The story reports on three drugs recently approved by the FDA to prevent headaches in people who get frequent migraine headaches. The drugs, known as calcitonin gene-related peptide (CGRP) inhibitors, are erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality).
The story did some things well–for example, it included the prices of the drugs and mentioned the lack of long-term safety data. However, the story didn’t disclose that one of the physicians quoted in the story has accepted hundreds of thousands of dollars from companies that make these and other migraine drugs. We also wanted to know more about the design and veracity of the clinical trials behind these drugs.
Migraines can be disabling. Better treatments that reliably ward them off could dramatically increase the quality of life for millions. But given their high costs and short track records, these new drugs need to be written about cautiously by journalists. Financial interests of sources should be made clear.
The story reported the drugs all cost about $600 a month and insurance is expected to offset the cost, “but patients will be eligible only if they have tried other drugs first and found they didn’t help.”
This was a tough call. The story reported that the drugs “appeared to be equally effective. About half the patients had a 50 percent or greater reduction in the number of headaches they experienced. Almost three-quarters had at least a 30 percent reduction.”
That’s not really enough information to assess the benefits (what was the frequency of headaches per month?), but the story follows that up with:
It also reported that chronic migraine patients “had about two fewer headache days a month than those who took placebos. The placebo group had a small reduction in headaches, too. In the treatment groups, the intensity of the headaches also went down.”
While this is more informative, it still doesn’t give readers a sense of the scope–how many migraine days were people experiencing before taking the drug, and then after? What about the placebo group?
For example, in a trial for Emgality, patients who averaged 19.4 migraine days per month saw their migraine days reduced by 4.8 or 4.6 days per month depending on their dosage, versus a reduction of 2.7 days for those who took a placebo.
This gives a more specific sense of the benefits than what the story included. It’s especially interesting to see how the drug compared to the placebo.
The story addressed the major concern with these medications: that it “remains to be seen how patients who take them for long periods will fare. As new drugs, their long-term impact is not yet known.”
The story story also reported the new drugs have “a lower side-effect profile” than other medications commonly used for migraine, and mild constipation was the most serious side effect of the drugs in the trials.
The story could have mentioned other adverse events. For example, with Emgality, hypersensitivity reactions such as rashes were reported in clinical studies.
We think readers deserved to know at least a few details about the quality of the data. The story didn’t give any.
For example, how many patients were these drugs tested on, and how typical were they of people with chronic migraines in term so age and health status? Were any of the drugs tested by independent researchers, or were all of the trails sponsored by the drugs manufacturers? And how did the drugs perform on the primary endpoints that their clinical trials had actually been designed to measure?
Although Dr. Silberstein suggests that these new drugs are equally as effective as existing preventive drugs, there are no comparative studies to confirm the statement. Studies to date have only compared the new drugs to placebo.
The story didn’t engage in disease-mongering. It said migraines affect 40 million people in the U.S., and one to 2% of the population falls into the category of chronic migraines patients, defined 15 migraines per month for at least three months.
The story used one source who appears to be independent, Katherine Hamilton, MD, of Penn State.
However, it didn’t disclose that another source, Stephen Silberstein, MD, has substantial conflicts of interest. He personally received more than $620,000 from companies that make those and other migraine drugs from 2013 to 2017, according to CMS’s Open Payments database. Most of the payments were for consulting, but he also pocketed money for such things as travel, food and beverages, and speaking fees.
The story did mention that Silberstein was involved in testing one of the drugs — erenumab — and helped design and run the trial for another — fremanezumab. But that didn’t fully inform readers.
The story didn’t offer meaningful comparisons of these drugs with existing alternatives.
The lead somewhat dismissively stated that people with migraines have had to “make do with drugs originally developed for other medical conditions, such as high blood pressure or depression.”
The story reported that all three drugs have been approved for sale by the FDA and a fourth — which isn’t named — is in development.
As the story suggested, these new drugs are the first on the market that are designed to block CGRP in migraine patients.
The story did not appear to rely on a news release.