Manufacturer of dubious $ 56,000 Alzheimer’s drug offers cognitive test that no one can pass

Have you ever forgotten things like a doctor’s appointment or a lunch date? Do you sometimes have a hard time finding the right word for something common? Have you ever felt more anxious or irritable than usual? Do you sometimes feel overwhelmed when trying to make a decision?

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

The six questions include the above four, plus questions to find out if you’ve ever lost track of your thoughts or got lost on your way to or around a familiar place. The questions not only raise common issues that perfectly healthy people may face from time to time, but the answers provided by any quiz participant are also totally irrelevant. No matter how you answer, even if you say you’ve never experienced any of these issues, the quiz will still prompt you to speak 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 a highly controversial history to say the least.

The drug failed in two identical Phase III clinical trials in 2019 before Biogen submitted it to the Food and Drug Administration for approval. FDA statisticians strongly criticized the drug, saying data from the post hoc trial did not indicate that it was effective against Alzheimer’s disease. A panel of FDA expert advisers overwhelmingly voted against the approval. Still, the FDA approved it on June 7, and soon after, Biogen announced the drug’s list price of $ 56,000 for a one-year supply.

Medical experts and industry watchers immediately berated the approval and the price. Three FDA advisers resigned in protest. A watchdog group has called on FDA officials to resign or be fired. Lawmakers have opened a congressional investigation into Biogen’s relationship with the FDA prior to approval. The acting commissioner of the FDA has also called for an independent investigation into the approval. Several hospital systems say they will not administer Aduhelm, and several health insurance companies say they will not cover it.

“An excellent strategy to increase Aduhelm’s prescriptions”

Nonetheless, on Thursday, Biogen’s head of research and development, Alfred Sandrock, called the controversy “misinformation and misunderstanding.” In a call with investors reported by Stat News, Biogen CEO Michel Vounatsos appeared to blame this “misinformation” on journalists in particular. According to the report, Jay Olson, an investment analyst at Oppenheimer, launched this exchange that raises eyebrows:

“It appears that since March 2019, Biogen has been the target of constant assault from the media and other groups, which obviously escalated on June 7, when Aduhelm was approved,” Olson said. “What do you think there is in 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 shown? rightly to the victims of other diseases such as 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 who suffer the most. We are still only in the early days of the launch. It is still the beginning. And whatever the grounds for the controversy, those who are potentially misled, confused and deprived of help are the patients. “

It is not known whether Biogen’s attempt to redirect the blame and downplay the controversy will be successful. But the company’s direct marketing strategy has already aroused the ire of medical professionals. Experts note that the company’s quiz website and other advertisements claim that “about 1 in 12 Americans aged 50 and over” suffers from mild cognitive impairment, which is due to Alzheimer’s disease. Experts say they know of no evidence to support this “1 in 12” statistic, however, and it appears to be a significant overestimate. Additionally, mild cognitive impairment has many causes, such as depression and drug side effects, but Alzheimer’s disease is not common. In fact, mild cognitive disorders often remain stable over time or disappear, unlike Alzheimer’s disease, which is progressive.

In a commentary article 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 a bid to diagnose the condition. Alzheimer’s.

The website “appears designed to increase anxiety in anyone juggling multiple responsibilities or being distracted in small conversations,” they wrote. “Convincing perfectly normal people that they should see a specialist, get tested for amyloid plaque and, if so, assume that they have early-onset Alzheimer’s disease is a great strategy to increase prescriptions for Alzheimer’s disease. Aduhelm … [It] could lead to millions of prescriptions – and billions of dollars in profits – for an ineffective and expensive drug. “