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Response to Gareth William's editorial "orlistat over the counter"
- Howard Marsh (23 November 2007)
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100kcal a day isn't peanuts
- Michael Cunningham (8 December 2007)
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Orlistat works and is safe and people should be free to spend their money as they wish
- Caroline Mozley (10 December 2007)
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Over-the-counter does not mean unsupported
- Jenny Scott (11 December 2007)
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Orlistat - is it worth it?
- Timothy P. Connery (12 December 2007)
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An apple a day
- David R Warriner (13 December 2007)
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Over the Counter Orlistat may help people with chronic constipation
- John C Alcolado (14 December 2007)
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Howard Marsh, Medical Director, GlaxoSmithKline Consumer Healthcare 07054 USA
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23 November 2007 Professor Gareth William's editorial on the use of weight loss aid, orlistat, correctly concludes that it is no substitute for a healthy lifestyle. As he pointed out, GlaxoSmithKline (GSK) launched a non-prescription version of orlistat (brand name alli) in the US in June this year, the first FDA-approved weight loss medicine to be available over-the-counter (OTC). Eating less and exercising more must remain the cornerstones of managing obesity. Indeed, this strategy, supported by the World Health Organization, is at the heart of the OTC orlistat programme and reinforced in all of the communication materials including an on line behavioural support programme, www.myalli.com. The prevalence of overweight and obesity is increasing dramatically worldwide and being overweight is now the norm in many countries. Excess body weight is associated with a variety of serious medical complications. Small degrees of weight loss produce health benefits, but there can be substantial health gains after a loss of 5-10% including improvements in hypertension, dyslipidaemia and a reduced risk of developing type 2 diabetes. (1, 2) Consequently, modest weight loss, if achieved on a widespread basis, could bring important public health benefits. In addition, weight loss in overweight individuals will help prevent obesity. Professor Williams opines that “selling anti-obesity drugs over-the- counter will perpetuate the myth that obesity can be fixed simply by popping a pill.” We have no intention or desire to perpetuate this myth. The weight loss that can be achieved with OTC orlistat requires commitment to adopt a low-fat, reduced calorie diet. Indeed all our communication, including television advertising, websites, in-store communications as well as materials provided to pharmacists stresses this requirement. These materials specifically state that “alli is not a magic pill” and provide candid information about the consequences of eating too much fat. Professor Williams further asserts that we do not know how well orlistat would perform without the kind of dedicated behavioural support seen in clinical studies. A 3 month open-label, actual use study was conducted in an OTC setting to determine whether consumers could correctly use orlistat based on the product label and in the absence of physician supervision. Subjects received educational materials providing lifestyle information and tools to encourage successful weight loss, (3) similar to those provided in the marketed pack. The weight loss achieved in this study was comparable to that seen in randomised, placebo-controlled studies with medical supervision, where orlistat provided 50% more weight loss than diet and exercise alone.(4) Individuals are easily able to recognise when they are overweight and usually manage their condition without the supervision of their doctor. Professor Williams notes that “we need all the weapons at our disposal to fight obesity”: OTC orlistat is a useful addition to that weaponry. Howard Marsh MRCP MRCGP
References 1. Clinical Knowledge Summaries. Obesity. September 2007. http://www.cks.library.nhs.uk/obesity/in_summary 2. Care pathway for the management of overweight and obesity. Department of Health. May 2006 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4134408 3. Schwartz SM, Bansal V, Hale C, Rossi M, Engle J. Compliance, behavior change and weight loss with orlistat in an over-the-counter setting. Accepted for publication in Obesity. 4. Anderson JW. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the- counter dosage. Expert Opin Pharmacother 2007; 8: 1733-42 Competing interests: Howard Marsh MRCP MRCGP Medical Director GlaxoSmithKline Consumer Healthcare 1500 Littleton Rd Parsipanny New Jersey 07054 USA |
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Michael Cunningham, Gastroenterologist Geneva, Switzerland
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Gareth Williams writes "People tempted to try Alli might be advised that taking it without medical supervision may achieve an average daily energy deficit of only 0.4 MJ (100 kcal)" the implication being that 100kcal is hardly worth bothering about. However, such a deficit translates, over a year, into a 4kg weight loss. Competing interests: None declared |
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Caroline Mozley, Head of R&D, North Yorks R&D Alliance York Hospital, York YO31 8HE
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If Orlistat is sufficiently safe to be sold over the counter that should be permitted. Prof. Williams’ ‘at first glance’ analysis is correct – “Orlistat works and is safe, and people should be free to spend their money as they wish”. His subsequent caveats have no merit. It is true that that users may see less benefit than the hoped-for loss of 10% of their weight; that they may abandon the drug altogether or avoid it when about to eat fish and chips. That is their choice and their problem! The medical profession doesn’t have a monopoly of knowledge about the input-output logic of weight control – most people, even we fat people, can read, and we are all bombarded on a daily basis with messages about exercise and other forms of ‘lifestyle modification’. As another correspondent has pointed out, removing 100 kcal per day from the equation is not irrelevant. Many people become overweight, not because they binge on six hamburgers a day and eat ice cream in the middle of the night, but because over a period of years they steadily ingest every day a few calories more than they use up. A drug that tips that balance, even marginally, has the potential to provide more encouragement for accompanying dietary control and exercise than any amount of medical supervision. This medical supervision that is supposed to save foolish patients from their unrealistic expectations is in fact something that many overweight people will do a great deal to avoid, having, in past encounters, been met with thinly-veiled disgust and no effective help. The medical profession doesn’t have a great record of success in this matter and should not be restricting access to a safe drug that may help people to help themselves. Competing interests: None declared |
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Jenny Scott, Senior Lecturer in Pharmacy Practice University of Bath
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Prof Williams rightly states the risk that over the counter orlistat may 'perpetuate the myth that obesity can be fixed simply by popping a pill'. Any anti-obesity tablet/capsule can be seen as a quick-fix. The strength of the public perception of this for orlistat will no doubt be influenced by the marketing strategies used and the hype in lifestyle magazines. However, Prof Williams seems to suggest that over-the-counter access to medication denies the patient access to any healthcare advice. When supplying over-the-counter medicines, the pharmacist will be in a position, as we are currently when dispensing such medicines, to provide advice and support to the patient. OTC orlistat will allow pharmacists to provide a pharmacological means to support non pharmacological interventions already commonly provided in community pharmacies. It is imperitive that patient expectations of OTC orlistat are realistic and that brief interventions are delivered by the pharmacist and their staff on diet, lifestyle changes and underlying reasons for over eating or poor eating habits. OTC does not mean 'supply on demand'. Pharmacists and their staff have to first ascertain if OTC requests are safe and appropriate. Pharmacy can potentially contribute to the health and wellbeing of the ever-growing public waistline. Those for whom OTC orlistat is not suitable or those in which the pharmacist identifies an adverse reaction will be referred to their GP, as is the current case with other OTC medicine requests. OTC supply goes hand in hand with healthcare advice and support. Orlistat will not be seen as any different. Competing interests: None declared |
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Timothy P. Connery, General Practitioner Nottingham NG1 3LW
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Stung by recent criticism that GPs were failing, amongst other things, to contribute to the thinning of the nation by not prescribing enough Orlistat, I carried out a brief audit of the patients for whom we had, in our Practice, prescribed this drug over the previous three and a half years. There were 52 patients and between them they lost 172Kg. Totalling up the cost of their prescriptions this worked out at a price of £74.34 per kilogram lost. Some of them actually put on weight while they were on Orlistat and at least 12 put on substantial amounts of weight when they came off it. It is acknowledged that this audit was small and had many limitations but it confirmed our gut feeling that merely prescribing medication is not the answer to the obesity epidemic, as Gareth Williams states in his recent Editorial (1). Most of these patients needed to lose at least 10Kg – for £740.00 they could have had a treadmill or several years’ subscription to a commercial weight reduction company or even a gym and this would have benefited their general health much more. It is a curious world that demands that we prescribe ineffective medication for people to lose weight and then in the next post asks us to prescribe sip-feeds to fatten up others. And all this when we have been watching the news from Darfur the night before. Tim Connery
1.G Williams Orlistat over the counter.BMJ 2007;335:1163-4 (8 December 2007) Competing interests: None declared |
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David R Warriner, F2 A&E Scarborough, YO12 6QL
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An apple contains approximately 50kcal and costs around 20-40 pence depending on weight, season and variety. Whilst we must absolutely accept a persons right to self determination, surely their money would be better saved by not eating 2 apples a day rather than buying Orlistat. Incidentally 100kcal not just peanuts, rather 22g of them. David Competing interests: A skinny, vegetarian, cyclist. |
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John C Alcolado, Reader in Medicine Cardiff University School of Medicine, Cardiff, CF14 4XN
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There is no doubt that Orlistat is not the answer to the obesity problem and that there is something slightly uncomfortable at seeing pharmaceutical companies making money in this way. However, given people can spend money on vitamin supplements, anti-ageing creams, sub- therapeutic doses of H2 antagonists and hair-dyes, they might as well invest in some Orlistat as well. A few people may benefit and, free of its prescription-licence indications, we could be bold enough to recommend it to people with chronic constipation. The 100 Cal expenditure during sexual intercourse is interesting; does anyone know if this was done using a box-calorimeter and, if so, whether recruitment into the study is now complete? Competing interests: None declared |
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