FDA Policy/General

Questions Raised on TV Show Drug Product Placement

David McFarland

— 2 min read
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Researchers at the Oregon Health & Science University and Memorial Sloan Kettering Cancer Center say there are questions raised by Incyte’s partnership with the television soap opera General Hospital over a story line involving a character diagnosed with polycythemia vera (PV) and a blood clot. Writing in the Journal of the American Medical Association, the researchers note that Incyte has only one FDA-approved product, ruxolitinib, indicated for treating myeloproliferative neoplasams (MPNs), including PV. The story line was intended to raise awareness of MPNs during Rare Disease Month,the researchers say.

However, they write, the drug is not first-line therapy for PV but rather has a precise and narrow indication, being approved only for patients with an inadequate response or intolerance to hydroxyurea, who are dependent on phlebotomy, and who have an enlarged spleen.

“Thus, if PV is rare, appropriate use of ruxolitinib in PV should be rarer still. The partnership between Incyte and General Hospital is an unprecedented form of disease awareness and raises four questions.” The article discusses these questions: 

  •          whether disease awareness is marketing in disguise;
  •          whether disease awareness campaigns promote specific drug sales;
  •          whether disease awareness has benefits; and
  •          whether this disease awareness campaign could lead to over-diagnosis.

“Collectively, these concerns highlight the creativity of disease awareness promotions and direct-to-consumer advertising,” the researchers conclude…. “The challenge that faces the medical profession is balancing the need to regulate truthful but perhaps misleading communication with the strong constitutional interpretation of free speech. A complete ban on direct-to-consumer advertising seems unlikely, and a recent ruling in favor of Amaryn Pharmaceuticals’ off-label promotion of fish oil has effectively weakened the government’s role in this space. But because disease awareness has tangible effects on healthcare behavior and can lead to unintended consequences, including wasteful diagnostic testing, over-diagnosis, and inappropriate therapy, other attempts may be necessary to regulate disease awareness promotions. Options include legislative efforts to regulate the content of advertising campaigns ensuring adequate information on potential harms of additional testing or treatment and closer (mandated) collaboration and input from FDA regarding the content of advertisements and disease awareness campaigns. 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.”

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