Fear Sells – Revisiting the Brain Health Registry
In 2020 I signed up for a clinical study out of UCSF called the Brain Health Registry. This study of 100,000 people uses online questions and cognitive testing to gauge brain health over time. Its stated goal is to enhance research into dementia diagnosis and treatment. Each participant is asked to return every six months to revisit the questions online.
My motivation to join the study was to help fight disease. But I saw the study differently when I returned to the website in 2021 for follow-up questions. I had just finished reading Dr. Becca Levy’s book, Breaking the Age Code. In that book, Dr. Levy summarizes her decades of research about the negative effects of internalized ageism on health and longevity. Her oft-quoted statistic that people with a positive view of aging live 7.5 years longer makes the point that our attitudes shape our future. So the ninety minutes of questions in the Brain Health Registry, which were laser-focused on age-related decline, set off my alarm bells.
There were pages of questions about hoarding (If emergency responders came to your home, is there so much clutter they would have trouble finding you?). There were many questions about memory (Do you have more difficulty remembering names than six months ago? A year ago?). There were plenty of emotional health questions (How often do you feel hopeless?). There were self-care questions (Are you able to wash your entire body by yourself?). Totally missing were questions about developing new skills, completing new accomplishments, or sharing a lifetime of wisdom in our older years. Most multiple-choice questions allowed graduated responses for how badly you were doing (from slightly worse than a year ago, down to a polite version of “I suck at this”). But there was no separate answer for doing better than a year ago, just a box that combined doing better with doing the same as a year ago. For almost every question, there was no way to stipulate positive change.
I had just published my first novel, had judged a statewide science fair for the first time, and was lifting weights four times a week. But as I answered question after negative question, I noticed that I felt less pride in my accomplishments and began to doubt myself. Maybe I did have more trouble remembering names than a year ago; how would I quantify that?
I began to question the motivation for such a study. I “followed the money” and learned that at least one biopharma company developing dementia drugs was among the study funders. Research to support the development of new dementia drugs is extremely expensive; yet the incidence of dementia is actually falling in the United States. Could it be that these companies were trying to create a market—by adding to the internalized ageism of participants and thereby damaging their cognition?
I contacted the Institutional Review Board (IRB) overseeing patient safety to express my misgivings.
I am a participant in the Brain Health Registry study and am concerned that the study focuses on negative effects of aging to the exclusion of any positive changes (including development of new skills and accomplishments in retirement). In fact, most of the multiple choice response options do not distinguish between doing as well as a year ago and doing better than a year ago. This is distinct from the multiple gradations for measuring decline in the responses. I recommend IRB members review the findings of Becca Levy at the Yale School of Public Health whose new book, "Breaking the Age Code," documents the negative effects on health and lifespan of the kinds of negative beliefs about aging that a study with such a negative focus could foster in participants. While the IRB may have approved this study in the belief that it would not impact participants, Levy's studies suggest otherwise. Thank you.
Three months later I received notice that the IRB had met and determined “no changes to the research surveys [were] required” to protect participants. Yet I wondered how participation in this sanctioned clinical study would affect participants who were not aware of the need to push back on internalized ageism.
My essay about that experience, “First Do No Ageist Harm,” struck a chord with readers. It generated more comments than just about any blog I have published over the past five years.
Revisiting the Brain Health Registry
Recently, in 2023, I revisited the study and completed an update. There were the same old questions in a format I’ve come to think of as “When did you stop beating your wife?” Or, in this case, “When did you start losing your mind?” But rather than causing me to question my competence, this time I was simply annoyed by the barrage of negativity.
And this time I was struck by what I can only call product placement in the study. The term “product placement” typically refers to inserting a brand name into a mass media product. For example, Heineken paid $45 million for James Bond to take a sip of their beer in Skyfall. In this case, the dementia-related products mentioned in the Brain Health Registry survey access a valuable market of 100,000 people who are likely concerned about brain function.
Multiple cognitive diagnostic tests are incorporated into the study, and the companies that produce them are called out by name and thanked, right in the clinical survey. And the study now asks participants to disclose whether or not they are taking any of five different dementia medications:
- Donepezil (Aricept) – A medication approved in the US in 1996 that has been shown to have a small benefit for some patients in slowing Alzheimer’s dementia. Common side effects include diarrhea, insomnia, and nausea.
- Rivastigmine (Exelon) – Used to treat mild to moderate Alzheimer’s. In the UK, this drug is also used to treat dementia related to Parkinson’s. Side effects include diarrhea and vomiting, and less commonly, aggression and convulsions.
- Memantine (Namenda) – Approved in the US in 2003 to treat moderate to severe Alzheimer’s. Side effects include blood clots, psychosis, and heart failure.
- Galantamine (Razadyne) – Approved in the US to treat mild to moderate memory impairments. This medication is derived from the snowdrop and its effects were known to the ancient Greeks. Side effects include nausea and vomiting.
- Aducanumab (Aduhelm) – Approved in 2021 by the FDA, this expensive medication is controversial because of its high cost and serious adverse events. While the cost is reportedly $56,000 per year, forty-one percent of patients in key clinical trials experienced brain bleeding or swelling. In addition, three members of the FDA Advisory Committee quit due to safety concerns and lack of evidence of efficacy. Biogen, the manufacturer, is one of the funders of the Brain Health Registry through an intermediate organization.
Which begs the question: How to sell products that are expensive, not very effective, and pose potentially serious risks to patients?
People often say that sex sells. A beautiful woman draped across the hood of a car is the stereotypical way to sell automobiles. But it’s also true that fear sells. Mouthwash is sold on the fear of bad breath. Masks were sold during the pandemic on the (very real) fear of COVID. The first time I completed the questions for the Brain Health Registry, I was most concerned with its potential for direct harm to participants’ cognition. This time around, my viewpoint shifted and I saw the study as a fear-based marketing tool. The overt goal of the Registry may not be to damage people’s health to create a market (although harm may result from repeated exposure to such slanted questions). The goal, I now suspect, is to encourage olders to focus on whatever is negative in their lives to scare them into asking their doctors for dementia medications, whether they need them or not. Lose your keys at twenty and you’re simply annoyed. Lose your keys at seventy and, if you’ve been conditioned to expect dementia, you may decide that you need medication—even expensive medication with uncertain effectiveness and potentially serious side effects. It is telling that the lead investigator’s biography says he “focuses on… detecting Alzheimer’s disease early in patients who are not demented, but risk subsequent development of dementia.” That is to say, detecting a disease in people who don’t actually have the disease.
Is marketing by fear a less sinister motivation than directly impeding cognition? Possibly. But is it a legitimate reason for a 100,000-person clinical study? Not in my book.
My outreach to the Institutional Review Board had no impact at all. But as I recently discussed with Margo Arrowsmith on her “Age Out Loud” podcast, if many of us enrolled in the study and then contacted the UCSF IRB to express concerns, who knows? The Institutional Review Board might take a closer look. As they say at the Old School Anti-Ageism Clearinghouse, when it comes to fighting ageism, you can’t start too late, and you can’t start too small.