Kathlyn Stone is an associate editor at HealthNewsReview.org. She tweets at @KatKStone.
In November 2015, on a popular discussion forum for patients, a new post popped up that was critical of Opdivo, a new immunotherapy drug. Under the topic headline “Opdivo…beware the hype and commercials,” and using the screen name “sleapdeac,” the writer said:
“I will preface this discussion by stating that I am a physician, not an oncologist, but a hospital based physician who deals with critically ill patients on a daily basis. We just had a funeral Friday for my father in law, a man I dearly loved and respected. He died 5 days short of his 76th birthday….
“I really think it was the side effects of the Opdivo that killed him. I also believe that although Opdivo may help some, I think there are others that it may harm. The drug is very new and I still feel there is a lot to learn. I think a lot of the oncologists are not aware of some of the serious side effects.”
“I write this not to trash the drug, but rather to see if any others have had a similar experiences?”
The thread took off–it still garners comments today, three years later. The 500+ responses reflect many different, passionate opinions that underscore the fact that there remains a lot we don’t know about one of the fastest-adopted cancer treatments to have burst on the scene in just a few short years. We’ve written about these unknowns previously and offered tips to journalists on things to consider when writing about immunotherapy.
During recent scientific meetings devoted to cancer research, the public was told, via news releases and news reports, that immunotherapy combined with chemotherapy is practice-changing for lung and other hard-to-treat cancers. And as a recent Yale University study suggests, new cancer treatments are reaching patients rapidly, often within a few short months of FDA approval.
But information about the potential harms of immunotherapy often lags behind, perhaps because that information is not systematically collected in the clinical trials used to support approval of these drugs. In fact, it was only in February 2018, years after these drugs had been in widespread use, that major cancer organizations issued guidelines for managing their sometimes-devastating immune system side effects.
Through multi-million dollar campaigns that feature exciting direct-to-consumer TV ads and spawn news stories, patients are becoming broadly aware of immunotherapy and bringing it up with their doctors. But one thing they’re often not told is just how limited the population is which stands to benefit from this approach.
Andrae Vandross, MD, an oncologist and clinical instructor at UCLA, and a frequent HealthNewsReview.org contributor, wrote in an email that “This is a big deal. Most patients (or friend/family of a patient) that I see in consultation or begin treating as a new patient will ask about Opdivo and its kin, or immunotherapy more broadly at some point.
“In principle, I’m not against direct-to-consumer advertising (mostly because I don’t think they are going away) in that I know that I just will need to spend a little more time providing context. It’s sad when folks have hopes up for a treatment that ‘my friend or uncle got and is doing great’ but is not indicated for their cancer sub type.
“I walk through the cancer type and indication in the ad and discuss how their diagnosis is different. I also discuss other cancer types that actually have some evidence of benefit (melanoma, non small cell, renal cell cancer, etc). Most people seem to understand. Although I feel bad when I perceive that some think I’m just not telling them about the drug.”
As oncologists and researchers Nathan Gay and Vinay Prasad wrote in a STAT opinion piece last year,
“When immunotherapy works, the result is terrific, even life-changing. Today, though, only a tiny minority of patients expected to die from cancer will benefit from immunotherapy. As is often the case, hype sadly exceeds evidence, creating misunderstandings between patients and their doctors.”
When I suggested that, based on available research, it appears that, immunotherapies have around a 30% success rate for some cancer sub types, Vandross agreed. “Around 30% response rate or so seems about right. I do talk about response rates with these and other drugs as well” when speaking to patients, Vandross said. He explained that he strives to use straight forward language about whether a drug is shown to help people live longer or whether it mitigates symptoms.
Even when you’re one of the 30% that immunotherapy helps, there can be complications.
Sharon Long, 58, a retired nurse living in New Haven, Indiana, got on board with Opdivo as part of a phase 3 clinical trial in 2015. She’d been diagnosed with stage 4 non-small cell lung cancer on Valentine’s Day 2014.
“I started on the standard chemo of Carbo [carboplatin] and Alimta,” she explains. “I had about 30% shrinkage after the third treatment so I was placed on Alimta maintenance. Before the third treatment of Alimta only we knew it was failing and failing horribly with four new tumors added to my already high tumor burden. I was horrified, scared and had only been under treatment for 6 months and was being told the best treatment available had not worked.”
In September 2014 Long’s doctor told her she should be enrolled in the Opdivo clinical trial. Long said after starting the trial she was “one of the lucky ones” since she responded quickly and went three years on the drug without any side effects. But then in September 2017 she developed colitis (an inflammation of the lining of the colon) and her treatment was put on hold while she was prescribed steroids for the colitis. Attempts to get back on Opdivo resulted in a return of colitis both times. As a result, she’s eight months in to a 1-year break from immunotherapy. No other treatment is planned unless her cancer shows signs of progression. She said she is still following the clinical trial protocols which call for imaging tests every eight weeks.
HealthNewsReview.org contributors Michael Wilkes and Harold DeMonaco have previously written about some of the problems with Opdivo’s advertising here and here. They point out that while consumer drug ads are permitted under the condition that they educate readers and viewers, the Opdivo ads overstate the benefits and neglect to inform the public about research where the drug isn’t shown to work. Michael Joyce’s piece on consumer drug ads hits on the same theme. We’ve also noted in our systematic reviews that news releases and news coverage about immunotherapies sometimes help propagate hype about these drugs.
Some — but far from all — of the comments in the thread mentioned at the beginning of this post also were critical of the ads, for different reasons. A sampling:
“….I do however think the [Opdivo] commercial makes people think there is a new wonderful drug that can extend your life so it gives false hope for many, but if you want to live you try it, risk and all and pray you’re one of the lucky ones. LC [lung cancer] patients don’t need to be frightened about trying a new drug, they just need to be enlightened to make their own decision. I wish everyone on it the best of luck.” – Lynkidd
“It seems to me that many chemo drugs and radiation have a small but real risk of interstitial lung disease and death. This includes many chemo and targeted agents. It also seems CRAZY to me that Opdivo has been so very advertised on TV and in magazines. It’s so inappropriate for so many reasons. it makes people think this is the ANSWER to lung cancer. Clearly it’s not. But just as clearly it is another new and exciting form of therapy. Everyone needs to know that it is as risky as all the other therapies are.” – pastelprairie (the poster self-identified as a doctor with stage 4 non-small cell lung cancer)
Long said that she doesn’t oppose drug advertisements; in fact, she feels quite the contrary. “Caretakers and patients need information of available treatments so they can ask their doctors about them. Knowledge can be life saving and people need that knowledge to be the best advocate for themselves or for a loved one.”
She does take exception to the side effects summarized in the ads “because nobody will remember half of them and I feel this is something that should be discussed in the doctors office where questions can be answered.”
It should be a sobering reminder for the gatekeepers – especially journalists, advertisers, and PR folks – that millions of patients and their families are seeking treatment and putting their hopes on the line based on direct-to-consumer ads and other messaging on cancer treatments.