In courses on social problems and health, gender, aging and disability, the harmful side effects of prescription drugs are an overlooked epidemic. They are the 4^th leading cause of death in the United States and result in an estimated 1.5 million hospitalizations a year.(1) An estimated 46 million Americans suffer from harmful side effects, especially from newer drugs tested in trials that companies design to minimize evidence of harm and maximize evidence of benefits. Most vulnerable are women, people with chronic conditions, and seniors.

Out of the roughly 100 new drugs approved each year, 3-4 offer significant new benefits, and another 7-11 offer some advantage over existing drugs. Over time they have contributed to a large medicine chest of drugs that greatly improve our lives. But the other 85-90 new drugs are judged by independent review groups as little or no better than existing ones. These new drugs, approved as “safe and effective,” have a 20 percent chance of getting a Black Box warning or being withdrawn because their side effects are so toxic.(2, 3) This is hardly the benefit-harm ratio that society thinks it is getting.

The sociological and institutional dynamics behind this man-made epidemic are explained in The Risks of Prescription Drugs (Columbia 2010). They involve incentives that reward companies for developing mostly drugs of little benefit, testing them to minimize evidence of harms, approving any drug not inferior to a placebo, massively marketing launches before good safety information is available, and paying lead clinicians to persuade colleagues to prescribe drugs for unapproved uses. Usually, patients are not told. Peter Conrad and Cheryl Stults illustrate in the book the pharmaceuticalization of women’s bodies, while Allan Horwitz describes the pharmaceuticalization of people’s minds and moods. Prescriptions for sadness, disappointment, anxiety, anger, and loss have increased many fold. These examples build on Conrad’s important earlier book, The Medicalization of Society.  

The epidemic of adverse drug reactions illustrates C. Wright Mills’ emphasis on how personal troubles are shaped by social institutions. Pharmaceutical companies lie at the heart of the medical-industrial complex. Market-driven research and company-sponsored researchers create new categories of risk and disease, often based on surrogate or substitute measures, such as high cholesterol as a surrogate for risk of heart disease, or serotonin levels as a surrogate for major depression. In both these cases and others, millions of people take billions of pills before independent researchers finally discover they benefit patients far less than claimed. Meantime, people think they are “sick” and take drugs that prompt adverse reactions.

The sociological study of the epidemic from harmful side effects is leading to new insights. One model of institutional practices is the Risk Proliferation Syndrome. It consists of network interactions between companies, regulators, insurers, clinical leaders and patients that maximize the number of people exposed to harmful side effects. How this works for people with different disabilities, compared to people with HIV/AIDS, or people who have no clinical symptoms but believe they have a medical problem is an area ripe for further exploration.

A related theory draws on the economic concept of a market for ‘lemons’ to argue that the epidemic of harmful side effects stems from pharmaceuticals being a market for ‘lemons’ in which the sellers know about dangers and risks but profit from not disclosing them to customers or diverting their attention from them.  Unlike the used car market, however, this is a market that produces new ‘lemons.’ For example, companies are developing cancer drugs by the score because they can charge so much for them. Yet most are approved with weak evidence of their clinical advantages over existing drugs, though most are highly toxic.  Heavy marketing, cash payments (called ‘rebates’) to oncologists who prescribe them, and close management of which trial findings are published in medical journals all contribute to underplaying or masking seriously harmful side effects. Sociological studies of how this epidemic is spreading are badly needed.

References

1. Light DW, editor. The Risks of Prescription Drugs. New York: Columbia University Press; 2010.

2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. Journal of American Medical Association 1998;279:1200-05.

3. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, et al. Timing of new black box warnings and withdrawals for prescription medications. Journal of American Medical Association 2002;287:2215-20.

Donald Light is a medical and economic sociologist who currently teaches at Stanford as the Lokey visiting professor about problems in health care services.