Drugmaker Avanir Pharmaceuticals has come under fire this week after allegations that its popular drug Nuedexta — approved to treat a rare condition linked to ALS and MS — is being inappropriately and fraudulently prescribed to nursing home residents with dementia.
An investigation by CNN found that the drug company may be paying doctors and hospitals kickbacks to get the drug into nursing homes, despite the fact that the drug is not approved by the U.S. Food and Drug Administration for treating dementia, resulting in adverse effects for dementia patients like dizziness, rashes, falls, comas, and more.
Now, the City of Los Angeles is launching its own investigation into Avanir to see if the company has broken any state or federal laws in its aggressive sales, marketing, and prescribing of Nuedexta, according to CNN.
While doctor and hospital kickbacks are something of an open secret in the pharmaceutical industry — a so-called “grey area” in the practice of medicine — the ethics of the practice regularly come into question, especially in cases where drugs are pushed for inappropriate, and potentially dangerous uses.
Now, the City of Los Angeles is launching its own investigation into Avanir to see if the company has broken any state or federal laws in its aggressive sales, marketing, and prescribing of Nuedexta.
The allegations levied against Avanir are especially contentious, because Nuedexta was pushed onto a vulnerable population — the elderly with dementia — and potentially harmed them in the process, according to reports of potential harm filed by caregivers to the FDA. These reports potentially link 113 hospitalizations, 51 deaths, 102 instances of sedation and sleepiness, and 101 instances dizziness, confusion, and falls to Nuedexta prescriptions.
Today, we look into just how prevalent doctor kickbacks are, and how pharmaceutical marketing spending may have had a hand in the prescription drugs you and your loved ones take on a daily basis, with insights from Morgan & Morgan Attorney James Young, a lawyer nationally known for his work in pharmaceutical litigation.
How Kickbacks Led to Nuedexta Being Pushed onto the Elderly
Nuedexta, approved in February 2011 and marketed by Avanir, is a drug approved to treat pseudobulbar affect, a condition that causes frequent, uncontrollable episodes of laughing or crying, according to the FDA. This condition is most commonly seen in patients with brain injuries or neurologic conditions, such as multiple sclerosis or ALS, also known as Lou Gehrig’s disease.
PBA is a very rare condition. But because the symptoms of PBA can occur in some patients with neurological conditions like dementia, doctors allegedly prescribed Nuedexta to nursing home residents by misdiagnosing these patients with PBA, allowing their off-label use to fly under the radar while prescriptions of the drug soared. CNN believes kickbacks are to blame.
From 2013 and 2016, Avanir and its parent company Otsuka spent nearly $20 million in doctor kickbacks and benefits, including promotional speaking, consulting, travel, diners, and more, according to CNN. The number of Nuedexta pills prescribed to nursing homes and long-term care facilities soared within this period of time, jumping nearly 400 percent in just four years.
One particularly damning example of Avanir’s off-label pushing of Nuedexta is during a pharmaceutical presentation, a recording of which was obtained by CNN during the investigation.
In this Avanir-sponsored presentation, a California pharmacist reportedly told those in attendance how Nuedexta could be used off-label, and how doctors could use a diagnosis of PBA to have the medication covered by insurance.
“I’m definitely pushing this a little bit, perhaps considered off-label […] but maybe it’s effective on some of the other behaviors too that we find challenging,” said the pharmacist, according to the audio recording obtained by CNN. “If they have an episodic behavior and they have an underlying neurological condition, you can pretty much come up with a diagnosis.”
It is violation a federal law to promote a drug for anything purpose other than its FDA-approved use. And yet, pharmacists sponsored by Avanir allegedly did just that, putting a vulnerable population at risk of serious injury and even death.
Drug Kickbacks: A Widespread Problem
While the investigation into Avanir highlights a particularly egregious example of aggressive, and potentially harmful, drug pushing, this type of marketing is far from uncommon in the industry.
Drug kickbacks are more than just an ethical dilemma within the pharmaceutical industry — some believe it is part of the foundation upon which Big Pharma builds its fortunes.
In a presentation entitled “Big Pharma: Putting Profits Over Patients,” Morgan & Morgan Attorney James Young — an attorney renowned for his work in pharmaceutical litigation — explained just how pervasive drug kickbacks are in the medical industry, even though it is technically illegal for pharmaceutical companies to pay a doctor to prescribe a certain drug.
“It’s a crime in this country to pay a physician to kickback for writing a prescription,” Young said. “So how do you go about doing it?”
To circumvent the law, many pharmaceutical companies exert their influence by giving other benefits to doctors with the implicit understanding they will promote their drug, Young explains. This can include paying doctors to conduct clinical trials, paying for meals, providing free products to use in the office, and even paying for travel to a luxury destination.
“Another form of kickbacks is recruiting physicians to be speakers for your pharmaceutical companies,” Young said. “And we’re not talking about conferences and events in Topeka, Kansas. We’re talking about Maui, South Beach, Las Vegas. These are very lavish, luxurious resorts that these physicians are paid to travel to, paid to speak at.”
And make no mistake: these kickbacks end up having the desired effect for pharmaceutical companies — namely, more brand-name drug prescriptions.
Physicians who received money from drug companies prescribed more brand-name drugs on average than doctors who didn’t, according to a report by NPR. Even physicians who only received meals from drug companies prescribed more brand-name drugs. And doctors who received more than $5,000 in benefits from companies typically prescribed the highest percentage of brand-name drugs.
“It again confirms the prevailing wisdom … that there is a relationship between payments and brand-name prescribing,” Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, told NPR.
Drug Kickback Spending by the Numbers
All of these kickbacks add up to a hefty sum each year. In 2016, it is estimated that pharmaceutical companies spent $8.18 billion on influencing physicians and teaching hospitals to promote their drugs. This amount is only growing year over year. In 2014, companies spent $7.86 billion on doctor kickbacks, and in 2015, $8.09 billion, according to the federal Centers for Medicare and Medicaid.
But not all drugs are pushed equally.ome are the subject of more doctor kickbacks than others. According to a 2015 report by ProPublica, the top drugs that companies paid doctors the most to promote include the following:
- Victoza, type-2 diabetes
- Eliquis, anti-clotting drug
- Brilinta, blood-thinner
- Invokana, type-2 diabetes
- Latuda, schizophrenia
- Xarelto, anti-clotting drug
- Humira, arthritis, ankylosing spondylitis, Crohn’s disease
- Tudorza, chronic obstructive pulmonary disease
- Daliresp, chronic obstructive pulmonary disease
- Abilify, schizophrenia
Worse yet, some of these top billed drugs are also drugs linked to dangerous side-effects and lawsuits, such as Abilify, Xarelto, and Victoza.
Similar to the allegation levied against Avanir about its pushing of Nuedexta for potentially harmful off-label uses to vulnerable elders, these aforementioned drugs were reportedly pushed heavily through doctor kickbacks despite their reported harmful side-effects.
Is Your Doctor Getting Kickbacks?
Naturally, you’re probably wondering if your own doctor is getting kickbacks from pharmaceutical companies after reading this.
Fortunately, there are signs of Big Pharma’s influence hiding in plain sight in your doctor’s office, according to Young, our attorney. Next time you visit your physician, be on the lookout for drug company-branded coffee cups or pens.
“If you notice the particular drug your physician is prescribing you, and your physician is drinking out of that drug’s coffee cup, and writing the script with that drug company’s pen, that tells you that the sales reps have been there, and they have gotten inside the doctor’s decision making,” he said.
Additionally, there is an Open Payments Sunshine Database that you can use to easily look up your doctor and see how much money they have received from drug companies for perks such as gifts, travel, research, speaking fees, meals, and more.
This website was created as a result of the Physician Payments Sunshine Act, a section of the Affordable Care Act, which requires medical manufacturers to disclose any kickbacks they give to doctors or teaching hospitals, whether it is a meal or speaking fees, or something else.
This allows patients to make informed decisions about which doctors they visit, the drugs they use, and whether the branded version of the drug is necessarily better than the equivalent generic version.
“Ask yourself if the company that is paying your doctor the most is the same company that makes the drug that your doctor just prescribed you a dosage for,” Young said.
Hurt by a Drug? We Can Help
Just because a drug is heavily pushed by a doctor doesn’t mean it’s necessarily the right drug for you — or even that it is a safe drug. If you or someone you love has been hurt by a drug that you believe to be defective or improperly prescribed, you have the right to pursue justice and potentially receive compensation.