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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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Orlistat OTC; Alli.
- David Haslam (24 October 2008)
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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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David Haslam, GPSI Obesity, Physician in Obesity Medicine Watton Place Clinic SG14 3SY
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Orlistat switch to OTC. Professor Williams is like my Mother, who entered our brand new kitchen for the first time and immediately grumbled about the size of the potato peeler. Some people obsess about the possible negatives of a situation, without even noticing the possible benefits. Alli represents more than just a switch of a drug from FP10 to Over The Counter, but the advent of a new stratum of care in the management of obesity. It is long overdue for Pharmacy to become fully embraced into the fold of Primary Care; pharmacists have the training, knowledge and skills to offer invaluable help in the management of chronic disease, as well as regular contact with, and detailed knowledge of the affected population by dispensing their repeat prescriptions every 28 days, usually more frequently than the GP or Nurse will see them. They are ideally placed to help out in obesity management because of their community role, and also their contract which stipulates their involvement in public health campaigns such as obesity management. To expect them to play such an important role in Public Health as well as the care of high risk individuals to prevent diabetes and heart disease, but to deny them the use of drugs such as Alli, an effective, scientifically validated anti- obesity drug, would be unhelpful. Vulnerable punters can easily buy Snake Oils masquerading as weight loss remedies off pharmacy shelves, despite the complete lack of any evidence for their efficacy, and the shameless lies peddled on their packs. They can spend even more money at Private Clinics buying drugs like phentermine, which have no evidence whatsoever in the long term management of obesity, and are prescribed with little or no support from a healthcare professional. Why then, would the introduction of a weight loss drug with robust evidence and almost a decade of use worldwide cause such consternation? Prof Williams grumbles that lifestyle changes are more important, but neglects to point out that we have already tried to counteract the obesity epidemic by putting people on diets, and urging them to do more activity, without making the slightest dent in the prevalence. We should certainly support lifestyle measures in the management of our patients, but the shocking facts surrounding obesity worldwide clearly suggest that we need more, and Alli offers such an additional element. Prof Williams¡¯ comment that eating one less potato per day is all that¡¯s needed to prevent obesity is just as clich¨¦d as the observation frequently made by bigots that ¡®No fat people came out of Belsen¡¯. If it was as simple as ¡®not eating a potato¡¯, there would be no obesity problem. People are a little tired of being told to eat one less potato per day, and need something additional. And as for his belief that 10 minutes sex per day will eliminate obesity, evidence suggests that the human race has been procreating for years; before, during and after the onset of the epidemic, without managing to solve the problem. GSK don¡¯t suggest that Alli could replace diet and activity interventions : on the contrary, they are at pains to emphasise that the weight loss induced is likely to be around 50% over and above that which could otherwise be expected on a traditional weight loss regime; coitus may therefore continue uninterrupted. Prevention of obesity is a crucial commitment for Government and Industry, but even if prevention is 100% successful, and no-one in the UK gains a single extra ounce, epidemics of diabetes heart disease and premature death are inevitable. There is already a sufficient number of obese people in the UK to ensure enough obesity-related disease to threaten to bankrupt the NHS. Prevention is crucial, but so is treatment of obesity, and the problem is so great that there is room for many different methods and partners: Weight Watchers, Slimming World, Low Carbohydrate diets, VLCDs, GPs and pharmacists. There may well be individuals who are attracted to Alli for the wrong reasons, who fall at the first hurdle, but there will also be those who succeed in losing significant amounts of weight, maintaining it, thereby avoiding serious chronic illness. There is as yet only a limited amount of evidence supporting the OTC use of genuinely effective weight loss agents, but nevertheless a new opportunity is being offered, and there is reasonable expectation that it might succeed, following a positive appraisal of Alli by the CHMP, confirming its imminent availability OTC in Europe. Xenical (orlistat 120mg) has a wealth of evidence with regard to weight loss, reduction in the cumulative incidence of diabetes, improvement in lipid profile, blood pressure, NASH and more, and there is growing evidence for the 60mg version. Alli has around 85% of the efficacy of the 120mg version, but with far fewer side effects. Prof Williams admits that there isn¡¯t much around that genuinely induces weight loss, and that orlistat is one of the few. He also states that 10% weight loss is the benchmark for clinical improvement, whereas studies such as the landmark DPP and DPS and others demonstrate that 5% or even less can induce clinically meaningful reduction in risk. He, and others should stop using the term ¡®steatorrhoea¡¯ (meaning offensive, pale, frothy, floating diarrhoea associated with pancreatic or malabsorptive pathology) when the ¡®Oops factor¡¯, which can actually aid compliance, is simply ¡®oily motions¡¯. Evidence shows that the use of orlistat 60mg improves patterns of food purchases, suggesting a long-term commitment to healthy eating. Williams is happy to use evidence from ConsumerPrice-Watch.net, to highlight what uninformed punters might think of the weight of evidence, without actually assessing the genuine data from scientific trials. A study of ¡®Actual Use¡¯ of orlistat 60mg demonstrated an 80% customer satisfaction rate, alongside a median weight loss of around 5% after ¡Ý60 days of use. Other, randomised placebo-controlled studies showed a weight reduction of 50% more than diet and physical activity alone. Williams states ¡°Clinical trials inevitably show antiobesity drugs at their best, because the participants are relatively motivated and are supported by dedicated staff who reinforce lifestyle advice.¡± Surely the same applies to other weight loss agents, as well as blood pressure lowering drugs, oral hypoglycaemic agents, statins and many more, which don¡¯t attract his similar vitriol. Prof Williams has observed the imminent introduction of Alli, and rather than welcoming the existence of a novel, and potentially beneficial stratum of obesity management for the personal and public health of the country, has seen fit to criticise its role. There is ample evidence of the benefits of orlistat over and above lifestyle alone; the fact that it hasn¡¯t yet been proven in this arena shouldn¡¯t be used as evidence against its use. It, like my new potato peeler, should be given a fair chance. Prof Williams doesn¡¯t work in the Primary Care arena where the majority of high risk obese individuals are seen, but in Bristol¡¯s Ivory Towers. Interestingly on his website he lists ¡®writing fiction¡¯ amongst his hobbies: his editorial states; ¡° Even though orlistat seems to be innocuous, selling it over the counter could cause insidious collateral damage¡. Globally, obesity is spiralling out of control and will only be reined in by public health campaigns that somehow persuade people to eat less and exercise more.¡± It is pure fiction to imagine that an obese person can change the environment in which he lives, and which has caused him to become fat. Even with the greatest motivation, people still need a little help. Sorry Mum; you¡¯re nowhere near as cynical as Prof Williams; at least you can see the benefit of a potato peeler for peeling potatoes! Competing interests: Advisory capacity on behalf of sanofi, MSD, GSK, Roche, Abbott Pfizer. |
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