tgacc oct 17 2019 an evaluation of the first 12 months of ...€¦ · tgacc meeting, canberra, 17...

TGACC Meeting, Canberra, 17 Oct 2019

Dr Ken Harvey 1

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An evaluation of the first 12 months of the TGA’s new advertising system


Dr Ken Harvey MB BS, FRCPA, AM

Associate Professor, School of Public Health and Preventive MedicineChoice representative, Therapeutic Goods Advertising Consultative Committee

President, Friends of Science in Medicinehttp://www.medreach.com.au

• Harvey K. Promotion of newer antimicrobial agents. Med J Aust 1983; 1: 27‐8.

• Member of the expert group that drafted the World Health Organization’s “Ethical Criteria for Medicinal Drug Promotion” (1988).

• Choice representative on the previous Therapeutic Goods Advertising Complaint Resolution Panel and Code Council.

• I supervise and assess around 415 Monash “Whack‐a‐mole” student projects each year.

My background

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Acknowledgments: Monash colleagues and research students

Basia Diug Bethany HowardKelly Allan Mal VickersAaron Kovacs Grace JackelAmy Yan Ned LathamSasha Hall Tiana MoutafisPrasad Ranaweera Amy VauxAmy Mustac Michael DongAlanna Rottler Darci BucheliLucy Romanoff Mary MalekKithmini Cooray BMS3052 students

Features of the TGA’s new regulatory system

• July 1, 2018: the TGA took over the advertising complaint system from the CRP with enhanced investigative, compliance and enforcement powers.

• The Therapeutic Goods Advertising Consultative Committee replaced the Code Council.

• March 7, 2018: A new, permitted indications list, with industry given 3‐years to implement it. This:

– eliminated the weasel word “may” (good),

– produced (to‐date) 1021 permitted indications of which 86% use “traditional” evidence; the industry’s “get‐of‐jail‐free” card, increasingly being used (bad).

Katinka Day (Choice), delivers mock-ups of

shonky products allowed by the TGA’s permissible indications determination

to Senators

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Features of the TGA’s new regulatory system

• TGA advertising hub with nice educational resources including the use of social media.

• A new legally enforceable Therapeutic Goods Advertising Code (No. 2) 2018 (from 1 Jan 2019; but “enforcement discretion” given, especially in the first 6‐months of 2019).

• Some products attracting many complaints were conveniently declared to be not therapeutic goods (ear candles and magnets to‐date).

• A new AUST L(A) category of “assessed listed” complementary medicines introduced to encourage research‐based products (from 27 March 2018) but only one application to‐date.

@TGAgovau

“will enable potential harms from inappropriate advertising to be comprehensively prevented but at the same time make it clear to industry that they have the responsibility to produce compliant advertisements in the first place”.

Health Minister Hunt said that the new measures:#

# Letter to Ms Catherine King MP, Shadow Minister for Health and Medicare and Mr Tony Zappia MP, Shadow Assistant Minister for Medicare, 3 Feb 2018

Expectations of the TGA’s new regulatory system

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The TGA investigations database

https://compliance.tga.gov.au/investigations-database/

TGA reference numbers and case numbers

One complaint about a sponsor’s product:

https://hydrodol.com.au/Submitted 30 July 2018

Given TGA Reference no: AC-MW9QQH4F/2018(but no case numbers)

More recently, complaints are allocated case numbers if

multiple advertisers identified

Reference Number: AC-MW9QQH4F/2018Case Number: CC-7WNIVTJT/2018*Responsible Person: Amcal ChemistOutcome: Case resolved (16-Nov-2018)Action: Initial contact with advertiser requiring action

09-Oct-2019: No case numberNo published outcomeNo change in advertisement




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The TGA investigations database: Problems

• The list of records available via the TGA database:

– May contains multiple entries for a complaint about the same product that cited multiple advertisers.

– Will show a complaint (reference no and case number) closed (for a particular product and advertiser) but does not show multiple unresolved complaints about the same product.

• The statistics we derived from the TGA’s database differ somewhat from those in the TGA’s draft 2019‐19 report.


Data from TGA investigation database 01/7/2018 to 30/06/2019

+ Low priority complaints only have “Action” published.# Of 135 medium priority records, 34% had the product details “Not Published”.

* Action, product details and Code violations published (but not the advertisement).


Priority Our record count

TGA’s record count

Low + 1678 (92.2)% 1480 (92.4%)

Medium # 135 (7.4%) 111 (6.9%)

High * 2 (0.1%) 2 (0.1%)

Critical * 6 (0.3%) 8(0.5%)

Total 1821 (100.0%) 1601(100.0%)

At: 11/10/2019

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Low priority complaints

Action takenOur

Numbers#

Regulatory Obligations letter sent to advertiser 1148 68%

TGA requested removal: achieved 213 13%

No action taken ‐ no breach identified 110 6%

TGA unable to act ‐ outside TGA's jurisdiction 65 4%

Educational campaign ‐ “bioresonance” devices 66 4%

Referred to external agency – AHPRA, ACCC, etc. 44 3%

Referred internally for review 29 2%

Total 1693 100%

# Differ from the draft TGA 2018-19 report and also the TGA database total of 1678.

At: 11/10/2019

• The low priority accorded some complaints was hard to understand.

• For example, complaint AC‐E7JS15BB/2018 was submitted on 03/08/2018 and closed a few days later by a “Compliance Notice sent with educational material”.

• This product won a 2017 Choice “Shonky” award, was the subject of a scathing N.Z. Consumer review and an upheld CRP complaint (26/03/2018) that was sent to the TGA by the CRP, for non‐compliance.

Choice says:

http://www.tgacrp.com.au/complaint-register/?_year=2018

Low priority complaints: Classification concerns

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• For low priority cases an obligations letter is sent to the advertiser which informs them of alleged non‐compliance and provides guidance to rectify the advertising.

• Obligations letters do not require a written response from the advertiser. The case is closed when the notice is sent.

• This is not regulatory action at law; no formal investigation is undertaken, and no formal regulatory finding is made.

• One cannot conclude that the low priority complaints listed have breached the Code or have broken the law.

The TGA says:

https://www.tga.gov.au/publication/complaints-handling-advertising-therapeutic-goods-australian-public

Low priority complaints:

• It’s disingenuous for the TGA to say that low priority complaints have not broken the law: – why else would breaches of the Act and Code be detailed, and action

such as, “Requested removal”, “Sent for internal review” and an “Educational campaign” be undertaken?

• The TGA’s new complaint system is much less transparent that the old one: – The CRP sent every complaint they judged breached the Code to the

advertiser, in full, for a considered response.

– They then published on their website a complete determination of claims alleged to breach the Code, often running into many pages.

Choice says:

http://www.tgacrp.com.au/complaint-register/?_year=2018

Low priority complaints:not broken the law?

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Medium priority complaints: 7.4% of 1821

At: 11/10/2019

Action taken Numbers

Initial contact with advertiser requiring action 84 60%

Letter requiring action sent to advertiser 19 14%

No action taken ‐ no breach identified 8 6%

TGA unable to act ‐ outside TGA's jurisdiction 4 3%

Guidance Letter sent to advertiser 1 1%

Not published (although they are meant to be) 29 21%

Total# 139 100%

# Database total 135; different number found analysing records.

Medium priority complaints:TGA report case study 6

https://theconversation.com/science-or-snake-oil-does-easeacold-really-help-to-shorten-your-cold-98311https://theconversation.com/science-or-snake-oil-will-horseradish-and-garlic-really-ease-a-cold-87602

• The TGA was not satisfied that the advertiser held appropriate evidence to support the use of the term "scientifically formulated" and concluded this breached s.4(2)(c) of the 2015 Code.

• The Advertiser replaced the term "scientifically formulated" with "specifically formulated" which was acceptable to the TGA.

AL-B81GN1V3/2018

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Medium priority complaints: Compliance achieved?

If you’re a student dealing with the demands of study and exams, then PINPOINT BRIGHT BRAINS may be your unfair advantage.

https://bodaustralia.com/pinpoint/

Bill board promotion

Billboard at Glenferrie Railway station, near Swinburne University (photographed 2/05/2018)

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Claims

• PINPOINT BRIGHT BRAINS contains a specific extract of Bacopa monnieri (BOD68), a plant‐based Ayurvedic medicine discovered in India over 2,000 years ago

• BOD68 is only available in PINPOINT BRIGHT BRAINS and is phytochemically comparable to the Bacopa monnieri extract that has been meticulously researched in multiple scientific and clinical studies

– “Improved Memory, Concentration and Focus”. 1,2

– “Assists Learning and Attention”. 3,4,5

– “Supports Cognitive Function”. 6,7,8

– “Improved Memory Retention and Recall”. 9,10

– “Better mental clarity”. 11

1 Roodenrys S, et al 2002, 2 Stough C, et al 2001, 3 Sharma R, et al 1987, 4 Negi KS, et al. 2000, 5 Usha PD, et al. 2008, 6 Benson S, et al 2014, 7 Downey LA, et al 2012, 8 Stough C, et al 2008, 9 McPhee GM, et al 2016, 10 Stough C,

et al 2013, 11 Singh & Singh, 1980.

Complaint to TGA

• This complaint was worked up by Monash “Whack‐a‐mole” students.

• They noted it’s only valid to extrapolate the results from clinical trials to a specific herbal product if they use identical, standardised extracts.

• The extract of Bacopa used in Bright Brains (BOD68) was not the same as that used in the trials cited and no clinical trials using BOD68 were found.

• They alleged the claims made were false, misleading and deceptive.

Reference: AC-X0BCJTUU/2018

Sent:11/09/2018

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From: TGA Advertising <[email protected]>

Sent: Friday, 9 November 2018 11:31

To: Ken Harvey <[email protected]>

Subject: Outcome of advertising complaint ‐ Bod Australia Pty Ltd ‐ AC‐X0BCJTUU/2018 TGA‐CM:0039005

Dear Sir/Madam,

Your complaint AC‐X0BCJTUU/2018 received on 11/09/2018 in relation to PINPOINT Bright Brains has been finalised.

The action taken: Formal contact requiring immediate action

The outcome: Compliance achieved without formal action required

The details of the outcome can be viewed on the TGA website via the following link: AC‐X0BCJTUU/2018. Thank you for bringing this matter to the attention of the TGA.

Advertising Compliance Section

Outcome of complaintReference: AC-X0BCJTUU/2018

09/11/2018

https://pinpointaustralia.com/

18/11/2018

Was compliance achieved?

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# TGA report shows 10* Different advertisers and case numbers

High & critical prioritycomplaints: 8# (0.4%) of 1821

Date Ref number Product Action Outcome

18‐Jul‐2018 AL‐803ZLMWJ/2018Peptide Clinics Australia SARMs

Directions notice then Injunction

$10 m fine ‐Liquidation

30‐Jul‐2018 AC‐22VHXCSG/2018Sawyer Extractor Snake bite kit*

Immediate contact Resolved





03‐Aug‐2018 AC‐BULV1O9Q/2018 Gumby Gumby* Directions notice Resolved

05‐Aug‐2018 AC‐LDMYY79Z/2018 Rigvir Immediate contact Resolved

09‐Jan‐2019 AL‐9M1WJCMS/2019 Gumby Gumby* Immediate contact Resolved

26‐Feb‐2019 AC‐QMUBSLLI/2019 Black Salve Immediate contact Resolved

High & critical priorityunresolved: AC‐C7NJIKYV/2018

24https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/

SARMs

• Complaint:

– 11 December 2018

• Direction notice:

– 23 January 2019

• Action required:

– 30 January 2019

• To date:

– still advertising

At: 12/10/2019

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Weight loss products

Public Health issues not yet resolved

• Numerous complaints about these products upheld by TGACRP and referred to TGA but with no outcome.

• 6 July 2018 complained to the TGA again (AC‐GBKDH2XG/2018).

• 17 August 2018 provided more information as requested (AC‐GBKDH2XG/2018)

• No outcome to‐date

. Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. MJA 2008; 188 (1): 21-25

Public Health issues not yet resolved

https://theconversation.com/science-or-snake-oil-do-hangover-cures-actually-work-101033

Hangover products

AC-MW9QQH4F/2018

AC-EN0KHC4U/2018

AC-JY0FXQ3S/2018

AC-JY0FXQ3S/2018

Complaints submitted 30 July 2018 and 7 August

2018: Numerous advertisements continue.

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Other issues not yet resolved

Homeopathic and other “Traditional” products

Formula derived from the classic book of Chinese Medicine known as Shang Han Lun (~ 200 AD).

Has herbs to clear dry dampness, caused by dampness toxins, emotion, postoperative bladder, anxiety or stroke conditions.

Winner of a 2018 Choice Shonky award.

Complaint AC‐9NXC9UV6/2018submitted 12 July 2018

No outcome to‐date.

These products need a mandatory educational statement: These claims are based on traditional beliefs and practices, not modern scientific evidence


Food‐medicine interface products

https://insightplus.mja.com.au/2019/15/where-food-meets-medicine-reform-needed/https://www.tga.gov.au/consultation/consultation-proposed-clarification-goods-are-

therapeutic-goods-goods-containing-folate-substances-certain-circumstances

Contains L-methylfolate, an active form of folate that addresses part of a complex deficiency found in people with depression.

AC-NLDGK2LY/2019

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Exploitative medical devices

After 290 complaints sent to the TGA by FSM and others over the last

10 years.

Other issues of concern: TGA KPI’s ‐ Tick and flick?

• There is little difficulty meeting time‐based KPIs if over 90% of complaints are judged “low priority” and closed by merely sending an educational letter.

• Equally, KPIs for higher priority complaints can readily be met if they are closed by stating that compliance has been achieved when it has not.

• KPI’s can also be more easily met if no information is provided on the complaint priority assigned or why some alleged Code violations were accepted but others were not.

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“will enable potential harms from inappropriate advertising to be comprehensively prevented but at the same time make it clear to industry that they have the responsibility to produce compliant advertisements in the first place”.

Health Minister Hunt said that the new measures:#

# Letter to Ms Catherine King MP, Shadow Minister for Health and Medicare and Mr Tony Zappia MP, Shadow Assistant Minister for Medicare

So, has Minister Hunt’s expectations been realised?

What do we want the TGA to do?

1. Bite advertisers and sponsors breaking the law:

– The penalty for non‐compliance must be greater than the profit that comes from breaking the law!

2. Eliminate “low priority” classification.

3. Send all complaints that document a Code breach (i.e. break the law) to the advertiser for a formal response and follow up to ensure compliance.

4. Regularly update the status of the above complaints in the database.

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5. Change KPIs to monitor when compliance is achieved; not when the case was “closed”.

6. Address products of public health concern that lack evidence of efficacy:

– Weight loss,

– Hangover,

– Detox products purporting to deal with smoking & environmental pollution.


7. Add an educational statement to products making “traditional” claims:

– These claims are based on traditional beliefs and practices, not modern scientific evidence.

8. Accept responsibility for policing all therapeutic advertising claims rather than handballing some to the ACCC:

– e.g. Ear candles, magnets.

9. Sort out “medical foods” with FSANZ.

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Permissible Indications Determination No.1 of 2019

Type of evidence Numbers

Scientific evidence only 147

Scientific or Tradition of use 618

Tradition of use only 57

Traditionally used in Ayurvedic medicine only 68

Traditionally used in Chinese medicine only 131

Total 1021

As at 8 October 2019

That is, 86% of permitted indications can be justified by “traditional” evidence

https://www.ebs.tga.gov.au/“Indications for listed medicines” Search "tradition" in "Evidence"

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Analysis of the work of the TGACRP (1989‐2018)

Mal Vickers Monash MPH studentMembers

• ASMI• CHC• MTAA• ATMS• Choice• CHF• Guild• PSA• RACGP

Regulations/Codes• Therapeutic Goods Act 1989• Therapeutic Goods Regulations 1990• Therapeutic Goods Advertising Code 2015

Respondents

Outputs• Publish: Determinations• Publish: Notifications of Withdrawn

Complaints• Publish: Annual Complaints Summary• Refer: Complaints to the TGA• Refer: Complaints to other bodies

No Powers of Enforcement• Publish outcome• Request ad withdrawal / retraction

Complaints

TGACRP Justified complaint determinations (1989‐2018)

2078 justified determinations

Analysis by Mal Vickers, Monash

MPH student

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Pharmacare Laboratories took over Cat Media Pty Ltd in 2006


MPH student


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28% of named companies had multiple justified complaints

72% of named companies had

only one justified

complaint

N=2078

Pharmacare


MPH student

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TGA post‐marketing surveillance

• 2014‐15: 73% of 161 products tested were non‐compliant (with 31cancelled by sponsors when notified of a review)

• 2015‐16: 80% of 408 products tested were non‐compliant (with 43 cancelled by sponsors)

• 2016‐17: 79% of 417 products tested were non‐compliant (with 74 cancelled by sponsors)

• 2017‐18: 75% of 171 reviews were non‐compliant (with 51 cancelled by sponsors)

• The commonest problems identified were misleading labeling, packaging and advertising material, and inability to produce evidence to substantiate the claims made.

https://www.tga.gov.au/annual-performance-statistics-reports

TGA’s first comprehensive consumer survey

It employed a random population‐based sample (Panel) and an Opt‐in sample sourced through known TGA contacts, networks and consumer stakeholders.

The responses confirmed survey participants had considerable concerns about the regulation of complementary medicines.

https://www.tga.gov.au/tga-consumer-survey-2018

June - July 2018

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In short:

• The failure of the TGA to bring the industry into check resulted in:

– Loss of trust in the TGA as a regulator.

– Ongoing harm to consumers:• Direct harm from poorly disclosed adverse events from complementary medicines and their interaction with conventional medicines.

• Indirect harm, by consumers forgoing more evidence‐based remedies (often to the detriment of their health) because they are sucked in by misleading and deceptive promotional hype. This also wastes their money which could be better spent.

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tgacc oct 17 2019 an evaluation of the first 12 months of ...€¦ · tgacc meeting, canberra, 17...

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