Dying to wait: how the Abigail court got it wrong.

• Author: Tovanche, Juan Joel

1. INTRODUCTION II. ABIGAIL ALLIANCE V. VON ESCHENBACH III. THE AMERICAN TRADITION OF SELF-MEDICATION A. Self-Medication in Early America B. The Patent Medicine Boom C. Americans and "Illicit" Drugs IV. THE AMERICAN TRADITION OF LAISSEZ-FAIRE DRUG REGULATION A. Consumer Protection in Early America B. State Regulations 1. The Virginia Act of 1736 2. The New Orleans Act of 1808 3. A Short Survey of State Regulations C. Federal Regulations 1. The Import Drug Act of 1848 2. The Pure Food and Drugs Act of 1906 3. The Food, Drug, and Cosmetic Act of 1938 and its 1962 Kefauver-Harris Amendments V. THE PROPOSAL VI. CONCLUSIONS I. INTRODUCTION

   At age twenty-one, Abigail Kathleen Burroughs met a fate usually reserved for aged men who have spent much of their lives drinking and smoking. (1) Diagnosed with cancer at age nineteen, Abigail battled the squamous cell carcinoma that invaded her body even as she struggled to maintain her characteristic optimism. (2)

   Abigail struggled with more than her illness, however. (3) In the last years of her life, Abigail and her family also wrestled with Food and Drug Administration (FDA) regulations that denied her access to medication that could have saved her life. (4) The policy at issue was the FDA's practice of progressive testing, which requires that experimental drugs pass at least three testing phases before the FDA will grant approval for commercial marketing and public access to a drug. (5) For Abigail, the process proved too long. (6) This policy denied her the experimental drug, Erbitux, a cancer-fighting drug that Abigail's oncologist believed had a significant chance of saving her life. (7) Despite her doctor's dedication and her family's continuing support, Abigail died in 2001--just two years after being diagnosed with the fast-moving cancer. (8)

   Following Abigail's death, her father, Frank Burroughs, founded the Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) (9) which has dedicated itself to removing the "regulatory barriers currently preventing seriously ill patients from gaining access" to potentially life-saving drugs. (10) Toward that end, the Abigail Alliance filed suit against the Secretary of the Department of Health and Human Services and the FDA Commissioner, seeking to enjoin enforcement of the ban on Phase I experimental drugs (11) that have been "deemed sufficiently safe for substantial human testing, but [have] not yet proven to be safe and effective [for commercial marketing]." (12)

   On August 30, 2007, the D.C. Circuit dealt the Abigail Alliance a harsh blow when it held in Abigail v. von Eschenbach that terminally ill patients, such as Abigail, have no constitutional right of access to drugs that have not been proven safe and effective by the FDA. (13) Consequently, seriously ill patients seeking access to experimental drugs must either fit the FDA's stringent qualifications for experimental trials or wait for the drug to make its way through the FDA's burdensome approval process. (14) For people, like Abigail, who are denied participation in experimental studies, (15) the typical seven-year wait will end in a death made all the more bitter by the knowledge that the FDA withheld access to potentially life-saving medications. (16) That the FDA eventually approved the very experimental drug Abigail sought to save her life must have been bitter medicine for her friends and family. (17)

   This paper will argue that the D.C. Circuit's decision in Abigail rested on faulty conclusions. Specifically, the Abigail court's cursory examination of the history of drug (18) regulation in the United States resulted in a mischaracterization of our nation's traditional attitude toward individual access to medicines. A close examination of the history of pharmacology in this country reveals the true tradition--a society accustomed to self-medicating and which implicitly assumed the government could not interfere with its personal choice to take certain medications. (19) Section II of this paper examines the holding in Abigail with reference to Washington v. Glucksberg, (20) which set out the test for determining whether a particular liberty interest is fundamental. Section III reveals the long-held American tradition of self-medication. Section IV surveys the American history of drug regulation and analyzes the text of several state and federal laws the Abigail court cited to support its holding. Section V proposes that application of the Glucksberg test to this country's long tradition of self-medication regulation renders the conclusion that there is in the United States a fundamental right of access to experimental drugs. Finally, Section VI concludes that courts should recognize the Abigail Alliance's fundamental right of access to experimental drugs.

2. ABIGAIL ALLIANCE V. VON ESCHENBACH

   The Due Process Clause of the Fifth Amendment precludes the government from depriving persons of "life, liberty, or property, without due process of law." (22) The Supreme Court has held that these rights warrant "heightened protection against governmental interference with certain fundamental rights and liberty interests." (22) Therefore, if the government impinges on fundamental rights, such as privacy, marriage, abortion, or bodily integrity, its action must be necessary to fulfill some compelling governmental interest. (23)

   In Abigail, the D.C. Circuit held that terminally ill patients do not have a fundamental right of access to potentially life-saving drugs that have not been fully approved by the FDA. (24) The Abigail court relied heavily on Washington v. Glucksberg, which held that a right is fundamental under the due process clause if it is "objectively, deeply rooted in this nation's history and tradition ... and implicit in the concept of ordered liberty." (25) The Abigail court concluded that there is no tradition in the United States to support a right of access to drugs that have not been proven safe. (26) Instead, the court stated that this country has a long history of drug regulation aimed at preventing access to unsafe drugs. (27) Accordingly, the court subjected FDA regulations prohibiting access to experimental drugs to the relatively undemanding test of rational basis scrutiny. (28) The court then concluded that FDA regulations limiting access to experimental drugs are rationally related to the state's legitimate interest in protecting the public from potentially unsafe drugs whose efficacy has not been established. (29) Had the Abigail court determined that terminally ill patients have a fundamental right of access to potentially life-saving experimental drugs, it would have then subjected the FDA policies at issue to strict scrutiny, a much higher constitutional standard. (30)

   To support its conclusions, the Abigail court offered a history of drug safety regulation dating back to 1736 and professed the existence of a long history of drug regulation in England. (31) The court's treatment of the history, however, was cursory and resulted in premature assumptions based on a mischaracterization of the laws it blithely cited. The court failed to consider the vast historical material which reveals the real tradition in this country: the individual's unfettered choice to ingest drugs, even those not proven safe for human consumption. (32) The true American tradition is one of self-medication, not government regulation. (33)

3. THE AMERICAN TRADITION OF SELF-MEDICATION

   1. Self-Medication in Early America

      For centuries, Americans enjoyed the right to decide how to cure themselves--a tradition inherited from English culture. (34) American colonists treasured their medical self-help books and brought from their mother country the custom of self-medication. (35) As early as 1613, books, such as The English Housewife and the English Husbandman, guided colonists in cultivating and administering medicinal herbs and drugs. (36) More than a century later, John Tenant of Virginia published Everyman His Own Doctor (1734), which was translated into German and used by common farmers throughout Pennsylvania Dutch. (37)

      Medicinal decoctions were often administered by the earliest medical practitioners in colonial America--British housewives. (38) This American tradition is reflected in Nicolas Culpeper's The English Physician, a book published in 1652 as a "Discourse of the Vulgar Herbs of this Nation; Containing a Compleat [sic] Method of Physick [sic]. Whereby a man may preserve his body in Health, or Cure Himself, being Sick, for three pence Charge with such things only as grow in England, they being most fit for English bodies." (39)

      The English settlers took advantage of their opportunity to experiment in their New World, a land that rendered new and diverse flora with immense curative potential. (40) Colonists learned to grow plants and indigenous herbs, and experimented with treatments learned from Native Americans (41) despite repeated admonitions from medical doctors, who warned against the dangers of unknown therapies. (42) For example, in his Centennial Address to the Massachusetts Medical Society in 1881, Dr. Samuel Abbott Green warned colleagues about the medical treatments colonists sought from Native Americans:

      The Indians had no knowledge of medicine, but were accustomed to treat disease largely by incantations and powwows. There is, however, a popular belief to-day that the Indian doctor is skilled in botanical remedies, as he is wont to use the infusions and decoctions of various roots and herbs. While there is no ground for such an impression, he will yet be consulted as long as the race of simpletons continues to exist--perhaps to the millennium. The ravages of small-pox among the ignorant natives were fearful, as they had no knowledge of inoculation or vaccination; and thus a new danger opposed the white settlers, who were already overburdened by their cares and trials. (43) Dr. Green's words reflect Americans' faith in...