The TGA has ignored advice from advocates of evidence-based medicine and adopted a new permitted indications list for complementary medicines, that critics say ranges from the bizarre to the scientifically implausible.
The list of over 1000 indications will allow companies to claim their product is TGA approved to “Moisten Dryness in the Triple Burner” or “Activate meridians/channels”.
When the list was released in draft form earlier in 2018, the TGA said its regulations would allow companies to make such claims based on ability to prove a tradition of use dating back 75 years.
However the proposals were blasted by supporters of evidence-based medicine, who said it would make Australia the laughing stock of the world.
Nevertheless, the TGA has pressed ahead and adopted the list, and says companies can now apply to have new indications considered for inclusion in the Permissible Indication Determination.
In its official response to objections the TGA said: “It is not correct to say that there is no evidence to support many proposed permitted indications”.
“Consistent with current arrangements, the permitted indications list includes indications that may be supported by evidence sourced from scientific literature or evidence of traditional use for example, based on long-term use and experience in a specific traditional paradigm outside modern conventional medicine, such as traditional Chinese medicine.”
The TGA also knocked back a call for mandatory labels on formulas making claims based on tradition of use warning consumers such claims are “not backed by good scientific evidence or accepted by most modern medical experts”.
And in a separate move, the federal government has ignored the recommendations by an independent review into the pharmacy industry to ban the sale of homeopathics in PBS-approved pharmacies and encourage signage in stores advising where complementary products are not backed by scientific evidence.
The decisions are “disappointing but not surprising, given the past track record of the TGA and the government rejecting sensible recommendations,” said Associate Professor Ken Harvey, from the Department of Epidemiology and Preventive Medicine at Monash University.
“The basic problem is the TGA gave the list to industry to formulate, and they came up with a list of over 1000 indications of which 86% can be satisfied by traditional evidence and of course that’s what they would do,” said Professor Harvey, a spokesman for Friends of Science in Medicine.
“Therefore, it’s perpetuating pseudoscience it’s putting traditional evidence on the same level as scientific evidence.”
The decision is at odds with the NHMRC’s hierarchy of evidence which puts traditional evidence and expert opinion at the bottom, and systematic reviews at the top, and its meta-analysis finding that there is no evidence for homeopathy, he added.
“It is bizarre you have one government department that says there is no evidence for homeopathy and another government department which equates it with scientific evidence.
“We used to have a tradition of blood-letting in western medicine for hundreds of years, we eventually discovered it killed people rather than helping them.
“Either the TGA is captured by industry, or they’re incompetent, or both.”