1/
The #Qcollar jugular compression device is "FDA CLEARED" to "protect athletes' brains during head impacts." @US_FDA
Does this mean that it is safe, effective, and based on sound science?
Not quite! Before you believe the company's big claims, read this full thread!
The #Qcollar jugular compression device is "FDA CLEARED" to "protect athletes' brains during head impacts." @US_FDA
Does this mean that it is safe, effective, and based on sound science?
Not quite! Before you believe the company's big claims, read this full thread!
Below is an index to my fully-referenced thread:
2/ A bit about what FDA cleared really means
3/ Critique of the study that got Qcollar FDA cleared
4/ Summary of problems w/ their other studies
5/ Qcollar's continued pattern of false claims
6/ Their plan to profit from taxpayers
2/ A bit about what FDA cleared really means
3/ Critique of the study that got Qcollar FDA cleared
4/ Summary of problems w/ their other studies
5/ Qcollar's continued pattern of false claims
6/ Their plan to profit from taxpayers
2a/
Some semantics, note this isn't "FDA APPROVED" but rather "AUTHORIZED".
QCollar isn't claiming "approval," but many confuse these terms and assume this more stringent standard.
APPROVAL is more appropriate for Class III devices, which undergo more rigorous review.
Some semantics, note this isn't "FDA APPROVED" but rather "AUTHORIZED".
QCollar isn't claiming "approval," but many confuse these terms and assume this more stringent standard.
APPROVAL is more appropriate for Class III devices, which undergo more rigorous review.
2b/
Qcollar was granted market approval through "de novo request." It's like a registration to market the device.
This means it's a new device classification for FDA, not comparable to other devices. NOT saying it's as safe/effective as another device (eg, helmets).
Qcollar was granted market approval through "de novo request." It's like a registration to market the device.
This means it's a new device classification for FDA, not comparable to other devices. NOT saying it's as safe/effective as another device (eg, helmets).
2c/
Level of evidence required for FDA clearance is dependent on the device's risk classification.
QCollar is a Class II device, which means it is lower risk (not as stringent of a review process for Class III devices, which have greater risk).
fda.gov/medical-device…
Level of evidence required for FDA clearance is dependent on the device's risk classification.
QCollar is a Class II device, which means it is lower risk (not as stringent of a review process for Class III devices, which have greater risk).
fda.gov/medical-device…
2d/
Many examples of other FDA cleared Class II devices which are NOT necessarily safe and effective.
Recent example from @statnews about concern that vaginal laser devices (Class II) cause harm and don't work, yet still marketed. @kristinrojasmd
statnews.com/2022/02/22/the…
Many examples of other FDA cleared Class II devices which are NOT necessarily safe and effective.
Recent example from @statnews about concern that vaginal laser devices (Class II) cause harm and don't work, yet still marketed. @kristinrojasmd
statnews.com/2022/02/22/the…
3a/
Let's focus on the "PIVOTAL STUDIES" that got QCollar FDA Cleared.
According to the announcement, a football study w/ 284 athletes was key.
Let's look at that study in greater detail. Will talk about others in Part 4.
Link to FDA Announcement:
fda.gov/news-events/pr…
Let's focus on the "PIVOTAL STUDIES" that got QCollar FDA Cleared.
According to the announcement, a football study w/ 284 athletes was key.
Let's look at that study in greater detail. Will talk about others in Part 4.
Link to FDA Announcement:
fda.gov/news-events/pr…
3b/
"Football Pivotal Trial" published in 2021 in Journal of Neuroscience Research.
There's only ONE peer reviewer! Not commenting on his ability, but he's listed as MD/PhD student at time of review.
Grad student is the ONLY reviewer in key study for FDA decision? Not typical!
"Football Pivotal Trial" published in 2021 in Journal of Neuroscience Research.
There's only ONE peer reviewer! Not commenting on his ability, but he's listed as MD/PhD student at time of review.
Grad student is the ONLY reviewer in key study for FDA decision? Not typical!
3c/
Plenty of issues w/ this trial, which are similar to all of the other Qcollar studies (eg inconsistency in brain regions reported).
Check out AWESOME thread by @TenanATC about the tiny effect & crazy number of multiple comparisons not accounted for!
Plenty of issues w/ this trial, which are similar to all of the other Qcollar studies (eg inconsistency in brain regions reported).
Check out AWESOME thread by @TenanATC about the tiny effect & crazy number of multiple comparisons not accounted for!
https://twitter.com/TenanATC/status/1367492955049754632
3d/
The trial protocol was registered, but details aren't clear. For example, only generic description of brain MRI given, rather than specific regions.
Registered protocol mentions a control group of distance runners, but they are never mentioned in the paper. Why not?
The trial protocol was registered, but details aren't clear. For example, only generic description of brain MRI given, rather than specific regions.
Registered protocol mentions a control group of distance runners, but they are never mentioned in the paper. Why not?
3e/
Many of other issues in the study, esp. inconsistencies w/ other Qcollar studies, incl. a soccer study that seemed to come out of the same protocol. Similar issues as discussed in Part 4/
Nice summary tweet by @griz1 - I'm not the only skeptic!
Many of other issues in the study, esp. inconsistencies w/ other Qcollar studies, incl. a soccer study that seemed to come out of the same protocol. Similar issues as discussed in Part 4/
Nice summary tweet by @griz1 - I'm not the only skeptic!
https://twitter.com/griz1/status/1425426776973533184
3f/
Research on Qcollar is funded by the parent company, Q30 Innovations. That disclosed, but important! They paid >$3 MILLION for the data.
The research papers often say "cautious interpretation" is necessary, but such "caution" is not reflected in marketing materials.
Research on Qcollar is funded by the parent company, Q30 Innovations. That disclosed, but important! They paid >$3 MILLION for the data.
The research papers often say "cautious interpretation" is necessary, but such "caution" is not reflected in marketing materials.
4a/
Since 2017, I've published a number of peer-review papers discussing why the Qcollar is highly flawed.
Why? Bc, I don't want athletes to get duped into buying something that sounds scientific, but doesn't work, and for them to find that out once its too late (eg #CTE).
Since 2017, I've published a number of peer-review papers discussing why the Qcollar is highly flawed.
Why? Bc, I don't want athletes to get duped into buying something that sounds scientific, but doesn't work, and for them to find that out once its too late (eg #CTE).
4b/
I've covered those papers in previous threads. Let's focus on the clinical data - the special MRI technique called DTI.
Read the thread linked below. It covers this COMPLEX topic in great detail.
(Note, I wrongly used the term FDA "approved")
I've covered those papers in previous threads. Let's focus on the clinical data - the special MRI technique called DTI.
Read the thread linked below. It covers this COMPLEX topic in great detail.
(Note, I wrongly used the term FDA "approved")
https://twitter.com/jsmoliga/status/1366468126452428800
4c/
For those not familiar with DTI, it sounds convincing. Those who wore Qcollar didn't experience damage, those who didn't wear it got damage.
As explained in thread from 4b, it's not so simple!
Check out my @JAMANeuro paper on it!
jamanetwork.com/journals/jaman…
For those not familiar with DTI, it sounds convincing. Those who wore Qcollar didn't experience damage, those who didn't wear it got damage.
As explained in thread from 4b, it's not so simple!
Check out my @JAMANeuro paper on it!
jamanetwork.com/journals/jaman…
4d/
The average consumer doesn't understand how to interpret. So, when Qcollar says "it protects the brain" people think the evidence is straightforward. It's not.
Here's a simpler explanation of why their data are wide open for interpretation. @ACSHorg
acsh.org/news/2020/10/1…
The average consumer doesn't understand how to interpret. So, when Qcollar says "it protects the brain" people think the evidence is straightforward. It's not.
Here's a simpler explanation of why their data are wide open for interpretation. @ACSHorg
acsh.org/news/2020/10/1…
4e/
Prior to showing that the DTI data isn't solid evidence of "brain protection," I focused on the ORIGINAL claims that Qcollar made - that their product would REDUCE THE RISK OF CONCUSSION.
This was clearly the goal - See thread below:
Prior to showing that the DTI data isn't solid evidence of "brain protection," I focused on the ORIGINAL claims that Qcollar made - that their product would REDUCE THE RISK OF CONCUSSION.
This was clearly the goal - See thread below:
https://twitter.com/jsmoliga/status/1170367883278524417
4f/
A key point in 4e/ linked thread is their original ClinicalTrials.gov protocol from 2014 was determining the risk of concussion.
They later engaged in the shady practice of "outcome switching" and changed the study's primary aim w/o justifying it.
A key point in 4e/ linked thread is their original ClinicalTrials.gov protocol from 2014 was determining the risk of concussion.
They later engaged in the shady practice of "outcome switching" and changed the study's primary aim w/o justifying it.
4g/
Fast-forward to 2021 and their own studies have now confirmed what we stated years ago (Yuan 2021).
Wearing a jugular compression collar DOES NOT reduce concussion risk!
Took them 7 years to finally admit what they originally planned to do did not work!
Fast-forward to 2021 and their own studies have now confirmed what we stated years ago (Yuan 2021).
Wearing a jugular compression collar DOES NOT reduce concussion risk!
Took them 7 years to finally admit what they originally planned to do did not work!
4h/
Do a google search for articles about the "woodpecker inspired" Q-collar back in 2015-2017. It's all about concussion prevention!
But, they changed their message later - I think they have known it didn't work as planned for years.
As stated in 2019:
Do a google search for articles about the "woodpecker inspired" Q-collar back in 2015-2017. It's all about concussion prevention!
But, they changed their message later - I think they have known it didn't work as planned for years.
As stated in 2019:
https://twitter.com/jsmoliga/status/1170367883278524417
5a/
Now, it's time to talk blatantly false claims.
To see a continued pattern of misinformation, we need to go back to original story based on:
1. Q-collar mimics the natural physiology of WOODPECKERS,
2 It should reduce CONCUSSION (distinct, single high-impact events) risk
Now, it's time to talk blatantly false claims.
To see a continued pattern of misinformation, we need to go back to original story based on:
1. Q-collar mimics the natural physiology of WOODPECKERS,
2 It should reduce CONCUSSION (distinct, single high-impact events) risk
5b/
Qcollar patent holder, Dr. David Smith claims he studied woodpeckers and other animals. This is commonly reported in news stories and interviews.
He avoids specifically stating that he got his hands on actual birds, but its implied.
Example:
web.archive.org/web/2017122108…
Qcollar patent holder, Dr. David Smith claims he studied woodpeckers and other animals. This is commonly reported in news stories and interviews.
He avoids specifically stating that he got his hands on actual birds, but its implied.
Example:
web.archive.org/web/2017122108…
5c/
In a 2014 @nytimes editorial titled "Can animals help limit concussions?" the lead Qcollar research makes it sound like they have actually directly observed woodpeckers (i.e., "we have observed").
Here, they also specifically address "concussions"
In a 2014 @nytimes editorial titled "Can animals help limit concussions?" the lead Qcollar research makes it sound like they have actually directly observed woodpeckers (i.e., "we have observed").
Here, they also specifically address "concussions"
https://twitter.com/jsmoliga/status/1167195520697360384
5d/
I debunked these woodpecker claims in the peer-review literature. @BJSM_BMJ
Nobody else has ever claimed woodpeckers have this jugular compression mechanism, except for those behind the Qcollar (telling a cool, but made up story to investors).
bjsm.bmj.com/content/53/20/…
I debunked these woodpecker claims in the peer-review literature. @BJSM_BMJ
Nobody else has ever claimed woodpeckers have this jugular compression mechanism, except for those behind the Qcollar (telling a cool, but made up story to investors).
bjsm.bmj.com/content/53/20/…
5e/
After I debunked this claim in the peer-review literature and social media, they knew they got caught making up "facts" about woodpeckers that weren't true.
So, the story had to change - check out this Feb 2020 video, beginning at 6:35 or so.
After I debunked this claim in the peer-review literature and social media, they knew they got caught making up "facts" about woodpeckers that weren't true.
So, the story had to change - check out this Feb 2020 video, beginning at 6:35 or so.
5f/
He states that in the USA, "woodpeckers are an endangered species," and that is why they couldn't actually study them hand-on.
That's an easy one to objectively fact check. It's simply not true! (See next)
Creating new false claims to cover up previous false claims!
He states that in the USA, "woodpeckers are an endangered species," and that is why they couldn't actually study them hand-on.
That's an easy one to objectively fact check. It's simply not true! (See next)
Creating new false claims to cover up previous false claims!
5g/
First off, "woodpecker" is not one species, there are many.
If you search the @USFWS Environmental Conservation Online System, you can find many different species of woodpeckers.
ecos.fws.gov/ecp/
MOST are classified as "Not Listed" (i.e., Not Endangered).
Example
First off, "woodpecker" is not one species, there are many.
If you search the @USFWS Environmental Conservation Online System, you can find many different species of woodpeckers.
ecos.fws.gov/ecp/
MOST are classified as "Not Listed" (i.e., Not Endangered).
Example
5h/
The other organization that decides if something is an "endangered species" is @IUCN. @IUCNRedList
Here's the URL:
iucnredlist.org/search?query=w…
And MOST (not all) species are "Least Concern" (LC) - which basically means "not endangered."
The other organization that decides if something is an "endangered species" is @IUCN. @IUCNRedList
Here's the URL:
iucnredlist.org/search?query=w…
And MOST (not all) species are "Least Concern" (LC) - which basically means "not endangered."
5i/
They studied woodpeckers...
until they didn't really... b/c they are endangered (even though they really aren't).
Many of their videos referencing woodpeckers have been removed. Delete the evidence of false claims!
How can we trust ppl behind Qcollar and their "science"?
They studied woodpeckers...
until they didn't really... b/c they are endangered (even though they really aren't).
Many of their videos referencing woodpeckers have been removed. Delete the evidence of false claims!
How can we trust ppl behind Qcollar and their "science"?
5j/
Why does this woodpecker claim matter at this point?
Because it represents how they were willing to use false information to market a product.
If they're willing to invent a story about woodpeckers to sell product, what's stopping false claims about "brain protection"?
Why does this woodpecker claim matter at this point?
Because it represents how they were willing to use false information to market a product.
If they're willing to invent a story about woodpeckers to sell product, what's stopping false claims about "brain protection"?
6a/
Since Qcollar doesn't protect against preventing concussion in sports, it also should not work for military applications (head impacts and blast injuries).
The goal has been to sell this non-sense technology to the DOD (at taxpayer expense!)
Ex: usammda.army.mil/assets/docs/pu…
Since Qcollar doesn't protect against preventing concussion in sports, it also should not work for military applications (head impacts and blast injuries).
The goal has been to sell this non-sense technology to the DOD (at taxpayer expense!)
Ex: usammda.army.mil/assets/docs/pu…
6b/
It's hard to know details about what this was for, but public information demonstrates those behind Qcollar have spent at least >$400,000 lobbying Congress regarding "Defense policy and acquisition matters."
projects.propublica.org/represent/lobb…
It's hard to know details about what this was for, but public information demonstrates those behind Qcollar have spent at least >$400,000 lobbying Congress regarding "Defense policy and acquisition matters."
projects.propublica.org/represent/lobb…
6c/
But wait, there's more!
Jugular compression "technology" now also claims to provide HEARING PROTECTION, IMRPOVE SHOOTING ACCURACY, and ENHANCE DRIVING FOCUS.
Is there anything this amazing piece of plastic can't do to help our military? 🤪
But wait, there's more!
Jugular compression "technology" now also claims to provide HEARING PROTECTION, IMRPOVE SHOOTING ACCURACY, and ENHANCE DRIVING FOCUS.
Is there anything this amazing piece of plastic can't do to help our military? 🤪
6d/
The driving claims is interesting. Besides using this for athletes and military, they are trying to make this standard safety equipment.
You drive a car? Wear a Qcollar! That's why they have a @NASCAR driver wearing one.
Example from old interview below.
The driving claims is interesting. Besides using this for athletes and military, they are trying to make this standard safety equipment.
You drive a car? Wear a Qcollar! That's why they have a @NASCAR driver wearing one.
Example from old interview below.
7a/
I've posted a bunch on this, bc I want to help consumers make well-informed decisions.
The marketing and media stories present an inaccurate picture of a convincingly effective product, and the FDA clearance seems to validate that.
There's clearly more to the story.
I've posted a bunch on this, bc I want to help consumers make well-informed decisions.
The marketing and media stories present an inaccurate picture of a convincingly effective product, and the FDA clearance seems to validate that.
There's clearly more to the story.
7b/
Check out my other major thread on this, which goes into more detail about the problems with the science and marketing claims.
(Apologies for all of the threads, but it's an efficient way to present the info)
Check out my other major thread on this, which goes into more detail about the problems with the science and marketing claims.
(Apologies for all of the threads, but it's an efficient way to present the info)
https://twitter.com/jsmoliga/status/1160225974136557568
7c/
If you find this thread helpful and informative, please share it with others!
If you find this thread helpful and informative, please share it with others!
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