A feature of snake oil therapeutics is often the wide range of conditions that will be prevented or cured through use of the particular product or practice. Sometimes regulators are very slow to respond.
In Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518 the Federal Court has ordered Oxymed to pay $2 million for advertising medical devices intended to administer hyperbaric oxygen therapy (HBOT) in breach of the Therapeutic Goods Act 1989 (Cth). Malcolm Hooper, the Director of Oxymed, was ordered to pay $1 million in penalties for aiding, abetting, counselling or procuring Oxymed's contraventions of the Act. Hooper and Oxymed were also hit with costs. It is unclear how much wealth Hooper has accrued from HBOT over the past decade and whether the Commonwealth can extract the $2m from Oxymed, whose sole shareholder is reported to be his daughter.
The Federal Court found that Oxymed's advertising was "intended to engender in the unscientifically trained and vulnerable reader a perception of credibility" as to the claims regarding HBOT as a treatment for specific conditions, with the use of hyperbaric oxygen therapy to treat most of those conditions not supported by scientific evidence. Oxymed and Hooper were held to 'have a practice of posting pseudo-scientific articles targeted at a vulnerable audience'.
Rofe J considered that although HBOT presented a limited risk of direct harm to patients, "there is a potential for significant harm if patients with conditions such as cancer or HIV/AIDS defer or avoid orthodox evidence-based treatment" in favour of hyperbaric oxygen therapy, alongside a "risk of substantial financial harm to patients" depending on the duration of the course of treatment.
What did the supposed therapy cover? The judgment lists Alzheimer’s disease, Amyotrophic lateral sclerosis, Autism spectrum disorders, Autoimmune illness, Back pain, Brain injury, Carbon monoxide (CO) poisoning, Cellulitis, Cerebral malaria, Cerebral palsy, Near drowning, Chronic fatigue illness, Chronic infections, Complex pain syndrome, Concussion disability, Coronavirus, Crohn’s disease, Crush injury, Cytokine storm syndrome, Dementia / cognitive decline, Disc prolapse, Failed back surgery, Fibromyalgia, Fracture repair, Gadolinium poisoning, Hearing loss, Hospital infections (MRSA, VRE), Irritable bowel syndrome, Infertility, Kidney disease, Live[r] disease, Lyme disease, Macular degeneration, Multiple sclerosis, Muscular dystrophy, Motor neuron disease, Osteoporosis, Pancreatitis, Paraplegia, quadriplegia, Psoriasis, Radiation necrosis, Reflex sympathetic dystrophy, Spinal cord injury, Spinal instability, Sensorineural hearing loss, Stroke, Tarlov cyst, Traumatic brain injury and Ulcerative colitis.
Action by the Commonwealth comes rather late.
Hooper appeared in Chiropractic Board of Australia v Hooper (Occupational and Business Regulation) [2011] VCAT 641 with the Tribunal referring to allegations that Hooper failed to -
make a proper assessment; obtain informed consent; prepare and modify the treatment plan; liaise with other treating health practitioners and monitor outcomes. Further ... misrepresented the likely efficacy of treatment; engaged in misleading and deceptive advertising and maintained an inadequate clinical file.
Subsequent appearances include Chiropractic Board of Australia v Hooper (Occupational and Business Regulation) [2011] VCAT 2400, Chiropractic Board of Australia v Hooper (Occupational and Business Regulation) [2012] VCAT 1042, Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 236, and Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 417.
In Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 878 the Tribunal noted referral pursuant to s 59(2)(g) of the Health Professions Registration Act 2005 (Vic), with allegations that Hooper failed to undertake a proper clinical assessment of patient QS prior to recommending and undertaking HBOT, failed to obtain informed consent from QS, failed to prepare a treatment plan or an adequate treatment plan in relation to treatment of QS, failed to modify the treatment plan (if it did exist), failed to clinically monitor or evaluate any measurable improvement in QS’s condition, misrepresented the likely effectiveness of treatment and in advertising treatment regarding 30 named conditions was misleading and deceptive about the effectiveness of that treatment.
Some of Hooper's patients were unhappy. One died. During January this year in DPP v Hooper Anor (application for trial by judge alone) [2021] VCC 34 Hooper and Oxymed were the subject of charges re six offences under the Occupational Health and Safety Act 2004 (Vic), with a conviction - as yet unreported - on some charges more recently.
It would appear that Hooper finessed the regulatory frameworks by ceasing to present as a chiropractor (struck off in 2013) and only belatedly being caught under the Therapeutic Goods Act. That might provoke some thought about regulatory coherence. There is no requirement for registration of HBOT devices under the Therapeutic Goods Act.
