New FDA ‘adverse event’ database is proving bad news for drugmakers

Online drug side-effect data enough to spook anyone!

You know those cheesy old horror flicks that force travelers to spend the night in a spooky castle? As the rain pours down and the lightning flashes through the windows, the resident mad scientist typically assures them: “Relax, you’re perfectly safe here.”

That’s exactly what came to mind when I heard the reaction to the FDA’s new and improved way for everyday folks to check on reported adverse reactions to drugs.

It’s called FAERS, which stands for FDA Adverse Event Reporting System. And, until recently, it took a degree in “data methodology” to get anything out of it.

Now, however, the FDA has made it easily searchable for everyone.

And the first thing that happened was that stock in the companies that make all those risky biologic drugs took a nosedive!

That’s right, once all those reported side effects were easily available online, shareholders started running for the hills.

So… how did a stock analyst who’s also a biotech specialist respond? “There’s nothing here for people to be worried about,” he assured us.

But unfortunately, there is.

In fact, it’s obvious that anyone who takes an Rx drug is going to be afraid — very afraid — after looking at this new database. And for some very good reasons.

I’ll give you the link to check this out yourself below. But be forewarned– you may never look at one of those cheery drug commercials the same way again!

Figures don’t lie…
If there’s one thing that irks Big Pharma more than anything else, it’s when the “possible” side effects start seeing the light of day and become actual side effects that real-life patients suffer from.

The typical response is the knee-jerk reaction of why these statistics are so unreliable and how any reaction — whether caused by the drug or not — ends up on FAERS.

But here’s the thing: The real shortcomings of this system are that these reports are totally voluntary for everyone except drugmakers. For doctors, nurses, pharmacists, and patients, there is no rule saying that adverse reactions of any kind — including death — need to be reported to the FDA.

And guess what? For the most part, they aren’t.

Experts say that what the FDA receives is typically just a drop in the bucket where reactions to any given drug are concerned.

Despite those data gaps, however, the rollout of this new FAERS dashboard was still enough to give pharma investors the jitters. And when news of its chilling effect on stock came out, even the FDA chimed in, saying that the agency “encourages” patients to talk to their doctor if they have any concerns about a drug — “due to the limitations of voluntarily submitted data.” But really, it’s not just those who have a financial interest in a med selling well who should be concerned.

With around 40,000 people dying every year in the U.S. because of drug side effects, anyone who takes prescription meds should be just as nervous when they look at some of these FAERS results.

For example, just yesterday, I told you about the big push to put more people on those new PCSK9 shots that can tank your cholesterol numbers down to previously uncharted health-effect territory.

And if you enter the one called Repatha into the new FAERS search box, here’s some of what you’ll see:

During the first year this drug was approved, there were 623 reported adverse reactions. So far this year, there have been over 16,000. Out of those, 3,704 were classified as “serious cases, including deaths.”
The reports sent into the FDA include reactions that range from rashes to heart rhythm disorders to kidney infections. Diabetes is listed numerous times.

While Big Pharma will continue to insist that we can’t trust this information to find out about a drug, that’s just not true!

When a med like Repatha shoots up to over 16,000 reports of side effects — including deaths — in such a short time, you can be sure something very bad is happening.

To search the FAERS database for any drugs you may be taking now or considering taking in the future, go to fda.gov and enter “FAERS public dashboard” in the top right search box.

“Biotech stocks drop after FDA makes it easier for public to search for drug side effects” Meg Tirrell, CNBC, September 29, 2017, cnbc.com