40 Years of Antibiotic Guidelines Anniversary Seminar, 13 November, 2018

Program: 40 Years of Antibiotic Guidelines Anniversary Seminar

Event Chair: Dr Liz Marles, Chair, Board of Directors of Therapeutic Guidelines Ltd.

Speakers:

  • Fighting Antibiotic Resistance in Melbourne Hospitals  Associate Professor Ken Harvey, School of Public Health and Preventive Medicine, Monash University
  • Surviving Antibiotic expert group meetings: Professor Bart Currie, Menzies School of Health Research, Royal Darwin Hospital
  • Embedding antimicrobial stewardship into acute care: Associate Professor Kirsty Buising, Deputy Director, National Centre for Antimicrobial Stewardship, Peter Doherty Institute
  • Improving antibiotic prescribing in primary care: Professor Paul Glasziou, Director,
    Centre for Research in Evidence-Based Practice, Bond University
  • New approaches to fighting antimicrobial resistance: Professor Lindsay Grayson,
    Director, Department of Infectious Diseases & Microbiology, Austin Health and
    Professor, Department of Medicine, University of Melbourne.

Media coverage: https://ajp.com.au/news/40-years-of-antibiotic-guidelines/

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Lighter Footprints Climate Change Forum: Hawthorn Arts Centre 30/10/18

Excellent meeting with over 400 people attending. Many suggestions for action.

See also: http://www.lighterfootprints.org/ and https://www.repowervic.org.au


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Letter to The Age 30/10/18: Probiotic Doubts (published)

I was disappointed to see that The Age published a full page, gushingly enthusiastic article about a probiotic product alleged to relieve and prevent mastitis (“Mums clamour for Aussie breast feeding probiotic“, 27/10). The article failed to report the dubious scientific evidence on which the claims are based. There have been published criticisms of the studies in question, including that some of the authors have ties to the company that owns the patent and markets the probiotic under study. This article should have been labelled “advertorial”.

Associate Professor Ken Harvey, School of Public Health, Monash University

See also:

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TGA Complaint Outcomes: Pharmacare Laboratories Ease-a-cold products

On 5 July 2018 I complained to the TGA about the promotion of Pharmacare Laboratories Ease-a-cold products (TGA reference AL-B81GN1V3/2018).

The TGA have now published the outcome of this complaint noting that in all cases that a breach was found, compliance was achieved by formal contact without any other action required.

The attached document contains screenshots (taken today) of promotion from the sites complained about. I argue they show that:

  1. Compliance has not been achieved in any of these sites. The name of the product, “Ease-a-cold”, the claims, “Scientifically/Specifically formulated to help shorten a cold”  and “reduce the severity of 31 different symptoms of a cold on your daily life”, are misleading, deceptive and lack evidence to substantiate them.
  2. The TGA has not addressed additional code breaches that were alleged, e.g. 4(1)(b), & 4(2)(a);
  3. The rationale for some breaches suggested by the TGA are unclear, e.g. 42DL(12), 22(5)and 42DLB(4);
  4. It is also unclear why the TGA found no Code breach for the Chemist Warehouse and Epharmacy web sites (illustrated).
  5. Public Summary Documents of several Ease‐a‐cold products continue to make claims that appear to breach the Code, e.g. 194706, 232713.

I have requested a meeting with the TGA to discuss these concerns.

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AHPRA to conduct pilot audit on advertising compliance in early 2019

A pilot audit to check health practitioner compliance with advertising requirements will be conducted by AHPRA in early 2019.

https://www.chinesemedicineboard.gov.au/News/Newsletters/October-2018.aspx

The pilot audit has been modelled on the well established approach to auditing compliance with core registration standards and involves adding an extra declaration about advertising compliance for two professions when applying for renewal of registration in 2018. (The National Law enables a National Board to require any other reasonable information to be included with a renewal application.)

The National Boards for chiropractic and dental are taking part in the pilot audit.

When applying to renew their registration, chiropractors and dental practitioners will be required to complete a declaration about their advertising compliance. The pilot audit will not delay a decision on the application for renewal.

Random audits of advertising compliance will advance a risk-based approach to enforcing the National Law’s advertising requirements and facilitate compliance by all registered health practitioners who advertise their services.

Regulatory Operations Executive Director Kym Ayscough said the audit for advertising compliance would provide opportunities to extend the current action under the Advertising compliance and enforcement strategy launched in April 2017.

‘This pilot audit will potentially improve compliance with advertising obligations across the entire registrant population, not just those who have had an advertising complaint,’ Ms Ayscough said.

‘It will also provide opportunites to become more proactive in preventing non-compliant advertising by registered health practitioners.’

The audit will be carried out by AHPRA’s Advertising Compliance Team from January 2019 and will involve a random sample of chiropractors and dental practitioners who renewed their registration in 2018.

‘One of the audit’s main objectives is to analyse the rate of advertising compliance for those practitioners who advertise and who have not been the subject of an advertising complaint in the past 12 months,’ Ms Ayscough said.

Other objectives of the audit are:

  • to inform the evaluation of the compliance and enforcement strategy
  • establish the rate of advertising compliance within the professions, and
  • address any non-compliance with advertising obligations identified during the audit.

A pilot audit report addressing the above objectives and including data analysis and recommendations will be prepared for National Boards to consider the pilot outcomes and implications for future compliance work.

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Therapeutic Goods Advertising Consultative Committee, First meeting today

This committee has replaced the now abolished Therapeutic Goods Advertising Code Council. Choice (Australian Consumers’ Association) was a member of previous Code Council (and Complaint Resolution Panel).

No doubt the failure of the TGA to invite Choice to this new Council was an “administrative oversight”, like government senators backing Pauline Hanson’s motion, ‘it’s OK to be white’!

The first meeting of the new committee is today. The members are:

Consumer organisations

  • Country Women’s Association
  • National Seniors Australia
  • Consumers Health Forum
  • National Rural Health Alliance

Health and healthcare

  • Australian Chronic Disease Prevention
  • Australian Traditional Medicine Society
  • Pharmaceutical Society of Australia
  • Pharmacy Guild of Australia
  • Royal College of General Practitioners

Media and Advertising Organisations

  • Interactive Advertising Bureau Australia
  • Communications Council
  • Commercial Radio Australia
  • Association for Data Driven Marketing
  • NewsMediaWorks
  • Ad Standards Australia
  • FreeTV Australia

Therapeutic Goods Industry

  • Australian Self Medication Industry
  • Complementary Medicines Australia
  • ACCORD
  • MTAA

Government

  • Food Standards Australia and New Zealand
  • Australian Competition and Consumer Commission
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TGA Consultation: Proposed therapeutic goods advertising code guidance

This submission by Alanna Rottler, Mal Vickers and myself  has also has been endorsed by Friends of Science in Medicine.

Our previous submissions to TGA consultations have noted that many recommendations made by civil society had been ignored.

Most have still been ignored in this draft Guidance document. Accordingly, we see little point in responding in detail to this consultation.

Instead, we wish to highlight the key point repeatedly made in previous consultations.

‘No amount of “guidance” will improve the current dysfunctional regulatory system for complementary medicines and advertising unless the TGA accepts that consumer protection is an equal objective to industry assistance and gains the will to act against companies that consistently break the law.’

Over the 18-year life of the Complaint Resolution Panel (CRP), the TGA received 755 complaints referred for non-compliance or because repeated upheld complaints about the same matter required regulatory action. The TGA have published the outcome of only 80 (11%) of these referrals (Mal Vickers’ research).

The TGA have failed to remove medical devices such as BICOM despite expert opinion pointing out that it does not fit the criteria of a legitimate biofeedback device and the claims made are preposterous.

The TGA have failed to act on multiple complaints about the commonest scam complained about: detox food pads.

The TGA have failed to act on companies such as Pharmacare Laboratories Pty. Ltd. that consistently break the law, nor have they targeted for post-marketing review products of public health concern, such as weight loss products, that have had many upheld complaints.

The TGA’s new complaint system is much less transparent that the CRP system it replaced. No information is provided by the TGA on complaints it decides are “low-priority”, even if complainants provide detailed allegations that the company concerned had broken the law. The TGA closes these complaints by merely  sending an “education letter” with no follow-up to see if these letters achieved compliance (which they usually do not).

Before it was abolished, CRP determinations revealed that around 80% of upheld complaints breached the Therapeutic Goods Advertising Code 2015 (and thus the Therapeutic Goods Act 1989) by containing misleading, incorrect or unbalanced statements which the sponsor was meant to have verified, but they could not!

The TGA has argued that its priorities are public health and safety, not protecting consumers from being deceived, misled, losing their money on products that don’t work, or having their health impaired because they have forgone more evidence-based solutions to their health problems. While this is convenient for industry and the TGA, it is appalling consumer protection.  It also disregards the purpose of the Therapeutic Goods Advertising Code 2015 and the Therapeutic Goods Act 1989 which the TGA is meant to uphold.

The critique by Commissioner Hayes of the financial services industry and their regulators is equally applicable to the complementary medicine industry and the Therapeutic Goods Administration. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.

 

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Natural health products the largest selling OTC medicines in 2015–16

From Australia’s health 2018 (full publication; 4 June 2018 edition); see also: http://www.abc.net.au/news/2018-10-03/chart-of-the-day-natural-therapies-vitamins/10328514

These results reflect the large amount of money spent on marketing these products (Swisse $50 million per annum) and the failure of the regulator (the TGA) to act on misleading and deceptive claims that target common insecurities of the public. For example:

In short, a triumph of hype, celebrity endorsement and regulatory inaction over science!

Are there any useful complementary medicines?

Yes, there are a few!  For example, folate for women wanting to get pregnant (preconception) and in pregnancy, iodine during pregnancy and while breastfeeding, Vitamin D in people with deeply pigmented skin, or chronic and severe lack of sun exposure for cultural, medical, occupational or residential reasons.

But most Australians can get what they need most of time from a healthy diet containing fish, fruit and vegetables. Supplements are no substitute for the latter!

And there is more and more evidence that many benefits touted are illusionary: https://www.theguardian.com/society/2018/oct/04/vitamin-d-supplements-dont-help-bone-health-major-study-concludes

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APHC 2018 Contested Policy: Complementary Medicines and Advertising Reform

Abstract:

PHAA Workshop – Complementary medicine and advertising reform

Chair:

  • Ken Harvey

Speakers:

Panel Discussion

  • Terry Slevin, John Skerritt, Jon Wardle, Alanna Rottler, Mal Vickers

Terry Slevin (CEO of PHAA) commented that Alanna & Mal’s research was important because it held the regulator accountable; it was also commendable that the Deputy Secretary for Health Products Regulation, Department of Health, (John Skerritt) attended, presented and engaged in the (often vigorous) debate.

Media coverage

Pharmacy Daily: Researchers challenge TGA

Monash School of Public Health Team

Alanna Rottler

Mal Vickers

Mal, Alanna and Ken

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TGA advertising system concerns: response from TGA

For background see: http://www.medreach.com.au/?p=2778

From: SKERRITT, John <John.Skerritt@health.gov.au>
Sent: Tuesday, 18 September 2018 21:13
To: ken.harvey@medreach.com.au
Cc: MCLAY, Nicole <Nicole.McLay@health.gov.au>; FRANCIS, Jenny <Jenny.Francis@health.gov.au>; SKERRITT, John <John.Skerritt@health.gov.au>
Subject: RE: Letter from ACCC – TGA advertising concerns [SEC=UNCLASSIFIED]

Dear Dr Harvey

Thank you for your email.

Like other regulators, including the ACCC, we apply a triaging or categorisation framework to complaints. In this regard I note that the ACCC has, for example, in recent years moved away from using the term ‘complaint’ and encouraged consumers and small business to ‘report’ information that may represent a breach. Noting the importance of concentrating on the most serious complaints the ACCC has also acknowledged that it may not provide a response to each report. Similarly, as you have advised publicly in recent days, the Ombudsman also triages complaints. Like other bodies they focus on genuine, most serious matters.

For our part, our advertising complaints framework takes into account, among other things, the objects of the Therapeutic Goods Act 1989. The objects are clear in their focus.  It is the provision of the establishment and maintenance of the national system of controls of therapeutic goods based on their quality, safety, efficacy and timely availability. The object of the Advertising Code 2015 is also important; to ensure that marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer.

Accordingly, we have, since our assumption of responsibility for all advertising complaints, applied a risk based framework to manage the receipt and consideration of complaints about therapeutic goods advertisements.

Priority is given to matters that might negatively impact public health including by the unsafe or improper use of the therapeutic goods. It is also important to keep in mind that, consistent with the objects of the Act and Code, we are not a regulator of services provided by “mainstream” or “alternative” health practitioners but a product regulator, and that public health and safety, rather than consumer financial interests, are our primary drivers.

We have noted the response that the Commonwealth Ombudsman’s office sent you in relation to your complaint about the TGA’s advertising complaints handling and their decision not to investigate.  In the 10 weeks since the introduction of the new framework we have been working to continually improve our processes. The intention to do so was discussed during the consultations on advertising over the last almost 18 months and is consistent with best practice public administration.

In the short time that we have been managing all complaints, we have 154 cases currently under investigation as medium category – this is by no means a trivial number –  in addition to low level cases, and 277 closed cases (including 5 critical and 4 medium cases which have been successfully resolved), the outcomes for which have started to appear on our website. As you know, more detailed information is published in relation to medium and higher level cases and as cases with this categorisation are closed more information will become available.

We have also been working to inform consumers and advertisers of the changes to the advertising framework and legislation. We have published detailed draft guidance on the application of the 2018 Code (to take effect from 1 January 2019), and final guidance will be published next month. We have provided information for consumers through the TGA website and social media on complaints handling and advertising requirements generally. We are also preparing face to face and online education activities and materials to equip advertisers with the information they need to ensure compliance with the 2018 Code on 1 January.

We are satisfied that two of the advertisements that you have brought to our attention, the PainErazor and foot patch matters, do not have implications for public health or the unsafe use of therapeutic goods. In considering these complaints, we noted your arguments that a history of a particular type of product with the Complaints Resolution Panel (CRP) is indicative of recalcitrant advertisers, justifying a category of medium or higher. However, I should emphasise clearly to you that while the CRP may have dealt with complaints about these types of products, upon receiving a complaint we look into the particular advertisers concerned and whether the particular advertisers have a history of non-compliance.

Thus, if a particular advertiser identified in a complaint has not come to our attention previously, and there are no public health and safety concerns, the case for that particular advertiser is likely to be assigned a low category.

For low category matters it is also important that we follow the principles of natural justice which are enshrined in Australian public administrative law.  It would be inappropriate to besmirch advertisers by publishing their name or the name of the product when there has been no formal administrative finding on the compliance of the advertising and TGA has not provided the advertiser with an opportunity to respond to such a finding. However, consistent with this approach, two of the advertisers identified in your complaint about detox foot patches are being dealt with as medium category cases (advertisers with prior history), with the remainder as low category.

Nevertheless, we appreciate, within the terms of the object of the Advertising Code 2015, that in some cases like these potentially inappropriate advertising of the products may continue and thus not be conducted in a manner that is socially responsible.  We will analyse data from complaints that will contribute to monitoring, and guidance and educational activities. Part of this work will entail flagging some low priority cases for future review to determine whether the advertriser has complied after contact from the TGA and if not whether the action should be escalated.

Such cases may be identified from clusters of compliance issues, repeat behaviour or the nature of the product and thus possible harm to consumers (whether directly, or indirectly through a potential delay to appropriate diagnosis and/or treatment). Based on these criteria, the advertising of PainErazor would likely be a candidate for such follow up if the advertisers’ compliance following initial contact from TGA is not satisfactory.

I trust that this information demonstrates that advertising complaints handling is one component of a broader advertising compliance framework designed to work synergistically and protect consumers from the public health and safety risks that may arise from advertising.

Yours sincerely
John Skerritt

Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Department of Health

(The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control)

PO Box 100 Woden ACT 2606 Australia
Phone: (02) 6232 8200  Fax: (02) 6203 1265
Email: John.Skerritt@tga.gov.au; John.Skerritt@health.gov.au

 

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