Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the way new drugs are tested and marketed, according to research to be presented at the annual meeting of the American Sociological Association (ASA).
"Drug disasters are literally built into the current system of drug testing and approvals in the United States," said Donald Light, the sociologist who authored the study and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. "Recent changes in the system have only increased the proportion of new drugs with serious risks."
According to a 1999 report for the Institute of Medicine, adverse drug reactions (ADRs) are the fourth leading cause of death in the United States and more than two million serious reactions occur every year. ADRs can occur for a number of reasons, including improper prescribed dosage, drug abuse and drug interactions.
Light's analysis identifies the organizational foundations of patient risk from prescription drugs and suggests institutional reforms to help avoid or reduce future drug disasters.
According to Light, rather than using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos. Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.
Based on this system, Light asserts that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.