Do you ever forget things, like a doctor’s appointment or a lunch date? Do you sometimes struggle to think of the right word for something common? Do you ever feel more anxious or irritable than you typically do? Do you ever feel overwhelmed when trying to make a decision?

If you answered “no, never” to all of those questions, there’s a possibility that you may not actually be human. Nevertheless, you should still talk to a doctor about additional cognitive screenings to check if you have Alzheimer’s disease. At least, that’s the takeaway from a six-question quiz provided in part by Biogen, the maker of an unproven, $56,000 Alzheimer’s drug.

The six questions include the four above, plus questions about whether you ever lose your train of thought or ever get lost on your way to or around a familiar place. The questions not only bring up common issues that perfectly healthy people might face from time to time, but the answers any quiz-taker provides are also completely irrelevant. No matter how you answer—even if you say you never experience any of those issues—the quiz will always prompt you to talk with your doctor about cognitive screening. The results page even uses your zip code to provide a link to find an Alzheimer’s specialist near you.

Biogen says the quiz website is part of a “disease awareness educational program.” But it appears to be part of an aggressive strategy to sell the company’s new Alzheimer’s drug, Aduhelm, which has an intensely controversial history, to say the least.

The drug flunked out of two identical Phase III clinical trials in 2019 before Biogen submitted it to the Food and Drug Administration for approval. FDA statisticians firmly panned the drug, saying the post hoc trial data did not indicate that it’s effective against Alzheimer’s. A panel of expert advisors for the FDA overwhelmingly voted against approval. Still, the FDA approved it on June 7 and, shortly after, Biogen announced the drug’s list price of $56,000 for a year’s supply.

Medical experts and industry watchers immediately rebuked the approval and the price. Three FDA advisors resigned in protest. A watchdog group called for FDA officials to resign or face firing. Lawmakers opened a Congressional investigation into Biogen’s relationship with the FDA prior to the approval. The acting FDA commissioner likewise called for an independent investigation into the approval. Several hospital systems say they won’t administer Aduhelm, and several health insurance companies say they won’t cover it.

“A great strategy for increasing Aduhelm prescriptions”

Nevertheless, on Thursday, Biogen Head of Research and Development Alfred Sandrock chalked up the controversy to “misinformation and misunderstanding.” In a call with investors reported by Stat News, Biogen CEO Michel Vounatsos seemed to blame that “misinformation” on journalists specifically. According to the report, Jay Olson, an investment analyst at Oppenheimer, kicked off this eyebrow-raising exchange:

“It seems like ever since March of 2019, Biogen’s been the target of constant assault from the media and other groups, which obviously intensified on June 7, when Aduhelm was approved,” Olson said. “What do you suppose it is about Alzheimer’s disease that causes the media to react so negatively to a drug that could actually help patients and their families and not treat them with the same respect that is rightly shown to victims of other diseases like cancer?”

“You are absolutely right in your question and your description of what we are exposed to,” Vounatsos replied. “But we are not the ones suffering the most. It is still the early days in the launch. It is still the beginning. And whatever the motives of the controversy are, the ones that are potentially misled, confused, denied help are the patients.”

It’s unclear if Biogen’s attempt to redirect blame and belittle the controversy will be successful. But the company’s direct-to-patient marketing strategy has already drawn the ire of medical professionals. Experts note that the company’s quiz website and other advertisements claim that “about 1 in 12 Americans 50 years and older” has mild cognitive impairment, which is due to Alzheimer’s. Experts say they know of no evidence to back up that “1 in 12” statistic, however, and it appears to be a significant overestimate. Moreover, mild cognitive impairment has many causes—such as depression and side effects from medications—but Alzheimer’s isn’t a common one. In fact, mild cognitive impairment often remains stable over time or disappears, unlike Alzheimer’s, which is progressive.

In a commentary piece published in the Baltimore Sun last week, two medical experts from Georgetown University blasted the company’s quiz website, which aims to identify mild cognitive impairment in an effort to diagnose Alzheimer’s disease.

The website “appears designed to ratchet up anxiety in anyone juggling multiple responsibilities or who gets distracted during small talk,” they wrote. “Convincing perfectly normal people they should see a specialist, be tested for amyloid plaque, and, if present, assume they have early Alzheimer’s is a great strategy for increasing Aduhelm prescriptions… [It] could lead to millions of prescriptions—and billions of dollars in profit—for an ineffective and expensive drug.”

https://arstechnica.com/?p=1782649