Polycythemia vera is so rare that just under 3 or so per 100,000 American men, most older than 60, are diagnosed each year with this rare form of blood cancer. Pseudobulbar affect, or PBA, is an uncommon neurological condition afflicting as few as 2 million Americans, causing them to experience uncontrolled, inappropriate bouts of laughter or tears.
What links these two unusual maladies? Big Pharma hype: Both have taken starring roles in audacious and apparently successful advertising and marketing campaigns that have surprised even experts in the field.
Two cancer researchers have published a medical journal editorial asking if Incyte, a biotech company, crossed proper bounds by hawking awareness of polycythemia vera and ruxolitinib, the company’s niche treatment for myeloproliferative neoplasm. Inctye paid to make the disease a central part of the plot of an episode of General Hospital, the hit daytime soap opera.
Anna Devane, a character who has recurred on the show for more than three decades and has survived attempted assassination, frost bite, explosions, and amnesia, is depicted as being hospitalized with debilitating fatigue. She not only is diagnosed with polycythemia vera but also demands to know if she has options so she does not have to be in lifetime care, including undergoing regular blood-letting. Her questions and her doctors’ responses, experts say, dance on a fine ethical and legal line, pointing to Incyte’s drug without naming it, all while increasing in acceptable and even encouraged fashion public awareness of a rare illness.
Neither the soap opera’s producers nor Incyte would provide details of their arrangement, including how much the company paid for its star TV turn.
This appears to be the first time that Big Pharma has knit drug marketing into broadcast programming in this way—and the cancer experts say researchers need to monitor to see if this ploy boosts drug sales and possibly over-diagnosis and over-treatment of a rare disease.
Turning to new ways of marketing its wares, such as through “unbranded” ads, is key for Big Pharma. It spent $5.6 billion in 2016 to promote its products, mostly through patient-direct ads that are uniquely American and have been opposed even by physicians. Most other advanced nations have stringent restrictions on drug ads. But the American print and broadcast spots may be reaching saturation. They litter many sports programs, and the cable television news shows are filled with them, wall to wall.
As Avanir Pharmaceuticals has found, direct to consumer ads for condition awareness and with subtle plugs to “ask your doctor” about a product can be powerful. The California company saw its revenues for Nudexta, an approved drug to treat PBA, increase from $37 million in 2012 to $218 million in 2016. The leap has occurred as Avanir has campaigned for Nudexta, with a commercial featuring Danny Glover, a well-liked actor. He demonstrates thespian extremes, laughing and crying and saying that for patients with PBA these are unhappy manifestations of their neurological disorder.
In my practice, I see the major harms, including economic hardships, that powerful and often dangerous drugs can cause for patients. I can see why critics long have questioned if Big Pharma’s giant budgets to hype its wares help to fuel soaring drugs costs in this country.
While research and development of prescription medications can be a long and expensive process, drug makers’ press to push out blockbuster therapies to benefit shareholders with big profits isn’t always best for patient-consumers. Studies have shown that 1 in 3 drugs recently approved by the federal Food and Drug Administration—an agency under fire by critics who want it to act even faster—have later been found to have serious safety issues. Johnson and Johnson’s growing woes with its Invokana diabetes medication—including now an FDA boxed warning about side-effects leading to possible foot and leg amputations—can only reinforce public concerns about highly promoted drugs.
Lawmakers and regulators need to hear and respond to the public clamor for Big Pharma to spend even more effort on the safety, lower cost, and effectiveness of our drugs—and less time, energy, and money in trying to get hype between our ears and in separating us from the money in our wallets.