The analysis, conducted by Donald Light, a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, found about 85 percent of new drugs offer few, if any, new benefits.
In one study of 111 final applications for drug approval, Light said 42 percent lacked adequately randomized trials, 40 percent had flawed testing of doses, 39 percent lacked evidence of clinical efficacy, and 49 percent raised concerns about adverse side effects.
“Sometimes, drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” Light was quoted as saying. “Then, they spend two- to three-times more on marketing than research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”
Light says three reasons why the pharmaceutical market produces “lemons” are: they have companies in charge of testing new drugs; they provide firewalls of legal protection behind which information about harms or effectiveness can be hidden; and they have a relatively low bar set for drug efficacy in order for a new drug to be approved.
Light’s paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” is an institutional analysis of the drug industry and how it works based on a range of independent sources and studies.
“A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs,” Light said. “We could also increase the percentage of new drugs that are really better for patients.”
SOURCE: 105th Annual Meeting of the American Sociological Association,