Drugs

Licit Drugs

Organized medicine in the United States faces distinct challenges with regard to the declining public trust of its patrons because of publicized instances of deceptive, dishonest, and fraudulent practices. Consequently, dependent financial relationships and lapses in ethical decision making have allowed for an erosion of trust between drug companies, physicians, and patients. After a highly publicized U.S. National Institutes of Health–funded biomedical research scandal in the late 1970s, public attention prompted the government to increase its efforts at addressing scientific misconduct in the pharmaceutical industry. As a consequence, the government since the 1980s has taken a more active role in regulating the medical field.

Despite these efforts, outright fraud in the pharmaceutical industry remains commonplace and takes many forms. For example, in 2009, pharmaceutical manufacturer Pfizer was forced to pay $2.3 billion for kickbacks and off-label marketing. “Off label marketing” refers to the marketing of a drug for use in conditions outside of those for which it was explicitly approved. After the global health care company GlaxoSmithKline was charged with fraud for knowingly marketing contaminated medical products, the company was forced to pay $750 million to settle the case in 2010. In July 2012, the same company had to pay $3 billion under the False Claims Act for behavior ranging from the fabrication of scientific research, kickbacks to physicians, bribes, and the use of off-label marketing for several of its drugs, including Paxil, a popular and widely used antidepressant of questionable medical utility, particularly in light of its dangerous side effects. These examples, among a steady flow of other recent cases, serve as evidence that the regulatory framework of the pharmaceutical industry is inadequate.

Bringing a drug to market is an expensive, lengthy, opaque process, sometimes costing hundreds of millions of dollars from the moment of a drug's conception until it can be prescribed by physicians. Most of the clinical trials conducted in the United States are funded by the pharmaceutical industry, and systematic analyses have shown that in some cases this process is fundamentally flawed. Medical journals have been reported to derive some (or most) of their revenue from corporate advertising, and these publications are not universally required to disclose any conflicts of interest among editorial board members. Some pharmaceutical researchers have been reported to hide or refuse the publication of studies that would negatively impact drugs under development. This basic conflict of interest undermines the ethicality of pharmaceutical research and calls into question the empirical validity of supporting studies.

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