Sue Rochman is an independent health care journalist and editor based in San Francisco. This is her first post for HealthNewsReview.org
Do you have migraine attacks? Use a $12 over-the-counter ear plug-type device called MigraineX, a recent news release insisted, and you’ll experience an 81% improvement in weather-related migraine headaches.
Some news organizations took the PR bait. Fox 4 Kansas City included the product in a news segment on natural, affordable migraine remedies, parroting the news release’s claim that the product is “clinically proven” to help reduce weather-related migraine pain and symptoms.
Likewise, an Atlanta Journal-Constitution article described MigraineX as a “new approach” for treating migraines triggered by changes in barometric pressure. The piece was syndicated and ran in several other newspapers.
MigraineX, made by Cirrus Healthcare Products, is marketed along with a free app that alerts users to barometric changes that are said to be a possible migraine trigger. The app, which made it into a Wall Street Journal health story in October 2016, tells users when it is time to proactively insert the ear device.
MigraineX shares positive news coverage on its Facebook page.
More examples of positive news stories are shared on the MigraineX Facebook page.
As someone who gets migraine attacks, I’m well aware of how difficult they are to treat. MigraineX was being touted as “clinically proven,” and the product packaging states it’s “clinically tested.” It’s not the first time I’ve seen phrases like these thrown around in a news release or in drug store aisles. But do they mean anything?
To find out, I requested any published studies the product’s media contact could provide. I was sent an unpublished clinical study paid for by Cirrus and conducted by Princeton Consumer Research, the “industry experts in claims substantiation studies.”
The study surveyed about 40 users’ perceptions of improvement when using the product. However, no actual clinical data was recorded about migraine frequency or intensity. There was no control group to detect the placebo effect. Also, the volunteers were told to use MigraineX along with their regular migraine medication, making it impossible to know if it actually helped or by how much.
Product Image (PRNewsFoto/Cirrus Healthcare Products)
In other words, MigraineX was hardly “clinically proven” to work. And none of the news stories we saw pointed out any of these caveats out to readers.
After looking at the study, Adam Cifu, MD, didn’t mince words. Via email, he described it as “utterly worthless.” Cifu is a professor of medicine at the University of Chicago and a HealthNewsReview.org contributor.
“To truly prove this treatment was effective, patients would need to be randomized to an effective device or a sham (control group) device. They would need to be treated over multiple headaches on multiple days and the results would need to show that the effective device outperformed the sham one only on the high barometric pressure days,” he said. “The study in question comes nowhere close to meeting this standard.”
Linda Sherry, director of national priorities for the Consumer Action, a consumer advocacy group, says the public should know that claims like clinically proven “are suspect, to say the least.” And if there are no “published studies in well-respected medical journals,” she adds, any claim that is made “means nothing.”
The FDA regulates medical devices and products that claim to or are intended to be used to diagnose, prevent or mitigate a disease or condition. However, the FDA’s regulation of medical devices is far less stringent than for drugs. Stephanie Caccomo, an FDA press officer, says her agency can’t comment specifically on MigraineX and how it is marketed. She can say that as of Dec. 13, 2017, MigraineX was “not cleared or approved” by the FDA.
The Federal Trade Commission (FTC), the government agency that protects consumers from deceptive business practices, couldn’t answer questions about MigraineX. Mary Engle, the associate director for advertising practices at the FTC, did say that “generally, if a company claims a product is clinically proven to show a benefit, then it must be tested in a reliable way by experts in the field.” However, the FTC doesn’t need to pre-approve a company’s claims. They only open an investigation if potentially misleading claims come to their attention after the product is on the market.
When the FTC conducts an investigation, says Engle, it looks at the quality of the studies the company provides. Typically, she says, these studies “have to be randomized controlled clinical trials” that include a sufficient number of subjects and were properly analyzed.
Some might wonder what’s the big deal about a product that sells for $11.99 and has no side effects? According to the Migraine Research Foundation, 38 million men, women, and children in the U.S. alone get migraine attacks. Most would do anything to prevent or stop the pain they experience, and for many something that costs $12 might be worth a try, especially when they hear that it’s “clinically proven” in a news story.
It’s misleading promotion, Cifu noted.
“Of all the absurd claims of effectiveness I have seen in my career, this might take the cake,” he said. “Their ‘clinical study’ supporting the device’s use is utterly worthless.”
Comments (1)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Kevin Patton
January 10, 2018 at 7:45 pmYou night like the reply from MigraineX.
https://m.facebook.com/story.php?story_fbid=882208991952490&id=645017382338320
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like