The practice of medicine in the age of generic pharmaceuticals is built upon the premise that these chemically identical medications have the same therapeutic effect as the brand-name ones. But do they? Generic: The Unbranding of Modern Medicine by Jeremy A. Greene, MD, PhD, of John Hopkins University is a fascinating exploration and challenge of this premise.
Generic Drugs Are the Same but Not the Same
While generics differ from brand-name drugs in appearance and in inactive ingredients like fillers, binders, and coatings, they are presumed to be identical to them in all the ways that matter. Yet this presumption may be overly simplistic and at times, not quite accurate. Dr. Greene points out bioequivalence can’t be guaranteed by chemical or biological assays alone. Other characteristics, such as physiology and pharmacology. can make a difference in the therapeutic effect. Moreover, factors unconnected to the field of medicine can also enter into the therapeutic equation, including economics, politics, morals, and beliefs.
The History of Generics in America
In addition to an examination of the potential differences between the two types of prescription drugs, the book is a chronicle of the history of generics in America. Health care history is full of failed attempts to offer equivalent value to the public for a lower price. Amid these efforts that fell short of their goal, the substitution of bioequivalent drugs for more expensive brand-name medications is an unusual success story. Dr. Greene describes the social and cultural issues that played a role in the evolution of generic drugs from being viewed as counterfeit medications in the mid-twentieth century to being a widely accepted industry in the twenty-first century.
Generic drugs are never fully identical to the brand name products they imitate. Rather, their claims to being ‘the same’ lies in proof that they are similar enough in ways that matter to be functionally interchangeable. As the market for generic substitutes has grown–from only 10% of the American pharmaceutical market in 1960 to nearly 80% by 2010–so too have epistemological and epidemiological conflicts over how one can prove that generics are truly equivalent to their brand-name counterparts. These conflicts over generic drugs reveal fundamental conflicts over what it means to practice rational medicine, and what role consumers, physicians, insurers, and others should have in defining that rationality. – Jeremy A. Greene, MD, PhD
Complexities and Controversies in Generic Pharmaceuticals
As the market for generics mushroomed from 10 percent in 1960 to 80 percent in 2010, conflicts arose over how generic substitutes are equivalent to their brand-name counterparts. When generics were embraced, they ignited a complex interplay between the practice of medicine and various aspects of society. Dr. Greene delineates the following controversies that were involved:
- Difficulties surfaced from the generalization of medical knowledge.
- Science had only a tenuous influence on public policy.
- Marketing, industry, and consumer factors emerged that had an impact on modern-day health care.
The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price.
A Multifaceted Tale
The tale of generics’ rise to prominence is a fascinating one with several facets. One aspect involves consumer attitudes, which shifted from initial suspicion to trust. Other facets woven into the story are black market drugs controlled by the mafia, resistance from the medical community, and generic pioneers who were willing to take risks. The account takes the reader from the past to the present but also looks to what lies ahead for prescription drug benefits and the pharmaceutical industry.
An Increasingly Generic Future for Prescription Drugs
Dr. Greene predicts an increasingly generic future due to the expiration of patents on blockbuster medications, along with a pharmaceutical innovation crisis resulting in the development of fewer new drugs. Since generics have become the primary tool doctors uses to treat illness, an understanding of the issues related to de-branding is helpful.
The author’s literary style is to intersperse dramatic historical narratives with scientific explanations, all of which are based on meticulous research and documentation. This method captures the reader’s interest and compels him to continue reading. It is recommended for anyone interested in pharmaceutical industry issues and prescription drug benefits.
Several august members of the medical profession have endorsed the book. Pulitzer Prize winning author and cancer researcher Siddhartha Mukherjee, MD, PhD of Columbia University Medical School lauded it with this statement: “An enlightening and passionately written work, ‘Generic’ opens the ‘black box’ of the pharmaceutical world.” The content of that black box is intriguing, indeed.
You may purchase Generic: The Unbranding of Modern Medicine from Amazon.com or Johns Hopkins University Press or any bookseller. Jeremy A. Greene, MD, PhD, is associate professor of medicine and the history of medicine and the Elizabeth Treide and A. McGehee Harvey Chair in the History of Medicine at the Johns Hopkins University School of Medicine.
He is the author of Prescribing by Numbers: Drugs and the Definition of Disease and coeditor of Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America, both outstanding reads and both published by Johns Hopkins University Press.