A recent article in the New England Journal of Medicine, Lost in Transmission- FDA Drug Information That Never Reaches Clinicians reported that key information is missing from prescription drug labels. Authors Dr. Lisa M. Schwartz and Dr. Steven Woloshin wrote, “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.” They go on to explain, “FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms” and “drug labels are written by drug companies, then negotiated and approved by the FDA.”
Schwartz and Woloshin profile three drugs, Zometa, Lunesta, and Rozerem as examples of how drug labels are missing information. All three drug labels were indeed missing information. In their review of Lunesta and Rozerem however something stands out, both Lunesta and Rozerem had intense direct- to- consumer advertising campaigns. Lunesta is reported have spent more than $750,000 a day in its 2007 advertising campaign and to have sales reaching almost $800 million last year. Rozerem is described as being “aggressively promoted to consumers.” This information could easily be omitted from the article without detracting from the issue of drug information not reaching clinicians; the inclusion of this information is interesting.
In 1997 the FDA issued new regulations governing television advertising of prescription drugs; following this change direct- to- consumer drug advertising soared. Prescription drugs became commercialized; direct- to- consumer advertising repackaged drugs into a shiny product to be sold to the public. In this light, is it surprising that drug companies would over exaggerate the benefits of their drug and down play the risks? The purpose of advertising is to make consumers think they need a product and make them want to buy it; drug companies are no different. Consumers have learned to be skeptical of the dubious claims made by advertisements but direct- to- consumer drug advertising is new. Consumers have more faith in the claims made by drug companies because the idea that drug companies might manipulate information at the risk of the consumer is so unsettling.
By including information on the direct- to- consumer advertising campaigns of Lunesta and Rozerem, Schwartz and Woloshim provide further insight into the motivations (money) behind excluding certain information from drug labels. It also highlights how for years the public has accepted and believed the claims of drug companies without question despite numerous incidents of drug companies being exposed as less than forthright. You can be angry with the drug companies for omitting information or mad at the FDA for not making it easier to access the information. But isn’t it time we as consumers start to demand more from drug companies?
Questions: Do you agree with the above statement that as consumers, it is time to start demanding more from drug companies? Have you experienced any type of negative side effects to your medication that was not listed on the label?
About the Author: Erika Christenson is a Staff Writer with the Clear Medical Solutions Communication Team. Her work is regularly shared on the Clear Medical Agency newsletter and the ClearNursingMatters.com blog.
Lost in Transmission- FDA Drug Information That Never Reaches Clinicians