Backed by a hyper-aggressive sales force, Avanir Pharmaceuticals is paying huge kickbacks to doctors to falsely prescribe its Nuedexta to subdue seniors with dementia and Alzheimer’s disease.
Nuedexta is being abused as a “chemical restraint” for elderly patients in long-term care, and they are at a high risk of falling or death as a result.
Avanir sales reps have taught doctors to fraudulently diagnose the elderly with the rare ailment Pseudobulbar Affect (PBA) so that Medicare will pay for the expensive drug. As a result, the number of Nuedexta pills dispensed to long-term care facilities jumped nearly 400% in recent years.
Medicare spending on Nuedexta has soared from $3.9 million in 2011 to $138 million in 2015. Avanir sales reps have helped doctors make false diagnoses so that Medicare will pay for the drug – priced up to $12.60 per pill.
Research shows that nearly 50% of the Nuedexta claims filed with Medicare in 2015 came from doctors who took cash, travel or food from Avanir. Some were paid more than $300,000 to promote the drug to doctors and patients.
In recent news:
- Avanir admitted on Sept. 26, 2019, to targeting elderly victims and to paying kickbacks to doctors to promote the drug. In the settlement of a whistleblower lawsuit, Avanir agreed to pay $109 million in criminal and civil damages. It also agreed to assist in the prosecution of a sales rep, a regional business manager and an Ohio doctor they manipulated.
- Dr. Franklin Price, a doctor in Mayfield, Ohio, pleaded guilty on Jan. 20, 2020, to wrongful disclosure of patient records. He gave confidential patient medical files to Avanir sales rep Gregory Hayslette – without notifying patients – to get Medicare approval to pay for Nuedexta prescriptions. Price has resigned as an MD.
- In 2019, a federal grand jury indicted Hayslette, his regional manager Frank Mazzucco, Dr. Deepak Raheja, a neurologist, and Dr. Bhupinder Sawhny, a neurosurgeon. They were charged for being in a kickback scheme to pay doctors to promote Nuedexta to subdue seniors with dementia or Alzheimer’s – a treatment not approved by the FDA.
How the Kickback Scheme Worked
Avanir promoted Nuedexta through a “speaker’s bureau” where company sales reps reached out to doctors to speak about and promote the drug. A typical engagement involved a dinner at an expensive restaurant where a doctor presented information about the drug through a slideshow provided by the company, according to the FBI. There was no educational value for the presentation.
Raheja joined Avanir’s speaker’s bureau in February 2011. He gave more than 200 presentations between 2011 and 2016 and Avanir paid him $331,500, according to prosecutors. Over those five years, Raheja wrote 10,088 prescriptions for Nuedexta — the most of any doctor in the country, prosecutors said.
Raheja falsely diagnosed patients with PBR and Sawhny permitted unauthorized access to patient health records.
Hayslette illegally promoted the use of Nuedexta that were not approved by the FDA, accessed patient health information without authorization and helped to submit false diagnoses for Pseudobulbar Affect to Medicaid programs.
“Kickbacks have the power to corrupt a provider’s medical judgment,” said Assistant Attorney Jody Hunt of the DOJ’s Civil Division. “And it is particularly concerning when a pharmaceutical company uses kickbacks to drive up sales in connection with a vulnerable population, such as elderly patients in nursing care facilities.”
Thanks to the kickbacks and falsified prescriptions, Avanir reaped $300 million in total sales of Nuedexta in 2016.
A Sordid Past
Nuedexta is a combination of 2 ingredients: dextromethorphan and quinidine. Dextromethorphan works in the brain, though it is not known exactly how it helps treat Pseudobulbar Affect. Quinidine is added to this medication to increase the effect of dextromethorphan.
The FDA approved Nuedexta in 2010 for treating PBA in patients with dementia. PBA is extremely rare in dementia patients. It is characterized by involuntary, sudden and frequent episodes of laughing and crying as the result of a brain injury or disease.
The FDA required that Nuedexta carry the black box warning for an increased risk of death in elderly dementia patients.
In earlier years, the federal government had cracked down on dangerous antipsychotic drugs. This created an opening or Nuedexta to control unruly and erratic behavior in nursing home patients.
Soon after Nuedexta hit the market in 2011, doctors, nurses and family members began filing reports of potential harm from Nuedexta — ranging from rashes, dizziness and falls to comas and death.
Internal company emails show a culture of intense pressure to sell the drug, with sales reps being encouraged to directly target hapless dementia and Alzheimer’s patients.
From 2013 to 2016, Avanir paid doctors nearly $14 million for consulting, promotion and public speaking for Nuedexta. The company also spent $4.6 million on travel and dining for doctors being targeted by salespeople.
Dr. Jason Kellogg, a geriatric psychiatrist at nursing homes in California, got $612,000 in cash, food, and travel from Avenir, according to government data. He was the top Medicare prescriber for the drug in 2015.
Doctors began to falsely diagnose PBR to have their prescriptions filled. In one example, the government charged that one doctor, who was also a paid speaker for Nuedexta, had “entire units” of patients on Nuedexta at the LTC facility where he worked, which contained a large number of dementia patients with behavioral issues. Meanwhile, another doctor who also worked in the same LTC, facility routinely discontinued Nuedexta for patients, only to have the doctor paid by Avanir “constantly re-initiate” the treatment.
CNN identified more than 80 cases in 19 states since 2013 where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta — often because residents hadn’t exhibited any symptoms of PBA. Many of the cases — about 40% — were clustered in Southern California, where Avanir is based and where former employees said there has been aggressive marketing.
“Doctors should prescribe medicine based on what is best for their patients, not on which drug company is paying for their travel and meals,” said U.S. Attorney for the Northern District of Ohio Justin Herdman.