Ad campaign for controversial Alzheimer's drug will 'overly medicalize' normal age-related memory loss, some experts say

Article Image

Ad campaign for controversial Alzheimer's drug will 'overly medicalize' normal age-related memory loss, some experts say

Posted: Jul 23, 2021 8:41 AM
Updated: Jul 23, 2021 8:41 AM

Do you sometimes lose your train of thought or feel a bit more anxious than is typical for you?

Those are two of the six questions in a quiz on a website co-sponsored by the makers of Aduhelm, a controversial new Alzheimer's drug. But even when all responses to the frequency of those experiences are "never," the quiz issues a "talk to your doctor" recommendation about the potential need for additional cognitive testing.

Facing a host of challenges, Aduhelm's makers Biogen and its partner Eisai are taking a page right out of a classic marketing playbook: Run an educational campaign directed at the consumer, one who is already worried about whether those lost keys or a hard-to-recall name is a sign of something grave.

The campaign — which also includes a detailed advertisement on The New York Times' website, a Facebook page and partnerships aimed at increasing the number of places where consumers can get cognitive testing — is drawing fire from critics. They say it uses misleading information to tout a drug whose effectiveness is widely questioned.

"It's particularly egregious because they are trying to convince people with either normal memories or normal age-related decline that they are ill and they need a drug," said Dr. Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center, who wrote about the website in an opinion piece.

The website's "symptoms quiz" asks about several common concerns, such as how often a person feels depressed, struggles to come up with a word, asks the same questions over and over, or gets lost. Readers can answer "never," "almost never," "fairly often" or "often." No matter the answers, however, it directs quiz takers to talk with their doctors about their concerns and whether additional testing is needed.

While some of those concerns can be symptoms of dementia or cognitive impairment, "this clearly does overly medicalize very common events that most adults experience in the course of daily life: Who hasn't lost one's train of thought or the thread of a conversation, book or movie? Who hasn't had trouble finding the right word for something?" said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who has been sharply critical of the approval.

Aduhelm was approved in June by the US Food and Drug Administration, but that came after an FDA advisory panel recommended against it, citing a lack of definitive evidence that it works to slow the progression of the disease. The FDA, however, granted what is called "accelerated approval," based on the drug's ability to reduce a type of amyloid plaque in the brain. That plaque has been associated with Alzheimer's patients, but its role in the disease is still being studied.

News reports also have raised questions about FDA officials' efforts to help Biogen get Aduhelm approved. And consumer advocates have decried the $56,000-a-year price tag that Biogen has set for the drug.

On the day it was approved, Patrizia Cavazzoni, the FDA's director of the Center for Drug Evaluation and Research, said the trial results showed it substantially reduced amyloid plaques and "is reasonably likely to result in clinical benefit."

Describing the website as part of a "disease awareness educational program," Biogen spokesperson Allison Parks said in an email that it is aimed at "cognitive health and the importance of early detection." She noted that the campaign does not mention the drug by name.

Earlier Thursday, in "an open letter to the Alzheimer's disease community," Biogen's head of research, Dr. Alfred Sandrock, noted the drug is the first one approved for the condition since 2003 and said it has been the subject of "extensive misinformation and misunderstanding." Sandrock stressed a need to offer it quickly to those who have only just begun to experience symptoms so they can be treated before the disease moves "beyond the stages at which Aduhelm should be initiated."

While the drug has critics, it is also welcomed by some patients, who see it as a glimmer of hope. The Alzheimer's Association pushed for the approval so that patients would have a new option for treatment, although the group has objected to Biogen's pricing and the fact that it has nine years to submit follow-up effectiveness studies.

"We applaud the FDA's decision," said Maria Carrillo, chief science officer for the association. "There's a benefit to having access to it now" because it is aimed at those in the early stages of dementia. Those patients want even a modest slowdown in disease progression so they have more time to do the things they want to accomplish, she said.

The drug is given by infusion every four weeks. It also requires expensive associated care. About 40% of the patients in the trials experienced brain swelling or bleeds, so regular brain imaging scans are also required, according to clinical trial results and the drug's label. In addition, patients will likely need to be checked for amyloid protein, which is done with expensive PET scans or invasive spinal taps, according to Alzheimer's experts.

To educate more potential patients, and customers, Biogen announced it has teamed with CVS to offer cognitive testing, and with free clinics for dementia education efforts.

Biogen is also picking up some of the laboratory costs for patients who get a spinal tap.

Still, the drug faces headwinds: There's a congressional probe of the drug's approval, the head of the FDA has called for an independent investigation of its review process, and there's pushback from policy experts and insurers over its price, which they say could seriously strain Medicare's finances. Some medical systems, including the Cleveland Clinic and Mount Sinai, say they won't administer it, citing efficacy and safety data.

None of that is mentioned in Biogen's campaign.

Instead, the advertisements and websites focus on what is called mild cognitive impairment, including a warning that 1 in 12 people over age 50 have that condition, which it describes as the earliest clinical stage of Alzheimer's.

On its website, Biogen doesn't cite where that statistic comes from. When asked for the source, Parks said Biogen's researchers made some mathematical calculations based on U.S. population data and data from a January 2018 article in the journal Neurology.

Some experts say that percentage seems high, particularly on the younger end of that spectrum.

"I can't find any evidence to support the claim that 1 in 12 Americans over age 50 have MCI due to Alzheimer's disease. I do not believe it is accurate," said Dr. Matthew S. Schrag, a vascular neurologist and assistant professor of neurology at Vanderbilt University Medical Center in Nashville, Tennessee.

While some people who have mild cognitive impairment progress to Alzheimer's — about 20% over three years — most do not, said Schrag: "It's important to tell patients that a diagnosis of MCI is not the same as a diagnosis of Alzheimer's."

Mild cognitive impairment is tricky to diagnose— and not something a simple six-question quiz can uncover, said Mary Sano, director of the Alzheimer's Disease Research Center at the Icahn School of Medicine at Mount Sinai in New York.

"The first thing to determine is whether it's a new memory problem or a long-standing poor memory," said Sano, who said a physician visit can help patients suss this out. "Is it due to some other medical condition or a lifestyle change?"

Carrillo, at the Alzheimer's Association, agrees that MCI can have many causes, including poor sleep, depression or taking certain prescription medications.

Based on a review of medical literature, her organization estimates that about 8% of people over age 65 have mild cognitive impairment due to the disease.

She declined to comment on the Biogen campaign but did say that early detection of Alzheimer's is important and that patients should seek out their physicians if they have concerns, and not rely on "a take-at-home quiz."

Schrag, however, minced no words in his opinion of the campaign, saying it "feels like an agenda to expand the diagnosis of cognitive impairment in patients because that is the group they are marketing to."

The-CNN-Wire
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

Terre Haute
Clear
56° wxIcon
Hi: 84° Lo: 56°
Feels Like: 56°
Robinson
Clear
55° wxIcon
Hi: 83° Lo: 58°
Feels Like: 55°
Indianapolis
Clear
58° wxIcon
Hi: 83° Lo: 58°
Feels Like: 58°
Rockville
Clear
53° wxIcon
Hi: 83° Lo: 55°
Feels Like: 53°
Casey
Clear
57° wxIcon
Hi: 82° Lo: 58°
Feels Like: 57°
Brazil
Clear
56° wxIcon
Hi: 84° Lo: 56°
Feels Like: 56°
Marshall
Clear
56° wxIcon
Hi: 83° Lo: 54°
Feels Like: 56°
Clear & Cool
WTHI Planner
WTHI Temps
WTHI Radar

WTHI Events

 

Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Cases: 1582392

Reported Deaths: 26884
CountyCasesDeaths
Cook60726610902
DuPage1026891351
Will862101080
Lake761221053
Kane65145838
Winnebago38503541
Madison37519564
St. Clair34621558
McHenry32619311
Peoria25609359
Champaign25478182
Sangamon24108264
McLean21470203
Tazewell19477326
Rock Island17502342
Kankakee16409232
Kendall15177104
LaSalle14258273
Macon14134230
Vermilion12805180
Adams12525147
DeKalb11460126
Williamson11116152
Whiteside7759176
Boone753381
Jackson748379
Coles7121109
Ogle699985
Grundy690481
Clinton673597
Franklin658994
Knox6439163
Marion6392135
Macoupin629997
Henry604172
Jefferson5933130
Effingham580980
Livingston560294
Woodford548291
Stephenson534088
Randolph517096
Monroe501098
Morgan477995
Fulton475369
Christian474980
Logan471373
Montgomery459776
Lee452456
Bureau421687
Perry407770
Saline393562
Iroquois389170
Fayette385256
McDonough350855
Jersey318753
Douglas301236
Shelby296943
Crawford294030
Union292445
Lawrence291031
Wayne263956
White259229
Richland254052
Hancock250934
Pike249456
Cass245628
Bond241524
Clark241038
Ford232755
Clay230547
Edgar226844
Carroll223637
Warren218655
Johnson207821
Moultrie206730
Washington203827
Jo Daviess201624
Greene197738
Mason194551
Wabash193715
Massac192643
De Witt191230
Piatt188314
Mercer185434
Cumberland172423
Menard154112
Jasper148718
Marshall132721
Hamilton125720
Brown10127
Pulaski96711
Schuyler9568
Edwards94015
Stark75426
Gallatin7214
Scott6885
Alexander66011
Calhoun6342
Henderson62614
Hardin55413
Putnam5414
Pope4685
Unassigned1192432
Out of IL80

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Cases: 918230

Reported Deaths: 15011
CountyCasesDeaths
Marion1252491952
Lake623371084
Allen52301746
Hamilton43009443
St. Joseph41155584
Elkhart32831485
Vanderburgh29698436
Tippecanoe26442247
Johnson23106414
Hendricks21708338
Porter21255340
Clark16988222
Madison16899378
Vigo15562272
Monroe14186190
LaPorte13961235
Delaware13613215
Howard13531258
Kosciusko11150134
Hancock10534159
Warrick10431174
Bartholomew10233166
Floyd10099202
Wayne9557216
Grant8858194
Morgan8654158
Boone8231109
Dubois7521123
Henry7391126
Dearborn734186
Noble7208100
Marshall7168127
Cass7060117
Lawrence6803150
Jackson638980
Shelby6386106
Gibson5999105
Harrison587984
Huntington586490
Montgomery5663101
DeKalb555691
Knox532999
Miami523183
Clinton522464
Putnam519067
Whitley509851
Steuben480267
Wabash470192
Jasper465760
Jefferson456091
Ripley439074
Adams435565
Daviess4008106
Scott389563
White383457
Decatur376895
Clay376455
Greene375589
Wells375183
Fayette363074
Posey351841
Jennings341756
Washington324046
LaGrange312074
Spencer310734
Fountain306553
Randolph302087
Sullivan294947
Owen275961
Orange269659
Starke268961
Fulton264451
Jay248134
Perry244950
Carroll239926
Franklin229337
Vermillion225850
Rush225530
Parke212020
Tipton205354
Pike200938
Blackford163834
Pulaski155250
Crawford140818
Benton138316
Newton138141
Brown130646
Martin124416
Switzerland122310
Warren112616
Union92211
Ohio75811
Unassigned0461