Kathleen Z. Rooney
On March 14, 2010, thieves cut a hole in the roof of an enormous Eli Lilly warehouse located in Enfield Connecticut. After they climbed a rope into the warehouse and disabled the alarms, they stole an estimated $75 million dollars worth of prescription drugs. These were not "Robin Hoods" stealing antibiotics in short supply to treat a devastating epidemic. The stolen goods were the bestselling antidepressants Prozac and Cymbalta. Clearly, the thieves wanted to cash in on the billion-dollar-market for these drugs, perhaps using the latest consumer outlet: internet drug sales.
Every current measure of economic growth shows the tremendous increase in pharmaceutical use and consumption in post-World War Two America. Measured against the wider backdrop of post-war consumer culture in America, this industry is absolutely typical of our culture yet stunningly exceptional in its growth and power. The Kaiser Family Foundation regularly analyzes industry and government data for trends in prescription drug use and sales. Their report on the past 20 years in prescription drug trends shows an average annual spending growth rate in the double digits. This is steep even when compared with single-digit growth in other parts of the already-fast-growing healthcare sector.
Pharmaceuticals are not merely a multi-million industry or multi-billion one. This industry dwarfs almost all other industries. It competes with big oil and the (too-big-to-fail) commercial banks to be among the top three overall of the nation's most profitable industries.
Healthcare is naturally a lucrative business. Health is one of the most important human needs along with food and shelter. What makes pharmaceuticals surpass housing and beat out agriculture is the centralized nature of the industry. The consumer protections implemented by the United States Food and Drug Administration throughout the 20
century resulted in the creation of "Big Pharma". The FDA not only approves drugs for market but regulates the marketing of those approved drugs. This has contributed to the centralized nature of the pharmaceutical industry and has created defacto government approved monopolies.
The standard use of controlled clinical trials developed through FDA oversight of the drug industry. The successes of the FDA built a public faith in the role of "The Study", and as the use of "The Study" grew, so did the role of statistics. Statistics moved into an academically recognized field with "real math chops" during the first half of the 20th century. The language of "The Study" and statistics have become an ubiquitous part of the modern consumer culture: economic statistics, weather statistics, sports statistics and the omnipresent medical studies, with the catch phrases "Four out of five doctors recommend..." and "Studies show…". Advertisers use the language of the pseudo-governmental "Study" to fuel demand for products that "The Study" recommends. Industry creates further demand for drugs and food products by designing studies to demonstrate a need. Their efforts are buoyed by the consumer society's infrastructure of mass marketing and the belief (in this case a literal belief) that a cure for all ills is through buying.
This unit will introduce students of high school statistics to the historical and contemporary role of statistics in the biopharmaceutical industry. This will be of particular interest to students who are pursuing careers in health or biomedical sciences. However, it is possible that this unit would be applicable to science and to political history classrooms, as much as to the math curriculum. As we look at a historical view of statistics and pharmaceuticals, we will see how the field of statistics is implemented in scientific research and discovery, in setting and enforcing governmental policies, and how that demand has transformed statistics into one of the most recognized and accepted forms of mathematics today.
While considering the role of statistics in developing and marketing pharmaceuticals, we will be looking at sampling methods and experimental design. We will discuss the role of random selection, and the advantages and potential biases of different sampling methodologies. We will describe the components of experiments graphically and verbally and analyze designs from the industry. Our purpose will be to understand the current application of statistics in the design and analysis of clinical trials. In particular, we will look at clinical trials as defined by the Food and Drug Administration (FDA). This is a valuable educational approach on two fronts. One is the acquisition of statistical skills through application-based learning. The other is to help students to perceive and value the role of statistics in their own contemporary culture.