TGA balances Lateline

THE Therapeutic Goods Administration’s (TGA’s) Special Access Scheme (SAS) Category B, by which patients can access a range of unregistered medicines, came under fire from the ABC Lateline television program this week, prompting a balancing response.

The show made claims that patients were turning to the black market for medicinal cannabis products because of excessive red tape involved in the SAS.

The TGA made the strong point that Lateline itself provided the answer to the problem of difficulty of access when one of the interviewees, Justin Sinclair, stated, “There is a great paucity of evidence in the literature, at least when it comes to human trials”.

Evidence based medicine is the cornerstone of the Australian health system, the TGA said, providing for the best possible care, “and importantly, protection of patients”.

The scarceness of evidential data, including that around safety, “means that it would be inappropriate to allow access without appropriate clinical oversight and would risk the health and safety of patients”, the TGA argued.

“Medicinal cannabis products are not treatments of first choice, precisely because they have not yet been assessed for safety, quality and efficacy.

“Until they are, it is appropriate to protect patient safety to ensure that doctors using these products are making an appropriate clinical decision based on sound evidence.”

The TGA said that while it is working with states and territories to streamline necessary state based approval processes, it is concerned about patients turning to dangerous black market products.