As I surf the internet in search of new information pertaining to hyperbaric, all too often I come across individuals making statements regarding FDA approval and efficacy. These statements typically are not an article or video of their own per se; rather, they are found in the comments of blog posts, videos, and articles throughout the industry. This fact alone should cause the reader to give little credence to such comments. After all, if they had a real argument, they would be writing an article quoting opposing research and case studies. This however, is never the case. In no way am I eluding that the individuals making such comments about the efficacy of hyperbaric are in opposition to the therapy for reasons of profit; possibly they are, but maybe they just don’t know any better. Personally, I have found the latter of the two to be the more common case.
Let me give you an example that hits pretty close to home. My wife has an uncle who suffers from Multiple Sclerosis. Over the years, his condition has advanced to the point that he can no longer work and he has suffered recent injuries placing himself in a wheelchair, potentially for the rest of his life. Sadly, hyperbaric oxygen therapy has shown to be of great benefit in the treatment of MS. In fact, in the United Kingdom they have included hyperbaric oxygen therapy as standard treatment for more than two decades. However, here in the United States it is not FDA approved; therefore, many dismiss the treatment for their faith in the FDA, potentially turning away from something that could have played a pivotal role in their recovery. Remember that uncle… remember that he could no longer work… ironically his work was as a medical doctor. Yes, an M.D. He had no interest in learning about the therapy nor doing his own research as he firmly believed the FDA would have “thoroughly” done theirs. If they aren’t approving it as a treatable indication, then their must not be any benefit.
Hopefully you can see the error in this thinking. The FDA is the FDA, they are an organization that serves a purpose in our government and in medicine. They are not incorruptible nor infallible, it is an organization made of imperfect people with the aim of providing sound regulations for the medical field; thats it, nothing more or less. Nobody is perfect, especially the FDA!
Just because a condition is not an approved indication via the FDA does not mean the treatment has no benefit. It just means the FDA has not seen sufficient evidence in the form of clinical trials to make a conclusive decision. Does this make it illegal to treat someone with hyperbaric therapy who suffers from a condition that is not approved? No, a physician can prescribe a therapy and/or drug for any condition they deem suitable. This is what is meant by the term off-label. This is usually how case studies are developed which lead to larger studies, eventually leading to clinical trials held via a university or other body. Point being, these things take time.
Hyperbaric therapies could have potential benefit in virtually any condition; approval from an organization does not change this. It may help validate the therapy for conditions that are approved; however, it should never speak volumes against the potential for those that are not.
Greg Harris - Hyperbaric Warrior