That rubber “approved” stamp is clearly getting quite the workout this year — because so far, the busy bees at the FDA have used it to allow 20 new drugs on the market!
One is Ilumya, which is for psoriasis. Another is Aimovig, approved to treat migraines, and then there’s Jynarque, for kidney disease. (Nope, I have no idea how to pronounce these, either!)
And aside from the fact that they’re heavy-duty meds that come with long lists of potential side effects (Ilumya can up your risk of a serious infection, and the Jynarque label warns about “potentially fatal liver injury”), they have something else in common.
These meds — and many, many others — were approved by the FDA on the condition that the drugmaker conduct what are called “post-marketing” studies.
In other words… approve first, ask questions later!
Now, a well-respected group of doctors and scientists has found how this ridiculous idea isn’t working. It looks like once a med is approved, drugmakers pretty much end up thumbing their collective noses at the FDA.
The truth of the matter is that new drugs are a mystery – to the FDA, your doctor, and even the manufacturers.
So, before starting up on any med — new, old, or in-between — you need to ask three important questions. Because taking a drug without knowing the answers can be a disaster waiting to happen.
The case of the disappearing results
Sometimes, I think the entire idea of these post-marketing studies is just a way for the FDA to wash its hands of a risky drug without disappointing drugmakers (who have already paid the agency up to $2 million each to get their products approved).
Take the migraine med Aimovig. Even the notoriously lax FDA is worried about what this drug might do to an unborn child.
Could the drug cause birth defects, spontaneous abortions, or premature labor? These are all things we don’t know.
And since migraines are known to hit women (especially those at an age when they may become pregnant) three times more than men… this would be vitally important information to have!
The FDA has directed Amgen, which makes the med, to conduct a study that involves setting up a “pregnancy exposure registry” — but that’s not scheduled for completion until 2026. No, I’m not kidding.
Chances are, we won’t know any more in eight years than we do right now.
And the reason for that should alarm you.
Researchers from Yale School of Medicine, the VA healthcare system in Connecticut, and the NYU School of Medicine, along with five other prestigious institutions, took a long, hard look at what actually goes on with these post-marketing study promises.
And what they discovered is… it’s not much!
Drugmakers, for the most part, aren’t making the results of their findings publicly available. And even when the results are published, important information that would allow doctors to reach any conclusions about the safety of the drug is often missing.
On top of that, the researchers found that pharma companies are being given “substantial flexibility” by the FDA in how these mystery studies are set up in the first place. And once a post-marketing study is said to be “satisfied,” the whole shebang disappears from the FDA’s public online database as if it never existed.
As more and more meds are being fast-tracked by the FDA — without any proof that they’re safe or effective available until years later — it’s obvious that taking prescription drugs has never been more of a crapshoot.
That’s why you need to do some research on your own and ask three important questions before starting up on one:
#1: When was the drug approved? The newer a med is, the more likely it is that surprise adverse reactions will turn up.
#2: Is the drug being prescribed to you off label? That could mean you’re taking a much bigger risk than called for.
#3: Has the drug actually been proven to be effective for your condition? While that sounds like a given, it’s really not!
The bottom line is that taking any prescription med is a risky proposition – especially if it’s been recently approved. And the more you know about any drug before you take the first dose, the more you can protect yourself.
Of course, taking as few drugs as possible is a surefire way to stay safe!
As we’ve told you, while it may seem that a strong pharmaceutical is the only answer to a debilitating problem such as migraines, there are numerous ways to beat them without resorting to risky meds.
For example, you can try supplementing with CoQ10, vitamins B2 and D, and the mineral magnesium – all of which have been found to significantly reduce the number of migraine attacks in study volunteers. Other methods include transcranial magnetic stimulation devices and acupuncture treatments.
Proven alternative treatments for plenty of other ailments and diseases are also out there, and they don’t involve taking dangerous drugs that may not even do a thing to help you.
“The trouble with those post-marketing studies required by the FDA, Ed Silverman, June 12, 2018, STAT, statnews.com
