Donna A. Messner
Donna A. Messner
Gordon Cain Fellow, 2010–2011
- E-mail: dmessner-at-chemheritage-dot-org
- Phone: 215.873.8240
- Fax: 215.629.5240
Donna A. Messner is a Gordon Cain Fellow in Technology, Policy, and Entrepreneurship. She received a Ph.D. in Science and Technology Studies from the University of Edinburgh, United Kingdom, in 2008. Her doctoral research was focused on processes of legal and regulatory oversight and innovation in the development of new therapies for serious and life-threatening diseases.
In 2006 Messner was also a visiting student at the School of Policy, Georgia Institute of Technology, with sponsorship from Policies for Research and Innovation in the Move toward the European Research Area (PRIME). For the past two years she has been a postdoctoral research fellow in the Penn Center for the Integration of Genetic Health Care Technologies in the University of Pennsylvania’s Division of Medical Genetics. At Penn she has been investigating the socio-legal implications of direct-to-consumer genetic testing, as well as the history and impact of selected gene patents.
Messner also holds an M.Sc. by research in Science and Technology Studies from the University of Edinburgh, an M.A. in literature with a cultural-studies concentration from George Mason University, and an undergraduate degree in chemistry from Virginia Tech. Prior to pursuing a Ph.D., Messner had an 18-year career as an analytical chemist, laboratory manager, and environmental-project scientist.
While at CHF, Messner will explore the early history of so-called medical foods. The term medical food refers to a nutritional product specially formulated to be ingested under the supervision of a physician to treat disease. Not to be confused with folk or naturalistic remedies, medical foods constitute a specific category of regulated products under the purview of the U.S. Food and Drug Administration (FDA). They are scientifically formulated products first developed in the U.S. in the mid-twentieth century to address the serious health-related consequences arising from inherited metabolic diseases. Medical foods were thus the products of the developing fields of medical genetics and enzymology, and emblematic of the growth of those areas of medicine.
In terms of food and drug regulation, these novel products straddled two worlds: they were food in that they were to be ingested to provide nutrition; and they were drugs in that they were required to be used under the supervision of a physician to treat disease. So it was that the first medical food, an infant formula called Lofenalac to treat phenylketonuria, blurred the definitional boundaries between food and drugs, initially confounding clear categorization for regulatory purposes. Importantly, Lofenalac came on the scene during a key time of transition for the FDA.
In the 1960s, the FDA was in the process of implementing sweeping legislative reforms enacted in 1962. Among other things, this legislation granted the FDA more extensive powers for premarket review of new therapeutic-drug products. As Messner’s doctoral thesis described in some detail, the practical application of this new authority was shaped significantly through conflict with the pharmaceutical companies, who challenged the FDA’s decisions and regulatory interpretations repeatedly in the courts and in other ways. Lofenalac was a new kind of product coming to the FDA for review at a transitional time, and the approach to the product reflected the times.
Thus, the immediate goal of this project is to explore the advent of medical foods as a technical accomplishment in enzymology and medical genetics and to examine how the first medical foods challenged existing regulatory practices. However this nascent project in medical foods suggests clear directions for the future. Although Lofenalac was finally declared a food for regulatory purposes in 1972, the boundaries between the definitions of many foods and drugs have continued to be porous, and this porosity has not been limited to FDA regulatory classification.
The early medical foods were developed during the formative years of food science as a profession. As Michael Pollan has described, in the 1970s American attitudes toward food and diet were changing. Foods increasingly began to be discussed in terms of their nutrients and chemical composition, and eventually were marketed that way. Hence, in the same decade that the FDA moved to treat medical foods less like drugs and more like foods, political discourse on diet and health (and ultimately also the language of marketing) was shifting to treat conventional foods less like food and more like chemical formulations.
Today we have a burgeoning marketplace of foods that are like drugs and drugs that are like foods.The development of a medically therapeutic nutritional formula for a genetic disease can be seen as foreshadowing today’s “nutraceuticals” and especially “nutrigenetic testing,” which purports to use DNA analysis as part of a program to custom-formulate dietary supplements for customers based on their individualized needs. Included under the industry-coined rubric of nutraceuticals are not only medical foods, but also “functional” foods (conventional foods specially formulated for augmented health benefits), and dietary supplements (isolated, purified components of foods or “natural” substances purported to give health benefits).
In the longer term, therefore, this work can lead toward an understanding of how the blended meanings of “food” and “drug” characteristic of these products continue to reverberate in today’s complex commercial and regulatory landscape of nutritional and therapeutic products.
- “AZT and Drug Regulatory Reform in the Late Twentieth Century US,” in John Pickstone, ed., Making Drugs: Ways of Regulating between Factory, Office, Consulting Room, and Court. Basingstoke and New York: Palgrave. (forthcoming)
- “Informed Choice in Direct-to-Consumer Genetic Testing for Alzheimer and Other Diseases: Lessons from Two Cases.” New Genetics and Society. (forthcoming)
- With Reed E. Pyeritz and Barbara A. Bernhardt: “Comment on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing: Lessons from Hereditary Hemorrhagic Telangiectasia.” Genetics in Medicine.(forthcoming)
- “Tales of Two Women: Review of Teman, Elly, Birthing a Mother: The Surrogate Body and the Pregnant Self.” Metascience (Published Online March 11): DOI 10.1007/s11016-010-9375-6.
- “AZT as Conceptually Pivotal to U.S. Drug Approval: FDA Therapeutic Drug Rule-Making and Practice, 1987-2000 and Beyond,” in Jean Paul Gaudillière and Volker Hess (eds.), Ways of Regulating: Therapeutic Agents between Plants, Shops and Consulting Rooms. Max-Planck-Institut für Wissenschaftsgeschichte, Preprint 363, Berlin 2009, pp. 247–270.
- “Rhetoric as Practice: Framing AIDS Knowledge.” Review of Preda, Alex, AIDS, Rhetoric, and Medical Knowledge. Metascience 15 (2): 353–357.