This is part 2 of a package on sponsored disease awareness campaigns and other controversial drug marketing practices, focusing on Biogen’s efforts to build a market for its recently approved drug for Alzheimer’s disease. Check out part 1, which posted on August 4.
Biogen’s marketing campaigns about mild cognitive impairment drew protests from several physicians, but don’t expect federal regulators to more strictly regulate such ads and similar disease-awareness promotions.
Neither the FDA nor the FTC actively monitors claims made in pharmaceutical marketing about medical conditions if the name of a medicine isn’t mentioned.
The FTC has not brought any action in the area of disease-awareness campaigns run by drugmakers, the agency told AHCJ by email. The FDA does keep tabs on pharmaceutical ads that identify specific drugs. But disease-awareness campaigns appear to fall outside of the agency’s normal regulatory reach, although FDA staff have had a persistent interest in studying the effects of these promotions.
The disease-awareness campaigns from Biogen Inc. and its partner, Eisai Co., demonstrate why it’s critical for journalists to help their audiences understand how marketing and promotion branded as “education” can create unnecessary fear, leading to demand for drugs that may not help — and could potentially harm them, Adriane Fugh-Berman, a physician and a professor at Georgetown University, told AHCJ. Fugh-Berman also is the director of PharmedOut, a project that seeks to expose the effect of pharmaceutical marketing on prescribing practices.
Disease-awareness campaigns have varied goals and sponsors in the U.S. The National Institutes of Health (NIH), for example, runs awareness campaigns such as “Know Stroke” to educate the public on signs of that medical threat and the Breathe Better campaign focused on lung diseases.
In other cases, pharmaceutical companies run these campaigns to draw attention to the conditions their products treat.
In Biogen’s case, the claims and phrasing of its disease-awareness campaigns about mild cognitive impairment are in contention. (See AHCJ’s recent blog, “Explaining Biogen’s controversial ‘MCI’ advertising to your audience”), as well as a July 16 Baltimore Sun commentary by Fugh-Berman and a July 16 article in STAT by Madhav Thambisetty of Johns Hopkins University.)
Biogen’s marketing “could have the effect of making a lot of perfectly normal people think they’re sick,” Fugh-Berman said in a phone interview.
Complicated terms for risks
As Biogen’s promotions about mild cognitive impairment don’t mention Aduhelm, these marketing campaigns avoid another thorny issue of pharmaceutical promotion — how to convey potential risks to patients.
Federal law requires that direct-to-consumer advertising specifically for medicines include details on their risks, according to the FDA’s Office of Prescription Drug Promotion (OPDP). The FDA encourages companies to use “clear and understandable” language to explain risks, OPDP said on its website.
In the case of Aduhelm, there’s a concern about how jargon used to describe side effects of this drug may mask the risk for consumers, Fugh-Berman said.
The FDA-approved label for Aduhelm discusses “amyloid-related imaging abnormalities-edema (ARIA-E),” referring to brain swelling, and ARIA-H, which includes microhemorrhage. The Aduhelm label then reports on how often these side effects were seen in the major tests of Aduhelm.
“ARIA (-E and/or -H) was observed in 41% of patients treated with ADUHELM with a planned dose of 10 mg/kg (454 out of 1105), compared to 10% of patients on placebo (111 out of 1087),” the label says.
Fugh-Berman advised journalists to avoid using that ARIA jargon. Instead, they should explain these risks in simpler terms of swelling and hemorrhage to better help people weigh Aduhelm’s risks against its uncertain benefits, she said.
“What desperate patients don’t necessarily think is that this drug could make me worse,”
Fugh-Berman told AHCJ. Aduhelm “is not a benign drug.”
Patients also need to know that common side effects include blurred vision, dizziness, falls, nausea, vomiting and diarrhea, all of which can be especially serious for older adults.
Michael Carome, M.D., the director of the health research group at the nonprofit Public Citizen, described the disease-awareness campaign from Biogen and its partner on Aduhelm sales, Eisai, as “a textbook example of disease mongering.”
“The companies are trying to convince people who are essentially well that they have an illness — in this case, early Alzheimer’s disease — in order to persuade them to seek treatment with the companies’ exorbitantly priced drug that has not been shown to provide any meaningful clinical benefit,” Carome wrote in an email. “The sole motive here is to drive up the companies’ profits.”
In an email exchange with AHCJ, Biogen said its marketing campaigns about mild cognitive impairment are meant to encourage people to talk with their doctors.
“We believe it is important for patients to feel empowered to have meaningful conversations with their healthcare provider that will hopefully lead to better disease management,” Biogen said.
AHCJ asked Biogen to respond specifically to concerns about harm from the drug for people unlikely to benefit from Aduhelm.
The label for the drug provides “clear medical guidance on the indications and usage for Aduhelm,” Biogen replied via email.
“We’re confident that physicians will make the prescribing determination that is best for each of their patients based on that guidance and individual doctor-patient discussions,” the company said.
FDA eying effects of disease-awareness campaigns
While the FDA doesn’t oversee disease-awareness campaigns as it does branded drug ads, the agency has expressed concerns over the years about these marketing techniques.
In 2004, the FDA sought to nudge drugmakers into clearly distinguishing
disease-awareness promotions from branded advertising. It issued draft guidance, Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. This proposal languished for many years and was never finalized. In 2015, FDA withdrew it along with 46 other unfinished guidance documents.
But the FDA officials have remained interested in disease-awareness ads.
In 2016, members of the FDA’s Office of Prescription Drug Promotion (OPDP) published a paper in the Journal of Health Communications, “Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study.” The paper summarized the findings of a study where participants viewed different versions of marketing for a fictitious prescription drug website. “Consumers seem to confuse information on disease websites with information on branded prescription drug websites,” the authors of the paper wrote.
In 2019, the FDA cited this paper and other research done on pharmaceutical promotion in outlining plans for further study of disease-awareness campaigns and prescription drug promotion on television. The FDA provided these details in a notice published in the Federal Register.
In it, agency staff noted that pharmaceutical companies often launch disease-awareness marketing when they introduce new medicines to the market.
“FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion,” the agency staff wrote in the notice.
Prior research has found “consumers tend to conflate the information presented in prescription drug promotional materials with the information presented in disease awareness communications,” the FDA added.
In an email exchange, the FDA told AHCJ that the research outlined in the 2019 notice is complete. Results are awaiting peer review and publication in a scientific journal. Upon publication, the study results and links to more information will be posted to the OPDP’s research website, FDA said.