What does it mean when the FDA designates an experimental approach with “breakthrough status”? You weren’t given an adequate explanation last night when CBS News led its evening newscast with a graphic reading “CANCER BREAKTHROUGH.”
It was a followup to what CBS says is its two-year exploration of a polio-virus-for-glioblastoma trial at Duke. It was featured on 60 Minutes last year, and we offered constructive criticism of that report at the time, noting that some experts called it “a disservice to the cancer community (physicians and patients) to present this in such a superficial and premature way” and “irresponsible journalism.” CBS says it will feature an update on 60 Minutes this coming Sunday.
For 40 seconds – an eternity by network TV standards – the words “CANCER BREAKTHROUGH” at the top of the newscast jumped out at the lay public. But what does it mean – and what might it NOT mean – when the FDA designates a procedure with “breakthrough status”?
An FDA Fact Sheet states:
A breakthrough therapy is a drug:
- intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Simply speaking, the FDA uses that designation to note that something has shown promise – “it may demonstrate substantial improvement.” It is not an announcement to the public that a breakthrough of substantial improvement has been declared.
But CBS called it a “cancer breakthrough” in its graphic behind anchor Scott Pelley during his introduction to the story last night. Veteran science writer Lee J. Siegel wrote to me immediately saying he gets “the willies” when he sees a network TV anchor use the term breakthrough. Me, too. Especially when it’s not explained and when it’s not put in context of how the term is being used.
Some journalists have addressed this head-on – in ways CBS could have but didn’t:
According to the dictionary, the word breakthrough means “a sudden, dramatic and important discovery or development.” However, what many doctors don’t know is that it doesn’t have the same meaning in the FDA drug approval process.
Some 77% of physicians think when the FDA designates a drug as a breakthrough therapy, it means there is “high-quality evidence” that the drug is more effective than current treatments, according to a study recently published in the Journal of the American Medical Association. The reality is that the FDA can give drugs a breakthrough therapy designation simply if early clinical evidence suggests an advantage over current options for serious or deadly diseases.
“When you hear the word breakthrough, it’s understandable to think that it means something definitively or a game changer,” said study co-author Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute. “But it gets confusing because the FDA uses it in a very different way.”
What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows.
The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims.
And since it is lay people to whom the CBS News is targeted – by definition, a “broadcast” audience – I think the network should stop and explain what FDA breakthrough status means before putting up a “CANCER BREAKTHROUGH” graphic for about 40 seconds to lead a newscast.
Sometimes, when TV networks latch onto a story, they tend to treat the finding as their own and ride it as long and as hard as it can. But the Duke trial doesn’t stand alone. FierceBiotech reported today:
Cue 60 Minutes throwing the words “miracle” and “cure” around, declining to add that necessary caveat that this is early-stage research that still requires many more years and many, many more patients before efficacy can truly be found and proved.
It’s also of course not the only group looking to use oncolytic viruses as a form of immunotherapy in cancer research. …
There are also a handful of other smaller biotech… which are also looking to create similar therapies.
But many of these drugs are now also being tested alongside other immunotherapies, such as checkpoint inhibitors, to expand efficacy.
People with glioblastoma can be harmed by breakthrough news that isn’t adequately explained. We profiled one such case a while back in one of our podcasts.
That’s why it matters. That’s why CBS should have put more time into providing context than creating larger, all caps font proclaiming BREAKTHROUGH at the top of last night’s newscast.
Addendum on May 16:
Last evening, CBS 60 Minutes devoted more than half of its hour-long program for a second time to the Duke research trial. It reported on some noteworthy results, including “three patients showed no sign of cancer at all after three years.” As would be expected with more time allocated, there was far more detail than in the Evening News piece we wrote about above. This is important research. It doesn’t need hyperbole, such as “cure” (appeared 5 times in the program) or “miraculous” (appeared twice). And on Twitter last night, CBS stated that the approach had been declared a breakthrough. Again, the FDA did not declare this a breakthrough. It granted this investigational approach “breakthrough status.” Those are two markedly different things. As Matthew Herper of Forbes wrote on Twitter: “I can’t believe @60Minutes is using ‘breakthrough’ for what’s basically a speed-up-the-paperwork thing.”
— 60 Minutes (@60Minutes) May 16, 2016
Addendum on May 17: on a Forbes blog, Arlene Weintraub wrote, “What 60 Minutes Still Isn’t Saying About the ‘Miracle’ Glioblastoma Drug.”