Key drug facts left off labels, experts say
October 21, 2009, MSNBC/Associated Press

Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient’s kidneys and raise their risk of death? Chances are you didn’t, and neither did your doctor.

Much of what the Food and Drug Administration knows about a drug’s safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible. In … the New England Journal of Medicine, researchers … argue that drug labels don’t reflect the nuanced decisions the FDA makes when deciding to approve a drug.

The editorial from Drs. Lisa Schwartz and Steven Woloshin recommends easy-to-read fact boxes to help patients weigh the benefits and risks of medications. If drug labels sometimes exaggerate benefits and play down drug risks, the authors say there’s a very good reason: they are written by drugmakers. While FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists.

The labeling is based on results from company studies, which generally compare results for patients taking the drug versus those taking placebo. If FDA decides the drug’s ability to treat or prevent a disease outweighs its side effects, the agency is obligated to approve it. But Schwartz and Woloshin point out that benefits may be slim and potential harms may not be fully understood. “The take home point is that just because a drug is approved doesn’t mean it works very well,” said Schwartz, in an interview with the Associated Press. “You really need to know more to see whether it’s worth the cost.” Schwartz and Woloshin say FDA labeling frequently fails to provide a full picture of a drug’s effects.

Note: For a powerful summary of corruption in the pharmaceutical industry, click here.