A medication called Nuedexta is providing its manufacturers with hundreds of millions of dollars every year. The small red pill has been marketed toward elderly, frail nursing home patients. It is used to treat a pseudobulbar effect (PBA). Those impacted by this disorder may suddenly burst into laughter or tears—and they are unable to stop it. However, such a condition is not common in the United States—less than 1 percent of Americans are affected by it.
That statistic comes from the manufacturer itself.
However, Nuedexta’s marketing team has focused on using the medication in Alzheimer’s and dementia patients. It has been reported that physicians have received bonuses from Nuedexta’s manufacturers for prescribing the medication and for advocating on its behalf.
For example, one psychiatrist, Romeo Isidro, has been given significant sums of money in bonuses from Avanir Pharmaceuticals, which makes Nuedexta. Dr. Isidro has reportedly received hundreds of thousands of dollars in promotional payments.
Over the past six years, more than half of all of the Nuedextra pills in the market have gone to nursing homes and other long-term care programs. In 2016, the number of pills had increased by 400 percent since 2012. Sales of Nuedexta were close to $300 million that year.
One especially disturbing fact about Nuedexta is that in the prescribing information provided by Avanir, there is a statement that acknowledges that the effects of the medication have not been extensively examined in elderly individuals. In fact, Avanir has conducted just one study on Alzheimer’s patients, which had a sample size of just 194 patients. The results showed that those who take Nuedexta fall more than twice as much as patients on a placebo.
Avanir has argued that PBA is “misunderstood” and that those with neurological disorders, including dementia, can be impacted by it. Avanir argues that up to 40 percent of dementia patients could have PBA. However, this statistic comes straight from a survey funded by Avanir.
The United States Food and Drug Administration has approved Nuedexta to treat patients with PBA, no matter what other neurological disorders they may suffer from. However, dementia researchers as well as geriatric physicians have argued that PBA is exceedingly rare in dementia patients. Many experts estimate that no more than 5 percent of dementia patients are affected by PBA.
However, some state agencies have caught doctors handing out PBA diagnoses to nursing home patients just so they could prescribe Nuedexta. Some physicians have prescribed the medication to control patient outbursts.
The role of Medicare
The federal government pays for a large portion of Nuedexta through its Medicare Part D prescription funding. For example, in 2015 alone, Medicare spent $138 million just on Nuedexta, a 400 percent increase from 2012.
However, Medicare is only supposed to pay for prescriptions that are safe and effective for their intended populations. Right now, the FDA has only approved Nuedexta for those who have PBA. Therefore, prescription coverage for Nuedexta depends on a PBA diagnosis.
During a three-year period, from 2013 to 2016, Avanir and Otsuka, its parent company, paid physicians close to $14 million for promotional speaking and consulting on Nuedexta. Around $4.6 million was also spent on dining and travel for doctors and speakers. Though it is not illegal to pay a physician to promote a medication to other physicians and professionals, it is against the law for a physician to prescribe a medication for a kickback payment.
Nuedexta was put on the market in 2011. Family members, nurses, and physicians have filed adverse reaction reports with the FDA since that point. Patients suffered a variety of ailments, ranging from rashes to death.
Liability for prescribing harmful medications
Physicians, nursing home facilities, and even drug manufacturers may face liability if a medication harms a patient. If you or a loved one has been injured by a medication, you should seek legal counsel as soon as possible.
Contact Leonard Legal Group today for legal guidance you can trust
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