I Echo the Call From Cantu


Dr. Robert Cantu recently wrote an article for the Health & Science section of Time that discussed some of the obstacles for true understanding of cumulative effects of collision sports.  As he notes some of it is ambivalence but the main reason is that we truly don’t have the hard data, only tiny snapshots.

Cantu begins his article by cementing his thoughts on youth football, it should be flag until age 14.  Although this is an arbitrary age the reasoning seems sound, immature brains do react differently than fully developed brains.  Research does indeed suggest that adolescent brains – especially prepubescent – are more susceptible and take longer to recover.  Granted if they are not playing tackle football there is a good likelihood that some will sustain a concussion riding a bike or jumping on a trampoline; doing general “kid stuff”.  The massive difference between that and organized sports is that concussions that happen in the playground or in a park are accidents.  Some of our sports mandate that you hit or create collisions.  As we should all be keenly aware, it doesn’t take a direct blow to the head to create the concussive injury.

Moreover, once a child had sustained a concussion getting the vital information from them in this subjective injury is difficult.  Children and young adults are not very good at describing or even acquiescing to what is wrong.  This puts them behind the 8-ball, so to speak, as the proper management is often delayed or not even sought.  Mismanagement is the true elephant in the room on this issue.  As seen above many concussions occur, by accident, outside of organized sports.

In no way has he, nor I, even remotely been associated with banning of organized sports; if anything we have championed ways to get MORE children involved through less potentially harmful ways.  If people would take a second to think about the benefits of making play safer for younger people perhaps they would ascertain that parents/caregivers would be more likely to enroll their young ones in activity.  There is a reason there are more youth soccer participants than football, it has less to do with the love of the game and more to do with the perceived risk.  In the grand scheme of things getting more kids out for flag football; where they can learn the sport at its most fundamental without the fears of getting concussed on a regular basis (where it would be an accident) or broken limbs or battered on a daily basis, it would be a tremendous thing for the sport.

All of that goes for all the “collision” sports, reducing the risk at a young age will help those that participate develop the skills necessary to be prepared when it does comes time to introduce the collision aspect.

Most poignantly in the Cantu article is the call for a long-term study of cognitive function in youth sport participants;

These scientists are skeptical because there are no longitudinal studies on the effects of tackle football or other collision sports such as lacrosse or ice hockey on the brains of young athletes.  In a sense, their doubts are understandable. Research science is, by necessity, driven by data and that’s the sort of reasoning that scientists bring to the problem. They want to see the numbers, and research on young athletes is relatively scarce. As a researcher myself, with more than 375 papers published in peer-reviewed journals, I want to see them, too.

Therefore, the next step in making sports safer for kids is obvious. What is urgently needed is the most ambitious, comprehensive study ever done on kids, sports and head trauma. I am talking about an unprecedented effort that, if properly designed, would give us the answer to the biggest questions.

That question is “how bad is the problem, or is it even a problem at all?”

I propose a study that follows youth athletes for ten years, from their first days on the field until age 15. It would include youth athletes in many sports. Although our primary concern is with children playing collision sports such as football, ice hockey and boys’ lacrosse, where banging into your opponent is an expected part of the game, this study would include swimmers, soccer strikers, volleyball setters and field hockey goalies. Let’s learn what we can about the relative exposure of these athletes and, of course, whether there is a discernible difference in the effects of head trauma between girls and boys. At least one thousand young athletes would be recruited for the study.

Such a study would be expensive, costing perhaps $10 million. (2012 the National Football League donated $30 million to the National Institutes of Health to study head trauma and degenerative brain disease in adults.  Last month, the NFL settled a massive head-trauma lawsuit with more than four thousand former players costing an estimated $800 million.)  But think about what will be learned and how it might change the futures of millions of youth athletes for generations to come. Then tell me whether it’s too much.

To which I completely echo his ideas and sentiments.  With the vast resource of willing athletic trainers and money that could be dumped into this idea there is no compressible way it cannot be done.  I am willing to help, and I am fairly certain many athletic trainers would be willing to help; not to mention the coaches, parents and players – all major stakeholders – that want to see sports like these continue.

Advertisements

11 thoughts on “I Echo the Call From Cantu

  1. George Visger October 17, 2013 / 14:36

    League of Denial:
    An NFL Brain Injury Survivor’s View
    10/09/13

    On October 8, 2013, PBS Frontline aired the Fainaru brothers documentary The League of Denial: The NFL’s Concussion Crisis. I probably have as vested an interest in this subject as anyone, and watched the show three times, taking copious notes. My take on the show is a little different than that of most viewers and fans.

    I spent two short seasons in the NFL, including that as a member of the 1981 San Francisco 49er’s Super Bowl championship team. During my rookie year in 1980, I suffered a serious concussion in the first quarter of a Dallas Cowboy game. Later in the week when my memory returned, the trainers and team doctor laughingly told me I went through numerous smelling salts during the game to keep me on the field. They told me they handed me a couple each time I came off, I’d pop em, clear my head, and return to the field. I never missed a play or practice.

    Early in the following 1981 Super Bowl season I developed major headaches, balls of light in each eye, loss of hearing with each beat of my heart, and projectile vomiting, several weeks after my first knee surgery. I was told by the same team doctor it was high blood pressure and prescribed high blood pressure meds. My condition deteriorated and 17 days later I developed focal point paralysis of my right arm. The next day the same doctor diagnosed me with a brain hemorrhage in the locker room. I was directed to go home, lie down, and drive myself to Stanford Hospital that afternoon to see a neurologist. I did, and underwent emergency VP Shunt brain surgery a few hours later.

    A hole was drilled in my skull and a tube inserted into the ventricles in the middle of my brain. The tube was plumbed to a pressure valve installed in the back of my head, with a drain tube running into my abdomen. I was 22 years old and had developed hydrocephalus, or water on the brain from concussions. While lying in Intensive Care during my 14 day stay, I was informed by the trainers and team doctor they were looking into having a special made helmet to allow me to continue to play. After being discharged, I returned to the team, and continued working out on Injured Reserve for the rest of the season, preparing for the following season.

    Four months after our Super Bowl XVI win, my shunt failed. I survived 2 more brain surgeries 10-hours apart and was given last rites. I was also given the hospital bills, as the 49ers denied I was injured playing for them. That began a several year legal battle fighting creditors, during which time I underwent 2 additional knee surgeries to repair the shoddy work conducted by the 49er’s orthopedic surgeon. The 3rd knee surgery was an experimental Gore-Tex ACL transplant. The 49ers and the NFL did everything in their power to prevent me from accessing my earned medical benefits.

    In 1984 I won my Workers Compensation case against the 49ers. They offered $35,000 to close my account. Luckily I refused, as I’ve incurred nearly a million dollars in hospital bills since, to cover the six additional brain surgeries I’ve had. I received no cash pay out and no monthly disability check . My entire settlement involved payment of past and future medical coverage for my injuries, I used Vocational Rehab to return to school to complete my Biology degree.

    I returned to school in 1986 to complete my biology degree, and survived 5 additional VP Shunt brain surgeries and several gran-lam seizures during a 10 month period in 1987-88, WHILE taking Organic Chem, Bio Chem, Physics and Pre Calc courses. During that time I developed dyslexia, major short term memory issues and cognitive impairment from the surgeries and anti seizure meds. In 1990 I completed my Bachelor of Science in Biological Conservation at age 32 and began my career as a wildlife biologist. I underwent my 9th VP Shunt brain surgery in 1995.

    In February of 2012, the 49ers Work Comp carrier, offered me a cash settlement to close my account. I declined as I can not get coverage for my pre-existing conditions. Soon after they fired my Nurse Case Manager, terminated my Vocational Rehab counselor two months into a 12 month contract when he completed a return to work plan for me, and refused to accept the plan he had written. They also ceased paying my medical bills and currently owe one of my providers $32,000, another over $7,000 and myself over $2,000 in out of pocket expenses. We are back into a protracted legal battle just to get my medical bills paid, a circus I have to go through every few years just to get my bills paid.

    As I watched League of Denial, I was livid. Watching the history of the NFL’s lies, cover-ups (many of which I have personally lived through), and grotesque revenues grow and grow, all at the expense of their players and the player’s family’s lives is unconscionable. But during this historical journey chronicling the NFL’s blatant cover up of the dangers associated with head injuries I noticed an important piece of the story was missing.

    Where was the NFL Players Association?

    It’s not only understandable, but nearly expected to hear the NFL’s attorney categorically deny any wrong doing. But where was our Union? We were paid to play the game, our union was paid to protect our rights. Not fill their pocket books off our health.

    Going back to 1970, the NFL began to profit off players injuries by pushing their NFL Big Hits videos. They glorified the violence and injuries, as they stoked the fans blood lust and increased their revenues exponentially. Not long after, Commissioner Tagliabue, an attorney by trade, stated, “There was no concussion problem, it’s a journalist issue, and relatively small.” Of course he’d take that stance. The NFL Big Hits videos were a cash cow, and the Commish never had to strap it on. He made his millions sitting comfortably behind his desk while the young players paying his salary shortened their lives.

    In 1994, Commissioner Tagliabue created the Mild, Traumatic Brain Injury Committee. He headed it up with his own personal physician, Dr. Elliot Pellman, a rheumatologist, who erroneously claimed a medical degree from State University of New York at Stony Brook, when in fact he attended medical school at the University of Guadalajara in Mexico, and received a degree from the New York State Education Department after a one-year residency at SUNY Stony Brook, state records show.

    He does not hold an M.D. From SUNY Stoney Brook, according to Dan Rosett, a university hospital spokesman.

    Dr. Pellman sent papers to Harvard University to speak at a seminar and to the House Committee on Government Reform regarding steroid use in baseball, where he identified himself as an associate clinical professor at the Albert Einstein College of Medicine.

    He is in fact, an assistant clinical professor, a lower-ranking and honorary position held by thousands of doctors. A medical college official stated Pellman did not teach at Albert Einstein. Dr. Pellman also stated “concussed players can return to play the same game and not suffer long term problems, and it might even apply to high school and college players.”

    Dr. Pellman, and I use the term Dr. very loosely, was also an adviser to Major League Baseball during the MLB steroid scandal. During his testimony to the House committee investing steroid abuse, Pellman stated, “Unlike some other medical professionals you will hear from today, I have extensive experience in the area of professional sports.” Pellman, an internist, had advised baseball executives who negotiated the steroid policy, yet stated, “he was not aware of a loophole which would allow a player to leave the room for an hour in the middle of the drug test,” while questioned by Representative Henry Waxman, Democrat of California.

    Representative Waxman stated, “Major League Baseball told us Dr. Pellman was their foremost expert, but he was unable to answer even basic questions about the league’s steroid policy at the hearing. This raises further questions about his credibility and the credibility of baseball’s steroid policy.”

    Despite these red flags on Pellman’s expertise, he led the NFL’s Mild Traumatic Brain Injury group from 1994 – 2007. A period during which we lost a number of former players to suicide and other neurological related deaths. The first high profile, untimely death was that of Mike Webster in 2002. After Dr. Bennett Omalu performed the autopsy, things were never the same for the NFL.

    Omalu’s 2002 study on Mike Webster was the first to diagnose Chronic Traumatic Encephalopathy (CTE) in a football player. His paper submitted to the Journal of Neurosurgery, was co-written with the leading Alzheimer doctor, one of the leading Pathologists and the leading Coroner in the county, unleashed a maelstrom of criticism from the NFL’s Mild Traumatic Brain Injury (MTBI) group. They demanded Omalu retract his paper, a move rarely seen with the exception of blatant plagiarism.

    Twenty three of the next twenty four NFL brains Omalu studied, all showed signs of CTE. He continue to post papers on each player he examined, and the criticism from the NFL’s MTBI group grew. I didn’t just grow. It becamed an inflamed, personal attack on Dr. Omalu himself.

    In 2006 Rodger Goodell, right hand yes man to Commissioner Paul Tagliabue for years, took over as head of the NFL, a position he pursued for over 20 years. Soon after taking his friends office, he appointed Dr. Ira Casson as new head of the Mild Traumatic Brain Injury group. Dr. Casson would soon earn the moniker Dr. No after his infamous grilling by Bernard Goldburg on HBO Real Sports in October, 2009. Every question regarding links to any degenerative, neurological disorders to playing NFL football were answered with a disdainful “No!”

    In 2007 the NFL continued to assert there were no dangers to playing the game, and to prove it, they quietly produced handouts for all players which included the following Q & A.

    “If I suffer a concussion, am I at further risk by continuing to play? Research has not shown any long term problems.

    Really? (Tell that to my family who has endured 9 brain surgeries with me the last 32 years, not to mention gran mal seizures.)

    About that time Omalu became associated with Chris Nowinski and Sports Legacy Institute. Nowinski played football at Harvard, graduated with a degree in Sociology and entered big time wrestling. He wrested in the WWE under the name Chris Harvard, but his wrestling career only lasted from 2002 to 2003 when he suffered a concussion. He was quoted as saying he was unable to wrestle for a year and retired. In 2006 he launched his book; Head Games: Football’s Concussion Crisis.

    As the Sports Legacy Institute began chasing NFL brains like vultures, Dr. Omalu reclused himself from any association with the group. He stated they were in it for the wrong reason. Dr. Omalu was under such pressure in Pittsburgh, PA for his studies on the 24 NFL players that he moved to the west coast and became the Chief Medical Adviser for San Joaquin County in Lodi, CA. Shortly after, Dr. Omalu quoted during a televised interview,

    “If you cross the NFL they will squash you.”

    Dr. Ann McKee of Boston University, a leading Alzheimer researcher who excitedly proclaimed in an interview she loves to dissect human brains on her days off, also stated she is an avid football fan. When Dr. Robert Stern from Boston University approached the Sports Legacy Institute to study deceased football player’s brains, Dr. McKee was beside herself. She squealed, “Are you kidding? I played football as a kid.” When Nowinski had approached McKee after Omalu pulled out of the Sports Legacy Institute, Dr. McKee stated it was, “The greatest collision on earth!” Nowinski offered to chase down and collect the brains and McKee could dissect them. Nowinski became the designed brain chaser.

    I personally found it disgusting and disrespectful to the deceased players and their families while I watched McKee and Nowinski gleefully talk about their findings. But then again I’ve survived 9 NFL caused brain with no NFL benefits, so I’m probably a bit more sensitive to the issue than those who make a healthy living off dead players brains.

    In 2009, a storm began brewing. The NFL Players Association unanimously selected De Maurice Smith, a slick, Washington D.C. white collar trial lawyer to head up the organization. Smith was quoted during a Congressional hearing that same year, “There is simply no justification for the NFL to have previously ignored or discredited Dr. Omalu and others with relevant, valid research. For too long our former players were left adrift. As I emphasized at the last hearing, we were complicit in the lack of leadership and accountability but that ends here. I am here again to make it clear, that our commitment is unwavering.”

    Spoken like a true attorney.

    We pre-93 vets, still haven’t seen an NFL benefit.

    The Sports Legacy Institute and Boston University continued to cheerfully do NFL brain studies. In October of 2009, Congresswoman Linda Sanchez and Representative Maxine Waters convened a hearing in Washington, and grilled Dr. Ira “No” Casson regarding the NFL’s mishandling of head injuries. Representative Waters (D-Calif.), called on Congress to end the National Football League’s antitrust exemption, due to what she called, “willful ignorance by the league of the debilitating effects the game has had on players who suffered multiple, repeated concussions.”

    Ms. Waters, whose husband Sid Waters, played 6 years in the NFL, made her statements during a House Judiciary Committee hearing, where witnesses testified about increased rates of neurological disorders among retired professional football players.

    But the NFL fought back and denied any link. They also assured Congress they were aggressively studying the problem. A near quote from Commissioner Tagliabue over 30 years prior.

    Dr. No begrudgingly stepped down after the hearing in 2009, and was replaced with Dr. Rich Ellenbogen in 2010. About the same time NFL spokesman Greg Aillelo, who may have been suffering a concussion himself at the time, stated to Alan Schwartz of the New York Times during a telephone interview;

    “It’s quite obvious from the medical research that’s been done, that concussions can lead to long-term problems.”

    Say What??

    Shortly after his statement, Aiello began a Michael Jackson like, moon walking back pedal from his earlier statement regarding concussions can lead to long-term problems.

    Pressure from the owners??

    By 2010, Boston University had studied 20 NFL brains of which 19 where diagnosed with CTE. As bodies piled up, and evidence mounted, and the NFL cranked up their defense, the victims were getting younger and younger, including Owen Thomas, a 21 year old Penn University player who hung himself. Thomas began playing organized football at age 9 and never sustained a diagnosed concussion.

    By 2011, Boston University and Dr. Ann McKee diagnosed CTE in 45 out of 46 brains studied, but the NFL wanted more evidence.

    We need more studies they said.

    Same thing Tagliabue said in the 70’s.

    At least they’re consistent.

    In 2011, the NFL and Riddell helmets were named in a lawsuit filed by 75 former players over allegations that the league and company concealed data about the dangers of concussions. Ultimately over 4,500 former players would be named in the suit. I was the 23rd plaintiff in the original suit.

    Jr. Seau, cousin to my 49er room mate Terry Tuatolo, shot himself in May of 2012 at age 43. Dr Omalu began the autopsy with permission from Jr’s son Tyler. Shortly after Omalu began the autopsy, Tyler Seau received a call from the NFL which stated Omalu’s character and research were bad. Tyler was angry and stopped the autopsy before Omalu was finished. The brain vultures swooped in, but the NFL threw up a barricade.

    “No one touches the brain till we say so,” said the NFL.

    What did they have to do with Jr after his death? Certainly nothing to help him with his struggles after 20 years of head banging in the NFL.

    Jr. Seau’s brain ultimately ended up at the National Institute of Health. Their initial finding showed no damage, which the NFL rewarded NIH with a handsome $30 million thank you. I personally corresponded with NIH’s top executives stating I would watch where the $30 million in blood money went. Shortly after a final report was released which stated that Jr. did indeed suffer from CTE.

    Really?

    About this time, Rodger Goodell cranked up the NFL PR machine and unveiled their new Heads Up Program with USA Football. A youth football program designed to reduce head injuries in lower level football.

    Goodell was concerned about Pop Warner but not about his own players.

    While all this was going on during the spring of 2012, the NFL’s Collective Bargaining Agreement expired and the players went on strike. For the first time in this decades long battle, De Smith and the NFL Players Association showed their head. After a hard fought battle, De Smith and the NFLPA retreated with a victory. A victory for the NFL and De that is. De was paid a handsome $1 million bonus on top of his $2.5 million salary. That was chump change compared to Goodell’s base salary of $7.2 million and his hard earned $22.3 million bonus.

    $22.3 million bonus! From the 501 c 3 NON PROFIT NFL.

    How many families of retired players could that have helped?

    Well done De and Rodger. And to think my 9 NFL brain surgeries aren’t worth a penny.

    Just prior to the start of the 2013 season, the $9.5 Billion NFL settled the head injury lawsuit with an offer of $765 million paid to over 18,000 former players over 20 years. We ended up with $177/mo over the 20 year payout period during which time the NFL is estimated to earn an estimated $323 Billion.

    And they don’t have to open their books as to when they knew brain damage was occurring.

    And they didn’t have to admit any responsibility.

    Thus, The League of Denial.

    As a matter of survival, considering the pre 93 players were basically left out of the equation during this last Collective Bargaining Agreement, I was forced to form The Visger Group – Traumatic Brain Injury Consulting (www.thevisgergroup.org.). My environmental consulting business began to implode in 2009 due to cognitive impairment and short term memory issues from my 9 NFL brain surgeries and 32 years of NFL caused gran mal seizures, and we lost our home shortly after.

    The Visger Group has aligned ourselves with groups and associations whose sole purpose is to empower and educate traumatic brain injury survivors and families, including military veterans and families, and former players and their families.

    It’s not a game to many of us. It’s a matter of survival.

    The Visger Group associations.

    Dave Pear’s blog http://www.davepear.com
    Brain Rehabilitation and Injury Network (B.R.A.I.N.) http://www.thebrainsite.org
    Cornerstone Hyperbarics http://www.cornerstonehyperbarics.com
    Hyperbaric Oxygen Clinic of Sacramento http://www.hbot.info
    South Bay Hyperbaric Center http://www.sbhbot.com
    Integrated Play http://www.integratedplay.org
    Archetype Player MD Biometrics http://www.archetypecorp.com
    Concussions Inc. http://www.concussioninc.net
    Amen Clinics http://www.amenclinics.com
    Gridiron Greats http://www.gridirongreats.org
    NFL Concussion Litigation http://www.nflconcussionlitigation.org
    Kyle Turley http://www.gridironrecords.com

    Other Affiliations
    Brain Injury Research Institute
    The Concussion Blog
    Gay Culverhouse Players’ Outreach Program
    Hydrocephalus Awareness
    Harry’s Hits
    International Hyperbaric Medical Association
    Jeff and Brandi Winans
    RetiredPlayers.org
    Ron ‘Jaws’ Jaworski
    RustyHilger
    Sports Brain Injuries
    TBI Strategies

  2. jbloggs October 18, 2013 / 09:01

    Cantu, Garza, Tator, Winston, Fink et al. are making a strong case for ending collision sports for those under a certain age. On the other other, how do Duma, Collins and Guskiewicz justify the ethics of running experiments of children? I have yet to see a consent form or study design published. Even more galling is the CDC in partnership with NFL pushing heads up football with no scientific evidence that it is any better than current practice. Is the NFL going to take responsibility if it creates more damage? Oh no, they lobbied the Lystadt law through 48 states. The CDC has a lot of explaining to do.

    Twenty years hence this may be viewed with the same disgust as Bowery Prostate experiments, I hope everyone is taking down the names of those involved.

    • Tom October 18, 2013 / 14:59

      jbloggs – since when does anyone ever publish a consent form? Are you suggesting/implying that UNC/Pittsburgh/VT investigators are conducting their research without appropriate informed consent (parents) and ascent (minors) on federally funded research projects – that is a serious allegation!! Do you have any evidence to support this allegation?

      As I’m sure you’re aware, appropriate IRB approvals are required in all research and most journals require you to either state your received IRB approval or, in some journals, provide the IRB approval prior to publication. In Daniel’s article on HITS in children (senior author was Duma), they clearly indicate they all parents provided informed consent and the children provided assent. Further, I can’t recall reading a concussion article by Collins, Guskiewicz, or Duma that does not clearly describe the study design – it’s called a Methods section.

      I don’t believe Tim Hewett or Doug Casa have ever published their consent forms either – are they unethical for doing knee and heat experiments on children??

      • joe bloggs October 18, 2013 / 21:59

        Tom,

        It depends on the IRB and what is stated to the IRB. I do have concerns about the content of the consent form offered to parents to participate in studies that can result in subtle but significant brain damage (the poster presentation AAN by CUMC researchers should give everyone pause – note this study was conducted on college athletes) as part of the exercise. Does the consent form indicate while the risks cannot be fully quantified, concussion in children is associated with higher incidence of learning disabilities, aggression, substance abuse; and lower academic performance (I believe that study was conducted in Canada)?

        As far as federally funded research, CDC is a marketing partner with the NFL for Heads Up (a program promoted without a stitch of scientific evidence), NIH gets money from the NFL and Russ Losner was serving both the NFL (head of research – LOL) and NIH (I know he is moving to OU). I do not have a great deal of confidence in either entities ethics regarding this matter.

        There are serious conflicts of interest. What an IRB might or might not understand regarding pediatric concussion is unknown and not well documented.

        Is there some reason none of the pediatric concussion trials seem to be posted on clintrials.gov (the summary on clintrials usually is a good starting point to understand study design as opposed to the ex-post methods section of a journal article that allows a PI to fit his data to his or hypotheses)? I thought that was an ethical violation. Odd that none of the studies you cited seem to have had its trial documented on the system.

  3. Tom October 21, 2013 / 09:09

    joe bloggs – I disagree with the premise of your opening paragraph. The purpose of the IRB/informed consent, from my interpretation, is to quantify the risk of participating in the study. Using Daniels study as an example, because he used very young participants, the “study” consisted of utilizing the HITS system in the helmets to quantify impacts. The risk you are discussing (e.g., cognitive deficits, impaired academic performance, etc) are risks associated with playing football (and maybe soccer, hockey, wrestling, men’s lacrosse, and cheerleading), not with participation in the study. Is there any reasonable argument that installing the HITS system will increase the risk of concussion or subconcussive blows? If not, then it’s not a risk of the study. Is there any reason to believe that the participation in the study will have increased risk of cognitive deficits, if not – then it’s not a risk of the study. I would argue the risks you are discussing are risks of playing football, not of participating in a study.

    As for clinical trials, I would argue none of these studies are clinical trials. As per the NIH definition, “Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective”. Nothing about tracking the number, acceleration, or location of impacts would meet this definition. Further, as many of these studies are federally funded, the funding agencies program officer and scientific review committee would be responsible for identifying a project as a clinical trial and requiring all appropriate documentation and registration. If you are correct, the breakdown would be not only with an “unethical” investigator, but also an incompetent program/scientific officer.
    A quick search of Clinical Trials.gov did find a clinical trial by UPMC (http://clinicaltrials.gov/ct2/show/NCT01673464?term=Kontos&rank=2).

    Finally, VT and UNC are public institutions. If you truly believe there is unethical practices going on with informed consent, you could always submit a FOA request and get the IRB’s. If you’re right, I would imagine there would be many in the media who would love to report on unethical practices related to concussion research in children.

    • joe bloggs October 21, 2013 / 20:31

      Tom,

      Okay, so you are saying an ignorant parent can offer consent for a child based on insufficient information that is available to the investigators based on the belief that it is not their responsibility to inform said parent. A parent has the presumption of being knowledgeable in face of propaganda promulgated by the NFL. I gather the Tuskegee investigators felt the same way. Perhaps PETA might intervene on behalf of children.

      Is there any proof that modifying a helmet with HITS system does not compromise the protective qualities of the equipment in the pediatric population? NOCSAE claims every system must be validated but is it verified in the pediatric population. It is typical of the sports world to assume children are little adults and extrapolate so I doubt anyone has done the work. Further, the notion that HITS does not influence the culture is yet to proven. It is scary as so-called advances in helmet system technology seems to have coincided with increase head trauma coupled (although skull fractures declined). Idiot coaches still blather put a helmet on somebody something no coach would have stated pre-1970. Once a so-called threshold is established, the more intellectual imbeciles will likely state put x g’s on somebody. Sorry, HITS and systems like it tells us almost nothing about what is going on in the skull; it tells us about external forces and finite element modeling is left to make assumptions about the damage being inside the skull that may not be evident for months, if not, decades.

      Okay, so you are claiming these studies are engineering studies and do not need to comply with a clinical trial construct. It would seem you wound not need a IRB either. It should be then noted that one should make no medical claims based on the results of these studies. It would also argue that FDA 510 k program validation studies need not comply with submitting to clintrials, except they do. I do find it interesting the CHOP publishes its non-intervention studies on children for but others seem to avoid it.

      I am not a resident of either state so FOIA has limited utility for out of stater residents. Nonetheless, spending a year getting sandbagged is a waste of my time. The media is already tunneling into most of the programs. LoD, the book, illustrates the compromises that many institutions have made including the federal government.

      The PIs are engaging children in studies and should have to elevate themselves to the highest plain. The simplest idea is to hold sponsoring institutions should be held monetarily responsible for any damage caused as a result of the study. I think one would see much more complete public disclosures.

  4. Parent November 8, 2013 / 19:07

    I’ve have read a tremendous amount on the subject of head trauma and sports. I was trained as a research and scientist, and went on to found and run a company with over 800 employees and 200 million in sales. I was an athlete in school, and love sports. My belief is the restrictions coming are far more than Dr. Cantu is proposing.

    1. High-school football will be banned. The purpose of high-school is to educate our youth – as it becomes clear that the risk of high-school football with respect to brain damage is significant, and impacts a significant percentage of every team, it will become clear that it cannot be a school sanctioned activity. Research will more clearly show that in the short-term it decreases brain functioning (slower, easier to fatigue), and in the long-term leads to a decrease in brain function and a greater chance of dementia. Are jocks dumb, as they are often called, or does banging your head 500 – 1,000 times a season make you a bit dumber? Do we really have to ask the question?

    2. Heading in soccer will be banned until 14 and discouraged in 14-18 year olds.

    3. Checking in hockey will be banned until 18 (already 14 in many locations).

    4. Basketball, baseball, and soccer participation will increase significantly. The same benefits we seem from football will be gained from these safer sports.

    5. College football will diminish over many years – hard for top institutions to support a sport so broadly that damages the brains of their students.

    6. Professional football will remain popular, albeit the talent level will decrease with a shrinking recruiting pool. If adults want to damage their brains in exchange for the sport they love, and for money, more power to them – we all will be fine with that.

    As parents and educators, we simply cannot actively support and promote activities that damage the brains of our youth. Far better we encourage safer sports, greater focus on academics and community involvement, and other behavior that helps them in the long-term as well as our society. There simply are no benefits from football that cannot be replicated in other sports.

    Let the deniers deny for now, but we all know its coming, whether we want to admit it or not.

  5. Jason January 18, 2014 / 00:39

    I started coaching flag football in the fall of 2012. My team was mainly 8 year olds. At the beginning of the season there was an expectation that 2-3 of the kids would play tackle in the fall of 2013. I ended up coaching these kids for the fall, winter and spring.

    During our spring end of season party, the talk of concussions came up and everyone decided that playing flag a couple more years would be in their kids best interest. Some of the dads had grown up playing football. It was surprising to see them want to push their kids away from tackle for now.

  6. Steve Michael February 8, 2014 / 01:34

    Man I love coaching the kids. The kids love playing flag football. The best thing I did was get the coach guide with flag football plays from http://www.flagfootballplans.com and it was amazing. It make coaching a no brainer very very easy with the colored wristbands.

    I agree we should all be aware but our kids love the game and always will.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s