City of Los Angeles Investigating Drugmaker After Reports ‘Unsafe’ Drug
Los Angeles City Attorney Mike Feuer has launched an investigation into California-based drugmaker Avanir Pharmaceuticals, the subject of a CNN report into its aggressive targeting of nursing home residents with a drug called Nuedexta that may be unnecessary or unsafe for this population.
Feuer confirmed the investigation to CNN, saying that his office is seeking information and tips from the public to help determine whether state or federal laws have been broken in the sale, marketing or prescribing of Nuedexta.
CNN’s reporting on Avanir revealed inappropriate and potentially fraudulent use of the medication — in some cases by doctors who have received tens of thousands of dollars to help promote the drug.
“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 said in an interview. “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.”
Because of CNN’s findings, Feuer said he will be on the lookout for illegal activity including potential patient privacy violations, kickbacks paid to doctors and off-label marketing, where a drug is improperly hawked for a purpose that hasn’t been approved by the federal government.
Avanir declined to be interviewed for CNN’s report and didn’t immediately respond to a request for comment about the Los Angeles investigation. In a previously emailed statement, the company said it was committed to “an ethical culture,” uses methods “that are consistent with the law” and that its goal is “to give doctors truthful, accurate and balanced information so they can decide on the proper treatment for their patients.”
Feuer previously made headlines when he took on Wells Fargo over allegations the bank had opened hundreds of thousands of fake accounts. Last year, Wells Fargo was required to pay $50 million in civil penalties.
The main focus of the current probe will be on Avanir, but nursing homes where the medication has been administered will also be examined.
Nuedexta is approved by the federal government for a rare condition characterized by uncontrollable laughing and crying, known as pseudobulbar affect, or PBA. While this can occur in patients with neurological conditions such as dementia, medical experts interviewed by CNN have said that it is not common in this group of people. And the drugmaker itself acknowledges in prescribing information that Nuedexta has not been systematically tested in the elderly.
State regulators, meanwhile, have found cases of doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.
In its report, CNN reviewed nursing home inspection reports and 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.
In one Los Angeles nursing home, regulators found that more than a quarter of its residents — 46 of 162 — had been placed on Nuedexta, noting that a facility psychiatrist had given a talk about the drug to employees. This psychiatrist was a paid speaker for Avanir.
At another facility, also in Southern California, an employee admitted to inspectors that a resident had been given a diagnosis of PBA to “somehow justify the use” of Nuedexta, even though its intended purpose was to control the resident’s “mood disturbances” and yelling out.
Avanir would not comment on any specific cases, but said that PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities.
The CNN investigation also uncovered instances of questionable sales tactics — specifically being used by California-based employees and speakers — through internal emails, documents and recordings. To rack up prescriptions, salespeople identified doctors, nurses and pharmacists who could serve as advocates for the drug. Salespeople then worked closely with these advocates to identify potential patients. In one case, a salesperson worked with a doctor’s office manager to pull patients’ charts, identify those who should be screened for PBA and make sure that Nuedexta brochures were inserted in their files. CNN’s investigation also found that the sales force coached doctors and facility employees on how to fight for Medicare coverage of the drug if it was initially refused.
Bound by strict regulations, salespeople can’t give favor or payments in exchange for a doctor prescribing the drug. They can’t have any contact with private patient records, without the patient’s consent. And they can’t promote use of a drug off-label, in a way that hasn’t been approved by the FDA.
Medical experts said some of the marketing tactics identified by CNN had appeared to cross ethical lines and suggested that Avanir salespeople were inappropriately involving themselves in prescribing decisions.
The City Attorney’s Office said it is seeking information from family members of those given the drug, former and current Avanir employees, nursing home workers and anyone else with information about Nuedexta or Avanir.
Those interested can call the office’s tip line (213-978-8371) or provide information online.