A medical food for depression?

http://www.grunbiotics.com/neurofolin-for-depression

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.

Furthermore, this 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.

Postscript:

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March for Science Event, Melbourne 4 May 2019, Picnic and panel session

Hosted by the Royal Society of Victoria.

How Best Shall we Advocate for the Sciences?

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.

Panelists
  • 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.

More information is available here:

Online:                        EventBrite

Facebook:                   How best shall we advocate for the sciences – Facebook Event

Twitter:                        @ScienceMarchMel

Contact: Kate Ferris 0435124858

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MJA Insight: Two new articles on Food-Medicine regulation

Where food meets medicine: reform needed

Junk food advertising to kids: the list of shame

See also: FSANZ Sports Supplements Roundtable: Report on Discussions and Next Steps

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Traditional Chinese Medicine in Australia: Yunnan Baiyao

Yunnan Baiyao


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!


Yunnan Baiyao

See also, Yunnan Baiyao for (veterinary) patients with hemorrhage, neoplasia.

For a broader perspective:

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?


Minister for Trade, Tourism and Investment, Steven Ciobo, and Chinese Commerce Minister, Zhong Shan, sign a Declaration of Intent regarding Review of Elements of the China-Australia Free Trade Agreement, in the presence of Prime Minister Turnbull and Chinese Premier Li at Parliament House in Canberra

https://dfat.gov.au/trade/agreements/in-force/chafta/news/Pages/declaration-of-intent-on-reviews-of-services-and-investment-commitments-signed-in-canberra.aspx
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TGA fails to act on illegal sports supplements

ABC story at: https://www.abc.net.au/news/2019-03-30/canberra-fitness-community-not-fazed-by-sarms-health-risk/10930470

But, this problem was publicised last year and a complaint sent to the TGA


https://www.auslabs.co/

And there are more complaints to the TGA that have not been dealt with:

https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/

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.

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SBS The Feed, Session 2019, Episode 7, Cure or Quack

A controversial government review that’s about to change what’s available for private health fund rebate.

Presented by: Marc Fennell and Jan Fran

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.

But Barbara’s work as an alternative healer is under threat. “Unfortunately, it is claimed I’m a health risk now”.  She is currently under a prohibition order from the NSW Health Care Complaints Commission. Jane Hansen has also written about Barbara in The Sunday Telegraph, 30 Dec 2018, “Naturopath’s cancer ‘healing’ claims under the microscope”.

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?

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Food-medicine interface problems

FSANZ, Consumer and Public Health Dialogue, 27 March 2019, Canberra.

I’ve now provided a report of my presentation and the discussion that ensured.

Summary

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.

The presentation I gave to the FSANZ Consumer and Public Health Dialogue is available here: Food-Medicine Interface Problems: The need for reform

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.

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Lectures in Canberra; ANU & FSANZ

In Canberra from 25th-27th March 2019 staying at University House, a guest of the ANU.

Two lectures to ANU BHSc students:

One lecture to FSANZ Consumer and Public Health Dialogue:

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SBS Insight – Vitamins: Sorting science from scam

https://www.sbs.com.au/news/insight/tvepisode/vitamins-supplements

The vitamins and dietary supplements industry has doubled over the last 10 years – we’re now spending an estimated $4.9bn each year on complementary medicines. But while some medical professionals say they work, others say the scientific evidence isn’t there, and warn we could be wasting money and risking our  health.

Available on SBS OnDemand: https://www.sbs.com.au/ondemand/video/1448561731545

See also: A closer look at Australia’s most popular supplements

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Laboratory tests commonly used in complementary and alternative medicine


Malvern Natural Health Care
https://www.mnhc.com.au/about-us/


Does it? See: Laboratory tests commonly used in complementary and alternative medicine: A review of the evidence.

Ann Clin Biochem. 2019 Feb 27:4563218824622. doi: 10.1177/0004563218824622. [Epub ahead of print]

Abstract

It is increasingly easy for the general public to access a wide range of laboratory tests. Tests can be ordered online with little or no input from a health professional. The complementary and alternative medicine (CAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes. They range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘CAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in CAM testing. Some CAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories. In this review, we explore CAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. We will also review proposed changed to in-vitro diagnostic device regulations and how these might impact on CAM testing.

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