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STAT’s look at migraine drugs in development skimmed over key research details

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2 Star

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The drug industry might finally have an answer for migraines

Our Review Summary

Asian caucasian woman with flu and feaver lying in bedMigraine headaches are a problem for millions of individuals, and current treatments are sometimes insufficient, leaving people to cope as best they can with this often debilitating condition. This story is an overview about how four drug companies are working to develop injectable drugs whose antibodies would bind to a protein that plays a role in the dilation of blood vessels in the brain, the purported cause of headaches.

The story’s headline—’The drug industry might finally have an answer for migraines’—is accurate, given its emphasis on conditional tense. But the drugs are still in development, and the story lacked important details on the trial data to indicate what potential these drugs may have. It tells us, for example, that migraine-days were cut in half. But half of what? Also, given the extensive sourcing of drug company representatives, we would have liked to have seen more specifics on the quality of the clinical trial evidence, the anticipated costs of these drugs, and side effects.

 

Why This Matters

These new drugs—if they pan out—may offer substantial relief to some patients. But this kind of early alert will likely send patients to their doctors way before medication is available, especially since it didn’t discuss downsides like predicted costs and specific side effects.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Cost or an expected cost range for these drugs in development is not mentioned in the story, although one drug company source notes that the “hypercompetition” among the four companies may well influence price.

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

Not Satisfactory

There is an attempt to quantify the benefits, but it wasn’t sufficient to earn a Satisfactory rating:

“In mid-stage clinical trials, each of the four treatments has eased symptoms for about half of study participants, cutting the number of days they’re afflicted by migraines roughly in half.”

The story needs to report enough data so we know the number of subjects in the trial(s), the number of migraine-days they had (in this case) at baseline, and the number of migraine days they had on treatment. The question is: “Half of what?”

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

Not Satisfactory

None of the companies has reported “serious side effects,” according to the story, which does go on to note that the studies so far have been short-term, 12-week trials and that an understanding of the impact of the drugs “will take years.”

However, we find this lacking. Even if there weren’t “serious” side effects, readers still want to know what the potential downsides are, and surely there were noted side effects that would have to be weighed against the benefits.

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

Not Satisfactory

We learn a bit about the trials, principally that they are “mid-stage,” involve some 1,500 patients and that participants were selected because they have serious migraine problems: at least four headaches per month. But important details—such as whether the trials were blinded and used placebo groups or another active medication—is not available.

Does the story commit disease-mongering?

Not Satisfactory

This was a close call, but we did feel the quote “It’s like you’re possessed” and similar strong statements crossed a line. Yes, migraines can be debilitating, but there are many effective treatments for most migraine sufferers. This story made it sound like the tortures of the damned and that none of the standard treatments helps. Although that is true for some people, it is unlikely to be true for a majority of migraine sufferers. Some attempt to acknowledge that there are effective treatments for many people would have helped balance this out.

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

Satisfactory

The story makes clear that four large drug companies are working to develop drugs, leading to an easy inference that the companies are funding the research. Among the story’s sources, those working for the companies are so identified and others are characterized as unaffiliated with the companies. Nothing in the story broaches possible conflicts of interest.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story includes the following discussion of alternatives:

“Existing therapies are plagued by inconsistent efficacy and troublesome side effects, and patients are often left to rely on a repurposed treatment for epilepsy. That medication, Topamax, has been dubbed “Sleepomax” by doctors and patients because it’s also a heavy sedative.”

Yet, there are many other treatments for migraine. Most people can learn triggers (changes in caffeine consumption, wine, etc); there are oral medications that can abort a migraine as it is started; and other classes of drugs (beta blockers and calcium channel blockers) can help prevent migraines in people who have them more than once per week. Only Topamax is mentioned, and is disparaged in the same sentence as being “plagued” with downsides.

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

Satisfactory

Yes, and the news is not good: The drugs are moving through the clinical trial process and have not yet received FDA approval. The story speculates that “the first therapy could hit the market in 2018,” a prediction that presumes no glitches will slow the process.

Does the story establish the true novelty of the approach?

Satisfactory

The story notes that “targeting CGRP is not a particularly new idea,” and cites an earlier drug that caused liver toxicity. It was also easy to identify publications about this new drug target in PubMed, going back to 2007.

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

Satisfactory

The inclusion of four drug companies in this story suggests that the reporter engaged in substantial enterprise reporting. That feeling is bolstered by the use of two testimonials from migraine sufferers.

Total Score: 4 of 10 Satisfactory

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