Hangover products still advertised despite complaints and lack of evidence

From July 2018 to July 2020, complaints about a convenience sample of eighteen complementary medicine hangover products, by eight sponsors, advertised on thirty different Internet sites (cases) were submitted to the TGA. It was alleged that all these advertisements breached the Therapeutic Goods Advertising Code and, as they encouraged excessive alcohol consumption, they represented a serious risk to public health.

Complaint details follow:

Followed up on 17 March 2021:

Hangover products are still advertised, despite complaints and lack of evidence. This has occurred even though hangover cures are said to be priority 2 (after COVID-19) on the TGA’s list of advertising compliance priorities. While some products had minor changes made to their claims, the overall impact was minimal.

In addition, extraordinarily little information about these complaints was found by searching their complaint reference numbers in the TGA Advertising Complaints and Investigations Information database. More information was sometimes found in ARTG cancellations requested by the sponsor or in ARTG cancellations by the TGA. All relevant information should be transparently presented in the complaint database to assist consumers to choose products wisely.

More recently the TGA has closed complaints with a statement to the complainant, ‘the information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach’. No further public information is provided; there is now even less transparency about how the TGA is handling complaints.

Finally, hangover products are increasingly invoking the TGA’s new permitted indication, ‘Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of occasional hangovers in healthy individuals’. This permitted indication is nonsense and should be disallowed. Allowing traditional permitted indications undermines the scientific evidence base of complementary medicines.

Complaint AC-MW9QQH4F/2018, submitted 30 June 2018

The ARTG listings of all five BioRevive® Hydrodol® Hangover Relief Products complained about were cancelled by the sponsor on 29 Nov 2019, but then relisted with new ARTG numbers. The new products now claim only to support energy production and general health and wellbeing in adults, but they are still packaged as Before and After! See https://hydrodol.com.au/. Meanwhile, hangover claims persist on YouTube videos, e.g., ‘Hydrodol, natural hangover relief, taken while drinking‘ and Facebook.

Complaint AC-JY0FXQ3S/2018, submitted 07 August 2018

ARTG: 296905, Rejoove, Clever Health. No longer listed on ARTG, but still advertised with the same claims (now illegally) at https://rejoove.co/

ARTG: 291026, Recoverthol, Plus Daily Ltd. Still listed on the ARTG and still advertised, albeit with hangover claims and pictures of drink taken off the pack. However, hangover relief claims are still present in testimonials at https://recoverthol.com.au/how-it-works.

ARTG: 306807, Hangover Relief Boon, D & X Pty Ltd (and others). All ARTG listings were cancelled by the sponsor on 23 Mar 2020, but one is still advertised at http://www.dandx.com.au/Hangover-Relief.html. However, this product no longer appears to be sold.

ARTG: 304293, Hangover Relief, Body Armour Pty Ltd. Still listed on the ARTG and still advertised as ‘hangover relief + liver support’ with glowing testimonials at https://www.bodyarmour.com.au/.

Complaint AC-EN0KHC4U/2018 submitted 10 September 2018 and an AC-BGKWMZBG/2018; resubmitted 31 October 2019

ARTG: 297954, Rapid Recovery Hangover Relief, Phoenix Pharmaceuticals. No longer listed on ARTG but still being advertised (illegally) as ‘clinically proven’ by Chemist Warehouse and others.

12 November 2020; email from TGA, ‘case closed. The information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach.

22 January 2021, ARTG No:297954 cancelled from the ARTG by the TGA under 30(2) of the Act. However, the sponsor has requested an internal review of this decision.

o9 March 2021, relisted by the sponsor with a new ARTG no: 356374 and new name: Rapid Recovery SOS; not yet being advertised.

Complaint AC-JJFAKREL/2020, submitted 09 July 2020

11 November 2020, the TGA closed the following complaints noting, ‘the information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach’. Regardless, their promotion continues.

ARTG ID: 309239, Recovery Enhance, Enervite (Health Spring Australia). Pack still claims, ‘serious help for hangover symptoms’ (not on the ARTG permitted indications), still advertised at https://www.enervite.com.au/product/recovery-enhance/.

ARTG ID: 314758, N+ Hangover Relief, Life Biotech Pty Ltd. Invokes permitted indication, ‘Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of occasional hangovers in healthy individuals’, still advertised at: https://www.mrvitamins.com.au/products/nadvita-9354721000063.

We also have:

ARTG ID: 266432, Drink Smart, Australian Antarctic Ocean Bio-Technology Pty Ltd. Permitted indication: ‘Traditionally used in Asian medicine to decrease/reduce/relieve symptoms associated with occasional overindulgence in healthy individuals’. Advertised at Chemist Direct, etc.

In conclusion, hangover products are still advertised, despite complaints and lack of evidence for their claims. These advertisements breach the Therapeutic Goods Advertising Code, encourage excessive alcohol use and are a serious risk to public health. The TGA should act.

See also:

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COVID-19 Vaccines: Talks to U3A Melbourne City

Covid-19 Vaccines talk

COVID-19 Vaccines – Topics:

  • The Immune System
  • How vaccines work
  • Three ways to make vaccines
  • How COVID-19 vaccines compare
  • Side effects
  • Australian roll-out, 2021
  • Administration and precautions
  • Additional shots for healthy ageing
  • Resource links

This talk can be downloaded as a PDF

See also: https://theconversation.com/after-a-year-of-pain-heres-how-the-covid-19-pandemic-could-play-out-in-2021-and-beyond-156380

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Complementary medicines weight loss complaints submitted to the TGA in 2018-2019. Follow-up in February 2021.

From July 2018 to July 2019, complaints about a convenience sample of twenty-tw0 complementary medicine weight loss products, by eight sponsors, advertised on 140 different Internet sites (cases) were submitted to the TGA. FatBlaster products sponsored by Cat Media (Naturopathica) were highlighted.

The complaints and their TGA reference numbers follow:

These complaints were followed up in July 2020 by Monash Work Integrated Learning (WIL) students. They were reviewed again in February 2021. A detailed Excel file of the findings can be downloaded here; also, a PDF of the images of all products complained about in 2018-19, still advertised in 2021. An example follows:

All twenty-two complementary medicine weight loss products complained about in 2018-19 were still being advertised on February 17, 2021.

A paper is being prepared for consideration of publication.

Update 17/03/2021. A TGA infringement notice was issued to My Community Pharmacy (Junction Rx) for illegal advertising of Naturopathica FatBlaster Apple Cider Vinegar & Garcinia Max. This product no longer appears to be advertised.

Update 24/03/ 2012. CW IP Pty Ltd fined $53,280 for alleged advertising breaches (of unlisted products) on the Chemist Warehouse and My Chemist websites; also, Epharmacy Group Pty Ltd fined $26,640 for alleged unlawful advertising (of unlisted products) on the ePharmacy website.

See also: TGA fines Chemist Warehouse | AJP

However, the following products that also lack a current ARTG listing are still being promoted at the time of writing.

Once cancelled, a therapeutic good can no longer be imported, manufactured, or exported from Australia, but it can be sold until the stocks run out. Advertising a product not on the ARTG is a serious breach of the Therapeutic Goods Act, but it appears that the TGA (and most advertisers) do not usually check ARTG cancellations to see if this is occurring. Advertisements for these products also provide no indication that they have been delisted.

Meanwhile, ‘FatBlaster Clinical’ (currently still being sold) was replaced by ‘FatBlaster Platinum + Thermoburn’ and ‘FatBlaster Platinum Metabolism’. The cancelled ‘FatBlaster FatMagnet also has a new listing: ‘FatBlaster FatMagnet Max’ with a new ingredient (Opuntia ficus-indica) that also doesn’t work.

New FatBlaster products

TGA action (albeit limited) appears to have eliminated the imagery of slim people on eleven weight loss products; however, ten remained unchanged.

There has also been a move by sponsors to use ‘traditional’ rather than ‘scientific’ evidence and to reformulate weight loss complementary medicines as food shakes to take advantage of the food-medicine regulatory divide.

New FatBlaster formulations: Traditional use and Food shakes

Yet another complaint was submitted to the TGA about these ongoing matters (AC-OD3FYZZ4/2021, 19 Feb 2021); followed-up on 24 Feb 2021, by AQ-JY6VZ5LA/2021 as no response had been received.

On 22 March 2021 I received the following from Advertising.Enquiries@tga.gov.au:

‘ At the time of submitting your report of suspected advertising non-compliance on 19 February 2021, you were provided with a receipt number (AC-OD3FYZZ4/2021). This is your reference for this matter. You will no longer receive an email to acknowledge the report that has been submitted.

Our new advertising compliance framework describes the TGA’s intelligence led, risk-based approach in responding to reports of non-compliance. Compliance activities under the new framework are focussed on three key priority areas. For more information, please visit our approach to managing advertising compliance.

Additional information:

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Unnecessary, expensive and potentially dangerous supplements consumed by older Australians

Researchers are worried older Australians may be buying ineffective complementary medicine at the expense of evidence-based treatment options.

A new study found almost 75% of older Australians take at least one type of dietary supplement or complementary medicine, most of which are not recommended by current medical opinion. The researchers said that the widespread use of complementary medicine in this population raised questions about their marketing and promotion.

Complementary medicine by 14 757 respondents to complementary medicine question in the ASPirin in Reducing Events in the Elderly (ASPREE) Longitudinal Study of Older Persons (ALSOP) baseline medical questionnaire:

See also:

Hardly ‘borderline unethical’!

Numerous representative complaints have shown that this discrepancy between use and scientific evidence is largely due to unethical advertising by the complementary medicine industry. For example:

Promotional claims remain unchanged, despite new evidence that has resulted in the products no longer being recommended by current medical opinion. Examples include glucosamine for osteoarthritis and fish oil for ‘heart health’.

Irrational multivitamin / mineral / herbal combinations are extensively promoted for ‘stress, stamina vitality, etc.’, and to fill alleged nutritional gaps caused by busy lifestyles, while Australian Dietary Guidelines (healthy eating) are rarely mentioned.

Claims are extrapolating from a nutrient’s important role in the body to implying that taking this ingredient as a supplement will benefit normal healthy people. Examples include Coenzyme Q10 and nicotinamide riboside chloride (Vitamin B3).

Ingredients such as probiotics and multi-vitamins are added to unhealthy products such as ‘Kids Smart Vita Gummies’ and ‘Probiotic Choc Balls’ to give them a ‘health halo’.

Clinical trial results from specific, well-characterised herbal extracts are extrapolated to generic herbal ingredients, despite only being applicable to the extract used in the trial.

‘Traditional’ rather than ‘scientific’ claims are increasingly used, removing the need for complementary medicines to have a scientific evidence base.

Regrettably, the regulator (the TGA) has failed to address these issues.

Potentially dangerous supplements?

Complementary medicines are regarded by the TGA as low-risk products, but that does not mean they are without risk.

While it’s impossible to overdose on vitamins and minerals in food, it’s certainly possible to consume too much from supplements and experience adverse effects. This is especially so for fat-soluble vitamins that accumulate in the body such as Vitamin A, D & E.  Calcium supplementation has also been associated with kidney stones, gastrointestinal side effects, and possibly an increased risk of cardiovascular disease.

Green tea extract supplements used for weight loss have been linked to rare cases of liver damage that needed liver transplants. Herbal supplements can also cause serious adverse effects, such as allergic reactions to Echinacea; they can also interact with prescription drugs, for example St John’s Wort (Hypericum perforatum) interacts with many drugs and can nullify the effect of oral contraceptives.

In short, a healthy diet (Australian Dietary Guidelines) provides all the nutrients most people need and is without risk.  However, there can be good reasons to take specific evidence-based complementary medicines for particular purposes. The need for supplements should be discussed with your doctor.

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Resignation from TGACC

My resignation from the Therapeutic Goods Advertising Consultative Committee (TGACC) was precipitated by the non-response of Adj Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health, to long-standing issues raised yet again at the Skepticon 2020 regulatory panel session (see below). These include ineffectual and token enforcement of complementary medicines violations by the TGA.

The Therapeutic Goods Administration (TGA) regulates more than 10,000 listed products, mainly complementary medicines. Unlike registered prescription medicines, listed products have no pre-market evaluation. The TGA ‘trusts’ each product’s sponsor to obey the rules. There are only two TGA checks on the regulation of listed products: a small number of post-marketing reviews and the advertising complaint system.

TGA post-marketing surveillance assesses around 160 listed products a year (out of more than 10,000). Over the last five years, on average, around 75% of products assessed have consistently been found non-compliant, mainly because companies are unable to produce evidence to substantiate claims for efficacy.

Since July 2018, the TGA has had enhanced investigative and compliance powers to take over the advertising complaint system. The previous Complaint Resolution Panel (CRP) had upheld virtually all the complaints it received but had no power to sanction companies which repeatedly breached the Therapeutic Goods Advertising Code. While there was support for the TGA takeover, there were also concerns that the TGA had rarely acted on non-compliance with Panel determinations previously forwarded by the CRP.

Under the new complaint system, the TGA classified most complaints as ‘low priority’ and closed them by sending an ‘educational letter’ to the company concerned. This letter reminding the company of their regulatory obligations, but also pointed out that no further action would be taken. In the first year of the TGA takeover, there were around 2,000 complaints; in the second year, there were more than 3,000. Delays in dealing with complaints increased.

A review by consultants recommended that the TGA should stop dealing with individual complaints. As a result, outstanding and most new complaints were now closed by sending complainants a letter stating that their complaint will be used for ‘intelligence’ to set priorities.

‘Your complaint has been finalised. The information you provided will be used by the TGA to inform compliance and enforcement activities under the TGA’s updated advertising compliance framework. The TGA is transitioning towards responsive regulation by utilising an intelligence led, risk-based approach to compliance activities. Thank you for bringing this matter to the attention of the TGA’.

Why would anyone bother to submit any more detailed complaints now this is the only response? Presumably, the TGA hopes for just this reaction. They will then be able to cite a falling-off of complaints as ‘evidence’ that unethical advertising has been brought under control. See also the articles below.

My talk (which sets out the issues) is available: Ken Harvey: Background to the Review

A video of the session is available below (Q&A starts at 51:57 minutes):

My resignation letter. Response from Adj Prof John Skerritt and Health Minister Greg Hunt

See also the appended correspondence:

——— Forwarded message ———
From: Kenneth Harvey <kenneth.harvey@monash.edu>
Date: Thu, 12 Nov 2020 at 15:51
Subject: Re: Rapid Recovery Hangover Relief – Outcome of advertising complaint – AC-BGKWMZBG/2019
To: TGA Advertising <tga.advertising@tga.gov.au>

Dear TGA advertising people,

I was intrigued by your appended response to this complaint, first sent to the TGA on 10 September 2018 and again on 31 October 2019.

This product is still being advertised today, e.g.

It is still listed on the ARTG (no 297954) with a permitted indication: ‘Helps decrease/reduce/relieve symptoms of occasional hangovers’, despite the lack of evidence for this indication. 

Yet, your new advertising framework lists ‘hangover products’ as priority 2! 
Why have you closed this complaint, but taken no action?

Also, I have pointed out that additional hangover products have recently been listed on the ARTG

Why have you not asked the sponsors to justify the claims made and the ‘traditional’ indications cited

Do you believe these products are appropriate, given public health concerns about Australian alcohol consumption?

Please respond. Or, should I be writing to the Minister of Health (and Shadow Minister) about these matters?

Sincerely,

Ken

On Thu, 12 Nov 2020 at 14:59, TGA Advertising <tga.advertising@tga.gov.au> wrote:


Dear Sir/Madam,

Your complaint (Case Ref. CC-39UT49KT/2019*) received on 31/10/2019 in relation to the advertiser, The Trustee for CW IP Unit Trust T/as Chemist Warehouse for the advertising of Rapid Recovery has been finalised.

The action taken in relation to this complaint was: Reviewed in accordance with the updated advertising compliance framework.The outcome was: Case closed.

The TGA has closed this complaint and the information you provided will be used to inform the compliance activities of the TGA.

Our new advertising compliance framework describes the TGA’s intelligence led, risk based approach in responding to reports of non-compliance.

Compliance activities under the new framework are focussed on three key priority areas. 
For more information, please visit our approach to managing advertising compliance.\

While your case has been closed, the information you provided will help the TGA to understand what issues are causing the most harm to Australian consumers, and where to focus our compliance monitoring and enforcement efforts.For more information on the TGA’s Regulatory Compliance Framework, please visit the TGA website.

Thank you for bringing this matter to the attention of the TGA.

Kind regards
Advertising Compliance Section
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606

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Independent Review of the Therapeutic Goods Advertising Framework: Recommendations

In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new therapeutic goods advertising measures within two years from the commencement of the changes to the Therapeutic Goods Act 1989 to support these measures. Ms Rosemary Sinclair AM led the independent review, which was conducted during the first half of 2020 and recently published. The Australian Government has accepted all 22 recommendations in her report.

However, if these recommendations are to be implemented the TGA will have to radically change its culture.

Key recommendations and my comments follow:

Recommendation: The complaints management system should be ‘reset’ to focus on published priorities that provide public health and consumer benefit and improved compliance outcomes.

Comment: To-date the TGA has failed to deal with complaints about misleading and deceptive advertising of therapeutic goods in public health priorities such as obesity and alcohol. See: Complementary medicine weight loss products complaints submitted to the TGA in 2018-2019 and Complaints about numerous hangover products submitted to the TGA in 2018

Recommendation: The TGA should develop a clear regulatory position on the use of the broadened sanctions and penalties to protect public health and safety, enhance its compliance and enforcement skills and reflect on the lessons learned from the COVID-19 experience.

Comment: The report notes that the TGA tended to adopt a ‘light-touch’ approach to industry advertising violations. Consumer groups noted that enforcement actions were not used effectively to deter behaviour, with an overuse of educational obligations letters, and a reluctance and time-consuming process for enforcing harsher penalties. See: TGA Therapeutic Goods Advertising Compliance 2018-19 Annual Report: Comments. More recently, the TGA has taken useful action on COVID-19 problem advertisements, but this has yet to be replicated in other areas of public health importance. See: The TGA and COVID-19: Starting to use its compliance teeth!

Recommendation: KPIs should focus on priorities and compliance outcomes rather than processes and deadlines.

Comment: The broad consensus from Departmental staff and stakeholders was that the current KPIs were not fit for purpose as they do not show achievement of advertising compliance outcomes. It was also suggested that the current KPIs, which focus on the timeliness of ‘closing’ complaints may lead to the risk that compliance officers prioritise deadlines over consideration of broader public health and compliance outcomes. See: The TGA, KPI’s and the budget surplus

Recommendation: Case studies of the TGA’s application and interpretation of the Code should be published and educational activities more effectively focus on consumer and industry benefit.

Comment: The previous Complaint Resolution Panel (CRP) published determinations on all complaints dealt with. These were educative for both complainants, advertisers, and industry. In the new TGA system around 80% of complaints are classified as ‘low priority’ and closed by sending the advertiser a regulatory obligations letter. No details of the product, sponsor or alleged Code breaches are published in the advertising complaint database. While the current volume of complaints may preclude detailed determinations, representative case studies are required. See: Launch of TGA Advertising Hub – Initial experience of submitting complaints

Recommendation: Information on cross-sector issues and complaint trends should be shared with other regulators such as FSANZ and ACCC.

Comment: See Where food meets medicine: reform needed.

Recommendation: The Therapeutic Goods Advertising Consultative Committee (TGACC) should be refocused to enhance its effectiveness as a collaborative forum focused on better outcomes for consumers through effective advertising compliance by industry.

Comment: To-date, the TGA has largely failed to use TGACC member’s expertise to discuss problems and solutions. Typically the TGA talks at the TGACC rather than talk with the group.

Recommendation: The TGA should develop a periodic (e.g. every two years) stakeholder survey to evaluate satisfaction with stakeholder engagement efforts and perceptions of the effectiveness of the TGA’s compliance framework.

Comment: The TGA has conducted regular stakeholder surveys but only recently have some non-industry stakeholders been surveyed. In addition, the methodology has not been consistent. See: TGA stakeholder survey 2019 and Share your views in the 2020 TGA stakeholder survey

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Complementary medicine weight loss products complaints submitted to the TGA in 2018-2019. Follow-up July 2020

This research was conducted by a team of Monash University BSc students on a Work Integrated Learning (WIL) placement, supervised by Assoc Prof Ken Harvey.

Monash University WIL Medreach Team, July 2020

The team reviewed the following complaints submitted on:

The students found that all products complained about in 2018-2019 continue to be promoted today (29/07/2020). Screenshots of current advertisements are appended.

They also reviewed the following literature and found no evidence to support the claims made for ingredients used in complementary medicine weight loss products.

  • Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr. 2004;79(4):529-536. doi:10.1093/ajcn/79.4.529
  • Saper RB, Eisenberg DM, Phillips RS. Common dietary supplements for weight loss. Am Fam Physician. 2004;70(9):1731-1738.
  • Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. Med J Aust. 2008;188(1):21-25.
  • Lobb A. Science of weight loss supplements: compromised by conflicts of interest?. World J Gastroenterol. 2010;16(38):4880-4882. doi:10.3748/wjg.v16.i38.4880
  • Mullin GE. Supplements for weight loss: hype or help for obesity? Part III. Nutr Clin Pract. 2015;30(3):446-449. doi:10.1177/0884533615578918
  • Maunder A, Bessell E, Lauche R, Adams J, Sainsbury A, Fuller NR. Effectiveness of herbal medicines for weight loss: A systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2020;22(6):891-903. doi:10.1111/dom.13973

They highlighted 27 permissible indications that they believed facilitated weight loss claims despite the lack evidence to support them. These are listed here.

They submitted a paper on their research for consideration of publication.

Finally, the advertisements appended are a sample of complementary medicine weight loss products complained about in 2019-2019 that students found were still being promoted today.

https://www.chemistwarehouse.com.au/buy/88367/naturopathica-fatblaster-clinical-60-capsules
https://vitaminsonly.com.au/products/naturopathica-fat-blaster-max-60-tablets
https://www.chemistwarehouse.com.au/buy/71930/naturopathica-fatblaster-garcinia-max-60-capsules
https://www.westfield.com.au/products/pharmacy-4-less/fatblaster-triple-tea-fat-burner-60-tablets/0c888589-51f0-4509-b76d-2ddfdf91d30d
https://www.goodpricepharmacy.com.au/naturopathica-fatblaster-apple-cider-vinegar-garcinia-max-60-capsules
https://www.superpharmacy.com.au/products/naturopathica-fatblaster-reducta-appetite-suppressant-40-tablets
http://www.empiresupplies.com.au/impromy-metabolic-c12-30-capsules.html
https://www.chemistwarehouse.com.au/buy/90045/optislim-clinical-60-capsules
https://www.ebay.com.au/itm/Healthy-Care-Forskolin-125mg-60-Capsules-supports-weight-digestion-metabolism/253186748486
http://healthycare.com.au/index.php/our-products/weight-management/item/89318-hc-ultra-strength-garcinia-cambogia-10000-100-capsules?category_id=62
https://www.ebay.com.au/itm/BLOOMS-MELT-COMPLEX-60-CAPSULES-METABOLISM-THERMOGENESIS-GARCINIA-WEIGHT-LOSS/162770031097?
https://www.evelynfaye.com.au/cabot-health-metabocel.html

In addition, new weight loss listed products have been added to the ARTG. These include FatBlaster Platinum Metabolism which contains the same SLENDACOR™ ingredients of the cancelled FatBlaster Clinical with minor additions.

https://pharmacyjunction.com.au/product/naturopathica-fatblaster-clinical-60-capsules/
https://www.woolworths.com.au/shop/productdetails/91646/naturopathica-fat-blaster-platinum-metabolism

See als0:

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Towards independence from commercial interests in health

An important collection of resources from the British Medical Journal (BMJ)

Growing evidence shows that extensive financial relationships between industry and healthcare decision makers distort scientific research, medical education and the practice of medicine. The biggest problem is that industry sponsored studies produce more favourable results creating biased evidence that overplays benefits and downplays harms. In response, many individuals and groups around the world are moving towards independence from commercial interests in research, education, practice and policy. This BMJ collection charts and encourages that move.

https://www.bmj.com/commercial-influence

Editorials

Commercial interests, transparency, and independence
Ray Moynihan, Helen Macdonald, Carl Heneghan, Lisa Bero & Fiona Godlee

Declaring interests and restoring trust in medicine
Carl Heneghan & Margaret McCartney

Industry influence in indoor tanning research
Jerod Stapleton & Joel Hillhouse

Financial relations between leaders of US medical societies and industry
Jake Checketts & Matt Vassar

Commercial influence and covid-19
Ray Moynihan, Helen Macdonald, Lisa Bero & Fiona Godlee

Analysis

Pathways to Independence: towards producing and using trustworthy evidence
Ray Moynihan, Per Vandvik, Beate Wieseler, et al.

Improving researchers’ conflict of interest declarations
Quinn Grundy, Adam G Dunn & Lisa Bero

Research

“Asset exchange”—interactions between patient groups and pharmaceutical industry
Lisa Parker, Alice Fabbri, Quinn Grundy, Barbara Mintzes & Lisa Bero

Effect of revealing authors’ conflicts of interests in peer review: randomized controlled trial
Leslie John, George Loewenstein, Andrew Marder & Michael Callaham

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases
Bruno Goupil, Frédéric Balusson, Florian Naudet, et al.

Association between financial links to indoor tanning industry and conclusions of published studies on indoor tanning: systematic review
Lola Adekunle, Rebecca Chen, Lily Morrison, et al.

Mixed methods evaluation of workshops for citizen health advocates about financial conflicts of interests in healthcare
Ray Moynihan, Alice Fabbri, Lisa Parker & Lisa Bero

Financial ties between leaders of influential US professional medical associations and industry: cross sectional study
Ray Moynihan, Loai Albarqouni, Conrad Nangla, Adam Dunn, Joel Lexchin, & Lisa Bero

Opinion

I’m more susceptible to drug company money that I’d like to be
Lisa Parker

Cochrane announces a new, more rigorous “conflict of interest” policy
Karla Soares-Weiser

The sun is shining on the South: advocacy and regulation of conflicts of interest in Chile
Bernardo Aguilera, Juan Carlos Almonte & Rodrigo Irarrázaval

Can expert bias be reduced in medical guidelines?
Sheldon Greenfield

The world’s most influential medical leaders are still dining on pharma’s pizza
Ray Moynihan

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TGA stakeholder survey 2019

Perceptions of the regulation of complementary medicines: GPs & consumers

This 2019 survey follows the first TGA (2018) survey of consumer perceptions about the regulation of complementary medicines. GPs were not surveyed in 2018. Pharmacists have yet to be surveyed. The results speak for themselves. It is suggested that such surveys should be a regularly repeated TGA key performance indicator (KPI).

For general practitioners, Qualtrics surveyed a validated sample of 138 current general practitioners (excluding those in the medical products industry) who had heard of the TGA before participating in the survey. Fieldwork for the general practitioner survey was conducted between 24 June and 1 July 2019.

The questions about GPs perception of the regulation of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

The consumer sample was composed of 1,045 adult Australians aged 18 and above. The sample was weighted to achieve broad representation across age, gender, and state-based location. Fieldwork for the panel consumer survey commenced on 21 June 2019 and was completed on 26 June 2019.

The questions about consumer perceptions of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

See also:

Update 2020:

The 2020 TGA stakeholder survey used a different methodology, was not publicised. and was only available for one month. See: https://www.tga.gov.au/media-release/share-your-views-2020-tga-stakeholder-survey

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The TGA and COVID-19: Starting to use its compliance teeth!

Significant changes were made to the advertising framework of therapeutic goods during 2018-19. These included the TGA taking over the advertising complaint system, an updated, legally enforceable, advertising Code and stronger investigative and compliance powers. Yet the TGA initially appeared reluctant to use the powers given, preferring instead to ‘educate’ industry rather than enforce the Therapeutic Goods Advertising Code.

Consumer groups have long argued that penalties, not negotiation, is required for sponsors, advertisers and products who repeatedly violate the rules. To change behaviour, these penalties must outweigh the profit that comes from breaking the law.

The COVID-19 environment has finally stimulated the TGA to action. Marketers never waste a crisis and misleading, deceptive and dangerous advertising claims to prevent or cure COVID-19 have proliferated. These have been accorded high priority by the TGA who are now starting to enforce the Therapeutic Goods Advertising Code using their compliance teeth.

TGA actions have included:

  • Warning letters requiring advertisers to cease and desist advertising within tight timeframes (generally 48 hours).
  • Focusing compliance responses on the most significant breaches, e.g. illegal advertising of unregistered goods or use of restricted or prohibited representations.
  • Stronger enforcement action such as infringement notices.
  • Publication of the details of infringement notices, now being done upon issue rather than upon payment to maximise the deterrence impact.

For example:

Next, what about tackling other areas of consumer concern such as numerous illegal products not on the ARTG, and others that lack evidence such as weight loss, hangover, cognitive enhancement and detox products?

See also:

Our desired TGA: Enforcing the Therapeutic Goods Advertising Code using their teeth!
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