Hyperbaric Oxygen Therapy (HBOT) has been used for many decades to treat a variety of maladies which have as their common denominator low tissue oxygen levels (hypoxia). Thanks to the pioneering work of Steve Thom and others, HBOT has also been proven to mitigate the impact of ischemia reperfusion injury.
The US Food and Drug Administration (FDA) has cleared HBOT (which involves the use of a medical device – a hyperbaric chamber – as well as a drug – oxygen) for a specific list of indications. If HBOT is used for conditions outside that list, it’s use is considered “off-label.” I have explained this in a previous article.
Because of the ability of HBOT to dramatically raise blood oxygen levels, it has been used for many years in cases of extreme blood loss anemia, including saving the life of patients who are unable or unwilling to receive a blood transfusion. The physiology is a fascinating discussion for another day. However, HBOT can sustain life in the complete absence of hemoglobin as shown by Ita Boerma in his famous experiment, “Life Without Blood,” published in 1959. Pigs whose blood was replaced by saline behaved normally under hyperbaric conditions, living off plasma dissolved oxygen, after which their blood was replaced and they were returned to the farmer.
There are numerous anecdotal reports of HBOT being used successfully to avoid intubation in COVID-19 pneumonia. Intubation in the setting of COVID-19 pneumonia has a mortality rate over 80%, and survivors commonly experience severe complications (e.g. pneumothorax, pressure ulcers, permanent lung damage, etc.). In contrast, the risks of HBOT are low and if patients do not improve, intubation can be performed.
In other words, HBOT has been an accepted treatment for hypoxia for more than 50 years and it is safe. Its use as an adjunctive treatment in COVID-19 pneumonia to avoid intubation should raise no ethical or medical concerns. It’s safety profile is better than the as yet unproven drugs currently being studied. In most cases patients are not even being charged for the treatment.
Why would the FDA wish to prevent HBOT from being used as a way to avoid intubation in COVID-19 pneumonia? What would motivate the FDA to refuse even an Emergency Use Authorization (EUA), or to refuse an Investigational Device Exemption for IRB approved clinical research?
I would like you to read this blog post by Dick Clarke. He describes his unsuccessful attempt to get the FDA to provide an EUA.
If any of you can explain why the FDA would take this stance, I’d like the insight. If you can’t explain it, then we will need to call our congressmen. I’ve reached out to mine already.
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
further evidence that the FDA often does more harm than good & needs a thorough overhaul
for decades this has been the case & clearly they are wrong …will write my Congress critters
You might as well ask why a medication that has been available for decades and thoroughly tested ( WHO study PRIOR to Covid 19 observed that with millions of doses cardiac deaths were not reported with HCQ) was suddenly maligned as being dangerous, (witness clearly fraudulent “studies ” published in major medical journals e.g. the Lancet + hydrochloroquine). Follow the money. If you can discredit any medication that costs pennies in favor of investigational agent drugs that cost thousands someone stands to make a lot of money. What are the current financial incentives for ICU stay and ventilation of patients? It should be inherently obvious by now that many FDA and other governmental decisions are strongly influenced by lobbyists with ties to the drug manufacturers and their stockholder’s. Key players are also subject to “leverage” (blackmail) Ask who all stands to make money when extra thousands of patients spend a great deal of time in the ICU setting. Even more disturbing is to ask yourself who benefits politically if death rates are high and hospitals are stressed … the narrative and its corollaries tell the population … what?
When it comes to the management of Covid-19 cases, FDA, WHO and CDC have miserably failed. Of course to a great extend these agencies have been discredited by the US Government under the pressure of the supreme commander!
When it comes to the management of Covid-19 patients, FDA, CDC and WHO have made mistakes. It is high time they increase their scientific capabilities, develop appropriate, well thought out guidelines and learn to be transparent
To be polite, it is another instance of: “The lunatics running the asylum!”
Dr. Fife:
Somebody, I thought it was you, linked to a series of articles re: HBOT use on pre-vent COVID patients in one of the meat packing plants in the midwest. I can no longer find those articles. If it was you, can you point me to the articles?
Brgds, Will.
An example of “The Tomato Effect”. Pulsed Hyperbaric Oxygen Is beneficial in several forms of central nervous system asphyxia:, blood loss anemia, CO poisoning, non judicial hanging and likely severe COVID infection where brain autopsies show widespread hypoxic changes.
“Everyone knows however that you can’t treat a cytokine storm with an oxidizer. That would be like throwing gasoline on a fire. Poison, just like tomatoes!
Since Dick Clarke’s blog suggests that the FDA is using the UHMS position on HBO for denying EUA for Covid 19, perhaps UHMS might consider modifying their stance to include recommending EUA by the FDA or the type of authorization that ECMO has received.pending published trials.
Also, it would be helpful to have a draft letter/call formulated and shared to contact Congress and HHS regarding this matter.
There’s a practical concern impacting general clinical use of such an otherwise ethically sound and scientifically reasonable modality. A Covid pt sick enough to be flirting with intubation is, eo ipso, too sick to be an HBO candidate for the vast majority of USA HBO facilities. This is often a consequence of deliberate “health system” choice (for economic reasons) to locate the HBO unit off-site from the hospital, where in-chamber monitoring, critical response, and general brain power would otherwise be available. Even many in-hospital units are equipped to treat only the walking wounded. Units enjoying crit care capabilities remain viable venues for future Covid HBO use. Unfortunately, they are in a meager minority.
I could understand and forgive the bias against HBOT if it was based on ignorance, but ignorance is no longer a valid claim. For example, we were asked to provide a proof-of-concept/rapid response HBOT-for-COVID-19 plan directly to Dr. Birx at the The White House. That plan outlined the use of two portable/inflatable HBOT chambers, capable of 2.0 ata, that can be installed directly in a single room in a COVID-19 ward, to avoid having to transport sick patients to the HBOT facility. The installation and necessary training can be accomplished in 48 hours, and the chambers will use oxygen concentrators to avoid tapping into the hospital oxygen system. Pressurization will be with ambient air, using a compressor designed for the chambers. The oxygen concentrators will enable continuous operations with 8 dives per day per chamber.
Since the FDA has already denied the issuance of an EUA for HBOT treatment protocols, the next step is the courts–specifically a Writ of Mandamus directing the FDA to issue an EUA allowing/including HBOT as an acceptable treatment protocol for COVID-19. The FDA’s mission is to protect the public health; it’s a shame–rather, it’s unconscionable if not derelict that the inclusion of a life-saving treatment with no side effects has to be brought into service through the courts.