麻豆传媒

A doctor and a drug rep from Ohio on Monday to their roles in a kickback scheme that pushed prescriptions for dextromethorphan/quinidine (Nuedexta) onto patients who didn't need it, according to the U.S. Department of Justice.

Deepak Raheja, MD, and Frank Mazzucco, a regional business manager for Avanir Pharmaceuticals, allegedly conspired to boost scripts for Nuedexta in exchange for monetary kickbacks and other items of value, according to DOJ.

The guilty pleas are the latest in an ongoing drama around Nuedexta, which was originally approved in 2010 to treat pseudobulbar affect (PBA).

that it has not been shown to be safe in other conditions such as Alzheimer's disease or dementia, but that didn't stop drugmaker Avanir's sales force from aggressively pushing the drug for off-label uses, frequently on elderly patients who may be harmed by the drug, .

Raheja joined Avanir's speaker's bureau in February 2011 and received about $331,550 to give talks about the drug from October 2011 to April 2016, according to the DOJ. During this time, Raheja wrote about 10,088 Nuedexta prescriptions, the highest in the country, DOJ said.

show that in one text exchange, Mazzucco texted the following to Raheja and another colleague: "Good morning Dr. Raheja! As of the 12/4 sales report, you posted the single greatest week of sales in Avanir History! 89 [prescriptions] in a single week. I am completely blown away by this number. Your leadership and effort is unparalleled, nationally."

DOJ also alleged that Raheja falsely diagnosed patients with PBA and recorded fictitious symptoms in patient records to support a diagnosis of the condition. Such falsifications included, "complains of crying often and is unable to control this emotion," and "has ongoing symptoms of emotional incontinence," according to court documents.

Those false diagnoses ended up in claims to federal insurers, DOJ said.

As part of the plea agreement, Raheja will surrender his medical license and will serve 30 months in prison. He will also pay about $1.2 million in restitution and another fine to be determined, according to the DOJ.

Last month, another doctor involved in the scheme -- Bhupinder Sawhny, MD -- pleaded guilty to accepting kickbacks in exchange for writing Nuedexta scripts for patients who didn't need them, . And in 2020, Franklin Price, MD, pleaded guilty to a misdemeanor charge of giving Avanir patient information without authorization.

In 2019, after a years-long federal investigation into Nuedexta marketing, Avanir to resolve civil and criminal allegations that it paid kickbacks to doctors to boost sales of the drug.

The company also allegedly targeted long-term care facilities "to induce them to prescribe [Nuedexta] for behaviors commonly associated with dementia patients, which is not an approved use of the drug," .

In 2017, a found the drug was aggressively marketed for elderly nursing home residents who didn't have PBA, and in whom the drug could be harmful. The news outlet reported that the drug was associated with almost 1,000 adverse events reports -- including rashes, dizziness, falls, and comas -- since it went on the market in 2011.

In addition, a 2019 found that in practice the drug was being prescribed mostly to those with dementia.

Avanir allegedly took advantage of a crackdown on the use of antipsychotics for dementia patients and actively instructed its salespeople to pitch Nuedexta to providers at long-term care facilities as a way to decrease reliance on anti-psychotics, according to CNN.

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