Pharmacopolitics
Interferon is a substance you rub on stockbrokers.
A scientist quoted in Forbes (September 1980).
Advice that is most needed is seldom heeded.
Chinese fortune cookie.
Over the centuries, pharmacopolitics (i.e., interactions between people concerning drugs) has taken many forms. Pharmacopolitics probably originated with a primitive medicineman interacting with his patients and deciding how to apportion the primitive society’s herbal supply. Today, at a national or international “macro” level, pharmacopolitics encompasses the allocation of each society’s resources to drugs, equipment, and hospitals and the implementation of healthcare policies that control or influence most aspects of a nation’s medical system and patient health.
At a “micro” level, pharmacopolitics is the interactions regarding drug discovery, development, and marketing at the individual pharmaceutical or biotechnology company. The micro level is characterized by the interactions of a pharmaceutical company with many external groups, including those listed in Table 28.1. Interactions within a company are also part of this micro level.
NARROW VERSUS BROAD DEFINITIONS
At the company level, the narrowest definition of pharmacopolitics considers only government interactions. Although the definition could exclude interactions with regulatory authorities and solely consider interactions with legislative and judicial groups, that would be overly restrictive. Progressively wider definitions would include more and more of the external groups with which a company interacts, until all of its external group interactions were included. This latter broad definition is favored by the author.
Even broader definitions of pharmacopolitics would include internal company interactions, which are often described as political (see Table 28.2). However, it is not appropriate to include these interactions since the concept of politics has long been rooted in
external interactions. Internal company interactions are therefore excluded from the definition of pharmacopolitics used here. Comparable considerations also exist at the industry level (i.e., a narrow definition would consider only government interactions and a broad definition would include all external group interactions).
external interactions. Internal company interactions are therefore excluded from the definition of pharmacopolitics used here. Comparable considerations also exist at the industry level (i.e., a narrow definition would consider only government interactions and a broad definition would include all external group interactions).
Table 28.1 External groups that interact with pharmaceutical companies | ||||||||||||||||||||||||||||||||||||
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The author’s preferred definition of pharmacopolitics from the industry’s perspective is “interactions of the pharmaceutical industry, one or more of its companies, or one or more of its representatives with external individuals or groups” (see Fig. 28.1). An alternative definition is “the interaction between two or more individuals or groups attempting to influence decisions or opinions of the other regarding drug discovery, development, production, marketing, sales, policy, or other related pharmaceutical areas, where one group (or person) is within the industry and the other is not.” The remainder of this chapter uses these definitions.
Table 28.2 Internal groups that interact within pharmaceutical companies | ||||||||||||
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The central group in Fig. 28.1 could also be a regulatory agency, legislators, consumer activists, third-party payers, physicians, patients, or other groups. If one of the other groups is considered to be at the center, then the definition of pharmacopolitics would involve interactions of that group with each of its external groups. Thus, the most general definition is simply interactions of two separate groups concerning drugs.
MAJOR PRESSURES AT THE INDUSTRY LEVEL THAT CREATE PHARMACOPOLITICAL ISSUES
The basis of many pressures that the industry faces from its critics results in part from the tension between the pharmaceutical industry being viewed both as a commercial for-profit business and also as a provider of drugs to help patients. Is this industry an essential part of the healthcare profession or is it a provider of drugs primarily to make money for its investors? The industry has not helped its position or image by sometime emphasizing one side of its Janus head to one group and another side to different groups. It has never decided to present itself solely as a profit making enterprise but wishes to benefit from being seen as a contributor to patient well-being. Many professionals inside the industry are clearly motivated by altruistic thoughts and goals, despite the orientation of the business in looking at the current and next quarter’s income.
United States Regulatory History
During the 19th century, the many problems of patent drugs and charlatans led to the need and eventual passage of laws in the United States to control vaccines (i.e., the 1813 Vaccine Act), imported drugs (i.e., the 1848 Import Drug Act), and adulterated and mislabeled drugs (i.e., the 1906 Pure Food and Drugs Act). These were followed by the well-known 1938 Food, Drug, and Cosmetic Act that focused primarily on ensuring that drugs were safe, and its 1962 Amendments (i.e., the Kefauver-Harris Amendments) that focused primarily on ensuring that drugs were effective.
 Figure 28.1 Examples of external group interactions (i.e., people and groups outside the double-line circle) between a pharmaceutical company and its external world. These are pharmacopolitical interactions. Internal groups with whom the external groups interact are shown within the double-line circle. Other constituencies (e.g., physicians or regulatory agencies) could be substituted for the company in the center and an entirely new set of external group interactions described. |
Increasing regulatory standards are pressuring companies to discover highly profitable drugs to support their large research and development budgets. Other pressures (e.g., increasing competition among companies, stockholders, and cost-containment practices) are also contributing to this result. On the other hand, scientific advances are leading the industry to a position where they will eventually discover more drugs for smaller patient populations and this will raise the question of whether a new paradigm of drug discovery and development and marketing will have to be used (see Chapter 16).
Many different groups are increasing their pressures on the industry to lower prices for older pharmaceuticals and to keep newer ones at relatively low prices. This is not a purely economic attack on prices; it is the tip of the political iceberg questioning whether a reasonable price for a pharmaceutical is based on free market economics (as exists for most industries) or is based on what the country can afford (i.e., more of a socialized healthcare concept).
Delays, unnecessary duplications, and inefficiencies in drug development plus inefficiencies in creating simultaneous regulatory submissions worldwide all create pressures on the industry to develop their drugs more rapidly and efficiently. Pressures from investors, analysts, and other financial professionals as well as price controls in some European and other countries create other pressures to charge high prices for their new drugs once they reach the market, even in highly competitive markets.
Pressures on the industry from external groups should elicit a broadly defined political response that is coordinated among many, if not most, companies. This response is often expressed through trade associations and by the company’s own lobbying efforts. In some cases, the companies act through independent organizations (e.g., think-tanks). Political attacks against companies should receive a political response, and economic issues and questions raised should receive an economic response. There are numerous occasions where the industry’s response to a political attack has been with an economic response (e.g., discussion of the high costs of research and development), which this author believes is overused and should be replaced with a message that is new and more targeted to addressing the concerns of industry’s critics.
MAJOR PRESSURES AT THE COMPANY LEVEL THAT CREATE PHARMACOPOLITICAL ISSUES
Some of the major pressures exerted on individual companies that generally elicit a political response include:
Pressures to maintain a full pipeline of medically and commercially promising drugs at each phase of development
Pressures to join other companies in mutually beneficial relationships to discover, develop, cross-license, or co-market drugs jointly or otherwise to create mutually beneficial relationships
Pressures to avoid costly litigation from those in class action shareholder lawsuits that claim the company’s stock was hyped at a time that the insiders knew or should have known that the main drug being promoted was in serious trouble (e.g., Vanlev)
Pressures to avoid costly litigation from injured patients or those in class action lawsuits claiming the company withheld important safety information from the public (e.g., Vioxx)
Pressures to respond to external crises (e.g., product tampering or organized demonstrations) or internal crises (e.g., fires or sabotage) in a prompt, ethical, and appropriate manner. Astute senior managers of some companies have created a number of contingency plans to deal with these and other crises.
Pressures on some individuals to compromise their high ethical standards (a) to design clinical trials at a less than appropriate standard, (b) to omit conducting clinical and nonclinical studies believed necessary or appropriate, or (c) to submit regulatory applications prematurely so that a list of deficiencies to remedy is received at an early date
Pressures on the company to provide patients with package inserts for each of the company’s products. Many perspectives exist on this particular topic (see Chapter 39).
Pressures from shareholders and financial analysts to provide a high rate of financial return on a continual basis to stockholders, recognizing the innately high-risk nature of the industry
SELECTED PHARMACOPOLITICAL ISSUES
Historically, many of the most important pharmacopolitical issues have arisen out of concerns expressed by groups external to the pharmaceutical industry. A number of goals and issues of importance to the industry are mentioned for several of these groups.
1. Legislators
Goal: To provide patients in their country or region with the lowest cost healthcare programs, which meet at least minimal health standards and do not grossly compromise quality or restrict access to those drugs (i.e., cost containment) Issues:
Assessing the direction of political and legislative pressures and changes
Generic substitution of drugs and biologics
Avoiding or imposing a maximum price at which a drug could be sold
Imposing sales caps on drugs for rare diseases that are given a seven-year period of exclusivity, or reassessing their profitability after a period of years
Use of essential drug lists created by the World Health Organization
2. Regulators
Goal: To ensure that government and pharmaceutical programs and marketed medical products do not directly or indirectly harm patients (i.e., to safeguard and maintain public health) Issues:
Assessing the speed of approval of new drugs and supplemental applications
Assessing the degree to which safety has to be confirmed both prior to and after marketing (e.g., using both passive and active methodologies)
Identifying the types of biologics (e.g., proteins) and genes that can be patented
Determining rules for approving patents and their duration
3. Physicians in practice
Goal: To provide healthcare in the manner as they have been trained, and avoiding harm to patients Issues:
Views of physicians regarding therapeutic substitution
Ensuring that the pharmaceutical industry’s practices in promoting drugs to physicians are ethical and do not create conflicts of interest
Determining whether the ability of sales representatives to detail directly to physicians should be curtailed in hospitals and elsewhere
4. Pharmacists
Goal: To expand their profession to include counseling patients and providing information to other healthcare professionals, rather than being limited in some areas to filling prescriptions Issues:
Do pharmacists have the ability to make sound medical decisions regarding both generic substitution and therapeutic substitution?
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