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A “Breakthrough” Drug? Don’t Believe It!

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When you read a news story that touts some new drug or surgical technique as a “breakthrough,” do you really know what that means?

Probably not, research shows.

But don’t feel too bad—there’s a good chance that your doctor doesn’t get it either, finds a disturbing new study.

And it’s largely the government’s fault.

Here’s why: An obscure recent FDA change in the definition of the term “breakthrough” has opened the floodgates for public relations promotions—and gullible news coverage—that is seriously misleading the general public and doctors.

Here’s how to protect yourself from false promises.

A NEW, MISLEADING DEFINITION

Once upon a time, we all knew what a “medical breakthrough” meant. According to the Oxford English Dictionary, a breakthrough is “a sudden, dramatic and important discovery or development.”

But in 2012, the Food and Drug Administration established its own definition as a way to identify drugs that qualified for a fast-track approval process. A drug study could be called a “breakthrough” if it was used against a serious condition and if—by itself or with other drugs—it provided “substantial improvement” over “existing therapies” on “one or more clinically significant endpoints.”

The key word is endpoint. It could be a lab measure or a physical sign that’s associated with improvement.  But it doesn’t mean patients actually got better, which would be a clinical improvement. Nor do “breakthrough” findings need to be based on randomized clinical trials, the gold standard of medical research. They don’t even need to show that they are better than existing drugs for the same purpose!

That’s not exactly what you or I think of when we hear something is a “medical breakthrough.”

But it sure makes for good news stories. Press releases now regularly tout studies about drugs as “breakthroughs,” which news journalists often pick up verbatim and use in headlines.

No wonder everyone is confused.

DOCTORS GET THE WOOL PULLED OVER THEIR EYES, TOO

In the fall of 2015, a study in The Journal of the American Medical Association (JAMA) showed how the new definition was confusing the public. For the study, about 600 participants were given written vignettes about a new cancer drug based on a real study. Some included the word “breakthrough,” and some didn’t. When everyday people read the ones that contained the word—with nothing else changed in the description—they were much more likely to describe the drug as “very effective” or “completely effective.”

Now a 2016 JAMA study finds that doctors—internists and specialists—get duped, too. Nearly 700 answered a questionnaire. The results…

  • 73% incorrectly believed that breakthrough drugs were more effective than other approved drugs.
  • 70% believed breakthrough drugs had a clinically important effect.
  • 52% believed that strong evidence, such as a randomized trial, was required to earn the valuable moniker “breakthrough.”

So, as always, it’s up to the ultimate consumer—you—to protect yourself from misleading information, including news stories. In particular, beware of words such as “breakthrough,” “promising” and even “new,” which sounds great but doesn’t mean it’s better than what came before. For more tips, see Bottom Line’s article “How Drug Ads Trick the Public.”

As for us, we’ll occasionally use the word “breakthrough,” as in this story about cancer, but only when we really think it fits the Oxford standard—sudden, dramatic and important.

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Source: Source: Research letter titled “A Randomized Trial Testing US Food and Drug Administration ‘Breakthrough’ Language” by researchers at Carnegie Mellon University, Pittsburgh, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, published in The Journal of the American Medical Association.   Research letter titled, “Physicians’ knowledge about FDA approval standards for ‘breakthrough therapy’” by researchers at Brigham and Women’s Hospital, Boston, Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth-Hitchcock Medical Center, both in Lebanon, New Hampshire, American Board of Internal Medicine, Philadelphia, published in The Journal of the American Medical Association. Date: April 26, 2016 Publication: Bottom Line Health
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