The Drug Maker Who Wouldn't Shoot Straight

Can clever marketing sell an expensive Alzheimer's drug that doesn't work?

Photo by National Cancer Institute on Unsplash

There’s good news and bad news in the quest for Alzheimer’s Disease treatments. The good news is that the Food and Drug Administration (FDA) approved a new drug for Alzheimer’s in June, the first new treatment for the disease in nearly two decades. The bad news is that there is no convincing proof that the drug actually helps Alzheimer’s patients.

The FDA approval of the new drug, Aduhelm, stirred up a hornet’s nest in the medical community. The FDA generally relies on a panel of scientists to advise it on clinical trials. After reviewing the data, the 11-member panel voted 10-0 against approval (with one member undecided), saying the trials not only did not prove the drug’s effectiveness but did reveal potential for serious side effects, such as brain bleeding and swelling.  The FDA ignored the scientists’ recommendation and approved Aduhelm anyway. Three members of the panel resigned in protest. Several investigations into how the FDA made its decision are under way.

This month the Cleveland Clinic and New York City’s Mount Sinai Health System said they would not offer Aduhelm, and several Blue Cross Blue Shield plans indicated they won’t cover treatments, citing the lack of proof that it works.

What’s the Issue?

Here’s the crux of the science: All Alzheimer’s patients have a build-up of amyloid beta plaque in their brains. Aduhelm reduces the plaque. But taking Aduhelm has not resulted in cognitive improvements for  Alzheimer’s patients.

And by the way, Aduhelm is not a pill. It’s delivered by intravenous infusion, which requires monthly visits to a clinic, as well as regular MRI scans to check for harmful side effects. Estimated cost: $56,000 per year. Some experts are concerned that this one drug could bankrupt the Medicare system.

Does This Sound Deceptive to You?

Meanwhile, doubts about the drug’s efficacy have not slowed the campaign to promote it to hospitals, doctors, and the public. Biogen, the drug’s maker, and Eisai, a Japanese drugmaker that co-promotes Aduhelm, launched an “informative” and “educational” website in May called “It’s Time We Know.” The website focuses on Mild Cognitive Impairment (MCI), and the essence of the message is this:

“Mild Cognitive Impairment? Holy Forking Shirtballs! I may have Alzheimer’s!”

It would appear that Biogen’s marketing strategy is to sow confusion and anxiety as widely as possible in order to drive of Aduhelm, a treatment that doesn’t actually do what it claims to do.

For example, the website text strongly implies that MCI is the first stage of Alzheimer’s. It is not. It is a risk factor for Alzheimer’s, but everyone who has MCI does not end up with Alzheimer’s. There is also no  clear medical definition of MCI, but the website seems to adopt the broadest possible interpretation. It offers a six-question “symptoms quiz” that asks how often you forget appointments, lose your train of thought, or struggle to find the right word. Whether you answer affirmatively to one, six, or none of the questions, the quiz concludes by suggesting that “if these symptoms concern you, you may want to make an appointment with your doctor” to discuss cognitive screening.

Look, I have been struggling to find the right words for years, and so does everyone else my age. It’s no big deal. In fact, these “symptoms” could apply to anyone from a healthy octogenarian to an absent-minded 14-year-old boy who can’t remember to pack his homework and his housekey. Should all these people live in fear that they have Alzheimer’s? Do they all need to visit a neurologist for screening? (And by the way, cognitive screening doesn’t get a clean bill of health either. The U.S. Preventive Services Task Force reviewed tests for elders in 2015 and concluded that “the evidence on screening for cognitive impairment is lacking, and the balance of benefits and harms cannot be determined.”)

Do all these otherwise healthy people need a PET scan to see if they have plaque in their brain? They certainly will have it if they live to a generous old age, and that’s a fact - but it still doesn’t mean they’re on the road to Alzheimer’s.

Fear and Confusion

What we have here is marketing by fear.  It’s a powerful corporation’s attempt to use the fear of a dreadful and, to date, incurable disease to profit by planting confusion and misinformation. We have seen similar behavior in the drug industry in recent years. Purdue Pharma’s deceptive marketing of OxyContin was instrumental in causing a nationwide epidemic of addiction and death. Biogen’s goal of bleeding the nation’s health care system of $9 billion annually, for a treatment with the proven effectiveness of patent medicine, seems benign only by comparison.

The world needs better treatments for Alzheimer’s. Aduhelm has not proven its ability to slow cognitive decline, yet its maker is boldly embarking on a campaign to create demand through deception and confusion. So far, scientists and health systems aren’t buying it. Neither should you.