Taking stock of new Alzheimer’s drug coverage: A “landmark breakthrough” that offers no “clinically apparent benefit”

alzheimersThe big story dominating this week’s health news has been the presentation of new results on studies of Alzheimer’s drugs at the Alzheimer’s Association International Conference in Washington.

Eli Lilly was there to show off data on solanezumab, a drug that previously failed to demonstrate benefits in two big studies but is now being retested in a different patient group.

Biogen reported findings from a small study about a new dosage of its drug aducanumab. It’s basically an addendum to results that were already reported in March.

By all informed accounts, these are interim studies that merely hint at the possibility that the drugs might be causing beneficial effects in the brain. They show that the drugs cleared plaque out of the brains of patients and may have had very small effects on some measures of cognitive functioning but not others. There could be something happening here, but an Eli Lilly consultant acknowledged that the effects they observed from solanezumab wouldn’t even be noticeable to patients or their families.

“The cognitive measures do not have a direct relationship to clinically apparent benefit,” said Dr. Paul Aisen, who is also director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California, speaking to NBC News

So why bother to present provisional results that don’t even demonstrate that the drugs had any noticeable effect? As Matthew Herper points out at Forbes, the show at this week’s conference may have been more about company stock prices than about informing patients and the public.

It’s only investors, who want to value these companies based on the odds of success of the drugs, and scientists and other drug companies, who are deciding how to develop other experimental medicines, who are really going to take any action based on these results. And for them, the new results probably change little.

But investors and scientists aren’t the only ones who’ll be reading the breathless media accounts that these presentations produced, such as this one from the UK Telegraph.

Telegraph story


When the drug has already been tested twice and failed to show any benefit in big randomized studies?

“Landmark breakthrough”?

Based on an interim analysis of research whose results wouldn’t be detectable to anyone but a statistician?

While the Telegraph was arguably the worst offender in the hype department, many other headlines that I scanned showed a markedly rosy view of the results as well:

Lilly’s Alzheimer’s drug may slow patients’ decline, study shows  – Wall Street Journal

New Drug Shows Promise for Early-Stage Alzheimer’s – Newsweek

Two drugs show promise in slowing Alzheimer’s progression – PBS

Early signs that drug ‘may slow Alzheimer’s decline’ – BBC

Many stories certainly did include caveats and limitations deeper in their coverage. Among the big media outlets, NBC was notable for leading with some tough, skeptical reporting on the real meaning of these results for anyone not trading stocks based on the information. It noted that the results are “not even close to being a cure, experts said — and they’re also not close to being on the market. And, researchers admit, the benefits they see amount to numbers on a graph, not anything that patients or their loved ones might notice.”

That’s vitally important context, and yet I wonder if that context was overwhelmed by NBC’s cheerleading headline — “New Alzheimer’s Drugs Offer ‘Exciting Possibilities‘” — which seems to bear little relation to the generally doubtful tone of the coverage.

An expert quoted in the NBC piece said he knew that headlines from the conference would falsely raise expectations that these drugs might soon be available.

“How am I going talk to my patients on Friday?” he asked.

I wish more media outlets would think about that question when they frame the results of preliminary studies on new drugs.

Note: We’ve also applied our systematic criteria to the Wall Street Journal story referenced in this post. Check out the review here. Our review team worried that the story may “stir up false hopes in Alzheimer’s patients and their loved ones, when it’s clear that neither of these drugs has yet demonstrated any clinically meaningful benefit — and that neither will be available to consumers for years, if ever.”

Kevin Lomangino is Managing Editor of HealthNewsReview.org. He tweets as @Klomangino.


Addenda on July 27:  Kristina Fiore of MedPage Today wrote, “Solanezumab Analysis Positive, But Clinical Benefits Unclear, Treatment effect, though detectable, may be too subtle to bend patient trajectories much.

And, in The BMJ, Dr. Margaret McCartney wrote, “The ‘breakthrough’ drug that’s not been shown to help in Alzheimer’s disease.

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