Sometimes drugs are prescribed for health conditions they aren’t approved for. This is called “off-label” use. But it’s not illegal. In fact, more than one in five outpatient prescriptions written here in the U.S. aren’t approved for the conditions they are prescribed for. But the makers of a drug called Nuedexta have taken it to extreme levels, and they are laughing all the way to the bank — no pun intended.

Back in 2010, Nuedexta was approved for a condition known as pseudobulbar affect (PBA). You may have seen commercials for the drug. It shows people who break into uncontrollable bouts of laughter or tears.

This is a very real condition. However, it only affects a very small group of people (less than 1% of the U.S. population — and even that’s a high end estimate). This makes it a very small, niche market.

It’s hard to imagine a company investing extensive resources toward the research, development and large-scale marketing of a medication for such a small customer base.But what if the makers of the drug, Avinir Pharmaceuticals and their parent company, Otsuka, started marketing it as a treatment for dementia and Alzheimer’s disease?

And what if they provided hefty payouts to the doctors, clinics and nursing homes for prescribing it?

Off-Label Use of Nuedexta May Harm Elderly Patients

A recent CNN investigation revealed that, since 2012, more than half of Nuedexta pills have gone to long-term care facilities. They are being used to treat Alzheimer's and dementia patients.

However, experts agree that PBA only affects a very small portion of these patients (about 5% or less). Additionally, this drug has not been studied for use in the elderly. It is also implicated in adverse events such as dizziness, falls, comas and even death.

To add more woes into the equation, one of the ingredients in Nuedexta is quinidine, which is an anticholinergic drug. Anticholinergens are known to contribute to confusion, memory problems and an increased risk of dementia.

This opens up an extremely important question: Why — and how — are so many of these patients being prescribed Nuedexta?

Doctors Received Money to “Push” this Pill on the Elderly

The CNN exposé notes that doctors may be inappropriately diagnosing patients who exhibit unruly behavior, such as confusion and agitation.

However, it’s glaringly obvious that a large number of prescribers are receiving financial incentives from Avinir and Otsuka. Between 2013 and 2016, over $18 million was paid out for consulting, speaking engagements, meals and other expenses related to promoting the product.

In one instance, about a quarter of a California nursing home residents were taking the drug. The facility’s psychiatrist was a paid speaker for Avinir.

In another, a doctor who accepted payments from the company is under investigation on charges of fraudulently diagnosing PBA and accepting kickbacks for prescribing the drug, the investigation found.

Considering the fact that a prescription for Nuedexta runs about $9,000 annually (depending on insurance coverage), Avinir can easily afford to develop a large team of paid-for doctors and speakers to promote their product.

The message here is clear. The company’s marketing efforts for this extremely over-priced drug greatly outweigh responsible diagnosing practices.

It is not only dangerous to prescribe Nuedexta as an off-label and unproven treatment for elderly dementia patients, it is unethical to take advantage of this population. And if any doctor or other practitioner tries to sway you otherwise, it’s important to keep in mind that you may be lining their pockets at your own risk.

By Dana Nicholas

http://www.liveinthenow.com/article/doctors-paid-push-pill-elderly