Selling Science

Stephen E. Mawdsley

• Publisher: Rutgers University Press
• Year: 2016
• Print ISBN: 9780813574394
• eBook ISBN: 9780813574400
• Topic: History
• Subtopic: Medical Theory, Practice & Reference
• Index: History

Today, when many parents seem reluctant to have their children vaccinated, even with long proven medications, the Salk vaccine trial, which enrolled millions of healthy children to test an unproven medical intervention, seems nothing short of astonishing. In Selling Science, medical historian Stephen E. Mawdsley recounts the untold story of the first large clinical trial to control polio using healthy children—55, 000 healthy children—revealing how this long-forgotten incident cleared the path for Salk’s later trial.   Mawdsley describes how, in the early 1950s, Dr. William Hammon and the National Foundation for Infantile Paralysis launched a pioneering medical experiment on a previously untried scale. Conducted on over 55, 000 healthy children in Texas, Utah, Iowa, and Nebraska, this landmark study assessed the safety and effectiveness of a blood component, gamma globulin, to prevent paralytic polio. The value of the proposed experiment was questioned by many prominent health professionals as it harbored potential health risks, but as Mawdsley points out, compromise and coercion moved it forward. And though the trial returned dubious results, it was presented to the public as a triumph and used to justify a federally sanctioned mass immunization study on thousands of families between 1953 and 1954. Indeed, the concept, conduct, and outcome of the GG study were sold to health professionals, medical researchers, and the public at each stage. At a time when most Americans trusted scientists, their mutual encounter under the auspices of conquering disease was shaped by politics, marketing, and at times, deception.
Drawing on oral history interviews, medical journals, newspapers, meeting minutes, and private institutional records, Selling Science sheds light on the ethics of scientific conduct, and on the power of marketing to shape public opinion about medical experimentation.  

Chapter 1

Forging Momentum

In the closing days of World War II, the rural Catholic orphanage of Saint Vincent’s near Freeport, Illinois, was mobilized for a medical experiment. A polio outbreak had taken hold in the facility, and there were many cases of paralysis. On the morning of August 26, 1945, a team of public health officers and scientific consultants arrived at Saint Vincent’s, seeking to control the outbreak by injecting a human blood fraction as part of a clinical trial.1 That afternoon, Saint Vincent’s staff divided the young residents along age and gender lines in preparation for injections. An efficient, assembly-line approach characterized the experiment, as a team of two nurses prepared syringes while two physicians administered the injections. That day, Saint Vincent’s charges became among the first humans to systematically receive gamma globulin (GG) in the battle against polio.2 Why did researchers believe that the blood fraction might be effective against the disease? What factors complicated the testing of GG in humans? This chapter explores the discovery of the blood fraction and how medical researchers attempted to assess its value for polio control.

Gamma Globulin in the Fight against Disease

The entry of GG into the lexicon of clinical interventions was a not radical departure, but was freighted on a long-standing fascination with human blood. Since the early twentieth century, doctors had believed that blood harbored protective properties that could be conveyed to others through injection. Some physicians experimented with blood to treat measles and scarlet fever with some success. As a result, the idea that the curative qualities in blood could be passed on to vulnerable individuals lingered, awaiting new studies and technology.3

Laboratory breakthroughs during the late 1930s and early 1940s rekindled interest in human blood to fight disease. Dr. Charles Armstrong’s development of an animal model for polio provided researchers an inexpensive means to evaluate new medical interventions.4 In addition, the 1936 discovery of human blood fractions connected prior optimism with a clinical reality. Dr. Arne Tiselius, a chemist at Uppsala University, Sweden, designated ƴ (gamma) globulin to a group of unique blood proteins.5 Tiselius found that protective proteins, called antibodies, permeated this fraction, but it was difficult to extract and concentrate them for clinical application.6 American researchers, funded through federal government initiatives ahead of World War II, turned Tiselius’s breakthrough into a practical solution. In 1940, the surgeon general of the U.S. Army solicited the National Research Council (NRC) to assist in meeting the military’s medical needs for chemotherapy and blood transfusions.7 The NRC established a series of committees that concerned themselves with the development of blood products, which could be stockpiled for use in distant theaters.8 Research funding combined with the impetus of impending conflict initiated a program to unlock the secrets of blood.

To investigate methods for processing and stabilizing blood products, the NRC turned to Harvard physical chemistry professor Dr. Edwin J. Cohn.9 Born to a family of wealthy New York City tobacco merchants in 1893, Cohn was educated at Amherst College, earned a degree from the University of Chicago, and pursued graduate research at Yale and Harvard.10 By 1940, he was director of the Department of Physical Chemistry at the Harvard Medical School, where he and his team worked on proteins and blood albumin.11 Applying this collective knowledge of proteins, peptides, and amino acids to blood, Cohn’s team devised a novel ethanol and centrifugation technique that separated blood into its five constituent parts—or fractions. Not until Cohn’s fractionation process was wedded to the American National Red Cross (ARC) blood donor program, however, were clinical possibilities brought to fruition.12 The result was a range of new blood products, including fibrogen (a clotting agent), gamma globulin (an antibody solution), and serum albumin (the purified liquid component of blood). When serum albumin was successfully administered in December 1941 to treat shock among Allied personnel at Pearl Harbor, the blood fractionation program was elevated to a pillar of the war effort. The U.S. Navy, enthralled with the potential medical value of blood fractions, encouraged their clinical application and contracted American pharmaceutical suppliers, such as Sharp & Dohme and Squibb & Son Co., to provide a steady supply.13 Health professionals and researchers clamored to assess the efficacy of gamma globulin in preventing illness. Although GG, as a derivative of blood, was not homogeneous and could vary in potency based on the size of the donor pool, its concentrated antibody composition promised remarkable benefits.

Among the first researchers to evaluate GG and determine its clinical utility was Dr. Joseph Stokes Jr. Born in 1896 in Moorestown, New Jersey, into a family of prominent physicians, Stokes attended Haverford College, earning a BA in 1916 and an MD in 1920 from the University of Pennsylvania Medical School.14 After interning at the Massachusetts General Hospital in Boston, Stokes returned to Pennsylvania, where he specialized in pediatrics at the Children’s Hospital of Philadelphia. Between 1923 and 1931, Stokes held various teaching positions at the Penn Medical School, where he earned full professorship and became chief of pediatrics.15 By 1942, he was appointed director of the Measles and Mumps Commission with the Armed Forces Epidemiology Board, while also acting as a consultant for the surgeon general.16 In these assignments, he assessed the potential value of GG in controlling influenza, measles, mumps, and hepatitis.17 During an outbreak of hepatitis at a summer camp near Philadelphia, Stokes administered GG and discovered that while 67 percent of the non-inoculated campers became ill, over 80 percent of the GG recipients remained well.18 Stokes also injected GG to control measles, which reportedly “prevented attacks” or “made them mild.”19 Through these studies, Stokes showed that GG had important clinical applications.

Complementing Stokes’s research, Dr. Sidney D. Kramer, the associate director of the Michigan State Department of Health, experimented with GG for polio. Kramer had a long-standing interest in blood products and developed a prototype polio vaccine that combined convalescent serum with live virus.20 In 1943, Kramer began experiments with monkeys and found that GG provided protection when injected eight to sixteen hours before a challenge response with poliovirus.21 Encouraged by these findings, Kramer believed that a human study was justified. However, acquiring enough GG for a clinical trial was difficult during World War II, as it was in short supply and closely regulated by the ARC and NRC. Since Kramer was doubtful that he could successfully obtain approval alone, he turned to the NFIP as a sponsor and negotiator.

NFIP medical director Dr. Donald W. Gudakunst was eager to support Kramer’s plan. Born in 1895 in Paulding, Ohio, Gudakunst earned a medical degree from the University of Michigan in 1919 and developed a strong background in public health during the 1930s as Detroit’s deputy health commissioner and later Michigan State health commissioner.22 Gudakunst was interested in pragmatic solutions to polio and in 1943 arranged for the NFIP to sponsor Kramer’s GG clinical trial.23 Since paralytic polio was relatively rare compared with other illnesses, Kramer estimated that hundreds of children would be needed to assess the potential value of the blood fraction. Kramer and Gudakunst collaborated on a protocol and submitted it to the ARC and NRC for consideration. However, when a severe epidemic emerged in Chicago, Illinois, Gudakunst was surprised to learn that both national agencies rejected the plan and would not release the blood fraction for the human study.24 Despite disappointment, Gudakunst and Kramer worked together to build support for a second application.

Many leading American medical scientists were in favor of testing GG as a means to control paralytic polio. In May 1944, researchers attending the NRC conference in Washington, D.C., discussed recent scientific developments, including the clinical use of blood fractions. A shared opinion emerged from this meeting that “the usefulness of human globulin concentrates on the human [polio] infection should be explored.”25 Dr. Joseph Stokes added to the momentum by writing to Gudakunst and Cohn, explaining that he was “considerably disturbed” that there were no known plans to assess GG for polio.26 The most “common sense” approach, Stokes argued, was to establish a NFIP committee to monitor polio epidemics and select a high-incidence community to serve as a test site. Stokes invoked the emotive call to action, long attributed to the March of Dimes fund-raising campaign, by asserting that “if our own children were in a summer camp or in a school where a sharp outbreak occurred, we would think of gamma globulin first and would probably use it.”27

Stokes offered advice on how NFIP officials might gain support from the ARC. He advised that any future study be “jointly supervise[d]” by the ARC and the NFIP. He advocated a reciprocal arrangement between trial participants and scientific investigators, so that for every 20 cc injection of GG into a child, the parent would be asked to donate one pint of blood. Stokes believed that parental blood donations would not only supplement ARC supplies, but also provide high-quality blood rich in polio antibodies. He hoped that ARC officials would look favorably on any program that increased blood supplies at a time of war.28 To bolster the scientific merit of the trial, Stokes advised observed controls. His rationale for selecting the control group was based on the tension between public faith in science and the fear of health risks. He reasoned that when some parents learned that the study was “experimental,” they would “not accept the procedure” and by default become the “essential” observed control.29 Stokes believed that fear of experimentation could be harnessed for scientific benefit. Although he did not offer to conduct the study himself, he added conviction, advice, and impetus to proceed.

Like Stokes, federal government and military researchers advocated a GG study. In July 1944, Dr. Alphonse Raymond Dochez at the Office of Scientific Research and Development encouraged Kramer to submit a clinical trial protocol to the ARC.30 Likewise, Dr. John H. Dingle at the Commission on Acute Respiratory Diseases at Fort Bragg, North Carolina, spoke in favor of a GG clinical trial.31 Dingle recognized the challenges such a study posed, since “more than two injections” per person would be needed to outlast an epidemic. He further postulated that urban centers were most suitable as test sites due to their “more consistent epidemic behavior, better diagnostic facilities, [and] geographic concentration.”32 In the waning years of the World War II, prominent scientists helped to justify the need for a GG study.

Kramer and Gudakunst organized a private meeting in June 1944 to discuss the possibility of a renewed effort to test GG for polio.33 They invited the recently appointed Michigan State health commissioner and former medical director of the ARC, Dr. William DeKleine, to join the meeting.34 DeKleine was a strategic choice, as he was knowledgeable about blood fractions and believed in the potential of GG.35 He agreed to extend state resources to the proposed study, while Gudakunst pledged to negotiate a supply of GG and manage the “executive aspects of the study.”36 In turn, Kramer accepted the role of chief investigator.37 DeKleine, Gudakunst, and Kramer emerged from the meeting with a plan to realize a GG study.

Gudakunst faced challenges negotiating a supply of GG.38 He realized that convincing the ARC and NRC would be difficult, considering their prior rejection. His fears were well founded, as ARC medical director ...

Table of contents

• Title Page
• Copyright Page
• Dedication
• Contents
• List of Illustrations
• Acknowledgments
• List of Abbreviations
• Introduction
• Chapter 1. Forging Momentum
• Chapter 2. Building Consent for a Clinical Trial
• Chapter 3. Marketing and Mobilization
• Chapter 4. The Pilot Study
• Chapter 5. Operation Marbles and Lollipops
• Chapter 6. The National Experiment
• Notes
• Bibliography
• Index
• About the Author
• Read More in the Series