2016 Monash University SPHPM Summer Vacation Scholarship Program Award

The School of Public Health and Preventive Medicine (SPHPM) Summer Vacation Scholarship Program supports the education of promising tertiary students by providing a means to engage and gain experience in research during the University summer vacation period.

The program is open to students completing degrees in Bachelor of Health Science, Bachelor of Public Health Science, Bachelor of Biomedical Science, or Bachelor of Medicine and Surgery. Students work with a senior researcher and their team to undertake a small research project, or contribute to current research in applied clinical and public health.

Since 2011, SPHPM has provided scholarships to approximately 20 students each year to participate in the 4-6 week program. The aim is to give students insight into opportunities in the growing area of public health research and an incentive to pursue higher studies and a career in research or academia.

 

In 2016, two Monash Biomedical Science/Law Summer Scholarship students (Sasha Hall and Tiana Moutafis) worked with me on our “Whack-a-mole” project.This involved submitting complaints about the promotion of complementary medicines to the regulators, media engagement and a submission to the TGA on regulatory reform.

Each student made a video about their work:

 

Which one do you think won the award for best presentation?

Additional students involved in the Whack-a-mole” project earlier in the year (along with Sasha and Tiana) also featured in a recent ABC Four Corners program: “Swallowing It: How Australians are spending billions on unproven vitamins and supplements“.

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Complementary medicine vending machines (with coke)… has it all gone too far?

“Vitamin Warehouse is now installing the world’s first refrigerated vitamins and health supplements vending machines with 42inc digitalised android touch screen computers allowing customers direct chat one on one with any of the brands sold in our machines. As well as chat to any of the 4000+ Australian Naturalcare professionals.” From: http://www.vitaminwarehouse.com.au/

See also:

The vending machines sell vitamins, medicines, perfumes and even 99c cans of soft drink.  These screens allow “the purchase of over 1,000 products of Swisse, Blackmores, Nature’s Own, Healthy Care, Centrum, Herron, Cenovis and every other brand not previously possible in any current pharmacy health food store or supermarket retail outlet.”

This highlights a key question that is currently being debated in AJP and was also the subject of a recent ABC 4-Corners program. Are complementary medicines (vitamins, herbals, etc.) normal items of commerce that can be sold anywhere without the availability of professional advice (as they currently are in supermarkets)?

Alternatively, given that these products are currently classified as “medicines” by the TGA, and they can have problems such as side-effects (e.g. allergy, Echinacea) and drug interactions (St John’s wort), should they only be sold where advice from a health professional is available?

Also, will advice from a naturopath in a health food store, or from the 4000+ Australian Naturalcare professionals allegedly available from the android touch screen of the vending machines, be better or worse than that obtained from a pharmacy: see https://www.choice.com.au/health-and-body/health-practitioners/doctors/articles/pharmacy-advice-for-stress?  Also: https://ajp.com.au/news/pharmacy-slammed-cm-kickback-scandal/.

This would make another interesting project for Choice mystery shoppers!

Finally, one of the recommendations of the MMD Review (no 48) accepted by the government was undertaking a review of the range of complementary medicinal products, currently listed in the ARTG and subject to regulation under the medicines framework, with a view to ensuring that products that might best be regulated under other regulatory frameworks, without undermining public health and safety, are removed from the auspices of the Act.  Vitamins and minerals have been suggested as one such category of product. But I can’t see how this would not undermine public health and consumer protection.

 

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ABC 4-Corners Swallowing It: How Australians are spending billions on unproven vitamins and supplements.

http://www.abc.net.au/4corners/stories/2017/02/13/4616948.htm

FEATURE: What’s the evidence supporting the use of Australia’s favourite supplements? | ABC Health & Science | 13 Feb 2017 – http://www.abc.net.au/news/health/2017-02-13/a-closer-look-at-australias-most-popular-supplements/8265840

STUDY Is your pharmacist giving you the right advice? We put pharmacists to the test – what do they recommend for stress and does it work? | CHOICE | Feb 2017 – https://www.choice.com.au/health-and-body/health-practitioners/doctors/articles/pharmacy-advice-for-stress

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Revive Health for All! Meet at PHA Bhaban, Bangladesh, 10-25 Nov, 2017

The initiative: Zafrullah Chowdhury formulated the idea of an international meeting following the December 2016 decision of the High Court of Delhi to set aside the March 2016 decision of the Indian Central Government banning 344 irrational fixed dose combinations (FDC).

Zafrullah noted that, since the 1985 Nairobi Conference on the Rational Use of Drugs, for every two steps we have advanced we have gone one step backward. A progressive agenda for people-centred, rational and affordable health care continues to be undermined by powerful vested interests.

The latest example is U.S. president elect Donald Trump’s nominee (Tom Price) for Secretary of Health and Human Services (HHS). Price has consistently opposed policies aimed at improving the care of vulnerable people. See also  Trump’s pick for the Environmental Protection Agency (Scott Pruitt)!

Zafrullah suggests that it is time for us to gather again globally to confront the forces and ideology that oppose Health for All.

The aim: To bring together like-minded groups such as Health Action International Asia Pacific (HAIAP) and the People’s Health Movement (PHA) to reflect on the vision of the late Dr Halfdan Mahler (1923-2016), share the achievements and setbacks of various countries Essential Drugs and Health for all campaigns and reinforce our commitment to the cause.

Dates: There is agreement that postponing the meeting to 10-25 Nov, 2017 will allow more time for planning, obtain greater participation and find funds. The exact dates are currently being finalised.

VenuePHA Bhaban (where the first People’s Health Assembly was held in December 2000). It has conference facilities and can accommodate 250 persons in a combination of single and double rooms and 8 bedded dormitories. Gono Bishwabidyalay (the People’s University) is a 10-minute walk away and has additional facilities and space.

Funding: People attending will be responsible for funding their travel to and from Dhaka. However, Zafrullah has kindly confirmed that Gonoshasthaya Kendra (GK) will extend full hospitality including airport pick up and drop, modest accommodation, all meals and AV facilities.

International Steering Committee: Zafrullah suggested this should include representation of activists, health workers, researchers/academics and policy planners belonging to different networks, agencies and academic institutions. Shila Kaur and Ken Harvey have been tasked to start this process along with Zafrullah.  Additional members of the steering committee are currently being finalised.

Topics: Planning notes (as at 12 January 2017) are  available. Currently under discussion using the HFA_Bhaban mailing list.

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Comment: Nurofen fine still insufficient; Hangover clinic craziness

Nurofen fine still insufficient

I support call to increase fines for misleading consumers, after Nurofen makers stung a mere $6 million:

http://www.abc.net.au/newsradio/content/s4593980.htm 

See also: Makers of Nurofen will feel no pain from $6 mil fine:

http://www.abc.net.au/pm/content/2016/s4593769.htm

Hangover clinic craziness 

My comment about this clinic on “The Project”, Dec 15, 2016.

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TGA Consultation: The regulatory framework for advertising therapeutic goods

Information about this consultation is available here.

A submission by my students (Sasha Hall and Tiana Moutafis) and myself is now available.  This may be of interest to people writing their own.

See also: Australia’s regulation of complementary medicines claims is badly flawed.

And: Dodgy claims for complementary medicines? Here’s how the drug watchdog could have more bite

N.B. Submissions closes on 21 December 2016.

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Australian Skeptics National Convention; Skepticamp; TGA Consultation

skeptics_convention_2016

  http://convention.skeptics.com.au/

 2016 Australian Skeptic of the Year:

Two talks:

This talk provided several examples of the craziness and consequences of the current “light touch” regulation of complementary medicines using clips from the ABC Checkout team. It also discussed whether the government’s response to the latest review on Medicine and Medical Device regulation is likely to fix the problems identified (a number of the recommendations made by the review have been rejected or watered down by the government).  It questioned whether the complaint system should be taken over by the TGA.  An alternative would be giving the ACCC greater involvement, as that organisation has a better consumer protection culture, regulatory expertise and the investigative and enforcement tools required. The talk ended (as did the Friday Skepticamp talk) by encouraging people to lodge submissions on the way forward.

  • The Monash SPHPM “Whack-a-mole” project (How to lodge a complaint about unethical promotion of therapeutic goods and services and what to expect).
    Dr Ken Harvey, Sasha Hall & Tiana Moutafis (BMedSci/Law students)
    University of Melbourne Secular Society, Skepticamp, Nov 25, 2016.

Why “Whack-a-mole”? Because, given the flaws in the current regulatory system, no sooner is one misleading advertisement “whacked” then others immediately pop up. This presentation used as an example the promotion of Blooms Coenzyme Q10 150 Max spruiked by pharmacist Gerald Quigley, “For heart health, stamina, performance and strength, 150mg of Blooms Coenzyme Q10 150 Max each morning is a great way to start the day”

Blooms and Gerald have been the subject of a previous upheld complaint to the Therapeutic Goods Advertising Complaint Resolution Panel (TGACRP) and also a complaint to the Pharmacy Board of Australia. Gerald has also been the subject of an ABC Media Watch critique. But he keeps on keeping on as this presentation will show. The presentation suggested that the current regulators are “paper tigers” and it reiterated the need for regulatory reform.

TGA Consultation

The purpose of this consultation is to provide an opportunity for interested parties to provide their views on the appropriate body or bodies for the handling of complaints under the design of a new centralised advertising complaints management-process and other recommended reforms to the advertising regulatory framework. Interested parties should respond by close of business Wednesday, 21 December 2016.

Your submission needs to be emailed to advertising.consultation@tga.gov.au and requires a completed coversheet. The latter is available here.

A submission by my students and myself is now available. It may assist your submission.

News from the Convention

Bent Spoon Award

The Bent Spoon is awarded to the perpetrator of the most preposterous piece of pseudoscientific or paranormal piffle of the year, and is one of the least desirable prizes in the country. Past winners have included Pete ’Paleo’ Evans, the CSIRO’s new head Larry Marshall, the ABC, the Pharmacy Guild of Australia, and a psychic dentist.

This year’s recipients are anti-vaccinationist Judy Wilyman, her academic advisor Brian Martin, and the Social Sciences Department of the University of Wollongong for awarding her a doctorate on the basis of “a PhD thesis riddled with errors, misstatements, poor and unsupported ‘evidence’ and conspiratorial thinking”.

“Wilyman continues to defend her degree with endless diatribes to all and sundry. Her university went into defence mode with a pathetic ‘free speech’ argument – which means free to present rubbish and be rewarded for it. Many within the university’s own staff, those who actually know what they are talking about, came out to criticise their own institution. A bad move by a respected institution; an expected move by a noted anti-science anti-vaccination zealot.”

Dishonourable mention goes to the ABC’s now-defunct Catalyst program and former reporter Dr Maryanne Demasi for an inaccurate and alarmist one-sided unscientific report on supposed brain damage from wifi technology, and for being a repeat offender in that respect.

Life Membership

Life membership of Australian Skeptics Inc was conferred on past Skeptic of the Year Loretta Marron, as well as tireless behind-the-scenes workers Margaret Kittson (Queensland Skeptics), John Turner and Kevin McDonald (both Hunter Skeptics).

 

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TGA has lost trust on CMS: Harvey

“a market flooded with shonky products and unethical claims”

Open debate needed for TGA to regain trust

 

TGA has lost trust on CMs: Harvey

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Complaint by Complementary Medicines Australia

See also:

An overview of the Monash University course complained about can be found here as can my lecture to the students.

My full response to the CMA allegations follows.

From: Ken Harvey [mailto:k.harvey@medreach.com.au]
Sent: Thursday, 29 September 2016 11:26 AM
To: ‘Carl Gibson’ <carl.gibson@cmaustralia.org.au>
Subject: RE: Formal complaint regarding the conduct of Dr Ken Harvey

Dear Carl,

Thank you for forwarding me the substance of a complaint you had previously sent to what you termed was the Therapeutic Goods Administration (Complaints Resolution Panel), the Therapeutic Goods Advertising Code Council and Monash University (appended).

I should be grateful if you could pass this response on to the Board of Directors of Complementary Medicines Australia. I also have cc’d it to the Chair and CEO of the TGACRP and TGACC, my Head of Department at Monash University, and the CEO of Choice (whom I represent on the TGACRP & TGACC).

First, I point out that the Therapeutic Goods Advertising Complaint Resolution Panel (TGACRP) is not a committee of the Therapeutic Goods Administration. Rather, both the TGACRP and TGACC were set up under the Therapeutic Goods Regulations 1990; Division 3, Regulation 42R, and Division 2, Regulation 42A, respectively. The regulations note that both the TGACRP and the TGACC are to have, as a member, one person nominated by the Australian Consumers Association (Choice). I have been so nominated by Choice to bring consumer concerns to both bodies. I regularly report and discuss relevant matters arising from these bodies with Choice management in order to represent their interests.

Second, the CMA Board allege that I have a conflict of interest, relating to my roles on the TGACRP and TGACC, as represented by my behaviour and public comments about complementary medicines, which is compromising the integrity of these committees as functional instruments.

The TGACRP has 9 members and the TGACC has 15. The membership of both bodies contains a broad mix of people representing a variety of stakeholder interests including industry, health professionals and consumers. I submit that it is inconceivable that one individual could, “compromise the integrity of these committees as functional instruments”. Neither am I aware that such a view has been expressed by members of the TGACRP and TGACC at meetings that I have attended.

In addition, it is a standard procedure for members of the TGACRP to declare possible conflicts of interest when assessing complaints. Accordingly, when a complaint has been submitted from Friends of Science on Medicine (FSM), I declare my membership and leave the room while this is being discussed. Other members of the TGACRP, for example industry members who may have been consulted on a product being complained about, do the same.

Third, the CMA Board allege that I have “anti-complementary” views as represented by my public comments.

I agree that I have made public statements expressing concern about aspects of the Australian complementary medicine industry. These include the fact that recent figures available from the TGA concerning random and targeted post-marketing reviews of listed complementary medicines show around 80% were not in compliance with the regulations. In addition, of all complaint determinations assessed by the TGACRP, 98% are upheld.

I have also expressed public concern that the current “light-touch” regulatory system makes it more profitable for sponsors of complementary medicines to invest in marketing hype and celebrity endorsement rather than research and development of evidenced-based products. The end result is a market flooded with products of doubtful value with claims that often go far beyond the limited (or absent) scientific evidence that sponsors are meant to hold in order to justify their claims.

However, I have also made public statements and submissions about how such problems could be redressed. I have supported providing incentives for sponsors to develop research-based products, such as the new TGA assessment criteria that are less rigorous that than for registered products. I have argued for more innovative consumer education, such as awarding a distinctive logo to products that have an evidence-base, to enable consumers to more readily distinguish them in the marketplace.

In addition, in my lectures to students and the public, I have pointed out that one of the winners of the 2015 Nobel prize for medicine was a Chinese researcher (Youyou Tu) who, through exploring Traditional Chinese Medicine texts that recommended the use of Artemisia annua (sweet wormwood) for fever, was able to extract Artemisinin, a drug that has significantly reduced the mortality rates for patients suffering from Malaria. In short, I support well conducted research into traditional and complementary medicines.

Fourth, the CMA Board allege that I have used my position in the School of Public Health and Preventive Medicine, Monash University, to solicit enrolled students to become involved in a political anti-CM campaign in league with the anti-CM lobby group Friends of Science in Medicine (FSM) under the guise of academic training.

I deny that I, or my colleagues at FSM, are anti-CM. Rather, we are pro-science. Which is why I was awarded the 2016 ANZAAS medal, “for contribution to science which go beyond normal professional activities”. I encourage people to read my entire address on receiving this award rather than the selective quotation used in this complaint. The full address titled, “Recommitting to the sanity of evidence” is available at: http://www.doctorportal.com.au/mjainsight/2016/34/recommitting-to-the-sanity-of-evidence/.

My mention of colleagues in the TGACRP was merely a reflection of the fact that the deliberations of the TGACRP are always based on a dispassionate view of the evidence presented by both the complainant and the product sponsor complained about. I deny that the TGACRP has been “factionalised”.

I also make no apologies in pushing for regulatory reform which inevitably involves engagement with the political processes (as do the CMA with their own political lobbying). There is a famous quotation by a German physician and public health advocate, Rudolf Virchow, “Medicine is a social science, and politics nothing but medicine at a larger scale”. See: https://www.ncbi.nlm.nih.gov/pubmed/19052033.

The student course that the CMA Board complained about is a legitimate academic exercise to provide students with practical experience of the role of regulators in protecting the public from false and misleading therapeutic claims, both by product sponsors and health practitioners. I have attached the course overview and the lecture I gave to the students. I am currently marking the student’s projects. The standard of submissions is high. The vast majority of teams have done an excellent job of documenting potentially suspect advertising claims, researching the literature, critiquing the claims and suggesting sections of the various Codes and regulations that are likely to have been breached. When faced with little or no published articles to verify the claims made, a number of students (as suggested) have contacted the companies involved (many of whom are members of CMA) to ask if more information was available.  It may be that this legitimate contact prompted the recent complaint from CMA. I have appended one small example of the student’s work. In my opinion, this exercise is innovative, it has certainly engaged the students and it will assist in policy reform. It also has the support of my Head of School and senior members of the School of Public Health at Monash University.

In conclusion, I deny the allegations the CMA Board has made. I reiterate that, as a consumer member representing Choice on the TGACRP & TGACC, I have the right and responsibility to put the views detailed above to these bodies and to the public.

Sincerely,
Ken

—————————————————-
Students: names redacted.

Biosun Ear Candle; ARTG: 19479

Sponsor: Biosun In Australia Pty Ltd

Postal address: 35 Station Street, Malvern, Victoria, 3144

The Chemist Warehouse promotion of Biosun ear candles claims that “BioSun Hopi Ear Candles (appendix 1a attached):

  • “May be beneficial in temporary relief of symptoms of sinus problems, earache, glue ear, swimmer’s ear, some chronic headaches, ringing in ears, hearing difficulties, headache, irritations in the ear, sore throat and allergies”
  • “Will aid in the removal of excessive earwax.”
  • “May also help relieve the pressure after flying, deep sea diving, or whenever an imbalance of pressure has occurred”
  • “May help to relax and calm, relieving symptoms of stress and anxiety”

In regards to BioSun ear candles we believe the claims listed above are in breach of these sections of the Therapeutic Goods Advertising Code, 2007

  • 4(1)b: must contain only correct and balanced statements which the product sponsor has verified
  • 4(2)a: must not arouse unrealistic or unwarranted expectations of product effectiveness
  • 4(2)c: must not mislead or be likely to mislead
  • 22(5): must not refer to therapeutic uses not included on the Australian Register of Therapeutic Goods (ARTG) for the advertised goods

A nice review of the literature followed.

  • Seely D, Quigley S, Langman A. Ear Candles-Efficacy and Safety. Laryngoscope. 1996 Oct;106(10):1226-1229.
  • Hornibrook J. Where there’s smoke there’s fire—ear candling in a 4-year-old girl. NZ Med J. 2012 Dec 14;125:138-40.
  • Zackaria M, Aymat A. Ear candling: a case report. The European journal of general practice. 2009 Jan 1;15(3):168-9.
  • Rafferty J, Tsikoudas A, Davis BC. Ear candling: should general practitioners recommend it? Canadian family physician. 2007 Dec 1;53(12):2121-2.
  • SchellenBerg R. Application Observation to prove relaxation effect by means of quantitative electroencephalogram. 2005. BioSun Gesundheit & Wellness.

My comment:

Complaints about these products keep on keeping on, despite the fact the TGACRP has made determinations about these products on 38 previous occasions.

The U.S. FDA and Health Canada have taken more definitive action against manufacturers of ear candles that the TGA, including import alerts, seizures, injunctions, and warning letters:

In Australia, at least 16 “Ear Candles” continue to be included / listed on the TGA’s ARTG. As with listed medicines there is no pre-market evaluation by the TGA of Class 1 medical devices. Sponsors can, and do, say whatever they like on the ARTG public summary document.

Ear candling is associated with real risks, non-existent or minimal health benefits and continued misleading and deceptive claims about its benefits.

It is my view (as a Choice consumer representative) that it’s time the TGA took similar action to the U.S. FDA and Canadian regulators.
—————————————————-

From: Carl Gibson [mailto:carl.gibson@cmaustralia.org.au]
Sent: Wednesday, 28 September 2016 5:11 PM
To: Ken Harvey <k.harvey@medreach.com.au>
Subject: Re: Formal complaint regarding the conduct of Dr Ken Harvey.

Ken,

After consulting with my President and Vice President, I can confirm that the Board of Directors of Complementary Medicines Australia requested that I submit compliant letters to the Therapeutic Goods Administration (Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council).

The full details of the complaints were made in confidence, but I have been asked to provide you with an overview summary:

The complaints referred to a conflict of interest as a member of the CRP and TGACC calling into question the independence and objectivity of these committees and hence their ability to fulfil their functions under Subdivisions 2 and 3 of the Therapeutic Goods Regulations 1990 (the Regulations).

CMA considers that the anti-complementary medicine conflict of interest represented by the behaviour and public comments relating to your roles on the CRP and TGACC (outlined below) is compromising the integrity of these committees as functional instruments.

Furthermore, it appears other parties on the CRP and TGACC have become factionalised in support of the anti-CM campaign – which you had alluded to in your public comments (outlined below).

FSM media release, 15 August 2016:

On 15 August 2016, FSM issued a media release announcing that Dr Harvey had been awarded the ‘Australian and New Zealand Association for the Advancement of Science (ANZAAS) Medal’ for 2016.

Dr Harvey stated):

“A number of purveyors of complementary, alternative and integrative medicine also make unethical claims. So what to do? Marshal the evidence; flood the regulators with complaints, engage the media and agitate for policy change. In these endeavours, I have been encouraged and supported by many like-minded groups, colleagues and friends: Therapeutic Guidelines, Health Action International, Friends of Science in Medicine, Australian Skeptics, AusPharm, the Australian Consumers’ Association, Consumers Health Forum, Therapeutic Goods Advertising Complaint Resolution Panel and colleagues from the School of Public Health at both La Trobe and more recently Monash University”.

We feel that there is an implication of a collusion between anti-CM political activities and the function of the CRP itself, as well as conflating other CRP member bodies as part of the campaign: the Australian Consumers Association (Choice) and Consumer Health Forum (CHF).

This further questions the independence and integrity of the entire CRP process.

In addition, I was requested to notify Monash University of the complaint to the Therapeutic Goods Administration because of the relevance to the University.

The complaint alleges that you are using your position in the School of Public Health and Preventive Medicine, Monash, to solicit enrolled students to become involved in a political anti-CM campaign in league with the anti-CM lobby group Friends of Science in Medicine (FSM). By recruiting Monash students to this cause, under the guise of academic training, they are becoming complicit in your anti-CM campaign and we question the breach of government statutory conflicts of interest provisions.

We asked Monash to consider the reputational risk relating to this issue and consider whether your position at Monash is consistent with the University’s standards of ethical conduct.

Regards,
Carl

Carl Gibson  | Chief Executive Officer Complementary Medicines Australia
Natural Health and Wellness
PO Box 450 Mawson ACT 2607 | Tel: +61 (0)2 6260 4022 | Fax: +61 (0)2 6260 4122 |
Email: carl.gibson@cmaustralia.org.au| Website: www.cmaustralia.org.au

On 28 Sep 2016, at 10:01 AM, Carl Gibson <carl.gibson@cmaustralia.org.au> wrote:

Ken

If the organisation had submitted any representation, then it will have been done with the agreement of the Board of Directors of Complementary Medicines Australia.

I am consulting with my President and Vice-President before responding to your request, as I believe any representation or complaint, if any, would have been submitted in confidence.

Carl

Carl Gibson  | Chief Executive Officer | Complementary Medicines Australia
Natural Health and Wellness
PO Box 450 Mawson ACT 2607 | Tel: +61 (0)2 6260 4022 | Fax: +61 (0)2 6260 4122 |
Email: carl.gibson@cmaustralia.org.au| Website: www.cmaustralia.org.au

On 22 Sep 2016, at 10:39 AM, Ken Harvey <k.harvey@medreach.com.au> wrote:

Hi Carl,

I understand that you have submitted a format complaint about me to the
Monash VC.

I was disappointed that you lacked the courtesy of sending me a copy of your
complaint.

Please send it to me now.

Sincerely,
Ken

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Medical Weightloss Institute (MWI) gets Choice “shonky” award

shonkys-logo

 

 

11th Annual Choice Shonkys Award 5th October, 2016

Which hasn’t stopped Geoff Jowett from cloning yet another business:

See also:

What are the regulators doing?

 

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