How to Spin a Harmful Clinical Trial to Your Advantage

Lilly Says Alzheimer Patients Didn’t Improve

By Albertina Torsoli – Jul 19, 2011 5:28 AM PT

Eli Lilly & Co. (LLY) said patients with Alzheimer’s disease whose conditions worsened upon taking the experimental drug semagacestat didn’t improve after dosing was halted.

Lilly stopped development of the pill in August after data showed it harmed patients instead of helping them. Even seven months after patients ceased the use of semagacestat, they still had more trouble with thinking, remembering and mental functioning than those who didn’t receive the medication, the Indianapolis-based company said today.

. . .

Lilly gathered information on the failed compound for 32 weeks after patients stopped taking the treatment.

“We wanted to understand what happened,” Siemers said. “Even though semagacestat didn’t work, we feel we moved the field forward in terms of our understanding of how you develop these compounds.”

Commenters outside of Lilly also expressed the opinion that causing further cognitive decline in Alzheimer’s patients was a fabulous idea:

“They did a great thing in modifying the trial to follow up on patients,” James Vornov, a neurologist who heads the central nervous system therapeutic area at Parexel International Corp. (PRXL) in Waltham, Massachusetts, in an interview after the presentation. “The data beautifully shows you can measure the decline” in patients, he said.

‘Wrong Direction’

“Unfortunately, the drug had an effect in the wrong direction, but you could clearly see the change in the direction and once a drug will go in the right direction, we will know,” Vornov said. Semagacestat data has “increased the anticipation” for results from other gamma secretase inhibitors as well as from other amyloid-targeting drugs, he said.

link via @vaughanbell via @jjvornov