New Alzheimer’s drugs may land on the FDA fast track for approval — a potentially dangerous plan
Jumping the sharks
It’s one of the cruelest diseases. While the victim usually has no idea what is happening, the family and loved ones watch as the person they knew completely disappears.
So a few years ago, when Dan lost his mother to Alzheimer’s, he felt a heartbreaking mix of sorrow and relief. But when he finally finished tying up his mom’s personal details, that’s when the fear hit him…
Having a mother with AD puts Dan in a high risk group. He’s in his 60s now, and that adds to the risk. Neither he nor his wife has noticed any signs of AD. But he knows they’ll need to be on alert the rest of his life — and that he likely won’t know if it actually happens.
As we become more aware of — and afraid of — Alzheimer’s, more and more of us try to stay on top of the latest research, hoping to hear about a breakthrough. And we might get it. Alzheimer’s is one of the most urgently researched diseases.
But that also means the sharks are circling.
Anyone with Alzheimer’s risk might be encouraged by this New York Times headline…
“FDA Plans Looser Rules on Approving Alzheimer’s Drugs.”
That might seem promising at first. But if you remove the word “Alzheimer’s,” you’ll see it’s just the FDA doing what they do… Helping drug companies approve as many new drugs as quickly as possible.
Out of harm’s way
Most people at risk of Alzheimer’s probably don’t realize what the FDA is getting them into. The prospect of rushing approval of several new AD drugs is a potential disaster.
As we’ve seen many times, the agency gives new drugs the green light even when side effects are potentially devastating. New AD drugs in the pipeline will require post marketing safety studies. But those can take years. Often, they never arrive at all.
Just look at these adverse effects of Aricept, the leading AD drug… Fainting, seizures, nausea, vomiting, stomach ulcers, gastrointestinal bleeding, diarrhea, muscle cramps, and loss of appetite. And these side effects are especially harsh on AD patients. They often don’t understand — or can’t articulate — why they are suffering.
Don’t get me wrong. I’m all for AD research and innovation. Yes, even in the form of drugs, if they’re safe and effective. But that’s a very big “if.”
While we wait to see what the FDA does with these new AD drugs, there’s something that every person at risk — and everyone who loves someone at risk — needs to know. There are non-drug interventions you can use right now, before any AD symptoms arise.
In research that I’ve told you about over the years, these interventions have been proven to help delay AD onset…
* Omega-3 fatty acid intake helps control inflammation
* Vitamins B-6, B-12, and folic acid reduce homocysteine, which is linked to amyloid plaque formation
* Supplementary curcumin provides antioxidant and anti-inflammatory properties that may break up amyloid
* EGCG is a green tea flavonoid that inhibits amyloid formation
* Brain scan research proves that walking just five miles per week reduces amyloid buildup
Chances of adverse side effects from any of these interventions range from very low to zero. And that sets them miles apart from whatever new Alzheimer’s drugs the FDA may soon approve.
Sources:
“Regulatory Innovation and Drug Development for Early-Stage Alzheimer’s Disease” New England Journal of Medicine, Published online ahead of print, 3/13/13, nejm.org
“F.D.A. Plans Looser Rules on Approving Alzheimer’s Drugs” Gina Kolata, The New York Times, 3/13/13, nytimes.com
