The tragic death of a 5-year-old boy in Michigan has sparked demands for increased regulation of hyperbaric oxygen therapy within the wellness industry, which currently operates with minimal oversight. Thomas Cooper lost his life on January 31 when a fire erupted in a hyperbaric chamber at the Oxford Center, an alternative medicine clinic located in Troy, a suburb of Detroit. Following this incident, the clinic's founder, CEO, and three employees have been charged in connection with Thomas' death.
Hyperbaric chambers are pressurized tubes where individuals breathe in pure oxygen to promote faster healing, though this creates a highly flammable environment. The FDA has approved this therapy for specific conditions like carbon monoxide poisoning and severe wounds, but the Oxford Center claims to treat over 100 conditions, many of which lack FDA approval for this therapy, such as cancer and autism. Despite this, using hyperbaric chambers for unapproved conditions is not illegal. The center expressed disappointment over the charges, stating that the investigation into the fire's cause is still ongoing.
Thomas was undergoing treatment for sleep apnea and ADHD, conditions not approved by the FDA for hyperbaric therapy. Michigan Attorney General Dana Nessel reported that a spark ignited the fire, resulting in the boy's death within seconds. The exact cause of the fire remains undetermined.
At a news conference, Nessel criticized the Oxford Center for prioritizing safety too low and highlighted the lack of regulatory authority to inspect other facilities without probable cause. Michigan law does not mandate oversight for hyperbaric chamber usage, restricting officials from conducting inspections without evidence of criminal activity.
The Troy Fire Department had inspected the Oxford Center periodically, with the last inspection occurring in March 2023. However, these inspections focus on fire and life safety, not the operation or maintenance of the chambers themselves.
John Peters, executive director of the Undersea & Hyperbaric Medical Society, noted that while hospitals follow National Fire Protection Association codes, there is no regulatory framework for hyperbaric therapy outside traditional healthcare settings. The society accredits facilities in the absence of government regulation, but many spas and wellness centers operate without such accreditation.
In response to Thomas' death, Michigan legislators Stephanie Chang and Sharon MacDonell are exploring regulatory measures. Chang expressed concern over the apparent safety lapses and aims to address these issues through legislation. MacDonell emphasized the need to prevent businesses from making unverified claims about the therapy's benefits.
The popularity of hyperbaric oxygen therapy has grown, partly due to celebrity endorsements, despite FDA warnings about unproven claims. Although fires in hyperbaric chambers are rare, a similar incident in Florida in 2009 resulted in two deaths and charges against staff members. Peters hopes Thomas' death will lead to mandatory accreditation for facilities.
Currently, there is no consistent oversight for hyperbaric therapy outside hospitals. The FDA regulates certain chambers as Class II medical devices but does not oversee medical practice. Other organizations, like the Centers for Medicare & Medicaid Services and The Joint Commission, have specific requirements but do not cover all facilities.
Michigan's health department and regulatory agencies do not oversee hyperbaric chambers, and facilities are not required to be licensed, a situation Peters finds alarming. He argues that even professions like hairstyling require licensing, yet hyperbaric chambers, which pose significant risks, do not.