When the drug naltrexone is swallowed, it blocks the action of heroin for about two days. Australians first heard about naltrexone as a new treatment for heroin dependence in 1997.
In the late 1990s, Dr George O’Neil, a Perth obstetrician, became a strong advocate of naltrexone in the treatment of heroin dependence and established a growing clinical service to provide this treatment to the soaring numbers demanding it. Dr O’Neil began to recognise the limitations of depending on drug dependent patients to administer naltrexone to themselves. When only taken intermittently, naltrexone was not only ineffective but also dangerous. Dr O’Neil began producing naltrexone implants and then inserting these surgically into some thousands of patients.
There has been considerable controversy in Australia for almost a decade because naltrexone implants have continued to be used very widely despite never having been approved by the relevant regulatory body, the Therapeutic Goods Administration (TGA). There has also been concern about the fact that Dr. O’Neil’s manufacture of naltrexone implants has never met the required regulatory standards.
On 22 October Ms Jane Halton, Secretary, Department of Health and Ageing, gave evidence to the Senate Standing Committee on Community Affairs. She said:
I can tell you that there has been a very long conversation with Dr O’Neil about the need to ensure that, if he is manufacturing, he meets good manufacturing practice. That has not happened, and the TGA is basically discharging its regulatory responsibilities in its dialogue with Dr O’Neil.
Ms Halton added:
…as has been pointed out to Dr O’Neil I do not know how many times, he can ensure that his manufacturing practice meets the standard that is required of every other manufacturer in this country. I do not think that is unreasonable.
Not only is Dr O’Neil not meeting required good manufacturing practice in production of his naltrexone implants, but the TGA and the Department of Health and Ageing may have been aware of this for some time. If that is so, why then have the TGA and the Department of Health and Ageing taken so long to act?
It has been well accepted since the thalidomide disaster that medical treatments should only be registered and provided in Australia if they have been proven to be effective and safe. If there is uncertainty about treatment effectiveness and safety but there is a plausible case for providing the novel treatment, rigorous research meeting required scientific and ethical standards is required. There is a good case for conducting naltrexone research in Australia but not for officialdom to tolerate an unregistered treatment which has also never met required manufacturing standards.
Australia has a good international name in health policy and regulation. Losing that reputation would inevitably have significant international consequences.