Clinical trials and the pharmaceutical industry.

Authorization to market a drug is conditioned on submitting the results of clinical trials, proving that the product meets national and international standards and that it can be used to benefit human health. Who presents the proof? The manufacturer. Who authorizes use of the drug? The national regulatory agencies. Clinical trials are the epidemiological approach that provides the best evidence of a drug’s safety and efficacy. The first record of a controlled trial dates to the 18th century, on a ship whose crew was racked by scurvy. The trial was conducted in 1747 by James Lind, who compared different diets in 12 sick sailors. The best results came from adding citrus fruit to the diet, which led to the routine inclusion of lemons in sailors’ rations on long seafaring voyages 1. One virtue of clinical trials is that they compare different treatments, or treatments versus placebo (a just tribute to spontaneous cure!). They also randomly distribute study subjects between treatment arms, thereby guaranteeing that characteristics unrelated to the experimental drug do not influence the results (either for or against). Such virtues also allow less “contaminated” observation of the experimental treatment’s effect and its role as compared to other therapeutic options. The pharmaceutical industry has been referred to as “Big Pharma”, possibly due to its enormous economic power. World pharmaceutical sales reached US$400 billion in 2002 2. Although manufacturers are required to submit their research results to the regulatory agencies, many clinical trials are conducted with government and university resources from the companies’ home countries. For the ten largest companies, spending on research and development corresponded to 11% and 14% of sales in 1990 and 2000, respectively 2. These percentages were exceeded by administrative and advertising expenditures. The relationship between the two sides of the “clinical trials-pharmaceutical industry” dyad entails an obvious contradiction. On one side, drugs as a technology are used to cure diseases and relieve symptoms; on the other, they are produced mainly by corporations with a firm footing in the economic market and that are subject to the market’s laws and driven by the pursuit of profit. This contradiction produces devastating effects that have become progressively more visible to health professionals and citizens, triggering vigorous challenges. A movement among the editorial boards of respected biomedical journals currently aims to overcome manufacturers’ resistance to publish their research results. Additionally, medicine and drugs have a huge role in spending, health, and life. And there is an in-