How CNN reported on Nuedexta
Updated 1723 GMT (0123 HKT) October 20, 2017
(CNN)CNN has released an investigation exposing the inappropriate and potentially fraudulent use of a popular nursing home drug called Nuedexta. Read it here.
During the reporting process, CNN analyzed payment, prescriber, adverse event and inspection report data from various government agencies and dug through internal company emails and documents. Reporters also interviewed dozens of doctors (including critics and paid promoters of Nuedexta), other medical experts, nursing home employees, family members of Nuedexta patients and both former and current employees of the drugmaker, Avanir Pharmaceuticals.
Nursing home citations
CNN used keywords "Nuedexta," "pseudobulbar affect," "PBA," "uncontrollable laughing," "uncontrollable crying," "Avanir" and "dextromethorphan-quinidine" (Nuedexta's generic name) to analyze data from the Centers for Medicare & Medicaid Services, and identified cases where Nuedexta use had resulted in a citation by state health officials.
CNN analyzed data from the FDA Adverse Event Reporting System to identify reports made involving Nuedexta since 2011, the year the drug hit the market. This database includes "adverse events" voluntarily reported by doctors, nursing home employees, family members and patients themselves. These events can include everything from minor side effects to hospitalization and death, and the FDA said reports do not necessarily "constitute conclusive evidence of a problem with the product."
CNN analyzed the adverse event data to find incidents where Nuedexta was deemed a "suspect" medication, meaning it was considered by the event's reporter to be a potential cause of harm. CNN analyzed this data to identify the number of incidents where patients experienced hospitalization, death or symptoms such as sedation (using keywords "somnolence," "sedation," "fatigue," "flat affect," "stupor" and "unresponsive to stimuli") or dizziness and falls (using keywords "dizziness," "confused state," "confusion," "falls," "gait disturbance," "fear of falling," and "confusional state.")
In addition, reporters read the full text of roughly 500 reports obtained through a federal Freedom of Information Act request.