Choice takes campaign to disallow the Permissible Indications Determination to Canberra

Katinka Day, Choice Campaigns and Policy Team Lead, delivers mock-ups of shonky products allowed by the TGA’s permissible indications determination to Senators, see:

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Campaign to disallow the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018

The Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 is currently on the Senate Disallowable Instruments List until 25 June 2018.

Friends of Science in Medicine (FSM) have joined Choice (the Australian Consumers’ Association) and other civil society organisations to petition Senators to disallow this determination.

A letter requesting disallowance has been sent to Labor, Greens and Independent Senators by FSM.

This is because the Government and the Department of Health have taken no notice of previously expressed concerns about this determination, for example:

The commendable aim of this determination was to stop sponsors of complementary medicines from making creative free-text indications that were then used to make misleading and deceptive advertising claims that lacked an evidence base.

However, the TGA allowed industry to formulate the list of permissible indications with the result that 86% of 1019 indications can now be supported by “traditional” evidence from belief-based alternative medical systems such as Homoeopathy, Traditional Chinese Medicine, Ayurveda Medicine and Western herbalism.

An inevitable perverse outcome of this determination will be that sponsors of complementary medicines will change the indications of many of their products from “scientific” to “traditional” to the detriment of public health, as illustrated in a classic ABC Checkout program. Why else would industry have produced such a list?

Australia is a multicultural and pluralistic society and it is appropriate we allow access to alternative medical traditions and products. There is also understandable national pride in Traditional Chinese Medicine (TCM), Ayurveda and other indigenous medicines. In addition, valuable knowledge can be found in such traditions. For example, the 2015 Nobel Prize award for medicine was awarded to a Chinese researcher for extracting an anti-malarial drug from the herb (Artemesia annua) mentioned as a treatment for fever in a 4th Century CE text of Traditional Chinese Medicine.

However, as Nobel committee member Hans Forssberg noted, “It’s very important that we are not giving a prize to traditional medicine, the award was only for scientific work that had been inspired by it.”

Traditional medicines are by default prescientific, and thus is not surprising that the theories on which such traditions are based have not been validated by scientific inquiry. These include the centuries old TCM concept of meridians through which the life-energy known as ‘qi’ flows, the Ayurveda concept of life-forces (dosha) and body types (vata, pitta and kapha) and the more recent homeopathic concept that ‘likes cure like’.

While the TGA appears to give equal validly to “traditional” and “scientific” evidence, this is not in keeping with modern scientific understanding as documented in the NHMRC’s levels of evidence which puts “traditional” knowledge on the bottom rung (below).

It is also not in keeping with the objects of the Therapeutic Goods Act 1989 which include providing for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods (my emphasis). Traditional use provides no evidence of efficacy nor does it guarantee quality or safety.

We believe it is important to ensure that consumers understand the difference between “traditional” and “scientific” evidence. We also need to restrain the increasing mass marketing of traditional medicines from taking advantage of consumer ignorance and we need to protect consumers from misleading and deceptive claims about such products.

Accordingly, FSM and others have advocated that an advisory like the following be added to the pack and promotional material of all products invoking a traditional paradigm:

“This product is based on traditional beliefs and not modern scientific evidence”.

In the Senate debate on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill, Senator McKenzie (presumably advised by the TGA) said,

“The evidence from the United States, where the US Food and Drug Administration has mandated such disclaimers, is that these disclaimers are ineffective in assisting consumers to make more informed choices when self-selecting medicines”.

Our own review of the literature shows that the evidence about disclaimers and advisories is much more nuanced that what Senator McKenzie stated.

In our opinion, the TGA has misled Parliament by failing to provide a balanced account of the evidence about advisories and disclaimers.

For example,

  1. The 1994 U.S. Dietary Supplement Health and Education Act (DSHEA) disclaimer is very different to what has been proposed in Australia. It reads,“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”.
  2. Dodge et al., 2011 showed that addressing deficits in individuals’ knowledge about the DSHEA influenced beliefs about dietary supplements. Specifically, educating individuals about the DSHEA made them more skeptical of the safety and effectiveness of dietary supplements.
  3. The U.S. Federal Trade Commission (FTC) acts against dietary supplement companies for product promotions that violate the Federal Trade Commission Act. In November 2017 they produced an advisory similar to what was requested in Australia for one category of traditional medicines, homeopathic products.
  4. More recently, the U.S. FDA have also proposed a new, risk-based enforcement approach to drug products labelled as homeopathic.
  5. Health Canada has now included an advisory on homeopathic products targeting children’s complaints, like what Australian consumer and health professional organisations recommended (Figure 1, below). If Health Canada can do it why not the TGA?
  6. Finally, although the TGA has stated disclaimers and advisories don’t work, they have nevertheless required advisory statements for some traditions in their Permitted Indications determination and the draft Code, for example:

“Seek advice from a registered Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you”.

The TGA have alleged that other belief-based traditions, such as Homeopathy, are better understood but that is not our experience in discussing TGA regulation with consumers.

Some politicians have said that they support the Permissible Indication determination because it is an improvement on what has gone before. We disagree. As pointed out above, we believe it will create a flood of products with “traditional” indications and claims that will confuse and mislead consumers. More importantly, these products have the potential to cause consumers to forgo more evidence-based treatment to the detriment of their health.

We ask you to support the campaign to disallow the Therapeutic Goods (Permissible Indications) Determination No 1 of 2018 so that educational advisories can be made mandatory. Please write to your Senator.

The Determination will expire from the Senate Disallowable Instruments List on 25 June 2018.

Figure 1. Advisory required on traditional homeopathic products by Health Canada

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TGA Consultation: Complaint handling and monitoring

Yet another TGA consultation; this one closing on 4 June 2018 for a new regulatory system that is meant to start on 1 July 2018! For the last one on the draft new Therapeutic Goods Advertising Code, see my comments here.

There are a number of concerns with the TGA proposal on their new complaint system (updated on 10/05/2018 after response from TGA):

Transparency:

A complainant who sends a valid complaint will receive an email with a case identification number. However, unlike the existing CRP system, it appears that the complainant:

  • Will NOT receive a detailed determination as to whether their allegations of specific Code breaches were agreed with or not (unlike what the CRP currently publishes),
  • Will NOT be told the priority level their complaint has been assigned to,
  • For a case the TGA regards as low priority, they may find some information about their complaint in bi-annually statistics the TGA propose to publish on the number, frequency and nature of complaints dealt with.
  • For cases the TGA regards as higher priority, it is said that complainants will be notified of a brief outcome posted on the TGA web site.

Low priority cases, the only details published appear to be the case identification number, date received, date completed and the outcome; that is, a “regulatory obligation notice” was sent. There apparently will be NO information published on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • If the “notice” achieved compliance (the TGA says some target reviews may be done on such cases)?

Why should the complainant have to follow up if compliance has been achieved; why not the TGA in all cases?

Medium priority cases, where an acceptable response is received to a warning letter (which appears to be merely a statement from the sponsor that the alleged breach has been responded to), the details of the responsible entity along with the case identification number, date received, date completed, the therapeutic goods involved, compliance action/s taken (or proposed) and the outcome will be published. Once again, NO information is provided on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • Whether the “response” achieved compliance or not?

Experience with the current CRP shows that many sponsors will assert they will fix the problem, but then don’t; alternatively, they may correct the breaches pointed out, but then create new ones!  In short, monitoring is essential; trusting sponsors is naive!

High priority and critical priority cases, a determination will be made as to the most appropriate regulatory tools to be used. Where these matters are resolved, the details of the responsible entity, the case identification number, date received, date completed, the therapeutic goods involved, the compliance action/s taken, and the outcome will be published.

It appears that these are the only cases in which the product involved may be identified. But apparently not if compliance is achieved by negotiation rather than administrative or regulatory action, such as cancellation or suspension of therapeutic goods from the ARTG, enforceable undertakings, infringement, directions and public warning notices, and court outcomes. Not good enough!

In conclusion, the proposed TGA complaint system provides much less transparency that the current CRP system; very convenient for industry and for the TGA!

Monitoring and trend analysis

There is considerable concern about the TGA’s ability to perform this task. My colleagues and I have previously asked that TGA post-marketing compliance data be broken down into targeted and random reviews. This breakdown is NOT found in the TGA’s annual performance statistics and half yearly performance snapshots.

Rather the TGA lumps data on compliance breaches for both targeted and random reviews together. This means that if the TGA targets a category of product (such as sunscreens) which have less compliance breaches than other categories (such as herbal or homeopathic products), then the overall compliance rate appears to improve as the latest TGA snapshot showed. This was reported by the media as, “Complementary Medicine Compliance Improves (80% non-compliance drops to 56%)”. TGA targets need to be reported publicly, not merely made available for industry to selectively report.

The latest data provided, “Listing Compliance Reviews FY2016-17” (attached) has the following problems:

  • It gives percentages but not absolute numbers. Good reporting practice means all percentages presented should be preceded by the numbers they represent.
  • It has added a new column to the table, Project” which is not present in the “Annual performance statistics report: July 2016 to June 2017 3.3.2 Compliance reviews”. What does this mean? If it’s projects mentioned in the annual report that targeted oral probiotics indicated for vaginal conditions and listed medicines with blood glucose and cholesterol indications, what other investigations comprise the “targeted” column?

It is also important to break down the results for the main categories of products targeted by random reviews: e.g. Vitamins and minerals, Fish oil, Western Herbal Medicine, Chinese Traditional medicine, Ayurveda (Indian) medicines, Homeopathic Medicines, Probiotics, Sunscreens and Aromatherapy products.

Finally, it’s crucial to report to consumers and health professionals the most non-compliant companies. This will help consumers to select products and health professionals to give advice. It will also provide a stimulus for the named companies to improve.

In the second Civil Society Seminar on, “The Advertising of Therapeutic Goods and Services (and its regulation)” held at Monash law Chambers on Sept 8, 2017, and attended by the TGA’s now departed Ross Hawkins, we heard a presentation by Suzanne Crowle, Director of Engagement and Complaints, of NSW Fair Trading.

The NSW Fair Trading Complaints Register provides information about businesses that are the subject of 10 or more complaints received by Fair Trading in a calendar month. It’s updated monthly and only includes complaints considered by Fair Trading to have been made by a real person, relating to a real interaction with a business. It provides information about the name of the business; the number of complaints NSW Fair Trading has received about the business in the last month and the product groups complained about.

If NSW Fair Trading can do this monthly, why can’t the TGA do it at least 6-monthly?

Finally, I reiterate the point made in other submissions; unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system.

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TGA Consultation: Draft therapeutic goods advertising code 2018 #2

For background, see TGA Consultation: Draft therapeutic goods advertising code 2018 #1

Our full submission is available here. It’s endorsed by Friends of Science in Medicine (FSM) and the writing was assisted by two Monash University students, Malcolm Vickers (MPH) and Alanna Rottler (BMedSci (Honors).

The submission points out that many suggestions put forward by civil society in previous consultations to the TGA, the Senate Inquiry into the Therapeutic Goods Amendment Bill (2017 Measures No. 1) Bill 2017, a Civil Society Public Forum held at the Australian National University, media articles and TGA stakeholder consultations have been ignored.

We note that the TGA appears to give equal validly to ‘traditional’ and ‘scientific’ evidence, which is not in keeping with modern scientific understanding as documented in the NHMRC’s levels of evidence. Traditional evidence (opinion) occupies the lowest level of the hierarchy of evidence. See below.

We also point out that ‘traditional’ medicines can be both ineffective and dangerous and their increasing mass marketing often includes misleading and deceptive claims which takes advantage of consumer ignorance.

Given our multicultural and pluralistic society, we accept that it’s appropriate for Australians to have access alternative medical traditions and products. There is also considerable national pride in Traditional Chinese Medicine (TCM), Ayurveda and Unani and valuable knowledge can be found in such traditions.

However, many of the theories on which such traditions are based have not been validated by scientific inquiry, such as the TCM concept of meridians through which the life-energy known as ‘qi’ flows, the Ayurveda concept of life-forces (dosha) and body types (vata, pitta and kapha), and the homeopathic principle of ‘like cures like’. In addition, traditional medicines can be both ineffective and dangerous.

We argue that it is important to ensure that consumers understand the difference between “traditional” and “scientific” evidence. We also need to restrain the increasing mass marketing of traditional medicines from taking advantage of consumer ignorance and we need to protect consumers from misleading and deceptive claims about such products.

In appendix I, III and IV of our submission we have listed many products invoking traditional paradigms that make claims we allege are misleading and deceptive.

We reiterate, a likely perverse outcome of the Permitted Indication policy will be that sponsors of complementary medicines will change the indications of many of their products from “scientific” to “traditional” and increasingly introduce the latter, to the detriment of public health.

Among many other changes needed to the draft Code:

  • All claims invoking traditional paradigms must be accompanied by an advisory statement such as, “The claims for this product are based on traditional beliefs and not modern scientific evidence”.
  • If there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, all labeling and advertising material must state: “This traditional use is not supported by scientific evidence”.
  • If there is both a history of traditional use and contemporary scientific evidence supporting the claims made then the above advisories need not apply.

There is dispute about the impact of advisories, yet the TGA has mandated several without research on whether consumers understand or will act on statements such as:

  • “St John’s Wort affects the way many prescription medicines work – including oral contraceptives. Consult your doctor.”
  • “Please seek the advice of a traditional Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you”.

Research is required on whether TGA advisories and others suggested will achieve the desired objective. This is now underway at Monash University.

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TGA Consultation: Draft therapeutic goods advertising code 2018 #1

The TGA is seeking comments from interested parties on the proposed draft Therapeutic Goods Advertising Code 2018 (the Code) and associated guidance document. Comments should be submitted to the TGA by COB Friday 27 April.

Typically, many suggestions to improve the Code made by non-industry stakeholders in numerous previous consultations have been ignored.

The TGA’s strategy is to overwhelm stakeholders with numerous consultations in the hope of inducing confusion and submission fatigue. Then they tell Parliament they have extensively consulted stakeholders, but not that they have taken no notice of non-industry submissions!

For example, the Explanatory statement of the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 states,

“The draft list of indications was then published on the TGA website for public comment between July and October 2017. 110 submissions were received during that period from consumers (12 submissions) and industry stakeholders (98 submissions). Industry submissions primarily proposed additional indications for inclusion in the instrument, while consumer submissions expressed concerns about the terminology and evidence base for ‘traditional indications’ and contended that the number of indications in the instrument should be reduced. Stakeholder comments were considered, and the instrument was further refined to incorporate some improvements for greater clarity and in order to ensure that the list of indications is comprehensive and commensurate with the low risk nature of listed medicines”.

This contains nothing about numerous submissions from the RACGP, ASCEPT and others that argued that if consumers were to make an informed decision on ‘traditional” medicines an advisory statement was required along the lines of

“This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts” &/or “No scientific evidence has been provided that this product works”.

It did not mention public concern voiced by the RACGP President, “Alarming health claims must not appear on complementary medicine” and others, such as “New list of permitted advertising lines for complementary medicine products does little to protect consumers”.

Non-industry stakeholders have two remaining strategies to stop this craziness:

  1. Insist that the above advisories and other matters be added to the draft Therapeutic Goods Advertising Code 2018 (see notes).
  2. Write to Senators supporting the CHOICE campaign to disallow the Therapeutic Goods (Permissible Indications) Determination until health professional and consumer concerns are considered (See Choice letter).

 

 

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Channel Nine ACA ADHD breakthrough; TGA response to FOI

For Background see: https://croakey.org/a-current-affairs-adhd-breakthrough-bona-fide-news-or-unethical-advertising/

On 27 March 2018, following FOI requests, the TGA confirmed that their Advertising Compliance Unit (ACU) did investigate a complaint about this program submitted by Prof Jon Jureidini to the Complaint Resolution Panel on 21 February 2017 who forwarded it to the TGA on 21 April 2017.

The ACU wrote to Channel Nine regarding the segment, and indicated that its preliminary view was that the segment may have satisfied the definition of ‘advertisement’ in the Therapeutic Goods Act 1989 and that the advertisement may have breached the Therapeutic Goods Advertising Code.

The ACU requested deletion of the following material which contained information presented in the broadcast, and, at that time, was still available:

  • A tweet posted by the ACA twitter account
  • A story on the 9 News website
  • Copies of the broadcast on digital streaming services, such as YouTube.

While no final position was reached in relation to the advertising requirements by the TGA ACU, Channel Nine removed the material referred to above.

Previously, in relation to a similar complaint, the Australian Communications and Media Authority (ACMA) concluded on 31 May 2017 that the licensee did not breach clause 3.3.1 of the Code, ‘In broadcasting a news or Current Affairs Program, a Licensee must present factual material accurately and ensure viewpoints included in the Program are not misrepresented’.

In making this finding, the ACMA did not consider whether the media release, the findings by the researchers, or their methods, were scientifically supportable (which was the thrust of the complaint), merely that it was ok for Channel Nine to presume that a media release was a reputable source of information!

This case has been used in Monash SPHPM Media Workshops in 2017 (to be repeated in  2018)

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ABC RN Roundtable: New regulatory framework for complementary medicines called into question

 

Presented by Hugh Riminton
Producer Skye Docherty

 

Broadcast Sunday 18 February, 2018. Listen or download here.

Hugh interviewed:

  • Adjunct Professor John Skerritt, Deputy Secretary for the Federal Department of Health in charge of medicines’ regulation
  • Dr Cameron Loy is the Chair of the Royal Australian College of General Practitioners in Victoria.
  • Dr Vicki Kotsirilos AM is a general practitioner who uses therapies such as acupuncture, nutritional and herbal medicine; also associate professor at Western Sydney University

Professor John Skerritt’s statements and my comment follow:

  1. ‘So, if you list a medicine in Australia you actually have to have evidence that the product works. And what we do is call in the evidence, so, let’s say there is a group of products making claims about weight loss, we call in that group, we assess the evidence, and if the evidence isn’t held, the product gets cancelled’.

This conveniently ignores the fact that TGA post-marketing surveillance, over many years, shows that non-compliance of Listed products with regulatory requirements runs consistently around 80% of products sampled; lack of evidence is the most frequent violation. The Complaint Resolution Panel reports similar findings for upheld complaints.

In addition, despite long-standing concerns about claims for weight loss products that lack evidence[1] the TGA has never called in the evidence for that group of products and on the rare occasion they have cancelled a weight loss product it has immediately been re-listed with a ‘traditional’ indication.[2]

  1. ‘There’s a small group, and we think in the marketplace it might be 5%, of medicines, that are allowed to be on the register but with a statement on the label, and a statement in the register, that they are based on traditional use’.

This ignores the fact that of 1019 final permitted indications (submitted by industry and endorsed by the TGA) only 14% the require the manufacturer to have scientific evidence to back them up. For the rest, evidence of “traditional” use can suffice; that is, use for more than 75 years in an alternative medical tradition, such as traditional Chinese medicine, Ayurveda, Unani, Western herbalism or Homoeopathy.

We anticipate this decision will result in a flood of ‘traditional’ products that will confuse, mislead and waste consumers money. Meanwhile, too many consumers are forgoing evidenced-based prescription medicines because they cannot afford increasing PBS co-payments.[3]

  1. ‘Most of those [traditional] products are actually provided through a relevant traditional medicine practitioner’ … ‘and generally, the traditional Chinese medicines are not advertised to the wider products [public?] so it will be the science-based claims that are on that list’.

I’m unaware of what data Professor Skerritt bases this statement on. Traditional medicines are increasingly being promoted to Australian consumers and their advertisements are being complained about (see examples). As noted above, the TGA decision to allow 86% of 1019 permitted indications to be based on traditional claims will accelerate this trend. Why else would industry have provided such a large list of traditional indications?

  1. ‘AHPRA regulate[s] Traditional Chinese Medicine practitioners’.

TCM practitioners were registered because of safety concerns, not because there was evidence their treatment modalities such as Chinese herbal medicine and acupuncture was clinically effective.[4]  In addition, there are increasing complaints about the advertising of these practitioners.[5]

More importantly, other traditional practitioners such as Ayurveda, Western herbalists, Homeopaths are not registered by AHPRA, yet the TGA has listed products citing these traditions that are increasingly being promoted to the public.

Australia is a multicultural and pluralistic society and it’s appropriate that we respect, understand and allow access to traditional, alternative and complementary medical traditions and products.However, it’s also important that we restrain purveyors of these medicines from taking advantage of consumer ignorance and that we protect consumers from misleading and deceptive claims about the products provided.

At a time when Australia’s health budget is severely stressed and Australians struggle to afford medical benefit cover and, quite often, proper medical treatment, it seems  highly questionable for a government to be knowingly supporting alternative health treatments that consistently fail to show any evidence of effectiveness and many of which the government’s own NHMRC has condemned in those terms.

The WHO Traditional Medicine Strategy 2014-2023 identified the following challenges for Member States: Development and enforcement of policy and regulations, Ability to control and regulate advertising and claims, and Ensure consumers can make informed choices.

This is why many civil society groups have demanded that these medicines be accompanied by an appropriate advisory statement to enable consumers not familiar with the ‘tradition’ to understand the often creative promotional claims involved.

  1. ‘All complementary medicines, including those based on traditional indications… have ingredients where there is evidence of safety, positive evidence of safety…. what we can do as a regulator is make sure that the products are safe’.

The Therapeutic Goods Advertising Code 2015, s4(2)(i) states that advertisements must not claim that goods are completely safe, harmless, or free of side-effects. Yet Professor Skerritt states the TGA makes sure these products are safe.The reality is that the TGA’s ‘Catalogue of permitted ingredients for use in listed medicines’ includes substances that are regarded as ‘relatively safe’.[6] For example, Black cohosh (Cimicifuga racemosa) has sometimes been associated with liver failure[7] while allergic reactions to Echinacea have included anaphylaxis (the most severe type of allergic reaction), acute asthma attacks, severe urticaria (hives) and swelling.[8]

  1. ‘People are taking these things [vitamins and minerals] to supplement dietary deficiencies’.

Professor Skerritt should have pointed out that vitamin and mineral supplementation is not a substitute for a healthy diet. Indeed, some trials suggest that micronutrient supplementation in amounts that exceed the recommended dietary allowance (RDA) e.g. high doses of beta carotene, folic acid, vitamin E, or selenium—may have harmful effects, including increased mortality, cancer, and haemorrhagic stroke.’[9]

  1. ‘Within defined periods, and for the most serious ones a matter of days, where advertisements will be able to be pulled; there will be penalty notices, a bit like a speeding fine, but with a higher cost to the advertiser, or the ability to seek a court injunction’.

These timelines appear improbable.[10] Even if a penalty notice is issued quickly, the recipient has the right to dispute the notice in Court. If fast-track legal proceedings are contemplated, the TGA must, as a matter of the government’s own Model Litigant Policy, provide adequate opportunities for sponsors to consider claims against them and respond. Average case completion times for the ACCC are closer to a year than a few weeks. The Administrative Appeals Tribunal and the Australian court system will not tolerate lack of due process.

[1] https://www.mja.com.au/journal/2008/188/1/commercialism-choice-and-consumer-protection-regulation-complementary-medicines

[2] https://www.youtube.com/watch?v=12ww26sQF7E

[3] https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-13-484

[4] http://ncp.ncc.gov.au/docs/VIC%20traditional%20chinese%20medicine.pdf

[5] http://www.ahpra.gov.au/annualreport/2017/downloads.html

[6] https://www.tga.gov.au/catalogue-permitted-ingredients-use-listed-medicines

[7] https://www.tga.gov.au/alert/black-cohosh-cimicifuga-racemosa

[8] https://www.allergy.org.au/patients/medication-allergy/adverse-reactions-to-alternative-medicines

[9] https://jamanetwork.com/journals/jama/fullarticle/2672264

[10] https://www.doctorportal.com.au/mjainsight/2018/6/tangled-web-around-the-tga-2017-measures-no-1-bill-2017/

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Letter in ‘The Australian’ 16/02/2018 – A triple cash burner

The revision of surgical procedures deemed “unnecessary, wasteful and risky” (“Health waste: spinal fusion added to list”, 14/2) is good news for the troubled health budget, but you must ask why this approach is so lamentably piecemeal, especially at the hands of those entrusted with protecting the health of Australians.

The Therapeutic Goods Administration, the chief body that vets medicines and medical devices for the nation, has just approved a vast array of patently absurd so-called alternative treatments — under the poor excuse of their being “traditional medicines” — that can be freely advertised and offered with no evidence at all required to show they are effective and plenty to show they are not.

The TGA is allowing a variety of “medicines”, for each of which is a nonsensical claim, such as it “softens hardness”, “tonifies kidney essence”, can “open body orifices”, “replenish the gate of vitality”, “moistens dryness in the triple burner” and more. Yet, many consumers are forgoing evidenced-based prescription medicines because they have wasted their money on this heavily promoted rubbish and can no longer afford PBS co-payments.

It’s no wonder that the nation’s health bill is billions of dollars and growing apace without a comparable improvement in health outcomes. Given TGA regulatory craziness, the odd spinal fusion or two hardly rates a mention.

Professors John Dwyer, Hubertus Jersmann, Marcel Costa, Associate Professor Ken Harvey, Friends of Science in Medicine, Adelaide, SA

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Therapeutic Goods Amendment Bill 2017 passed by Senate

This Bill was passed this morning (15/02/2018) by the Senate with the Labor supporting a Government amendment to continue advertising pre-approval (in mainstream media) for 2 years with a review after 18 months.

The Government and Labor did not support Senator Di Natale’s amendment:

All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective’.

The main speakers:

Extracts from Hansard follow:

Senator DI NATALE (VictoriaLeader of the Australian Greens) (10:43): by leave—I move Greens amendments (1) and (3) to (6) on sheet 8353.

These amendments relate to the pre-approval process, which is an important safeguard for consumers. We think it’s critical that it remain. The government, which initially had indicated it was going to abolish the pre-approval process altogether, has decided, after some pressure from the Greens, to amend its own legislation, which was going to be passed as non-controversial legislation. We are pleased there has been a concession. We think it’s an important concession, but we think the government needs to go further, and that’s why we’re moving these amendments.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:44): Thank you for your words. The government has listened to concerns raised and has agreed to move our own amendment, with respect to the pre-approval processes, to keep the current conditions in place for two years and then to run an evaluation of the whole new advertising framework in 18 months. I’m looking forward to moving those amendments, hopefully with the Greens’ support.

Senator POLLEY (Tasmania) (10:45): Labor are satisfied that the amendment we have negotiated with the government addresses our primary concern. We will not be supporting any further amendments, because we want to facilitate a speedy passage of the legislation so that the measures relating to the provisional approval pathway can commence as soon as possible. The negotiations that have taken place and the fact that the government have sought to amend their own legislation are evidence to us that, at this point in time, we will support this legislation, and it should be passed as soon as possible.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:45): Just for clarity around that: given that we have been able to reach the middle ground with respect to review and the pre-approval processes, we won’t be supporting the Greens amendments at this stage, because it would actually delay any action for at least four more years.

Question negatived.

Senator DI NATALE (VictoriaLeader of the Australian Greens) (10:46): by leave—I move amendment (2) on sheet 8353.

(2) Schedule 2, item 15, page 19 (after line 24), after subsection 26BF(5), insert:

(6) All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective.

It is really important to note that the Sansom review suggested a range of changes. They suggested a change that meant that sponsors of products couldn’t list the indications for that product as free text—in other words, they couldn’t decide what they wanted to say about a particular product; there had to be a list of pre-approved options. We’ve got some concern that that list seems to be growing, but ultimately we do support the recommendation from the Sansom review which said that there have to be a range of pre-approved indications and that sponsors need to indicate that they’re going to choose one of those pre-approved indications rather than simply stating in their own words what they believe a product might do, which on a number of occasions has been found to be misleading.

But the second thing the Sansom review also recommended was that there needed to be a disclaimer put alongside these indications—in other words, basically a statement on all products sold so that, while a particular indication, say for a traditional medicine, has been listed, it’s followed up with a statement in the same space, using the same font, which basically says, ‘Look, this is what the traditional indication for this medicine is, but it has not been scientifically tested.’ That is very important because having an indication like that might give a consumer some confidence that, given that this product has been approved by the TGA, there’s been some scientific testing to validate that indication, when in fact that’s not the case. So the Sansom review said: ‘Get rid of this free text. Don’t allow sponsors of products to say what they want about a particular drug. That can be misleading and give the false impression to an individual that a product has a scientific basis behind it, so you’re going to have to basically tick a list of pre-approved indications, but you also need to make sure that you make it very clear to the individual purchasing the product that it hasn’t been scientifically tested.’

That was what the review recommended, and we support that. That recommendation was also supported by a number of other health bodies and consumer groups—for example, CHOICE, the Consumers Health Forum and the Friends of Science in Medicine. They all raised concerns in their submissions. We’re simply saying that, if you’re purchasing a product, you should have all the information available. You shouldn’t be misled about the particular scientific evidence behind a product, which I think is really important protection for people who spend often a lot of money on this stuff in the belief, sometimes mistaken, that there is a valid, scientifically tested indication for that product. So we’d like to see that statement included, and that’s effectively what this amendment does.

Senator McKENZIE (Victoria—Minister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:50): Thank you, Senator Di Natale.

Obviously, the government similarly wants to ensure that when Australians are purchasing products they have the required information to make informed choices. We agree with the Sansom review to that extent. We also recognise, again, that we have a $4 billion export industry in this type of product and we walk that line between recognising traditional medicine and ensuring that Australians’ safety is not compromised. We have to recognise that all of these products, all the ingredients in these products, have been approved for consumption, so there is not a safety risk per se.

But we have to get the balance right and recognise that for some, particularly those using Chinese medicine, the history of practising in that traditional medicine paradigm goes back thousands of years. It’s been extensively refined, practised and documented and in many cases incorporated into mainstream medicine. So, a statement required by the Australian government that the indication is not in accordance with modern medical knowledge and that there is no scientific evidence will be seen as arrogant and insensitive to those practising and using traditional Chinese medicines.

The government will not be supporting this amendment by the Australian Greens.

Overseas experience shows that the suggestions of the Australian Greens will actually be ineffective in practice. The evidence from the United States, where the US Food and Drug Administration has mandated such disclaimers, is that these disclaimers are ineffective in assisting consumers to make more informed choices when self-selecting medicines. So those who want to purchase a certain product, irrespective of the disclaimer made, will still choose to purchase such a product. It won’t change behaviour. Many stakeholders did not support this proposal. We consulted extensively on the bill itself and the stakeholders did not support it.

The reforms will introduce measures to improve transparency for consumers, including a new mandatory requirement for listed medicine products to identify their evidence base for efficacy. For example, they’ll be required to say, ‘traditionally used in Western herbal medicine’ or ‘traditionally used in Chinese medicine’. That will be required to be put on the product.

As I’ve stated earlier, I think it is offensive and disrespectful to those who practice traditional medicine. It’s not consistent with the World Health Organization. We, as a country, have endorsed the World Health Organization position on the role of complementary medicines in the national medicines framework, and this position acknowledges that traditional medicines do have a valid function in modern medicinal frameworks.

Traditional Chinese medicine practitioners are recognised under the national law governing medical practitioners administered by the Commonwealth and AHPRA. It follows a detailed review by government of which modalities are evidence-based and, therefore, have credibility. We have done a lot of thinking around this and we think we’ve hit the mark on the types of labels, disclosure and information that will be available to Australian consumers. We’ve committed to increased compliance activity for listed medicines. I know that Senator Di Natale in his comments made reference to past incidents of concern. We’ve actually strengthened compliance around that to ensure the health and safety of all Australians as much as possible. So the government will not be supporting the amendment.

Senator POLLEY (Tasmania) (10:56): As I outlined previously, in the debate on the first amendments, it has been Labor’s position that, first and foremost, there is always going to be concern for the consumer. We want the best health outcomes. We have negotiated with the government on this piece of legislation and we’re satisfied that this legislation is a good first step. This is a good framework that we, at this point in time, can work with. I do note the concerns that were raised by the Greens, but I acknowledge, too, the government’s responses to those amendments, and I don’t intend to take up the time of the Senate to reiterate those responses.

The TEMPORARY CHAIR ( Senator Williams ): The question is that Greens amendment (2) on sheet 8353 be agreed to.

Question negatived.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:54): I move government amendment (1) on sheet JC487:

(1) Clause 2, page 2 (table item 6), omit the item, substitute:

6. Schedule 6, 1 July 2020. 1 July 2020

Part 2

As I said earlier, this amendment was reached, noting the concerns of the Australian Greens and in consultation and negotiation with the Australian Labor Party. We thank them for their approach and for being so proactive in finding a middle ground where we will be reviewing after 18 months and continuing the existing pre-approval process for two years.

Senator POLLEY (Tasmania) (10:57): As outlined during my speech in the second reading debate on this legislation, Labor had concerns about scrapping the pre-approvals and we intended to move our own amendment. Having extracted a key concession from the government that the pre-approvals will remain until 1 July 2020 and that there will be a review in 18 months—and I think that’s the important element that the minister has just touched on—the legislation is acceptable to Labor. We shall be supporting this amendment and, in fact, we will be supporting the bill.

The TEMPORARY CHAIR: The question is that amendment (1) on sheet JC487 moved by Minister McKenzie be agreed to.

Question agreed to.

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, as amended, agreed to; Therapeutic Goods (Charges) Amendment Bill 2017 agreed to.

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 reported with amendments; Therapeutic Goods (Charges) Amendment Bill 2017 reported without amendments; report adopted.

Third Reading

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (11:00): I move:

That these bills be now read a third time.

Question agreed to.

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Complementary medicines: The Peoples Choice?

An article in AJP asks, ‘Are complementary medicines conventional medicine’s inferior cousin or a key player in health?

The arguments put forward in this article in favor of complementary medicines are:

  1. They are frequently purchased by consumers (which fails to mention the impact of the enormous amount of money spend on their promotion which make extravagant claims that often bear no relation to evidence supporting their use).
  2. They contribute to consumer health through primary and secondary prevention of illness (which fails to acknowledge the lack of evidence to support this assertion).

Both these strategies are highlighted  in a complaint for Swisse Ultiboost Lung Health Support.

Finally, Friend of Science in Medicine (FSM) pharmacist, Ian Carr has written a nice article in response, ‘Supplements exploit consumer ignorance‘.

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