There is a new pill on the market, and it is intended to treat a rare condition. The pill is bringing in millions for its maker, but there’s a problem: It’s being pushed on elderly patients in nursing homes who may not need it. Worse, it may be unsafe.
The little red pill is called Nuedexta. It was initially approved to treat a disorder that causes sudden and uncontrollable laughing or crying. This display of emotion is called pseudobulbar affect, or PBA. The condition itself affects fewer than 1 percent of the population. That number is based on research conducted by the pill’s manufacturer.
While the condition primarily affects those with multiple sclerosis or Lou Gehrig’s disease, the sales force behind the drub is pushing it on elderly patients who are suffering with some type of dementia. The high volume of prescribing, research has shown, may be because the maker is paying doctors to hand out the drug.
The company QuintilesIMS tracks the sale of pharmaceutical drugs. It found a rise in the sale of Nuedexta pills had jumped over a four year period. In 2016, sales of the drug had jumped close to 400 percent when compared to sales across the previous three years. Sales of the pills reached nearly $300 million last year. Most of the drug sales have been due to its use in nursing homes and long-term care facilities.
The drug maker, Avanir Pharmaceuticals, has acknowledged that the drug has not been studied in elderly patients over the long term. Critics of what is being called the over-prescription of the drug are now likening the use to an uncontrolled experiment. A single study conducted on patients with Alzheimer’s only utilized 194 subjects and discovered that at even that low number, patients who were taking the drug experienced twice as many falls as those who were given a placebo.
For its part, the drug company says that PBA can affect close to 40 percent of people with some form of dementia. The study that gave the company that number was funded by the company itself and the percentage has been strongly refuted by medical professionals, including some of those being paid by Avanir Pharmaceuticals.
The FDA has approved the drug to treat any person dealing with PBA, not just those with Lou Gehrig’s disease or multiple sclerosis. That has given doctors free reign in prescribing the drug to people with dementia and a variety of other neurological conditions. Medical experts, however, have spoken to news outlets such as CNN and said that the condition is rare, extremely rare in fact, in patients with dementia. State regulators have found that some doctors may be inappropriately diagnosing dementia patients with PBA in order to justify that exorbitant use of the drug.
According to Kathryn Locatell, a physician in California who assists in investigations of nursing home abuse, “There is little to no medical literature to support the drug’s use in nursing home residents [with dementia].”
Several nursing home inspectors across the country have raised questions about the prescribing of the drug in facilities in their states. For example:
Los Angeles: 46 out of 162 residents of one nursing home were placed on Nuedexta. The prescribing psychiatrist was a compensated speaker for Avanir Pharmaceuticals.
Southern California: Residents were diagnosed with PBA when they did not have it in order to justify use of the drug.
Ohio: A doctor is under investigation for diagnosing patients with PBA when it did not exist in those patients. That doctor is also under investigation for receiving kickbacks from Avanir for prescribing its little red pill.
Thousands of doctors have received some sort of gift from the drug company for prescribing Nuedexta. In fact, between 2013 and 2016, close to $14 million was paid out to doctors for promotional speaking, consulting and other services. Close to $5 million was paid for dining and travel costs. While the practice is legal, it’s raising some eyebrows in the medical community.
The drug hit the market running in 2011. Since it has been used, medical professionals and family members of patients have been filing reports of harm. Those reports range from dizziness and falls to rashes. In some cases, Nuedexta use led to comas and death. There were close to 1,000 adverse event reports filed with the FDA, causing Nuedexta to be put on the “suspect” medication list. The FDA is refusing to comment on these reports.
Nuedexta is comprised of two drugs — a heart medication and a cough suppressant — that used to cost less than $1 to make at a pharmacy. Today, thanks to rising drug costs, Nuedexta is costing patients close to $13 per pill. The cost of the medication per year can reach nearly $9,000, only part of which is covered by Medicare Part D. The pill is now the biggest money maker for Avanir Pharmaceuticals.
Despite company documents stating that only a small fraction of people suffering from PBA are in long-term care facilities, nursing homes are the biggest growth market. This simply doesn’t make sense. To learn more about how the drug became so popular in this market, read Part 2 of this blog here.
If you or a loved one have been prescribed Nuedexta even though there have been no symptoms of PBA, and have suffered injury or illness because of it, you have legal rights. Contact the West Palm Beach medical malpractice attorneys at Steinger, Iscoe & Greene today for a free, no-obligation consultation.