Civil Society Hearing on Therapeutic Goods Amendment Bill, ANU 24 Jan 2017

Hosted by Prof John Braithwaite, School of Regulation and Global Governance (RegNet), Australian National University

The Therapeutics Goods Administration (TGA) has tried to bypass the Senate Committee system on the Therapeutic Goods Amendment (2017 Measures No.1) Bill by arguing that it was non-controversial! Which it certainly is not regarding its provisions for advertising and complementary medicine regulation! Fortunately, Senator Richard Di Natale (Greens) responded to requests to get the Bill reviewed by the Senate Community Affairs Legislation Committee.

In response, submissions were scheduled over the Christmas, New Year holiday period and the public hearing requested was rejected because Senators were on holiday. Regardless, several civil society organisations have joined together to hold a public hearing to debate contentious provisions of the Bill. The venue is the Australian National University, 24 Jan 2018, from 2:00-5:00 pm.

While leading experts in regulation, public health, and civil society are supportive of the positive aspects of the Bill proceeding, they ask that three contentious aspects be excised so that they can receive better consideration.

First, the Bill removes pre-approval of advertisements for therapeutic goods in favour of self-regulation.

Pre-approval is the only defence against seriously misleading advertisements appearing on prime-time television or in national newspapers. The current pre-approval process reviews over 2000 advertisements per year with an average turnaround time of 7 days. Most advertisements require changes, sometimes wholesale revisions.

The complaint system takes a long time to remove bad advertisements. Meanwhile, the damage has been done. Prevention is better than cure. It is also more economically efficient given that fraudulent therapeutic claims create unnecessary health expenditure and diverts scarce health resources from remedies that work, to ones that don’t.

We want pre-approval of advertisements to continue until the other measures being introduced (increased post-marketing reviews and more stringent penalties for regulatory violations) have shown pre-approval is no longer necessary.

Schedule 6, Part 2 ‘Removal of requirement for advertisements to be approved’ should be excised.

Second, the TGA is taking-over of the advertising complaint system without ensuring ongoing stakeholder input or transparency of complaint outcomes.

Stakeholder involvement is currently provided by the independent Complaint Resolution Panel and Code Council which are to be abolished from July 1, 2018. That’s happening even though the TGA has a track record of making bad decisions in isolation and an unenviable reputation as a ‘blackhole’ with respect to advertising complaints.

In addition, loop-holes in the complaint system such as those at the food-medicine interface need to be addressed by broadening the scope of the Therapeutic Goods Advertising Code and Complaint System to cover all therapeutic claims, regardless of whether they refer to a medicine, food or medical device.

Schedule 6, Part 1, Advertising system should be excised.

Third, the Bill will authorise an industry submitted list of ‘permissible indications’ for complementary medicines.

The TGA recently circulated a final list of 1019 such indications. It contains 140 indications which must be supported by scientific evidence and 879 indications that can be supported by a tradition of use, such as Traditional Chinese Medicine (TCM), Ayurveda, Homeopathy, etc. Examples of traditional indications include, ‘Balance Yin and Yang’, “Upraise/lift sunken middle Qi’, ‘Pacifies Kapha’, ‘Increases Pitta’ and ‘Replenish Essence’.

The TGA have ignored submissions that pointed out that including numerous traditional indications encourages industry to evade the requirement to have scientific proof of efficacy for their products, endorses pseudoscience and will confuse the average consumer as the terms used will not be understood.

The TGA have ignored requests that claims based on ‘traditional use’ should always have an advisory along the lines of what the US Federal Trade Commission uses for homeopathic products, ‘This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works’.

Schedule 2, Part 1, 26BF, ‘Permissible indications’ should be excised.

To attend the Civil Society Hearing on Therapeutic Goods Amendment Bill please register at https://civil_society_hearing_tga_bill_register.eventbrite.com.au. The final program and venue details will then be forwarded to you.

Further information is available from: Assoc Prof Ken Harvey, Monash University (0419181910), Katinka Day, Choice (02 9577 3307), Allan Asher, Access2, (0408375642) and Prof John Braithwaite, Australian National University (0437788006)

 

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Monash School of Public Health & Preventive Medicine Students: A Tribute

An end of year tribute to the Monash SPHPM students I’ve been engaged with, especially those who worked with me on the Summer Vacation Scholarship Program and those who presented at the Victorian Skeptics meeting on 18 December, 2017.

2017 Summer Vacation Students

Victorian Skeptics Presentation Students 18 December 2017 

 

 

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Therapeutic Goods Amendment (2017 Measures No. 1) Bill now sent to Senate

This is a win! The Department of Health, TGA and the Health Minister’s Office have been trying to bypass the Senate Committee system on this Bill arguing that it was non-controversial! Which it is not!

 

 

 

 

Fortunately, Greens Senator Richard Di Natale responded to requests to get the Bill reviewed by the Senate Community Affairs Legislation Committee.

A public hearing was requested but rejected because of short time-frame encompassing Christmas & New Year. Regardless, concerned civil society actors are holding our own public hearing at the Australian National University, (building venue to be confirmed) on 24 Jan 2018, from 2:00 – 5:00 pm. The media have been invited.

See invitations to:

The Committee invites written submissions by 12 January 2018. For ideas see:

See, talks to:

And, “TGA Consultation Submissions: Regulatory reform of complementary medicines and advertising

The Committee prefers to receive submissions online as an attached document by accessing the committee website and selecting the Upload Submission Online link. Alternatively, submissions may be emailed as an attached document to committee.sen@aph.gov.au.

Submissions become Committee documents and are made public only after a decision by the Committee. Publication of submissions includes loading them onto the Internet and making them available to other interested parties including the media. Persons making submissions must not release them without the approval of the Committee. Submissions are covered by parliamentary privilege but the unauthorised release of them is not protected. Information relating to Senate Committee inquiries, including notes to assist in the preparation of submissions and a submission checklist is available at: http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/How_to_make_a_submission.

If you require further information please contact the Committee secretariat on (02) 6277 3585.

 

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Very profitable: Australia overdosing on dietary supplements

https://www.australiandoctor.com.au/news/very-profitable-australia-overdosing-dietary-supplements

The marketing power of the complementary medicines industry has been highlighted by figures showing that half of Australian women and a third of men are taking dietary supplements.

Supplements are taken predominantly by well-nourished people and often in excess of recommended levels, a national study of almost 5000 people revealed.

Data from the 2011-2012 National Nutrition and Physical Activity Survey showed that dietary supplements use was higher among older people and among more affluent and educated groups who were already meeting recommended nutritional intake targets.

Researchers from Victoria’s Deakin University noted with concern that intakes of vitamins E, C, B12 and zinc from supplements were, in some cases, in excess of the recommended daily intake “which may result in toxicity”.

Nutritionist Dr Rosemary Stanton (PhD) said excess zinc intake could lead to diarrhoea, nausea, abdominal pains, lethargy and interfere with absorption of iron and/or calcium. But excess vitamin E intake was the main concern.

“The main thing is to warn patients having some types of surgery to stop taking vitamin E several weeks prior to surgery.

“This is because vitamin E may be associated with increased bleeding and haematoma. This could also apply to herbal and omega 3 supplements,” Dr Stanton added.

 

 

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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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