Sola, developed by drug maker Lilly, emerged as a potential Alzheimer’s cure. Discover how newspaper headlines overhyped this treatment, leading many to believe it would be a miracle cure for this heartbreaking disease.
The Origins of Alzheimer’s Disease
Auguste Deter was admitted to a mental asylum in Frankfurt, Germany, on November 25, 1901. She was an educated, 51-year-old woman, married for 28 years.
But her husband Karl had noticed troublesome changes in his wife. She was becoming jealous, and had trouble getting along with people. Her memory, too, was failing, and she would sometimes become disoriented and confused.
Her attending psychiatrist at the asylum was Alois Alzheimer. After Frau Deter died, he kept her medical records and brain. He later published descriptions of the disease that was given his name.
But Alzheimer’s disease didn’t attract any attention at first. His initial report at a meeting in 1906 was largely ignored—the audience had no questions and no comments for him afterwards. They were restlessly waiting for the next presentation, which was about compulsive masturbation.
Alzheimer himself referred to Frau Deter’s illness as presenile dementia, and thought it was unique from the dementia that strikes elderly people. That distinction remained in place until the 1970s, when it became clear that Alzheimer’s disease and senile dementia were the same thing.
This is a transcript from the video series The Skeptic’s Guide to Health, Medicine, and the Media. Watch it now, on The Great Courses Plus.
The decline in mental functioning in elderly people is not inevitable, though it does become more common with age. About 5% of people in their 70s have some degree of dementia, and that percentage increases to 25% of people in their 80s and about 40% of people in their 90s.
Those numbers are scary but might hide the truth that 60% of people in their 90s do not have Alzheimer’s disease. Still, we’re talking about a lot of people, here.
And with the aging of our population, Alzheimer’s disease will only become more common. It’s an illness that’s very costly, difficult to treat, and heartbreaking. So any news about a new therapy is bound to make headlines.
But unfortunately, headlines aren’t always the best way to get your health information.
Learn more about new drugs on the block
Sola: A Cure for Alzheimer’s?
We don’t know exactly what causes Alzheimer’s disease. But Dr. Alzheimer noted plaques of material in the brain cells of his patients with this kind of dementia. These plaques were later found to be made of tangles of proteins called “beta amyloid.”
Though these clumps of protein are always seen in Alzheimer’s (and in some other neurodegenerative diseases as well), we don’t actually know for sure whether they cause Alzheimer’s, or are caused by some other factor. It’s kind of a chicken and egg story, and we don’t know for sure which comes first.
Still, medications that might reduce the growth of these amyloid plaques could be a promising lead in the fight against Alzheimer’s. But the initial studies of one such medicine showed only mixed results.
Drug manufacturer Eli Lilly had developed a medication called solanezumab (sola). Sola is a unique and potentially powerful way to fight these plaques. The drug is what’s called a monoclonal antibody, a molecule that mimics part of your immune system to bind to amyloid and clear it from the body.
Eli Lilly sponsored two trials studying its effects on people with mild to moderate Alzheimer’s, but in 2012 the studies showed that the drug sola did not work.
“Did not work” means that Lilly found in two studies that Alzheimer’s patients taking sola didn’t find a positive impact on either cognition (thinking power) or on their functional outcomes—that is, what the patients were able to do.
You’d think that might be the end of the story.
Learn more about this Alzheimer’s “wonder drug”
Reframing Data to Shift Public Perception
But there was more. In the initial press releases in 2012, Eli Lilly said that while sola failed in the primary goals of their two studies, there was still a glimmer of hope.
When they combined the two studies, kind of mashing their numbers together into one larger study, and focused only on the patients with milder Alzheimer’s, they did see a small but significant improvement on their drug. Headlines said things like, “Eli Lilly’s Experimental Alzheimer’s Drug Solanezumab Fails Study but Shows Potential.”
That was 2012. In 2015, Eli Lilly completed their re-analysis of the original data, and it was formally presented at the Alzheimer’s Association International Conference in Washington, D.C.
The news headlines following that event were ecstatic. The Telegraph, from the UK, said “First Drug to Slow Alzheimer’s Disease Unveiled in Landmark Breakthrough,” and Yahoo.com announced that sola was “A Possible Cure for Alzheimer’s.”
Not every media outlet was quite as optimistic. The Financial Times’s headline was “Eli Lilly Raises Hopes for Breakthrough Alzheimer’s Drug.”
See how these stories are framed differently? Remember, this wasn’t really new information—this was all based on data re-analyzed in 2015 from the 2012 studies. There was nothing new here.
But the glimmer of hope from 2012 had grown into some huge expectations. Eli Lilly needed to prove that their drug really worked on patients with mild Alzheimer’s, and launched a new placebo-controlled trial, focusing only on the patients most likely to benefit from the drug.
About 2,100 patients were enrolled, and the data from that study was released in November 2016. These headlines painted a very different story.
From The Telegraph, again: “Bitter Disappointment as Alzheimer’s Wonder Drug”—somehow, it became a wonder drug—“Fails to Help Patients in Final Trials.” The drug showed no benefit, and Eli Lilly said they wouldn’t be pursuing regulatory approval to market the drug.
They did, however, announce that they were organizing another clinical trial, this time looking at patients in an even earlier stage of Alzheimer’s.
Looking at the big picture, what happened? The bottom line is that the press over-relied on preliminary information and press releases, and emphasized the potential positive news far more than the more solid negative findings of the original studies.