Regulating unproven medicines a sore point even before COVID-19

People who offer complementary medicine and companies that profit from their use are opposed to new guidelines intended to protect patients.

Sep 08, 2020, updated Sep 08, 2020
The death of a 23 year old man at a music festival has renewed calls for pill testing. (AAP image).

The death of a 23 year old man at a music festival has renewed calls for pill testing. (AAP image).

More than 18 months ago, the Medical Board of Australia began consulting on options for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments.

It followed long-held concerns from the medical establishment that some practitioners were providing false hope through medicines, therapies and treatments that had not been sufficiently studied or otherwise found wanting. The biggest concern was that vulnerable patients would eschew conventional treatments, for example people terminally ill with cancer looking for a more natural cure instead, and possibly die as a result.

The board gave two options: retaining the status quo; or, its preferred option, the introduction of targeted guidelines.

“For consumers this should include improved safeguards and access to better information while still enabling choice,” the board said at the time.

“For medical practitioners, there would be clear, nationally consistent guidance about the Board’s expectations of medical practitioners in relation to the provision of complementary and unconventional medicine and emerging treatments. While some medical practitioners would need to review their processes and practices, the guidelines are expected to have a minimal regulatory impost.”

In the months that followed, the board received, and last week published, almost 13,500 submissions – a record for a board consultation. Some were from organisations, many from individuals, and about 1200 were considered out-of-scope. There was also a degree of confusion about what was at stake – such as outright bans instead of specific guidelines – and who was conducting the review, with governments, ministers and the Australian Medical Association wrongly accused of meddling.

The AMA, for its part, found the proposed guidelines to be “clear and comprehensive” but suggested they needed fine-tuning, particularly around definitions.

The Royal Australian College of General Practitioners agreed, saying integrative medicine should be distinguished from “alternative, unconventional and experimental medicine and therapies”. The college reiterated the need for practitioners to be open about the evidence base and risks, and for patients to discuss their use of complementary therapies with their GP.

But the Australian Naturopathic Practitioners Association, National Institute of Complementary Medicine, and the Australasian Academy of Anti-Ageing Medicine all called for the status quo to remain. They, and others in the sector, argued patients would be worse off.

While the board noted that some submitters were under the mistaken belief that it wanted to ban practitioners from recommending vitamins, for example, it still met opposition from corporate giant Blackmores.

The Federal Government has already, controversially, rejected calls to better regulate pharmacies where prescription drugs are sold alongside vitamins and supplements not required to meet the same standards.

Blackmores argued the board’s intervention would have a “very negative outcome for the health, wellbeing and freedom of choice of Australians”.

“The proposal would see a split between conventional doctors and integrative medicine doctors,” Blackmores stated in its submission.

“It would sanction doctors who use safe and effective integrative medicine in their day-to-day practice. Integrative medicine doctors combine quality conventional medicine with safe and effective complementary medicine to improve health and reduce unnecessary medical treatments.

“They embrace prevention as a first principle of healthcare, help manage complex illness and care for patients for whom conventional medicine has not assisted.”

The board was supported by another regulator, the Therapeutic Goods Administration, which has long called for practitioners and patients to be better education about complementary medicines.

In its submission, the TGA noted there were already low-risk complementary medicines and unconventional treatments in use, and suggested the board offer more stringent guidance in relation to higher risk interventions.

“At the moment it is a little generic,” the TGA argued, before suggesting an area that could benefit from more guidance.

“There could be more specific discussion of the challenging situation that medicinal cannabis has exposed for prescribers – unapproved medicines (obtained through Special Access Schemes), variable evidence for efficacy, strong pressure by some patient groups and individual patients for access to the products (with some seeing that it is a “right” to access a prescription substance).

“While the focus is on medicinal cannabis now, there will be other emerging treatments that will pose a very similar set of challenges for individual clinicians and for the Medical Board in the future.”

The board is considering the submissions.

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