Fads and Fashions in Drug Development
Great things are not accomplished by those who yield to trends and fads and popular opinion.
–Jack Kerouac, American writer.
You go through these little phases and fads and it never turns out the way you think it’s going to turn out.
–Will Sergeant, English guitarist.
Don’t chase the latest management fads. The situation dictates which approach best accomplishes the team’s mission.
–Colin Powell, US General and Statesman.
DIFFERENTIATING BETWEEN CURRENT FASHIONS (I.E., FADS) AND MAJOR INNOVATIONS IN DRUG DEVELOPMENT
Every professional discipline has current fashions (i.e., fads) that influence (a) which research topics are conducted, (b) the types of articles that are published, (c) the style of advertising, and (d) professionals’ views about their careers and research activities. There is usually a mixture of sound reasons and promotional exaggeration (hyperbole or “hype”) underlying the choices of fashionable activities being pursued; whereas some may be primarily based on important scientific grounds, others may be entirely hype. Probably the greatest threat to a pharmaceutical company from new fads is the strong encouragement to adopt the latest management fad to redesign, re-engineer, or simply reorganize part or all of the company.
Certain ideas or topics are promoted by those who are most closely associated with the idea professionally. These people often have a great deal to gain in terms of tenure, reputation, invitations to speak at prestigious meetings, and the likelihood of obtaining academic grants and other funds to pursue their research when their ideas are accepted.
In some cases, financial benefits are a factor favoring the promotion of certain research topics, particularly when academic researchers are aware of one or more companies that are interested in specific areas of research and there is a possibility of having a consulting or other type of financial arrangement if they study and/or endorse a specific hypothesis or research area. Orienting their research in certain directions to test theories of interest to the industry may be highly remunerative.
Some professionals within or outside of industry support currently fashionable ideas because they want to be seen as early supporters of a novel idea or activity or because they think that they will benefit professionally or economically by their support. This group includes:
Authors who want to publish results as rapidly as possible
Journal editors who want to publish the latest articles on new “hot topic” fields and subjects
Professionals who want to organize the first professional meeting or symposium on a new hot topic
For-profit course organizers who want to introduce a new course or retread their old ones
Since many people, including investors, want to know the current hot topics, there is always a large number of people who want to jump on the bandwagon to satisfy their desire to be part
of what is considered new. Although there are pros and cons to the actions of these groups, there is nothing wrong per se in promoting new ideas, early research data, or the latest hot topic. Senior executives of poorly run companies often look for a “quick fix” to their problems and adopt the latest trend, such as bringing in “Six Sigma” to their company, thinking it will help save their positions. In reality, such shortsighted “fixes” rarely work.
of what is considered new. Although there are pros and cons to the actions of these groups, there is nothing wrong per se in promoting new ideas, early research data, or the latest hot topic. Senior executives of poorly run companies often look for a “quick fix” to their problems and adopt the latest trend, such as bringing in “Six Sigma” to their company, thinking it will help save their positions. In reality, such shortsighted “fixes” rarely work.
Members of the media are always looking for stories to sell newspapers, newsletters, and magazines. They often create a story about the “latest trend” (or about a future one) where there is no trend at all or take an unsubstantiated concept and weave it into an apparently solid-sounding story that suggests that the trend may eventually have a major impact on the discipline.
There is an excessive amount of data and information in our society. Given the large background noise of information and the need to shout to be heard, how is one supposed to get a message across and encourage others to study a new concept?
A commonly used approach is to exaggerate the importance of an experiment or observation. Another approach is to lie about one’s results (which has occurred all too frequently over the past several decades, although the safeguards in place to prevent this are now stronger than ever).
Another way to be heard is to put a new interpretation on results that will make them sound exciting to others.
Finally, exploiting the commercial value of scientific results or hypotheses cannot be overlooked. This has become very important in recent years and has helped spawn entire industries (e.g., biotechnology, gene therapy, genomics, drug delivery technologies) and will undoubtedly lead to the creation of other industries in the future. Each of those technologies has demonstrated tremendous scientific and medical value, but there has been almost as much hype as legitimate science in the early days of each of these new fields and in other start-up technologies.
Venture capital companies have played a major role in funding many start-up firms that have promising new technologies or products, particularly in the biotechnology industry. They provide not only money but sometimes also management expertise and often place at least one member on the company’s board of directors. They have a reputation for having unrealistic financial expectations and unrealistic timelines and often try to hype a company to increase its value so that they can harvest their profit and sell the company through an initial public offering or other exit strategy. They operate on the principle that if one of every ten or 20 companies becomes a huge success, then their goals are met.
The traditional approach of testing a hypothesis and finding important results before forming a new company seems to be old fashioned and out of favor today. There is an old joke about people starting a biotechnology company and then asking investors for money to test their hypotheses (in some cases, they are starting with almost no experimental data). The reason why this is an old joke is that it has become an all-too-frequent reality for the past 15 years! The chances of commercial success are very small for biotechnology companies, but many investors believe that it is worth owning a stock portfolio of approximately 20 companies in the hopes that at least one or two will become major commercial successes.
Important innovations such as biotechnology and “in silico” discovery and development tools (see Chapter 114) have had a monumental impact on the pharmaceutical industry and have created new related industries. However, many new types of drugs and innovations expected to be revolutionary have fizzled and died. It is important, therefore, to develop an approach or even sixth sense to differentiate between true innovations and current fashion when grandiose claims are made for a new technology, drug, or other scientific advance.
Threats to a Pharmaceutical Company from New Fads (Fashions)
Probably the greatest threat to a pharmaceutical company from new fads is the strong encouragement to adopt the latest management fad to redesign, re-engineer, or simply reorganize the company. Every year brings new management fads that attain great popularity in the business media and are used by many management consultant firms to encourage and even pressure certain managers within a company to hire the firm to modify procedures or to conduct a major evaluation. This evaluation is always “guaranteed” to produce a list of recommendations that the consulting firm or the latest business book is (surprise, surprise) ideally able to implement.
Given these issues, how can one readily determine whether what one is told by consultants, business press, or the current fad is true? For people outside a company, trying to learn many details about a company is often difficult, particularly for privately owned companies. When one reads a prospectus about a new company, there are often claims of a major scientific and medical breakthrough. It is usually impossible to know whether the company’s hopes will come to pass, but one can generally assess the degree of risk involved. Relevant questions include: “Is there really a medical need?” “What is the probability of getting the product to market within the timeframe and the budget parameters this company has to work with?” “What is the probability of commercial success by this company if and when the product is commercialized?”
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