In one example, Light and Brody point out that expert guidelines have steadily lowered the blood glucose levels that determine a diagnosis for diabetes. As this threshold was lowered from 140 milligrams per deciliter to 126 and then to 110, millions of additional patients received medications originally formulated to treat people above the original, higher thresholds. The authors argue there is little evidence that people at the lower thresholds are helped by the medications, and yet all were exposed to the drugs’ potential side effects.
According to the authors, drugs intended to treat severe mental illness are also overused. “One serious example is the widespread promotion and use of anti-psychotics for adults and children who are not psychotic,” Light said.
The authors say marketers also overreach by creating medical problems out of factors that are weakly associated with a serious clinical condition, such as high cholesterol as a risk factor for heart disease in people not already at risk. They write that lowering cholesterol levels in people already at risk is beneficial, but much less so when taken by people not already at risk.
The authors also describe how selective COX-2 inhibitors, a group of nonsteroidal anti-inflammatory drugs (NSAIDs), were massively marketed in the past decade, even though there was no evidence they were more effective in treating pain and inflammation than older drugs such as ibuprofen or naproxen. The newer drugs’ only potential advantage was protecting against gastrointestinal bleeding, which affects fewer than five percent of patients. Yet these drugs caused thousands of hospitalizations and serious coronary events each year, and some were withdrawn from the market.
The pharmaceutical industry does not set out to market bad drugs that could cause public harm, the authors emphasize. “Rather, the scientific arm of the industry works hard to discover new drugs that are both effective and safe. The marketing arm then turns those good drugs into bad drugs, in effect, by extending their use beyond proper evidence,” they write.
Patients’ health can be improved, the authors believe, by restricting promotion of medications for unapproved uses as well as mass direct-to-consumer advertising. The U.S. is only one of two countries that allow consumer advertising of prescription medications, a practice that may put undue pressure on physicians and nurse practitioners to prescribe drugs their patients do not need.
Drugs that reach consumers also would be safer, say the authors, if tested first with “independently funded and designed (clinical) trials focused on safety and efficacy,” rather than having companies test their own products in ways that can minimize evidence of adverse effects. Light described in greater depth the biases that can affect the outcomes of clinical trials in his recent book, The Risks of Prescription Drugs.
To access the article, type “The Inverse Benefit Law” in a search engine. Journalist wishing to interview Dr. Light can contact him at (609) 216-0071 or by calling Jerry Carey, UMDNJ News Service, at (856) 566 6171 or (973) 972 3000.
The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation’s largest free-standing public health sciences university with more than 6,000 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health on five campuses. Annually, there are more than two million patient visits at UMDNJ facilities and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, which provides a continuum of healthcare services with multiple locations throughout the state.