The first time I remember hearing about the Breakthrough Therapy designation was during the height of the AIDS epidemic.
The Breakthrough Therapy designation was created by the US Food and Drug Administration (FDA), which fast-tracks the approval of drugs intended to treat serious life-threatening conditions. This allows patients faster access to therapies.
And throughout the late 80s and early 90s, anti-viral drugs were fast-tracked in order to save the lives of millions of people. It was a big win for Big Pharma, and they continue to reap large rewards for the development of these life-saving drugs.
Unfortunately, these fast-tracked drugs don’t always work out so well. In fact, it’s the exception, not the rule. And new research shows why so many new “breakthrough” drugs end up causing problems.
And sadly, Pharma had been using this designation as a loophole to approve new drugs that aren’t necessarily intended for immediate, life-saving treatments. And that’s a big problem — especially when it comes to the safety of so many Americans suffering from illness and disease.
Greater risk than benefit
The FDA’s swift approval processes has brought drugs to market based on trials that don’t actually measure clinical outcomes. And a new study suggests that the FDA’s expedited review programs actually cause more harm than good.
The new study, published in the Journal of the American Medical Association (JAMA), reviewed all FDA approvals that were given Breakthrough Therapy designation from 2012 to 2017.
The authors of this study, led by Joseph S. Ross, MD, looked at the pivotal trials (clinical trials that serve as the basis of approval, drug development, and review).
They identified 46 drugs that had received Breakthrough Therapy designation based on 89 pivotal trials. Of these, 54.3 percent were for cancer, and 17.4 percent were for infectious disease treatment.
Many of these drugs had only been subjected to one clinical trial before being approved. That’s insane!
Historically, the FDA requires at least two clinical trials with “clinically meaningful endpoints.” Basically, this ensures that the outcomes aren’t purely coincidental. In essence, the researchers should be able to replicate the results over and over again — which is key to proper clinical research.
However, this new study shows that pivotal trials used as a basis for these Breakthrough Therapy designation approvals frequently lacked randomization, double-blinding, and control groups… which are all reliable and standard research methods. All that on top of the fact that over half of the approvals were based on the results of only one trial.
Without solid research and data, the fact is, doctors really have no idea what they’re prescribing. And patients have no idea what potential risks they’re facing. It’s pretty scary stuff…
On the rare occasions when I do prescribe drugs, I always opt for ones that’ve been around for a long time. (My rule of thumb is that they should be on the market for at least seven years). Not only have older drugs gone through more clinical trials, but they’ve also stood the test of time in terms of patient safety.
So if your doctor prescribes any new drug—even one claiming to be a “breakthrough”— ask if you can try an older one first.
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