https://goo.gl/jnCs79
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.
And much of the money is coming straight from the federal government.
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.
(S)tate regulators have found 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.
"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."