DeGette has introduced H.R. 4808: Stem Cell Research Advancement Act of 2009—the House version of Thomas Harkin’s S. 487.Versions of similar bills were passed by Congress, but vetoed by President Bush in 2005 and 2007. (See: Karen Kaplan. Congress registers its support for human embryonic stem-cell research. Los Angeles Times. September 13, 2010.)

September 16, 2010: Senator Thomas Harkin will hold a hearing on “The Promise of Human Embryonic Stem Cell Research” before The U.S. Senate Committee on Appropriations. The hearing will be available as a webcast at http://appropriations.senate.gov/ Speakers include: Francis S. Collins, NIH; George Q. Daley, Children’s Hospital Boston; Sean J. Morrison, University of Michigan; Jean Peduzzi-Nelson, Wayne State University; and Cody Unser, Cody Unser First Step Foundation. (See: U.S. Senate Committee on Appropriations. Committee Schedule for the Week of Sept. 13th. Press Release. September 13, 2010.)

Related Links:
NIH Stem Cell Information
Stem Cells: The New York Times
Insoo Hyun. Stem Cells. In From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 159-162.
Andrew Siegel. Ethics of Stem Cell Research. The Stanford Encyclopedia of Philosophy (Fall 2008 Edition), Edward N. Zalta (ed.)

Other Research Ethics News

Editorial: Bank of infant blood spots is valuable resource for medical research. The Detroit News. September 5, 2010.

Timothy Caulfield. [Commentary] The cure for MS includes healthy skepticism and a dose of hope. The Globe and Mail. September 2, 2010.

Dan Frosch. Will Aging Chimps Get to Retire, or Face Medical Research? The New York Times. September 1, 2010.

CIHR Press Release. CIHR makes recommendations on Canadian MS research priorities. CIHR. August 31, 2010.

Henry I. Miller. [Commentary] Anti-drug fear factor trumps facts. The Washington Times. August 24, 2010.

Kaiser Family Foundation. Study Examines Movement Of Pediatric Drug Testing Outside The U.S. Kaiser Daily Global Health Policy Report. August 24, 2010.

Gina Kolata. What to tell the patients after a trial goes awry. The New York Times. August 23, 2010.

Scott McLemee. The mild torture economy. Inside Higher Ed. August 18, 2010.

Eugenie Samuel Reich. High price to pay for misconduct investigations. Nature News. August 17, 2010.

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