10 Aug 2015

Doctor censured over experimental drug

6:15 pm on 10 August 2015

A family doctor has been censured for failing to ensure a patient who died after being given an experimental drug was fully informed about the risks.

Health and Disability Commissioner Anthony Hill.

Health and Disability Commissioner Anthony Hill Photo: Supplied

In a report released today, Health and Disability Commissioner Antony Hill said the 45-year-old woman died in 2013 following treatment with a psychoactive substance, Ibogaine.

The drug is extracted from the root bark of a plant in the African rainforest, where it is used in low doses by indigenous peoples to combat fatigue, hunger and thirst, and in higher doses in religious rituals.

It was considered by Medsafe in 2009 and, the following year, listed as a prescription-only drug.

In today's report, Mr Hill said there was scant evidence of the drug's safety and efficacy, with no reported randomised clinical trials in humans.

He said the drug may cause sudden cardiac death up to seven days after treatment, but there was also anecdotal evidence that some people had gained benefits from it.

The unnamed woman had a history of drug use and sought treatment for her addiction at a clinic owned by Iboga New Zealand.

According to the report, she had been using various drugs since she was a teenager, and at the time she contacted the clinic she had been taking intravenous drugs.

She was given Ibogaine over two days and was found dead three days later.

The report said she received, over six doses, a total of 2220 milligrams over about 24 hours.

Mr Hill said that was not the normal treatment protocol, which would have been three treatments over four hours and no more than 1600 milligrams in total.

The woman's doctor left the country after giving the final dose, leaving her in the care of an assistant.

No treatment to be started on new clients

A post-mortem concluded there was a strong possibility that her death was related to Ibogaine ingestion - and, most probably, an irregular heartbeat.

Mr Hill has made several recommendations, including that the woman's doctor undergo a competence review if he returns to the country to practice.

Iboga New Zealand told the commissioner it had not carried out an investigation or review into the death because it was waiting for the coroner's report.

The company has decided no further Ibogaine treatment will be started on new clients.

The firm has also agreed to a review of its documentation, consent forms, processes and protocols before using the drug again.

Both the assistant and the doctor have apologised to the woman's family.