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Reuters numbs with numbers on experimental migraine drug

Rating

2 Star

Categories

Amgen's Aimovig halved migraine days in 30 percent of trial patients

Our Review Summary

migraine

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This story about an experimental migraine drug delivered a superficial and imbalanced account of new study results. Leaning heavily on an Amgen news release, the story explains, rather confusingly, that the drug, Aimovig, “reduced episodic migraines by at least half in 30 percent of patients who had failed up to four previous treatments, while 14 percent of placebo patients achieved that goal.”

This result suggests that the drug might be useful for a small number of patients who aren’t helped by other treatments. It also suggests that the majority of such patients won’t benefit from the drug or will only experience a very modest reduction in symptoms. It would have been very helpful to estimate what proportion of migraine sufferers fall into the subpopulation that might stand to benefit.

The story also didn’t provide important information about potential harms of the drug or address limitations of the study, such as its relatively short (3 month) duration. These deficiencies could have been addressed with the inclusion of an independent expert voice; however, the only sources in the story were the trial’s lead researcher and an Amgen executive.

 

Why This Matters

This story about an experimental drug for migraines was focused on investors and meant to deliver a quick update on market-moving news. Yet the story will also show up in the searches of many patients who suffer from migraines and can be misled by such one-sided coverage. One of the main points emphasized in the story is that it’s important to consider treatments for people who haven’t benefited from prior therapy. This is true. But it’s also important to give readers an accurate sense of how many patients overall are likely to benefit from a new drug. To provide this context, news organizations should consider and apply our 10 criteria for news stories. Even a nod in the direction of these issues can vastly improve the message that reaches consumers.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story did not discuss costs except to mention a $4 billion sales estimate. This doesn’t help consumers. According to some estimates, pricing for the drug will start around $8,500/year. That’s not chump change.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story says the drug “reduced episodic migraines by at least half in 30 percent of patients who had failed up to four previous treatments, while 14 percent of placebo patients achieved that goal.”

Although this is a faithful account of what the study authors reported in the abstract, this somewhat tortured description is not helpful for readers, since it doesn’t convey just how few people benefited from the drug. Nor does it explain what a reduction of “at least half” means. The story should have stated how many migraines participants experienced before treatment and how many afterward.

Bottom line: If 30% of participants had a 50% reduction in migraine days, this means that 70% of participants didn’t achieve such benefits. The story should’ve spelled this out more clearly.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story says “no Aimovig patients stopped treatment due to side effects, while around 1 percent of placebo patients discontinued because of side effects.”

Although this is helpful information, it doesn’t give any insight into what side effects did occur or how frequently. Just because patients didn’t discontinue treatment, that’s not an assurance that the drug didn’t cause meaningful adverse effects.

Moreover, the story should have cautioned that there are concerns about the long-term effects of this type of therapy — particularly risk of cardiovascular disease — which can’t be assessed with a 12-week study. MedPageToday shed some light on those concerns in its coverage.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story tells us very little about the quality of the study and does not address any of its limitations. Specifically, are the benefits durable? The study lasted only 12 weeks. It also would have been helpful to note that the study was a double-blind, randomized controlled trial. Lastly, the story should have noted that the findings have not yet been published in a peer-reviewed journal, and should be considered preliminary until they are.

Does the story commit disease-mongering?

Satisfactory

No disease-mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The only sources in the story are the trial’s lead investigator and an Amgen official. Many aspects of this coverage could have been improved with an independent voice.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story alludes to the existence of other preventive therapies for migraines when it tells us that participants did not respond to other treatments. However, it doesn’t say what those treatments are.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story states that the drug is under review by the FDA and that a decision is expected in May.

Does the story establish the true novelty of the approach?

Satisfactory

The story tells us that similar drugs are under development, and that the new medication is meant for people who haven’t benefited from prior treatment.

Another claim to novelty is made when the story says that  Aimovig is the only drug under development “that targets the CGRP receptor pathway, rather than CGRP itself.” It’s unclear what this means or why it’s important.

We’re on the fence with this one but will give the benefit of the doubt. 

Does the story appear to rely solely or largely on a news release?

Satisfactory

While most of the information in the article is taken from this news release, the story is transparent about this. It also includes quotes from a telephone interview with the study’s lead investigator, so we can be certain that at least some original reporting went into the piece.

Total Score: 4 of 10 Satisfactory

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