How a DTC Campaign for a Drug to Treat Laughing & Crying Sent Sales Soaring | Pharmaguy's Insights Into Drug Industry News |

An overhead light drawing attention to his face, the actor Danny Glover drops his head into one hand and starts to cry. Then, he abruptly switches to deep belly laughs, before resuming a straight face.


“When I act, if I do this, it’s totally in my control,” he says into the camera. “But for someone with pseudobulbar affect, choosing to cry or laugh may not be your decision.”


The 60-second TV advertisement, aired widely until late last year, has raised questions about the role of direct-to-consumer advertising — typified by ads that call on you to “ask your doctor” about possible treatment — in promoting the use of medicines for uncommon conditions far beyond the narrow population of people who most benefit from them.


Pseudobulbar affect, or PBA, is a neurological condition characterized by inappropriate, uncontrolled outbursts of laughing or crying. The ad did not mention any drug by name. But it was sponsored by Avanir Pharmaceuticals, the California firm that manufactures Nuedexta, a medicine that targets the disorder. The ad ends by referring viewers to a “Facts About PBA” website and a toll-free number.


PBA mostly affects those with neurological conditions such as multiple sclerosis, a recent stroke or Lou Gehrig’s disease. Because the definition of the condition is ambiguous, estimates of its prevalence vary. Doctors may find PBA common or uncommon, depending on their specialty. Avanir sets the number at two million Americans.


The market has proved lucrative. Nuedexta’s sales rose to $218 million last year from about $37 million in 2012, according to EvaluatePharma, which tracks pharmaceutical pricing and markets.


“I suspect this disease is being redefined to include overly emotional people” through advertising, said Adriane Fugh-Berman, a doctor who teaches at Georgetown University Medical Center and has investigated pharmaceutical marketing practices. The United States is one of two countries that allows advertising of prescription drugs.


Nuedexta has also attracted attention because it is expensive, more than $700 a month for a supply of twice-a-day pills. The drug is a combination of two low-cost ingredients — an over-the-counter cough medicine and a generic heart drug — that, purchased separately, would run roughly $20 a month, according to online cost estimators.


Nuedexta doesn’t cure PBA, but it must be taken for the rest of a patient’s life to help reduce episodes of laughing or crying. While it’s the only drug approved specifically for PBA by the Food and Drug Administration, doctors have successfully used several less expensive treatments, all antidepressants, to treat the condition.


“The cost for mixing two old drugs together is unconscionable,” said Dr. Jerome Avorn, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.


The strategic marketing of Nuedexta is part of a trend in which even small pharmaceutical firms turn to the airwaves to encourage use of their products. Pharmaceutical industry spending on television ads has been on the rise — up 62 percent since 2012 to an estimated $6.4 billion — even as TV advertising for other product types has stayed flat, according to Kantar Media, a firm that tracks multimedia advertising.


By last year, drug ads were the sixth-most-common category of television advertisement — behind cars and restaurants — up from 12th just five years ago. A number of the ads, like Nuedexta’s, promote medication for unusual conditions, such as a sleep disorder that affects only people who are blind. Others target more common conditions, such as opioid-induced constipation.


After F.D.A. approval of the drug, Avanir began its pitch to consumers with a 2013 ad campaign online and on television that directed viewers to the PBA facts 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.


But after marketing surveys found that only about one-third of potential patients and primary-care doctors who treat such patients knew about PBA, Avanir enlisted Mr. Glover’s celebrity firepower, said Lauren D’Angelo, the senior director of marketing for Avanir. The advertisement featuring Mr. Glover, who doesn’t have PBA, appeared on cable and national news programs in 2015 and through the end of last year. Mr. Glover’s publicist said he didn’t have any comment on the campaign.


After the ad ran, a subsequent survey found that awareness among primary-care doctors rose to 72 percent, and to 52 percent among patients (read “25% More People Think They Have PBA After Seeing Danny Glover Laughing Uncontrollably!”;


“It was an extremely successful campaign,” Ms. D’Angelo said. “We drove a lot of patients into doctors’ offices. The challenge was that they did not ask for Nuedexta by name.”


For sales, that was a problem. Instead of receiving Nuedexta, some patients were prescribed an antidepressant or received an incorrect diagnosis, she said.


So in 2017, the drug maker unveiled a new advertising campaign. This one, currently running on prime-time TV, features a man bursting into tears at a child’s birthday party. It specifically calls on viewers to “ask about Nuedexta.”


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