Medication Mayhem: The FDA Gives Another Head-Scratcher Approval

Let’s talk about a decision that’s got the medical world scratching its head. It’s the kind of move that makes you wonder if the folks making the call are really seeing the full picture. The story? A controversial antipsychotic drug called brexpiprazole, also known as Rexulti, just scored a speedy approval from the US Food and Drug Administration (FDA). But here’s the kicker: this drug didn’t quite hit the mark when it comes to delivering real benefits, and it even brought a higher risk of death to the party. So, why did the FDA wave it through?

Investigative journalist Robert Whitaker takes a magnifying glass to this head-scratcher of a situation in a recent piece for The BMJ. And here’s where it gets interesting. This isn’t the first time the FDA’s given the green light to a drug with some pretty iffy credentials. It’s almost like they’ve got a track record of putting the rubber stamp on things that don’t quite measure up.

Now, Rexulti’s makers—Otsuka and Lundbeck—are probably doing a victory dance right about now. This drug comes at a hefty cost of around $1,400 a month, and they’re looking at potentially pocketing an extra billion bucks a year. But here’s the twist: the potential profits are throwing shade on some serious questions about whether the risks outweigh the rewards.

Hold on tight, because this isn’t your typical medication approval. Rexulti comes with a “boxed warning,” which is like the FDA’s way of shouting, “Danger ahead!” It’s the most serious warning they can slap on a drug. And here’s where it gets downright worrisome: the pre-approval trials showed that folks taking brexpiprazole were four times more likely to kick the bucket compared to those on a placebo. That’s a red flag waving in the wind if we’ve ever seen one.

But wait, there’s more—or less, in this case. The drug’s performance on the effectiveness scale? Well, let’s just say it fell flat. On a scale of 1 to 174, Rexulti only managed a paltry 5.3 points better than the placebo. You don’t have to be a math whiz to know that’s not a game-changer. The kicker? Public Citizen health researcher Nina Zeldes says, “This is a drug that can kill patients without providing a meaningful benefit.” Ouch.

Yet somehow, the FDA gave it the thumbs-up. Professor Lon Schneider from the University of Southern California points out that this scenario isn’t new. Other antipsychotic trials in Alzheimer’s patients have shown similar results, yet those drugs didn’t get the go-ahead for treating elderly dementia patients’ behavior.

So, what gives? Critics are saying that the FDA’s bar for approval is getting lower by the day. It’s like they’re saying, “Eh, close enough.” And that’s got experts worried about the future. Will we see more drugs getting the nod without solid proof? Especially for a group as vulnerable as elderly patients with dementia?

The FDA committee gave a cautious green light, but questions linger. Advisors, even those who voted yes, expressed concerns about the drug’s use in patients with milder symptoms. Some highlighted the need for a personalized risk-benefit analysis, done in partnership with the patients’ families. It’s a glimmer of cautious hope in a sea of uncertainty.

Here’s where things take a turn. Interviews with the advisory committee and the FDA aren’t exactly flowing in. It’s like the questions are hitting a wall. And patient advocacy groups, well, they might have cheered for the drug’s approval, but there’s more to the story. Commercial interests might be playing a role in the public support, and that’s a curveball in itself.

So, what’s the bottom line? Approving a drug is a complex dance of weighing pros and cons. But when it comes to people’s lives, it’s not a dance we can take lightly. It’s about ensuring that the steps we take are safe, smart, and backed by solid evidence.

With the dust settling, it’s clear that a more holistic approach might be in order. Natural and non-pharmaceutical options should be on the table, considered before drugs like Rexulti. Because when it comes to healthcare, it’s not just about making decisions—it’s about making the right ones.