Scott H. Podolsky

The Burden of Disease and the Changing Task of Medicine

Disease has changed since 1812. People have different diseases, doctors hold different ideas about those diseases, and diseases carry different meanings in society. To understand the transformations of disease over the past 200 years, one must explore its social nature.

Assessing the Gold Standard — Lessons from the History of RCTs

Randomized, controlled trials have become the gold standard of medical knowledge. Yet their scientific and political history offers lessons about the complexity of medicine and disease and the economic and political forces shaping the production and circulation of knowledge.

Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50

In 1962, President Kennedy signed into law the Kefauver–Harris Amendments to the Federal Food, Drug, and Cosmetic Act. Many issues covered by provisions cut from the bill continue to confront those who would ensure access to innovative, safe, efficacious, affordable therapeutics.

Massive Myocardial Necrosis in Thrombotic Thrombocytopenic Purpura A Case Report and Review of the Literature

Thrombotic thrombocytopenic purpura (TTP) is an uncommon syndrome resulting from diffuse occlusion of small arterioles and capillaries by hyaline microthrombi. It is characterized by fever, thrombocytopenic purpura, microangiopathic hemolytic anemia, and neurologic and renal dysfunction. While cardiac pathology in TTP is commonly seen at autopsy, clinical cardiac dysfunction is rare and typically results from conduction system involvement. While 3% to 8% of patients with TTP report chest pain on admission, reports of fatal ventricular pump failure are extremely rare. We now report a case of TTP resulting in death from widespread myocardial necrosis. This patient presented with elevated cardiac enzymes and electrocardiographic disturbances that mimicked viral myocarditis, as well as a profound thrombocytopenia. Such a case may represent the extreme of a distribution of cardiac involvement in TTP or the consequence of an unidentified autoimmune process capable of precipitating severe myocardial TTP.

A Historical Perspective of Pharmaceutical Promotion and Physician Education

THE MEDICAL PROFESSION HAS RECENTLY AWAKENED to a crisis over industrial influence in medical education. In recent years, the problem of industrial funding of continuing medical education (CME) has been the subject of stern warnings from academic medicine, prominent congressional hearings, and strict revisions of the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support. Commercial support for CME continues to increase and now comprises more than half of all CME income. These clear indicators of dependence have raised widespread concerns of bias in the ongoing education of practicing physicians regarding new drugs and failure of the medical profession to assume responsibility for educating physicians. How did this come to be? Critics of the role of pharmaceutical promotion in medical education have claimed that policy changes in the 1980s altered relations between the medical profession and the pharmaceutical industry. However, in the late 1950s and early 1960s, divisions over the role of pharmaceutical marketing in physician education had already surfaced in the medical literature and in Congress. On closer analysis, the history of industry involvement in medical education involved tensions between promotion and education dating back to the origins of the wonder drugs, from antibiotics to antipsychotics. To provide a better understanding of the present medical educational dependence on the pharmaceutical industry, this Commentary traces the problem of commercial influence on physician education from the advent of the wonder drugs through current concerns regarding formal CME, with particular attention to a critical period in the late 1950s and early 1960s during which most positions in the current debate were firmly established.

The Emergence of the Randomized, Controlled Trial.

Randomized, controlled trials date back much farther than is usually recognized, and their history offers insights into the intellectual and social forces shaping what would become a medical research standard and a mechanism for taming the therapeutic marketplace.

Keeping Modern in Medicine: Pharmaceutical Promotion and Physician Education in Postwar America

Recent critiques of the role of pharmaceutical promotion in medical practice invoke a nostalgic version of 1950s and 1960s medicine as representing an uncomplicated relationship between an innovative pharmaceutical industry and an idealistic and sovereign medical profession—a relationship that was later corrupted by regulatory or business practice changes in the 1980s or 1990s. However, the escalation of innovation and promotion in the pharmaceutical industry at mid-century had already provoked a broader crisis of overflow in medical education in which physicians came to use both commercial and professional sources in an attempt to “keep modern” by incorporating emerging therapeutics into their practices. This phenomenon was simultaneously a crisis for the medical profession— playing a key role in attempts to inculcate a “rational therapeutics”—and a marketing opportunity for the pharmaceutical industry, and produced the structural foundations for contemporary debates regarding the role of pharmaceutical promotion in medical practice. Tracing the issue from the advent of the wonder drugs through today’s concerns regarding formal CME, we document how and why the pharmaceutical industry was allowed (and even encouraged) to develop and maintain the central role it now plays within postgraduate medical education and prescribing practice.

Commentary: The evolution of methods to assess the effects of treatments, illustrated by the development of treatments for diphtheria, 1825–1918

References 1 Choksy NH. Letter to the Editor: Professor Lustig’s plague serum. Lancet 1900;156:291–92; Reprinted Int J Epidemiol 2013;42:654–56. 2 Nathan R. The Plague in India, 1896, 1897. Simla: The Government Central Printing Office, 1898. 3 Condon JK. The Bombay Plague, being A History of the Progress of Plague in the Bombay Presidency from September 1896 to June 1899. Bombay: The Education Society’s Steam Press, 1900. 4 Lustig A, Galeotti G. The Prophylactic and Curative Treatment of Plague. Brit Med J 1901;1:206–08. 5 Choksy NH. The Treatment of Plague with Professor Lustig’s Serum. Bombay: Indian Textile and Municipal Journal Company, 1903. 6 The Indian Plague Commission: 1898–99: Bombay: Minutes of Evidence taken before the Indian Plague Commission at the Secretariat. 7 Haffkine WM. Concerning Inoculation Against Plague and Pneumonia and the Experimental Study of Curative Methods. J Hyg (Lond) 1915;15:64–101. 8 Bannerman WB, Haffkine WM. Serum-therapy of Plague in India; (Scientific Memoirs by Officers of the Medical and Sanitary Departments of the Government of India; New Series). Calcutta: Government Printing Office, 1905; p. 73. 9 The Plague. Br Med J 1907;1:878. 10 Choksy KBNH. On recent progress in the serum therapy of plague. Br Med J 1908;1:1282–84. 11 Choksy NS. Public health in India. Br Med J 1923;569.

History Teaches Us That Confronting Antibiotic Resistance Requires Stronger Global Collective Action

Antibiotic development and usage, and antibiotic resistance in particular, are today considered global concerns, simultaneously mandating local and global perspectives and actions. Yet such global considerations have not always been part of antibiotic policy formation, and those who attempt to formulate a globally coordinated response to antibiotic resistance will need to confront a history of heterogeneous, often uncoordinated, and at times conflicting reform efforts, whose legacies remain apparent today. Historical analysis permits us to highlight such entrenched trends and processes, helping to frame contemporary efforts to improve access, conservation and innovation.

Jesse Bullowa, specific treatment for pneumonia, and the development of the controlled clinical trial

Jesse Bullowas 1928 report on the use of antipneumococcic serum in lobar pneumonia1 was subtitled ‘Data necessary for a comparison between cases treated with serum and cases not so treated, and the importance of a significant control series of cases’. It stands out as one of the most sophisticated invocations of the controlled clinical trial in the 1920s, and as a self‐conscious attempt to justify and promote the methodology. Indeed, Bullowas contribution to a symposium on the treatment of pneumonia at the New York Academy of Medicine in December 1927 was entitled simply ‘The control’.2 In focusing explicit attention on methodological issues, Bullowa made clear that he wished to determine ‘whether there was conclusive proof that the serum is of value’.1 Bullowa, nearly 50 years old at the time of his presentation at the New York Academy of Medicine, was a clinical professor at the New York University College of Medicine3 and co‐director, with Milton Rosenbluth, of Harlem Hospitals pneumonia service, then ‘the largest therapy unit of any hospital in the city’.4 During the previous decade, Rufus Cole and his colleagues at the Hospital of the Rockefeller Institute had introduced serotype‐specific antiserum for the treatment of pneumococcal pneumonia (as of 1928, only four such pneumococcal serotypes were known). When the Metropolitan Life Insurance Company lost 24 million dollars in excess death benefits during the influenza epidemic of 1918, it established an Influenza Commission, which would soon focus its attention upon pneumonia and its treatment with antipneumococcal antiserum.5 Intending to fund alternate control studies at multiple institutions,6 the company would ultimately fund published studies arising from Bellevue and Harlem Hospitals in New York, and from Boston City Hospital.7–9 However, none of the pneumonia investigators – who included such eventual luminaries as Russell Cecil (at Bellevue Hospital in New York) and Maxwell Finland (at Boston City Hospital) – would so explicitly advocate the methodology of the controlled clinical trial as would Jesse Bullowa.