CBS proclaims ‘cancer breakthrough’ – doesn’t explain what FDA means by that term

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.”

CBS 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.

Other reading:

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.”

Addendum on May 17:  on a Forbes blog, Arlene Weintraub wrote, “What 60 Minutes Still Isn’t Saying About the ‘Miracle’ Glioblastoma Drug.”

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Comments (16)

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Ruth SoRelle

May 13, 2016 at 9:14 am

In 20 years as a medical writer for a major newspaper and as science editor for a major medical school, I never used the term breakthrough, no matter what FDA jargon said. It is more important to understand what the audience thinks it means and avoid overstating the case. True breakthroughs are best defined in the rear view mirror.

Marc Beishon

May 13, 2016 at 2:58 pm

The FDA is at major fault here. It should not have labelled anything with ‘breakthrough’. There’s enough hype from industry without the regulator joining in.

    Gary Schwitzer

    May 13, 2016 at 9:55 pm

    Marc,

    I agree with you.

    But that doesn’t absolve CBS of the responsibility to get the context right and to clarify for its audience.

Kent Goodwin

May 13, 2016 at 9:44 pm

It occurs to me that the FDA should be influenced to revise its definition of “breakthrough” so that it is consistent with the lay person’s understanding of the term.. This would eliminate this type of confusion at the source.

John Smith

May 14, 2016 at 12:25 pm

I’m not bothered by the terminology used.
Cancer treatment has changed little in decades. Immunotherapy drugs are humanity’s best hope at beating cancer. During the last few years, they have revealed impressive, durable responses in a variety of tumor types for which conventional therapies historically have had limited success (melanoma, leukemia, lymphoma, lung, liver, etc). We’ve reached an inflection point to change the trajectory of cancer treatment. Immunotherapies need to reach a broader audience, so I’m glad 60 Minutes is reporting this story, regardless of how they use the term “Breakthrough”.
I hope every patient watching the episode asks their oncologist about these treatments. Perhaps the patient pressure will turn into political pressure and we can get a MASSIVE injection of funding (beyond projects like Parkers $250 Million Immmunotherapy initiative) for researchers to do the basic science that will lead to more Immunotherapy discoveries.

    Gary Schwitzer

    May 14, 2016 at 12:58 pm

    John,

    You are entitled to your opinion.

    But let me emphasize that the CBS story was about one small trial of a polio virus to treat glioblastoma. To wave off how CBS dealt with that trial because you believe that “immunotherapies need to reach a broader audience” seems to miss the entire mission of our project, which is to improve the public’s ability to evaluate claims about interventions and to help people hone their own critical thinking skills. The fact that CBS called this a cancer breakthrough just because the FDA had granted the approach investigational “breakthrough status” makes the public comprehension challenge just that much more difficult. You may wave off concern for how CBS used terminology, but we will not. And, based on the strong response we’ve received, neither will many of our readers.

    When you write that you “hope that every patient watching the episode asks their oncologist about these treatments,” you ignore that this was one approach being tested for glioblastoma. What would be the impact of “every patient watching the episode” going to ask their oncologist about it? Through the years, we have seen many examples of phone lines and email inboxes being overloaded with calls and questions from people who did not grasp what a network television news story was – and was not – about. And many times it’s not the viewers’ fault but the fault of a lack of accuracy, balance and clarity in the journalism involved. So I strongly challenge your suggestion that even more viewers make oncologic appointments to ask about what they saw in a network television program.

    Gary Schwitzer
    Publisher

      Joel Bender

      May 15, 2016 at 7:29 pm

      I am neither a member of the medical field, nor a patient. I am an American,.and a.consumer of medical products.and procedures, as needed. I have learned one thing above all others….use my own.judgement, and make all medical decisions myself, based on my best assessment of the facts. I have learned all researchers and doctors have a vested interest, medical or personal, in their chosen fields and in their professional decisions. When I read journalists, even medically knowledgeable ones, take other media.outlets to task, I always presume there are reasons. I have learned, over and over, that those reasons are far more telling about the questioners, than the motivation of the original piece in question. I can watch a 60 Minutes piece like this with a sufficiently questioning mind, and draw.my own conclusions. All medical researchers are beholden to their benefactors, no matter how much they profess otherwise. All medical researchers are.prone to see the rosy future of their project. I can factor that in and tire of articles like these which tsk tsk the work of others, and more clearly demonstrate the writer’s inclination to demonstrate how much more aware he is than the average viewer, reader, or medical consumer. Just give me information, and I’ll sort out my emotional responses from the presenters and I’ll take responsibility for doing so. My chances are at least as good as they would be with any doctor’s best guess.

      Gary Schwitzer

      May 15, 2016 at 10:25 pm

      Joel,

      It’s not tsk tsking the work of others – as you state – to correct misleading statements.

      On Friday on the CBS Evening News and again tonight on Twitter, CBS stated that this approach had been “declared a breakthrough.” That is not what is meant by the FDA granting an investigational approach “breakthrough status.” That’s what we wrote on Friday. It’s inaccurate and misleading.

      Our motivation is to improve the public dialogue about health care interventions. Period.

      Gary Schwitzer
      Publisher

    Dan Koborg

    May 19, 2016 at 3:26 pm

    I fully agree with John’s above written rationale, I believe using the breakthrough term is an overall positive. Immunotherapy has shown significant results and the story of this and other current research and trials in progress should be made widely available to the general public, such as through such stories as on 60 Minutes, Criticizing use of the term is a waste of resource, in my opinion.

John Demitri

May 16, 2016 at 6:51 am

Thank you for bringing clear, easy to understand clarity to complex medical issues. As a society I think we are always looking for the dream. The better, faster, prettier way in life. Everything in our lives appears to have been reduced to sales to capture our attention and further someones agenda. As long as there are outlets like yours to bring a deeper explanation, we (society) has a chance. Keep the excellent work up.

Lee J. Siegel

May 16, 2016 at 9:45 am

They did it again last night on the longer “60 Minutes” version of the story, and again didn’t explain what FDA means by breakthrough status. If I heard correctly, the story said 8 of 21 people in the trial have died, and the excitement is over the extension of life. The husband of one lady who died was grateful for the extra time. And I gather the fact the other 13 are alive at this time is what the excitement is about. The results just seem a bit more incremental to me than “breakthrough” implies.

    Jack Neveaux

    May 16, 2016 at 10:49 pm

    I’m the husband of a GBM IV patient who has survived 33 months with standard Stupp Protocol treatment.(Surgery x2, radiation, chemo). The limited field of the Duke polio “vaccine” does nothing to show its absolute advantage over standard treatment. For my wife to watch this 60 Minutes report and be led to believe there is a “cure” waiting out there because of this “Cancer Breakthrough” is not only poor journalism, it is immoral. (It’s a good thing Morley Safer retired. He wouldn’t have signed off on such poor journalistic work.)

Stephen Cox, MD

May 16, 2016 at 11:41 am

This was an excellent critique of a very important “development” in cancer research and treatment. One can research the survival of glioblastoma patients and it is clear that prognosis is universally dismal with current therapies. The costs need to be addressed but are more important when it becomes available. Joel Bender’s comments fail to appreciate the significant misinformation consumers/patients are exposed to and unfortunately believe, especially from numerous alternative sources, whose credibility is based on non science, faith, magic, placebo and smooth salesmanship. Not everyone is as discerning as he thinks he is. It helps to have a professional, experienced scientist/physician/reporter explain health related details honestly and factually.

    Jack Neveaux

    May 17, 2016 at 5:08 pm

    The doctor is right. Unfortunately, the 60 Minutes report begs the question: was this “a professional, experienced scientist/physician/reporter explain[ing] health related details honestly and factually”, or hyperbole for the sake of entertainment or ratings?

Mark Hochhauser

May 17, 2016 at 5:26 am

Don’t forget that May is a ratings sweeps month. I suspect that “Breakthrough = more viewers = higher ratings for 60 Minutes.

Dave Putlak

June 6, 2016 at 7:32 am

I watched the 60 Minutes report on-demand a second time last night, and I don’t think a disservice was done here. The report spelled out clearly that the polio treatments were done AFTER traditional chemo/radiation methods proved either non or minimally effective. As someone with a relative that was just recently diagnosed with gioblastoma, it is good to hear that researchers are trying techniques and treatments beyond what’s being used with apparently little benefit today. I don’t view polio vaccine treatment as a cure-all (to me, it was not portrayed in this light), but as a step in the journey toward new, more effective approaches in the future.