This year on General Hospital, central character Anna Devane is stricken with a rare and life-threatening type of blood cancer. Gasp! OK, this may not be shocking; dramatic, unlikely, and always tragic events are the norm on soap operas. But this one is a little different.
Prior to the tear-jerking diagnosis, the ABC daytime drama—the longest running soap opera in the US—made a deal with a pharmaceutical company to come up with her fate. And the company, Incyte Corporation, just so happens to make the only targeted therapy for fictional Anna’s very real form of cancer. This did not sit well with two doctors.
In an opinion piece published this week in JAMA, Sham Mailankody of Memorial Sloan Kettering Cancer Center and Vinay Prasad of Oregon Health & Science University systematically question the intent of the promotion. The piece ends with a call to arms to medical policy makers and regulators to try to stamp out these “creative” promotions.
These promotions have “tangible effects on health care behavior and can lead to unintended consequences, including wasteful diagnostic testing, overdiagnosis, and inappropriate therapy,” the pair argue. “The status quo appears increasingly untenable: direct-to-consumer advertising is a massive medical intervention with unproven public health benefit, dubious plausibility, and suggestive evidence of harm.”
General Hospital’s partnership with Incyte was ostensibly forged to raise awareness of the disease, polycythemia vera (PV), a slow-progressing cancer in which bone marrow overproduces red blood cells. It’s diagnosed in only about two people per 100,000 each year. Mailankody and Prasad wonder: can a promotion simply be “disease awareness” when the company promoting it is the only one making a specific drug to treat that disease?
Incidentally, unlike overt drug advertisements, “disease awareness” promotions and campaigns aren’t regulated by the Food and Drug Administration.
Further adding to the doctor’s concern, Incyte only has one FDA-approved drug to sell—the one for Anna’s cancer. And in the diagnoses episode, Anna, played by Finola Hughes, and her fictional doctors subtly promote Incyte’s drug, ruxolitinib, by not-so-subtly criticizing other methods of managing the disease—despite a lack of data to back up those criticisms.
Ruxolitinib is the only treatment that targets the underlying genetic mutation that causes PV. But it’s only approved for use in patients with complications and who do not respond to standard treatments that manage symptoms. In the episode, Anna balked at treating just the symptoms. “Although targeting the underlying mutation is attractive, the clinical benefit to patients, particularly those with early disease, remains speculative,” Mailankody and Prasad clarify. “Carefully conducted trials, which have not yet occurred, are required to justify an expanded role of this medication.”
Moreover, the symptoms for this blood disease can be vague and diagnoses can be tricky, opening a real possibility for over-diagnoses and treatment, the doctors warn.
“Collectively, these concerns highlight the creativity of disease awareness promotions and direct-to-consumer advertising,” they conclude. With the industry spending more and more on drug ads—hitting $5.6 billion in 2016—this is a “challenge that faces the medical profession.”
More Info: arstechnica.com