What do you think about a pharmaceutical company purposely targeting ill nursing home residents to get them to buy their product? What do you think about this same pharmaceutical company paying doctors to prescribe this product to their patients? The name of this “product” is Nuedexta, and is said to treat a disorder known as pseudobulbar, or PBA.
PBA is a neurologic disorder that causes an individual to suddenly experience uncontrollable emotions, such as crying and/or laughing. People who have a brain injury or specific neurological complications are more likely to have PBA. According to a credible source* that provides information about PBA, the percentages of those with “common neurologic conditions who have PBA symptoms” are: 48% traumatic brain injury (TBI), 39% Alzheimer’s Disease/Dementia, 28% stroke, 46% Multiple Sclerosis (MS), 50% Lou Gehrig’s Disease (ALS), and 24% Parkinson’s Disease. The source also states, “while there are almost 2 million people in the U.S. with neurologic conditions or traumatic brain injury who have PBA, over 7 million people in the US have symptoms that may suggest PBA.” *When clicked on link from source about treatment, redirects to a website about Nuedexta.
Since the pill hit the market in 2011, the maker of Nuedexta has profited hundreds of millions of dollars a year, and a majority of this money is coming directly from the federal government. A year after Nuedexta debuted, “more than half of all Nuedexta pills” have gone to long-term care facilities. In 2016, nearly 14 million pills were produced, an increase of 400% in four years. Initially the pill was meant to be specifically for patients with PBA, but now the sales force is trying to broaden the drug’s use to be prescribed to patients with Alzheimer’s disease and dementia. The drugmaker of Nuedexta, Avanir Pharmaceuticals, has even addressed the fact that the medication “has not been extensively studied in elderly patients.” In some instances, the individual’s health declined after taking Nuedexta. Shortly after Nuedexta came on the market, numerous reports of potential harm with side effects–ranging from dizziness, body rashes, comas and death–were filed.
Despite thousands of reports being sent, the FDA still allowed for the drug to be produced and prescribed.
Nuedexta is a mixture of two generic drugs–heart medication and a cough suppressant. At one point in time specialty pharmacists were “willing to combine the ingredients” for less than $1/pill. Now with the official FDA approved medication, the cost rose to $12.60/pill–which plays in favor for the pharmaceutical companies. Depending upon the dosage a patient is prescribed, having to take this medication can add up quickly.
While all of this has been said, Nuedexta is already approved by the FDA for the purpose of treating anyone with PBA, and those who have other neurological issues, such as dementia. The source used for this article was published by CNN and it was cited that geriatric physicians, dementia researchers, and other medical experts have said that it is “extremely rare” for dementia patients to have PBA. In addition, state regulators have discovered several doctors who have been falsely prescribing Nuedexta to nursing home residents.
As reported by government data, Avanir and its parent company, Otsuka, have paid doctors around $14 million for “Nuedexta-related consulting, promotional speaking and other services.” The contributing factor to their success is that the companies have spent $4.6 million on dining and travel costs for speakers and doctors who are being recruited by Nuedexta salespeople. In one instance, a salesperson worked closely with a doctor’s office manager and looked at patient’s medical charts to determine who should be checked for PBA and have Nuedexta brochures placed in their files. Communications from within the Avanir company reveal that the salespeople were told to “target facilities that historically used high levels of antipsychotic medications–facilities that would see Nuedexta as an attractive alternative.” Federal laws curb the strategies used by pharmaceutical sales representatives to sell their products. The companies cannot give payments to doctors for prescribing the medication and they cannot have access to patient records, but yet Avanir sales representatives have done just this.
Unfortunately it has been exposed that some facilities for the elderly give their patients medications, such as Nuedexta, because they are too hard to treat. The standards of nursing home inspections have been ignored by both the regulators and public–CNN was able to pinpoint more than 80 cases in 19 states since 2013 where “inspectors cited nursing homes for appropriate monitoring and use of Nuedexta.” At an elderly center near Los Angeles, three residents were being given Nuedexta without a doctor’s prescription. It was not until 2015 that regulators finally became aware of these unauthorized dosages after a concerned family member came to learn that her relative in the home was being given Nuedexta without her personal consent.
It is intolerable that Avanir has been able to continue producing Nuedexta with its lack of research and reputation, while still obtaining large sums of profit. Multiple doctors and nursing homes have been caught in the act, but yet have not been punished for their crimes. Hopefully the regulators and FDA will come to realize this smoke-screen called Nuedexta, finally putting an end to the harm the company has caused.