‘PROTECTING AMERICA'S HEALTH (2003)

By Philip J. Hilts, New York City, Alfred A. Knopf, Hardcover, 2003, 394 pages, $26.95 There is probably no set of initials more necessary for the practice of modern day medicine than the three letters FDA. While the practicing physician may have a vague idea of the Food and Drug Administration's responsibilities in approving prescription and over-the-counter drugs for human use, very few of us are truly knowledgeable about the incredible extent and depth of the FDA's involvement in literally every aspect of human medicine. In view of this long-standing and unfortunate ignorance on the part of the medical profession, the appearance of a superbly crafted book providing an exciting review of the 100-year history of the formation and development of the FDA is a wonderful happening. This book by Philip J. Hilts, a highly respected and experienced medical journalist, provides a thrilling literary road map that begins with the agency's inception as the Bureau of Chemistry, within the Department of Agriculture. As the agency's history begins, we meet President Theodore Roosevelt, who, early in his political career, had become exceedingly concerned about the quality of foods and medicines sold to the public. We also meet Dr. Harvey Washington Wiley, a truly “larger than life” figure, who would become the first head of the agency. Dr. Wiley struggled for more than 25 years for the passage of legislation to assist in eliminating scandalous market conditions. Finally, in 1906, with the backing of the President, Congress passed the Pure Food and Drug Act. Despite its limitations, the legislation represented the true birth of the Food and Drug Administration and the beginning of its regulatory life. Incidentally, the American Medical Association strongly supported the passage of this law. At first, a few scientists who concentrated on controlling and limiting the sale of contaminated, adulterated, and rotting foods staffed the bureau. Eventually it grew into a governmental organization that, according to the book, is responsible for regulating products worth more than one trillion dollars a year and manufactured by 95,000 different companies. Prepare for a fascinating journey through the 20th century as the FDA is born and its mission and responsibilities are defined and redefined, and strengthened and weakened. Finally, we see it emerge from the crucible of 100 years of formation, responsible for the safety and efficacy of all medications and food products. Unending Opposition Maintaining oversight of the food and pharmaceutical industries has always been a contentious process. Since its inception, the agency has been at war, and it continues to fight numerous battles in the marketplace and in the halls of Congress on behalf of patients and consumers. Many readers will argue that the author presents a biased view of the evolutionary development of the FDA. And it does appear that at almost every confrontation he sides with the agency against the food and drug establishment and their political allies. Yet, it must be admitted that his opinions are extremely well referenced. As you read this fast-paced volume you will discover heroes and villains, all of whom have made unique contributions to the creation of the most influential governmental agency in the life of the American public. As one continues to read this book, it becomes increasingly difficult to understand why, at every stage, the food and drug companies continued to oppose the requirements the FDA wanted to put in place to assure the purity and usability of all pharmaceuticals and foods sold to the public. Plethora of Case Studies The book's plethora of case studies documenting the economic selfishness and total disregard for human injury or even death by the pharmaceutical industry throughout the 20th century are truly frightening. What is also disturbing is the collusion between various members of Congress and the business leadership to seriously limit or eliminate the FDA's regulatory powers. Unfortunately, this immoral association between industry and certain elected officials continues to this day. A good example is the continued sale of dietary and medicinal supplements, including herbal drugs for clinical purposes, without any regulatory control. These dangerous and worthless substances have evaded regulatory control largely through the influence of Senator Orrin Hatch of Utah, and others who are alleged to have a financial interest in the sale of these alternative medical products. 1938—The Turning Point In the chapter “The Birth of the Modern Pharmaceutical Trade,” the author states, “The revolution in medicine took place between that summer afternoon in 1938, and an October day in 1951.” It was during this period, which began with the passage of the Food, Drug and Cosmetic Act of 1938, that the giant pharmaceutical industry came into being. This seminal chapter reviews how elements of science and business combined for the first time to develop the unique “biotechnological engine” that produced the thousands of medicinal products and instruments that have significantly improved human health around the world. This resulted in the formation of the first gigantic food and drug conglomerates.Figure: Robert J. White, MD, PhDBut it was the new testing and labeling requirements mandated by the law of 1938 and finally put into effect by the FDA that formed the basis for their economic achievements. In order to comply with these regulations, the commercial institutes, at long last, had to embrace medical science. This led to the creation and development of well-equipped laboratories and the hiring of outstanding scientists. These skilled researchers not only designed and fashioned new drugs, they also provided assurance that those products had been properly tested. In essence, the author argues that the 1938 law authorizing new regulatory practices, such as pre-testing, built the pharmaceutical industry itself. A Gallery of Heroes Philip Hilts has woven an outstanding historical tapestry in which he incorporates the enactment of the legislation that built the FDA and biographies of commissioners that gave it life. He emphasizes the contributions of former Commissioners such as Harvey Wiley, James Goddard, and David Kessler, and discusses the politicians whose political intervention assisted in its evolutionary development. They include Presidents Theodore Roosevelt, Franklin D. Roosevelt, and Lyndon Johnson as well as members of Congress, such as former Tennessee Senator Estes Kefauver. Also included are those who attempted to curtail the regulatory functions or even destroy the agency, such as former Congressman Newt Gingrich. All add fascinating biographical colors to this history. Modern day criticism of the FDA is not overlooked, particularly the issues of slow drug approval (significantly improved) and delay in removing inappropriate pharmaceuticals from hospitals and pharmacies. The importance of this volume cannot be overestimated, particularly for members of the oncology specialty, who are so dependent on the discovery, development, and approval of new chemotherapeutic agents. In truth, it is a must read for every practicing physician.