Medicines

New endocrinology indications list will make TGA ‘laughing stock of the world’


TGA proposals to allow alternative medicine manufacturers to make efficacy claims based on traditional use rather than scientific evidence will make Australia the “laughing stock” of the world, critics say.

The regulator has come under fire for its draft list of permitted indications for complementary medicines, which features over 1000 indications ranging from the bizarre to the scientifically implausible.

The list – still out for consultation – would provide “greater certainty and protection for consumers” by placing boundaries on the currently unlimited list of descriptions that can be made for low-risk products, the TGA says.

But advocates of evidence-based medicine say the vast majority of ‘indications’ are unsupported by scientific evidence and many of which have no meaning in the western medical model.

For Traditional Chinese Medicines the permitted indications include “Moisten Dryness in the Triple Burner” and “Activate meridians/channels”.

Advocates are also seriously concerned that the approved list will allow manufacturers to make therapeutic claims for their products in areas such as pain [etc] based on tradition of use, which could be as little as three generations.

For endocrinological conditions, some of the permitted claims based on traditional use include:

  • Maintain/support (state mineral) absorption in bones
  • Helps reduce occurrence of menopausal symptoms
  • Maintain/support healthy pancreatic function
  • Maintain/support healthy reproductive hormone/s
  • Adrenal restorative
  • Maintain/support healthy thyroid gland function

Labels must specify that products are not suitable to treat serious hormone imbalances.

To make such claims, those who market alternative remedies are required to have documentary evidence of a tradition of use dating back 75 years, without which they could face “action” the TGA warns.

Associate Professor Ken Harvey, from the Department of Epidemiology and Preventive Medicine at Monash University, says the list was put up by industry and makes a mockery of the TGA.

The medicines watchdog has repeatedly ignored calls by consumer and doctors’ groups to require a disclaimer on labelling for complementary medicine to make it explicit where claims are not backed by modern medical science.

“There was a lot of concern previously that the TGA was too close to industry, and not considering consumer and health professional views and this is confirming that,” Professor Harvey told the limbic.

He pointed to trade agreement pressure from Chinese and Indian governments for Australia to open up its healthcare markets to their multi-billion dollar traditional remedy industries as possible reasons why the TGA was forging ahead with the plan, despite criticism from consumer and health interest groups. Professor Harvey also noted that the TGA’s funding model meant it is required to recover 100% of the cost of its activities from industry.

“To have traditional indications with no research, no evidence…is just crazy stuff,” he said.

“The TGA has lost the plot, I am sure they are embarrassing the Minister and causing a lot of bad publicity and I think they are going to be a laughing stock internationally,” he said.

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