Sherley v. Sebelius: a Call to Congress to Explicitly Support Medical Research on Human Embryonic Stem Cells

• Publication year: 2010

Layla Cummings⁰

Progressive biomedical research is the key to developing new and effective treatments for many of the diseases and conditions that afflict our society. The scientific community is in agreement that human embryonic stem cell research is a field that holds great promise. The recent federal district court opinion in Sherley v. Sebelius threatens to derail the progress of science and the hope of millions by denying federal funding of this research based on an appropriations rider known as the Dickey-Wicker Amendment. While the rider's plain language bans federal funding of any research that creates or destroys embryos, it has been accepted for over a decade that the government may fund research on stem cell lines that are obtained through private funding. With an uncertain outcome pending in the Court of Appeals, it will be argued that the Dickey-Wicker Amendment should be amended or repealed to give effect to the longstanding practice by the National Institutes of Health of funding human embryonic stem cell research within ethical guidelines. Furthermore, Congress should make it a priority to pass the Stem Cell Research Advancement Act in order to explicitly support the efforts of scientists working with human embryonic stem cells to develop groundbreaking medical advances.

I. Introduction

Embryonic stem cell research has been a divisive political and social issue since its inception. It provides hope of progressive new treatments to the millions suffering from devastating medical conditions, such as diabetes, heart disease, vision and hearing loss, and spinal cord injuries.¹ Unfortunately, since embryonic stem cell research involves the destruction of human embryos, it also stirs intense debate mainly focused on the moral status of days old embryos.² In late August of 2010, a federal district court judge sent the medical research community into a panic by declaring that federal funding of embryonic stem cell research is contrary to federal law.³ In Sherley v. Sebelius, Judge Royce Lamberth relies on an appropriations rider known as the Dickey-Wicker Amendment ("Amendment")⁴ to strike down new guidelines developed by the National Institutes of Health ("NIH"). These guidelines were designed to increase the quantity of embryonic stem cell lines available for medical research purposes.⁵

The technique to isolate and grow stem cells from human embryos was first perfected in 1998 by researchers at the University of Wisconsin.⁶ In the decade since the scientific breakthrough was made, the issue has garnered attention from conservatives and liberals alike. The first federal funds to go towards human embryonic stem cell research were approved by President George W. Bush, albeit with significant restrictions.⁷ Under President Obama, support for embryonic stem cell research was to be expanded by an executive order that would lift the restrictions put in place by President Bush.⁸ Despite a change in executive policy, the district court decision in Sherley v. Sebelius demonstrates that President Obama may not be able to expand embryonic stem cell research without the support of Congress.

Part II of this Recent Development briefly discusses the current state of stem cell research and sets the foundation for the argument that embryonic stem research should continue as a means of ultimately providing effective treatment to life-threatening conditions and diseases. Part III discusses the regulatory framework surrounding stem cell research in the United States, the holding reached in Sherley v. Sebelius, and the rationale behind the decision. Part IV recommends that Congress act to amend or repeal the Dickey-Wicker Amendment as well as pass legislation codifying President Obama's executive order, which called for the expansion of stem cell research within a responsible ethical framework.⁹

II. The Basics of Stem Cell Research

A. What Are Stem Cells?

Stem cells are important for research purposes because, unlike other cells, they are undifferentiated. This means that they have yet to transform into the many different types of cells in the body.¹⁰ There are three basic types of human stem cells: 1) embryonic stem cells ("hESCs"); 2) adult stem cells ("ASCs"); and 3) induced pluripotent stem cells ("iPSCs").¹¹ Human embryonic stem cells are typically derived from pre-implantation stage embryos¹² and are pluripotent, meaning they have the ability to divide into almost any type of cell in the body.¹³ Pluripotent cells provide a unique glimpse into the study of cell development and are a potential source for new replacement cells and tissues to be used in medical treatments.¹⁴ Adult stem cells are cells found in organs and tissues and are multipotent, meaning they are further differentiated than hESCs but they can still be specialized into a few different cell types.¹⁵ The area of the body where the particular adult stem cell originated (i.e. the heart, bone marrow, blood) generally limits the research value of ASCs.¹⁶ Research on ASCs has been conducted since the 1950s and is accepted as uncontroversial because it involves adult donors, not embryos.¹⁷ The third type of stem cell, induced pluripotent stem cells, are adult cells that have been "genetically reprogrammed to an embryonic stem cell-like state."¹⁸ Research on human iSPCs began in late 2007 and is a promising new area of research that may lead to the same type of potential for medical treatments as hESCs.¹⁹

B. The Significance of Human Embryonic Stem Cell Research

Currently, federal funding supports all three types of stem cell research.²⁰ There have been policy arguments made that question the necessity of human embryonic stem cell research when adult stem cell research is successful and induced pluripotent stem cell research may provide similar benefits. However, an argument in favor of abandoning human embryonic stem cell research for adult stem cell and induced pluripotent stem cell research is shortsighted.²¹ The reasoning against using exclusively adult stem cells to conduct such research is simple: as multipotent cells, ASCs have limited utility.²² Adult stem cells do not have the flexibility to turn into almost any of the cells of the body, as hESCs and iPSCs can when manipulated by researchers.²³ Additionally, hESCs are capable of "long-term self renewal,"²⁴ allowing them to continue dividing without becoming differentiated for months or even years, whereas most adult stem cells cannot perform this function.²⁵ Long-term self-renewal allows researchers to experiment on these particular lines of cells, which will help them understand more and gain an understanding of the cellular regulatory process, which could prove valuable for treatment purposes.²⁶

The abandonment of hESC research may also be premature because induced pluripotent stem cell research is in its infancy and human embryonic stem cells are still the "gold standard."²⁷ With only a few years of research completed on iPSCs, the research on hESCs must continue in order to develop meaningful comparisons between the two types of cells and their potential benefits to medical research.²⁸ In the meantime, the medical significance of this research demands that we "simultaneously pursue all lines of research."²⁹ Human embryonic stem cells provide a novel way to conduct early stage screening for new drugs and "may hold the secrets to creating entirely new targeted clinical therapies."³⁰ Developments in the public and private sector, including the first Food and Drug Administration ("FDA") approved trial involving the use of hESCs, demonstrate that the need for hESCs in biomedical research is, and will remain, of significant importance for the foreseeable future.³¹

III. The Law and Embryonic Stem Cells

A. A Brief History of the Dickey-Wicker Amendment

The Dickey-Wicker Amendment was first added to the Balanced Budget Downpayment Act of 1996³² and has been reenacted without "substantial alteration"³³ every year since as part of the Health and Human Services Appropriations bill.³⁴ The relevant language states that federal funding will not support:

(1) the creation of a human embryo or embryos for research purposes; or

(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero . . . .³⁵

Simply put, federal agencies may not fund research that will result in the creation or destruction of embryos. This section of the

appropriations bill is known as an appropriations rider,³⁶ and is commonly used to limit the funding that federal agencies may use for specific purposes.³⁷ Limitation riders such as the Amendment can be controversial because they do not involve the same review process as substantive legislation passed by Congress that directly bans agency action.³⁸

Human stem cell research took off in earnest in 1998 when Dr. James Thomson's method of isolating stem cells was developed.³⁹ This development occurred two years after the Amendment was signed into law.⁴⁰ The Amendment has been passed every year since 1996 without "substantial alteration"⁴¹ as part of the Health and Human Services appropriations bill.⁴² Given the timeline, proponents of hESC research will argue that the Amendment was not passed with the specific intention of limiting hESC research.⁴³ However, opponents have a strong argument that the Amendment was passed with the intention of regulating the use of federal funds for research that was not yet in existence, but could involve human embryos.⁴⁴

The Amendment can be interpreted to ban all research activity that will result in the destruction of human embryos.⁴⁵ After stem cells were first derived from embryos, a process that necessarily destroys the embryo,⁴⁶ the NIH requested guidance from the u.S. Department of Health and Human Services ("HHS") regarding funding of embryonic stem research.⁴⁷ In 1999, near the end of the Clinton Administration, HHS legal...