With TV viewers increasingly turning to streaming services or fast-forwarding through commercials on their DVR, product placement is hotter than ever. Reality show contestants have to carry around a company’s mascot for an entire episode; there’s an entire show coming that’s just an ad for an app (it rhymes with “blazzam”). But did a classic soap opera cross the line when a character becomes sick with a rare disease and the show’s partner just happens to make a drug that can treat her ailment?
A recent plot twist on ABC’s General Hospital had one character not just getting any cancer, but polycythemia vera (PV), a myeloproliferative neoplasm (MPN). In other words, a rare form of blood cancer for which the standard treatment is blood-letting and anticoagulants.
The TV patient, not satisfied with this prognosis, demands of the doctor, “this protocol sounds like you are treating the symptoms of this cancer; how do we beat it?… I have to keep going to bloodlettings for the rest of my life?”
Why is GH highlighting this incredibly specific cancer? It’s ostensibly the culmination of a partnership between a company called the Incyte Corporation and the producers of the show to raise awareness for MPNs as part of rare disease month.
But in an opinion piece published this week in medical journal JAMA , Dr. Sham Mailankody of Memorial Sloan Kettering Cancer Center and Dr. Vinay Prasad of Oregon Health & Science University argue that this is really just stealth advertising for Incyte, which just so happens to make only one FDA-approved product, ruxoltinib, which (you can probably see where this is going) is used to treat MPNs, including PV.
And of all the treatments out there aimed at this cancer, ruxolitinib is the only FDA-approved drug that targets the underlying genetic mutation believed to cause this kind of cancer.
But the fictional circumstances could make it seem like ruxolitinib is a first-line therapy for PV, which it is not, the doctors note.
“Instead it has a precise and narrow indication,” they write, explaining that the drug is approved only for patients with an inadequate response or intolerance to chemotherapy, who are dependent on blood-letting, and who have an enlarged spleen.
“Thus, if PV is rare, appropriate use of ruxolitinib in PV should be rarer still,” the doctors say.
The Incyte/ABC partnership is publicized as a “disease awareness” campaign, with the purported intent of shining a light on an illness that doesn’t usually make headlines. However, the doctors say these deals raise serious questions.
First of all, are such disease awareness campaigns just another form of marketing? The authors once again note that although there are other older drugs used to treat PV, ruxolitinib is the only one that targets the genetic mutation that is thought to drive the disease process.
“The comments of the character on the soap opera expressing dissatisfaction with phlebotomy (blood-letting) or treating just the ‘symptoms’ may constitute subtle promotion of ruxolitinib,” they write.
And while going after the underlying mutation sounds great, the clinical benefit to patients “remains speculative.”
“Carefully conducted trials, which have not yet occurred, are required to justify an expanded role of this medication,” the doctors note.
As for disease awareness campaigns themselves, the doctors ask whether they could promote specific drug sales, pointing to a 2000 Novartis campaign in Netherlands that studies said may have led to an increase in prescriptions only for that company’s drug used to treat nail fungus, and not any other treatments.
The article’s authors also question whether or not disease awareness campaigns have any benefits in the first place, noting that the claimed goal is to give individuals with the disease to seek care earlier on and thus, improve their outcome.
“This situation is plausible for conditions that are common and otherwise may be underrecognized and for which early treatment is superior to delayed therapy,” the authors write, but PV and MPNs in general are rare and readily indicated on routine blood work. Reliable evidence as to whether early treatment is beneficial is lacking for these kinds of cancer, they add.
In addition, this kind of campaign could lead to over-diagnosing and medical error: Experts warn that there’s no single diagnostic test, and often not even a combination of tests, that is sufficient to establish a PV diagnosis. These awareness efforts “may merely result in the disease label being applied excessively,” the doctors write.
At the end of the day, the doctors say that the challenge that’s now facing the medical profession is balancing the need to regulate truthful — but perhaps misleading — communication, with “the strong constitutional interpretation of free speech.”
Banning direct-to-consumer advertising isn’t likely going to happen, so other attempts may be necessary to regulate such disease awareness promotions.
To that end, legislators could step in to regulate the content of ad campaigns to make sure that they contain enough information about the potential risks of certain tests or treatments, as well as mandates that would require more input and collaboration from the FDA wen it comes to the content of these ads or disease awareness campaigns.
“Ultimately, the status quo appears increasingly untenable,” the doctors write. “Direct-to-consumer advertising is a massive medical intervention with unproven public health benefit, dubious plausibility, and suggestive evidence of harm.”
We’ve contacted ABC for comment on the JAMA article and will update if we receive a response from the network.
[h/t Ars Technica]