New marketing campaigns about forgetfulness and distraction could lead people to seek the costly Aduhelm drug for Alzheimer’s disease even if they haven’t been diagnosed with the condition, several experts have warned.
By working to expand the market of people seeking treatment for mild cognitive impairment, Biogen could needlessly expose many people to a drug with known risk but as yet unproven potential benefit, some researchers said. (See “Do we all have Alzheimer’s? Drug makers might want you to think so,” Adriane Fugh-Berman and Patricia Bencivenga of Georgetown University, Baltimore Sun, July 16, and “‘When Memory Fades’: Misinformation about Alzheimer’s disease and Aduhelm must be limited,” Madhav Thambisetty of Johns Hopkins University, STAT, July 21.)
There’s agreement that some people taking Aduhelm in studies experienced temporary swelling and bleeding in the brain but disagreement about the evidence used to clear the drug for sales. In June, the FDA approved Aduhelm based on a surrogate measure, its ability to clear amyloid plaque in the brain. That decision ran counter to an FDA advisory panel’s November vote against the drug. (See AHCJ’s recent blog, FDA approves new Alzheimer’s drug, but controversy persists.)
Biogen has launched a disease-awareness campaign that could expand the market for its newly approved drug, although Aduhelm is not mentioned by name in these promotions. One is a paid post on the New York Times website and the sponsored disease awareness site It’sTimeWeKnow.com, both backed by Biogen and its partner, Japanese pharmaceutical developer Eisai Co.
Biogen told AHCJ that the promotions are critical to expanding awareness of this condition. “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,” the company said in an emailed statement.
But researchers see Biogen’s promotions as seeking to alarm people unnecessarily in a bid to get more people to seek Aduhelm.
The Biogen ads, for example, cite a questionable estimate on how many people may suffer from mild cognitive impairment (MCI), both Fugh-Berman and Thambisetty said in their articles. Biogen’s “It’s Time” website says, “About 1 in 12 Americans 50 years and older have the earliest clinical stage of Alzheimer’s, MCI — that’s the stage when symptoms become noticeable.”
Julie Appleby of Kaiser Health News reported on comments from another expert who challenged that statistic. In Appleby’s July 23 story, Matthew S. Schrag, a vascular neurologist and assistant professor of neurology at Vanderbilt University Medical Center in Nashville, Tenn., says he doesn’t believe Biogen’s estimate is accurate. Some people with mild cognitive impairment may eventually progress to Alzheimer’s, but many do not, according to Schrag.
“It’s important to tell patients that a diagnosis of MCI is not the same as a diagnosis of Alzheimer’s,” Schrag told Appleby
Disease-awareness campaigns differ from direct promotions of medicines, for which companies have to adhere to FDA standards. (See the FDA’s “Bad Ad” website for more details.) But companies have freer rein to advertise the conditions that their medicines treat in disease-awareness campaigns as long as they don’t mention their drugs. Neither the FDA nor the Federal Trade Commission (FTC) actively monitors disease-awareness campaigns.
Identify the formula in disease-awareness ads
Journalists can help their audiences understand the strategy at work in Biogen’s marketing pitches and similar promotions, said Steven Woloshin, M.D., co-director of the Center for Medicine and Media at Dartmouth University.
The Biogen MCI ads include hallmarks of the formula observed in other disease-awareness campaigns, said Woloshin, founder of the Lisa Schwartz Foundation for Truth in Medicine. That group, named for his late wife with whom he published research, including an often-cited overview of drug promotion, “Medical Marketing in the United States, 1997-2016,” (JAMA Internal Medicine, January 2019)
The Biogen MCI ads seek to lower the bar for getting a medical diagnosis for a condition, raise the perceived stakes of failing to get tested and spin the evidence, implying there is a treatment for the highlighted condition, according to Woloshin.
“If people keep the formula in mind, they will be a little less susceptible and start seeing through it,” Woloshin said in a phone interview.
The “It’s Time We Know” symptom checker, for example, works to lower the bar for diagnosis, Woloshin said. It asks people about memory lapses such as forgetting important appointments, losing their train of thought and whether they feel depressed and anxious. Survey respondents who say they are concerned are advised to ask their physician about cognitive screening.
So are those who say they aren’t worried.
“Even if you answered ‘Never’ or ‘Almost Never’ to all questions, it’s important to stay on top of your cognitive health. Talk to your doctor about any concerns you may have and ask if cognitive screening is right for you,” the symptom checker instructs.
Try answering “no” to all questions for yourself here, as Biogen declined AHCJ’s request for permission to show an image of this answer.
Biogen’s marketing about mild cognitive impairment may also give people the false impression that there’s a proven treatment to reverse memory loss and struggles mentioned in the ad, Woloshin said.
“We don’t have any treatments for the condition that will fix that,” he said.
Thambisetty, the author of the commentary in STAT, was among the FDA advisers who voted against Aduhelm’s approval last year. He wrote of his worries about the potential harm from such “unchecked advertising in the `When Memory Fades” campaign.’”
“Clinicians like me need to mount a conscientious and concerted effort to push back against this misinformation and educate our patients,” Thambisetty wrote. “We must ensure that their desperation is not monetized, and their hopes are not held hostage to profit.”
In part 2 tomorrow, we will look more broadly at disease-awareness campaigns. Neither the FDA nor the FTC now monitors how the pharmaceutical industry uses disease-awareness campaigns to boost sales of their medicines. However, the FDA is showing interest in the issue.