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Is this “ask your doctor” advertisement educational or overly emotional?

Strategically Raising A Drug’s Profile

The story of Nuedexta began with Richard Smith, a neurologist whose Center for Neurologic Study was looking to develop a new treatment for Lou Gehrig’s disease, also known as ALS. In the early 2000s, Smith combined dextromethorphan — the main ingredient in cough syrups such as Robitussin — with quinidine, a drug used to treat irregular heart rhythms. The heart drug helps boost and maintain levels of the dextromethorphan in the bloodstream.

What his research team observed in preliminary studies was that patients “almost immediately started reporting an effect on PBA,” said Smith, in a telephone interview. The drug was eventually sold to Avanir. In October 2006, the FDA responded that the drug looked approvable, but investigators had “fundamental questions about both the effectiveness and safety of the product.”

The company then lowered the dose of the heart drug and performed another clinical trial, which found the drug cut in half the number of episodes of uncontrolled laughing or crying by patients who took it rather than a placebo. It was not compared with other treatments already in use and the patients in the study had either MS or ALS. It gained the FDA’s OK in late 2010.

Early on, Avanir executives were clear that they had big ambitions for the new product. In 2013, then-CEO Keith Katkin touted the drug as a “pipeline in a pill” to investors, predicting it could eventually be used in a host of conditions, from pain related to MS to agitation in patients with dementia.

During and after approval of the drug, Avanir provided educational talks for doctors aimed at raising the profile of the little-known condition and expanding the use of their drug.

It made a pitch to consumers with a 2013 ad campaign online and on television that directed viewers to a website. The campaign produced “an overwhelming” response, with “350,000 new unique visitors to the website or calls to the hotline,” Keith A. Katkin, the chief executive at the time, told investors that year.

That potential — along with other drugs in Avanir’s research labs — helped prompt Japan-based Otsuka Holdings to purchase Avanir in 2014 for $3.5 billion.

But after marketing surveys found that, still, only about one-third of potential patients and primary care doctors who treat such patients knew about PBA, Avanir decided to enlist Glover’s celebrity firepower, said Lauren D’Angelo, senior director of marketing for Avanir.

The ad featuring Glover, who doesn’t himself have PBA or any personal link to it, was on cable and national news programs sporadically in 2015 and through the end of December the following year. Glover’s publicist didn’t offer any additional comment for this story.

The ad is “non-branded” — meaning the drug is not mentioned — and therefore isn’t required by the FDA to list side effects and risks. Instead, it simply suggests patients ask their doctor about treatment or go a website to find out more about PBA. Awareness among primary care doctors rose to 72 percent and 52 percent among patients.

“It was an extremely successful campaign,” D’Angelo said. “We drove a lot of patients into doctors’ offices. The challenge was they did not ask for Nuedexta by name.” For sales, that was a problem. Instead of getting Nuedexta, some patients were incorrectly diagnosed or prescribed an antidepressant, she said.

So, in 2017, the drugmaker unveiled a new advertising campaign.

This one, which is currently running on prime-time TV, features a man inexplicably bursting into tears at a child’s birthday party. It intends to move potential customers beyond “could you have PBA?” to “ask your doctor for Nuedexta.”

“We are mimicking what we want them to do, to ask about PBA and ask about Nuedexta,” said D’Angelo.

And there’s good reason for this kind of messaging. A 2016 poll, for instance, conducted by Medscape, an online physician education website, found that 62 percent of physicians said they would or might prescribe an innocuous, even placebo treatment to a patient who didn’t need it but demanded it.

Some neurologists are fans of the drug. Kenneth Heilman, a professor of neurology at the University of Florida School of Medicine and a fellow of the American Academy of Neurology says Nuedexta “seems to control [PBA symptoms] very well.” He also doesn’t object to the advertising campaign, since it might be useful in alerting family physicians who don’t know about the disorder. (Dr. Heilman does not get any money from Avanir.)

Who Needs Nuedexta? Do You?

But PBA can be difficult to diagnose, because symptoms — crying and emotional volatility — can be attributed to other conditions, such as depression. Inappropriate laughter or tears are relatively common in dementia, referred to merely as “emotional lability” in many other countries, but may not constitute a problem that needs treatment. Many experts worry that “patient awareness” and pressing doctors to write prescriptions will lead to overuse.

On the PBA informational website, created by Avanir, the company provides a seven-question self-assessment.

The questionnaire allows a range of answers about the frequency of symptoms, with test takers able to respond never, rarely, occasionally, frequently or most of the time. Questions include: “There are times when I feel fine one minute, and then I’ll become tearful the next over something small or for no reason at all.” “I find myself crying very easily.” “There are times when I won’t be thinking of anything happy or funny at all, but will suddenly be overcome by funny or happy thoughts.”

The scale automatically awards seven points to those who take it — even when “never” is the answer to all questions. A score of 13 is needed to indicate the potential for PBA. A consumer answering “never” to one of the questions, “rarely” to five and “occasionally” to just one scores 14.

Early on, FDA reviewers raised questions about this test and some experts continue to express similar concerns.

Diagnosing who actually has a PBA condition requires asking how it affects a person’s life, said Dr. Laura Boylan, a neurologist and adjunct professor at New York University School of Medicine who treats patients with psychiatric concerns related to neurological diseases.

While she acknowledged that PBA — which she says is more accurately called “pathologic affect” — is under-recognized by the medical profession, she worries about overprescribing: “I’m the kind of person who gets all teary at AT&T ads,” said Boylan. “I’m just like that and would not want to take a medicine to stop that. What if we start giving Nuedexta to people who are just emotional people?”

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Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

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