Saturday, April 11, 2009


Untested implant linked to deaths

Ruth Pollard Investigations Editor, smh

April 11, 2009

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THE country's drugs watchdog has failed to regulate untested medical implants used in thousands of Australians over the past 10 years, allowing doctors to exploit a loophole to either produce or import the implants without having to register them.

Despite serious safety concerns raised by drug treatment experts, the Therapeutic Goods Administration has struggled to curtail the widespread use of unregistered naltrexone implants to treat heroin addiction.

Not approved for therapeutic use in Australia, the implants have been implicated in several deaths and many hospital admissions, leading to calls for their use to be suspended pending proper clinical trials and government registration.

Critics say people who request help for their heroin dependence should have the same regulatory prediction as those with other health problems to ensure they receive safe treatment.

Emergency departments are treating people in extreme distress and in rapid detox after a naltrexone implant and doctors warn these cases will continue unless the drug is regulated.
The Therapeutic Goods Administration claims its hands are tied and it is up to the Federal Government to toughen the regulations for unapproved medication and medical devices.

The parliamentary secretary responsible for the organisation, Senator Jan McLucas, said the Commonwealth had "limited powers to control the activities of individuals where they operate solely within state borders".

"The TGA is the safety regulator of medicines and medical devices, but it has no role in regulating the appropriateness of the clinical decision to use the naltrexone implants."

Such is the concern about the widespread use of naltrexone implants, the chairman of the Federal Government's medicines advisory group, the Australian Pharmaceutical Advisory Council, co-authored an editorial in the Medical Journal of Australia, calling for an independent review.

Lloyd Sansom and his colleagues wrote: "The disturbing suggestions of mortality and morbidity from unregistered naltrexone implants make a strong case for an independent review to determine whether this treatment is sufficiently safe for such widespread use.

"Constant vigilance is required to ensure that only new medications and devices of proven effectiveness and safety are permitted widespread use."

In the same journal, a group of emergency doctors from two Sydney hospitals reported treating 12 patients over 12 months with severe health problems related to the implants. Six of those had to stay in hospital for at least two days, while one was admitted to intensive care with acute renal failure, the doctors reported.

"These events challenge the notion that a naltrexone implant is a safe procedure … and suggests that adverse events with naltrexone implants are not rare or uncommon," they wrote.

That study was published one year ago and there is yet to be any action. The Herald put detailed questions to the TGA's principal medical adviser, Rohan Hammett, and to the secretary of the Department of Health and Ageing, Jane Halton, about the unregistered implants.

Both had expressed concern in the Senate Standing Committee on Community Affairs about the way the implants were used.

Neither responded to the questions - instead a TGA spokeswoman, Kay McNiece, provided a written response.

"It is important to recognise that the naltrexone implant is an unapproved product and as such neither the safety nor the efficacy of the product has been evaluated by the Therapeutic Goods Administration." she said. "The TGA is aware of the possible adverse events related to the use of implants and has actively sought information in this regard."

Ric Day, a professor of clinical pharmacology at St Vincent's Hospital and the University of NSW, said the failure of the TGA to "exert its power to deal with this problem" was difficult to understand.

The Age