The Guardian covers a new phase III clinical trial of erenumab, a drug injected monthly, designed to reduce the frequency of painful migraines. The piece does a good job putting the results into context and even compares those findings to the placebo group, giving them a more transparent and helpful context. However, readers would have appreciated being told more of the basics. What are the possible side effects? How much might the drug cost? How is this different from other migraine treatments?
Many news organizations used more sensational “breakthrough” language than The Guardian did in this story. But this was still only half a loaf, inexplicably reporting on one migraine study in the New England Journal of Medicine without even mentioning or linking to another migraine study in the same journal with a somewhat similar antibody agent. Why?
About one in four US homes and perhaps 12% of the US population (much of it female) experiences migraines, according to the Migraine Research Foundation, affecting the lives of hundreds of millions of people each year. There’s no cure-all for the severe headaches, and current treatments and preventative drugs can cause unwanted side effects like tiredness, dizziness, nausea, weakness, heart rate issues, and more. So any alternative that is both effective and safe would be good news.
But, as Dr. Richard Lehman wrote on his terrific BMJ blog, “the real worry is that antibodies beget antibodies, and we don’t know how long these (drugs) will remain effective or what long-term harms they might have.” And The Guardian story didn’t adequately address either concern.
No cost estimates are provided. But cost is a big deal with this drug. According to a November 2016 story by The Verge, erenumab could cost $8,000-$20,000 a year — or about $667-$1,667 per monthly injection. We understand that this story originated in the UK, where perhaps there’s a different journalistic attitude about the importance of citing costs because the UK has a National Health Service, unlike the US. But this story appeared in the US edition of the Guardian, so big deal cost estimates matter.
This story does a decent job summing up the study design and presenting key results from the study, down to the differences between dosage and even placebo groups.
While we give the story a satisfactory score on this criterion, we also suggest that the numbers could have been explained far more clearly. Our heads are still spinning a bit from this paragraph in the story:
The research revealed that by months four to six, at least a 50% reduction in mean migraine days per month was achieved for just over 43% of patients injected under the skin with 70-mg of erenumab each month, while half of patients injected with the higher dose of 140-mg had such results. However, those given a placebo also saw benefits, with 26.6% of participants in this group experiencing such a reduction.
A sidebar infographic would have helped, breaking down precisely how many days, how many people, and on what dose. Yes, the results were quantified, but in a less than optimal way.
The story teases us with the tidbit that erenumab may come with fewer side effects, yet not one of them or their potential frequency is established. The reported adverse event numbers are important: About 63% of the placebo group experienced at least one, compared to 55.5%-57.3% of the drug groups.
Some key numbers from the study are recapped, including how roughly half of patients in the erenumab groups saw an approximately 50% decline in migraine-days-per-month. But the article also compared this result to the placebo group’s result of 26.6%, which suggests perhaps half of the effect might not be attributable to the drug — and added a source’s brief explanation as to why that number may have been so high. (Injections, the source says, tend to trigger strong placebo effects.)
A quote by an outside expert highlights the debilitating pain that many migraine sufferers experience, plus the real-world ramifications of that pain. Statistics are provided to give an estimate of how common migraines are, but we think it’s always best practice to provide a source for such statistics, and none was provided by The Guardian.
Many news stories fail this test, but this one shines: Not only does the article cite an expert who wasn’t involved in the study, but it also discloses that the drugmakers of erenumab — Amgen and Novartis — funded the study, supplied the drug, and did the data analyses. (One thing the story missed, though: The first draft of the study was put together by a company-funded writer.)
The quotes from the principal investigator demand further explanation and context. He calls his study: “an incredibly important step forward for migraine understanding and migraine treatment….“The results…represent a real transition for migraine patients from poorly understood, re-purposed treatments, to a specific migraine-designed therapy.” But readers weren’t told anything about other treatments. Imagine taking one of the commonly-used drugs for migraine and now hearing – perhaps for the first time – that it is a poorly understood drug. The story should have explained what treatments the researcher was talking about, and, in an ideal story, would have compared results from this study with what is known about effectiveness of other treatments.
More puzzling is why The Guardian didn’t mention in this story that another migraine study was reported in the same issue of the New England Journal of Medicine. And Dr. Peter Goadsby, lead investigator of the study that The Guardian reported on, was also involved in the other study as well. So why mention only one? Is it possible that it’s because the King’s College PR news release only mentioned one?
The availability of erenumab was never clear established. Yes, one could deduce that a Phase III trial was just reported, so it probably isn’t on the market yet. But the story never said that. In addition, there can still be a troubled road between completion of a Phase III trial and approval. For a story that trumpeted “incredibly important step forward….start of a real change (in treatment)…first drug in 20 years proven to prevent migraine attacks” and other superlatives, the story could have helped readers see through one trial’s optimism to explain what pitfalls might lie ahead.
The story did describe the novelty of laboratory-made antibodies to prevent migraines. But, as already noted in the “Alternatives” criterion above, The Guardian didn’t even mention in this story that another migraine study was reported in the same issue of the New England Journal of Medicine involving another antibody drug – fremanezumab. So erenumab – the subject of this story – isn’t the only game in town. It’s not even the only game in this class. What were the results from the fremanezumab study? And how are the two agents different? We got nowhere near those questions – much less answers – from The Guardian in this story.
The story quotes the principal investigator, Peter Goadsby, but doesn’t note the source of those quotes: A press release by King’s College London, where Goadsby is a professor. So when The Guardian reports that Goadsby “said” such and such, it implies that he said it directly to someone at The Guardian. But he did not. In fact, we don’t even know if Goadsby “said” those things or wrote them, in a note to the PR people. It’s not a best practice to grab quotes from a PR news release while failing to attribute the source.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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