November 2, 2017; CNN Health
More than half of all Nuedexta pills sold since 2012 have been prescribed to residents of long-term care facilities, so why wouldn’t the company that produces them want to advertise with nonprofit organizations that support the families of Alzheimer’s sufferers? Perhaps a better question is why organizations meant to serve Alzheimer’s patients and their families would allow themselves to be used to market a drug that is inappropriate and dangerous to their members.
The recent decision of the Alzheimer’s Association to relinquish support from Nuedexta’s manufacturer, Avanir Pharmaceuticals, doesn’t much impress us. First, they did so only after a CNN investigation revealed Nuedexta is used largely in nursing homes despite the fact that its effects on the elderly have not been extensively studied and the drug is seen to increase patient vulnerability to falls.
Subsequently, the Los Angeles city attorney’s office— Avanir is based in Southern California—launched its own investigation into possible violations of state or federal laws. Nuedexta treats a rare disorder known as pseudobulbar affect, or PBA, and is not approved to treat dementia patients unless they also suffer from PBA, but regulators found that doctors diagnose PBA for nursing home residents to help the homes manage patients who are confused, agitated, or unruly.
Only after these two investigations did the Alzheimer’s Association declare it would not accept further funding from Avanir—after having received nearly $200,000 from the drug company this fiscal year.
“We are committed to people living with the disease,” the association declared in a statement, “and we encourage vigorous review and oversight of companies and prescribers to ensure best practices are followed for those impacted by Alzheimer’s disease.”
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Why does this ring to us as “too little, too late?”
Avanir has been an active sponsor of nonprofits studying Alzheimer’s and supporting those affected by Alzheimer’s. The Alzheimer’s Foundation of America, for instance, still receives money from the corporation, saying Avanir is only one of its many sponsors. The foundation went so far as to provide one of its medical advisory board members to make a statement. But the medical professional, Dr. Jeffrey Cummings, has himself received nearly $50,000 from Avanir in the form of consulting and royalty or licensing fees. Cummings also was “the lead researcher on Avanir’s study of Nuedexta in Alzheimer’s patients with agitation, which included 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.”
Avanir has also made itself a fixture in academic and government settings where the disease is being addressed.
Much of the money being spent on Nuedexta is coming straight from the federal government, in the form of Medicare Part D prescription drug funding, for people 65 and over and the disabled. In 2015, the most recent year for which data is available, this Medicare program spent $138 million on Nuedexta—up more than 400 percent from just three years earlier.
A professor of ethics at Harvard Medical School, Eric Campbell, said such conflicts are common in nonprofits that support medical research. “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.”
The ethical violations and potential for human harm in this situation are legion but hardly uncommon in the world of patient advocacy organizations. One would imagine it’s not that difficult to review the track records and marketing practices of one’s sponsors before agreeing to display their names all over your materials. Perhaps the priorities for these groups are not as pure as advertised.—Ruth McCambridge