Introduction

“The perfecting of ovariotomy has resulted in saving and prolonging the lives of multitudes,” the British surgeon John Halliday Croom declared in 1896. Croom was reflecting on an operation that had, over the preceding fifty years, irrevocably altered the landscape of surgery. In the second half of the nineteenth century virtually no other operation garnered as much attention in Britain as that for the removal of diseased ovaries, and during which the operation undulated between controversy and accolade. In the mid-decades those who performed it were frequently lambasted, ridiculed, and even condemned as criminals by opponents who considered its high mortality rate unjustifiable. By the 1890s, with a drastic diminution in the operation's mortality, and a rich archive of printed material now circulating among the medical community that showed hundreds of cases of the operation where the patient had been cured, ovariotomy had ascertained not just respectability but was viewed as emblematic of Victorian progress in medicine. The fruit of ovariotomists’ labor was manifest in the many numbers of patients who had survived the operation and could now return to a life free of ovarian disease. In 1877 Thomas Spencer Wells (1818–97), Britain's most eminent and well-known ovariotomist, gave the address in surgery at the annual meeting of the British Medical Association in Manchester. In his speech Wells proclaimed that his ovariotomy operations alone had added eighteen thousand years to the lives of European women. Such sentiments fitted in with broader understandings Victorian surgeons had of themselves as a civilizing force, both an intellectual and a moral one, their life-saving work a melding of sagacity and selflessness, augmented by the fact that it was women—the wives, mothers, and daughters of Britain—who were being drawn away from the clutches of disease.

Looking back, the history of ovariotomy might initially be viewed as simply one more example of a typically successful medical innovation: the resistance its advocates encountered before improvements in the procedure, and subsequent acceptance among the majority of the profession, marked its introduction into mainstream medicine. Certainty as the first major abdominal procedure to come into practice, ovariotomy raised difficult questions about the propriety and management of innovation as surgeons began to venture into the peritoneal cavity.

Introduction

What counts as progress in surgery? And how are the advances measured? In exploring innovation in surgery, it is necessary to ask how innovations are judged, and about the mechanisms for evaluation. This paper will consider the changing methods of evaluating surgical procedures in the later twentieth century by following the fortunes of one alternative and especially contentious method, the placebo-controlled clinical trial. On first consideration, the idea of a surgical placebo may seem odd, or even unsettling. A surgical placebo trial involves fooling some patients into thinking that they received a surgical procedure, with the goal to compare their outcomes to patients who did receive the procedure. The technique entered the modern experimental repertoire as an exciting, if controversial, method in the late 1950s. It subsequently dropped from sight and was considered for a time to be perhaps fundamentally unethical. In the 1980s, however, the placebocontrolled surgical trial reentered use. The surgical placebo—or the sham surgery—is now in the early 2000s an accepted part of the experimentalist's toolbox, if still controversial.

The fraught history of placebo surgery is interesting for what it reveals about the introduction in the late twentieth century of new methods for judging the effects of surgical procedures. In a conventional version of this story, surgery over the last few decades has witnessed a competition between two basic methods for building evidence of effect—the case series and the randomized clinical trial (RCT). For centuries surgeons measured the success of a new procedure in the accumulated experience of use and gradually formalized this process in the mechanism of the case series. Results from a single patient's case, if promising, led to further cases until a convincing series materialized, providing evidence of therapeutic effect or its absence. Accumulating experience could lead to a registry of cases, creating a larger body of evidence. To generate a traditional case series, the surgeon had only to operate and collect results in a systematic, attentive way. The case series proved both practical and influential and remains, with subsequent refinements, a mainstay of the surgical scientific literature.

The surgeon Johann Friedrich Dieffenbach is often referred to as one of the most innovative characters in the development of German surgery during the early nineteenth century, particularly in the area of plastic surgery. But for a figure that has become almost emblematic of surgical innovation, Dieffenbach's case also challenges two common assumptions about innovation in surgery. One is that innovation in surgery during the nineteenth century was largely the product of technological change, particularly the introduction of anesthetic and aseptic techniques. The other, that a vital factor in the success of surgical innovations is the degree to which they can be reproduced and diffused. As for the first, Dieffenbach's work is located in the early part of the nineteenth century, rendering explanations of the growth of surgery based solely on technological determinism problematic, and opening up new questions about the driving forces behind innovation in surgery. With regard to the second, Dieffenbach's brand of innovation was formulated in a way that made it essentially inimitable. Dieffenbach's writings therefore provide an opportunity to reexamine these assumptions and offer alternative explanations.

The flourishing of plastic surgery in the early nineteenth century is a particular puzzle. Why would a technique dedicated to non-life-threatening conditions gain such momentum in the pre-anesthesia world? Many histories of plastic surgery avoid this question altogether and merely chart the diffusion of plastic surgical techniques, from the moment of the “rediscovery” of a technique for reconstructing the nose developed in India in the late eighteenth century, to the uptake of this and similar techniques by a number of surgeons in the German states and other countries in the early decades of the nineteenth century. More analytically oriented works have vaguely relied on a certain spirit of the age for answers. “Innovation was in the air,” writes Roy Porter about the introduction of a number of new plastic surgical techniques by the German surgeon Johann Friedrich Dieffenbach. Other authors have expressed surprise that plastic surgery boomed in spite of, not because of, the Zeitgeist. “The German enthusiasm for plastic surgery was a puzzling development,” observes David Hamilton, “because German-speaking thinkers were the origin of Naturphilosophie and the Romantic movement, whose antiscience stance rejected the scholarly achievements of Enlightenment thinking and substituted a free-floating theorizing and philosophical stance. Somehow,” he concludes, “plastic surgery, a fundamentally mechanistic human endeavor without the slightest hint of the mystical, flourished.”

Heart failure is a progressive, life-threatening condition that affects an estimated twenty-six million people worldwide, including 5.8 million Americans. For the patient in heart failure, their heart is simply not pumping blood as it should, and most die within five years after diagnosis owing to complications arising from poor or inadequate blood flow (such as organ failure) or from contracting infections in their weakened condition (such as pneumonia). The problem may be a case of left-sided heart failure (most common), right-sided heart failure, or both. The heartfailure patient may feel extreme fatigue, a shortness of breath, and possibly an increased heart rate, which will make everyday activities like walking and climbing stairs increasingly difficult. As the condition worsens, the patient experiences a buildup of fluid in the feet, ankles, and legs (edema), a congestion of blood in the lungs, perhaps memory problems, and even impaired thinking. There is no cure for heart failure. As one physician commented, “Heart failure is a lethal disease with a worse life expectancy than many types of cancer.”

In the United States, heart failure is among the most costly cardiovascular disorders owing to its intensive use of medical resources, including lengthy hospital stays and expensive medications. The number of new cases of heart failure increases with patient age, and with the rising number of elderly people in the United States, a greater proportion of the American population suffers from heart failure each decade. In 2013, the direct and indirect costs of caring for the heart-failure patient in the United States, including hospitalization and medications, is about $31 billion, and this number is expected to more than double by 2030. More people are surviving heart attacks and other cardiac conditions, perhaps because of more successful therapies or better education about heart disease. This means that people are living longer with damaged hearts and thus carry the risk of heart failure. To be clear, mortality rates from coronary heart disease have been declining since the 1960s yet it still remains the leading cause of death in many developed countries.

In November 1960, Time magazine ran a splashy medical news report with the rather futuristic title “Spines of Steel.” The article featured the work of the orthopedic surgeon Paul H. Harrington (1911–80), who had devised a method of straightening scoliotic spines using a series of implantable metal rods and hooks embedded in the vertebral column. So as to visualize the sleekness of Harrington's instrumentation, Time included a black-and-white photograph of the physically imposing surgeon, his large hands gracefully clutching one of his metal rods, slender as a soda straw. Although Harrington did not have a definitive cure—or a method to prevent the occurrence of spinal curvatures caused by scoliosis—his rods promised a new era in scoliosis treatment, with traditional and seemingly more cumbersome modes of medical intervention left behind (figs. 5.1–5.2).

To many surgeons today, Harrington's innovation is seen as a pivotal moment in the surgical management of severe scoliosis. From the 1960s onward, Harrington's instrumentation would become the standard method of scoliosis correction and fusion throughout the world for more than a quarter of the century. In the words of two orthopedic surgeons writing in 1999, Harrington's “instrumentation was a clear milestone in scoliosis surgery providing for the first time, a reliable means of obtaining and maintaining maximal deformity correction.” The advantages of Harrington's system, they write, “were obvious.”

Whereas the success of Harrington's surgery may seem obvious to orthopedists practicing now, the advantage of metal implantation was not at all clear to his contemporaries. In the mid-twentieth century, leading practitioners in the field endorsed various forms of scoliosis treatment. According to a 1941 study of sixteen US orthopedic clinics in prominent university research centers, postural exercise was one of the most commonly prescribed modalities of treatment, even though many orthopedists doubted its efficacy. Other popular forms of treatment included body casts, bone fusions, or a combination of the two. Of the sixteen clinics surveyed, thirteen used the Risser turnbuckle cast, named after the inventor-orthopedist Joseph C. Risser (1892–1982).

Speaking at a conference in Houston in 1985, the surgeon René Favaloro described 1968 as “the year of revolution.” He was not referring to the assassinations of Martin Luther King Jr. or Robert Kennedy or the protests against the Vietnam War. Instead, his revolution was the development of coronary artery bypass grafting (CABG) to treat coronary artery disease (CAD). For that operation, 1968 was indeed transformative. In April Favaloro published the results from his first fifty-five patients. By the summer of 1970 he and his colleagues at the Cleveland Clinic had performed CABG on over one thousand patients. Their success was matched by surgical teams in Milwaukee and New York City. Surgeons throughout the country took note. By 1977, surgeons in the United States completed over one hundred thousand CABG operations each year.

The CABG “revolution” provides an important case study of surgical innovation. Over a single decade the procedure emerged from obscurity to become one of the most common major surgical procedures. Many aspects of the innovation are interesting. First, its rise was not the result of a new discovery: Alexis Carrel had first attempted to place a bypass graft between the aorta and a coronary artery in 1910. Second, it was not the result of a lone genius, or the group at the Cleveland Clinic. Instead, researchers worldwide had tried to make Carrel's technique a success for decades, conducting extensive animal research and occasional human trials in the 1950s and 1960s. They had also developed dozens of other surgical techniques to treat CAD. Third, it was not the result of a landmark clinical trial, of the sort described by Shelley McKellar in this volume. In fact, Favaloro later downplayed the magnitude of the innovation, describing it in 1998 as a simple progression through a series of related procedures: “The evolution took place in just a few months from patch graft to interposition graft to bypass graft.”