CNN had a great article on the menace of a “little red pill” pushed on nursing home residents.  “The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe, a CNN investigation has found.”

“The pill, called Nuedexta, is approved to treat a disorder marked by sudden and uncontrollable laughing or crying — known as pseudobulbar affect, or PBA. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.”

“Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company, CNN found.”

“Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.”

“Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.”

“There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) — the population apparently being targeted.”

“Medicare is supposed to pay for drug uses that have been proven safe and effective for the population they are intended to treat or that have been otherwise supported by a specific collection of medical research. Nuedexta is currently only approved by the FDA for patients who have PBA. So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition. So-called “off-label” prescribing, in which doctors use the drug to treat patients who have not been diagnosed with PBA, would typically not be covered.”

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