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FDA Warning: No dietary supplements approved to treat concussions or other brain injury.
The Food and Drug Administration (FDA) has issued a warning that there are no approved dietary supplements to treat a concussions or other types of brain injury.
Can a Dietary Supplement Treat a Concussion? No!
The concussion supplement warning published by the FDA is published in full below:
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.
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August 2014 brain injury legislative update
The following August federal brain injury legislative update was prepared by the Brain Injury Association of America (BIAA):
TBI Act Reauthorization
The United States Senate planned to pass TBI Act Reauthorization this week but further action on the bill will be taken in September. BIAA thanks Sens. Harkin (D-Iowa), Alexander (R-TN), Hatch (R-UT) and Casey (D-PA) for their continued leadership on passing this important legislation to the brain injury community.
Assisted Living TBI Pilot Program Extension
The U.S. Senate overwhelmingly passed a $16 billion overall to the Department of Veterans Affairs Thursday night which included a three year extension to the Assisted Living TBI Pilot Program. Sens. Corey Booker (D-NJ) and Dean Heller (R-NV) introduced the Assisted Living Pilot Program for Veterans with Traumatic Brain Injury Extension Act, S.2607. The AL-TBI Extension Act authorizes the continuation of a critical VA program that provides intensive care and rehabilitation to veterans with complex brain injuries. AL-TBI consists of community-based residential/transitional rehabilitation programs around the country in which veterans are immersed in therapies for movement, memory, speech, and gradual community reintegration. This model of care allows veterans facing similar challenges to live together while receiving 24/7 care, which has yielded impressive results and helped rehabilitate hundreds of veterans from severe injuries that are notoriously difficult to treat. BIAA thanks Sens. Booker and Heller for their leadership and to Congress on extending this vital program to our Veterans with TBI.
U.S. Department of Education
On Tuesday, BIAA staff attended a meeting with Michael Yudin, Assistant Secretary of Special Education and Rehabilitation Services and other senior leadership at the Department to discuss New York State's Elementary and Secondary Education Act (ESEA) waiver extension which included a provision to test students with disabilities two grades below their enrolled grade level. On Thursday, the Department approved New York's ESEA Waiver Extension without Amendment 1. Amendment 1 was the provision that would have allowed NY to test students with disabilities at two grades below their enrolled grade. BIAA could not be more pleased that this provision was not included in the waiver - its removal means that thousands of students with disabilities including brain injury won't be taken off the track to graduation.
SAFE PLAY Act Introduced
On Thursday, Rep. Bill Pascrell, Jr. (D-NJ-09), Senator Robert Menendez (D-NJ), and Rep. Lois Capps (D-CA-24) introduced the Supporting Athletes, Families and Educators to Protect the Lives of Athletic Youth (SAFE PLAY) Act, a bill that would promote youth safety in athletic activities.
According to the Centers for Disease Control, participation in organized sports is on the rise. Almost 30 million children participate in youth sports in the U.S. This increase in participation has also led to an increase in injuries - more than 3.5 million kids under age 14 receive medical treatment for sports injuries each year, 21 percent of all traumatic brain injuries among U.S. children are associated with sports participation, and children ages 5 to 14 account for nearly 40 percent of all sports-related injuries treated in hospitals.
To address this, the bill would take a multipronged approach of research, community education, and federal support for school district to adopt best practices to keep kids safe, focusing on several areas, including heat exposure, CPR and AED training, concussion response, and energy drink consumption, to ensure children's safety in athletics and on campus.
Specifically, the SAFEPLAY Act would direct the Center for Disease Control (CDC) and the Department of Health and Human Services (HHS) to:
• Develop recommended guidelines for the development of emergency actions plans for student athletes
• Develop information on the ingredients used in energy drinks and the potential side effects of energy drink consumption
• Recommend guidelines for the safe use of energy drink consumption by students
• Report to Congress on the number of sports related fatalities and catastrophic injuries and the cause
• Develop and disseminate information about the health risks associated with exposure to excessive heat and humidity, and how to avoid heat-related illness
• Assist schools in developing and implementing an excessive heat action plan to be used during all school-sponsored athletic activities that occur during periods of excessive heat and humidity
The bill would also help local education agencies develop and implement safer schools. The bill would provide assistance for school districts to develop and implement a standard plan for concussion safety and management and set up concussion management teams to respond to incidents on campus. It would also support schools by providing access to critical resources to teach students across the country the life-saving skills of cardiopulmonary resuscitation (CPR) and how to use automated external defibrillators (AED).
Congress is out of session for the month of August and will return to Washington D.C. on September 8, 2014. Policy Corner will resume on September 12, 2014.
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Lead Off Speaker at American Association for Justice-Traumatic Brain Injury Litigation Group
On Sunday, July 27th, I will be the lead off speakier at the annual conference of the American Association for Justice, Traumatic Brain Injury Litigation Group’s annual program to be held this year in Baltimore, Maryland.
My topic this year is entitled, From Concussion to the Classroom and Playing Field. I will explore the many legal issues in recently enacted concussion management legislation, public health issues and additional steps that must be taken to protect our nation’s youth from the epidemic of traumatic brain injury in all sports.
Recent evidence points to over 250 million of our nation’s youth sustain some type of a traumatic brain injury each year while participating in athletic competition all athletic training. Brain injury in sports is a public health crisis that must be approached from many different areas including education, prevention, return to play guidelines and legal liability when a preventable brain injury takes place.
The legal conference is a part of the four day conference sponsored each year by the nation’s largest trial lawyer association, the American Association for Justice. The conference each year is attended by over 2,000 attorneys from across the nation. The conference provides educational skills to attorneys on how to more effectively represent their clients following a personal injury.
The traumatic brain injury litigation group is comprised of attorneys who have a special interest in the area of traumatic brain injury litigation. I have been honored to have been a chair of this group and continue to serve on the group’s executive board.
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Save VA Benefits for Brain Injured Veterans
The Brain Injury Association of America has just issued the following Action Alert:
Protect Access to Care for Veterans
Call Congress Today!
As a member of the large and growing community that understands the importance of thoughtful, comprehensive care for individuals living with brain injury, we wanted to inform you of an important program for America's veterans that is in danger of shutting down if Congress does not act soon.
Established by Congress in 2008, the Assisted Living TBI Pilot Program has made it possible for hundreds of wounded warriors to receive specialized, post-acute brain injury rehabilitation in the community.The program provides critical, real-life skills to help veterans return to their homes and communities. It has been a lifeline for dozens and dozens of veterans.
Unfortunately, the Department of Veterans Affairs has announced that it will end the pilot program on September 30, 2014 unless Congress takes action to extend it. This means that the VA will soon begin to discharge veterans from the program.The Wall Street Journal recently highlighted the importance of the program and the challenges faced by many if Congress doesn't act soon.
We need your help to make sure the Assisted Living Pilot Program for Veterans with TBI continues to make a meaningful difference for America's heroes.
Please call your Member of Congress and make sure they know how important the program is to veterans and urge them to support extending the pilot program. You can reach your Representatives and Senators by calling the U.S. Capitol Switchboard at (202) 224-3121 where you will be transferred directly to their offices. Thank you for your crucial contribution to this effort.
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Brain Injury Association of America July Legislative Update
The following legislative summary was prepared by the Brain Injury Association of America (BIAA):
BIAA Presents at Congressional Briefing Highlighting Study on Outcomes for People with TBI:
Brain Injury Association of America (BIAA) president and CEO Susan Connors presented at a Congressional briefing hosted by Sens. Tim Johnson (D-S.D.) and Mark Kirk (R-Ill.) on Thursday, July 10. The briefing was held to announce the results of a study on outcomes for people with traumatic brain injury (TBI) and stroke conducted by Dobson DaVanzo & Associates, LLC.
The study, Assessment of Patient Outcomes of Rehabilitative Care Provided in Inpatient Rehabilitation Facilities and After Discharge, is the most comprehensive national analysis to date examining the long-term outcomes of clinically similar patient populations treated in inpatient rehabilitation settings and skilled nursing facilities. The research shows that people with TBI and stroke who were treated in inpatient rehabilitation settings had better long-term outcomes than those who received care in a skilled nursing facility.
The Workforce Innovation and Opportunity Act
The Workforce Innovation and Opportunity Act (WIOA) passed the House of Representatives this week. WIOA will provide better employment opportunities for individuals with disabilities. The Senate passed the bill with a 95-3 vote. It is expected the President will sign the WIOA bill into law soon. This legislation is considered the most important disability legislation passed since the groundbreaking Americans with Disabilities Act which was passed in 1990. BIAA applauds Congress for working together to pass this important legislation that will improve the lives for individuals living with disabilities caused by brain injury.
Congress Introduces the IMPACT Act
On June 26, Senators Ron Wyden (D-OR) and Orrin Hatch (R-UT), as well as Congressmen Dave Camp (R-MI) and Sandy Levin (D-MI) introduced the Improving Medicare Post-Acute Care Transformation (IMPACT) Act. They introduced the bill almost three months after releasing a bipartisan discussion draft. During the past few months, Senate and House committee staff have been meeting with a series of stakeholders on the bill including the Brain Injury Association of America.
The IMPACT Act lays out a framework for collecting standardized assessment data across post acute care (PAC) settings, which could then be used to transition Medicare's current silos of PAC payments from a fee for service payment structure to a pay for performance reimbursement structure. This payment structure would be prospective, unified across settings, and based on patient assessment data, as opposed to being dependent on the PAC setting in which the patient is treated.
TBI Act included in Mid-Year Committee Report
This week, U.S. House Energy and Commerce Committee Chairman Fred Upton (R-MI) released a report on the accomplishments of the committee in the first six months of 2014. The TBI Act, HR 1098, which was passed by the House of Representatives in June 2014, was included in the report.
Congressional Brain Injury Task Force Hosts Crash Reel Screening
The Congressional Brain Injury Task Force, co-chaired by Reps. Bill Pascrell Jr. (D-NJ) and Tom Rooney (R-FL), will host a Congressional screening of the film Crash Reel on Tuesday, July 15, 2014 from 6:00-8:00 p.m. in the Rayburn House Office Building, Room 2103. BIAA is sponsoring the screening of Crash Reel. The film features Kevin Pearce, a professional snowboarder, who sustained a TBI at the height of his career. This event will feature a discussion with Kevin Pearce who is now retired from professional snowboarding.
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Even Phineas Gage would be denied benefits under the NFL class action settlement if received his injury while playing football!
Illustrative of the inadequacy of the NFL class action settlement are the injuries sustained by Phineas Gage and how he would fair under this agreement.
Perhaps the most famous traumatic brain injury patient in the history of medicine was Phineas Gage. In 1848, Gage was a 25-year-old railway construction foreman, working with explosive powder and a packing rod. A spark caused an explosion that propelled the three-foot long pointed rod through his head. It penetrated his skull at the top, passed through his brain, and exited through his temple. Before the accident Gage was a quiet, mild-mannered man; after his injuries he became an obscene, obstinate, self-absorbed man. His personality and behavioral problems persisted until his death in 1861.
Had Phineas Gage sustained these injuries while playing professional football, he would not be entitled to any benefit under the proposed settlement agreement.
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Hearing needed before NFL revised settlement agreement is considered by Federal Court
The revised NFL brain injuy settlement agreement is fatally flawed. Judge Brody should hold a hearing before she even considers granting preliminary approval to the settlement.
Here are some preliminary observations that were published yesterday by my partner, Shana De Caro and myself on the Huffington Post:
The revised proposed settlement of the class action lawsuit against the NFL remains fundamentally flawed. The settlement neither recognizes nor compensates the majority of players who suffer the long-term consequences of repeated concussive injury.
The foundation of the lawsuit was the deliberate and longstanding misrepresentations by the NFL and its committee on traumatic brain injury, concerning the known health risks that players confronted from repetitive brain trauma so ingrained in the game. For years, the NFL has staunchly refused to acknowledge the accumulating body of objective medical evidence revealing the risk of permanent brain damage from repeated head trauma. The NFL remained shrouded by inaccurate statements propagated by its own Committee on Mild Head Injury, including false declarations that "mild TBIs in football are not serious injuries" and that "many NFL players can be safely allowed to return to play on the day of the injury after sustaining a mild TBI." This deception imperiled professional football players and was calculated to mislead players and the public.
Today's proposed revised settlement persists in disregarding the issues that are essential to the vast majority of players that are affected. A concussion is a brain injury. A mild brain injury is only mild if it is someone else's brain. The silent majority of players who have cognitive, emotional, and behavioral impairments because of their reliance on the fraudulent conduct by the NFL will remain uncompensated under this settlement.
The court has an obligation to protect all players who are part of this class action lawsuit. Any settlement that fails to address the claims and interests of the majority of players should be rejected as imprudent and contrary to the best interests of the majority of class members.
The claims of the preponderance of players must be allowed to continue in order to expose the reprehensible pattern of deception and intentional misconduct committed by the league, whose control of the negotiations of this settlement, elevates profits over player safety.
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Traumatic Brain Injury Act unanimously passes U.S. House of Representatives
Late last evening the United States House of Representatives unanimously approved passage of H.R. 1098, the Traumatic Brain Injury Reauthorization (TBI) Act of 2013.
Approximately 2.5 million Americans experience TBI each year and an estimated 5.3 million Americans are living with long-term, severe disabilities as a result of brain injury.
The Brain Injury Association of America (BIAA) and its executive director, Susan Connors as well as the leaders of the Congressional Brain Injury Task Force, Representatives Bill Pascrell, Jr. and Tom Rooney all need to be thanked for their hard work in passing this important legislation.
Originally passed in 1996 and reauthorized in 2000 and 2008, the TBI Act represents a foundation for coordinated and balanced public policy in prevention, education, research, and community living for people with TBI. The TBI Act specifically allocates federal funds for programs supporting individuals with brain injury to federal agencies including the Centers for Disease Control (CDC), the National Institute for Health (NIH) and the Health Resources Administration (HRSA).
BIAA and other TBI Act stakeholders are continuing to work with the United States Senate to introduce a companion bill.
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Sports Concussion Summit-Listen this Sunday when I share my thoughts with Bob Salter on WFAN
Last Thursday, I joined President Obama at the White House for his Summit on Youth Sports Concussions. I will be discussing my thoughts about the new sports concussion initiatives and the need for comprehensive federal legislation this Sunday morning at 7 AM with Bob Salter on WFAN Radio 66 AM, 101.9 FM You can listen to a live stream of my interview on Sunday by clicking here.
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The White House Concussion Summit-No Quick Fixes Please
I had the honor and privilege to be a participant in yesterday’s White House Sports Concussion Summit.
President Obama’s inaugural concussion summit presented a watershed moment in validating and tackling the public health crisis of the long term hazards posed by concussions in sports and its ramifications. The President’s opening remarks were very encouraging and he deserves credit for bringing everyone together around this issue. Unfortunately, the momentum was lost when the panelists shifted the focus to protection of sporting activities from the negative publicity associated with brain injury rather than protection of players.
The White House Summit on sports was an opportunity to embrace a uniform national protocol comprehensively tackling the multi-dimensional issues related to sports concussion management. It is critical to avoid preventable brain injuries and manage the brain injuries that unfortunately but inevitably occur. Though many coaches and parents fear the over-protective label, they have justification for their safety concerns.
Contrary to the perspective of the panel, brain injury is not a simple event with a simple solution. One only need listen to the many young adults who suffer permanent disability in the pursuit of athletic participation. No one is suggesting a ban on athletic activities. Yes, concussions happen. It is part of the game, but we must implement initiatives to reduce the risk of injury, and prevent, preventable injuries.
This national summit on the public health crisis of sports related brain injury missed an important opportunity to set forth a meaningful agenda and address the needs of the millions of individuals who have sustained a brain injury both on and off the playing field.
Increased government funding is crucial for continued meaningful and targeted research on prevention, diagnosis and treatment and much more will be necessary in our efforts to comprehend the complexities of traumatic brain injury.
Traumatic brain injury affects 5.2 million Americans. Government initiatives must extend beyond the athletic fields and focus on all aspects of this silent but burgeoning epidemic. A brain injury is not a passing illness. The lifelong cognitive, emotional, and behavioral consequences of this condition affect every aspect of the victim’s life. A brain injury can affect anyone, anytime, anywhere, and unfortunately, it does. A national proposal attempting to prevent, reduce, and treat brain injury must be comprehensive in scope.
There are those who might have another agenda, not entirely focused on public health. Multi-billion dollar enterprises, such as the NFL, have been jeopardized, and its image tarnished by mushrooming liabilities and the trickledown effect on college and youth sports. The league might have other motivation in joining this project. The NFL employs marketing masterminds to control the public’s perception of concussion risks. The league’s “Heads Up Football” tackle program attempts to convince parents that football can be made safe. Football is a concussion delivery system. While it is beneficial to improve and require “safe” tackling procedures, there is no empirical evidence supporting the position that changing the tackle rules will either reduce the rate or decrease the severity of concussions.
Pixie dust solutions only work in fairy tales. The dangers of concussions remain constant. A concussion is a brain injury: a significant event with potentially life-altering consequences.
Doubtless NFL monetary contributions to fund brain injury research are beneficial. These funds must not be allowed to subtly influence the outcome of that research. When the fox supervises the chicken coop, the outcome becomes predictable. The NFL’s proposed settlement of the pending mass injury lawsuit is a perfect example of the league’s duplicity. No settlement funds have been committed to players who continue to suffer the long-term consequences of the post-concussive syndrome. Despite overwhelming medical evidence, the league steadfastly refuses to acknowledge that a concussion can cause life-long consequences. Those who control the flow of funds, and research, must be vigilant to be impervious to outside influences and any invisible strings that might be attached to the money.