The Alzheimer’s Association — one of the leading advocacy groups for people suffering from the memory-robbing disease – has cut ties with Avanir Pharmaceuticals, following a CNN report suggesting that Nuedexta was being marketed for off-label use in elderly nursing home patients,
“We are committed to people living with the disease, and we encourage vigorous review and oversight of companies and prescribers to ensure best practices are followed for those impacted by Alzheimer’s disease,” the association said in a statement.
Avanir’s Nuedexta is only approved to treat pseudobulbar affect (PBA), a rare condition seen in less than 1% of Americans. The disorder occurs secondary to other neurologic diseases or illnesses, such as ALS, and causes inappropriate emotional outbursts, such as laughing and crying.
While Avanir maintains that 39% of dementia patients suffer from the PBA, experts say the rate is less than 5%.
Nuedexta has not been shown to be safe and effective in treating other types of emotional lability that can commonly occur with Alzheimer’s disease and dementia, nor has it been well studied in elderly patients.
In a report broadcast last month, CNN identified numerous instances where nursing home patients suffering from Alzheimer’s or dementia were inappropriately treated with Nuedexta. Doctors – many of whom had received speaking fees or other payments from Avanir – had diagnosed PBA to justify prescribing the drug to manage their confusion, agitation or unruly behavior.
The CNN report also highlighted Avanir emails in which sales reps were encouraged to push Nuedexta on nursing homes.
While physicians are permitted to prescribe medications for any purpose they deem appropriate, it is unlawful for drug makers to promote their products for off-label indications that have not been approved by the U.S. Food & Drug Administration.
According to CNN, Avanir has relationships with a number of patient advocacy groups.
For example, the Alzheimer’s Foundation has received $60,000 from the drug maker over the past two years. Dr. Jeffrey Cummings, a member of the foundation’s advisory board, received $50,000 from Avanir between 2013 and 2016 for consulting, royalty or licensing fees, and travel and meals.
Cummings was also the lead researcher on a study investigating Nuedexta for Alzheimer’s disease patients. Those who received the drug were twice as likely to fall compared to those who were given a placebo.
“Yes, this is a conflict of interest,” Eric Campbell, an ethicist at Harvard University, told CNN “There is not a single aspect of medical practice and medical education in the United States in which drug companies don’t have extensive financial relationships aimed exclusively at promoting their products. The marketing plan is money and payments which buys influence, attention and ultimately results in increased sales.”
Recently, Avanir sponsored a medical summit hosted by the Department of Health and Human Services and the non-profit Foundation for the National Institutes of Health.
The pharmaceutical company is also helping to launch an Alzheimer’s training program at a New Jersey community college.
New Jersey Congressman Donald Norcross, a supporter of the training program, called CNN’s finding’s “deeply troubling” and called for an investigation.