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Posted by on Sep 1, 2010 in Ethics, Legal

DoJ to Appeal Stem Cell Ruling

DoJ to Appeal Stem Cell Ruling

hESCs.jpg

In an effort to better understand the legal issues surrounding the use of human embryonic stem cells (hESCs) for research, the following timeline is provided. It is is mostly informed by Judge Royce C. Lamberth‘s August 23rd decision, which blindsided many researchers who work with hESCs; however, it is also supplemented (and confirmed) by other linked sources.

1960s: Researchers discover, isolate, and begin to work with human stem cells, which are derived directly from bone marrow, peripheral blood, or discarded tissues, like the umbilical cord and placenta. These cells are multipotent, meaning that they can differentiate into a limited number of cell types. Their most notable therapeutic use during the next decades is the reconstitution of bone marrow during bone marrow transplantation.

1996: Congress passes and President Bill Clinton signs the Balanced Budget Downpayment Act, which contains the Dickey-Wicker Amendment. The amendment, or really rider, prohibits the use of federal funds to support research “in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero.” Since 1996, Congress includes the Dickey-Wicker Amendment in every iteration of its appropriations bill for the DHHS.

November 1998: James Thomson, VMD, PhD, of the University of Wisconsin, and colleagues report their process of creating stem cells from human embryos. The hESCs are pluripotent, meaning that they can differentiate into any of the 200 or so cell types found in the human body. They can also be maintained indefinitely. The potential of hESC-based research surpasses that of work on traditional stem cells, because the latter are only multipotent, not pluripotent. Creation of the hESCs, however, requires destruction of a human embryo (or really its potential to develop into a human being), which produces a moral/ethical dilemma.

July 7, 1999: The Clinton administration circumvents the Dickey-Wicker Amendment by arguing that hESCs are not embryos as defined by the statute and that research on existing hESC lines should not be prohibited, because it does not destroy embryos. Congress subsequently fails to alter the Dickey-Wicker Amendment.

August 9, 2001: President George W. Bush publicly addresses the use of federal funds to conduct research on hESCs. Informed by his conservative beliefs, he reports to the nation,

As a result of private research, more than 60 genetically diverse stem cell lines already exist. They were created from embryos that have already been destroyed, and they have the ability to regenerate themselves indefinitely, creating ongoing opportunities for research. I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life and death decision has already been made.

June 20, 2007: President Bush issues Executive Order 13435, which expands on his statement from August 2001. The order stipulates,

The Secretary of Health and Human Services (Secretary) shall conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus [emphasis added].

And

…[T]he destruction of nascent life for research violates the principle that no life should be used as a mere means for achieving the medical benefit of another…human embryos and fetuses, as living members of the human species, are not raw materials to be exploited or commodities to be bought and sold…

December 2007Thomson et al report their success in genetically reprogramming some specialized adult human cells to assume a stem cell-like state. Through the use of viral vectors, these induced pluripotent stem cells (iPSCs) are forced to express genes that confer the defining properties of ESCs. The NIH later warns, however, that, although iPSCs meet the defining criteria for pluripotent stem cells, it is not known if iPSCs and ESCs differ in clinically significant ways. Moreover, in animal studies, the virus that is used to introduce stem cell factors sometimes causes cancers. According to the NIH, researchers are investigating nonviral delivery methods. If iPSCs become, for all practical purposes, equivalent to ESCs, their use cannot be objected to on the basis of the destruction of human embryos.

March 9, 2009: President Barak Obama issues Executive Order 13505 (Removing Barriers to Responsible Scientific Research Involving Human Stem Cells), which states that the DHHS Secretary (Kathleen Sebelius), through the NIH Director (Francis Collins, MD, PhD), “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.” The executive order pertains to extramural NIH-funded stem cell research. The executive order revokes the President Bush’s statement of August 9, 2001 and his follow-up Executive Order 13435 of June 20, 2007.

April 23, 2009: In response to Executive Order 13505, the NIH publishes draft guidelines, “National Institutes of Health Guidelines for Human Stem Cell Research,” which allow for the funding of research with hESCs “that were derived from human embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.” The NIH receives approximately 49,000 comments on the draft guidelines.

July 7, 2009: The NIH publishes its final guidelines for scientific work on hESCs, with a number of stipulated conditions for their use. The guidelines also acknowledge,

Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted this provision as not applicable to research using hESCs, because hESCs are not embryos as defined by Section 509. This long-standing interpretation has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which federal funding is permitted.

August 19, 2009: Plaintiffs James L. Sherley, MD, PhDTheresa Deisher, PhD, Nightlight Christian Adoptions (“Nightlight”), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association (“CMA”) file suit in the US District Court for the District of Columbia against Kathleen Sebelius et al. The plaintiffs seek declaratory and injunctive relief to prevent the NIH’s Guidelines for Human Stem Cell Research from taking effect. Specifically plaintiffs argue that the NIH guidelines violate the Dickey-Wicker Amendment.

October 27, 2009Judge Lamberth dismisses the plaintiffs’ suit, finding that the plaintiffs lack standing. Lamberth also denies the plaintiffs’ motion for a preliminary injunction as moot. The plaintiffs appeal.

June 25, 2010: The Court of Appeals reverses, concluding that Drs. Sherley and Deisher, who work with adult stem cells, had standing under the competitor-standing doctrine. Because the other plaintiffs did not contest the Court’s prior finding, the Court of Appeals treats “their lack of standing as conceded.” The Court of Appeals then remands the matter back to the US District Court for the District of Columbia to consider the plaintiffs’ motion for a preliminary injunction.

August 23, 2010: Judge Lamberth rules “that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction.” Lamberth agrees that federal funding of hESC research increases competition for limited NIH funds, thereby causing an “actual, imminent injury” to Drs. Sherley and Deisher. “Accordingly, plaintiffs would suffer irreparable injury in the absence of the injunction,” Lamberth writes. Moreover, Lambert concludes that the imminent injury to Drs. Sherley and Deisher outweighs any potential harm to individuals who may otherwise benefit from hESC research. He concludes, “It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease.” Lamberth did not agree with the defendants that the Dickey-Wicker Amendment is ambiguous (thus allowing for the distinction between the creation of hESC lineswhich necessarily destroy an embryo’s potential to develop into a human beingand subsequent research on extant hESC lines). On the contrary, he ruled that adherence to the amendment is in the public interest.

Here, the will of Congress, as expressed in the Dickey-Wicker Amendment, is to prohibit federal funding of research in which human embryos are destroyed. Accordingly, it is in the public interest to enjoin defendants from implementing the Guidelines because the Guidelines allow federal funding of ESC research, which involves the destruction of embryos.

August 31, 2010: The Justice Department files an emergency motion, asking Judge Lamberth to temporarily stay his ruling, while the government appeals.

Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.

bmartin (1130 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.