New push to deregulate drugs makes vigilance especially important

Taking prescription drugs is about to become a whole lot more dangerous.

To hear Big Pharma talk about it, the new state laws beginning to pop up will help your doctor to better help you.

That’s what those who support the unravelling of Rx drug regulations will tell you, too.

Sweeping away long-held FDA restrictions that prevented pharma from marketing off-label drugs directly to docs, we’re being told, will make your MD smarter. He’ll be able to learn about more drugs for your condition — even if they’ve never been approved or tested for that purpose.

But while this is going to be a dream come true for Big Pharma, it’s a potential nightmare for the rest of us.

It will mean that you’ve got to be even more vigilant than ever whenever you’re given an Rx. Because we’re all being turned into lab rats for one of the biggest drug trials imaginable.

Throwing caution to the wind
You’ve heard this question before about certain drugs: Do the benefits outweigh the risks?

Realizing that all drugs come with potential side effects, that’s a very important question. But it’s one that’s now being tossed aside, leaving everything in the hands of drugmakers and their sales reps.

In the past, when drug companies wanted to encourage doctors to prescribe their meds off-label, it was done with a wink and a nod. And while it’s perfectly legal for your doctor to write you an Rx for any approved drug for any condition, when pharma sales reps were caught promoting that practice, it resulted in some of the biggest fines ever levied on drugmakers.

Four years ago, for example, GlaxoSmithKline paid out $3 billion in the largest drug fraud settlement ever. The company was accused of promoting its meds for unapproved reasons, such as its antidepressants Paxil (to kids) and Wellbutrin (for weight loss and sexual problems).

But what better way to make something perfectly legal than for the “crime” to simply disappear?! And that’s exactly what’s going on.

Arizona recently passed a law that’s being called the “Free Speech in Medicine Act.” But it could be just as easily be dubbed the “Let Pharma Do Whatever It Wants Act”!

This new legislation will allow sales reps to hound doctors with any shred of information to promote the use of their Rx drugs for any purpose under the sun — even if the FDA hasn’t approved it for that reason.

Things are bad enough right now, with 1 in 5 prescriptions being for off-label uses. But should bills like Arizona’s pass in other states — something that’s expected to happen — things are going to get even worse.

I recently told you about how the Alzheimer’s med Aricept was being given to normal seniors who told their doctors about some troublesome moments of forgetfulness. And that drug can actually “accelerate cognitive decline.”

And studies, including a new one published in JAMA, have found that when a med is given off-label, your chances of having an adverse reaction skyrockets.

Look, I’m no fan of the FDA and how it allows drugs to speed their way onto pharmacy shelves — but this is, in effect, dismantling the entire agency brick by brick.

The watchdog group Public Citizen noted that allowing off-label marketing would “undermine” the entire idea of FDA drug approval.

As I said, you’ve got to be on your toes when you get a prescription. And the most important thing to do is ask your doctor whether any drug he wants you to take is for an off-label use.

If it is, or he doesn’t know, it’s time to do more research before you take pill #1. You can easily find a drug’s “full prescribing” label online — and right up at the top left, it will typically say what that drug was approved for.

Because no matter how bad headaches, hot flashes, or insomnia may be, popping a dangerous med that was developed to treat bipolar disorder or schizophrenia just isn’t worth the risk.

“Pressure mounts to lift FDA restrictions on off-label drugs” Michael Ollove, October 8, 2017, The Washington Post, washingtonpost.com

Before taking any Rx drug, ask THIS