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 Ruth Weise

Ruth Weise was born in Oak Park, Illinois. She received her diploma from St. Francis Hospital School of Nursing in Evanston, Illinois, in 1944, her Bachelors in Nursing Education from the University of Minnesota in 1946, and her MA in Nursing Education also from the University of Minnesota in 1954. She joined the faculty of the School of Nursing at the University of Minnesota in 1946, and, during her time at the University of Minnesota, she helped to establish a course in operating room nursing. She left the University of Minnesota in 1963 to work at St. Barnabus Hospital in Minneapolis. In 1973, she was invited back to the University of Minnesota to establish a partially external master’s degree program. She retired in 1986.Ruth Weise starts with describing her background, including her education and why she went into nursing. She discusses her experiences as a student at the University of Minnesota, working as a staff nurse, teaching operating room nursing, why she left the University of Minnesota, and her work at St. Barnabus Hospital. She describes working with iron lungs, surgeons’ treatment of nurses, working in the operating room and with different technologies, and the Area Health Education Centers program. She discusses the relationship between diploma and degree nurses at the University of Minnesota; curriculum changes in the 1940s and 1950s; changes in the School of Nursing between the 1950s and 1970s; the move in nursing to working with communities; the relationship of the University of Minnesota School of Nursing to other nursing programs in the region; the closing of nursing diploma schools, changes in the School of Nursing after the reorganization of the health sciences in 1970; the perceived shortage of health care professionals in the 1950s through 1970s; public health nursing; and the move to have nursing faculty with Ph.D.s and what it was like to not have a Ph.D. in this context. She remembers Katherine Densford, Isabel Harris, Edna Fritz, Irene Ramey, and Ellen Fahey

Interview with Lee Stauffer

Lee Stauffer was born in Wisner, Nebraska, on March 20, 1929. He received his BS from the University of Nebraska in 1951 and his Masters in Public Health from the University of Minnesota in 1955. After he received his BS, he worked as a sanitarian for the Lancaster County Health Department in Nebraska from 1951-52. He then worked for the UMN University Health Service as a housing inspector (1952-54) and as an assistant to the public health engineer (1954-55). Stauffer then joined the faculty of the UMN School of Public Health, first as a sanitarian and instructor (1955-58), then senior sanitarian and assistant professor (1958-62), and assistant professor and assistant director (1962-66). From 1966-68, he was executive secretary of the American College Health Association. In 1970, he returned to the UMN as assistant director of Continuation Medical Education in the College of Medical Sciences and assistant professor of the School of Public Health. In 1970, he was appointed dean of the School of Public Health. He resigned in 1982 to return to the faculty and conduct research. He retired in 1991.Lee Stauffer begins by discussing his background, including his education and employment history. He describes his experiences working for Gaylord Anderson, becoming dean of the UMN School of Public Health, working as a sanitarian, inspecting student housing for the UMN, as assistant to the public health engineer, as a student in the School of Public Health, and as dean of the School of Public Health. He discusses Gaylord Anderson, Lyle French, Richard Bond, Ancel Keys, Robert Howard, Alma Sparrow, Henry Blackburn, Richard Chilgren, Edith Leyasmeyer, and Neal Vanselow. He describes the School of Public Health in the 1950s and 1960s; the Environmental Health summer institute courses and the ground water development training program; the relationship between divisions in the School of Public Health; the position of the School of Public Health within the College of Medical Sciences; space; funding; concern about a shortage of health care workers in the 1950s and 1960s and federal support to increase enrollment in the School of Public Health; the controversy about the salary difference between himself and the dean of the School of Nursing, Isabel Harris; the nursing Ph.D. program; the public health nursing program; the Rural Health Care Committee; the state legislature; the Department of Family Practice and Community Health; continuing medical education; the Medical School’s relationship with private practitioners; the health sciences reorganization in 1970; the effort to establish a School of Allied Health; the environmental activism movement and activism on campus during the 1960s and 1970s; the Pilot City Health Project; the Program in Human Sexuality; the Center for Health Services Research; the focus on health care delivery in the 1970s; budget retrenchment in the late 1970s/early 1980s; the public health administration program; and recruiting minority students

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