Polycythemia vera is an uncommon blood cancer that can be controlled with long-established treatments. So it seemed more than a little suspicious to Vinay Prasad, M.D., M.P.H., when the disease took center stage in an episode of “General Hospital” – the longest running daytime drama on American television.
“I felt there had to be some backstory,” Prasad, an OHSU Knight Cancer Institute hematologist-oncologist told listeners of the public radio program Think Out Loud. “What we found was that a company called Incyte Corporation, which actually manufactures a very costly new drug for polycythemia vera, was in a partnership with ‘General Hospital’ and had helped craft this plot line in an effort to raise awareness for this condition.”
The partnership between Incyte and the soap opera is an unprecedented form of disease awareness marketing, according to Prasad and Sham Mailankody of Memorial Sloan Kettering Cancer Center, who explained their concerns in a commentary they co-authored in the Journal of the American Medical Association.
Unlike the promotion of specific drugs, advertisements intended to create disease awareness aren’t regulated by the U.S. Food and Drug Administration. Prasad and Mailankody describe how disease awareness campaigns have the potential to drive overdiagnosis and inappropriate prescribing.
“direct-to-consumer advertising is a massive medical intervention with unproven public health benefit, dubious plausibility, and suggestive evidence of harm”
In the “General Hospital” episode, the character Anna Devane (played by British actress Finola Hughes), expresses dissatisfaction with standard therapies that are just “treating the symptoms” – which may constitute subtle promotion of ruxolitinib, Prasad and Mailankody assert.
Incyte’s drug, ruxolitinib, is the only FDA-approved medication that targets a genetic mutation in the JAK2 gene that’s thought to drive the disease process in polycythemia vera. But the approved indication is limited to patients with an inadequate response or intolerance to hydroxyurea, who are dependent on phlebotomy, and who have an enlarged spleen.
“Clinical benefit to patients, particularly those with early disease, remains speculative,” the two physicians point out. “Carefully conducted trials, which have not yet occurred, are required to justify an expanded role of this medication.”
Furthermore, precise diagnostic criteria are lacking for polycythemia vera, the authors note, and the associated JAK2 mutation can be found in people who don’t have the disease. With such uncertainties around diagnosis, increased disease awareness could lead to the disease label being applied excessively.
While a complete ban on direct-to-consumer advertising seems unlikely, the commentary concludes that disease awareness promotions can and should be reined in. “Ultimately, 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.”
◊ ◊ ◊
Pharmaceutical Marketing for Rare Diseases: Regulating Drug Company Promotion in an Era of Unprecedented Advertisement by Sham Mailankody and Vinay Prasad, JAMA (May 18, 2017)