The Medical Board of Australia wants practice-specific guidelines to strengthen current guidance for medical practitioners providing patients with “complementary and unconventional medicine and emerging treatments” that includes stem cell therapy.
Concerns about insufficient information to patients and the ordering of inappropriate tests, prescriptions and treatments for vulnerable consumers prompted the board to consider additional guidance for practitioners in nine areas of practice. They are contained in a consultation paper released last week by the board.
To encourage feedback from stakeholders within the next two months, the board considered two options. Under Option 1, the status quo is maintained, although the board “could issue a statement drawing attention” to its Good medical practice: a code of conduct for doctors in Australia about the standards expected of all registered practitioners under the National Law.
Option 2, the board’s preference – and also that of rheumatologist and director of the Monash Department of Epidemiology, Professor Rachelle Buchbinder, proposes draft guidelines under nine headings: discussions with patients, knowledge and skills, conflicts of interest, informed consent, assessment and diagnosis, treatment, patient management, advertising and research and advancing knowledge.
While the TGA regulates human cell and tissue-based products as well as ‘complementary medicines’ that contain herbs, vitamins, minerals, nutritional supplements and homeopathy and aromatherapy preparations, ‘stem cells’ have not been regulated under therapeutic goods legislation. In 2015 the NHMRC stated that there was “no reliable evidence that homeopathy is effective” in any health condition.
And though CAM, complementary health care and alternative and integrative medicine are already used as ‘definitions’, the Board’s suggested definition of “complementary and unconventional medicine and emerging treatments” is designed to capture all elements.
For instance, “complementary” is to include the practice of herbal medicine and homeopathy, “unconventional” would include conventional treatments outside conventional protocols such as long-term antibiotics for Lyme-like illness, and “emerging” would include new, experimental treatments like stem cell therapy.
Clearer regulation, the Board proposed, was needed in the practise areas of CAM, Lyme-like illness and Lyme disease, stem cell therapies, platelet rich plasma, anti-ageing cosmetic regenerative medicine and anti-ageing treatments and therapies.
It is estimated that well over 40 private clinics already offer stem cell therapies in Australia, and that more than two-thirds of consumers use complementary medicines.
Professor Buchbinder, the lead author on a Lancet paper last year calling for an end to the millions wasted on ineffective treatments for lower back pain, would prefer a “more strongly worded” option by the board, “based upon evidence not convention”.
Professor Buchbinder hopes that if the guidelines are adopted, they “would curb the use of promising but unproven new therapies until they have been properly tested in high quality trials, and if they are used that the patient is fully informed that it is an unproven treatment”.
“I would hope that [they] would curb the use of both tests and treatments that have been proven to be ineffective and/or harmful but are still being used for a variety of reasons such as vested interests, beliefs contra to the evidence, or lack of knowledge about the evidence.”
“Stem cell therapies for MSK conditions remain unproven and should not be ‘going mainstream’, she warned, “until their benefits and safety are proven.
The guidelines, if adopted would act as a standalone document to be reviewed every five years and used alongside the board’s code. Updatable supporting documents that include the scope of and examples of the medicine and treatments covered would be available alongside the guidelines.