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3 Questions on... When Research Is Groundbreaking, Revolutionary, & Game-changing—and When It's Not

DiGiulio, Sarah

doi: 10.1097/01.COT.0000476203.50896.20
Opinion
VINAY PRASAD, MD, MPH

VINAY PRASAD, MD, MPH

What makes a drug a game changer? What about revolutionary? Groundbreaking? A miracle?

“Every year I go to scientific meetings and conferences and you're sort of used to hearing that something is the next big thing—hearing things called ‘game changers,’ ‘revolutionary,’ ‘miracles,’” Vinay Prasad, MD, MPH, Assistant Professor of Medicine in the Division of Hematology and Medical Oncology at Oregon Health and Science University, said in a phone interview.

So he (along with medical student Michael Abola) systematically investigated how frequently the aforementioned superlatives and a few others are being used, and in what contexts (JAMA Oncology doi:10.1001/jamaoncol.2015.3931). They searched 10 superlative terms used in conjunction with “cancer drug” using Google's news search for a five-day period in June 2015, and found that 94 news articles from 66 outlets used the searched superlatives 97 times, referencing 36 specific drugs.

Among the concerning findings were that half of the drugs described with the superlative terms had not yet been approved by the U.S. Food and Drug Administration; and 14 percent of the drugs described with such words had not been tested in humans—the articles being about mouse, cell culture, or preclinical work, Prasad said.

“It would be like doing a news story about a guy who has won the lottery, but it turns out he didn't win the lottery, he just bought a lottery ticket.”

Having a vested interest in what words oncologists deem inappropriate, we asked Prasad the following questions about his research and the implications.

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1. Is there an appropriate use for these words in oncology? Medical research?

“I think that one of the most powerful words is ‘game changer.’ And for me I think there has only been one drug in the last 25 years that has been a game changer: Gleevec. Before Gleevec, patients were thinking of their life in terms of the next three four five years. Then Gleevec comes along and patients can think about life in terms of the next 20 years, 25 years—a normal life expectancy. And for me that is a game changer. The majority of people that take the drug can re-conceptualize their lives. So I would say it has to be something that would benefit the majority [to use one of these superlatives].

“Some of the drugs coming along may be very good and super valuable and very important, but I might think that they might not be up to that level of ‘game changer.’ It's okay to call them exciting drugs, highly promising drugs, or drugs that work very well in a subset of patients.

“But a lot of the drugs we have in cancer, even the drugs that have been really good in the last couple of years don't work in the majority of patients. And I think that's important to acknowledge. The majority of patients that take even the best drugs that we have right now will not respond.”

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2. What are the harms of overusing these words?

“I don't even need to speculate. Another recent JAMA Internal Medicine paper describes an experiment in which people were given a vignette about a drug being developed—and for half the people they described it as a ‘breakthrough drug’ and for the other half they didn't use the term ‘breakthrough’ [2015;175:1856-1858]. The people had a much more favorable impression of the same facts if the drug was labeled ‘breakthrough.’

“We certainly want to be optimistic as oncologists, but we want a realistic optimism. We don't want to make grandiose claims that are not supported by data. In my experience, I have patients that walk into the office with something they've read on the Internet and show us and say—‘Look it's a miracle drug. What do you think, doctor?’

“It sets false expectations and fuels this narrative that the newest thing has to be the best thing. Sometimes that's true, but we certainly don't want to say that about things that have never even been tested in humans.

“Oncology is a unique place where this happens because the sad truth is that for the majority of the more common solid tumors, our gains have been modest and incremental. That kind of language—i.e., the superlatives—really stands in contrast to the reality of actual progress in cancer care in the U.S. in the last 10 years.”

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3. Who's to blame for the overuse of these words?

“It's no one party. It really is the continuum of people who are involved in drug development; the journalists who may be using some of this language in part because it drives readership; academics who do trials may be using it because it may help them compete for grant funding; and the industry, small biotech companies may be using it to help get bought out by a bigger company.

“At every step of this process, there's an incentive for somebody to speak a little bit more grandiose about something.

“The goal of our research is not to be some sort of language police. Our goal is to try to engage the patients and the public in more meaningful conversations about what progress is coming and set realistic expectations.”

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More 3Qs Online!

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Read more answers straight from the experts on the latest news and provocative topics in Sarah DiGiulio's award-winning blog: bit.ly/OT-3Questions

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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