Following a safety investigation by the TGA, Global Therapeutics, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury caused by an ingredient: Fallopia multiflora also known by the Chinese name ‘he shou wu’ (何首乌). It is marketed for hair thinning, ‘blood tonifying’ and a variety of other conditions.
It is now a TGA requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: ‘Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional’.
However, other products containing Fallopia multiflora continue to be promoted without these warnings (above). Do they escape warnings by being regarded as a food, not a medicine? See:
The university initially stood by the claim, but on Monday, following repeated questions from The Age and The Sydney Morning Herald it acknowledged there was no evidence to support that assertion.
It now has withdrawn the press release and launched an investigation into how it was produced, and said it would change its practices to always highlight industry funding.
The study itself involved dosing human cells in a lab with concentrated elderberry juice. There were no tests on humans, or even on mice. In addition, the press release did not mention the study was funded by Pharmacare, a company that sells elderberry-based natural supplement Sambucol.
“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” See also:
Relevant to concerns about FSANZ Standard 2.6.5 which has allowed products such as Souvanaid® and Ceretain® to be self-assessed and promoted for the dietary management of Alzheimer’s dementia or related mild cognitive impairment.
On supplements, WHO says: Vitamins B and E, polyunsaturated fatty acids and multi-complex supplementation should not be recommended to reduce the risk of cognitive decline and/or dementia. Quality of evidence: moderate. Strength of the recommendation: strong.
As reported by CBS News: Eating well, and possibly following a Mediterranean-style diet, may help prevent dementia, the guidelines say. But they take a firm stance against vitamin B or E pills, fish oil or multi-complex supplements that are promoted for brain health because there’s strong research showing they don’t work.
“There is currently no evidence to show that taking these supplements actually reduces the risk of cognitive decline and dementia, and in fact, we know that in high doses these can be harmful,” said the WHO’s Dr. Neerja Chowdhary. “People should be looking for these nutrients through food … not through supplements”. Maria Carrillo, chief science officer of the Alzheimer’s Association, agreed.
Neurofolin® (containing 15 mg of L-methylfolate calcium) is a self-declared food for special medical purposes promoted for dietary support of depression management.
Advertisments claim that L-methylfolate is, “an active form of folate known to be deficient in individuals with depressive disorders and helps nutritionally support mood regulation”.
There are listed medicines containing the same ingredient, such as L-5MTHF (ARTG no: 270098), whose TGA indication requirement states: “Product presentation must not imply or refer to mental illnesses, disorders or conditions”.
Mental illnesses such as depression are regarded as
restricted representations by the Therapeutic
Goods Act 1989. Advertisements for therapeutic goods may only refer to such
a representation if prior approval has been obtained.
Yet Neurofolin® is self-declared and promoted as, “a food
for special medical purposes for the dietary support of depression management”
and this claim does not need prior approval (according to FSANZ Standard 2.6.5).
I argue there is insufficient evidence to support the use of L-methylfolate calcium for depression, either as adjunctive, or especially as sole therapy. In my opinion, depression does NOT have special medically determined nutrient requirements for 15 mg of L-methylfolate calcium daily and there is no good evidence that the dietary management of patients with depression cannot be completely achieved without the use of this “food”. In short, Neurofolin® does not meet the requirements of FSANZ Standard 2.6.5.
In addition, I allege the advertising claims made breach
Australian Consumer Law (and would breach many sections of the Therapeutic
Goods Advertising Code if this product was classified as a complementary
medicine). Furthermore, the regulatory double standard involved is misleading
for consumers and unfair to the complementary medicine industry.
I have sent a complaint to the TGA, with a copy to FSANZ, because this is yet another example of problems at the Food-Medicine interface which both the TGA and FSANZ have so-far failed to deal with. I presume the TGA will hand-ball the complaint to the Victorian Health Department because the company involved is based in Victoria. Regardless of who deals with this complaint, I have requested a written determination as to whether Neurofolin® meets the requirements of FSANZ Standard 2.6.5.
case, and others such as Souvanaid®, Ceretain® and Neurothrive®, raise
important questions regarding the ability of product sponsors to self-declare under
FSANZ Standard 2.6.5 that their products are beneficial for serious conditions
such as depression and Alzheimer’s disease
without any independent assessment of all the available evidence. I argue that sponsor
self-determination of Standard 2.6.5 is inappropriate and an independent
assessment of evidence should be required before a product can be promoted as a
“food for special medicinal purposes”.
I have asked that the appropriateness of “food” sponsors to self-declare “food for special medicinal purposes” without independent assessment be addressed by both FSANZ and the TGA.
Join us for the Melbourne edition of this year’s global March for Science event. Bring a picnic lunch and a poster to celebrate science with us, and join in a panel discussion that will challenge and inspire you to be a better advocate for science.
When: Saturday, 4 May 2019, 12:30 pm-4 pm; Where: The Royal Society of Victoria, 8 La Trobe Street Melbourne
Starting at 12:30 pm we will hold a picnic on the grounds
of the Royal Society of Victoria (or on the ground floor of the building in
case of wet weather).
This will be free, but you will need to bring your own everything. There will be a poster competition with prizes to be awarded at about 3:30 pm. This is an opportunity to be creative *and* civil in your poster making (my poster is here).
The panel discussion, will be 2 pm to 3:30 pm, followed by tea and biscuits, for a $5 fee. Our host is Mike Flattley, CEO of the Royal Society of Victoria.
Dr Amy Edwards (Homeward Bound 3; Postdoctoral Research Officer, Ecology, Environment & Evolution, Latrobe University)
Dr Anita Goh (Homeward Bound 3; Superstars of STEM 2019; Clinical Neuropsychologist and Research Fellow, National Ageing Research Institute. Neuropsychiatry Unit, Royal Melbourne Hospital. Academic Unit for Psychiatry of Old Age, The University of Melbourne)
Dr Kudzai Kanhutu (Superstars of STEM 2019; Infectious diseases physician, Telehealth Clinical lead, Deputy Medical Information Officer, Royal Melbourne Hospital. University of Melbourne)
Mr Simon Pampena (Catalyst reporter and presenter of Outrageous Acts of Science) is is a leading Australian mathematician and communicator. He has also been honing his comedic skills with the goal of making math accessible to everyone.
March for Science is a non-partisan, grassroots movement calling for better science literacy, open science communication between scientists and the public, stable investment in science by the government, and evidence-based policy.
An illustrative example of products available in Australia from local Chinese outlets. Illegally supplied (no ARTG number), a potentially dangerous ingredient (Aconiti Kusnezoffii Radix), claims that breach numerous section of the Therapeutic Goods Advertising Code (No.2) 2018 (including promoting for serious disease such as TB). This product has been recalled from the market in Hong Kong, but not China. A complaint has been sent to the TGA but presumably it will be classified, ‘low priority’ as most are!
Also, in the Senate debate on the Therapeutic Goods Amendment Bill 2017, Senator Di Natale argued for an amendment:
‘All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective’.
But Senator McKenzie said:
‘ A statement required by the Australian government that the indication is not in accordance with modern medical knowledge and that there is no scientific evidence will be seen as arrogant and insensitive to those practising and using traditional Chinese medicine…. The government will not be supporting this amendment by the Australian Greens’.
Senator Di Natale’s amendment was lost.
One of the many fruits of the China and Australia Trade Agreement (2015) which strengthened cooperation in the field of Traditional Chinese Medicine?
These are illegally supplied and promoted products by Australian companies in breach of the Therapeutic Goods Act 1989. The companies involved are breaking the law. So why has the TGA hand-balled the latest publicised problem to ACT Health? This appears to be yet another example of food-medicine interface buck-passing between the TGA and FSANZ.
This is not good enough! Consumers are being put a risk. The ACCC (which takes consumer protection more seriously) must get involved.
A controversial government review that’s about to change what’s available for private health fund rebate.
The program featured Naturopath Barbara O’Neil and her Misty Mountain Health Retreat, “where some people come with quite serious illness, like Lisa”. Lisa has gone against her doctor’s advice to have surgery and put her trust in Barbara instead.
Barbara says, “If someone has cancer my suggestion is no fruit for 6 weeks…”. “It’s the cycle of life that proves why vaccines don’t work because the body can heal itself…”. A petition in support of Barbara currently has 21,689 signatures.
The government review that’s about to change what’s available for private health fund rebates will mean no more money back on things like Yoga, Pilates and Homeopathy from April 1, 2019.
A therapeutic Yoga teacher who works with mainstream organisations such as the Cancer Council of NSW said the changes will mean that many people will miss out on the health benefits of yoga because it’s going to cost them too much money now.”
Assoc Prof Jon Wardle said, “There is good evidence for some natural therapies, it’s just that the government review excluded it. It didn’t look beyond the English language, so things like yoga, where much of the research is Indian, things like Tai Chi, where much of the research is Chinese…. were not even looked at”.
In fact, Table 5 of the, “Review of the Australian Government Rebate on Natural Therapies for Private Health Insurance” detailed the relatively small number of potentially relevant studies excluded due to language difficulties. For yoga, the review assessed 67 systematic reviews and 111 randomised controlled clinical trials involving 31 clinical conditions and 6,562 participants. The report also noted that advice was sought from the Indian Council of Medical Research to identify appropriate research. Despite follow-up, at the time of writing the report, a response had not been received.
Also, the program did not mention that Jon Wardle is trained as a naturopath and his University Research Centre for Complementary and Integrative Medicine (ARCCIM) receives funding from the Jacka Foundation. The latter’s stated vision is, “A society where natural therapies are the first choice for people seeking informed control of their health and wellbeing”. In short, Wardle has a conflict of interest that was not reported.
When I was interviewed, I pointed out that the Private Health Insurance rebate is paid for by 100% of taxpayers yet it only benefits around 50% of people who can afford private health insurance. I agreed that exercise, including Yoga and Tai Chi is good, but why not subsidise gym membership or walking clubs? More money should be spent on prevention, but this should be for everyone, not just for those who can afford private health insurance. This and other relevant comments did not make it air.
Finally, making an informed choice means having access to good information, not the information purveyed by people like Barbara O’Neill.
I leave it to others to answer the question, was this was a balanced presentation?
The regulation of health claims for foods and complementary medicines is inconsistent; complaint systems are problematic, no effective penalties are applied for documented breaches of the law, and shonky (and dangerous products) are proliferating. The consequence is consumer detriment. There needs to be one ethical Code governing the advertising of health claims for food, medicines and medical devices and one timely, effective and accountable complaint system, with penalties that deter the profit that currently accrues from breaking the law.
I suggested that the ACCC should invite FSANZ to join the Consumers Health Regulators Group and the topic of consistent and effective regulation of health claims should be a high priority agenda item for this group.
In submissions to the Senate Community Affairs Legislation Committee on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, the Public Health Association of Australia, Choice and Friends of Science in Medicine suggested expanding the Therapeutic Goods Advertising Code to a Therapeutic Claims Advertising Code so complaints could be dealt with by one authority. In response, a submission from the Department of Health stated that it was beyond the scope of the Therapeutic Goods Act, and potentially the Commonwealth’s constitutional powers for the TGA, to manage complaints related to foods that make health claims.
Another suggestion was for the Australian Competition and Consumer Commission (ACCC) to act using s.18 of the Competition and Consumer Act 2010 which prohibits misleading and deceptive conduct. The ACCC responded: “While this is ultimately a matter for government, the ACCC is not in a position to step in where another regulator has resource constraints or makes a different assessment of priorities given our broad consumer and competition remit”.
We agree with the ACCC. The problems documented above should be a matter for the new government that will be formed after the 18 May 2019 election. We suggest the new government asks the Australian National Audit Office (ANAO) to revisit their 2011 audit of the TGA, add FSANZ to the terms of reference, and focus the audit on ensuring ethical health claims are made in both food and medicines.