It’s time for the FDA to re-evaluate its decision to authorise Q-Collar, say James Smoliga and Mu Yang
A wearable “brain protection” device known as the Q-Collar, which sells for $199 (£149; €170), is increasingly used in contact sports in the US. Pitching the product as “the only equipment proven to help protect the brain,” its manufacturer, Q30, boasts more than 46 000 units sold and more than a dozen professional athlete “ambassadors.” In 2022 the US based Premier Lacrosse League teamed up with the company in promoting Q-Collar use among its players, after an “in-depth review of the studies behind the Q-Collar.”
Worn around the neck, the semi-rigid, C-shaped silicone collar applies pressure to the jugular vein, increasing blood volume in the brain. Spurred on by a bold claim from the device’s inventor—the internist David Smith—that “woodpecker” physiology is the key to avoiding brain injury, the Q-Collar’s deceptively simple mechanism and sophisticated marketing campaign have fuelled headlines such as, “How woodpeckers will save football.”1 Favourable articles about the device—cleared by the US Food and Drug Administration (FDA)—have appeared in Bloomberg Businessweek,2MIT Technology Review, and Sports Illustrated, as well as the ESPN website. Woodpecker references even appeared in the 2015 Hollywood movie Concussion, starring Will Smith. Q30’s chief medical adviser, the neurosurgeon Julian Bailes, was portrayed by Alec Baldwin and was a consultant for the movie.
Behind the headlines, however, the Q-Collar is beset by scientific problems that we have been cataloguing for years (video 1). A careful review of the device’s history shows that “the science” behind the Q-Collar is unsound. Q30’s claims keep evolving: as one big assertion is debunked and shown to be unsupported by studies, a new claim arises, only to be debunked again. We are now in a situation where a device that restricts blood flow and is worn around the neck, that has not been shown to provide any clinical benefit, is being sold to vulnerable populations—including children as young as 13. It’s time for the FDA to review its decision.
Video 1 The BMJ Investigates
“Bubble wrap for the brain”
Smith, the Q-Collar’s inventor, claims that by studying woodpeckers3 he discovered that jugular vein compression was the mechanism that protected their brains while pecking.4 This supposedly fills the cranium with around a teaspoon more blood to create a “tighter fit” of the brain inside the skull, preventing it from “sloshing” around during physical impact.2
Smith began working with Greg Myer, a sports medicine researcher at Cincinnati Children’s Hospital, to test his idea that the device would reduce the risk of concussion. Myer likened the collar’s effect to “bubble wrap” for the brain,5 saying that Smith had “figured out how to prevent concussions.”6 This narrative wooed journalists and sports figures, paving the way for a promotional media campaign. Myer published a 2014 op-ed in the New York Times on this woodpecker inspired “tighter fit” approach to concussion prevention and promoted the “bubble wrap” claim to the National Football League.7
Smith’s claims attracted investors. Q30 received $4m in venture capital funds by October 2015 and secured a $7m licensing deal. The company provided more than $3m in research funding to Myer at Cincinnati Children’s Hospital from 2015 to 2018 that has resulted in numerous publications, and Q30 has spent at least $900 000 lobbying Congress since 2018. Myer’s industry funded research was then used to support Q30’s application for FDA authorisation.
But the woodpecker based hypothesis—the Q-Collar’s central origins story—has yet to be substantiated.89 Smith’s 2012 rodent model papers merely speculated that woodpeckers used jugular compression,1011 but they have subsequently been cited as evidence for this claim. And in more than a decade since he made his woodpecker discovery, Smith never studied woodpeckers directly.
In a response to The BMJ, Smith said that “since woodpeckers are endangered, they couldn’t be studied.” (In fact, most woodpecker species are not endangered.) He added, “I never touched an animal, nor human subject, nor did I ever touch the data.”
In 2018 one author of this investigation (JMS) showed that Smith’s jugular compression claims were inconsistent with decades of meticulous research on woodpeckers’ multiple protective mechanisms.9 The next year Smith admitted in an interview that he never was able to get his hands on a woodpecker.12 The Q-Collar’s promotional claims then shifted away from bird brain origins of the device, and original promotional videos featuring the woodpecker disappeared from the internet. Yet interest in the Q-Collar grew.
In a statement emailed to The BMJ, Q30 said that Smith “was inspired by thinking about woodpeckers,” but it declared that “Q30 does not claim that the Q-Collar mimics the physiology of the woodpecker, did not use the woodpecker for its product development and does not use a woodpecker in its marketing.”
Concussion prevention claims quietly dropped
There can be little doubt that the Q-Collar’s promoters hoped to reduce concussions. In 2017 a few National Football League players adopted the device, leading to headlines such as, “Luke Kuechly is wearing a woodpecker collar to prevent concussions.”
And there’s ample evidence that the investigators sought to assess whether the Q-Collar conferred a concussion benefit. In 2014 one Q30 sponsored trial specified “concussion incidence” as the study’s primary endpoint.13 Other trials included “concussion prevention” in their study titles.
But real world experience of the device has proved problematic. News reports state that Kuechly, a linebacker, sustained a concussion within weeks of wearing it, and Vernon Davis, another early adopter in the National Football League (NFL), got two concussions. Both athletes, however, now advise the company, and media stories tout how the device has helped protect them.
After these high profile concussions Q30’s marketing de-emphasised concussions, and the narrative switched to a more nebulous concept: “brain protection.” By 2019 most Q30 press releases didn’t even mention the word “concussion.”
Also that year, Myer retrospectively changed the primary endpoint of Q30’s 2014 study from “concussion incidence” to magnetic resonance imaging (MRI) based metrics.13 This was years after a paper from that same trial had been published, which didn’t report on concussions and presented MRI based metrics as the trial’s primary endpoint.14 Data on concussion risk (from a different, larger study) weren’t reported until late 2021—months after the FDA authorisation—and found no significant difference.15
In an email to The BMJ Myer acknowledged that study endpoints had changed over time, “in light of emerging evidence—an essential principle of the scientific method.” But Myer didn’t address why his publication of the 2014 study failed to disclose that the original primary endpoint had been switched.
Q30 told The BMJ that it had a limited role in the research. “Q30 does not have its own lab or perform its own research,” it advised. “Although Q30 provided significant funding (but not all) for the laboratory and clinical trials, Q30 did not control the research, develop the protocols, enrol the participants, observe the studies, collect or analyse the data, or write the study reports. All of those tasks were performed by well trained scientists at leading research institutions.”
“Didn’t notice the effects aligning with the claims”—one professional athlete’s story
By the time he left the American professional football Kansas City Chiefs for a second career in pro bobsledding, Johnny Townsend had already experienced numerous high level concussions—once in high school, twice in college, and more during his five seasons in the National Football League (NFL).
“As somebody that’s been in contact sports for as long as I have,” said Townsend, concussions had pernicious effects—not just those on a player’s personal health, emotional wellbeing, and cognitive function but also ripple effects on “families and the people around them.”
Always “looking for ways to reduce that impact” and gain an edge in his game, Townsend was curious to try the Q-Collar. “When Q-Collar came about, it was, ‘Wow, now here’s an actual device that can help prevent concussions beyond just changing my process’ . . . so instead of adapting the way you play, you can continue to play but still have the same preventative measures.
“I really just wanted to try it out. Seeing all the science that was behind it, reinforcing their claims on how it can support athletes—I wanted to try it.”
Experimenting over the next three months while going at 90 miles an hour down the ice, Townsend put the Q-Collar to the test—sometimes on, sometimes off, and comparing the two. But the US bobsledding team Olympic hopeful found himself disappointed in the product. He told The BMJ that he didn’t feel much of a difference when wearing a Q-Collar and “didn’t notice the effects aligning with the claims.”
He then spoke with colleagues. “I’ve talked to a lot of NFL guys as well that wear [the Q-Collar], because part of my evaluation of whether or not I would continue using it was the feedback of peers that I trust and guys that have played contact sports also for a long time—but at more dangerous positions like running back, linebacker, offensive line,” he said. “Getting their feedback was important. And the majority that I got from them was pretty similar to my experience: ‘Didn’t really notice any positive or negative effect from wearing it.’”
FDA said yes, despite inconclusive evidence
The FDA’s February 2021 authorisation of the Q-Collar was a huge boost to company growth. A careful reading of regulatory documents, however, reveals that FDA scientists were well aware that the evidence base hadn’t demonstrated clinical effectiveness—but they approved it anyway. Announcing the authorisation, the FDA issued an upbeat press release, calling the Q-Collar “an additional piece of protective equipment athletes can wear when playing sports to help protect their brains.”
But lower down the press release, the language weakened. Regarding the diffusion tensor imaging (DTI) and functional MRI (fMRI) data—the endpoints evaluated in Q30’s studies—the FDA wrote that these only “appear to indicate protection of the brain.”16 Even lower down, in a single sentence without elaboration, the FDA addressed the most important finding of all: “Data do not demonstrate that the device can prevent concussion or serious head injury.” The identical single line appears in the fine print of the Q-Collar’s 10 page user guide—the only place we could find that Q30 ever stated this among all its promotional literature.
Unsurprisingly, disclaimers did little to stem the marketing machine: in the month after FDA authorisation Q30 landed an additional deal worth over $15m according to the financial analytics company PitchBook.17
But just how clearly the FDA is aware of the deficiencies in the Q-Collar data becomes apparent in reading the agency’s own scientific review memorandums—many of which we obtained after a freedom of information request—documenting the FDA’s evaluation of Q30’s submitted data. These revealed that the FDA’s statistical reviewer had recommended against authorisation, finding that key studies “failed to meet the specified endpoints,” calling the study design “flawed,” and noting that alterations to the analyses had occurred “without IRB [Institutional Review Board] or FDA approval.” Instead of spelling the end of Q30’s bid for FDA authorisation, however, the agency agreed to relegate these serious issues to statements in the fine print of the product’s labelling.
In a written response the FDA told The BMJ, “The clinical study data reviewed by the FDA supported the safety and effectiveness of this device as an aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts. The data do not demonstrate that the device can prevent concussion or serious brain injury.”
Q30 told The BMJ that “all of Q30’s marketing is consistent with the FDA’s decision and findings and is fully compliant with applicable laws and regulations.”
“Brain protection”
The claims of “brain protection” now authorised by the FDA are largely based on data from three animal studies, three pilot studies in humans, and one major clinical trial that focused on MRI techniques to examine changes within athletes wearing Q-Collars and those without.
These studies have numerous ambiguities, inconsistencies, and biases.18 The peer reviewer of the pivotal football study,19 whose report was posted online by the Journal of Neuroscience Research,20 stated that authors were internally inconsistent and selective in their biomarker interpretations, with clear bias towards claiming a “protective” effect. The reviewer emphasised that no clinical implications could be drawn from the data and later publicly expressed concern that the paper’s finding would be taken out of context for marketing purposes.
In a 2022 New York Times investigative story, multiple independent experts interviewed (including one of us) disagreed with Q30’s and the FDA’s interpretation of the biomarkers.21 In response, Myer provided an unusually reserved interpretation of his Q-Collar data: “hard to explain exactly what the results mean but certainly a target for future research”—a stark contrast to his peer reviewed publications that have regularly suggested a “protective” effect.
Red flags, recycled data, and possible research misconduct
We began our current investigation of the Q-Collar because of concerns that young athletes were trusting their long term brain health to a device rooted in unreliable claims. If Q-Collar stakeholders would create and promote a false “scientific” narrative about woodpeckers to gain investment and market their product, why should we believe that their research was trustworthy?
In March 2024 we teamed up to examine Q30’s literature forensically. One of us (MY) noticed that in one study of 48 female soccer players,22 one table had some odd coincidences of repeated numbers: how could the medians all be exactly the same for both collar and non-collar groups, at both pre-test and post-test time points? After staring at those suspicious numbers, we moved on to examine a different study of 18 SWAT team members23 and were surprised to find the exact same numbers. These were two different papers, reportedly with two different samples, yet the results summary table values were identical. This seemed unlikely to be a copy-and-paste error because there were subtle differences in the table headers, participant descriptions, and sample sizes (fig 1).
Fig 1
Two different studies report the same exact values for working memory tests. While all 96 values are identical, subtle differences exist in the row and column headers. Note that the column headers in the top table (soccer study)22 reflect “pre-season” and “post-season,” whereas the bottom table (SWAT study)23 has “pre-training” and “post-training.” Row titles include different participant numbers, reflective of each respective study. Other subtle differences exist, such as the top table (soccer study) including the A’ abbreviation for Accuracy and capitalising the T in time, whereas the bottom table (SWAT study) does not.
As we screened and cross referenced each of Q30’s papers we found that data anomalies were rampant across studies. There were multiple instances of values reported in tables not matching that reported in the text, divergent data from what should have been identical values, numbers not adding up as they should, mathematically impossible values, and various internal inconsistencies. Regardless of whether this was a series of sloppy mistakes or worse, it became clear that the results reported in Q30’s studies could not be trusted. Many of the papers we flagged were cited in the company’s FDA application.
For convenience we initially focused on six papers with serious issues, all published in the Journal of Neurotrauma. Five of these came from Myer’s research group. We reported these to the journal on 15 May 2024 and received a reply that evening, indicating that it would begin a serious investigation. On 31 July 2024 the journal informed us that its investigative team had “attempted to reach out to the original authors without success.”
On 20 August the journal informed us that Myer was willing to provide the raw data for the investigation and would reanalyse the data in question. We countered that raw data reanalysis couldn’t explain many of these issues, such as factual discrepancies between tables within a paper.24 Myer then published three corrigendum statements in December 2024, each attributing a different form of “error” at the root of the data anomalies. The duplicate table was blamed on the “wrong version” being provided to the journal—yet the “corrected” version still contained a mathematically impossible value. We were invited to submit a letter to the editor, which we did with additional coauthors in March 2025. Our letters remain unpublished.
The journal told The BMJ in August that it would publish our letters, as well as responses from the authors, once its investigation into data anomalies was completed. In the meantime, it has published an expression of concern for six articles.25
Myer told The BMJ that many of these concerns were “due to misunderstanding . . . and thus did not warrant further actions with the journal.” He acknowledged “a few cases where minor reporting errors were identified” but added that “none of the raised issues altered the conclusions of the studies—no previously unreported benefits of the collar were introduced, nor were statistically significant findings changed. We remain committed to the highest standards of academic integrity and transparency, and we will continue to correct any genuine errors in our published work.”
Q30 stakeholders can argue that the wealth of data anomalies doesn’t undermine the reported findings that the Q-Collar had a protective effect. However, given the diversity of issues spread across multiple papers, it would be naive to think that only a subset of the data was compromised but that the remainder were of the highest scientific standards.
When is enough, enough?
By the time the FDA granted the Q-Collar authorisation as a class II (“moderate risk”) medical device in February 2021,16 seven years of largely uncritical media hype had already paved the way for marketing success—and a powerful placebo effect.26
The product’s woodpecker origin story has been debunked. The primary claims for the Q-Collar’s effectiveness have shifted from concussion prevention to vague promises of “brain protection” rooted in non-validated surrogate outcomes. And the supporting data are riddled with “mistakes” and anomalies. At what point do these stop looking like mere isolated errors?
The average consumer sees an FDA authorised device, apparently scientifically validated and backed by 25 peer reviewed studies. They won’t read the papers, much less parse the nuances of imaging biomarkers or statistical inconsistencies. But, if journal editors and peer reviewers missed red flags indicating compromised data, how can we expect the average parent, or professional athlete, to detect them? The “science” will remain convincing to many. So, who is left to inform the public that one of the most highly marketed protectors against concussion and other forms of brain injury in contact sports may, in fact, be rooted in nothing of any scientific validity?
Maybe the FDA missed these research integrity failures when Q30’s application first came through. But now it’s time for the agency to commit to a serious, independent re-evaluation. In the face of mounting inconsistencies and shifting claims, the real question is no longer whether there’s a problem—it’s whether anyone with power is finally willing to admit it and take action.
Footnotes
Competing interests: JMS and MY declare no competing interests.This feature has been supported by the BMJ Investigations Unit. For details see bmj.com/investigationsProvenance and peer review: Not commissioned; externally peer reviewed.
References
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