Bioequivalence: The Regulatory Career of a Pharmaceutical Concept

Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history of bioequivalence, which emphasizes the shaping role of the state upon scientific processes, networks of regulators and scientists, and the centrality of transnational dynamics in the formation of drug regulatory standards.Governmen

Interview with Robert Geist

Robert Geist was born in St. Paul, Minnesota, on May 4, 1928. He attended the University of Minnesota for his undergraduate and medical degrees. He received his BA in 1951, his BS in 1952, and his MD in 1954. He did a one-year residency at the Washington, DC General Hospital and then returned to the Minneapolis Veterans Administration (VA) Hospital to complete his residency in urology. Geist went into private practice in 1960, where he initially worked alone. In 1968, he went into group practice with two other urologists. This group practice grew over the years to six urologists. In 1994, this group practice merged with another practice, became known as Metro Urology, and grew to include more than twenty urologists, including many with subspecialties. Metro Urology’s only link with the UMN is through pediatric urology, with which Geist was involved. Geist retired in 1997, but returned to the VA for three years in the urology department because of a shortage of urologists. He also served in the Army after graduating from high school (1946-48).Geist first discusses his background, including his education. He then discusses his residency at the Minneapolis VA Hospital. He describes going into private practice, his experiences building his practice, the challenges he faced, and his relationship with the University of Minnesota. He discusses women in his medical school class and in urology, the impact of the introduction of Medicare and Medicaid, the concerns over the shortage of doctors in the 1960s, and the increase in the UMN Medical School’s class size because of those concerns. He discusses some of his involvement in medical politics since 1973, including his experiences with HMOs after their creation, with the Minnesota Medical Association, and with fee-splitting and referral practices. He reflects on the relationship between St. Paul and Minneapolis physicians and between them and the UMN, including the contentious politics between some St. Paul doctors and the UMN in the 1960s, particularly in relation to the attempt to establish a St. Paul medical school

Interview with Eva Kloempken

Eva Kloempken was born in 1908. She attended the School of Nursing at the University of Minnesota and graduated in 1929. After graduating, she worked as a nurse until her retirement at Northern Pacific Beneficial Association Hospital in St. Paul.Eva Kloempken discusses some of her experiences as a student at the UMN, including descriptions of some of the faculty and her anatomy class. She describes some of her experiences as a nurse, including relations between nurses and doctors, living in dorms at the Northern Pacific Beneficial Association Hospital, some technologies she used, and nursing uniforms. She also discusses why she became a nurse and the changes in nursing that took place during her career

Interview with John Westerman

John Westerman was born and raised in Minneapolis, Minnesota. After earning a bachelor of science in law from the University of Minnesota in 1954 and then attending law school for two years, he was called up as a member of the ROTC to serve in the Air Force. When he returned, he took additional coursework and earned a bachelor of business administration with a major in finance in 1958. He then attended the University of Minnesota for his Masters in Hospital Administration, which he earned in 1960. He then completed his administrative residency at University Hospital under Ray Amberg from 1959 to 1961. From 1961 to 1964, he served as assistant administrator, in a position akin to chief operating officer, at Strong Memorial Hospital in Rochester, New York, part of Rochester University. Westerman returned to the University of Minnesota to work with Dr. Richard Magraw, under Dean Robert Howard, on expanding the Comprehensive Clinic. As the project grew, he transferred to President O. Meredith Wilson’s office as an executive secretary, serving as the coordinator of the Committee for Long Range Planning in the Health Sciences. After serving in this position from 1964 to 1966, he took over as general director of University Hospitals and Clinics in November of 1966. He served in this position until 1982. He then moved to Pittsburgh, PA to serve as president and CEO of Allgheny Health Services from 1982 to 1985. From 1985 to 1992, he served as president and CEO of The Hospital of the Good Samaritan, part of the University of California system, in Los Angeles, CA. He served as interim president for the Association of University Programs in Health Administration in Arlington, VA in 1993, and then moved to Hawaii where he served as CEO of Hilo Medical Center from 1993 to 1996 and then CEO of Hawaii Health Systems Corporation from 1996 to 1997. He continues to serve on a number of boards and trusts within the health care industry.Westerman begins by discussing his childhood and youth in Minneapolis. He describes his time in the US Air Force and in Tachikawa, Japan. He discusses his time as a student in the Masters in Hospital Administration program and his interactions with James Hamilton and James Stephan. He describes Ray Amberg and other University Hospital administrators. He discusses being CEO of Strong Memorial Hospital and working at the University of Minnesota Hospitals. He describes the physical reorganization of the Health Sciences and the reputation of the PhD programs in other parts of the country. He discusses collaborations between the Mayo Clinic and the University of Minnesota. He describes the Hospital’s referral system. Westerman discusses the atmosphere of the Hospital and its relationship with the Mayo Clinic in Rochester, MN. He discusses nursing at the Hospital and the influence of Marie Manthey and Florence Julian. He also discusses the role of Pharmacy and having pharmacy students in the Hospital. Westerman discusses abortions at the University Hospital. He also describes the increasingly competitive hospital marketplace in the 1970s. Finally, he discusses the Consortium of University Hospitals

Interview with Davitt Felder

Davitt Felder was born in Providence, Rhode Island. He attended Rollins College in Winter Park, Florida, and graduated in 1938. He then went to Yale Medical School and graduated with his MD in 1942. He interned at the University of Minnesota in surgery. After nine months of his internship, he was activated in the Navy and spent the next three years in the Navy. After leaving the Navy, he took a job at the Massachusetts General Hospital in Boston and established a vascular laboratory there. He then returned to the University of Minnesota and became chief resident in the Department of Surgery under Owen Wangensteen. After finishing his chief residency in 1951, he was appointed as an instructor in the department of surgery and assigned to the general surgical services at the University Hospital, Anchor Hospital in St. Paul, and the Minneapolis General Hospital. In 1952, he was appointed to supervise the surgical teaching service at St. Joseph’s Hospital in St. Paul. In 1953, he earned his Ph.D. In 1953, he also went into private practice. He retired from practice in 1986.Davitt Felder discusses his background and provides an overview of his career. He describes why he went into medicine and surgery; his decision to enter private practice; and his decision to retire. He discusses at length the establishment of the Northern Association for Medical Education and the organization’s attempt to establish a medical school in St. Paul. He describes his work in vascular surgery and the establishment of the Midwestern Board for Medical and Allied Education. He discusses the relationship between Minneapolis and St. Paul private physicians and the University of Minnesota; the private practice issue at the University of Minnesota; and Robert Howard, Owen Wangensteen, Walter Lillehei, Michael E DeBakey; the relationship between the Surgery Department and other clinical departments; and his work with the Health Care Financing Administration

Interview with Mitzi Duxbury

Mitzi Duxbury was born in Jersey City, New Jersey. She received her nursing diploma from Madison General Hospital in Madison, Wisconsin, in 1952. She worked as a nurse, mostly in obstetrics, from 1952-64 in various locations, including Fort Riley Hospital in Kansas and the Washington, D.C. General Hospital. She received her BS in Nursing in 1966, her MA in Educational Policy in 1970, and her Ph.D. in Educational Administration in 1972, all from the University of Wisconsin. She worked as Assistant Professor at the University of Wisconsin School of Nursing from 1971-73. From 1972-1976, she worked for the March of Dimes. In 1977, she came to the University of Minnesota as the Director of Graduate Studies and Associate Professor in the School of Nursing. In 1979, she was appointed Assistant Dean for Graduate Studies and was promoted to Professor. She left the University of Minnesota in 1983 and moved to the University of Illinois at Chicago as the Dean of their School of Nursing.Mitzi Duxbury begins by describing her background, including her education and why she went into nursing. She discusses her experiences as a nursing diploma student; working at Cook County Hospital as a diploma student; and working as a nurse at Fort Riley Hospital in Kansas and at the Washington, D.C. General Hospital. She also describes her experiences as a baccalaureate student at the University of Wisconsin, working at the March of Dimes; and as assistant dean for graduate students at the University of Minnesota. She describes her graduate work; relations between nurses and doctors in the different hospitals in which she worked; the techniques and technologies she worked with as a nurse; developing contracts with North Dakota University for the UMN School of Nursing; the building of Unit F; lobbying for the School of Nursing budget at the state Legislature; and working with the World Health Organization. She discusses midwifery as a nursing specialty; nursing autonomy; the efforts to establish a Ph.D. program in nursing at the University of Minnesota School of Nursing; faculty research and funding; and the Committee for Long Range Planning for the School of Nursing. She also discusses how gender affected her career, and the health care systems of different countries. She talks about Irene Ramey, Ellen Fahey, Lyle French, and other School of Nursing faculty

Interview with Neal A. Vanselow

Neal Vanselow was born March 18, 1932 in Milwaukee, Wisconsin. He earned his bachelor’s degree in political science in 1954 and his M.D. in 1958, both at the University of Michigan. Dr. Vanselow completed his internship at Minneapolis General Hospital (now Hennepin County Medical Center) and returned to the University of Michigan for his residency and a fellowship in immunology and allergy. He completed a master’s in Internal Medicine in 1963. He then became a faculty member in the Department of Internal Medicine at the University of Michigan Medical School and became chairman of Post Graduate Medicine. From 1974 to 1977, Dr. Vanselow served as dean of the University of Arizona College of Medicine in Tucson. Dr. Vanselow then became chancellor of the University of Nebraska Medical Center in Omaha in 1977. From 1982 to 1989, he served as vice president of the Academic Health Center at the University of Minnesota. Dr. Vanselow was named chancellor of Tulane University Medical Center in New Orleans in 1989. He also served in leadership positions on the Association of Academic Health Centers, the Council of Graduate Medical Education, and the Association of Graduate Medical Colleges.Dr. Neal Vanselow begins his interview by reflecting on his education and training at the University of Michigan and his internship at Minneapolis General Hospital (now Hennepin County Medical Center). He then discusses his tenure as dean at the University of Arizona College of Medicine and his move to the University of Nebraska Medical Center in Omaha. He relates the reasons for his move to the University of Minnesota Academic Health Center (AHC). Concerning the University’s AHC, Dr. Vanselow describes all of the following: the culture of the AHC particularly town/gown relationships; the relationship between the AHC and the rest of the University; the relationship between the AHC and Central Administration; relations among units in the health sciences; the incorporation of the College of Veterinary Medicine into the AHC; and Ken Keller’s Commitment to Focus and the threatened closure of the Dental School and the College of Veterinary Medicine. Reflecting on larger trends in healthcare and health education, he discusses: efforts to admit more minority students; issues regarding the rising costs of hospital care and the impact on University Hospital; faculty practice; retrenchments; the creation of the Biomedical Ethics Center; and the issues surrounding the University’s production and sale of Antilymphocyte Globulin (ALG). Dr. Vanselow also describes the tenures of the presidents of the University and the regents with which he worked; his work with the Legislature; the differences between a private and public academic health center; and his time on the board of the Association of Academic Health Centers. He concludes his interview with a reflection on his experiences as part of the Institute of Medicine’s Committee on the Future of Primary Care and the Continuing Evaluation Panel of the American International Health Alliance