Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
338 pp. Hoboken, NJ: Wiley; 2005. $27.95. ISBN 0-471-61091-7
Virtually everything a cardiologist does, whether it involves prescribing drugs, implanting a device, providing dietary advice, or setting healthcare policy, involves a decision at some point made by the Food and Drug Administration (FDA). Although cardiologists have at least a passing familiarity with the Cardiorenal Advisory Committee process via articles in standard cardiology journals, the history of the FDA and the complexity of its decision-making processes are a black box to most cardiologists. After a moment’s thought, it becomes clear that a well-written contemporary text describing the FDA would be a valuable resource for cardiovascular specialists.
That resource is now available in a 338-page book entitled Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat. As described on the book’s inside flap, Fran Hawthorne, the author, is a senior contributing editor of Institutional Investor and is a seasoned reporter covering healthcare and business for more than 20 years for Fortune, Crain’s New York Business, and several other publications. She regularly contributes to The New York Times, Worth, and Self.
I found this book a fascinating read. It consists of 15 chapters, penned in an absorbing and readable style. Fran Hawthorne scrupulously avoids the dry, literal descriptive mode of conveying information—those lectures are always unpopular in medical schools anyway! Instead, she brings critical issues to life by describing the material in a “case presentation” format, always a popular approach in medical education. The reader literally travels through this book from the perspective of the individuals involved, complete with colorful descriptions of their personalities, in many cases from the ground up as new drugs or devices are discovered, tested in clinical trials, and summarized in investigational reports and applications to the FDA. It is clear that Fran Hawthorne has done her homework in preparation for this book. A unique and laudable aspect of her description of events and decisions by the FDA is the insight she provides about the trickle-down effect of regulatory decisions on patients and their families. This rich and at times poignant aspect of Inside the FDA speaks to the societal obligations of physicians as well as of the FDA itself.
Early in the book, readers will find a chapter on the first 100 years of the FDA. This places the mandates to the FDA in perspective. Subsequent chapters describe the bureaucratic complexities of determining which agency is in charge of a given issue as well as the necessary but mind-numbing task of reviewing truckloads of paper for new drug and device applications.
Toward the middle of the book, an important and disturbing theme is introduced—the influence of industry. Although the impact of industry on physician behavior and medical education is discussed in other texts, this book in a fair and equitable manner describes the complex interdigitation of industry efforts to develop new drugs and devices, the FDA process of reviewing applications, and the occasional phone call or letter from an influential congressperson, putting pressure on the review process.
The latter third of the book speaks to the interface of the FDA and the public. This interface is addressed in chapters describing efforts at consumer activism (the patient side of the equation) and the controversial technique of direct-to-consumer advertising (the industry side of the equation).
There are no easy answers to the questions frequently raised by Fran Hawthorne in this book. I found myself thinking about many of her questions quite frequently: How should we as cardiologists respond when a perfectly acceptable generic version of a drug is available but has to compete with a heavily marketed agent that reflects a minor modification of the molecule to extend patent protection? Given the explosion of the pharmacopeia and the increasing technical complexity of new devices, is it realistic to expect the FDA to monitor drugs and devices after they have been marketed? Relatively low-frequency but serious events, such as a myocardial infarction in a patient taking a COX-2 inhibitor, are a great challenge for the FDA. How many patient-years of safety should be required to avoid ending up in a situation such as the coxib/NSAID story of increased thrombotic risk?
I would highly recommend that cardiovascular specialists read this book. It is our societal and professional obligation to be informed about important matters such as those that have an impact on the FDA, and many of our patients are highly informed and come to us with questions. Clinical investigators and healthcare policy experts will find this book valuable for framing their thinking and may even cite it in their own writings or lectures.
We cannot simply hide behind our prescription pads, stethoscopes, scalpels, and so forth. We must know how the therapies placed in our hands were approved for our use. This book helps us along that educational path.