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 template is currently being prepared and will be available here soon.

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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Antibiotic resistance: the need for innovative global and local policy in response to market failure

This was the title of an invited key-note address delivered to 550 medical students at a University of Queensland Global Health Conference, held on Sept 24, 2016.

I was welcomed by Professor Darrell Crawford, Medical Dean of the School of Medicine who highlighted my long involvement in rational drug use initiatives and my award of the 2016 ANZAAS medal, “for contributions to science which lie beyond normal professional activities”

See also: Editorial, “A Global Antimicrobial Conservation Fund for Low- and Middle-Income Countries

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MWI: Patient stories

See NINE TV News 22/09/2016 (Devon)

More below; some names have been changed but the stories are authentic.

Rosemary said:

I first became aware of the Medical Weightloss Institute through its full page ad in the Brisbane Courier Mail in June this year.  I have struggled with obesity for 20+ years following the birth of my last child.  At 63 and trying to recover from a torn plantar fascia for 6 months when I saw the ad, I thought this could be the answer for me – viz. a medically supervised mechanism with lots of support from doctors and other staff.

In addition to the stated claims and testimonials in the ad, the words ‘medical institute’ and inclusion of the iconic medical symbol as part of its logo led me to believe the organisation was credible.  The ad’s representation convinced me this would be a scientific approach given it was based on blood tests and, I thought, close and ongoing medical oversight.

When I initially responded to the ad, the person I spoke to was very engaging and personable. We discussed my health history to determine if I was suitable for the program.  She mentioned that she had lost weight on this program and commented that the medication was key to its success.  She gave me her direct line and mobile phone number and went to great pains to reassure me that I could call her any time for support.  Given that my program was lasting 35 weeks, I was quoted a total cost of $9,600 but that with the promotional discount it would be $5,420. I was able to pay 50% deposit and the remainder charged to my credit card in fortnightly instalments.

Following this conversation, I received my first email which notified me: “Each of our weight loss programs are custom tailored by our medical team based upon your medical history and a comprehensive blood test analysis. Our team comprises of expert weight loss specialists including doctors, nurses, nutritionists and motivational psychologists……… All of the medications, doctor consultations and pathology tests you receive are included in the cost of the program and will be monitored by our team to ensure that you receive the best possible care….” (full email is attached).

While the cost of the 35 week program was mind-blowing and not really something that I could afford, I committed to it because I believed it was genuine and expected there would be substantial support from the medical staff as well as others.  I also assumed there would be periodic repeats of pathology tests to measure changes to the baseline result.  Otherwise, what did this incredible amount of money cover????  So I ‘signed on’, paid the deposit of $2,710 and have made fortnightly payments since totalling $774.30 as at today (see payment receipt email attached).  After paying the deposit, I was given access to a members-only website that really doesn’t contain the sort of information one would expect to justify the cost of the program.  The access to “motivational psychologists” seems to be a number of short videos featuring Geoff Jowett.

Immediately I started to feel uneasy.  I then received calls/emails from a ‘coordinator’ and a ‘nurse’.  I was told the contact who spoke to me in the beginning and who had given me her direct line and mobile number was not my contact and I would be advised later of my assigned Program Manager/Nutrition Coach.  When that person was assigned, I was only given the phone switch number and an email address.  I specifically asked for her direct line as her colleague had done previously but this was declined.  I cynically mentioned that I wasn’t feeling as supported now that I was ‘on board’!!

I don’t feel the Program Manager/Nutrition Coach provides any expertise in terms of nutrition or talking through side effects as I have outlined in the paragraph below.  She simply calls once a week to see how everything is going and parrots what I feel are quite disingenuous statements that are probably said to everyone to be ‘encouraging’.  There is no skill here tailored to my circumstances!

Toward the end of the first week on the program, I became acutely constipated and asked the Program Manager if I could discuss this with the MWI doctor.  The Program Manager said this was not possible and I should consult my own GP, which I did.  However the problem persisted and I wondered if the problem could be caused by one of the prescription drugs.  I mentioned that, with what I was paying for this program, I shouldn’t have to also pay for my own GP consultations.  The Program Manager then arranged for Dr Jacqui Forrester to phone me.  Rather than being friendly and making me feel like I was being supported, she just said to stop the Metformin medication and she would arrange for replacement medication to be sent to me.  However this did not fix the problem and I ended up consulting my own GP again for a long consultation that cost me $140.

Very recently I saw a full page ad, again in the Courier Mail while I was visiting family in Brisbane, for Geoff Jowett’s new organisation treating men with testosterone problems.  I was flabbergasted and this confirmed once and for all that MWI is simply a rort.  I mentioned the ad to my Program Manager when I returned from Brisbane and she informed me this was MWI’s “sister organisation”!!  At this point I googled information on MWI which returned the article in the Sydney Morning Herald and a copy of your submission to AHPRA and the ACCC.

Since then I have called the TGA and enquired about the appetite suppressant drug I have been prescribed (Diethlpropion) and found it is not registered with TGA and that the MWI compounding pharmacy seems not to be subject to any regulation in Australia!  Information I accessed on the FDA website makes me very concerned about the way this drug has been prescribed for me by MWI.  I know I won’t be able to talk to Dr Forrester about my concerns and I shouldn’t have to pay yet again to discuss this with my GP.

I am very embarrassed that I have been ‘taken in’ by MWI.  Apart from withdrawing from their program and getting my money back (and I appreciate whatever help you can provide with this), I would like to see them held accountable by the relevant authorities for their malpractices and prevented from establishing ‘institutes’ for other health issues under the guise of medically based treatments.

Dorothy said

Hi, I recently read your complaint regarding this program. I am writing to you with embarrassment as I have fallen for this scam. I recently inherited a small amount of money from my father and decided he would want to gift me my health back. I would not of been able to afford this otherwise. I have had some serious medical issues over the years that actually bankrupted me. I am crawling out of the mess I was left in but not before gaining a lot of weight. I tried all sorts of things and was convinced I must have an imbalance. I saw the MWI on Facebook and to me it couldn’t of shown up at a better time. Long story short: I paid them $4400.00 (1/2 price supposedly), the medication they have prescribe can make me feel nauseated, I get a phone call a week and a two page menu suggestion. That’s it! First 3 weeks I lost 3 kilos, fourth week gained one back and tomorrow starting on fifth week.

I can not help to think I am being scammed and this not only infuriates me but I have concerns with the medication. I am sure if I tell them, they will just adjust the concoction.

I have not complained to them yet. Do you have advice on how I should handle this?

Christie said:

I was ripped off by Medical Weightloss Institute. They promised that I would lose a erratic amount of weight within a time frame. It did not lose the weight and they extended the program. Not with any extra medication or anything, just a suggestion for a change of breakfast smoothie. I did not lose any more weight and have put it all back on. I was so disheartened by their lack of concern and frequent change of staff who spoke to me, I asked for a refund and received $149.37. I paid $2,495.

They are snake oil salesmen and I caution anybody to think again and go to their doctor who sees them and knows them rather than a disembodied voice who does not know you or have any interest in you apart from your money.

I was relieved to see the SMH article exposed them as frauds.

Beverley said:

I also have done this paid $2500 plus fees which were not stated at the start of the program.  I saw this originally in the body and soul newspaper. I definitely got scammed.

Doctor didn’t even ring me, I had to ring him, blood tests cost me extra in money, out of my pocket as Medicare didn’t cover all of it. After 6 weeks I got a phone call saying my program was about to end. What the! I said no way I haven’t lost 10kgs. I rang many times to be told my coach will ring me back, never did. I then sent an email and said I was not very happy about the message received stating program end when I haven’t even been spoken to. I also had 3 different coaches. When I told them I was getting onto body and soul they said they would give me another 6 weeks. They sent me more tablets. I have lost 2kgs but that’s it. I then got told that I need to exercise more so have added body pump and more cardio to my routine. I eat healthy and take the tablets but have just plateaued in my weight. 2kgs is all I’ve lost. Tablets don’t do anything. Now I have to pay $58 per week if I want to stay on the program, which is doing nothing for me. My opinion is it’s a waste of money. Weight loss coaches that you can’t get a hold of ever and basically all you get are some tablets and then ur on your own. $2500+ waste of money”.

Carrie said:

I have paid for this yesterday afternoon; the girl gave me 5 minutes to decide I haven’t received anything as yet is there any way I can get my money back? Desperate and feeling very sick about this scam $3500 down the drain that I really can’t afford but am desperate. Is there anyone that I can contact to help me????

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A compounding pharmacy has been criticised for dispensing a withdrawn substance… but is the reproval warranted?

The compounder, the doctor and the institute

In response to the defence offered in this AJP article by compounding pharmacist Daryll Knowles and MWI chief spruiker Geoff Jowett (and concerns expressed by Jarrod McMaugh and Jignesh Patel) I provide the following additional information.

The Pharmacy Board Guidelines on Compounding of Medicines state:

S2 “A compounded medicine should be prepared only in circumstances where an appropriate commercial product is unavailable…..The compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product, and would not be likely to produce a different therapeutic outcome to the commercial product, should not take place. In the case that such a medicine has been prescribed, the pharmacist should notify the prescriber that this medicine cannot be compounded under these circumstances.”

First of all, following a review of the risks and benefits of diethylpropion and related anorectic drugs by the European Committee for Proprietary Medicinal Products (CPMP), the European Commission decided that the drugs’ licences should be withdrawn. Licences were withdrawn in the UK on April 9, 2000 and the drug was also withdrawn by the sponsor in Australia, Canada, and the majority of other countries of the world.

Second, a related weight loss medication, phentermine (Duromine modified release) is registered by the TGA for the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction.

S15. “Pharmacists should ensure that every patient or their agent are offered counselling and relevant consumer medicine information on each occasion a compounded medicine is supplied. Written consumer medicines information leaflets are not usually available for compounded medicines. However, alternative written information should be provided by the pharmacist to assist in the communication of the following counselling points to facilitate the safe and effective use of the compounded product:

  • an explanation of why a compounded product is being supplied, and how this differs to a commercially-available medicine which requires the manufacturer to meet the requirements of the TGA for addition of medicines to the Australian Register of Therapeutic Goods;
  • instructions on the correct use of the product;
  • the appropriate storage requirements and expiry date of the product;
  • the side-effect profile of the product, any contraindications and any other specific counselling points which would normally be contained in a written consumer medicines information leaflet, and
  • how to report adverse events”.

Patients have reported both to me and Prof Dixon that the medications arrived by mail from the compounding pharmacy and no written information was provided about the dot points above. Hence the AHPRA notification of compounding pharmacist Daryll Knowles.

In the AJP article Mr Knowles asserted that:

  • Diethylpropion was associated with less reported adverse reactions than celecoxib; however given the vast difference in prescribing rates that defence is meaningless.
  • The TGA had provided him with an permit to import diethylpropion. Given that the TGA have a track record of bizarre decision making that is also an unsatisfactory justification.
  • There have been no reported adverse reactions to diethylpropion dispensed by ACP. Given that ACP provides no information to patients about such matters and the doctors involved do not follow up the patients or adequately respond to their concerns that is hardly surprising.
  • He is considering legal avenues for his slanderous statements. As have others in the past.

With respect to the prescribers at the Medical WeightLoss Institute (MWI), Dr Thomas Goyer the initial doctor involved, has had unfavourable comments made about him by the Judge who heard the AMI case concerning the promotion and supply of medications for erectile dysfunction, with whom Dr Goyer was also involved. He has also had a number of conditions placed on his practice by the Medical Council of NSW &/or AHPRA.

The MWI modus operandi appears based on that of the AMI; MWI recruit vulnerable patients by placing prominent advertisements making extravagant claims; they order a large number of pathology tests of dubious relevance (at taxpayers’ expense) to give an appearance of authenticity; their doctors write ‘scripts for a cocktail of complementary and prescription drugs without seeing or examining the patients, and a closely related compounding pharmacy dispenses the drugs and fails to provide patients with the information expected by the Pharmacy Board’s Compounding Guidelines.

I suggest readers of AJP watch both Dr Goyer’s and Mr Geoff Jowett’s promotional videos, review the additional information below, and then make up their own mind about MWI and whether you, as a pharmacist, would dispenses their medication.

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Posted in Medicine policy, Pharmaceutical Promotion, Weight loss | Tagged , , , , , , , , , , , , | 1 Comment

Chiropractic Journal of Australia; my article up alongside dissenting opinion!

http://www.cjaonline.com.au/index.php/cja

See also article by Matthew Doyle and commentary from Phillip Ebral

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AMI begat MWI begat AMHC begat ACTIVATE

Here we go again; Geoff Jowett (now M&CO Consulting Pty Ltd) spruiks yet another weight loss scam (Activate) while the regulators (NSW HCCC) apparently do nothing.

“Get started for just a single dollar… watch the introduction videos… and start your weight loss journey… Once you prove to yourself that this is THE SOLUTION you’ve been dreaming of… Then, you will be automatically charged $67 each week for the 4 week duration of the program (full lifetime investment = only $268).”

activate“Create Your Perfect Life In The Next 30 Days…

Impossible? Not at all… In fact, one well-known Sydney medical doctor has described this as potentially the “greatest weight loss breakthrough in a generation…”

This discovery was made by Geoff Jowett, the creator of Bodytrim, Australia’s most successful weight loss program. He is also the co-founder of the Medical Weight Loss Institute (MWI) and Vision Fitness”.

See also: More on MWI; prescribing dangerous drugs banned in Australia

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Posted in Complementary medicine, Natural Therapies, Pharmaceutical Promotion, Weight loss | Tagged , , , , , , , | Leave a comment

More on MWI; prescribing dangerous drugs withdrawn from Australian market

Another patient has come forward who was charged $5420.00 for the MWI program and prescribed a cocktail of drugs including diethylpropion; a drug withdrawn from the Australian market because of serious adverse effects, including irregular heartbeat, high blood pressure, seizures, nervousness, and reports of people becoming psychologically dependent on this medicine.

The drugs prescribed by MWI registered medical practitioner Dr Jacqui Forrester (MED0001634323) and dispensed by the compounding pharmacy, Australian Custom Pharmaceuticals, owned by registered pharmacist Daryll Knowles (PHA0001315498) are seen below.

medicationAccording to the patient, the instructions were, take one capsule from bottle 1 (Diethlpropion HCI 75mg and 60mcg Chromium Picolinate) taken every 2nd day.  Two capsules from bottle 2, and three capsules from bottle 3, taken morning and evening respectively, after food, on alternate days to Bottle 1.

In my opinion, this prescription by Dr Forrester puts her in breach of s.2.2 (2),(4),(6); 2.4 (4) and 7.2(1) of the Medical Board of Australia’s, “Code of Conduct”. In addition, in my opinion, dispensing this cocktail of drugs (including diethylpropion) puts the Australian Custom Pharmaceuticals (and registered pharmacist Daryll Knowles) in breach of s.6 and s.15 (erratum: originally cited as s.5) of the Pharmacy Board of Australia’s, “Guidelines on compounding of medicines”.

I reiterate, the regulators should obtain an urgent Court order to take down the offending websites and Facebook material of both MWI and AMHC and place a full page retraction of claims in all the newspapers and all other media in which they have appeared. Retractions are important as they correct egregious misinformation that has previously been promulgated. Penalties should then follow. AHPRA and the MCNSW should deregister Dr Goyer, Dr Forrester and the other doctors involved, the Pharmacy Board of NSW should discipline Daryll Knowles and the NSW Health Care Complaints Commission should issue a public warning about Jowett (an unregistered health practitioner) and permanently prohibit him from providing health services.

For background, see:

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Posted in Complementary medicine, Medicine policy, Pharmaceutical Promotion, Weight loss | Tagged , , , , , , , , , , , , , , , | 2 Comments