In Australia the war against obesity commenced quietly for health workers on 18 September 2003 with the release of the National Health and Medical Research Council's (NH&MRC's) 'Clinical practice guidelines for the management of overweight and obesity in adults' (www.obesityguidelines.gov.au ). On 1 May 2004 a new chapter in the history of primary prevention and primary care in Australia' community pharmacies may unfold with the availability of the Schedule 3 (S3) agent orlistat the only efficacious non-prescription weight-lowering pharmacotherapy. This report proposes a national pharmacy strategy involving orlistat as a key weapon in the war against the overwhelming threat posed by obesity to population health.
This is a referenced but un-reviewed report so should be carefully interpreted.
It is delivered in two parts over two editions of this publication.

1.0 Background in 2004
The 'down-scheduling' to Schedule 3 (S3) on 1 May 2004 of the weight-lowering 'Xenical' (orlistat) , a gastrointestinal pancreatic lipase inhibitor , has been heralded for months by the Australian pharmacy media. 1 Orlistat and just the three prescription drugs phentermine, diethylpropion and sibutramine have so far been approved by Australia's Therapeutics Good Administration ".. as adjunct therapy for weight loss in people with a BMI greater than 30 or greater than 27 with co-morbidities…" 2

1.1 Orlistat's unique status in pharmacy
Orlistat and other medications approved for lowering weight should only be considered for people whose health is impaired by their excess weight and who have failed to lose weight with other methods. 2 For people who fulfill these requirements , orlistat's new S3 status elevates it into the therapeutic stratosphere
(i) of proven pharmacist-only agents such as folic acid , low dose aspirin and nicotine which can be initiated by pharmacists for primary prevention purposes (ie in clients with undiagnosed and untreated conditions) and
(ii) as a proven primary care agent for overweight or obese patients diagnosed with overweight-associated disorders such as type 2 diabetes, hypertension, dyslipidaemia , asthma, sleep apnea and daytime sleepiness . 2

But for the above outstanding opportunities offered by orlistat to be realized, all sectors of Australian pharmacy need to comprehensively and promptly act if we are to be taken seriously in the war against obesity.
In particular, community pharmacies need to become publicly visible and recognised as the frontline troops in measuring overweight status in two strategic situations:
1. Detecting overweight people in the population and referring them for further assessment and management where necessary, and
2. Monitoring the overweight status in patients diagnosed and treated for overweight-associated disorders in order to ensure that the drugs prescribed for these disorders are optimally effective.
These of course require pharmacists to not just be knowledgeable in overweight and obesity but also to become competent in measurement and in methods of evaluation, which are part of clinical testing , the many pharmacy benefits of which I raised in my report entitled "Strategies for pharmacy in the 21st century" in the April 2004 issue of i2P (no.25) .

1.2 The worldwide obesity threat

Obesity is pandemic in all developed countries (Figure 1). According to the US Centers for Disease Control and Prevention overweight due to inactivity and poor diet may have already passed tobacco smoking as the major cause of death in developed countries .3

Figure 1.Percentage of population with Body Mass Index over 30 kg/m2

1.3 Fighting the war against the obesity terrorism threat
If I was a cartoonist I would caricature the infamous international terrorist Osama von Dracula who hails from the mountains of east Transylvania as the monster of El-Obesity standing astride Europe and North America dropping thousands of obesity bombs, first on existing developed countries, then serially on each country emerging from their present developing economies around the world. This would serve as a sign to the world that a new coalition of committed health workers was needed to fight an ominous war.
1.3.1 International pharmacy commitment to war
If I was omnipotent in international pharmacy , pharmacy would join the committed coalition in the war against Osama von Dracula's obesity invasions in developed countries . I would order pharmacies to be troops at the forefront of the war against the international threat posed by obesity.

1.3.2 Australian pharmacy anti-obesity strategy proposal
In Australia I would activate a national strategy to :
· select a command headquarters to implement and assess the national anti-obesity strategy
· appoint a group of savants to assess the NHMRC's 'Clinical practice guidelines for the management of overweight and obesity in adults' (2003) and identify the crucial elements
· ask the savants to map the distribution and size of obesity in order to target the strategy
· publicise that a strong commitment by pharmacies will reward them , the clients and the country
· assemble the controllers of pharmacies in the QCPP (over 90%) , banner groups (c. 50%) and Friendlies (non-pharmacist owned) pharmacies to agree on locations to fight the anti-obesity war
· organize nationwide anti-obesity training of pharmacy staff by the PSA, Guild and CHAPANZ (Committee of Heads of Pharmacy Schools in Australia and New Zealand)
· test and assure the competence of pharmacies in implementing the training programs
· promote publicly and locally of pharmacy's commitment to the anti-obesity war
· install in each pharmacy the key search and measuring devices - weighing machines and tape measures - to measure BMI and waist circumference 2
· assure the orlistat strategy is well implemented, 1 agree on measurable performance indicators, ensure its adoption in pharmacies and quantify the outcomes against the obesity terrorism threat
· regularly evaluate the campaigns and modify accordingly the strategies and tactics .

This will be an ongoing and difficult war but this is typical of fighting all chronic disorders which in developed societies have largely replaced the communicable diseases which 'terrorised' them up to the 1950s. Pharmacies will be a key force along with other primary care health workers and legislators who will introduce inhibitions on the food industry just as they have with the cigarette producers and promoters. Pharmacy will be rewarded many-fold if the commitment to the war is well implemented .
Together with the smoking cessation effort commenced by Australian pharmacy around 1987, fighting in the anti-obesity war will consolidate pharmacists' primary-prevention-skills base for future campaigns against other risk factors for the host of preventable, deferrable or modifiable health disorders which threaten developed societies.2,4

1.3.3 Pharmacy Guild national actions
The Pharmacy Guild launched a national weight management strategy entitled Lifeweight in the Australian Pharmacy Professional conference held on the Gold Coast, Queensland in March 2004 (refer Section 4.1) . We understand a national pharmacy working party has been formed by the Guild to advise in this area.

1.4 Australia: the costs of obesity and the market for weight-reduction
An estimated 67% and 52% of Australian adult males and females were overweight or obese in 1999-2000. 2 Obesity cost Australia an estimated $840 million in 1992-93 and Australians spent approximately $500 million yearly on commercial weight control measures in the mid-1990s. 2, 5 Based on estimates of $USD 40 billion pa spent yearly on weight reduction in the USA, the annual expenditure on all weight reduction methods is likely to have grown to more than two billion dollars in Australia . This figure represents more than 20% of the annual total turnover of community pharmacies in this country.6a Community pharmacy's share of the national market has not been reported but it is unlikely to exceed $300 million yearly or perhaps one-sixth of national sales of all weight reduction methods. There is much scope therefore for pharmacy's share to grow.

1.5 Prescription weight-lowering pharmacotherapies
Weight lowering drugs have a clouded history of efficacy and safety . There are four approved weight lowering drugs in Australia. Of these, phentermine (eg Duromine) and diethylpropion (eg Tenuate) are limited to short term use mainly because efficacy beyond 12 months is unproven.2 Sibutramine and orlistat are efficacious for weight loss for years with adjunctive lifestyle changes. 2 Up to 1970 , amphetamines were frequently prescribed for weight loss but the evidence of widespread abuse curtailed their approval. 2 Dexfenfluramine and fenfluramine were prescribed for weight loss for nearly two decades before September 1997 when they were withdrawn for their associated risk of valvular heart disease.2,7
The global pharmaceutical industry is therefore seeking the elusive prize of a pharmacotherapy efficacious in weight-associated disorders as well as in weight reduction, safe with no dependence properties and able to be used long term .2 The multiple hurdles of synthesis, patenting, formulating, evaluating, registering, subsequent safety and acceptable price, imply that a 'magic bullet' weight-lowering agent will not be registered before 2020. Instead, drugs with incremental weight-lowering advances like orlistat will emerge, hence the systematic implementation of a 'coordinated approach'. 1

1.6 Over-the-counter weight lowering products
The issuing of OTCs is a major outcome of primary care in pharmacies. The weight-lowering OTC products currently available in Australia have a poor records of efficacy from eight weeks to two years.2,5 A number of OTC agents promoted for weight-lowering have also been withdrawn for their significant risks to population safety. In 2004 for example, OTC agents containing ephedrine (ephedra) in the USA have been associated with four deaths in the three months after the December 2003 warning of an impending ban by the Food and Drug Administration.8 The FDA's ban on sales was based on adverse cardiovascular effects and poor efficacy for weight loss by ephedra. 9
The New York Times reported a survey where sales of ephedra products continued in a variety of non-pharmacy retail outlets such as a gymnasium, health food centre and a diet-supplement website for months after the FDA warning.8 Inappropriate sales of OTC products by non-pharmacists in the USA have been previously reported by Professor Steven Pray an OTC expert : "…grocers and other non-pharmacists see outdated nonprescription products in much the same way as outdated cheese or pickles , selling them at a discount in specially marked bins…" 10
The de-scheduling or 'switching' of prescription drugs in the USA has been followed by varying degrees in other countries . It has been influenced by the US pharmaceutical industry since the 1970s. We must expect, in planning any strategy for pharmacy in primary care in this country, a stream of de-scheduled potent agents. We must therefore not only get the 'coordinated approach' to orlistat right, but have the processes to ensure our practitioners are not just well trained but also demonstrably competent in managing obesity and other primary health care challenges .

2.0 2004 headlines on the obesity war
The following sample of headlines in the lay media since January 2004 indicate community pharmacy should take a leading role in the war against obesity :
· "Children are at risk of having a lower life expectancy than their parents for the first time…." Prof. D'Arcy Holman, head of the school of population health University of Western Australia (April 21,2004) . 11
· McDonald's , the USA's No. 1 fast-food maker announced "…the Go Active! Adult Happy Meal…that comes to just nine grams of fat and 240 calories …Adults in search of a toy with their Happy Meal will find instead a pedometer, a device which helps people keep tack of how much they walk…" (April 16, 2004). 12
· "As ephedra (promoted for weight loss) ban nears, a race to sell the last supplies." (April 11,2004). 8
· "Physical inactivity and poor nutrition catching up to tobacco as actual cause of death" (March 9, 2004). 3
· "Fad diets that can starve you to death" (January 9,2004). 13
The above reports reflect a decline internationally in physical activity and poor nutrition leading to rising obesity-related premature deaths in developed countries , to the extent that these contribute to shorter longevity for the first time in Australia's recorded history .3,11 McDonald's , the world's biggest fast food company provides pedometers to customers of their new labeled low calorie meals to their menus. 12 McDonald's is responding to consumer and class actions which have led to falling sales worldwide. The FDA, health departments, politicians and consumer bodies are pressing the US food industry for lighter food servings, calories for meals in menus and labels on packaged foods. The US Congress has countered these actions by protecting food companies against lawsuits taken for weight problems.13 The safety and efficacy of Atkins and other low carbohydrate (www.atkinsdietalert.org ) diets have been challenged in 2004 . 13
The media reports emphasise the international threat posed by obesity, the tactics applied at the international and national levels and the precautions required by individual pharmacies engaged in the war against obesity

References
1. Advertorial. Profession and industry unite over Xenical's new pharmacist-only status. Aust J Pharm 2004; 85: 232-233.
2. National Health and Medical Research Council (NHMRC). Clinical practice guidelines for the management of overweight and obesity in adults. Canberra: Commonwealth of Australia, 2003. www.obesityguidelines.gov.au accessed 26 April 2004.
3. Center for Disease Control. Fact Sheet : Physical inactivity and poor nutrition catching up to tobacco as actual cause of death. Atlanta (Georgia): Office of Communication, March 9 2004. www.cdc.gov./od/oc/media/pressrel/fs040309 accessed 21 April 2004.
4. Berbatis CG, Horsfall WJ, Morgan DJ et al. Smoking, drugs and smoking cessation. Canberra: Pharmaceutical Society of Australia, 1989 (38 pages).
5. Wong L, Hughes J. Over-the-counter weight loss products, how effective are they? Aust Pharmacist 2002; 21: 276-281.
6a. Berbatis C, Sunderland VB, Bulsara M, Mills C. National pharmacy database project. School of Pharmacy, Curtin University of Western Australia. www.guild.org.au/public/r&d.adpreports# accessed 10 March, 2004. The report and questionnaire can be found in the "Reports and Reviews of Completed Projects" section of this page. Refer Section M (Q33) for pharmacy turnover.
6b. ibid, Section B (Q7) for enhanced pharmacy services.
6c. ibid Section G ( Q16-18) for primary preventive services .
7. Bantle JP. Weight management and type 2 diabetes mellitus. Medscape Diabetes and Endocrinology 2004; 6(1). www.medscape.com/viewarticle/473049 accessed 24 April 2004.
8. Hurley D. As ephedra ban nears, a race to sell the last supplies. New York Times April 11,2004. http://query.nytimes.com/serach/restricted/article?res=F20614F6385C0C728DDDAD accesses 24April,2004.
9. FDA News. FDA issues regulation prohibiting sale of dietary supplements containing ephedrine alkaloids and reiterates its advice that consumers stop using these products. US Food and Drug Administration, February 6, 2004. www.fda.gov/bbs/topics/NEWS/2004/NEW10021.html accessed 24 April 2004.
10. Pray JJ, Pray WS. Nonpharmacy OTC sales : patients lose. US Pharmacist 2003; 28(5). www.medscale.com/viewarticle/456001 accessed 5 August 2003.
11. McKimmie M. WA expert despairs for child health. The West Australian April 21,2004 : page 1.
12. Witte G. McDonald's meal designed to keep adults happy too. The Washington Post April 16, 2004 : page EO1. www.washingtonpost.com/ac2/wp-dyn/A16039-2004Apr 15? accessed 20 April 2004.
13. Stein R. FDA aims at obesity epidemic. The Washington Post March 1, 2004: AO1.
13. Rasdien P. Fad diets that can starve you to death". The West Australian January 9,2004 : page 1.

The end of Part 1.