The WA Minister for Mental Health, Mr Graham Jacobs, issued a press release on 9 January, announcing that his government would provide additional funds for Dr George O’Neil, Director of the Fresh Start Recovery Program, to assist the programme to continue surgical insertion of naltrexone implants into heroin users.
Naltrexone blocks the action of heroin. After being surgically inserted into the body, the implants slowly release naltrexone into the blood stream for several months. Several thousand naltrexone implants have been surgically inserted in Australia.
Jacobs said “the value and importance” of Dr O’Neil’s Fresh Start Recovery Programme is recognised by the WA Government, which provides substantial and recurrent annual funding to the service. Jacobs said the Drug and Alcohol Office had provided more than $8 million to the programme over the past eight years, including $1.153 million in the 2008-09 financial year.
A local community newspaper claimed that the WA Government had rejected a funding request of $3 million over three years because the treatment “is still experimental”.
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The Minister said that he had met Dr O’Neil in December 2008 and would hold another meeting with him and the Premier, Mr Colin Barnett, later in January to discuss his request for extra WA Government funding.
If Dr O’Neill’s program has received more than $8 million dollars from the WA Government over the past few years, how much has he received from the Federal Government? And when?
While Minister for Health, Mr Tony Abbott was an enthusiastic supporter of naltrexone implants although Dr O’Neil’s naltrexone implants were not registered with the TGA and were not supported by clear evidence of effectiveness and safety. Doctors inserting these unregistered implants have only been able to do so because they have exploited a loophole in the Special Access Scheme (originally designed to enable compassionate access to experimental drugs for the terminally ill).
Published articles in leading medical journals report patients requiring hospitalisation soon after receiving implants. This suggests that there may be something seriously wrong with these implants.
Naltrexone implants are potentially very high risk medical devices. According to internationally accepted standards of ‘Good Manufacturing Practice’ (GMP), naltrexone implants have to be produced in highly specialised aseptic (sterile) facilities approved by the national regulatory agency (the TGA in Australia).
Failure to meet the international manufacturing standards risks introducing potentially life threatening infections into the bodies of unsuspecting patients.
Patients having naltrexone implants (and their families) often say that they have to pay thousands of dollars for each implant and operation.
How many people have become seriously ill or experienced unnecessary pain and suffering because of implants which may not have been manufactured in an approved facility? Have there been any deaths?
On 22 October 2008, Ms Jane Halton, Secretary, Department of Health and Ageing, told a Senate Standing Committee on Community Affairs that authorities had made it very clear to Dr O’Neil many times that he needs to meet good manufacturing practice standards for naltrexone implants.
Why did the “authorities”, presumably referring to the TGA, have to make it clear on many occasions to Dr O’Neill that he needs to meet good manufacturing practice standards?
Surely this can only mean that these authorities have some concerns about Dr. O’Neill’s manufacturing practices. Interestingly, only a few years ago the TGA saw fit to remove over 1000 complimentary medicines manufactured by Pan Pharmaceuticals from retail sale when these medicines allegedly failed to meet GMP standards.
This raises the question, what has the TGA been doing about these naltrexone implants?
Surely the TGA has not been ignoring mounting evidence and concerns just because the recipients of the implants are ‘only drug users’? Australia requires a vigilant and diligent TGA to carry out its regulatory duty to all our citizens.