SHIFT Daily News


Will You be a Guinea Pig for Newly Approved Meds?

Will You be a Guinea Pig for Newly Approved Meds?
April 28
11:00 2017

(HSIOnline) – There hasn’t been this much back-patting going on since baby Jessica was rescued from falling down that well back in 1987!

The big news is that the FDA is off to a “hot start,” approving more drugs so far this year than for the last six. But wait! There could be more — much more.

Reportedly there are 20 additional new drug and biologic applications still in the loop that may hit the pharmacy shelves in 2017. So this could be the FDA’s “best” year yet!

But in reality, no one really knows how safe (or effective) a new drug is until the millions of unpaid guinea pigs (a.k.a. patients like you) start using them.

And then there’s the not-so-little issue of known dangers that Big Pharma somehow manages to turn a blind eye to

The truth of the matter is that when a new drug lands on the market, its actual effects are a bigger mystery than what’s behind one of those doors on Let’s Make a Deal.

The cost of doing business?
The FDA readily admits that the real side effects of new drugs typically only turn up years after millions start using them.
And, of course, you’ve heard about those gigantic settlements Big Pharma has been forced to hand over to patients harmed by adverse reactions to those meds. But they’re just considered the “cost of doing business” by drugmakers.

All of which may make 2017 a banner year when it comes to drugs that result in dangerous and deadly surprises months or years down the road.

So far this year, the FDA has already approved 14 new meds, including ones for constipation due to opioid use, Parkinson’s disease and two skin ailments.

Among the latest is Siliq, approved for treating plaque psoriasis. I told you early this year how it was considered so risky that it was dubbed a “suicide stunner,” after its trial results were released. And how AstraZeneca and its partner Amgen started searching for another drugmaker to take it off their hands.

Now that it’s on the market, it has a black-box warning of suicide “ideation and behavior” and a special risk-education program that requires doctors to be “certified” that they know enough to counsel patients on the dangers of the drug!

Another newbie is the eczema med Dupixent. It was approved with a warning about inflammation of the cornea that can result in serious complications, including blindness.

Will Dupixent put the eyesight of millions in jeopardy? Will the eye and eyelid “redness, swelling and itching” already warned about on the label become chronic in users?

These are some of the things we just don’t know… yet.

And of course, you’ll hear a lot about how we need these fast-track drug approvals so those suffering from rare and deadly diseases will have something to try. And that was certainly the case with Emflaza, also approved this year for kids with the devastating, fatal disease called Duchenne muscular dystrophy.

In February, when Emflaza was given the FDA’s go-ahead, the media offered up news clips showing kids suffering from DMD and their parents who were cheering the agency’s decision.

But here’s the thing about Emflaza: It’s actually an old steroid (deflazacort) that’s been available to patients from outside of the U.S. for around $1,200 a year. And somehow its maker, Marathon Pharmaceuticals, managed to set the price of its “new” med at an obscene $89,000 a year!

Plus that, the drugmaker received a special perk from the FDA called an “Orphan Drug” designation voucher, which gives Marathon seven exclusive years — and billions of dollars more in revenue — to make it.

All this is just the tip of the iceberg when it comes to turning patients into guinea pigs for Big Pharma’s latest experiments. And why you need to do your own research before agreeing to take any new drug.

Find out when was it approved, what the risks are, and what older meds are on the market that can treat your problem. These are all things you need to know before popping pill number one.

“FDA hits the ground running with 12 first-quarter 2017 drug approvals” Eric Sagonowsky, April 18, 2017, FiercePharma,

516 total views, 1 views today

About Author

Shift Daily News

Shift Daily News

Related Articles