TGA provides complementary medicine industry with “Get Out of Jail Free card”

The TGA have recently given approval (under section 42DF of the Therapeutic Goods Act 1989) for a restricted advertising representation by The Tomato Pill Company for Ateronon XY Pro:

“Saw Palmetto is traditionally used in herbal medicine to help relieve the urologic symptoms (e.g. weak urine flow, incomplete voiding, frequent daytime and nighttime urination) associated with mild to moderate medically diagnosed benign prostatic hyperplasia”.

This conflates the “traditional use” of a herb with a “scientific medical diagnosis” (benign prostatic hypertrophy (BPH)).

This is especially inappropriate because scientific studies on the herb in question (Saw Palmetto) have shown that this herb is no more effective than a placebo in relieving urinary tract symptoms caused by prostate enlargement. These studies include a Cochrane review and a 2011 NIH-funded study that tested saw palmetto in amounts up to three times the usual dose. The lycopene component (not mentioned in the approval or the ARTG Public Summary) also lacks evidence of efficacy for BPH.

Presumably the “Tomato Pill Company” asked the TGA for a “traditional use” advertising exemption because they knew that “scientific” claims cannot be substantiated!

A similar strategy has been observed in the list of over 1000 “traditional” permitted indications submitted by industry and approved by the TGA. This provides the “Tomato Pill Company” (and others) with numerous “Get Out of Jail Free cards”.

I cannot understand why Delegate of the Secretary to the Department of Health (Simon Waters) has approved a restricted representation for this product. The TGA’s own “Evidence Guidelines” state (page 26):

“If you are aware that there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, then it is advisable to include a statement to this effect in any labelling and advertising associated with the medicine, for example: ‘this traditional use is not supported by scientific evidence’. This will ensure that the advertised information relating to your medicine is truthful, valid and not misleading”.

Yet, the Delegate has approved a misleading and deceptive restricted representation. And this is not the first time!! Which is why many stakeholders have lost confidence in the TGA’s ability to operate in isolation, without advice from the soon-to-be-abolished TGACC & TGACRP.

A complaint has been submitted to both the TGA (from which we never hear the outcome) and the TGACRP (who at least provide a public determination).

See also: Submissions to TGA on “regulatory reform”.

And: Drug regulator under fire over herbal supplement company’s claims

In the latter, the TGA spokeswoman said, “Other medicines and device regulators internationally also are fully or significantly funded by industry fees. This takes the burden off the taxpayer”.

First, this statement is disingenuous. Regardless of whether the regulator is funded by industry fees or the government, the consumer pays, either through higher prices on therapeutic goods or increased taxation.

Second, even for U.S. FDA industry fees only account for around a quarter of all FDA funding.

In summary: the benefits of industry funding are that the regulator is not constrained by cut-backs in government budgets, efficiency dividends and other constraints. It is easier to increase industry fees to deal with new regulatory initiatives, such as those currently proposed by the TGA for complementary medicine and advertising reform, than to obtain increased government allocations.

The downside is that industry has a greater say in how its fees are used and there is an increased risk of regulatory capture. For example, industry is likely to support measures to register new drugs and devices drugs faster but will not be so enthusiastic to support increased post-marketing surveillance and the imposition of more effective sanctions for regulatory violations.

I suggest that several regulatory decisions by the TGA of late support concerns about regulatory capture. What other explanation, apart from “too close to industry”, is there for the TGA approving restricted representation for the advertising of products such as Ateronon XY Pro (above), Homeopathic restless legs relief, etc.?

Hopefully, these matters will be debated in the Senate when the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 is referred to the Senate Standing Committees on Community Affairs.

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U3A Melbourne City Short Course – Complementary Medicine: Exploring the Issues

Healthy growth, healthy people?

  • The value of sales of Australian complementary medicines (CM) has doubled from $2.3 billion to $4.7 billion in just over three years.
  • This corresponds to a Compound Annual Growth Rate of 26.9% compared to the 1.7% growth rate of the broader Australian economy.
  • Australian consumers spent over $A550 per capita on CM in 2016, which has increased from $A472 over the past five years.

From: Complementary Medicines Industry Audit 2017

or

Unhealthy promotion, ineffective regulation?

These and other issues were explored over 3 sessions in October 2017:

  • What is a complementary &/or alternative medicine?
  • Who uses it, why and what for?
  • Regulation: products, promotion, practitioners.
  • The review of the private health insurance rebate for natural therapies.
  • How do we know if it works: what is evidence?
  • Evidence for and against specific products &/or therapies for certain conditions.
  • Sources of good information about complementary medicine, and
  • Using complementary medicine (and other health care interventions) wisely.

Lecture notes are available:

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TGA Consultation Submissions: Regulatory reform of complementary medicines and advertising

See also:

And an old but still relevant article:

 

 

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Concerns about the Exposure Draft of Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

See the paper: “Concerns about the Exposure Draft of Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

See also submissions to TGA Consultations on “regulatory reform

 

 

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Chemist Warehouse-Swisse-Voost AFL grand final promotion kicked

A formal complaint has been lodged with government health authorities around last weekend’s Chemist Warehouse- Swisse-Voost AFL grand final promotion (PD 28 Sep).

The promotion, described by the company as the largest it had ever undertaken, was described by Dr Harvey as “irresponsible because it was distributed at public venues containing children of all ages. “Patrons were encouraged to take the packs home,” he said, with items including a free sample of Swisse Ultiboost Magnesium tabs. “The container was not childproof and had no information on the recommended upper limit of magnesium intake (as a supplement) for young children,” Harvey wrote in his submission.

He argued that the promotion “breached the Object of the Therapeutic Goods Advertising Code 2015 (the Code) and the spirit of s.4(8),” while claims on the product pack, the promotion to children and the exclusive ‘buy one, get one free’ offer also breached the Code.

The Therapeutic Goods Administration, the Australian Health Practitioners Registration Authority and the Australian Competition and Consumer Commission were all contacted by Harvey, who suggested the company distributing the 110,000 packs of Swisse product worth $20.99 each be fined the equivalent amount of the retail value of the giveaway, or $2.31 million.

Pharmacy Daily Thursday 5th October 2017

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Australian Male Hormone Clinic (AMHC) convicted and fined $127,500 plus costs

http://www.ahpra.gov.au/News/2017-10-04-media-release-advertising.aspx

However, the company concerned was placed into voluntary liquidation on 12 September 2017 and presumably will escape the fines and costs.  Many consumers taken in by these scams are left out of pocket. The regulators concerned move far too slowly to be effective; they need to up their act!

See: http://www.abc.net.au/news/2017-10-04/mens-health-clinic-fined-for-unlawful-advertising/9016174

Also: case study (Sept 8, 2018 Seminar): AMI begat MWI begat AMHC…

The AHPRA press release follows:

In an Australian-first, Wellness Enterprises Pty Limited, which traded as Australian Male Hormone Clinic, has been fined $127,500 plus costs after being found guilty and convicted of 17 charges related to unlawful advertising of regulated health services.

Charges brought by the Australian Health Practitioner Regulation Agency (AHPRA) followed advertisements the business published in newspapers around Australia between February and August 2017 for treatment of testosterone deficiency.

The full page ‘advertorial’ style advertisements made a number of claims about the benefits of treatment, including increased energy, focus, masculinity and strength, and ability to satisfy sexual partners. AHPRA challenged the validity of the claims citing best available evidence.

In the Downing Centre Local Court in Sydney on 3 October, the corporation was found guilty and convicted on 17 charges. Magistrate Atkinson cited the seriousness of the offences in fining the corporation $7,500 on each charge, totalling $127,500. The corporation was also ordered to pay court costs of $3,000 and professional costs up to $3,000.

This is the first time that a corporation, not an individual health practitioner, has been convicted following advertising charges brought by AHPRA under section 133 of the National Law1.

AHPRA CEO Mr Martin Fletcher welcomed the court’s decision.

‘Our primary objective is to protect the public. Advertising can heavily influence a patient’s decision-making around their healthcare needs and information in advertising must be accurate and based on acceptable evidence. AHPRA and the National Boards will continue to take action against unlawful advertising in the best interests of all consumers of regulated health services,’ he said.

 

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Letter to The Age 02/10/2017: Heed evidence

Consumer Affairs Victoria ordered Penguin to provide a “prominent warning” on all future books they publish about natural therapies (“Shining a spotlight on the self-help industry”, The Age, 30/9), explaining that the claims made are not evidence-based.

A similar disclaimer was recommended for all listed complementary medicines by a recent independent Medicines and Medical Devices Review. The Therapeutic Goods Administration trusts that sponsors hold evidence to support the claims made. Not surprisingly, in a regulatory system that provides no pre-market evaluation and no effective penalties for non-compliance, this trust is misplaced. Eighty per cent of the small number of products subjected to post-marketing reviews by the TGA are found non-compliant.

The government rejected the recommendation. It also rejected the findings of a review of natural therapies, set up with the NHMRC, to determine if these therapies should continue to attract a private health insurance rebate. Despite finding no clear evidence that these therapies were clinically effective, the government declined to remove the rebate.

Dr Ken Harvey, Associate Professor, Monash University

http://www.theage.com.au/comment/the-age-letters/energy-supplies–when-a-solution-is-just-a-breakdown-in-logic-20171001-gys65q.html (Scroll down)

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Seminar Program, Papers and Presentations: The Advertising of Therapeutic Goods and Services (and its regulation)

Seminar program

Papers

Ken Harvey. Seminar Background Paper

Sitesh Bhojani and Jodie Valadon. The multi-regulator model for Australian Consumer Law: effective or useless?

Paul Lacaze & Jane Tiller. Online Direct-To-Consumer Genetic Testing in Australia: Concerns, Regulation and Recommendations

Presentations delivered

Some photos of presenters are also available thanks to Sasha Hall

Audio: Introduction (Allan Kirkland) and Case Study (Ken Harvey) and Panel discussion

Slides (Ken Harvey): Case study – AMI begat MWI begat AMHC

Slides (Ross Hawkins): Update on Medicines and Medical Devices Review: Advertising implementation

Audio (Ross Hawkins): MMD Reform

Slides (John Dwyer): Complaining about chiropractors to AHPRA

Audio: Chiropractic Update

Slides (Megan Munsie): Curbing the big business of selling stem cells

Audio: Stem Cells

Slides (Suzanne Crowle): NSW Fair Trading Complaints Register

Audio: NSW Fair Trading

Slides (Bill Dee): A better multi-regulator model?

Slides (Alan Asher): Australian Consumer Law Review

Audio: ACL Review

Audio (John Braithwaite): Concluding remarks.

Presentations for reference

Michael Gordon: Advertising and the National Law

Relevant AHPRA communique (Sept 7, 2017)

Update to the Health Practitioner Regulation National Law

These changes will strengthen the management of complaints (notifications) and disciplinary enforcement powers of AHPRA and National Boards, including:

  1. Provision of practice information: A National Board may require a health practitioner to provide details of their practice arrangements, regardless of how they are engaged to practise. This will mean health practitioners that practise in multiple locations or under different employment, contractual or voluntary arrangements will be required under law to provide this information to their National Board when asked to do so.
  2. Public interest grounds for immediate action: Broadening the grounds by which a National Board may take immediate action against a health practitioner or student if it reasonably believes it is in the public interest.
  3. Extension of prohibition order powers: A responsible tribunal may issue a prohibition order to prohibit a health practitioner from providing any type of health service or using any protected or specified title. A breach of a prohibition order in any State or Territory will also become an offence with a maximum penalty of $30,000.
  4. Communication with notifiers: This change will improve communication for people who make a complaint or report concern to AHPRA and National Boards (notifiers) about a registered health practitioner’s health, performance or conduct. National Boards will now have the discretion to inform notifiers of a greater range of actions taken by the National Board in response to their complaint or concern and the reasons for their actions.

Additional powers for the COAG Health Council (formerly operating as the Australian Health Workforce Ministerial Council) to change the structure of National Boards: This means that Health Ministers may make changes to the structure and composition of the National Boards by regulation following consultation. There are no current proposals to change the structure of National Boards

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

Exposure draft: Explanatory Memorandum

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New TGA consultations relevant to Sept 8, 2017 Seminar

There were two new additions to the TGA web site yesterday that are relevant to next Friday’s seminar:

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Case study (Sept 8, 2018 Seminar): AMI begat MWI begat AMHC…

In the beginning there was the Advanced Medical Institute (AMI).

 

AMI begat the Medical WeightLoss Institute (MWI)

 

MWI begat the Australian Male Hormone Clinic (AMHC)

 

 

This presentation and others are now available.

See also:

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