Accomplia, (active ingredient rimonabant), the long awaited anti obesity drug, was approved for use in the twenty -five member states of the European Union in June 2006. Long before the drug was formally launched the media have been taking a close interest in this drug, developed by Sanofi-Aventis. The media hype fanned the flames of consumer demand and each of the 6,600 participants in the clinical trials could have been replaced with an army of willing volunteers. (1)
Could it be true, could a pill be developed to cure obesity?
In the battle of the bulge we have all been there and bought the XXXL T shirt before. How many previous miracle diets and drugs have we earnestly believed only to be disappointed, disillusioned, depressed and, usually, a few pounds heavier.
Why do we need any weight loss drugs?
It does not take a genius to look around and see that the number of overweight and obese Americans are on the increase. Just in case any one thought that they have been hiding away the National Health and Nutrition Examination Survey NHANES estimated that 65.2% of adult Americans fell in to that category in 2002 (2) , the level of obesity increased 91% from the 1991 survey.
Researchers at Harvard School of Public Health (HSPH) found that most men over estimated their height and most women underestimated their weight in these surveys, (3) big surprise. The effect generally lowered the average BMI and so obesity was underestimated. CDC is now sending disease detectives, into communities to collate actual data, just as they would for a SARS out break or flu epidemic.
To be described as clinically obese you must have a Body Mass Index (BMI) greater than 30(stage II Obesity). (5) Put simply if your waist measurement is more than40 inches if you are a man and more than 35 inches if you are a woman you are obese. According to the Harvard study concluded in April this year 28.7% of men and 34.5% of Americans are obese, (stage II obesity) A BMI of between 25 and 30 (stage I obesity) means that you clinically overweight, again, you are not alone a further five out of ten Americans fall into this category.
A BMI of over 40 is termed as stage III obesity and cheerfully termed Morbidly obese. The Harvard University research concluded that 4.7% of American adults
These figures mean that on average, eight out of ten Americans are being overweight to a greater or lesser degree.
There are three stages of obesity (6)
Stage I BMI 25-30 Overweight
Stage II BMI 30- 40 Obese
Stage III BMI 40+ Morbidly Obese
Understandably no one wants to be labelled “Obese” which, according to the Collins dictionary is “ adj excessively fat or fleshy; corpulent. (C17 from L obesus from ob- (intensive) +edere to eat)”. Never fear shortly the term obese will be replaced with the new term “Metabolic Syndrome”, the symptoms of which bear an uncanny resemblance to obesity.
Why does it matter if we become obese?
Obesity is rapidly catching up, and will soon overtake, the single biggest cause of premature death, smoking. The leading causes of premature death in America in 2000 were (7)
A cigarette will not kill you but the side effects of long-term smoking, most certainly will. The same can be said of the symptoms of obesity including heart disease, high blood pressure, arthritis, diabetes, indigestion, gallstones, cancers (e.g. breast, prostate), snoring and sleep apnoea, loss of libido, stress, anxiety, and depression
In 1998 five percent of the annual total medical budget, over $117 Billion Dollars, is spent on obesity related conditions. Indirect costs, such as the 2 to 5 additional days off per year an obese employee has to his normal weight colleague, amount to over $56 Billion Dollars annually. (8) The obese even cost the state an extra $250, just for the additional manpower required to lift their bodies to and from the autopsy table.
We may be living longer than ever before, but, for those that have even one of the chronic diseases associated with obesity, certainly feels like it
Is obesity a disease or a “lifestyle” choice?
Many Health Professionals genuinely believe that obesity is caused by “lifestyle choices”. The stereotypical media image of a fat slob, sitting in front of the television, cigarette in one hand, can of larger in the other, surrounded by take out cartons does much to re-enforce this image. This would not be painting the full story. Scientists are looking at evidence of a “thrifty” gene, whose basic function is to convert food into storage, as fat, when food is scarce. The problem with this theory is why has this gene only decided to turn itself on across the globe, in the last six decades. There is mounting evidence of chemical, and hormonal imbalances in the obese, maybe the well known cry “its my glands” is nearer the mark than science has yet to confirm.
The US diet industry was worth $19billion dollars in 2004, but only 5% of people who lose weight keep it off, leading the remaining 95% into a world of yoyo and fad dieting, causing even lower levels of self esteem resulting in “comfort” eating.
We all know that fast food packed with salt, sugar, preservatives and fat is not good for us. Americans now spend, in real terms, ten times the amount eating out than they did thirty years age. In the same thirty year period money spent on eating out has risen from $6 Billion in 1974 to $110 Billion in 2004. Good business plan, increase your footfall by a factor of ten and your income by a factor of 18, in an increasingly competitive market, every body wins, right? Even those that eat a balanced diet including plenty of fresh fruit and vegetables, wholegrains and pulses, fresh oily fish and good quality organic meat are putting on weight. The food that we eat today is radically different to the food eaten at the end of the Second World War. Intensive farming, herbicides, pesticides, antibiotics and growth hormones have changed the quality and quantity of raw food available. Methods of preservation, and preparation have changed the level of nutrients in the foods. A 2002 survey of foods for the United States
Department of Agriculture examined the nutritional content of food in 1940 and compared with results compiled in 2000. The levels of iron recorded in the average rump steak have dropped by 55%, while magnesium fell by 7%. Looking at 15 different meat items, the analysis found that the iron content had fallen on average by 47%. The iron content of milk had dropped by more than 60%, and by more than 50% for cream and eight different cheeses. Milk appears to have lost 2% of its calcium, and 21% of its magnesium too. (9)
Most cheeses showed a fall in magnesium and calcium levels. According to the analysis, cheddar provides 9% less calcium today, 38% less magnesium and 47% less iron, while parmesan shows the steepest drop in nutrients, with magnesium levels down by 70% and iron all gone compared with its content in the years up to 1940.
Rapid growth grasses on which cattle feed dilutes the availability of nutrients, which are already depleted in poor over, farmed soils. Similar drops in the nutritional value have also been found in studies in the UK, and Denmark. The average person consumes 6 kilos of additives in their food each year. Add to that as well as breathing air polluted by aircraft flying food thousands of miles, to provide us with choice, and cocktails of pesticides and herbicides and their subsequent run off into the water table is it any wonder that our immune systems are overloading? It is unfortunate that our bodies appear to be screaming for nutrients and micro nutrients in food but no matter how much we eat our bodies don’t seem to be getting them from our normal diet
Drugs that we are given to combat illness and the symptoms of illness are causing side effects that require even more treatments. Renaming obesity “Metabolic Syndrome”, it becomes a treatable disease and so insurance companies can be persuaded to pay for more treatments?
If we treat our bodies and the environment with respect we will be rewarded with food that is not nutritionally deficient and does not require taste to come in the form of sugar, salt and additives? Of course that would take a groundswell of international public opinion and if they can’t waddle further than the mall to fill up on empty calories that groundswell, conveniently for some, is not going to happen. There is no point running to a lawyer, the proof, if it could be found would take many years and then there would be mass litigation just to apportion the degree of blame. The only people who would make money are the trial lawyers.
Another “lifestyle” myth, that of poverty, is rapidly falling apart at the seams. In 1974 the incidence of obesity in the affluent (those earning above $60,000. in today’s money) was 9.7% and compared to an obesity rate of 22.5% for those on an income of less that $25,000. per year. The figures for 2004 are 26.8% in the higher income group and 32.5% in the lower income group. This article is not designed to give tax advice, but it seems to be a little known fact that in 2005 the IRS classified obesity as a disease for tax purposes. (10) This means that certain expenses relating to weight loss can be deducted as medical expenses, and whilst not all weight loss aids, ie gym membership, are deductible, your accountant should be able to advise which are.
Happily, we know that we can trust that our government agencies are checking the quality of our food and drink. We must also thank those selfless manufacturers who sponsor the scientists in the government labs, to prove that the food and drugs that they provide are safe.
Obviously if you are reading this in an outsized t shirt, staring at the remains of a take away, a glass of merlot in one hand and a cigarette, in the other, then shoving down the latest obesity drug will not have the same effect as a determined effort to regain your health.
How does Accomplia work?
Accomplia is different to most weight loss drugs, which are suppressants, in one form or another. Accomplia works by blocking the stimulants produced CB-1 receptors, which are found in the Endo-Cannobinoid (EC) system. In simple terms these are the stimulants that send out a signal “to eat and eat now”, known to habitual cannabis users as “the munchies”. (11) Over stimulation of the CB1 receptor is associated with excessive food intake, accumulation of fat and Nicotine dependence. Here once again we find a “catch 22” scenario as these CB1 receptors are found in the brain, Liver, Muscles, digestive system and most importantly the adipose (fat) tissues of the body. The more fat in the body the more CB1 receptors there are.
Exactly the same impulses come into play when people eat, smoke and drink alcohol. The principle behind Accomplia, is that, if the “high” is not achieved in the first place, then the stimulant for more of the same will not be sent. It is for this reason, that as well as the effects on obesity Accomplia trials are on going at to its effectiveness as an aid to stopping smoking and alcohol abuse. The system at the FDA is that they can only license a drug for one benefit, for one disease at a time, and so at the moment they are only examining the results of the clinical studies relating to obesity. This system seems odd to us non-scientists. What would happen, for example if the FDA were presented with that well known substance that has many uses for many diseases H2O (water)?
Does Accomplia Work?
For obesity, in a word, yes. In a year long clinical double blind study 1,036 obese patients received 5 mg or 20 mg of Accomplia or placebo daily. Patients were told to reduce caloric intake by 600 calories a day and were given nutritional guidance.All patients were treated for a year. A third dropped out of the trial due to side effects, but ,of those that completed the trial, more than 70% of patients in the 20 mg group lost 5% of total body weight and 44% lost more than 10% of total body weight over the one year period. Other benefits found were, a 23% increase in HDL (“good” cholesterol), a 15% decrease in triglycerides (blood sugars), a 27% reduction in C-reactive protein, a marker of inflammation linked to cardiovascular disease .It is, indeed, unfortunate that the FDA can only license for one benefit at a time. It would appear from the clinical studies that Accomplia could lessen or negate the need for additional drugs to treat high cholestoral and high blood pressure.
As for an aid to stop smoking, more than 700 smokers who had smoked at least 20 cigarettes a day for between 11 and 24 were given 5 mg or 20 mg of Accomplia or a placebo pill daily. At the end of the 10 week study 36% of the Accomplia patients taking the 20 mg dose had quit. Twice the rate of the placebo group, and slightly better than people who use nicotine replacement devices. Interestingly those who quit taking Accomplia 20mg daily did not put on weight. (12)
Who should take Accomplia?
It will be a long time until the questions regarding the nutritional quality and the effects of enviromental pollution have been satisfactorally answered, and strategies for change put in place. Until then, anyone who is overweight, and is ready to take responsibility for their own health, should consider Accomplia as a part of a health and lifestyle overhaul. Taking responsibility for your own health should include discussions with your Doctor to rule out simple causes to weight gain such as a candida infection or a chronic food intolerance. Medical advice is essential if you are taking any other form of medication as any new chemical combinations in the body could have additional side effects. Take a supplement to get rid as many toxins in the body as possible, as well as a complete multivit/mineral. Start taking exercise even if it is only to walk to your organic grocers each day to collect fresh ingredients for that days meals. Even better walk to the nursery and buy some herbs that you can grow on your
windowsill to flavour your food. Once bitten by the bug you will want to grow more of your own fruits and vegetables. The benefits, exercise, healthy, very local food, after all how many obese gardeners do you see? The other benefit is that when you grow your own food you are less likley to cook all the goodness out of it.
What are the side effects of Accomplia?
Accomplia has very fewer and milder side effects than other weight loss medications. The most common being nausea, dizziness, and diarrhea. Twice as many people taking Accomplia 20mg gave up the clinical trial due to depression as the placebo group.
The side effects must be balanced with some of the side effects of obesity include heart disease, high blood pressure, arthritis, diabetes, indigestion, gallstones, cancers (e.g. breast, prostate), snoring and sleep apnoea, loss of libido, stress, anxiety, and depression.
(1) Effect of Rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomised controlled trial by Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin Rosenstock J; RIO-North America Study Group. Obesity Research Center, St Luke’s-Roosevelt Hospital Center,Columbia University College of Physicians and Surgeons, New York, NY 10025, USA. JAMA. 2006 Feb 15;295(7):761-75.
(2). Flegal KM, Carroll MD, Ogden CL,Johnson CL- Prevalence and Trends in Cbesity among US Adults JAMA 288 1723-7 2002
(3) Journal of The Royal society of Medicine: May 2006.
(4)CDC Telebriefing Transcript Overweight and Obesity: Clearing the Confusion June 2, 2005.
(5) Clinical Guidelines on Identification, Evaluation and treatment of Overweight and Obesity in Adults, NHLBI, September 1998.
(7) Ali H Mokdad Phd; James S Marks MD MPH; Donna f Stroud Phd,Msc, Julie L. Gebending Md MPh. JAMA 2004 291:1238-125
(8) Wolf AM, Colditz GA: Current Estimate of the Cost of Obesity in USA Obesity Research. March 1998
(9) Susan Gebhardt, Robin G Thomas USDA Nutiritive Value of Foods: Home and Garden Bulletin 72
(10) IRS Ruling 202-19
(11) Harrold JA and Williams G (2003) The Cannaboid System: A Role in bothe the Homeostatic and Hedonic Control of Eating. Br Journal of Nutrition 90, 729-734
(12) Effect of Rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomised controlled trial by Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin Rosenstock J; RIO-North America Study Group. Obesity Research Center, St Luke’s-Roosevelt Hospital Center,Columbia University College of Physicians and Surgeons, New York, NY 10025, USA. JAMA. 2006 Feb 15;295(7):761-75.
(2). Flegal KM, Carroll MD, Ogden CL,Johnson CL- Prevalence and Trends in Cbesity among US Adults JAMA 288 1723-7 2002