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Pharmacopolitics
Drug Regulation in the United States and Germany
By Arthur A. Daemmrich The University of North Carolina Press
Copyright © 2004 The University of North Carolina Press
All right reserved. ISBN: 0-8078-2844-0
Chapter One
Medicine, Politics, and Governance In recent years, pharmaceutical drugs have become implicated in global politics as never before. Inequitable drug prices, persisting differences in national regulatory approaches, and debates over how to define safety and efficacy for diverse patient populations around the globe now attract an unprecedented degree of attention. The political, financial, and human health stakes have never been higher for patients, manufacturers, government agencies, or the medical profession.
Unlike the conventional terrain of macro-politics where states collide over interests of national security, pharmaceutical politics play out at a level where citizens deal with illness and health and small organizations voice demands for greater representation. The "high" politics that shape relations among countries and determine governance structures at the national and international level now can be found in the "low" arenas of drug regulation and health care delivery. Power and politics are not just found at the level of nations or international agreements, but are wrapped up in seemingly innocuous pharmaceutical drugs and supposedly standardized regimes for verifying their safety and efficacy. Debates over pharmaceutical drugs in this "low" arena ultimately shape the organization of states, industry, the medical profession, and non-governmental organizations (NGOs).
Recent events offer some striking illustrations of these points. Seeking to reduce the cost of medicines for their citizens, the governments of India, South Africa, Brazil, and other countries have threatened to ignore drug patents and institute compulsory licensing initiatives. Pharmaceutical firms headquartered in the United States and Europe defend drug prices by explaining the expenses accrued during research and testing. Between 6,000 and 10,000 compounds are synthesized in the laboratory for each drug that ultimately enters the marketplace. During 2001, pharmaceutical companies spent an average of 17 percent of sales on research and development, an outlay of $30 billion in the United States and $12 billion in Europe. According to industry-sponsored surveys, getting a new drug from the laboratory to patients requires companies to invest $800 million over the course of ten to twelve years. As evidence for current pricing patterns and enforcing strict patent laws, these facts nevertheless fall on deaf ears when government officials and activists attack firms for failing to meet the health care needs of patients in developing countries. In response, the industry has slashed prices-most notably for AIDS drugs-and has increased efforts to help poor nations improve their health care systems.
Drawing a link among disease, poverty, and terrorism, U.S. President Bush recently proposed an "Emergency Plan for AIDS Relief" to help an estimated thirty million Africans suffering from the illness. In his 2003 State of the Union address, Bush asked for $10 billion in new funds so that "this nation can lead the world in sparing innocent people from a plague of nature." Much of this new support would underwrite the purchase and delivery of anti-retroviral drugs, which Bush noted had declined in price from $12,000 to under $300 per year of treatment. A $15 billion initiative took shape during spring 2003; among other goals, the Bush administration plans to use these funds to make therapeutic drugs available to two million Africans with HIV. Not coincidentally, Bush's speech turned next to national security: "And this nation is leading the world in confronting and defeating the man-made evil of international terrorism." In the context of security concerns, Bayer was forced to renegotiate the price and availability of its antibiotic Ciproflaxin following anthrax attacks in the fall of 2001. An uproar concerning bioterrorist threats brought shifts in the relationship among government, industry, and the public to the fore. When Tom Brokaw of NBC Nightly News held up a container of the pills and stated, "In Cipro we trust," he drew attention to the significance of modern biomedicine for national security and the public's trust in governing authorities. Fearing shortages, government officials in Canada and the United States threatened to ignore Bayer's patent rights by licensing generic manufacturers to produce the drug. The company ultimately avoided this scenario by increasing stockpiles and cutting prices.
In both the case of AIDS medicines in developing countries and anthrax treatments in industrialized nations, intellectual property rights and drug prices came under fire for threatening public health and national security. Policy solutions in both settings involved negotiated compromise rather than strict regulation. States that once governed industry sectors through command-and-control mechanisms now negotiate with global companies. Patients who once interacted with issues of drug prices, safety, and availability mediated only through their physicians now are organized as autonomous influential political actors. These developments offer an interesting and exciting vision for the future as power and authority are shared among national governments, multinational companies, and NGOs.
Offering a distinctly technocratic vision for this future, government officials and representatives of the pharmaceutical industry from the United States, the European Union, and Japan have met regularly during the past decade in an attempt to develop uniform standards for clinical trials and regulatory review. They intend to standardize all aspects of drug testing and reduce the costs and time involved in bringing new medicines to the market. Participants in this "International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH) hope to achieve this goal by rationalizing safety and efficacy testing. They expect test results, like the pills themselves, will transfer easily from any one political and medical context to another.
The standardization of medical policies along the spectrum from premarket testing to patient surveillance once drugs are marketed will require the mobilization of multiple actors. It will also require changes in a variety of less visibly political settings. Concerns about representation, drug costs, and access to medical care are not just negotiated in the course of government regulatory decisions, but also during clinical trials and in the doctor-patient relationship. As the examples of AIDS and anthrax illustrate, the extremely contentious issue of drug prices is linked to regulatory demands for product safety, scientific debates regarding testing methods, and moral concerns with patients' rights. These features of national medical politics are likely to resist global standardization.
Therapeutic Cultures in the United States and Germany
Advances in medicine, the emergence and persistence of intractable diseases, high-profile drug disasters, and even low- profile medical errors all fuel debates among the principal actors in medical politics. Throughout this book, I advance the concept of therapeutic cultures as shorthand for relationships among the state (including legislatures and regulatory agencies), the pharmaceutical industry, the medical profession, and disease-based organizations. These actors frequently offer rival visions for health care with profound implications for the organization of modern societies. Competition over who can best speak for "the patient" was fundamental to the assertion of authority in this arena. While the direct claims made by patients regarding the impact of disease and the appropriateness of competing treatments have reached broader audiences in recent years, for the bulk of the twentieth century, patients did not speak directly in health care policy. Instead, professional groups and government agencies competed for the authority to represent them. As we shall see, differences between therapeutic cultures in the United States and Germany, the two countries on which this book focuses, resulted in very different choices for regulatory structures and produced different therapeutic orientations to their national polities.
Therapeutic cultures, as I employ the term, refers specifically to the historical evolution of a distinctive set of institutionalized relationships among the state, industry, physicians, and disease-based organizations. I argue throughout this book that the United States and Germany have put into place two different sets of these institutional relations through incremental historical processes. Their therapeutic cultures share a close interface with broader political and cultural beliefs and practices that are intriguingly similar and different between the two countries. Since 1950, citizens of both West Germany and the United States have experienced stable forms of democratic governance, remarkable advances in medical technologies, capitalist economies that support free trade, and government involvement in medicine through research support and regulation of the pharmaceutical market.
These similarities are offset by contrasts in their health insurance arrangements, access of patients to the political process, the authority wielded by physicians, and social insurance systems. For example, health care in the United States is generally seen as a private good associated with individual choice and the availability of "menus" for insurance, thereby rationing care by price. In Germany, by contrast, health care is seen primarily as a right or entitlement. It serves as an instrument of broader social justice, and rationing, if at all, is controlled by providers on a local and individual level.
This institutionalist perspective on politics and culture sheds light on the relation between broader cultural beliefs and practices on the one hand and institutional relations and policy outcomes on the other. The case of pharmaceutical regulation and medical care shows that there is no simple causal relationship between these two domains: we cannot argue that because Germany has cultural belief X, it has institutions x; or alternatively, because the United States has institutions y, it has cultural belief Y. Yet in key instances, the cultural patterns exhibited in medical care in Germany differ from those of the United States in the same way that their institutions differ. In action-not least in the definition of "the patient," care for the ill, and formal medical policy-there are tight reciprocal relationships between cultures and institutions.
The concept of therapeutic cultures helps to untangle some of these connections and draws attention to important contrasts between the United States and Germany. Differences between the two countries are especially meaningful in light of similarities in their official requirements for drug safety and efficacy, as well as their overarching similarities in medical care. Therapeutic cultures are active in three primary arenas: legislative/regulatory mandates, scientific testing in clinical trials, and oversight of adverse drug reactions. Because of their different therapeutic cultures, the distribution of authority among the quartet of actors in medical policy has shifted frequently in the United States, but remained comparatively stable in Germany. In one key feature of medical policy, American regulators delineated a strict boundary between premarket testing and market approval, whereas their German counterparts adopted a more flexible approach that blurred the line between pre- and postmarket oversight. More recently, differences between their therapeutic cultures promoted the emergence of disease-based interest groups targeting regulatory policy in the United States, while few such organizations sought to change regulatory approaches in Germany.
This means of explaining differences between the two countries brings into focus the shifting role of politics in medicine. Instead of viewing regulatory differences as the outcome of variation in state structures, we see that the political challenges posed by medical risks are mediated by a more complex web of relationships among the state and the other major participants in health care delivery-including, most significantly, the medical profession. The United States and Germany have some similar and some different ways of interrelating patient needs with pharmaceutical research and testing, medical care, and government regulation. In both countries, knowledge production and decision-making authority are distributed across a network of key actors including industry, the medical profession, government agencies, and disease-based organizations. Yet differences in the relationships among the actors account for the fact that drug testing and scientific procedures have become politicized in the United States, but not in Germany.
Comparing the United States and Germany
The primary purpose of this book is to compare drug regulation in the United States and Germany between 1950 and the present. For the period between 1950 and 1990, "Germany" refers explicitly to the Federal Republic of Germany, or West Germany. The German Democratic Republic (DDR) had a unique set of political and structural constraints on medicine and a radically different relationship between the state and civil society, making it inappropriate for this study. During the past decade, a reunited Germany has gradually integrated key features of its government with the European Union. For that reason, the comparison is expanded in Chapter 4 to encompass European-level regulations and clinical testing.
Throughout the book, I explore several puzzling differences between the United States and Germany. First, government officials in the United States closely control the production of information about the safety and efficacy of new medicines, whereas the medical profession has retained greater autonomy to design and oversee clinical testing in Germany. Second, a strict division between testing and marketing prevails in the United States, while German institutions follow a more flexible regime regarding pre- and postmarket regulatory oversight. Third, patients in the United States increasingly challenge expert risk assessments and demand access to drugs, even in early stages of clinical trials. A comparable politics of patient identity and access to medicines is strikingly absent in Germany, where professional associations continue to operate as intermediaries between citizens and the state.
While important in their own right, these differences become even more interesting in light of major similarities and often-subtle contrasts between the principal actors in medical policy and politics in the two countries. Multinational firms headquartered in each country develop most new pharmaceuticals, but frequently market different drugs in each nation. Drugs intended for both countries undergo distinctive tests in each of them.
Continues...
Excerpted from Pharmacopolitics by Arthur A. Daemmrich Copyright © 2004 by The University of North Carolina Press. Excerpted by permission.
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