SoCal's Avanir Scrutinized for Nudexta Prescriber Support Program

Drug Product

Avanir Pharmaceuticals is under fire after CNN filed a report showing how the company paid 500 prescribers about $14 million over three years for prescribers to tout the benefits of its leading CNS drug Nuedexta.

Although a legal practice, CNN noted in its report that a number of the prescribers paid by the company had a history of negligent behavior. One doctor was charged with endangering nursing home patients by prescribing excessive dosages of medications. Three of the physicians had had criminal convictions for illegal prescribing, CNN said. About a dozen of the doctors have been disciplined by state medical boards, according to the report. At least one of the physicians paid to speak about the benefits of Nuedexta by Avanir is currently under federal government investigation. The physician is accused of accepting kickbacks in exchange for prescribing Nuedexta, CNN said.

The report indicated that many of the doctors were prescribing the medication to patients who might not really need the drug, which has been approved by the U.S. Food and Drug Administration to treat pseudobulbar affect (PBA). The rare neurological condition is characterized by uncontrollable laughing or crying. CNN said many of those physicians were prescribing the drug to nursing home patients as a way to “control unruly behaviors.” The “off-label” use for the drug helped spur greater revenues for Avanir, CNN said.

Nuedexta is a combination of dextromethorphan hydrobromide and quinidine sulfate, a metabolic inhibitor enabling therapeutic concentrations of dextromethorphan.

CNN said as a result of its investigation into Avanir the city attorney of Los Angeles said he intends to launch an investigation into the prescribing practices of the company. CNN identified Cleveland neurologist Deepak Raheja as the physician under investigation. CNN said Raheja is under investigation for “fraudulently diagnosing patients with PBA in order to secure Medicare coverage for off-label use and increasing dosages of Nuedexta beyond what is recommended.”

Michael Santoro, a Santa Clara University professor identified as an expert in pharmaceutical ethics, told CNN that the physicians tapped by Avanir are nothing more than an arm of its sales force. Santoro said the prescribers are not “scientific leaders” nor are they “practitioner leaders.”

“They are basically being signed up as a sales force. Even those who would advocate a strong view of the propriety of paying thought leaders would not approve of these kinds of payments,” Santoro said, according to CNN.

Avanir said it opposes “any mischaracterization” of how the company interacts with the medical community.

“Patients and doctors want options for treatment and pharmaceutical companies engage physicians in ways that are both ethical and appropriate to convey the state of medical conditions and FDA-approved treatments that could otherwise remain unknown to patients in need.  Such relationships allow research companies, physicians, and other health care professionals to share first-hand knowledge and raise awareness of medicines that could improve patient conditions,” Avanir said in the statement posted on its website.

Regarding the questionable prescribers that CNN noted Avanir said it has a “robust physician-verification system” that is used “to determine if a physician has been disbarred, accurately represented his or her qualifications, and continues to maintain his or her fitness for practice.”

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