The headline reads “Alzheimer’s Drug Misses Goal, but Offers Hint of Potential”. It’s clear the drug didn’t work, but Lilly is spinning the results like mad—it’s stock actually rose.
An Alzheimer’s drug being tested by Eli Lilly failed in its main goal of halting progress of the disease, the company said Friday, but there were some signs it could slow cognitive decline in patients with mild cases.
The study found:
The two clinical trials involved a total of more than 2,000 patients with mild or moderate Alzheimer’s disease who received either solanezumab or a placebo for 18 months. In both trials, those treated with the drug were not better off at the end of the trial than those who received the placebo, either in terms of cognition or daily functioning.
Sounds conclusive to me, but through manipulation of data Lilly found that
there was a statistically significant slowing of the decline in cognition. When the data was further broken down, it was found that this beneficial effect was found in the patients with mild disease but not those with moderate disease.
Medicynical Note: It would be nice if we could suspend reality and say that this drug had benefit but it’s hard to ignore the first part of the findings. The discussion notes that “It is also not clear whether a slowing of cognitive decline, without an improvement of the ability of a patient to perform daily activities, would be sufficient for approval.”
Kind of pathetic. It seems clear that the drug didn’t work and that Lilly is grasping at the straw of a subgroup without revealing the extent of the “benefit,” or the number of patients out of 2000 who “benefitted.”
The press report and presumably Lilly’s press release reeks of a (Medi)cynical statistical manipulation designed to boost Lilly’s stock, not to improve the care and outcomes of these patients
In the words of Mark Twain, “There’s lies, dam lies and statistics” This is a perfect example. I have my doubts about “statistically significant” as is used in this rather pathetic attempt to “make lemonade out of lemons”.