Professor Boyd Swinburn, professor of population health at Deakin University and Director of the WHO Collaborating Centre for Obesity Prevention, has sent in the following critique of the report:

“The Parliamentary Inquiry on Obesity served up a largely evidence-free set of weak recommendations for obesity prevention.  The Committee took a feather duster approach to the prevention part of their brief, lightly touching all options without disturbing the status quo.  They dismissed the mountain of direct and indirect evidence that marketing increases junk food consumption and obesity and instead plumped for two programs which cost hundreds of millions of dollars and have no evidence for any effect on reducing obesity.

Indeed, the Active After School Communities program and the Stephanie Alexander Kitchen Gardens are not even aimed at reducing childhood obesity.  Their websites claim that the AASC ‘aims to engage traditionally non-active children in structured physical activities and to build pathways with local community organisations, including sporting clubs’ and ‘The aim of the Kitchen Garden Program is pleasurable food education for young children’.  Excellent programs at achieving their aims, no doubt, but in no way should they form the backbone of programs to turn around the serious problem of childhood obesity.

Add to that the solid backing the Committee gave to education, information and social marketing approaches and you have a full house of photo opportunities and weak strategies.

The Committee did not seem to get the point that obesity is not a knowledge deficit disorder which can be solved with a bit of information. Leaving the obesogenic environments to a few guidelines and industry self-regulation is a recipe for the continuing upward trend in Australian fatness.

But the public get the point.  They understand.  They are not taken in by the ‘pull-up-your-socks’ solutions (led by the former Health Minister Tony Abbott), or the ‘public-health-advocates-are-baddies’ cries (led by conservative think tankers like Chris Berg), or the ‘trustworthy-food-industry-is-making-big-changes’ claims (led by the Australian Food and Grocery Council).

The public are not that stupid.  Opinion polls consistently show that 80-90% of the public want stronger restrictions to cut the amount of junk food advertising seen by children.  This level of support far exceeds the support for bans on tobacco advertising when that legislation was being drawn up.

It is time for the politicians to look at the evidence, listen to the people and do something meaningful about obesity prevention, especially childhood obesity.

‘Marketing works’.  These are the first words of the US Institute of Medicine’s comprehensive review of the evidence on junk food marketing to children.  Indeed, the global food industry would not be spending $10 billion annually on marketing targeting children if it was not getting increased sales for its money.  They are very smart people working in a highly competitive industry with all the evidence of the effects of their marketing campaigns on sales at their finger tips. They make hard-nosed, evidence-based decisions and they keep investing.  Big time. This is strong indirect evidence of the effects of marketing on consumption even though we never get to see the raw data.

The other part of the evidence chain that links junk food marketing to obesity is the incontrovertible evidence that diets high in junk food put children at risk of unhealthy weight gain.

Aside from the piles of evidence reviews on the topic, it is also question of ethics and children’s rights.  In an age of burgeoning childhood obesity, to allow multinational companies to continually bombard children with sophisticated marketing techniques to get them to pester their parents to buy them the very foods that promote obesity is downright unethical.

We may not see junk food marketing as an ethical issue in 2009 because is just the cultural wallpaper all around us.  Remember, we used to live and work in rooms filled with tobacco smoke and thought it was just normal.

However, in 2019, or maybe 2029 if we continue along this slow route to action, we will look back and wonder in disbelief at lack of leadership shown by our current politicians as they tip toe around with their feather dusters, avoiding the piles of evidence, deaf to the public, but kowtowing to the demands of the food industry.”

The Food and Drug Administration says the supplements have been associated with serious side effects, including liver toxicity.  In Canada, a class action law suit has been filed.

Harvey, Adjunct Senior Research Fellow School of Public Health, La Trobe University, says the key issue is why do the company &/or the TGA believe that Australian products are safe when some of those withdrawn in the US appear to be the same as those available in Australia; see here.

He says: “To-date, the TGA has only warned consumers not to purchase US productsvia the Internet! The assumption is that the Australian products have a different formulation and that makes them safe. No evidence has yet been provided to support this assumption.”

Here is Harvey’s letter with some questions for the Federal Government:

6 May 2009

Senator Jan McLucas
Parliamentary Secretary to the
Minister for Health and Ageing
Parliament House
Canberra ACT 2600

Dear Senator McLucas,

Re: TGA warning issued on complementary medicines weight loss products  (Hydroxycut)

Adam Cresswell reported today that “AUSTRALIA’S drug watchdog has warned consumers to stop using a range of weight-loss products bought on the internet from the US, after 23 reports of serious liver problems, including one death” .

“A TGA spokeswoman said last night it had been informed by the Australian sponsor, Export Corporation (Australia) Pty Ltd, that the four Hydroxycut products approved for sale in Australia had a different formulation to the products sold in the US, as some of the US ingredients were not permitted here”.

I am unclear why the TGA warning is restricted to US products bought on the Internet and why the TGA has accepted the sponsor’s advice that the Australian listed products differ from those removed in the US and Canada.

I have appended the names of Hydroxycut products (and their ingredients) listed on the ARTG as sponsored by Export Corporation (Australia) Pty Ltd.

I have attached printouts of three current Australian advertisements for Hydroxycut products from:
http://www.mrsupplement.com.au/

One advertisement promotes Hydroxycut (ARTG No: 154243) as “America’s #1 selling weight-loss supplement. The ingredients in this product appear to be the same as those in product removed from sale in the US and Canada. In particular, they include Garcinia quaesita (cambogia) . The latter ingredient has been associated with hepatoxity .

I have also attached the detailed US Health Hazard Evaluation Board Report concerning Hydroxycut, “Liver toxicity following consumption of dietary supplement”.

I have the following questions:
1.     In what way does the formulation of Hydroxycut product (ARTG No: 154243) differ from those removed from sale in the US and Canada?
2.    Why has the TGA not withdrawn this product from the Australian market as has occurred in the USA and Canada?
3.    Does the TGA agree that the claims made for these products in the attached advertisements breach the Therapeutic Goods Advertising Code? If so, what action will be taken?

Yours sincerely,

Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au

It includes more than a dozen stories of how doctors and their patients have worked together to overcome various health problems.

Stories include:

• A woman who was blind and in a wheelchair due to paralysis in her right leg, who was able to see and walk again after being helped to deal with a mental health problem that was manifesting as physical symptoms

• A woman who went from a size 26 to a size 12 within about a year, thanks to the help of a GP who set up a dedicated weight management unit

• A man who was successfully treated for heroin, crack and alcohol addiction and now helps people with alcohol-related problems

• A rheumatologist who has embraced the use of emails, texts and telephone counseling to improve the care of his patients.

Of course, it’s all a nice bit of PR for the NHS and the doctors involved. Still, the document makes an interesting read and it is refreshing to see a medical organisation promoting the notion of real partnerships between doctors and patients.

There’s a lot of talk about the importance of partnerships but we too often still hear organisations like the AMA saying they are talking for patients.

Pharma Focus recently reported the ASMI’s concerns about “mischievous misrepresentation” of the guidelines.

The discussion continues below. Read on…

Part 1
From: Ken Harvey, Adjunct Senior Research Fellow
School of Public Health, La Trobe University
To: Deon Schoombie, Australian Self-Medication Industry

Dear Deon,

It has been reported (in Pharma Focus) that, “Negative media reaction to the new guidelines has irritated the Australian Self Medication Industry (ASMI)”.

In response to queries from a colleague the TGA has stated, “It has not yet been proposed that all products would be scientifically tested for the evidence. The [draft] guidelines simply outline scientific evidence considered acceptable to support claims so that sponsors are aware of the type of evidence they should hold”.

In short, the TGA will continue to rely on sponsors doing the right thing or consumers and health professionals challenging the claims made.

While I accept that members of your association may respect the revised guidelines, you are well aware that there are many other non-ASMI sponsors who have consistently ignored the previous TGA’s “Guidelines for Levels and Kinds of Evidence to Support Indications and Claims,2001.” Why would they change what is obviously a profitable approach?

In addition, industry personnel who “pre-approve” advertisements (only in specified media) do not have the time to routinely ask for, and checkclaims against the evidence, as shown by successful complaints against advertisements with CHC pre-clearance numbers.

Furthermore, you cannot expect consumers and health professionals to continue to submit complaints when the CRP now merely forwards these to the TGA whereupon they disappear into a black hole and are never heard of again!

I (and others) would be much more positive about responding to these draft guidelines if the TGA had announced any intention of implementing them!

With best wishes,
Ken
–

Part 2
From: Deon
To: Ken

Dear Ken

Thank you for your email.

In our view there are 2 aspects to the issue of supporting evidence for indications and claims – the first is setting the rules (through regulatory requirements and/or guidelines) and the second is ensuring compliance with those rules. The guidelines address the first aspect and we believe it to be a major step in clarifying the required standards.

On the issue of compliance (and bearing in mind that the draft is still subject to public consultation and amendment) I believe it won’t be too difficult to request sponsors (at the time of pre-approval of ads, or when dealing with complaints or at the time of post-market audit – which could perhaps be stepped up in specific areas like weight loss as ASMI has been advocating for some time) to submit the “piece of paper” which supports weight loss of 5% and 3% above placebo in 2 – 6 months in the intended target population – no less and no more. Issues arising from sample size and research methodology (outlined in the guidelinesdocument) will also become evident straightaway and should result in a simple pass/fail conclusion.

The message will get out soon enough and most sponsors will get their houses in order. The others will get caught through the complaints process and post-market audits (increased targeted audits). In addition penalties and sanctions should be heavy enough to act as effective deterrent.

Kind regards
Deon
***

Part 3: PostScript from Ken

While I accept that the draft guidelines COULD be implemented along the lines Deon suggests, the TGA has shown no inclination to do so. In addition, there are still loopholes in the draft for claiming “traditional use” and using non-randomised, non-placebo controlled trials.