26 September 2013

FDA Now Against Hyperbaric Oxygen Therapy

The FDA likes to be embroiled in controversy and they chose to do it quite regularly recently. This time they choose hyperbaric oxygen therapy. As is so often the case, what they don’t tell you is more important than what they do tell you. Yes, they are correct in issuing the warning as hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes.

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).”

What surprises me is the Department of Defense claims. They say that the will not use HBOT off-label because they claim that they don't prescribe off-label use of medications and treatments for veterans. If this were true, then the DoD needs to stop using off-label antipsychotic drugs to treat traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD).

In a study conducted in Israel, the use of HBOT helped TBI that had existed for many years and successfully. Yet the US DoD is rejecting this help for veterans. Where is our humanity? Oh, right, it is an off-label use. Yet 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.

Part of the warning says, “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.” I wonder which proven medical therapies they are talking about, dangerous drugs and expensive, invasive surgeries?

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.” Bold is my emphasis.

The final bit of information the FDA did not mention in their warning is that the patents on HBOT ran out years ago. This means that this therapy will not garner additional use approvals because the FDA cannot require money for approval. HBOT is a dead issue as far as FDA is concerned and human suffering can continue.

Congress needs to step in and limit the funds FDA can require for approvals and put some other restrictions and orders in place to encourage better actions. Otherwise like HBOT, other projects such as diabetes test strip accuracy won't be acted on either.

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