Last week the National Operating Committee on Standards for Athletic Equipment (NOCSAE) awarded a research grant to Jason P. Mihalik, PhD, who will lead a study entitled "Effect of hyperbaric oxygen therapy on acute treatment of sport-related traumatic brain injury" at the Department of Exercise and Sport Science's Matthew A. Gfeller Sport-Related Traumatic Brain Injury Research Center at the University of North Carolina, Chapel Hill. Directed by 2011 MacArthur Fellow Kevin Guskiewicz, PhD, the UNC center will split more than $845,000 with four others. Mihalik's is the only study to investigate the use of hyperbaric oxygen. CLICK HERE to read the full NOCSAE news release.
Tuesday, January 31, 2012
NOCSAE Awards Grant for Hyperbaric Study at University of North Carolina Sports-Related TBI Research Center
Last week the National Operating Committee on Standards for Athletic Equipment (NOCSAE) awarded a research grant to Jason P. Mihalik, PhD, who will lead a study entitled "Effect of hyperbaric oxygen therapy on acute treatment of sport-related traumatic brain injury" at the Department of Exercise and Sport Science's Matthew A. Gfeller Sport-Related Traumatic Brain Injury Research Center at the University of North Carolina, Chapel Hill. Directed by 2011 MacArthur Fellow Kevin Guskiewicz, PhD, the UNC center will split more than $845,000 with four others. Mihalik's is the only study to investigate the use of hyperbaric oxygen. CLICK HERE to read the full NOCSAE news release.
Monday, January 30, 2012
Football Injury Rehab: Bad Information Sparks Silly Debate About Hyperbaric Oxygen Therapy
Now that the Pro Bowl is over, most star NFL players can limp into the off season and head home to nurse their injuries. Many of them were lucky to make the final game at all. One of them, supposedly with the help of hyperbaric oxygen therapy, was Chicago Bears running back Matt Forte. (See our December 18 post, "Off the Football Field and Into the Hyperbaric Chamber.") Earlier this month, local PBS affiliate WTTW spun the Forte story into an odd debate between wound care physicians at a community hospital and a major academic medical center. Click play to watch the video below. Read the full Chicago Tonight story here.
We have a few quibbles:
We are grateful none the less for the link to the HyperbaricLink treatment center directory. On our website all interested readers will enjoy access to important clinical information and other reliable resources to set the record straight.
We have a few quibbles:
- Forte likely self-administered mild hyperbaric therapy in a zip-up bag at home, not in a pressure-safe chamber at a hospital. Learn more about hyperbaric chamber types.
- Hyperbaric oxygen therapy is not indicated for the type of knee injury Forte suffered. Learn more about FDA clearance and UHMS approval.
- University of Chicago wound care director Dr Lawrence Gottlieb seriously misrepresents the state of clinical evidence in the peer-reviewed medical literature on the efficacy of hyperbaric oxygen for chronic wounds, diabetic ulcers, radiation injury, and associated infections. Learn more about diseases and conditions treated with hyperbaric oxygen.
- WTTW reporter Paris Schutz wrongly concludes that only community hospital wound centers use hyperbaric oxygen chambers. Consider local university-affiliated hospitals like Loyola, Northwestern, and the University of Chicago's own NorthShore system, and national academic powerhouses like Mayo Clinic, Cleveland Clinic, and Virginia Mason.
We are grateful none the less for the link to the HyperbaricLink treatment center directory. On our website all interested readers will enjoy access to important clinical information and other reliable resources to set the record straight.
Friday, January 27, 2012
Carbon Monoxide Poisoning: Eau Claire, Wisconsin, Center Treats Three and Teaches All
Yesterday a faulty propane tank sickened 13 at a livestock rendering facility in Alma Center, Wisconsin. After treating 3 for carbon monoxide (CO) poisoning, the hyperbaric safety and technical director at OakLeaf Surgical Hospital took to the local media (and YouTube) to help educate the public about this most common cause of death and injury by poisoning. Philip Schell pretty clearly explains how CO kills and how hyperbaric oxygen works. Read more in the Eau Claire Leader-Telegram.
Thursday, January 26, 2012
British Forces Open "World-beating" Diving and Hyperbaric Test Centre in Gosport, Hampshire
By all appearances the newly refurbished Diving and Hyperbaric Test Centre (DHTC) at Haslar is indeed the state of the art in underwater safety testing and simulation. Defence contractor QinetiQ has made the facility available to the commercial sector as well. Read more at Advance: The UK Magazine for Aviation, Defence, Security and Space Industries.
Wednesday, January 25, 2012
Today's Wound Rounds LIVE Broadcast Postponed
Episode 4 of the interactive and always edutaining Wound Rounds LIVE, normally broadcast on the last Wednesday of every month, has been postponed until Wednesday 1 February 2012. Dr Jeffrey A. Niezgoda and Sharon Baranoski co-host the free webcast, which covers new technologies, products, and devices, clinical
insight, new procedures, and robust literature reviews covering every
aspect of wound care.
[Image: WebCME]
Tuesday, January 24, 2012
Alzheimer's Association Corrects Dr Oz Show
Yesterday the Alzheimer's Association joined us in correcting the Dr Oz Show for airing false scientific information about hyperbaric oxygen therapy. See our Friday post, "Hyperbaric Oxygen for Alzheimer's: Clinical Evidence Does Not Support Claims on Dr Oz Show." Writing for the Northern California and Northern Nevada chapter, chief program officer and research expert Elizabeth Edgerly, PhD, concludes:To the best of our knowledge, there is no substantive research evidence for this treatment in Alzheimer’s. A quick review of the published literature by the Alzheimer’s Association found no studies that support hyperbaric oxygen as a treatment for Alzheimer’s. And, as of today, there are no clinical trials of hyperbaric oxygen for Alzheimer’s listed on clinicaltrials.gov. For now, I wouldn’t put too much faith in this type of therapy for Alzheimer’s.
CLICK HERE to read the entire post. On behalf of the evidence-based hyperbaric medical community, HyperbaricLink thanks the Association for publishing this important information.
Monday, January 23, 2012
Hyperbaric Oxygen Treatment Centers: Advantages of Participating in the HyperbaricLink Directory
Let's pick one center at random from today's newsfeed. Almost precisely one year ago, we wrote with enthusiasm about the expansion of the hyperbaric wound care program at Oakwood Heritage Hospital, in your faithful correspondent's idyllic hometown of Taylor, Michigan. We immediately gathered what information was available and posted standard profile MI019 in the HyperbaricLink treatment center directory. Take a quick look and come right back.
What's missing? An email address to contact. The name of a medical director or administrator. What else? Without the benefit of any communication with the center, we simply don't know.
Now go read about the center on the hospital's website. About advanced wound care and hyperbaric oxygen therapy the hospital provides very little information for patients, families, and referring physicians. But here we do learn what conditions this center treats: chronic wounds, diabetic ulcers, skin grafts and flaps, osteomyelitis, and radionecrosis. That's three more than we listed. Had this center worked with us to publish a complete and accurate listing, HyperbaricLink visitors would get all the right information, complete with links to our trustworthy content on HBOT, diseases and conditions treated, the published clinical evidence, and plenty of helpful, reliable resources.
What other advantages might Oakwood Heritage gain by participating with HyperbaricLink? Try googling wound care taylor mi. Your local search results will differ from ours, but likely you'll find our directory listing equals or beats the hospital. List with us, link to us, and we all secure the top spots for the most relevant queries. About this subject we have dedicated an entire page, where you can also request our white paper on Internet Best Practices for Hyperbaric Oxygen Therapy Providers.
Only by working together can we make the evidence-based hyperbaric community more prominent and more discoverable on the web. And don't worry, Oakwood. We'll be in touch.
[Photo: Oakwood Healthcare website]
What's missing? An email address to contact. The name of a medical director or administrator. What else? Without the benefit of any communication with the center, we simply don't know.
Now go read about the center on the hospital's website. About advanced wound care and hyperbaric oxygen therapy the hospital provides very little information for patients, families, and referring physicians. But here we do learn what conditions this center treats: chronic wounds, diabetic ulcers, skin grafts and flaps, osteomyelitis, and radionecrosis. That's three more than we listed. Had this center worked with us to publish a complete and accurate listing, HyperbaricLink visitors would get all the right information, complete with links to our trustworthy content on HBOT, diseases and conditions treated, the published clinical evidence, and plenty of helpful, reliable resources.
What other advantages might Oakwood Heritage gain by participating with HyperbaricLink? Try googling wound care taylor mi. Your local search results will differ from ours, but likely you'll find our directory listing equals or beats the hospital. List with us, link to us, and we all secure the top spots for the most relevant queries. About this subject we have dedicated an entire page, where you can also request our white paper on Internet Best Practices for Hyperbaric Oxygen Therapy Providers.
ATTENTION Treatment Centers. Start your countdown to a complete and accurate listing in our directory. It's as easy as 3-2-1. See what's new and create the profile that's right for your facility.
CLICK HERE to learn more about directory listing options.
Only by working together can we make the evidence-based hyperbaric community more prominent and more discoverable on the web. And don't worry, Oakwood. We'll be in touch.
[Photo: Oakwood Healthcare website]
Sunday, January 22, 2012
NFL Divisional Playoffs: Which Players Are Using Hyperbaric Oxygen Chambers?
Are you ready for some football? Many NFL stars these days don't feel they are unless they've spent some quality time in a hyperbaric chamber, either to recover from sports injuries or to enhance their game performance. We find there's not much clinical evidence to recommend hyperbaric oxygen therapy (HBOT) for these uses. But to find out which Ravens, Patriots, 49ers, and Giants think differently and routinely use HBOT, or even own chambers, we turn to the Hyperbaric Therapy Center. Here's the lineup:
Baltimore: L.J. Smith and Ray Lewis.
New England: Albert Haynesworth, Herana-Daze Jones, and Shawn Springs.
San Francisco: Madieu Williams, Patrick Willis, Tony Parrish, and Vernon Davis.
New York: Hakeem Nicks and Mathias Kiwanuka.
We cannot confirm this list, and all names and spellings are the Center's. Most or all of these players use zip-up bags, or mild hyperbaric oxygen therapy chambers, as does the Center. Here's what we have to say about mild HBOT on our About HBOT page:
So-called mild HBOT, or mHBOT, is administered in inflatable bags that operate with room air (21% oxygen) at slightly increased pressure (< 1.5 ATA). Some mild hyperbaric devices are FDA-cleared for the treatment of Acute Mountain Sickness (AMS). None is FDA-cleared to treat any other disease or condition.In our opinion a mild hyperbaric device cannot safely deliver a therapeutic dosage of pressure. Using medical gases or oxygen concentrators with mild hyperbaric devices may also create a safety hazard. UHMS warns that hyperbaric treatment should not be self-administered or administered by nonprofessionals in the home. Also, we run across too many quacks and fraudsters in the mild HBOT and personal hyperbarics community. Their claims are as wild as their HBOT is mild. Still, many people with many diseases and conditions have reported real health benefits with mHBOT, and we eagerly await the publication of new clinical evidence.
This information echoes the National Board of Diving and Hyperbaric Medical Technology (NBDHMT), the chief certifying body for hyperbaric medical technologists. The NBDHMT stresses important safety issues in its April 2011 Position Statement on Portable, Fabric, Low-pressure Hyperbaric Chambers. Safety is of special concern when such devices are used for self-care at home alone.
None of these facts or opinions are stopping mild chamber manufacturers from recruiting NFL players and other sports celebrities to promote their devices for off-label uses. Every day the league and the FDA let it slide. We'll have more to report on this front before Super Bowl Sunday.
[Image: NFL.com]
Friday, January 20, 2012
Hyperbaric Oxygen for Alzheimer's: Clinical Evidence Does Not Support Claims on Dr Oz Show
To borrow a pun from this episode of the Dr Oz Show, the way some so-called experts talk about hyperbaric oxygen can be absolutely breathtaking. Board-certified neurologist David Perlmutter, MD, FACN, made some bold claims and did not hesitate to recommend HBOT for Alzheimer's disease to millions watching. CLICK HERE to see the video.
Perlmutter directs the Perlmutter Hyperbaric Center in Naples, Florida, and practices Functional Medicine, an integrative medical approach we cannot quite understand after considerable reading. Alzheimer's is not an FDA-cleared indication for hyperbaric oxygen, nor does the medical literature support Perlmutter's violative claims. From our Alzheimer's page:
Let's repeat and italicize that last line for emphasis: Patients and families should be wary of bolder claims.
[Photo: Video still from The Doctor Oz Show website]
Perlmutter directs the Perlmutter Hyperbaric Center in Naples, Florida, and practices Functional Medicine, an integrative medical approach we cannot quite understand after considerable reading. Alzheimer's is not an FDA-cleared indication for hyperbaric oxygen, nor does the medical literature support Perlmutter's violative claims. From our Alzheimer's page:
Hyperbaric oxygen therapy (HBOT) has not been shown to slow the progression of Alzheimer’s or other age-related dementias. Some physicians and families claim HBOT helps manage Alzheimer's symptoms and improve activities of daily living by increasing the circulation of oxygenated blood to functioning areas of the brain, but these palliative effects do not last.... Weak evidence from primary research and clinical trials does not support the use of hyperbaric oxygen for Alzheimer’s disease. Patients and families should be wary of bolder claims.
Let's repeat and italicize that last line for emphasis: Patients and families should be wary of bolder claims.
[Photo: Video still from The Doctor Oz Show website]
Thursday, January 19, 2012
In Memory of Eric P. Kindwall, MD, 1934-2012
American College of Hyperbaric Medicine (ACHM) executive director and hyperbaric medicine pioneer Dr Eric Kindwall died yesterday after long illness with cancer. He was 78. From the ACHM announcement:
Kindwall's family has expressed gratitude for all the well wishes he received from friends and colleagues in the past several months. See our 29 July 2011 post, "ACHM Saying Farewell to Father of Hyperbaric Medicine."
[Photo: ACHM]
His considerable contributions to hyperbaric medicine in education, publication, and organization of the field, are legendary. [He] was the founding chairman of the UHMS Committee on Hyperbaric Oxygen Therapy and would later create the first hyperbaric medicine course to train doctors and nurses.... Dr Kindwall published the first textbook in hyperbaric medicine, thereby consolidating much of the world's literature into a practical reference.
Kindwall's family has expressed gratitude for all the well wishes he received from friends and colleagues in the past several months. See our 29 July 2011 post, "ACHM Saying Farewell to Father of Hyperbaric Medicine."
[Photo: ACHM]
Wednesday, January 18, 2012
Blackout: In Solidarity with All SOPA Protesters
In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters In Solidarity with All SOPA Protesters
Tuesday, January 17, 2012
Hyperbaric Chambers Delivered in Style to Providence Regional Medical Center, Everett, Washington
They say Providence Regional is the last medical center in Snohomish County to get hyperbaric chambers. The Everett, Washington, hospital's new wound healing and hyperbaric medicine center is scheduled to open February 8. In the meantime, don't miss any of the wonderful photos installed with the full story on HeraldNet.
[Photo: Dan Bates/The Herald]
[Photo: Dan Bates/The Herald]
Monday, January 16, 2012
Postscript: Autism mHBOT Kerfuffle at Meadowlands Hospital Medical Center, Secaucus, New Jersey
The scandal continues in the New Jersey case involving hospital-sponsored mild hyperbaric therapy for children with autism. See our December 19 post, "Hyperbaric Oxygen for Autism: Evidence-based News and Further Reading." Now the main character in this story, director of the hospital's Neurosciences Center, has been fired and his appointment to the New Jersey Commission for Brain Injury Research delayed for review. Read all about it in "Meadowlands hospital neuroscientists fired over controversial autism treatment" on NJ.com. Controversial indeed. Go to our autism page for preliminary information on the clinical evidence and links to the medical literature and other resources.
UHMS Accredits Hyperbaric Medicine at Comprehensive Wound Care, Kinston, North Carolina
Comprehensive Wound Care in Kinston, North Carolina, has received accreditation from the Undersea and
Hyperbaric Medical Society (UHMS). The outpatient center is the only accredited hyperbaric facility in the state east of Raleigh. Read more on Kinston.com. Learn
more about facility accreditation in our UHMS profile and on the UHMS website.
[Photo: Charles Buchanan/The Free Press]
[Photo: Charles Buchanan/The Free Press]
Sunday, January 15, 2012
Please Stand By

"Do not adjust your set. The problem is with our transmitter."
At approximately 10:00 pm Central Time Saturday night our website, usually found at www.hyperbariclink.com, went off-line due to a technical problem encountered during a routine equipment upgrade. Our hosting provider, one of the largest in the US, tells us the issue is effecting dozens of websites and they've been working through the night to resolve the problem. Great.
Expect to see the site back up sometime this afternoon. We'll keep you posted.
Update, Sunday, 6:12 pm - The hosting provider says they're still struggling with it. For the technically inclined, the issue is apparently a significant problem with the storage array connected to the grid the provides CPU's for websites in our cluster.
Update, Sunday, 9:40 pm - And...we're back. An outage of nearly 24 hours isn't our favorite spare time activity, but this is the reason big hardware upgrades are done on the weekend. We resume our regular programming on Monday.
Friday, January 13, 2012
Traumatic Brain Injury: More High-Profile Coverage of Treatment with Hyperbaric Oxygen
From this local TV spot one might conclude the evidence is in on HBOT for traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD). It's not. But important research is under way, and when Michelle Obama appeared this week in Richmond, Virginia, she was making a case for training medical students how best to treat military veterans with TBI and PTSD. Once again we find the stories depicted here quite moving and the breach in scientific public relations somewhat disconcerting. See our December 28 post, "Hyperbaric Oxygen for TBI: Some Clinical Evidence New and Forthcoming," for our quick take on this important subject.
Thursday, January 12, 2012
Philanthropic Gifts and the Hyperbaric Oxygen Treatment Center
Lest we forget, hyperbaric treatment centers and other healthcare providers depend upon the thoughtful kindness of charitable donors. Volunteer auxiliaries and family foundations often lead the way to major building projects and capital equipment purchases. Two recent stories exemplify the role of philanthropy in the establishment of new hyperbaric oxygen therapy and wound care centers. Last month the hospital auxiliary at Northern Duchess Hospital in Rhinebeck, New York, fulfilled its $70,000 pledge to build a center slated to open in late 2012. The auxiliary raised the funds with bake sales, lunch events, and gift shop sales. In Nashville, Tennessee, the family of a former patient donated $5 million to expand the Wound Care and Hyperbaric Center at Baptist Hospital. The news inspired a nice piece in The Tennessean, including the following and a companion video primer on hyperbaric wound care.
[Video: The Tennessean and Baptist Hospital, Nashville]
[Video: The Tennessean and Baptist Hospital, Nashville]
Wednesday, January 11, 2012
FDA Social Media Guidance: More Insights and Commentary from Around the Web
One of our go-to healthcare social media observers, P. F. Anderson, has posted a thorough summary of the FDA's new guidance and a roundup of insights and commentary from around the web. Read "FDASM: Initial Draft Guidelines Focus on Social Media Requests for Off-Label Uses" on the Emerging Technologies Librarian blog. See our previous post on the subject. And enjoy the following slide presentation from Palio, a healthcare advertising agency based in Saratoga Springs, New York.
Tuesday, January 10, 2012
Carbon Monoxide (CO) Poisoning: Fumes Overcome 42 in US Merchant Marine Academy Dorm
A carbon monoxide (CO) leak, apparently from heating equipment, last night filled a dormitory at the US Merchant Marine Academy in Kings Point, Long Island, New York. The New York Post reports 42 midshipmen were sickened and 39 treated at local hospitals. Three victims with the highest CO levels were airlifted to the nearest emergency-ready hyperbaric oxygen chamber at Jacobi Hospital in the Bronx. Every year CO poisoning accounts for some 50,000
emergency room visits
and kills about
450 Americans
by accidental exposure alone. Visit our Carbon Monoxide Poisoning
page for more information about the use of hyperbaric oxygen and the
mounting clinical evidence for this FDA-cleared and UHMS-approved
indication.
Monday, January 9, 2012
National Board of Diving and Hyperbaric Medical Technology (NBDHMT) Recognizes Veterinary HBOT
The National Board of Diving and Hyperbaric Medical Technology (NBDHMT), in conjunction with the Veterinary Hyperbaric Medical Society (VHMS), now offers a Certified Hyperbaric Technologist-Veterinary (CHT-V) program. Qualifying applicants must complete
prerequisite training. NBDHMT is the chief certifying body for hyperbaric medical
technologists, including Divers Medic Technologists (DMT), Certified
Hyperbaric Technologists (CHT), and Certified Hyperbaric
Registered Nurses (CHRN). Learn more about CHT-V training and certification on the NBDHMT website. Read the full news release from Veterinary Hyperbaric Oxygen, Inc (Lexington, Kentucky), a veterinary HBOT chamber manufacturer behind the video of this adorable little horse.
[Video: Veterinary Hyperbaric Oxygen, Inc]
[Video: Veterinary Hyperbaric Oxygen, Inc]
Saturday, January 7, 2012
Board-Certified Hyperbaric Physician Doubles in Emergency Room and Wound Center
It's good to see another good hyperbaric physician getting some good coverage in the local news. Read about Dr Brian Paterick in the Wrangler News story "Undersea science inspires hyperbaric medicine doc." He serves both in the emergency room and as medical director of wound care and hyperbaric medicine. Last month Paterick (pictured right) received certification in Undersea and Hyperbaric Medicine from the American Board of Emergency Medicine (ABEM), and his Wound Healing and Hyperbaric Oxygen Center at Chandler Regional Medical Center (Chandler, Arizona) is accredited, with distinction, by the Undersea and Hyperbaric Medical Society (UHMS).
[Photo: Wrangler News, Tempe, Arizona]
[Photo: Wrangler News, Tempe, Arizona]
Thursday, January 5, 2012
OxyHeal Installs New Multiplace Hyperbaric Chamber at University of Toledo (Ohio) Medical Center
The new Center for Wound Care and Hyperbaric Medicine at the University of Toledo Medical Center (UTMC) has taken delivery of a model 8000-10 multiplace chamber from OxyHeal Medical Systems, Inc. The one-of-a-kind hyperbaric system was manufactured in six months and will be seamlessly integrated into UTMC's Heart and
Vascular Center. Read the full news release via PRWeb.
[Photo: OxyHeal Health Group]
[Photo: OxyHeal Health Group]
Wednesday, January 4, 2012
West Virginia Hyperbaric Wound Care Center Lands Choice Promo on Local TV Healthbeat
Here's a 4-minute clinic in how to promote your hyperbaric wound care center. Click here to watch medical director Rolando Cunanan, MD, clearly and soberly explain how he and his team heal with hyperbaric oxygen therapy at United Hospital Center (UHC) in Bridgeport, West Virginia. For a local TV news spot, with a junior healthbeat anchor, this is about as good as it gets.
[Photo: Video capture, WDTV.com]
[Photo: Video capture, WDTV.com]
Tuesday, January 3, 2012
Chronic Fatigue Syndrome: XMRV Debacle Makes List of Top Science Stories of 2011
Science Friday featured XMRV in its "Year in Review: Top Science Stories of 2011." We also recommend the Wired article "How a Collapsing Scientific Hypothesis Ended in an Arrest." Lawsuits. Jail. Death threats. The self-correcting mechanisms of science have rarely been so dramatic. See our December 23 post, "2009 XMRV Paper Fully Retracted," where we now note the authors of the only other study supporting a CFS-XMRV connection have also retracted their paper.Monday, January 2, 2012
FDA Quietly Issues Draft Guidelines for Manufacturers Responding to Off-label Info Requests via Social Media
A couple days after Christmas, with no warning or fanfare, the Food and Drug Administration (FDA) posted its long-awaited social media guidelines for pharmaceutical and medical device companies. Sort of. In the draft guidance for industry entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (see the Federal Register notice), the FDA for the first time considers communications via "emerging electronic media."
We see nothing here that should alter HyperbaricLink's position on FDA Clearance and UHMS Approval and the marketing of hyperbaric chambers as Class II medical devices. We note, with emphasis, the language beginning at line 392 of the document:
Click here to download the 15-page guidance document [PDF]. Interested readers will find worthwhile commentary and analysis at Ad Age ("FDA's Social-Media 'Guidelines' Befuddle Big Pharma: After Two-Year Wait, Guidance Addresses Only Off-Label Uses of Drugs") and on the Pharma Marketing Blog.
We see nothing here that should alter HyperbaricLink's position on FDA Clearance and UHMS Approval and the marketing of hyperbaric chambers as Class II medical devices. We note, with emphasis, the language beginning at line 392 of the document:
A firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information.
- The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
- The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.
Click here to download the 15-page guidance document [PDF]. Interested readers will find worthwhile commentary and analysis at Ad Age ("FDA's Social-Media 'Guidelines' Befuddle Big Pharma: After Two-Year Wait, Guidance Addresses Only Off-Label Uses of Drugs") and on the Pharma Marketing Blog.
Sunday, January 1, 2012
Hyperbaric Wound Care Helps Heart Attack Survivor Spend Holidays with Family
Hyperbaric oxygen therapy may have saved this man's life in more ways than one. Having survived a heart attack, Roger Wilkins needed open-heart surgery. But during the attack he also sustained a wound that required speedy healing before he could safely undergo surgery. Dr Tram Hill and the team at TMC Center for Wound Healing and Hyperbaric Medicine in Sherman, Texas, got the job done, the surgery was a success, and Wilkins was able to spend Christmas and New Year's with his family. Read the story and watch the video at KCII.com, the CBS affiliate serving Ada, Ardmore, Durant, Denison, Sherman, and Gainesville, Texas.
Most advanced care wound centers use hyperbaric oxygen to accelerate healing in chronic wounds. Wilkins's wound didn't fit the description of "skin ulcers or sores that do not heal without special treatment," but it surely required swift action and excellent results. And it could be that hyperbaric oxygen provided other important benefits in this special case. From our acute coronary syndrome (ACS) page:
Acute coronary syndrome includes heart attack, or myocardial infarction. Compelling evidence for hyperbaric oxygen received wider attention with the publication of a Cochrane Review article in August 2011. See our ACS page for more information, commentary, and links to helpful resources.
[Photo: KXII CBS video capture]
Most advanced care wound centers use hyperbaric oxygen to accelerate healing in chronic wounds. Wilkins's wound didn't fit the description of "skin ulcers or sores that do not heal without special treatment," but it surely required swift action and excellent results. And it could be that hyperbaric oxygen provided other important benefits in this special case. From our acute coronary syndrome (ACS) page:
Hyperbaric oxygen therapy (HBOT) may reduce the risk of dying, the time to pain relief, and the chance of future heart attacks in people with acute coronary syndrome. HBOT increases the supply of oxygen to the heart and may decrease the area of damage and death in the heart muscle. More research is needed to confirm the efficacy of HBOT in conjunction with standard regimens and to identify the types of patients who may benefit the most.
Acute coronary syndrome includes heart attack, or myocardial infarction. Compelling evidence for hyperbaric oxygen received wider attention with the publication of a Cochrane Review article in August 2011. See our ACS page for more information, commentary, and links to helpful resources.
[Photo: KXII CBS video capture]
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