A sociologist says fatal flaws in the way new drugs are tested and marketed mean that American consumers are likely to be exposed to unacceptable side effects of FDA-approved drug such as Vioxx in the future.
In a study presented at the American Sociological Association annual meeting, University of Medicine and Dentistry of New Jersey professor of comparative health policy Donald Light said disasters “are literally built into the current system of drug testing and approvals in the US.”
A release on Light's paper said his analysis identifies the organizational foundations of patient risk from Rx drugs and suggests reforms to help avoid or reduce drug disasters. Light said that rather than using current approved drugs as benchmarks of efficacy, the current drug system evaluates effectiveness based on comparisons with placebos. Systematic review indicates, he said, 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, including black-box warnings or withdrawal from the market.
New drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs, Light asserted. His analysis also suggested a flaw in clinical trial design.
“Based on our current system, the designation of ‘safe and effective' on today's new drugs could be replaced with ‘apparently safe based on incomplete information, and more effective than a placebo,'” Light said.