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An important paper, “Reporting harms more transparently in trials of cancer drugs,” was published in The BMJ last week. Some excerpts follow, but also additional thoughts about how journalism and public relations (which sometimes are indistinguishable) make the matter worse.
The paper’s lead author is Bishal Gyawali, MD, PhD an oncologist from Nepal currently working as a Research Fellow at Harvard and Brigham & Women’s Medical Center in Boston.
The research examined how cancer drug harms were described in clinical trial results published in five major medical journals in 2016. They looked at 122 such trials in journals, and found that 53 of them – 43% – used terms that downplayed harms.
The paper points to vague descriptions of harms regarding three cancer drugs: “Acceptable adverse-event profile….a manageable and mostly reversible safety profile….the tolerability was good overall.” With subjective terms like these, it’s anyone’s guess what “acceptable” levels of nausea or “manageable fatigue” means.
Additionally, Gyawali and his team found these vague descriptors at odds with what they saw in the actual data, where side effects were more common than what the phrases above implied.
The following excerpt is a good summary of what the researchers saw in their broader analysis (parenthetical notes are ours):
Acceptable—Acceptable to whom? Were the patients asked if the toxicities were “acceptable” to them? (Toxicity is defined as the extent to which something is poisonous or harmful.)
Manageable—Serious events and deaths can never be considered manageable. Even manageable toxicities incur burden and decrease patients’ quality of life. (In other words, even side effects perceived as manageable by researchers can add up to a miserable day–or week, or month, or year–for a cancer patient.)
Feasible—What is the threshold for feasibility of a treatment? Will the mention of “the treatment is feasible” be enough to obtain patient’s consent to a treatment? (In other words, what does it mean when researchers report that it is possible or reasonable to do the treatment?)
Favourable toxicity profile—Favourable compared with what? The threshold of enduring toxicities and thus favourability is different from patient to patient.
Tolerable or well tolerated—Only the patient can decide whether any side effect is tolerable
Safe—Any cancer treatment that has resulted in a treatment related death cannot be considered safe
And here is an excerpt of the paper’s key messages, as laid out by the journal:
Vague and subjective terms can lessen the perception of harm and influence decisions about treatment
All cancer trials should fully report adverse events and avoid subjective terms
Gyawali emailed me some background on why he pursued this topic.
“I felt it was some sort of deception. To the family of a patient who died due to treatment toxicities, I imagined what would they feel if they read this report that said ‘toxicities were acceptable’ or ‘treatment was safe.’ Further, I felt it was inappropriate for us clinicians to label a toxicity our patients experience as acceptable. My view is that only patients who experience those side effects can say whether it was acceptable or not. This downplaying of toxicities is very harmful because it makes us clinicians believe that a drug is safer than it actually is.”
He felt so strongly about what he found that he posted a Tweetorial to further explain the research he and his colleagues had done.
Now think about what happens when journalists or marketing people try to translate these kinds of clinical trial results that are described in these ways in medical journals. The vague, subjective terminology serves to minimize the sense of potential harms, while the discussion of potential benefits is often emphasized and exaggerated.
This is another example of the polluted stream of health care information that we’ve been discussing so often on this site, and another example of patient harm from misleading media when you include journal articles under the umbrella of media, as we do. Journals are daily and weekly purveyors of news, courting and thriving on the attention.
Whether a news story or a PR news release adequately explained and quantified the potential harms of an intervention is one of our 10 review criteria. In our explanation of why that harms criterion matters, we state:
Many stories emphasize or exaggerate potential benefits while minimizing or completely ignoring potential harms. They may:
• Fail to mention potential harms.
• Fail to quantify potential harms.
• Fail to describe the severity of potential harms.
• Fail to account for “minor” side effects that could have a significant impact on a patient’s life.
• Rely too heavily on a patient anecdote about safety.
• Rely too heavily on a researcher’s comment that an approach “appears to be safe” – without supporting data.
Step back and look at how many of the journal articles on cancer drug trials soft-pedaled harms. In Gyawali’s paper, 43% of cancer drug trial reports contained one or more of the vague euphemistic terms for drug safety mentioned above. In our data, when journalists report on stories with claims about new interventions, 63% of more than 2,600 news stories we’ve reviewed over the past 12 years were graded unsatisfactory on this criterion. That is a terrible reflection on that huge sample of daily news. Public relations news releases are even worse: 78% of the nearly 600 PR news releases we’ve reviewed were graded unsatisfactory on the harms criterion. This helps you to see the combined amplified effect of the polluted stream of health care research news as it reaches an uninformed public.
We see it not only in media messages about cancer drugs, but in stories about all sorts of health care interventions. Some examples:
Gyawali agrees that journalists become complicit in spreading the misinformation on harms.
Media usually pick up the abstracts/conclusions (from the journal article) to make generalized statements or headlines such as “a new cancer drug is found to be effective in XXX cancer and is totally safe.” No cancer drug is safe, it’s always a trade-off. This understanding is crucial because most cancer drugs provide only modest benefits, very few are truly game-changers. Thus, statements such as “toxicities were manageable” gets propagated to media from scientific papers and then to patients who will have false beliefs of exaggerated benefits and diminished harms.
Readers of these trial reports–physicians, patients, media people–will all trust these generalized statements on toxicities that paint the new drug as having better risk-benefit profile than what actually exists. This will ultimately harm the patients.
I think it’s the responsibility of media to dig deeper and report the true incidence of toxicities rather than copy these generalized phrases.