Russell has obtained documentation from the TGA (Therapeutic Goods Administration in Australia) that indicates that Nitschke does not have permission to import Nembutal. Link to this important article.
Nitschke, Nembutal and the TGA
by Paul Russell:
For some time now, Philip Nitschke has been claiming that he had ‘discovered’ a ‘loophole’ in the Therapeutic Goods Administration’s (TGA) procedures and protocols that would allow him to import the drug Nembutal into Australia.
The Adelaide Advertiser today (26th September) reports that, ‘…Nitschke has gained permission to import a drug used in voluntary euthanasia.’ Not so. Nor was there a ‘loophole’.
The TGA gave the following explanation today:
- The TGA has not approved the use of Nembutal by Dr Nitschke.
- Dr Nitschke has notified the TGA that he intends to use Nembutal for a patient under Category A of the Special Access Scheme (SAS).
- Category A of the SAS is intended to allow doctors to treat life-threatening diseases with medicines that may not yet have gone through formal clinical trials.
- Use of unregistered medicines under Category A of the SAS requires the use to be in accordance with good medical practice, but does not involve any approval process by the TGA.
- The TGA has written to Dr Nitschke advising him of these requirements and of the need for him to ensure his prescribing is in accordance with good medical practice
- There is a clear process for doctors to follow in order to import and prescribe unapproved drugs and if Dr Nitschke does not follow appropriate clinical practice, he could face a range of serious sanctions from professional bodies
- There are strong safeguards in place to ensure that practitioners act in accordance with good medical practice and Professional bodies have very high standards in place so that this occurs
The conditions under which an ‘unregistered medicine’ could be used seem to indicate that Nembutal would not qualify. It is not a drug which is ‘yet (to) have gone through formal clinical trials’; it could not be construed as ‘a treatment’ in the ordinary understanding of that term, nor could it be said that prescribing Nembutal would be ‘good medical practice’ given the fact that for use as a sedative, there are any number of legally available, effective alternatives. But, of course, providing a good night’s sleep is not really what this is all about.
The Advertiser article quotes Nitschke as saying: “The drugs will be provided to her (a Victor Harbor patient) with clear instructions,” he said. “ They are to help her sleep.
“If she breaches those instructions she will be aware there are significant dangers."
And, “The patient will also have to sign a statutory notification that she is aware of the risks associated with taking more than one tablet a night to help her sleep.”
Nothing new here. All prescription drugs come with instructions and, where there are possibilities of significant side-effects – warnings. The statutory declaration seems to be something Nitschke himself cooked up as a protection mechanism.
The Advertiser also says: ‘Dr Nitschke said there was not much doubt that Nembutal was the best end-of-life drug.’ Indeed.
Nembutal was, at one time, used as a sedative. However, its use ceased because of inherent dangers and the high risk of addiction. It remains in use in veterinary practice to euthanase animals and its only use in humans, in places such as Switzerland and Oregon, is to kill humans.
Euthanasia supporters can often be heard to say that ‘we put dogs out of their misery – why not humans?’ This implies either that we wish to treat dogs like humans or humans like dogs. Either way, Nembutal’s only use is to that end. Nitschke is kidding us to suggest otherwise.
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