The agency has just issued a warning to consumers. As is so often the case, what they don’t tell you is more important than what they do tell you.
The agency’s warning begins, “No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.”
HBOT is approved to treat thirteen conditions: decompression sickness, thermal burns, non-healing wounds, necrotizing soft tissue infections (a.k.a. flesh-eating bacterial disease), acute traumatic ischemias (e.g., crush injury, compartment syndrome), radiation tissue damage, smoke inhalation and carbon monoxide poisoning, air or gas embolism, severe blood loss anemia, refractory osteomyelitis, compromised skin grafts, and clostridial myonecrosis (gangrene).
There are, however, many other conditions that HBOT appears to treat effectively, based on solid or promising research. Licensed physicians and healthcare institutions may legally use an FDA-cleared hyperbaric chamber to treat unapproved or “off-label” diseases and conditions, though it is illegal to promote or advertise such uses. A few doctors are already using HBOT off-label, but not nearly enough of them. Here are some of the off-label applications:
- Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD), both suffered most often by returning wounded veterans. Tragically, the Department of Defense refuses to use HBOT off-label for veterans, claiming that they don’t prescribe off-label medications and treatments for these diagnoses, and saying they can only use HBOT after it has been approved by the FDA for this use.
This isn’t even true. The DoD often uses antipsychotic drugs off-label to treat TBI and PTSD. About 20% of veterans diagnosed with PTSD—or nearly 87,000 patients—are prescribed an antipsychotic each year even though it is an off-label use.
In total, including prescriptions outside the military, nearly 280,000 individuals received antipsychotic medications in 2007. Yet over 60% of them had no record of a diagnosis for which these drugs are approved. Antipsychotic drugs were prescribed off-label for PTSD (42% of the patients), minor depression (40%), major depression (23%), and anxiety disorder (20%)—with about 20% having more than one condition.
- Autism. You may recall our story from two years ago where we told you about the successes one mother of three autistic boys had with HBOT. This treatment, like the treatment for brain injury, was pioneered by Dr. Paul G. Harch, president of the International Hyperbaric Medical Association Foundation.
- The American Cancer Society says HBOT can help when used as a mainstream treatment for the prevention and treatment of osteoradionecrosis, a term for delayed bone damage caused by radiation therapy. There is also some evidence suggesting HBOT may be helpful as an extra treatment for soft tissue injury caused by radiation.
- The Undersea and Hyperbaric Medical Society’s Committee on Hyperbaric Oxygen Therapy also recommends it for treatment of thermal (heat) burns, abscess in the brain or head, osteomyelitis (chronic bone inflammation) that does not respond to standard treatment, and blockage of the retinal artery (blood vessel in the back of the eyeball).
- Some research indications—where HBOT is performed on a more experimental basis—include acute carbon tetrachloride poisoning, cerebral palsy, cerebrovascular accident (acute-thrombotic or embolic), fracture healing and bone grafting, hydrogen sulfide poisoning, invasive aspergillosis, sickle cell anemia crises, brown recluse spider bites, and acute spinal cord injuries.
- Stroke, Lyme disease, major viral infections, multiple sclerosis, heart disease, sinusitis, head injuries, and many other problems may respond well to HBOT, but it is rarely prescribed for any of these conditions.
Oxygen is necessary for healing. HBOT saturates tissues with ten to thirteen times as much oxygen as can normally be breathed in. Hyperbaric chambers and hyperbaric oxygen therapy have been used clinically since the mid-1800s. HBOT was tested and further developed by the US military after World War I. Today, nearly every hospital owns a hyperbaric oxygen chamber. Most of these sit empty and unused.
With so many conditions that HBOT can treat effectively, why in the world should we keep people sick or in pain when we have the means to ease and even reverse their condition? And why is FDA issuing warnings to consumers to keep them from pursuing such a vital therapy?
The FDA’s consumer warning continues that HBOT is not “the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.”
The warning continues, “Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies.” “Proven medical therapies” like dangerous drugs and expensive, invasive surgery, perhaps?
This is part of the problem. The FDA tends to protect therapies that are non-natural and patentable, so that drug companies can afford to spend $1 billion on average for agency approval. Bringing these drugs through the approval process pays the agency’s bills, including salaries. Indeed much of the cost of the FDA is born directly by drug companies, which creates a huge conflict of interest.
The other piece of information left out of the FDA’s warning is that patents on HBOT tanks ran out long ago, so that bringing the therapy back for additional use approvals is very difficult if not impossible. The FDA is thus telling you not to use it for unapproved uses, but failing to disclose that other uses will likely never be approved, that pleas for government funding of HBOT research will go nowhere, and that the agency itself won’t lift a finger to do something about this situation, no matter how much human suffering this policy creates.
44 thoughts on “FDA Issues Deceptive Statement about HBOT (Hyperbaric Oxygen Therapy)”
My father was greatly helped by the use of HBOT. My father had a war injury from the 40’s that caused a wound the size of a 50 cent piece to never heal. HBOT was the only thing in 40 years to heal his wound.
Anyone who was educated in nutrition will realize that hyperbaric oxygen therapy (HBOT) is the way to go even though it has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. Do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.
Sometimes a personal story on how a procedure works is just as good as a hugely expensive clinical trial that nobody or no company wants to pay for.
I have used hyperbaric oxygen treatment after my foot surgery and my doctor said I healed faster than most people.
Wow. In the “Land of the Free and the Home of the Home of the Brave” this should not be happening! What has happened to ethics? Let alone consideration for those who are suffering.
Hi, I did the HBOT 3X. I have MS. It hurt the back of my brain. I took histadine and the pain went away. I think people should try the HBOT since it will be different for each person.
Gangrene maybe helped by EDTA/DMPS IV chelation…but the person may need Celiac help first..no gluten/dairy/soy/sugar…vitamins/good oils and LDN and take good minerals afterwards. HBOT did not help my brother’s gangrene…but a little. His cells were not made right due to Celiac (not absorbing nutrients due to gluten) to absorb the oxygen that was added to him by the HBOT. I did the HBOT at an acupuncturist…was $200. My brother’s was $1300 per time and he did it about 5X a week for 3 1/2 months at a local hospital.
PTSD…drugs may make it worse. It can be due to burned out adrenals due to Celiac and stress. No gluten/dairy/soy/sugar…vitamins/good oils, LDN, fish oil, Vit D3, Vit C, zinc and more may help instead.
Autistic kids…may need detoxing…Vit C and more and no vaccines and Celiac help. They may need Amour thyroid if heavy metals are blocking the thyroid. That would raise oxygen 24 hours a day.
It may help burns, cancer. stroke, spinal cord injuries and more and release stem cells. To me the people should be allowed to try it and see. The people may also need other help…vitamins/good oils/Celiac diet/acupuncture/exercise and more.
Diabetics..EDTA IV chelation may help unclog blood vessels and Celiac diet (no gluten/dairy/soy/sugar…vitamins/good oils and LDN)…not Diabetic diet may help.
Any condition where oxygen is low in the brain/body ,it may benefit. I pray it is always available to help people.
So the pharmaceutical companies cannot patent oxygen and therefore it must not be a good therapy. Scare off the public and make the MDs using it appear to be charlatans.
This is an excellent article, however, I saw no mention of HBOT for use in the treatment of
stroke or heart patients. I remeber reading an article by Julian Whitaker, MD concerning the
successful benefits of HBOT for both stroke and heart patients. Was this an oversight? Has
there been new research to indicate that HBOT would not be beneficial in these applications?
Could someone answer these questions for me?
Please stop limiting treatment protocals that have not had reports of harming patients. Also, remove your approval for drugs that have had reports of harming patients. Please do your job.
I consider the FDA to be the most corrupt agency of the US government !
The uses for hyperbaric treatment are just becoming understood, it is a important tool in the arsenal of treatments for any living thing. I am a benefactor of HBOT, and I have seen what it does to help others, it ‘s uses are almost to the point of being miraculous.
We really need to use it more to understand the potential and not hamstring it!!!!! That will only come through it’s continued use and experimentation!
When will the FDA be investigated for their conflicts of interest?
Where do these people come up with these absurd notions that Nano-silver isn’t an effective antibiotic?
I use it evry day and I gurantee it works.
If “a quick search on the Internet” could find actual cures that have “has not been cleared or approved by FDA.” then I’ve missed years of romance by deleting all those spam emails.
Selection of treatment by belief is bowing to tests of statistical effectiveness. The British health service relies heavily on the Cochran reviews and ACA will inevitably force the same in the U.S. Percentages talk and XX walks.
Every treatment costs the patient something even if it is only time. Would you waste your time on a treatment that regularly fails to help your condition? The patient is more important than the sad Billionaire trying to market an expensive machine.
Any treatment might be right for some subset of patients. A humanitarian would mine his records for those who do benefit, find what is special about them and seek approval to offer his treatment to that select few.
The sad Billionaire who can’t become a multi-Billionaire off of that subset must not be allowed to prey on those unlikely to benefit. Steve Jobs would be alive today if he had not been sold a meditation and herbal cure.
People with limited money or limited time should hope that the FDA runs interference for them.
@ Robert Cruder… Believe in our failed system if you like!! I will take my chances with a “meditation and herbal cure.” My mother died of complications from her cancer treatment!!
I use a machine just approved by FDA, to help with joint pain, high sugars, and other health problems. I have read research for HBOT, and believe it would help me quicker; but cannot afford it, and cannot find a Dr. who has it, and without coverage for it; cannot get it either. Thank you for the information confirming my belief that it will help me; if I can get it before dying.
You can buy portable Chambers for around $5,000. I do not know if there are restrictions on whom they may sell to. Some of them are quirky that way. You may need a Dr. prescription for one.
There are doctors out there that have them! Research DAN (defeat autisim now) doctors. Go to the TACA (talk about curing autism) website and find someone on there to ask. Even though ASD doesn’t appear to be your health issue, ther are so many people in the field with info that might be able to help you!
Why isn’t there a petition to the FDA to loosen up their restrictions on HBOT? As I was reading the article, I thought that there would be a petition for me to sign.
THE Pharmaceutical Cartel is treating symptoms with their poisons and toxins. They are not interested in curing the disease. To cure the disease would kill their cash cow. That would be the end of their cash flow. Their drugs are dangerous, and if taken long enough will in time weaken the immune system and cause other disorders to arise. This is how they enrich themselves at your expense. In time, more and more disorders will arise, and where you started on one pill, will in time become seven or eight or even more pills. Their number one agenda is profits, not health nor cures, because they have investors, and those investors demand profits above anything else, even healthcare. And this is a hugh conflict of interest when it comes to healthcare. Because when money is involved, real healthcare takes a backseat. This is the main problem when dealing with the Pharmaceuticle Cartel. But natural remedies do cure, and have been doing so for thousands of years. 2400 years ago, the “Father of Medicine”, Hippocrates, spoke these words: “Let thy food be thy medicine, and thy medicine thy food.” Those words still ring as true today as when he spoke them.
FDA, it is one of the most corrupt agencies, and the USSA is suffering from a Moral rot that as become endemic
Since cancer cells cannot survive in the presence of oxygen, it makes sense that HBOT may have tremendous potential as a cancer treatment because it saturates the tissues with oxygen.
In the local newspaper about a year or two ago, there was a feature article about HBOT and its use to treat PTSD. Apparently, many veterans have experienced tremendous relief from their PTSD symptoms after a series of HBOT treatments.
Considering how little oxygen we have in our atmosphere compared to centuries ago, and since I live at a relatively high elevation where there is less oxygen anyway, it stands to reason that HBOT has been found helpful in treating many illnesses.
Of course cancer cells can survive in the presence of oxygen. Cancer creates a new blood supply line towards its mass (angiogenesis) to survive. The concept that cancer can’t survive around oxygen is a myth. I am a natural medcine practitioner who has worked with cancer research and researchers. Cancer as a mass is generally multilayered and not unicellular. The core of a cancer tumor may be anaerobic but the rest of the cancer mass does just fine with oxygen and thrives on it. HBOT may actually stimulate angiogenesis and create more harm than benefit in Cancer patients.
It is true that some cancers do thrive with oxygen and neogenesis occurs. What is not being stated is the 150% increase in oxygen dissolved in the plasma. The induced oxidative stress will overwhelm the mitochondria of the mutated cancer cells and cause apoptosis. A little causes proliferation, a lot causes cell death. The same cannot be said for normal cells as the mitochondria are working well enough to regenerate the underperforming and improving the production of existing mitochondria. It is always recommended by people who know what they are doing with HBOT that patients need to be on added B vitamins and folinic acid to improve detoxification and antioxidants to battle the induced oxidative stress.
I found your post very interesting. I honestly don’t know anything about cancer/tumors but wouldn’t it be amazing if we could target the HBOT to the inner part of the tumor, the part you said can’t survive with oxygen and then suffocate the outter part with something like medicinal mud. Just a thought : ) I have recently thought about the idea of persuing a career in environmental/natural medicine. It just makes so much sense. I am an assistant pre school teacher and I see more and more “sick” kids all the time. I feel like as a teacher I am trying to modify behavior when really what I want to do is find and treat the root cause.
the scientific studies should not be the only tools for reporting the true facts –
It’s not bad to caution or warn about false hopes, but don’t sandbag me with misleading but authoritative pronouncements which short-change the truth.
Michelle Obama has recently convinced the senate in the USA to provide research funding for HBOT to treat soldiers suffering from PTSD and TBI. Dr Paul Harch the president of the International Hyperbaric Medical Association has researched and documented years of conducted trials advising the medical profession the benefits of HBOT. It has taken Michelle Obamah to stimulate and convince the senate to provide funding for research for neurological conditions.
Well Done Michelle you are a GEM and I know this research will convince the medical profession and the FDA Neurological indications should be funded by Medicare or private health funds.
Thank you Dr Harch your persistence, dedication and professional approach has been rewarded.
Again Vets lose, patients lose. The FDA should no must maintain a neutral stance on what it does in order to protect people from bad actors, not protect the bad actors. It’s disheartening.
You’ve hit the nail on the head in identifying this situation as a conflict of interest. Years ago, our government enacted conflict of interest legislation that reformed the Department of Defense weapon system acquisition procedures. Those provisions remain effective today.
Which begs the question: why are there not similar laws on the books to govern our health care system? The answer is that too many people in that system benefit financially from the status quo. From members of Congress, to FDA officials, to academic research centers, to major pharmaceutical companies, all of them feed at the trough. Yet the public remains silent in the face of abuses which, to an extent unmatched in other areas of government, cause human suffering and death.
I believe that real health care reform must begin with correction of these conflicts of interest. Otherwise, we will only be putting a Band Aid on a large, festering and growing sore.
Considering that the FDA doesn’t do any of its own testing and allows the drug companies to provide their own “fairy tales” to get approval, it’s amazing to me that they do know who to target for persecution. Good going guys, you are becoming very very transparent.
Good stuff here. I have read about all the benefits of HBOT and am sure it is an effective treatment for many issues as it just makes logical sense…that being oxygen as a healing agent. I have not had the need to try it yet though. However, anyone interested in the various oxygen therapy’s should also be aware of a product called Cell Food. It is a liquid containing dissolved oxygen, amino acids and digestive enzymes and works wonders for many ailments as well. All you do is mix 8 to 12 drops in a glass of water 3 times a day is suggested at a cost of about $30 a month. I highly recommend this product and there is plenty of reseaerch out there to read before buying. It was developed back in the 1940’s by the folks who developed the trigger for the atomic bomb as a way to detoxify themselves from radiation poisoning. I have been using it daily for about 4 years now and am in the best shape of my life at age 49. After stopping it for a week or so you really notice the difference as far as energy levels go. Try it!
Where do you buy Cell Food?
For all practical purposes the FDA is owned by the big pharmaceutical industry, and Congress knows it. For most practical purposes, Congress is also owned by the pharmaceutical industry (and the oil industry and the military industrial complex and so on ad nausea-um.). We should accept the understanding that the government’s so-call consumer protection agencies are actually business protection agencies. They function to mediate between the citizen and business to provide a comforting illusion of consumer protection with a minimum of interference for business.
In at least one European country, HBOT is used to treat cancers with success, but of course most U.S. citizens have absorbed the propaganda that everything we do is better than anything foreigners do, and that if it was any good, we’d already be doing it. With that imbecilic mindset, they would consider it “unAmerican” to criticize agencies like the FDA.
My mother did HBOT for 6 weeks/5 days a week for approx. 1 1/2 hours each time (that was as long as medicare would pay), however they didn’t even tell us it was available until my mother nearly died from a severe “staph” infection, which was basically killing any healthy tissue left in her lower back. It was amazing how well HBOT worked during the time she was authorized to use it. It seemed to help with her Rheumatoid symptoms too. I was very upset with the doctors that they hadn’t told us about it when mom was first diagnosed with the infection……..they couldn’t cause they can’t “advertise” it.
Actually, the information on the VA is incorrect as they have been successfully testing this therapy in experimental trials for veterans with head injuries and receiving good results.
what are you replying to?
If I ever get a stroke, the first place i’d head, for when I could, would be a hyperbaric oxy chamber for sure. Just think of all the people who could benefit from it, who have had a stroke, or other debilitating illnesses. It’s darn near criminal not to at least make it part of a treatment recommendation if other things have failed. what is there to lose at that point? There is one south of me that’s being used, and has been used for over 16 years now. Thank goodness!
I think it would be good to have a petition to sign urging the FDA to stop interfering with HBOT usage. It would also behoove us to state that there are enough conflict of interest red-flags to warrant an FDA investigation. Wonder to whom that could be sent – perhaps all the pharma-backed legislative officials we’ve elected.
Guess a petition to leave HBOT alone (both in word and deed) will have to suffice.
There needs to be an investigation alright. But with our present AG, Lois Lerner, it is a lost cause. It wasn’t long after she was appointed AG that a man was charged with extorting $50million from clients. Not only did she refuse to prosecute him, but he got to keep the money as well. I just wonder how much bribery he paid and to whom or where he paid it. But if we cannot find where Hillery’s state department lost $6BILLION, I doubt we could learn where a million or so from Mr. Extortion went. lol.
I used HBOT for a month, for treatment of a chronic pain disorder called RSD. It worked in all aspects. Objective tests proved my swelling was reduced, discoloration went away, and pain levels went to 0. I had to travel about 7,000 miles round trip to get it. When I returned and reported my findings to the VA, I got the same load of stuff about how the FDA doesn’t approve off-label uses, but many off my prescription DRUGS FROM THE VA ARE OFF-LABEL USE. I’m given Lyrica for pain, which is an off-label use–normally used as a seizu by the medication. Off-label is good for one, but not the other–What gives? As a result of no treatment by the VA, I must have my leg amputated.
VA DEntal watched my front tooth rot from the outside in all the way up to the root and did nothing. I complained about the odor and they STILL Did nothing. They get paid for denying care to Veterans. They, then gave me a dangerous 1 month long antibiotic regimen and I started having diarhea and other adverse effects from the overuse of antibiotics. During this time they gave me nothing to counteract the intestinal flora being destroyed. Probiotics would’ve been appropriate. This was all from the VA Dental clinic in Mandeville, Louisiana which never even looked busy! Finally one dentist apologized to me for the maltreatment I received and stated the stub of the tooth (which broke off due to decay) had to be pulled and pulled it. I now have a missing front tooth courtesy of the VA DEntal Clinic and their maltreatment. I think the VA purposely maltreats and mistreats veterans to ensure they die faster. I have been on a detox regimen since then since all kinds of bacteria go into your bloodstream from an infected root . I have researched this due to their egregious maltreatment.
Dear Doug Strand, I am glad HBOT helped you initially. I am very sorry that you need to have an amputation now. I also have RSD, whole body. May I ask where you successfully went for HBOT treatment of RSD? I know different centers experiment with different protocols for our condition.
Agreed! The VA has a tunnel view on healthcare! Go civilian! We had to with my father dealing with amputation from exposure to Agent Orange.. We believe the HBOT helped with his wounds. I spoke to a really great doctor after the fact, who told me, we should have started ozone therapy before the decision to amputate.. It’s been a rough recovery year and he’s still not walking on his own and sits in a wheelchair a lot of the day.. We are now doing Ozone Therapy for part of his recovery and it seems to be helping. Check out Dr. Robert Rowen, who is considered the Godfather of Medical Freedom! Good luck!
Does FDA’s HBOT warning to consumers constitute its whole interference?? The warning is probably in error but is still a legitimate government function. I want to know if FDA by itself or its influence on other government bodies has prevented consumer access to HBOT….warnings are ok but bans trample on liberty