Another risky Alzheimer’s dud being fast-tracked by FDA
Only in Big Pharma’s world could a drug like this be called a “game changer.”
But when you’re talking about a med for Alzheimer’s disease, it appears there’s a new playbook out that drugmakers — and the FDA — are following.
Despite the fact that the trial for this new med was a small one, and a quarter of the patients in it dropped out, and the only dose that did anything produced serious brain swelling, it’s full speed ahead!
So far, the drugs being developed to treat this devastating disease have been epic fails, and this one looks to be no different.
And while the press gushes over it, don’t expect to hear the good news about treatments that actually are doing something to help Alzheimer’s patients. The ones that are the real game changers.
Drugmaker Biogen has just been given the green flag by the FDA to fast-track its Alzheimer’s drug aducanumab.
That means it will soon start phase III trials, and recruit close to 3,000 patients who are “worried about” their memory.
But there’s a problem. Despite several trials to test the med, it keeps “falling short of clinical significance.” In other words, it doesn’t appear to work very well.
On top of that, the doses of the drug that are needed to reduce brain plaques (one of the theories behind the development of Alzheimer’s) can cause “serious swelling” of the brain — something all of these plaque-reducing experimental meds seem to have in common.
In fact, the FDA asked drugmakers to get together six years ago and figure out what to do about this side effect of fluid or blood buildup in the brain that they can cause.
But that was then. Now, we’ve got a fast-track “game changer” on the horizon.
And it’s one that’s not even expected to prevent or reverse Alzheimer’s, but maybe, just maybe, have patients score better on a test called the “Mini Mental State Examination.” And remember, these people don’t have full-blown Alzheimer’s, but just early or mild symptoms!
There’s no doubt that an Alzheimer’s pill — whether it works or not — will be worth billions.
But here’s the thing: breakthroughs in treating dementia have been coming out for some time now. They’re not drugs, and they don’t cause your brain to bleed or swell. Just don’t expect to read about them in the mainstream press or your AOL news feed.
For example:
- Just last month I told you about a study that found acupuncture can help protect the brain from memory loss. The researchers said that this centuries-old treatment “has a significant positive effect” on memory and cognitive function.
- Last year, a UCLA study found that by treating inflammation, nutritional deficiencies and imbalances, they could actually reverse symptoms of dementia! The treatment consisted of raising vitamin D levels, adding supplements such as DHA, improving gut health and normalizing blood-sugar levels with carefully-controlled fasting. The people in the trial also upped their consumption of fresh fruits and veggies.
- And almost two years ago I told you about research from the Center for Healthy Aging at the University of Copenhagen, that found medium-chain fatty acids, like what’s found in coconut oil, can “postpone aging processes” and help Alzheimer’s and Parkinson’s patients.
If any of these findings had come from a drug, why, we’d be playing the national anthem while parading some Big Pharma executive down Fifth Avenue!
But until the day comes when an Alzheimer’s med actually has to work — and without killing you in the process — I’m sure we’ll keep seeing more and more glowing banner headlines about risky treatments that end up doing nothing but raising our hopes.
Sources:
“High hopes new drug could be a ‘game changer’ against long-incurable Alzheimer’s” Jennifer Yang, August 31, 2016, The Star, thestar.com
