This highly readable first-person story by a writer who suffers from migraine headaches describes new antibody treatments that are under FDA review. The story effectively conveys the risks of trying monoclonal antibodies, describes how they work, and explains hurdles to getting them. Especially effective is a description of the litany of treatment approaches the writer has tried over the years, to little avail, and her quest to participate in clinical trials in pursuit of the “tantalizing reward of a migraine-free life.”
The story is also open about costs and potential harms from the therapies. However, the story could have used more discussion of the evidence for these new therapies–what kind of trials have been conducted, and what are their limitations? What did the trials measure, exactly? Also, the optimistic tone of the headline and lead — which describes their “potential to turn migraine treatment on its head” — doesn’t hint at the cautions further down in the story.
There is clearly a big need for effective new treatments for migraine. This story paints a clear picture of the history of past attempts, accidental discoveries, the range of symptoms that migraines present in different people, and the possibilities, costs, and potential long-term side effects of drugs now being tested.
The story says these treatments could cost “anywhere from $8,000 to $18,000 a year.”
The story didn’t provide any sense of the scope of potential benefits seen in the trials so far. The story says only that “one injection appears to be effective for up to three months with almost no noticeable side effects.” Is this to suggest that everyone in the trials is getting relief for up to three months from one injection? It’s not clear.
Initially the story says patients “report limited side effects that consist mostly of pain at the injection site. Unlike the current preventive medications, there is no nausea, no fuzzy thinking, no nerve pain, no weight loss or gain.”
But it also notes a lack of long-term safety data and “potential long-term effects on blood pressure or other cardiovascular function” as well as potential effects on fertility or placental function.
In the end, the reporter reflects on her own migraines and her own choices: “I think about my two young children and my risk tolerance. Perhaps in ten years I’ll feel differently. For now, however, I pick up the phone and cancel my clinical trial appointment.”
We also like this cautionary sentence: “Right now, the longest patients have been on one of these new therapies is one to two years.”
The story doesn’t give much data on the evidence backing these new treatments, except to say that the longest patients have been on them is “one to two years.” What type of trials have been conducted? How many patients were involved, and how severe or frequent were their headaches? How did the treatments stack up against placebos? Those are just some of the questions that would have been useful to explore. (And if the drug companies aren’t making this information public, that should be clear, too.)
No disease mongering here. The story reports federal data that about 10 percent of men and 20 percent of women in the U.S. reported having a migraine in the last three months, and as many as 2 percent of Americans have at least 15 migraine days every month. “The toll such pain can take on health, morale, and productivity is substantial,” it says.
Two physicians who don’t appear to have interests in promoting these treatments are quoted.
The story gives plenty of details:
A number of people prescribed medications for depression, high blood pressure and epilepsy discovered migraine relief, too. Now, many of those drugs, including propranolol and topiramate, have been tested and approved for migraine. But no one drug works for everyone, and side effects can prove intolerable or downright unpleasant.
The writer also describes her own quest for relief:
Since that day more than 17 years ago, I have tried six preventive prescription medications. Not one helped. I alternated among four different, neurologist-recommended supplements, all to no avail. I received bi-monthly injections of magnesium and participated in one of the first clinical trials of Botox. And while Botox seemed to decrease my migraines by one or two per month, it wasn’t enough to bother fighting about it with a new insurance company. I exercised regularly. I experimented with an elimination diet that left me eating nothing but broccoli and white rice, but still the migraines came. I averaged about 15 to 20 each month.
The story makes it clear these injections aren’t available yet:
Two manufacturers, Amgen (in collaboration with Novartis) and Teva Pharmaceuticals, have completed clinical trials and expect to hear from the FDA by June whether the therapies have been approved. Two more companies, Eli Lilly and Alder Biopharmaceuticals, plan to file for FDA approval later this year.
It also cautions that their high cost means insurance companies might “require patients to have tried just about everything else first.”
The lead states “there isn’t a drug on the market today that prevents (migraines) by targeting the underlying cause.”
This story doesn’t rely on a news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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