Some of the doctors paid by Avanir Pharmaceuticals to promote the drug Nuedexta had questionable pasts, a new CNN report has revealed.
These physicians include:
In all, a dozen of the nearly 500 physicians who were paid by Avanir to speak or consult on Nuedexta were disciplined by their state medical boards for offenses that ranged from the “harmful treatment of nursing home residents and ‘grossly negligent acts’ involving the inappropriate prescribing of dangerous and addictive drugs.”
According to CNN’s latest installment of its Nuedexta investigation, the physicians’ misdeeds led to probation, suspension, fines and revoked licenses.
At least one Avanir-paid doctor is currently the subject of a federal investigation, and has been accused of accepting kickbacks in exchange for prescribing Nuedexta.
Avanir’s Nuedexta is only approved to treat pseudobulbar affect (PBA), a rare condition that causes inappropriate emotional outbursts, such as laughing and crying. PBA is seen in less than 1% of Americans, and occurs secondary to other neurologic diseases or illnesses, such as ALS,
Avanir states in its Nuedexta marketing materials that PBA occurs in 39% of dementia patients suffer from the PBA. However, experts have told CNN that the rate is actually less than 5%.
Nuedexta has not been shown to be safe and effective in treating other types of emotional lability that can commonly occur with Alzheimer’s disease and dementia, nor has it been well studied in the elderly.
Avanir’s only Nuedexta study focusing solely on Alzheimer’s disease patients found that those treated with the drug were twice as likely to experience falls compared to those who received a placebo.
Over the past several months, CNN has aired a series of reports investigating Avanir’s efforts to promote the use of Nuedexta in elderly nursing home patients.
Among other things, the network has highlighted numerous instances of doctors – many of whom had received speaking or consulting fees from Avanir – inappropriately prescribing Nuedexta to nursing home patients suffering from Alzheimer’s disease or dementia. In some cases, physicians had diagnosed PBA to justify prescribing the drug to manage their confusion, agitation or unruly behavior.
While doctors are permitted to prescribe medications for any purpose they deem appropriate, it is unlawful for drug makers to promote their products for off-label indications that have not been approved by the U.S. Food & Drug Administration.
According to CNN, Avanir and its parent company, Otsuka, paid doctors nearly $14 million between 2013 and 2016 for consulting, promotional speaking and other services related to Nuedexta.
When asked about the questionable disciplinary records uncovered by CNN, Avanir maintained that it only worked with experienced and knowledgeable doctors to “advance effective treatment options for people suffering from central nervous system disorders.”
But according to an expert in medical ethics, the use of doctors with troubling pasts is problematic.
“The doctors who are being paid are obviously not scientific leaders,” Michael Santoro, a Santa Clara University professor and an expert in pharmaceutical industry ethics, told CNN. “They are not practitioner leaders either, it would appear. They are basically being signed up as a sales force.”