Frequently Asked Questions The Department of Health and Human Services’ Food and Drug Administration, or FDA, is the agency responsible for protecting the public health and regulating pharmaceutical drugs, biologics, medical devices, tobacco products, food, cosmetics and more. For a drug, medical procedure, or device to receive FDA approval, the manufacturer must prove that they are safe and effective. The FDA makes its decision by reviewing laboratory results, test results, and clinical studies. If a drug or device receives approval, this means the FDA determined that the benefits of the product or treatment outweighed the possible risks.
What conditions are FDA Approved
In the case of HBOT, there are currently 14 conditions FDA approved for treatment. The newest one received approval on October 8, 2011. These FDA approved conditions include:
Air or Gas Embolism Carbon Monoxide Poisoning Clostridial Myositis and Myonecrosis (Gas Gangrene) Crush Injuries, Compartment Syndrome and Other Acute Traumatic Ischemia Decompression Sickness Arterial Insufficiencies, such as Central Retinal Artery Occlusion Severe Anemia Intracranial Abscess Necrotizing Soft Tissue Infections Osteomyelitis (Refractory) Delayed Radiation Injury (Soft Tissue and Bony Necrosis) Compromised Grafts and Flaps Acute Thermal Burn Injury Idiopathic Sudden Sensorineural Hearing Loss
Why Are Some Conditions Not FDA-Approved Even Though HBOT Treatments Are Successful?
Because HBOT is still gaining in popularity and usage, clinical studies for all the potential conditions it may benefit have yet to meet FDA standards. This does not, however, mean that HBOT does not help or treat these conditions. In many cases, there are studies that show promising results and benefits already but they are not enough. Current conditions that show promise include Reflex Sympathetic Dystrophy (RSD) (also known as Complex Regional Pain Syndrome, or CRPS), Lyme Disease, Alzheimer’s Disease, Multiple Sclerosis, Macular Degeneration, and many more.
What current trials and treatments are showing promise?
While many of these conditions do not have FDA approval, studies are taking place to evaluate HBOT treatments and how they help. For example, Professor Uri Ashery from TAU’s Sagol School of Neuroscience and the Faculty of Life sciences show that hyperbaric oxygen therapy improves the pathology of Alzheimer’s patients, as well as corrects behavioral deficits associated with the disease. Dr. Daphne Denham, the nation’s premier expert on HBOT concussion treatment, for example, reports that 98 percent of her patients treated with HBOT within 10 days of suffering a concussion see symptoms resolved within 5 treatments or less. The U.S. Department of Veterans Affairs announced that it will offer HBOT treatment to veterans suffering from persistent post-traumatic stress disorder (PTSD). Pilot tests of this treatment are available at Oklahoma State Medical Center and David Grant Medical Center on Travis Air Force Base. A neurologist at the Florida VA, along with seven other states, now treat Traumatic Brain Injuries (TBIs) and PTSD with HBOT treatment. A study by Dr. Gary Steinburg of Stanford University shows how HBOT therapy promotes the production of stem cells in the bone marrow of patients suffering from a stroke. This stem cell production leads to brain healing, the growth of new brain cells, neuronic tissue, and repair of the white and grey matter in the brain.
Why is My Condition Considered Off-Label?
The term “FDA Approved” is something you may be familiar with. In contrast, a drug or treatment receives the term “Off-Label” when doctors use it to treat a condition that is not FDA approved. HBOT treatment, or hyperbaric oxygen, is only approved for 14 different medical conditions to date. However, physicians and researchers see positive results in many more conditions. Therefore, HBOT treats off-label conditions on a daily basis. This practice is not new to medicine. It would amaze you at how many conditions find relief through off-label use every day.
What does Off-Label Mean?
The term “Off-label” means exactly what it says. A doctor prescribes a medication that is not approved for a specific condition. The use of off-label treatment does not come on a whim. Physicians, researchers, and beginning clinical trials have shown positive or promising results with treatment. While it might not yet have FDA approval, it is an option for patients to make when it comes to their care. In many cases, physicians may prescribe medication and not even mention that it is off-label. In addition, while the treatment does not have FDA approval, other countries use it with great success and approval.
The use of off-label medications and treatments is nothing new to everyday medicine. It is also not something that is HBOT specific. By FDA rules, physicians have the ability to treat their patients with medications off-label and as a result, often find surprising results. When doctors use a medication off-label and find positive results, they trigger the beginning of medical research and clinical trials necessary to receive a new FDA approval. In the case of HBOT, physicians use and find success in treating many off-label conditions. These conditions include RSD, Alzheimer’s disease, Lyme disease, traumatic brain injuries, PTSD, Fibromyalgia and many, many more.
What other treatments outside of HBOT are considered Off-Label?
The use of off-label medications and treatments is nothing new to everyday medicine. It is also not something that is HBOT specific. By FDA rules, physicians have the ability to treat their patients with medications off-label and as a result, often find surprising results. When doctors use a medication off-label and find positive results, they trigger the beginning of medical research and clinical trials necessary to receive a new FDA approval. In the case of HBOT, physicians use and find success in treating many off-label conditions. These conditions include RSD, Alzheimer’s disease, Lyme disease, traumatic brain injuries, PTSD, Fibromyalgia and many, many more. Many other antidepressants are only FDA approved for depression. Off-label, they treat migraines, chronic pain syndromes, and brain injuries. For example, the drug Neurontin is FDA approved for seizures. However, besides seizures, most Neurontin prescriptions treat a variety of off-label conditions including shingles and peripheral neuropathy. As you can see, while hyperbaric oxygen and HBOT may not be an FDA-approved treatment for your condition, it may still be very effective in treating it. If you would like to learn more about how HBOT can help you, contact our office for a consultation with Dr. Spiegel. He will address your concerns and show you how the off-label use of HBOT can help.
What are the downside to Off-Label HBOT Treatments and Conditions?
There is one downside to off-label treatments with hyperbaric oxygen and HBOT. Insurance companies typically do not cover HBOT treatments that are not FDA approved. Despite numerous studies and proven success with off-label treatments, coverage is usually denied. Unfortunately, it may be a long time before many conditions receive approval. Patents on hyperbaric chambers ran out a long time ago, so there is not a lot of money in HBOT, unlike with new pharmaceuticals. Funding for the studies necessary to receive new FDA approval is not available. Dr. Spiegel, along with other physicians and researchers, continues to plead with government agencies for HBOT funding. After treating patients with off-label conditions for over 14 years, Dr. Spiegel is confident in HBOT.
Nevertheless, he will continue to fight for its approval. Meanwhile, we work with patients to create an affordable treatment plan.
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