Enter pharmaceutical company Avanir and its little red pill called Nuedexta, which is a combination of a generic heart medication and cough suppressant and has a similar calming effect on patients. There’s just one small glitch, however: Nuedexta has only been approved to treat a disorder called pseudobulbar effect, or PBA. Marked by sudden episodes of uncontrollable crying or laughing, it affects only a tiny portion of Americans – less than 1 percent – and is mainly found in those suffering from ALS or MS.
Why, then, has the number of pills for this rare condition jumped by 400 percent in just four years, bringing the total sales of Nuedexta close to $300 million last year? The answer can be found in Avanir’s aggressive sales push to expand the use of the drug among elderly patients who have Alzheimer’s and other forms of dementia. Hoping to exploit this huge and ever-growing potential customer base, their savvy marketers and sales people have been trying to convince doctors to diagnose patients who are difficult to manage with PBA so they can be given the drug – and they’ve found plenty of doctors who are willing to play ball.
A very thorough investigation by CNN exposes the lengths this company has gone to in order to get the drug to as many people as possible, even though in many cases it is not only unnecessary but also quite dangerous. The prescribing information for the drug itself clearly states that it has not been studied extensively in elderly patients, making this widespread use little more than an uncontrolled experiment on uninformed participants. The single study that was carried out on Alzheimer’s patients actually found that those who took the pill had twice as many falls as those taking a placebo, and many people have reported a severe decline in their loved ones’ conditions after going on the medication.
The company insists that PBA is “misunderstood,” and their website states it can affect as many as 40 percent of dementia patients, but this figure is based on a survey the drug maker funded themselves and has been disputed repeatedly by experts. In fact, geriatric physicians and other medical experts informed CNN that PBA only affects less than five percent of dementia patients.
Another questionable FDA approval
During the drug’s FDA approval process, two of the key doctors on the committee expressed concerns about using Nuedexta for PBA in people with Alzheimer’s, strongly recommending that the drug only be approved for PBA in those with ALS or MS. They said that there wasn’t enough information about its safety, evidence of its efficacy was weak, and that it wasn’t even clear if Alzheimer’s patients can have PBA in the first place. Nevertheless, the agency approved the drug for PBA in neurological conditions like dementia. It didn’t take long for the first reports to come through of adverse events, from rashes and dizziness all the way to comas and even death.
Doctor payouts common
State regulators have found plenty of instances where doctors are inappropriately diagnosing patients in nursing homes with the condition for the express purpose of justifying Nuedexta use, with salespeople deliberately targeting facilities that had records of using high levels of antipsychotics before the crackdown and would therefore be more receptive to using Nuedexta.
One Los Angeles nursing home had placed more than a quarter of its residents on the drug, and it was discovered that the facility’s psychiatrist was a paid speaker for Avanir who had given a talk about the medication to employees. An employee at another California facility admitted that a resident was given a false PBA diagnosis to justify Nuedexta in hopes of controlling the resident’s “mood disturbances.”
Avanir paid out nearly $14 million for Nuedexta-related consulting and promotional speaking from 2013 to 2016, and they spent $4.6 million on dining and travel costs for speakers and doctors who salespeople were courting. Not surprisingly, Medicare’s top prescriber of the drug in 2015 had been given $612,000 in payments, travel and meals from Avanir. As long as these practices are allowed to continue, we will probably see much more of this type of behavior. That’s why it’s always a good idea to pay close attention to the medications your elderly loved ones are being prescribed and question whether they are truly necessary.
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