$3 million penalty for clinic offering scam neurology therapies

A company that promoted hyperbaric oxygen therapy devices for the treatment of conditions including dementia and stroke has been ordered to pay $2 million in penalties by the Federal Court of Australia.

The Director of Oxymed, Mr Malcolm Hooper, was also fined $1 million in penalties for aiding, abetting, counselling or procuring the contraventions of the Therapeutic Goods Act by Oxymed.

The former chiropracter ran a ‘NeuroRecovery’ clinic in Melbourne, and was previously fined more than $700,000 over charges relating to the death of a patient  with multiple sclerosis and epilepsy who died after becoming unconscious during hyperbaric oxygen treatment.

Oxymed’s advertising was found by the Court to be ‘intended to engender in the unscientifically trained and vulnerable reader a perception of credibility as to the claims of [hyperbaric oxygen therapy] as a treatment’ for the conditions in issue. According to the TGA, which brought the legal case, the Court further concluded that Oxymed and Mr Hooper ‘have a practice of posting pseudo-scientific articles targeted at a vulnerable audience’.

Oxymed and Mr Hooper have been ordered to pay the Department of Health’s costs of the court proceedings, and have been issued with an injunction preventing them from advertising hyperbaric oxygen therapy devices for a period of seven years that have not been included in the ARTG, or in a way that refers to prohibited or restricted representations.

New guidance for depression in people with epilepsy

Clinical practice recommendations for the medical treatment of depression in adults with epilepsy have been released by the International League Against Epilepsy (ILAE).

Developed by a taskforce of international experts in epilepsy and psychiatry, the recommendations focus on first-line drug and non-drug treatments, inadequate response to first-line antidepressant treatment, and duration of such treatment and augmentation strategies within the broader context of electroconvulsive therapy, psychological, and other treatments.

First-line treatment for mild depressive episodes should psychological interventions, the ILAE recommends. Where medication is used, SSRI antidepressants are first-choice medications for moderate to severe depressive episodes. However, in patients who are partially or non-responding to first-line treatment, switching to venlafaxine appears legitimate.

The guidelines advise that antidepressant treatment should be maintained for at least six months following remission from a first depressive episode and it should be prolonged to nine months in patients with a history of previous episodes. Longer term antidepressant treatment should continue in severe depression or in cases of residual symptomatology until such symptoms have subsided, the recommendations advise.

Espionage claims for hospital PET scanner

A Sydney hospital’s acquisition of a PET scanner is facing opposition in NewsCorp media campaign that claims the $14m deal will allow the Chinese government to steal confidential medical data.

In an editorial published on December The Australian newspaper called for the Royal North Shore Hospital’s purchase of the scanner from Australian-based United Imaging Healthcare to be blocked under the Foreign Relation Act to prevent China stealing research data and patients’ personal medical information.

The editorial quoted un-named ‘intelligence sources’ claiming that the scanner would operate within the NSW Health system’s firewall and this would potentially allow healthcare data to be acquired by the parent company United Imaging Healthcare UK, which in turn is owned by Shanghai United Imaging Healthcare. The newspaper said this company’s shareholders might have links to the Chinese government, and thus there was a potential risk of data espionage.

The article suggested that the hospital consider alternative PET scanner vendors. The scanner industry has traditionally been dominated by US companies such as General Electric.

In a statement, the University of Sydney, which is responsible for Royal North Shore Hospital, said it’s contract to buy a PET scanner had not yet been awarded and did not breach any regulations, including  DFAT obligations.

“We have rigorous and clear processes to ensure all relevant checks and balances are completed; this includes an external independent assessment. We are jointly working with the Northern Sydney Local Health District on this tender for an important piece of medical technology equipment that will provide benefits for patients and researchers,” it said.