Not a snowball’s chance in, well… you know.

That’s what an ex-FDA official thought of Eli Lilly’s chances of getting the brain drug solanezumab (sola) approved after data started leaking out a few years back.

I’ve told you before how sola was supposed to prevent amyloid plaques from forming on your brain — the same plaques commonly found in people with Alzheimer’s.

But sola’s 18-month EXPEDITION trial was such a disaster that Eli Lilly decided not to file for approval pulled from the Big Pharma-friendly FDA.

That should have been the end of sola for good. But it looks like Eli Lilly has hatched a new plan to bring the drug back from the dead and win FDA approval.

And you won’t believe how they’re gaming the system.

The greatest snow job on earth

Eli Lilly has just started a clinical trial to see if it can get away with marketing sola to healthy seniors who don’t have Alzheimer’s.

We already know sola can’t do a darned thing to treat the disease — the EXPEDITION trial showed it didn’t help Alzheimer’s patients improve their memories, thinking, or ability to complete daily tasks.

So now Eli Lilly wants to market the drug for prevention. But the clinical trials it’s running are looking a lot more like a set-up than legitimate research.

You see, those healthy adults who will be suckered into this trial will be undergoing a PET scan to look for amyloid deposits in their brains.

If those people with plaque don’t go on to develop Alzheimer’s, Eli Lilly can claim that sola worked.

And if some of them do get Alzheimer’s? Well, no drug is perfect.

But there’s one really big catch. You see, studies have found that up to 30 percent of elderly people with well-functioning memories have amyloid deposits in their brains.

On top of that, experts have said that a “significant increase” in those amyloid plaques can be found in the “normal elderly.”

In other words, many people with these damaging brain deposits never go on to develop Alzheimer’s.

And that puts sola in a no-lose situation. The study includes a placebo group, but in some cases it could look like the drug worked preventing Alzheimer’s, even if it didn’t do a thing.

Of course, the poor seniors enrolled in this study have plenty to lose. Aside from giving these people false hope, sola could leave them with reduced blood flow to their hearts, brain swelling and even internal bleeding.

And those are just some of the side effects that previous studies have turned up with this med.

Certainly Alzheimer’s is frightening. But if you’re serious about preventing it, your best bet is to follow the advice of researchers from the University of California, Berkeley who have extensively studied the disease.

They’ve found that engaging in mentally stimulating activities actually helps your brain adapt to potential damage that can develop with age.

And a daily crossword or Sudoku makes a lot more sense to me than helping Eli Lilly recycle a dud drug that’s delivered nothing but disappointment.

Sources:

“Preventing memory loss before symptoms appear” Houston Methodist, October 8, 2015, houstonmethodist.org

“Two drugs show promise in delaying Alzheimer’s” Mark Huffman, October 13, 2015, ConsumerAffairs, consumeraffairs.com

Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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