Self-regulation or government regulation of transparency?

In 2012, when edition 17 of Medicines Australia Code was released, the Australian Competition and Consumer Commission (ACCC) limited its authorisation to 2 years, rather than the 5 years sought, to encourage Medicines Australia to improve transparency around payments to individual health care professionals.

This was in accord with international developments such as the US Open Payments (the Physicians Payment Sunshine Act), which mandated full public disclosure of these relationships.

Edition 18 of Medicines Australia Code has now been submitted to the ACCC for authorisation. It “encourages” healthcare professionals to consent to disclosure. However, it also allows them to opt-out of disclosure while retaining the financial and related benefits of their interaction with member companies. As Senator Richard Di Natale noted, “The voluntary nature of disclosure makes the Code next to meaningless. It’s like making a breathalyser voluntary for drink drivers”.

Medicines Australia Code is weak because other therapeutic goods industry associations have not adopted transparency provisions in their own self-regulatory Codes and many have also opted out of ACCC Code authorisation (and thus being subjected to ACCC persuasive powers). In addition, there are increasing numbers of non-members of therapeutic goods industry associations (for example, the Indian generic company Ranbaxy Australia) who are not bound by any self-regulatory Code. Furthermore, Australian health professional organisations have also failed to address &/or incorporate transparency provisions in their own Code.  It’s therefore not surprising that many members of Medicines Australia were worried that attempting to force full disclosure would put them at a competitive disadvantage with other therapeutic goods companies, especially generic companies.

Medicines Australia argue that disclosing transfers of value from those health professionals who consent (and lumping together the total value of benefits received and the numbers of those who do not) is an incremental improvement (and public benefit) on the previous Code and thus their latest Code should be authorised.

The alternative view is that it would be to the public detriment to authorise a Code that fails to deliver on the key principles agreed to by Medicines Australia Transparency Working Group, including the key outcome raised by many interested parties in deliberations about edition 17 of the  Code: transparency on individual payments made to healthcare professionals (consistent with developments in the U.S.).

My own view is that the ACCC should not provide a fig-leaf of respectability to edition 18 of Medicines Australia Code by authorising the flawed outcome achieved. Rather they should defer authorisation and refer this mess back to where the responsibility lies: the Regulatory Policy & Governance Division of the Australian Department of Health, the Therapeutic Goods Administration (TGA) and the government, all of whom have failed to address the limitations of self-regulation.

A number of counties such as France, Portugal and Turkey have now embraced government regulation of transparency in addition to the USA. I also believe that Australian legislation should also make transparency (and other ethical considerations) a condition of market authorisation by the TGA.

My full submission (and others) can be found here. A (much) shorter version has published by MJA Insight.

If others wish to engage in this debate the ACCC is accepting submissions until August 1, 2014.

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Recent activities (U3A Melbourne)

I’ve just delivered a short course on,  “Complementary medicines: Exploring the Issues” for U3A Melbourne.

The material presented is available (as PDF’s) here: Background reading I & Background reading II , Questionnaire and presentations (2 slides per page)  Session I, Session II & Session III.

As expected, when questioned at the start of the course, none of the course participants knew what AUST L or AUST R on the labels meant!

As part of the course I showed some recent TGA videos which participants felt were informative.

There was criticism of the static talking head format (boring); some would have preferred a more lively interview format such as the one I also showed presented by Norman Swan (ABC Tonic) for NPS Medicine Wise.

Regardless, many older participants appreciated that the TGA video had the spoken word duplicated by the text and also a transcript available to read at their leisure.

In addition, the information presented at , “Listed medicines: The role of Australia’s medicines regulator” is excellent, in particular the “Buyer – be aware” section.

This TGA material deserves wider publicity.

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Monash University appointment confirmed

My appointment as Adjunct Associate Professor, in the School of Public Health and Preventive Medicine, Monash University has now been confirmed.

I thank Prof John McNeil for offering me this position.

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ABC1 The Checkout: Swisse Chlorophyll

See the advertisement for

As “evidence” for the claims made they cite: Food Standards Australia New Zealand (FSANZ, 2013). Nutrition, Health And Related Claims, Standard 1.2.7. 1–48.

Now view this segment of The Checkout (Episode 3, March 6, 2014).

See also this advertisement for BioGlan’s Chlorophyll, their statement and “The Checkout’s” response.

And Nature’s Sunshine Liquid Chlorophyll advertisement. Ironically, unlike the others this product is Listed on the TGA’s ARTG (No: 26033).

Yet more examples of food-medicine inconsistency (and outrageous claims)!

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Coming out of retirement

As reported today, I’ve been offered, and accepted, an adjunct Associate Professor position at a university that was also approached by Swisse with an offer of funding but which did not accept.

See: Ken Harvey cancels retirement as Swisse spat turns personal  and

Swisse complains of resignation ‘stunt’


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Latest Press Release from Swisse; my response

The Swisse press release is available here

I quote from it:

  • Our prerequisites were simple….

This list of prerequisites does not include the key concern of myself and others; that the research proposed was to specifically evaluate the efficacy of Swisse products.

 Do we really want University researchers to spend their time assessing the efficacy, for example, of Swisse Men’s Ultivite which contains 52 “premium quality vitamins, minerals, antioxidants and herbs” in a potpourri of ingredients many of which lack logic (and are present in non-standardised, sub-therapeutic amounts)? These ingredients are presumably included in the hope that “more is better” has marketing appeal.

What about Swisse “Liver detox” and “Ultiboost Hunger control” (the subject of a 2013 ABC Checkout program)? See:

There are many worthwhile complementary medicine questions to be researched such as exploring the efficacy of certain traditional medicines (from which many useful active pharmaceuticals have been derived). However, that was not what the Swisse – La Trobe MOU (as announced) proposed.

  • The top 10 patent protected drugs that are prescribed by doctors in Australia all rely on efficacy from research that was industry funded. This is absolutely no different to what Swisse is aiming to do, with the support of additional industry players, government and other financial backers.

Not true! Most research on product efficacy by conventional pharmaceutical companies is undertaken prior to marketing and is used as part of an application for product registration where it is independently assessed by regulators such as the Australian Therapeutic Goods Administration (TGA).

Swisse products are listed by the TGA; a process that requires no pre-market evaluation of efficacy.  However, the sponsors of listed products are  meant to hold purity, safety and efficacy data for potential audit, compatible with the product labelling and advertising claims. So if a company needs to find this evidence after marketing it would seem that their listing claim must be dubious.

  • Given that Swisse does not hold patent protection for any products to be researched, it means that the entire nutraceuticals industry can benefit from the research findings. 

Swisse (and other supplement company) products usually contain a unique mix of ingredients, for example the Swisse Men’s Ultivite F1 contains “52 premium quality vitamins, minerals, antioxidants and herbs”. Results found from trials using Men’s Ultivite F1 cannot be extrapolated to other multivitamin, mineral and herb products (unless they had an identical formulation) and thus other supplement companies cannot benefit from such research.

  • The Australian Integrative Medicine Association (AIMA) has publically stated itself that the attacks from the Friends of Science are hypocritical.

Ironically, AIMA did not disclose their own relationship with Swisse in this press release. In addition, FSM have clearly pointed out their many concerns about the Swisse-La Trobe MOU which are in no way “hypocritical”; see:

  •  Dr Harvey advised last September that he intended to retire from all “watchdog activities”, suggesting that his recent retirement announcement from La Trobe, citing concerns over the Complementary Medicine Evidence Centre (CMEC), could merely be seen as yet another publicity stunt for a final farewell.

While it’s true I had intended to retire later this year, following publicity about the Swisse-La Trobe MOU I’ve had had many requests to keep on keeping on. In addition I’ve also received also an offer of an Adjust Assoc Prof appointment at another university that refused the Swisse offer. Accordingly, I’ve accepted the latter and postponed my retirement.

Swisse will be pleased to know that I have more complaints about the promotion of complementary medicines (and the ineffectiveness of the regulators) currently in train.

  •  Professor Paul Glasziou of Bond University suggested that the CMEC research concept was bad because he incorrectly claimed that complaints were made about Swisse misleading the public through our advertising. The complaints that Professor Glasziou refers to were from one anonymous source, and were over semantics… Swisse have never been fined…

 Swisse have claimed that a number of their products were “proven”, “clinically proven”, “scientifically shown”, “clinically tested with proven results” and “proven in clinical trials”; claims that the independent Complaint Resolution Panel (CRP) found breached the Therapeutic Goods Advertising Code, see: . In my view (and that of the CRP) these “semantics” are important and the Swisse distortion of previous research results for marketing purposes was another concern about the research proposed.

Regrettably, the CRP has not got the power to “fine” companies who breach the Therapeutic Goods Advertising Code.

  •  … let’s celebrate the success of an Australian company that is making millions more people happier and healthier around the globe.

 With some important exceptions, there is little evidence that the majority of people who consume complementary medicines are made happier and healthier as a result. Most consumption would appear to be driven by hype and celebrity endorsement; not by evidence.

In conclusion, the following poll was conducted by MJA Insight:



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La Trobe – Swisse update

This issue has attracted considerable media attention. For example:

More recently:

La Trobe University has published its defence of the deal:

Finally, last year, the Australian Broadcasting Corporation (ABC) targeted Swisse (and the regulator: Australian Therapeutic Goods Administration (TGA)) in its consumer  affairs program, “Checkout” see:

They reinforce their views in a new video aimed a promoting the 2014 series of the show:

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Resignation as Adjunct Associate Professor, La Trobe University

Today I tendered my resignation as Adjunct Associate Professor in the School of Public Health because of the recently announced partnership between La Trobe University with Swisse Wellness Pty Ltd.

The reasons are outlined in the attached letter.


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Souvenaid update

A recent NPS review is relevant:

Also, I understand that the subsidy of Souvenaid was considered at a recent meeting of the Repatriation Pharmaceutical Reference Committee (RPRC). I have yet to be informed of the outcome.

Finally, I am still waiting for the outcome of a complaint about the promotion of this product submitted in May 2013 to the TGACRP and handballed to the NSW Food Authority. Correspondence appended.

From: Ken Harvey []
Sent: Monday, 13 May 2013 7:01 AM
To: Judith Brimer (; Mick O’Connor (mick.o’
Subject: Re: CRP / TGA Complaint Souvenaid

Dear Judith and Mick,

I’ve attached a complaint about Souvenaid, currently being heavily promoted to consumers (and health professionals):

  • “For the treatment of mild Alzheimer’s disease”,
  • “A new approach in the early stages of Alzheimer’s Disease”,
  • “Nutritionally supports memory function in the early stages of Alzheimer’s disease” and
  • “Clinically proven”.

I submit that the claims made, the defined ingredients and the dose (1 bottle a day) satisfy the definition of a therapeutic good contained in the Therapeutic Goods Act 1989. As such the promotion of this product breaches Section 22(5); 42C(1) and 42DL(1)(c) of the Act and at least Section 4(1)(a), 5 and 6(b)(iv) of the Therapeutic Goods Advertising Code 2007.

Alternatively, these claims breach Section 7 of Standard 1.2.7 (Nutrition, Health and Related Claims) under section 92 of the Food Standards Australia New Zealand Act 1991 &/or Section 3 of Standard 1.1A.2 as amended operating as a transitional alternative standard to Standard 1.2.7.

I would prefer that the CRP &/or the TGA investigate this complaint because, when complaints about products that bridge the medicine – food divide are declared a food and are sent to State Health Departments nothing happens. The CRP at least provides accountability if not redress!

Please acknowledge receipt of this complaint (and the appended references) and let me know how you intend to handle it.


Dr Ken Harvey
Adjunct Associate Professor
School of Public Health,
La Trobe University
VOIP (03) 90293697 | Mobile +614 1918 1910 | Fax: +613 9818 1875

—–Original Message—–
From: Judith Brimer []
Sent: Tuesday, 14 May 2013 1:21 AM
To: Ken Harvey
Cc: Janine Curll
Subject: RE: CRP / TGA Complaint Souvenaid

Dear Ken,

I have referred this complaint (our reference Complaint 2013/05/007 Souvenaid) to the NSW Food Authority as it is a food for special medical purposes that is regulated by Standard 2.9.5.

As you can see, I have copied Janine Curll, NSW Food Authority, on this email so that this matter can be followed through with you directly.

Kind regards,

Judith Brimer
Executive Officer
Therapeutic Goods Advertising Code Council and Complaints Resolution Panel
Tel: 02 9460 2796 | Fax: 02 9460 2798

—–Original Message—–
From: Janine Curll []
Sent: Tuesday, 14 May 2013 1:53 AM
To: Ken Harvey
Cc: ‘Judith Brimer'; Ian Beer; Greg Vakaci
Subject: RE: CRP / TGA Complaint Souvenaid

Dear Dr Harvey

Thank you for the complaint regarding this Food for Special Medical Purposes. I encourage you to refer complaints regarding compliance with this standard and other food compliance matters to the Authority.

I will be reviewing your complaint and will provide a considered response shortly.

I welcome you to the food regulatory space and thank you for your efforts in the health products space past, present and into the future. I am the primary regulatory enforcement officer in NSW responsible for implementing standard 1.2.7 and enforcing the relevant laws relating to claims on food generally. Please do not hesitate to contact me on my direct line at any time.

Kind regards

Janine Curll BSc LLB
NSW Food Authority
6 Avenue of the Americas Newington NSW 2127 | PO Box 6682 Silverwater NSW 1811 Switch +61 2 9741 4777 | Helpline 1300 552 406 | Direct line 9741 4728 | Fax +61 2 9741 4888 | Mob 0427 427 785




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Bayer finally capitulated over Berocca

Yesterday the TGA published the following update about this long-running saga:

Update following compliance with decision

“On 26 September 2013, Bayer Australia Limited advised the TGA that they have complied with and will continue to comply with the regulation 48 decision made by the delegate of the Minister for Health on 15 July 2013. This includes withdrawal of any representations, including implied representations, that “Berocca Performance” has been clinically trialled and demonstrated to improve concentration and reduce tiredness, and that they will not use these representations in any other advertisement”.

The history of this saga can be found here.

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