It might seem obvious to many people that “common sense” should be a guiding beacon for professionals to use in discovering, developing, and marketing new and older drugs. Reality has shown that this simplistic view is rarely true. If it were the best approach to use, then any astute professional, academic scientist, or practicing clinician could start a pharmaceutical company and have a high likelihood of being successful as long as they had a good drug or product to develop. Also, any nonpharmaceutical company could acquire an existing pharmaceutical company and be commercially successful.

Many bright people with great ideas or products to develop have started pharmaceutical companies and have not been successful. Giant chemical companies are in a closely related industry, and many have bought or established large pharmaceutical companies. Their collective efforts in the pharmaceutical industry over a period of several decades have been a general failure. For the most part, they have been forced to sell their interests, be acquired, or accept minimal financial results. The reasons for this failure are described later in this chapter and can be attributed, in a large degree, to using common sense rather than pharma sense.

The need to develop and use pharma sense rather than common sense is based in part on the fact that the pharmaceutical industry has major differences from almost all other industries and that a large amount of specific knowledge and experience is needed. One must learn the optimal questions to ask and what data to collect in order to make decisions that will lead to success. Major differences between the pharmaceutical and other industries are that the pharmaceutical industry is one of the most highly regulated
industries and that managers have to deal with a large amount of uncertainty. Some of the characteristics of an individual with highly developed pharma sense are listed in Table 6.1.

Pharma sense is achieved by learning and practicing the principles that experienced pharmaceutical managers must understand and utilize. These are described throughout this book. Pharma sense leads to knowledge of when to extrapolate data to another situation and when not to do so. For example, principles of developing drugs are similar for most therapeutic areas, but there are important differences in developing most drugs in oncology because few effective and safe drugs exist, and use of placebo is generally not considered ethical. In oncology, Phase 1 trials are designed differently, and the standards used to define a successful chemotherapeutic drug differ from standards used in other therapeutic areas. The ability to extrapolate preclinical data to the clinical situation is more limited in oncology than in most other therapeutic areas.

Just as the ability to extrapolate animal data to humans or data from one group of patients to different groups of patients requires substantial knowledge, so does the extrapolation of decisions made using one set of issues and data to another set of issues and data. Some people who join the industry rapidly acquire a sound pharmaceutical understanding to viewing pharmaceutical issues, whereas others never acquire an adequate understanding or the ability to decide on the optimal approach for a given situation.

Pharma sense is global, although there are some important differences among countries. These differences relate to differences in interacting with regulatory authorities and understanding their requirements, as well as to differences in marketing because of important differences in medical practice, cultures, and reimbursement policies among countries. On the other hand, common sense differs from:

Ultimately, common sense becomes a highly individual set of beliefs.

A good example of where common sense varies among cultures is that of an accountant or other professional such as a dentist in a given European country who chooses to work a limited number of hours per week (approximately half-time) because the tax rates greatly escalate when a professional earns more than a specific amount of money. In other European countries, people in lower income brackets engaged in performing services (e.g., house painting) do not always work very hard or as many hours as they could because there is an attitude that doubling one’s income will only lead to a small gain in one’s standard of living, again because of heavy taxes. Common sense suggests that these are appropriate practices to follow.