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?