Is General Hospital Plot a Veiled Cancer Drug Ad?

May 23, 2017

Vinay Prasad, MD, a hematologist-oncologist at the Knight Cancer Institute in Portland, Oregon, does not watch soap operas. But he ended up becoming very interested in an episode of General Hospital in the past half-year.

It all started in February, when Dr Prasad heard from an oncology fellow that one of their centers' nurses had been home sick, watched America's longest-running daytime drama, and came back to work with the news that a character on the show had the blood cancer polycythemia vera (PV).

"Knowing how rare it was, I was floored," Dr Prasad told Medscape Medical News.

Curious, he and a collaborator, Sham Mailankody, MBBS, a hematologist-oncologist at Memorial Sloan Kettering Cancer Center in New York City, decided to investigate. Last week, the fruits of their investigation were published online May 18 in a Viewpoint essay in JAMA.  

They learned that the soap opera's episode was a collaboration between Incyte Corporation and the producers of General Hospital to raise awareness about myeloproliferative neoplasms (MPNs), of which PV is one, during Rare Disease Month.

"This is the first time a rare disease gets awareness on daytime soap opera to our knowledge," said Dr Prasad, who is also assistant professor of medicine at the Oregon Health and Sciences University.

Incyte is a US pharmaceutical company with only one drug approved by the US Food and Drug Administration. That product, ruxolitinib (Jakafi), is a Janus kinase 2 (JAK2) inhibitor used for the treatment of MPNs, including PV.

From their work as hematologist-oncologists, Dr Prasad and Dr Mailankody know that ruxolitinib is not a first-line treatment for PV. Instead, it has a "precise and narrow indication" and is only for patients who have an inadequate response or intolerance to hydroxyurea (a generic drug), who are also dependent on phlebotomy and who have an enlarged spleen.

Dr Prasad and Dr Mailankody observe that PV is rare (an incidence of 1.9 cases per 100,000 person-years) and that appropriate use of ruxolitinib is "rarer still."

In their new essay, the pair reviewed the General Hospital episode, which was promoted heavily by ABC television, and arrive at a basic question: Was this disease awareness collaboration really drug marketing "in disguise"?

In the end, they don't explicitly answer the question but conclude that there may be good reasons to regulate not just direct-to-consumer drug advertising but disease awareness efforts in general.

In the General Hospital plot, the character Anna Devane (played by British actress Finola Hughes, who in real life is an Incyte spokesperson) is lying in a hospital bed.

Anna, who has been described as "invincible" for her ability to survive attempted assassination, toxic relationships, and countless other traumas over a 30-year span on General Hospital, has been hospitalized for a blood clot. Her doctors, who include Griffin Munro, MD, the illegitimate son of Anna's ex-husband, tell her that she has PV, which if untreated could lead to stroke or heart attack.

The doctors recommend that she start anticoagulation therapy and phlebotomy. Anna asks, "But this protocol sounds like you are treating the symptoms of this cancer — how do we beat it?"

Then, she gets angry about the idea of undergoing phlebotomy: "That's it — I have to keep going to bloodlettings for the rest of my life?" (The scene can be viewed here.)  

Drs Prasad and Mailankody point out that "the mainstays" of therapy for PV include hydroxyurea, phlebotomy, and cardiovascular risk management. They say that other generics (aspirin and interferon) are also used to treat PV and that anagrelide is approved for the treatment of thrombocythemia associated with PV.

But only ruxolitinib targets the underlying genetic mutation (in the JAK2 gene) that is present in nearly all patients with PV and is "thought to drive the disease process," say the essayists.

Given that treatment landscape, Anna's frustrations with her doctors' recommendations are significant, suggest Dr Prasad and Dr Mailankody.

"The comments of the character on the soap opera expressing dissatisfaction with phlebotomy or treating just the 'symptoms' may constitute subtle promotion of ruxolitinib," they write (although the drug is not mentioned by name in the TV show).

The problem is that clinical trials have not been conducted to justify wider use of ruxolitinib; the indication is, as noted above, limited to patients with a specific set of circumstances.

Nevertheless, there is financial incentive for Incyte to encourage Anna's line of thinking among patients with PV, said Dr Prasad. "If the promotion in the show encourages patients to be dissatisfied with phlebotomy and pursue ruxolitinib, or for people without the disease to be screened, I suspect even a small increase in these activities could pay for the campaign, given how expensive ruxolitinib is," he said. 

But is this an ad? After all, the drug is not explicitly mentioned by name.

However, according to an article on STAT, this approach of describing a disease but avoiding mentioning a product is a phenomenon called "unbranded advertising." The omission of a drug name avoids the cumbersome need to list adverse events required by law.

Other drug makers, including Mylan, Novartis, Merck, and AstraZeneca, have used unbranded advertising.

Incyte and ABC did not respond to requests from Medscape Medical News about whether the collaboration was paid for by Incyte, as would be the case in advertising.

The essay authors also say that disease awareness campaigns can result in ad-like results: increased sales of specific drugs. For example, in 2000, Dutch authorities allowed Novartis to run a disease awareness campaign for onychomycosis, for which the company has a treatment, terbinafine. A 2004 study later revealed that the campaign was followed by an increase in terbinafine sales, but not for competitor products (BMJ. 2004;328:931).

The JAMA essayists are also concerned that the Incyte–General Hospital disease awareness campaign could lead to overdiagnosis. They point out that the diagnostic criteria for PV include elevated hemoglobin (a surrogate for erythrocytosis) and the presence of a JAK2 mutation among other things. However, elevated hemoglobin is not specific or sensitive for erythrocytosis, they say. Furthermore, JAK2 mutations have been increasingly noted in healthy individuals, they add.

"In the absence of precise diagnostic criteria and presence of a relatively large reservoir of the genetic mutation, disease awareness of PV may merely result in the disease label being applied excessively," they write.

The essayists think that it may be time for the FDA to restrict the content of disease awareness campaigns.

Notably, a visit to ABC television's webpage for General Hospital reveals that viewers who have PV, or are relatives of PV patients, were grateful for the show's creating awareness of their condition.

"Thank You General Hospital for the Awareness!" reads one post on the webpage, which was echoed by multiple others.

However, some fans expressed a worry that dovetails with concerns from Dr Prasad and Dr Mailankody.

"Thank you for bringing light to this disease. But please keep the information you put out there the correct information," reads another post.

Dr Mailankody was supported in part by the National Cancer Institute MSK Cancer Center Support Grant/Core Grant. Dr Prasad is funded by the Laura and John Arnold Foundation. The authors have disclosed no other relevant financial relationships.

JAMA. Published online May 18, 2017. Full text

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