Fast track drug approval produces huge benefits...for drug companies -- not for patients

What does a yellow light mean

So what does the FDA actually do?

Well, if you ask them, it’s simple:

    1. “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs…”

That’s the first thing. But when you keep reading…and read between the lines, you see what they REALLY do. Because in the next line, they tell it like it is.

      1. “FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more…”

Okay…sorry to bore you with government mission statements. But did you catch the critical part of the FDA’s mission?

It “speeds innovations.”

Now it may tell you it’s doing this to make medicine more effective, safer and more affordable. But nothing could be further from the truth.

In fact, speeding innovations to market makes drugs LESS effective, more DANGEROUS and hasn’t brought costs down at all (except, of course, for Big Pharma!).

That’s the catastrophe of fast-track drug approval. FDA minions actually pride themselves on moving more drugs through the approval process more quickly. So much so it’s the second thing in their mission statement!

Like I said, that speed doesn’t do you or me any good. But it sure makes FDA’s Big Pharma buddies happy. They just shove safety concerns off to “post-marketing research.” Then they can get straight to work hawking their wares faster, with as little interference as possible.

And post-marketing research is so slow it sometimes doesn’t move at all. Drug companies know there’s no need to rush once their drug is approved. So they often take many years to get around to that annoying little issue of safety.

And even with that, the FDA has decided to put us at even greater risk by “loosening” rules on the approval of certain drugs.

What makes it especially terrifying is that they’re loosening the rules on drugs targeted at the most vulnerable people…Alzheimer’s patients.

To get an idea of the danger, just look at these adverse effects of Aricept, the current leading AD drug… Fainting, seizures, nausea, vomiting, diarrhea, muscle cramps, and loss of appetite.

And you can imagine that these side effects are especially harsh on AD patients. They often don’t understand — or can’t articulate — why they are suffering.

Of course, it won’t stop here. Once the Big Pharma coffers fill up with fast-track profits, they’re going to entice the FDA to “loosen” more and more of their annoying little rules.

The FDA fast track plan is designed solely to benefit Big Pharma’s bottom line even though it puts you, or your spouse or other loved ones in danger.

In fact, they’ve made it their mission.

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

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