Avenir Pharma’s marketing of Nuedexta for elderly targeted for investigation

 

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Nuedexta May Have Been Pushed on Elderly Patients According to Pharmaceutical Investigation

 The makers of Nuedexta have found themselves in the middle of a far-reaching scandal that could have ties to federal money.   According to an in-depth pharmaceutical investigation by CNN, the pill is treating conditions well beyond its FDA approved purpose; their investigation alleges that the drug makers are “paying off” doctors to push the pill on the elderly and the government is picking up the tab. Avanir created Nuedexta to treat a rare condition called pseudobulbar affect, or PBA, that only impacts 1% of the U.S. population.  Nuedexta is only approved to treat pseudobulbar affect (PBA), a rare condition marked by inappropriate outbursts that occurs secondary to other neurological illnesses or injuries, such as multiple sclerosis.Yet, somehow, Nuedexta is the company’s number one money maker.  The CNN investigators, Blake Ellis and Melanie Hicken found that the company is “aggressively” targeting nursing homes and their personnel are prescribing the drug unnecessarily.The City Attorney for Los Angeles has launched a new investigation, following broadcast of a CNN report detailing the rising use of Nuedexta among elderly nursing home patients, especially in Southern California.

According to the cable network, Mark Feuer is seeking information and tips from the public to determine if California-based Avanir Pharmaceuticals broke any laws in aggressively marketing Nuedexta to treat elderly people with Alzheimer’s disease or dementia.

“Those to whom this medication is being administered are as vulnerable as anyone can be. They rely on other people to make decisions for them,” Feuer told CNN. “If there is a possibility they are being administered a medication not because it is in their best interest, but because it is in the financial interest of, say, the drug manufacturer, then it is important for us to intervene.”

Feuer said he is interested in potential patient privacy violations, kickbacks paid to doctors and off-label marketing.

Money Changing Hands

 The far-reaching pharmaceutical investigation found that Nuedexta’s sales force is working to expand among elderly patients suffering from dementia and Alzheimer’s disease.  And at least some doctors who are prescribing the drug are receiving payments from the company. A look at the numbers shows that since 2012, over half of all Nuedexta pills have gone to long-term care facilities and that the number of pills jumped nearly 400% in just four years.  That data is according to QuintilesIMS, which tracks pharmaceutical sales.  In that same tracked time period, Nuedexta sales reached almost $300 million.

According to CNN, thousands of the doctors prescribing Nuedexta have received money, or at least a meal from the parent company.  This practice is legal but controversial in the pharmaceutical industry.  Pharmaceutical companies can pay doctors to promote a particular drug to medical professionals.  BUT it is illegal for doctors to prescribe the drug in exchange for payments from drug makers.  According to government data cited in the pharmaceutical investigation, between 2013 and 2016, doctors were paid almost $14 million for Nuedexta-related costs by Avanir (and its parent company, Otsuka).   And here’s a real kicker, the CNN analysis found that nearly half the Nuedexta claims filed with Medicare in 2015 came from doctors who had received money and/or perks from the company. These practices mean that taxpayer dollars are footing the bill for a big portion of the money being spent on Nuedexta.  Government money, in the form of Medicare Part D prescription drug funding, spent $138 million on Nuedexta.  Authors of the investigative article, Blake Ellis and Melanie Hicken, say that is up more than 400% from three years prior.

The Centers for Medicare & Medicaid Services (CMS) did not wish to issue a comment to CNN for the pharmaceutical investigation.  Avanir’s parent company, Otsuka, also declined comment.

Dangerous Impact

 This isn’t just a case of a harmless drug being pushed on the elderly with no real-world consequences.  Nuedexta has not been studied in elderly patients, according to its maker.  CNN states that Avanir did not wish to be interviewed but did email them this statement that said PBA is often “misunderstood” and can impact the elderly.  Read that statement here.

Lon Schneider, director of the University of Southern California’s California Alzheimer’s Disease Center, reviewed CNN’s information.  Schneider specializes in geriatric and dementia care.  He expressed concern about interactions between Nuedexta and other medications often prescribed to people battling dementia.  The doctor noted that just one pill can have dangerous side-effects.

The truth is there are no FDA-approved drugs for treating people who have the dementia-related agitation that Nuedexta is being prescribed for. Other pharmaceutical companies have been cited and penalized for making claims that their drug can help this type of agitation.

Jeffrey A. Newman represents whistleblowers. 1-800-682-7157