Myth: Most drugs are discovered and developed by the government. Companies put the finishing touches on and market them.
Reality: The Pharmaceutical Research and Manufacturers of America member companies’ R and D spent $24 billion on clinical trials in 2005 versus $2.5 billion by the government (Ken Getz, personal communication, 2007), and the industry’s R and D budget has been increasing at a much greater rate than the National Institutes of Health’s budget for over a decade. The gap between the two is, therefore, widening year by year. In addition, only a small fraction of the total National Institutes of Health budget (about 5%) is even possibly associated with drug discovery and development. The government focuses on basic knowledge, and only the industry has the infrastructure, staff, and mission to develop drugs.
Myth: Most new drugs are highly profitable.
Reality: Only three of every ten marketed drugs produce revenues that match or exceed their average R and D costs
(Grabowski and Vernon 1994). The costs of developing new drugs have escalated exponentially over time, from $54 million in 1976 to $231 million in 1987 to $802 million in 2000 (DiMasi et al. 1991; DiMasi et al. 2003). An even greater figure of approximately $1.2 billion to develop biotech products was recently reported.
Table 44.1 Selected myths of innovation
1.
Complete technical specifications and a thoroughly researched market plan are invariant first steps to success.
2.
Substantial strategic/technological plans greatly increase the odds of a “no surprises” outcome.
3.
Big teams are necessary to rapidly blitz a project, especially a complex one.
4.
Time for reflection and thought built into the development process is essential to creative results.
5.
Big projects are inherently different from small projects and must be managed differently.
6.
Strong functions such as marketing, production, and finance (and, consequently, functional organizations) are imperative if the would-be innovators are to get a fair hearing.
7.
Product line/product family compatibility is the key to economic success.
8.
Customers tell you only about yesterday’s needs.
9.
Technology push is the cornerstone of business success.
10.
Strive to optimize technical forecasting with 10,000 bubble PERT charts and other methods because perfectionism pays off.
PERT, program evaluation and review technique.
From Peters TJ. The mythology of innovation, or a skunkworks tale. Part I. Stanford Mag. 1983a;Summer:12-21 and Peters TJ. The mythology of innovation, or a skunkworks tale. Part II. Stanford Mag. 1983b;Fall:10-19 with permission of the Stanford Alumni Association.
Table 44.2 Additional myths of drug discovery
1.
Empirical screening of compounds is being phased out as a means of discovering new drugs.
2.
Rational drug discovery will be the major method used to discover drugs in the very near future.
3.
Biotechnology methods are the only important tools for drug discovery today.
4.
Molecular designing of drugs on computers will enable drugs to be designed to reach almost any desired target.
Myth: The Food and Drug Administration’s (FDA) standards for safety are too lax.
Table 44.3 Selected myths of drug development
1.
The time planned to develop a drug can be accurately determined at the outset of a project.
2.
The master plan for drug development can be followed without major alteration for most drugs.
3.
A “quick and dirty” clinical trial is usually adequate to determine whether a drug has activity in patients with a new disease.
Reality: No drug is totally “safe,” nor is it expected to be. Scaremongers often present minor risks as major ones. For example, it is possible to express an increase of five cases to six of a rare problem per 100,000 patients as a 20% increase. While the increase is 20%, that calculation exaggerates the real implication and understanding of the actual increase observed. Safety can only be judged in terms of the benefits one receives in balance with the risks one accepts, but most people omit consideration of the benefits and only discuss drug safety in terms of risks. The FDA‘s standards for safety represent a real-world compromise that has to be made because approving only drugs with a nearly perfect safety record would mean that no new drugs would be approved.
Myth: More drugs are being removed from the market now than in the past
Reality: The FDA, as well as the pharmaceutical industry, carefully evaluated the number of drug withdrawals for safety reasons over several decades. Both groups showed that the numbers of withdrawals have been constant in the 1980s, 1990s, and 2000s, at a rate of 2% to 3% of all drugs introduced to the market. This is a reasonably low number, and the creation and implementation of safety methodologies are improving every year. The FDA concluded that the number of withdrawals is independent of the speed of approval and has not changed over the past few decades. The same conclusions were reached by the pharmaceutical industry. More recent data gathered by Tufts Center for the Study of Drug Development (CSDD) has shown that faster approval times do not correlate with increased drug safety withdrawals and the rate of drug withdrawals has dropped in half since the 1980s (Kaitin 2005).
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Myths about the Pharmaceutical Industry and Drug Development
Myths about the Pharmaceutical Industry and Drug Development
The most important scientific revolutions all include, as their only common feature, the dethronement of human arrogance from one pedestal after another of previous convictions about our centrality in the cosmos.
–Stephen Jay Gould
No amount of experimentation can ever prove me right; a single experiment can prove me wrong.
–Albert Einstein
The industry has been on a downward curve for the past decade in its image and ability to influence the public about its value and the prices it charges for the drugs it discovers, develops, and sells. This has been particularly true in the United States, where public relations efforts have often focused on old tired messages about the amount of money spent on research; these messages have lost their traction and do not influence many people. As a result, the state legislatures in the United States are seeking ways to reduce the prices of drugs through encouraging use of generic drugs, importing less expensive drugs from Canada, and sometimes seeking controls on prices. Of these efforts and numerous others that are detrimental to the industries (pharmaceutical, biotech, diagnostics, and medical devices), the most onerous are price controls. If price controls are implemented in the United States, they will cause a decrease in the research and development (R and D) funds devoted to research for new drugs and other medical products. Some of these reactions by legislators and the public result from a series of myths that are pervasive in developed countries; several of these myths are mentioned briefly in this chapter. These are followed by a discussion on ways in which reality can be perceived that may provide some thoughts about how the industry can better present its reality to the stakeholders it interacts with.
CONSUMER-BASED MYTHS ABOUT INNOVATION, DRUG DISCOVERY, AND DRUG DEVELOPMENT
The fields of pharmaceutical and medical device research are laden with persistent myths about innovation and discovery. Some general myths of innovation within R and D are listed in Tables 44.1, 44.2, and 44.3. Commonly perpetrated myths are one major reason why it is often dangerous for a pharmaceutical company to allow nonscientists to make decisions on technical issues. In the world of drug discovery and development, many myths exist both in the public realm as well as within the industry itself. Some myths represent wishful thinking by knowledgeable experts; others originate in news stories by reporters seeking to create a good story. Many have a grain of truth. Several common public misperceptions about the industry and drug use are mentioned as follows; each of these has numerous variations.
