You may have seen the hype. GAME-CHANGING CURE FOR ALZHEIMER: THE NEW DRUG, NEW BREAKTHROUGH. Next Best Thing To Alzheimer’s Cure: Solanezumab May Delay Onset Of Dementia By 30%. Have scientists found a drug to stop Alzheimer’s disease?
I’m going to have to pop your balloon. Someone knowledgeable actually looked at the study.
I searched the internet; there was a conference in the United States. I searched the website and found a press release: it seems that Lilly has funded research. EXPEDITION and EXPEDITION2 are published placebo controlled trials of solanezumab, which did not reach statistical significance on their primary endpoints.5 However, cognitive scores in a subgroup analysis of people with milder symptoms were purported to show benefit.
So, in an extension study (EXPEDITION-EXT), which has given rise to all of this fuss, patients in this subgroup were offered a further trial. Those previously taking placebo crossed over to the active drug, and the groups were compared. The researchers comparing cognitive function noted, “Treatment differences between the early start and delayed start groups . . . remained significant through 52 weeks.”
I asked Lilly what the differences were. The company sent me an interim analysis—“in press” as of 15 July—which seems to have got no attention. It contains graphs that allow comparison of various cognitive instruments over time between the two groups of the extension trial. There’s one that I know: the mini mental status examination, which is scored out of 30. The graph’s axis runs from 0 to –8, and the difference between the two groups never exceeds 1 point.
Two other cognitive scores are ADAS-Cog14 and ADCS-iADL. Never is there a difference of more than 2 between the groups, and they are scored out of 90 and 56. These are tiny differences: they may mean nothing at all for quality of life, and they may have occurred by chance.
This is no breakthrough. How did this paper score such extraordinary publicity?
That’s a really good question Margaret McCartney asks.
Colour me cynical but any actual medical breakthrough would probably go unnoticed and be quietly implemented by the medical community. Laypeople would only learn about said breakthrough years later when they were (in)directly affected or happened to read about it somewhere by chance. Either that or when the prestigious awards (such as Nobel) are finally handed out.
I did notice a pattern though. It is apparently enough to just compare the overblown headlines of several news sites to get everything you need. “Next best thing” neatly answers the question of there being an actual cure. As usual in these cases, the answer is no, saving you the trouble of reading the articles altogether.* It seems two or more clickbait links annihilate each other, releasing unprecedented amounts of rubbish onto the internet.
*I firmly believe blissful ignorance to be superior to information assimilated from a telegraph news article.
Can I just leave this here,
I would belive Derek Lowe before anything published by soeme thing called “THE MARKET BUSINESS”
Pierce R. Butler says
How did this paper score such extraordinary publicity?
Consider it the Kardashian family of Alzheimer’s cures. Or maybe the Donald Trump.
I imagine it scored due to the majority of people being unable to correctly read and parse a med paper, along with an extraordinary fear of this particular disease. Fuck, I find the thought of being diagnosed with Alzheimer’s to be terrifying.
slithey tove (twas brillig (stevem)) says
“next best thing to a cure” for which there is currently no cure, says nothing more than “this drug does something”.
I need to read the paper to understand the “May Delay Onset Of Dementia By 30%.” bit.
30% of what? Time, or severity? If time based, units are off; if severity, what is the metric?
slithey tove (twas brillig (stevem)) says
To answer my own question regarding the 30% bit:
the drug solanezumab is able to slow cognitive decline in patients going through the early stages of Alzheimer’s disease by 30 percent
so, the 30% refers to the slope of the decline of without vs with med. Which, to me, is a little different than “delay onset …”. just me
I interpret every “breakthrough” story as a “might be bullshit” story.
Even if the effect size is small, if the finding were true, it would be of tremendous importance as a step forward. The important story isn’t whether the drug produced a clinically useful improvement in that particular study – it doesn’t; as stated, the differences are minimal. The important story is that there has been some detectable effect (assuming you believe the analysis). If true, this would partly validate the “amyloid hypothesis” and would be a major indicator for future research directions. That would be HUGE.
However, there’s a problem with Lilly’s so-called results: it’s a post-hoc analysis conducted on a cherry-picked subset of open-label data from an extension of the original trial. Before anybody concludes that solanezumab is beneficial in A.D. there should be a blinded, controlled trial which succeeds on the primary endpoint, measured in the full population.
Somebody at Lilly is willing to take a big gamble on whether these preliminary findings are valid. They are already conducting the next trial, in early-stage A.D. You can look it up on clinicaltrials-dot-gov (NCT02008357). It’s a 3-year study in >1000 patients and it will cost them (at a guess) several hundred million dollars.
Disclaimer: I work for a drug company (not Lilly, and not currently on any Alzheimer’s treatments).
I was wondering “where can I get information on this?” although to be honest I wasn’t expecting anything new – virtually all press about the latest cure for this-and-that is 100% nonsense. I have no trouble believing this is more junk science from Eli Lily designed to push a failed drug onto the market. We really need an open and transparent system for drug approvals; personally I’d like published protocols and data from Phase 1 and all data from any pre-clinical trials.
Now there’s another one I’m curious about – anyone got the dirt on this anti-malarial vaccine?
Surly Siren says
I doubt scientists have much say in the level of hype that the press release contains. If their process is anything like it is at the place where I work, those things are written by science writers who operate from the premises that unless it’s a real breakthrough that will impact everyone, tomorrow, the public doesn’t need to know and you shouldn’t take up their time with your inconsequential papers. Add the requirement to keep the text at most at the 8th grade level, and all you can achieve is prevent blatantly wrong things from being written there. Which takes a surprising amount of effort and time…
So if I see a press release about something in my field and it’s intriguing, I just go to the original paper. About things not in my field (where I might not be able to read the paper) , I apply universal “common sense filter”. This one would get to be “early indications that it’s possible to slow cognitive decline somewhat with a new drug”. Which is exciting enough as far as I can tell, because it shows a new direction, but it’s also clear that it’s not the final word on the matter.
Raging Bee says
This Alzheimer’s bullshit isn’t that much worse than most of the fake news items and juvenile clickbait that pass for advertising here on FtB. Hell, it’s downright plausible compared to such gems as “New US Currency Will Bankrupt Millions of American Families!!!” or “5 Veggies That Destroy Stomach Fat” or “Fight Diabetes and Avoid Amputation by Doing This.” And those are just three examples I’m now seeing on this very page.
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