The story looks at the status of two drugs that are being evaluated as treatments for delaying the progression of Alzheimer’s disease. One drug, solanezumab, has been in the news off and on for years. Early trials failed to show positive benefits for the drug, but now the manufacturer is poised to release findings that it says will show a benefit for patients with so-called “mild” Alzheimer’s. The second drug, aducanumab, was recently the subject of a small, early-stage clinical trial. Its manufacturer is poised to announce that the drug appears to slow cognitive decline. Both drugs are designed to lower levels of amyloid in the brain, which is thought by many scientists to play a causal role in the development of Alzheimer’s disease. However, as the story itself notes, neither of the new findings tell us whether these drugs will actually work. A more definitive, large-scale study of solanezumab is not expected to report findings until late 2016 (at the earliest). And the wait for definitive results on aducanumab will be even longer.
Drug development is a big business; new drugs for treating Alzheimer’s disease would generate billions of dollars in revenue for pharmaceutical manufacturers. Here we see that these companies are promoting interim findings that, one suspects, they hope will positively affect their stock price. And this story will likely help them accomplish that goal. But it may also 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.
We recognize that these results have business implications and that this story is targeted at a business and investing crowd, Nevertheless, the piece will inevitably be read by many general readers conducting searches on the Internet — which is how we found it. And for those readers, we think it’s vitally important for stories like this to include a clear explanation of potential benefits and harms as well as a discussion of the evidence on offer. We suspect that business readers would also profit from that information.
While the story tells readers that solanezumab and aducanumab could generate annual sales of $3 billion and $10 billion respectively, it says nothing about the potential cost of the drugs to consumers or insurance companies. Those billions would likely come largely from Medicare. These drugs are still far removed from the marketplace, but presumably the experts they spoke to were basing their annual sales estimates on more than guesswork. That makes it particularly problematic that the story doesn’t touch on cost at all.
The story describes the benefits of these drugs in broad, qualitative terms. E.g., a drug appeared to slow down cognitive decline. That makes it difficult or impossible to tell how well either of these drugs performed in the relevant trials. Were these marginal benefits? In other coverage of these studies, an Eli Lilly consultant noted that the results “do not have a direct relationship to clinically apparent benefit.” So it seems premature for anyone other than investors to be getting too excited about these findings just yet.
The story doesn’t address harms at all. One of the most important aspects of clinical trials is determining whether an experimental drug causes significant side effects. And at least one of these drugs is associated with brain swelling associated with headache and confusion. To be clear, this is not about asking reporters to paint a grisly picture of potential harms. If a drug had no adverse side effects, that’s great — but tell readers that. And if a drug does have adverse side effects, tell readers that too.
[Editor’s note: An updated version of the story now includes the following line: “Some patients receiving solanezumab experienced swelling in the brain and other adverse events, but researchers said the drug was generally well tolerated.” This line was not in the version of the story that we originally reviewed. We applaud any effort to get better, more complete information to readers. But such updates do miss readers like us who only saw the original version of the story.]
The story gets credit for making clear that previous studies of solanezumab did not have promising results, and that a separate, ongoing trial scheduled to end in late 2016 will have more definitive results on the drug. However, the story tells readers very little about the solanezumab trial it is reporting on. How large was the trial? What was the study design? Who conducted it? What were its limitations? The portion of the story on aducanumab is equally vague. All readers are told is that the relevant results stem from a “early-stage clinical trial” in which varying doses of the drug were given to “a very small group of participants with mild memory problems.” How small is “very small”? How long was the trial? What do they mean by “mild memory problems” — were any of the study participants diagnosed with early-stage Alzheimer’s? We understand that not every story can provide an exhaustive overview of a clinical trial’s study design, but the limited information offered here provides more questions than answers.
Two clearly independent sources are quoted, but both are market analysts who offered only global, annual sales estimates for the drugs. There seem to be no independent sources cited in regard to how promising the drugs are, what the clinical trial findings might mean, how far the drugs might be from reaching the market, etc. That’s a significant oversight. Even if readers are interested in this solely as a business story, expert evaluations from independent sources on those issues would be enormously valuable. The conflicts of interest seem clear, with one exception. The story quotes Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California, “who presented the results” on solanezumab. Aisen is also a consultant to Eli Lilly and many other drug companies, which should have been mentioned.
The story does note that existing medications on the market “can alleviate symptoms but don’t slow underlying disease progression.” We’ll rate this Satisfactory, although these medications are really only marginally effective in a minority of patients.
The story clearly notes that solanezumab is the subject of a more definitive trial that won’t end until at least 2016, and that aducanumab is still in early-stage clinical trials. That’s sufficient for a Satisfactory rating. However, we wish that the story had explained that it will be years — at least — before either drug is on the market. And it’s entirely possible that neither will come to market. On a health issue like this one, when people are often willing to grasp at straws to help a loved one, it’s important to be as clear as possible when it comes to availability.
The story discusses these drugs in the context of other drugs seeking to do similar things, and offers a concise background on the history of the development process for both drugs.
While it seems clear that the story was driven by news releases from both manufacturers, the reporters clearly offered background that went beyond the news release material.
Systematic, Criteria-Driven
More for milk debates: "Switching to skim #milk may slow biological aging" https://upi.com/6975065t via @upi cc @garyschwitzer @joansalgeblake
"We can't say that this was caused by milk fat." As is often the case with nutrition studies: correlation ≠ causation.
#RelaxDammit
@HealthNewsRevu @mcjaklevic HealthNewsReview once again revealing hype that far outstrips reality. I suspect that one day, AI will meaningfully contribute to good patient care. Whether that's in 10 years or 100, I couldn't say. What is clear is that we ain't there yet.
Comments (1)
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Linda Furlini
July 27, 2015 at 2:29 pmNot only does the story not grasp the quality of the evidence, it does not make any reference to the controversies regarding the amyloid hypothesis. This hypothesis has been tested for about 20 years with very poor results. Reducing amyloid in the brain may not produce any clinical benefit, whatsoever.
The propaganda strategy produced by the company to promote that this new drug delays the course of dementia is the same as was used to introduce current dementia drugs 15 years ago. One only has to find stories from that time and replace Cholinesterase Inhibitors with solanezumab. The lack of evidence when Cholinesterase Inhibitors were first introduced was well known at the time, yet they were promoted relentlessly. No one is accountable for the false hope these stories produce, then or now.
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