Study Faults FDA for Communication Shortcomings

Lack of Transmission of Significant Data by the FDA to Clinicians

In a NEJM Perspective, Drs Lisa Schwartz and Steven Woloshin (Dartmouth Institute for Health Policy and the white river Junction, VT V.A.) decry the lack of transmission of data to clinicians. Pointing out that pharmaceutical companies rather than the FDA write the drug labels so familiar in the PDR and drug inserts rather than the FDA. While the FDA evaluation (often taking up to a year to process) is posted at www.accessdata.fda.gov/scripts/cder/drugsatfda/, critical data is often buried in massive documents.

They point to 3 drugs as examples: Zoledronic Acid (Zometa) for hypercalcemia of malignancy for failure to identify the higher dose as associated with a higher death rate; Eszopiclone (Lunesta), a drug approved for chronic insomnia, for having marginal efficacy; and Ramelteon (Rozerem), a drug for chronic insomnia, also for having marginal efficacy. These statistics do not appear in the drug labels.
Eszopiclone and Ramelteon are of particular interest to pain management health care professionals because of the frequent association of sleep disturbances with chronic pain.

Ref: NEJM 2009 361:1717-1720