Abstract
Background Self-monitoring of blood glucose (SMBG) confers no benefit for many people with type 2 diabetes not being treated with insulin. It accounts for 21% of diabetes prescribing costs.
Aim To improve care quality at reduced cost for type 2 diabetes by reducing unnecessary SMBG.
Design and setting Non-randomised, observational controlled study in two intervention clinical commissioning groups (CCGs) and one control CCG in east London.
Method In total, 19 602 people with type 2 diabetes not being treated with insulin were recruited from two intervention CCGs; 16 033 were recruited from a control CCG. The intervention (from 2010 to 2013) comprised implementation of a locally developed guideline, including IT support and peer feedback of performance. Data on practice prescribing SMBG testing strips were gathered using GP electronic health records. Information on costs were obtained via the ePACT electronic database.
Results Over 4 years, in all non-insulin type 2 diabetes treatment groups, use of SMBG was reduced in the two intervention CCGs from 42.8% to 16.5%, and in the control CCG from 56.4% to 47.2%. In people on metformin alone or no treatment, intervention CCGs reduced SMBG use from 29.6% to 6.0%, and in the control CCG use dropped from 47.1% to 38.7% (P<0.001). From 2009 to 2012 the total cost of all SMBG prescribing (type 1 and type 2 diabetes, including users of insulin) was reduced by 4.9% (£62 476) in the two intervention CCGs and increased in the control CCG by 5.0% (£42 607); in England, the total cost increased by 13.5% (£19.4 million). In total, 20% (3865 of 19 602) fewer patients used SMBG in the intervention CCGs.
Conclusion This low-cost programme demonstrated a major reduction in unnecessary prescribing of SMBG, along with cost savings. If replicated nationally, this would avoid unnecessary testing in 340 000 people and prescribing costs that total £21.8 million.
Full text here: http://bjgp.org/content/65/633/e256
Graham
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Tuesday, 31 March 2015
A Tasty Trifle - Low Carb Of Course
Ingredients: Serves 6-8
100 grams of ground almonds
100 grams of ground almonds
1 teaspoon of baking powder
2 large eggs
1 tablespoon of melted butter
2 tablespoons of double cream
2 large eggs
1 tablespoon of melted butter
2 tablespoons of double cream
A pack of frozen lowcarb summer fruits
300ml of extra thick cream
A handful of toasted flaked almonds
2 x 12.5 grams of instant jelly crystals
Method
Mix all dry ingredients in a bowl.
Melt the butter, I use a Pyrex jug, add the eggs, cream, then add the dry ingredients and mix. Pour into a 6" microwave proof dish. Microwave in a 700watt for 3 minutes. Allow almond sponge to cool and break up into small pieces.
Layer up in a Pyrex bowl ( 7" wide by 4" deep ) the fruit, and sponge. Pour over the lowcarb raspberry liquid jelly and allow to set in the fridge. Cover top with extra thick cream and toasted flaked almonds.
With the Easter weekend nearly here this makes a great family low carb dessert.
All the best Jan
Monday, 30 March 2015
Increased dietary magnesium intake associated with improved diabetes-related health outcomes
Northridge, CA (March 30, 2015) - A recent analysis published in the Journal of Human Nutrition & Food Science reveals a beneficial relationship between dietary magnesium intake and diabetes-related outcomes including decreased risk for metabolic syndrome, obesity or overweight, elevated blood pressure, and reduced HDL (good) cholesterol(1).
This secondary analysis examined the relationship between dietary magnesium intake from food and food combined with supplements and diabetes and other related health factors in adults (? 20 years) using data from the National Health and Nutrition Examination Survey (NHANES), 2001-2010. NHANES is a program of studies designed to assess the health and nutritional status of adults and children in the United States, conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).
"Our analysis found that dietary intake of magnesium from foods or from food plus supplements was associated with improvements in many diabetes-related health outcomes. These results further demonstrate the importance of meeting magnesium intake recommendations and illustrate the usefulness of dietary magnesium supplementation when these recommendations cannot be met with diet alone." said Yanni Papanikolaou, Vice President of Nutrition Research at Nutritional Strategies, Inc. and co-lead researcher of the analysis.
Magnesium, an essential micronutrient, assists in more than 300 metabolic reactions, helping support bone health, as well as nerve and muscle function. It also helps convert food to cellular energy. Sources of dietary magnesium include fruits, green leafy vegetables, whole grains, nuts and dairy products. The estimated average requirement (EAR) for magnesium is 330-350 mg/day for men and 225-265 mg/day for women. The 2010 Dietary Guidelines, and more recently the 2015 Dietary Guidelines Advisory Committee Report, indicate magnesium is commonly under-consumed relative to the estimated average requirements (EAR).
"Insufficiency of micronutrient intake is a global issue," commented Dr. James Brooks, Vice President, Science, Technology and Quality, Pharmavite, and study author. "Dietary magnesium supplementation, coupled with appropriate food choices, offers an evidence-based option to meet the estimated average requirements.
The analysis funded by Pharmavite LLC, makers of Nature Made® brand dietary supplements, included data from more than 14,000 NHANES participants. Adults aged > 20 years with adequate intake (defined as meeting the EAR) of magnesium from food alone had significantly lower odds ratios for metabolic syndrome (0.88, p=0.0166), overweight or obesity (0.91, p=0.0305) elevated blood pressure (0.88, p=0.0205), elevated systolic blood pressure (0.87, p=0.0070) and reduced HDL (0.84, p=0.0039) compared to adults with inadequate intake of magnesium from food. Additionally, magnesium intake from food in combination with dietary supplements had significantly lower odds ratios for elevated glycohemoglobin (0.88, p=0.0046), obesity (0.92, p=0.85), overweight or obesity (0.86, p=0.0011), elevated waist circumference (0.88, p=0.0057) and reduced HDL (0.81, p=0.0034) compared to adults with inadequate intake of magnesium from food plus supplements.
Because this analysis is an examination of survey data, it does not indicate cause and effect, but rather demonstrates associations between dietary magnesium intake and health outcomes. Although results of this analysis may have been limited by errors in self-reported dietary intake and use of a 24-hour dietary recall, NHANES is recognized as a very credible source for dietary patterns and health outcomes data.
Access the full study, entitled "Dietary Magnesium Usual Intake is Associated with Favorable Diabetes-Related Physiological Outcomes and Reduced Risk of Metabolic Syndrome: An NHANES 2001-2010 Analysis," at http://www.jscimedcentral.com/Nutrition/nutrition-2-1038.pdf. Study authors include Yanni Papanikolaou, Nutritional Strategies, Inc.; James Brooks, Pharmavite, LLC; Carroll Reider, Pharmavite, LLC; and Victor L. Fulgoni, III, Nutrition Impact, LLC.
This secondary analysis examined the relationship between dietary magnesium intake from food and food combined with supplements and diabetes and other related health factors in adults (? 20 years) using data from the National Health and Nutrition Examination Survey (NHANES), 2001-2010. NHANES is a program of studies designed to assess the health and nutritional status of adults and children in the United States, conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).
"Our analysis found that dietary intake of magnesium from foods or from food plus supplements was associated with improvements in many diabetes-related health outcomes. These results further demonstrate the importance of meeting magnesium intake recommendations and illustrate the usefulness of dietary magnesium supplementation when these recommendations cannot be met with diet alone." said Yanni Papanikolaou, Vice President of Nutrition Research at Nutritional Strategies, Inc. and co-lead researcher of the analysis.
Magnesium, an essential micronutrient, assists in more than 300 metabolic reactions, helping support bone health, as well as nerve and muscle function. It also helps convert food to cellular energy. Sources of dietary magnesium include fruits, green leafy vegetables, whole grains, nuts and dairy products. The estimated average requirement (EAR) for magnesium is 330-350 mg/day for men and 225-265 mg/day for women. The 2010 Dietary Guidelines, and more recently the 2015 Dietary Guidelines Advisory Committee Report, indicate magnesium is commonly under-consumed relative to the estimated average requirements (EAR).
"Insufficiency of micronutrient intake is a global issue," commented Dr. James Brooks, Vice President, Science, Technology and Quality, Pharmavite, and study author. "Dietary magnesium supplementation, coupled with appropriate food choices, offers an evidence-based option to meet the estimated average requirements.
The analysis funded by Pharmavite LLC, makers of Nature Made® brand dietary supplements, included data from more than 14,000 NHANES participants. Adults aged > 20 years with adequate intake (defined as meeting the EAR) of magnesium from food alone had significantly lower odds ratios for metabolic syndrome (0.88, p=0.0166), overweight or obesity (0.91, p=0.0305) elevated blood pressure (0.88, p=0.0205), elevated systolic blood pressure (0.87, p=0.0070) and reduced HDL (0.84, p=0.0039) compared to adults with inadequate intake of magnesium from food. Additionally, magnesium intake from food in combination with dietary supplements had significantly lower odds ratios for elevated glycohemoglobin (0.88, p=0.0046), obesity (0.92, p=0.85), overweight or obesity (0.86, p=0.0011), elevated waist circumference (0.88, p=0.0057) and reduced HDL (0.81, p=0.0034) compared to adults with inadequate intake of magnesium from food plus supplements.
Because this analysis is an examination of survey data, it does not indicate cause and effect, but rather demonstrates associations between dietary magnesium intake and health outcomes. Although results of this analysis may have been limited by errors in self-reported dietary intake and use of a 24-hour dietary recall, NHANES is recognized as a very credible source for dietary patterns and health outcomes data.
Access the full study, entitled "Dietary Magnesium Usual Intake is Associated with Favorable Diabetes-Related Physiological Outcomes and Reduced Risk of Metabolic Syndrome: An NHANES 2001-2010 Analysis," at http://www.jscimedcentral.com/Nutrition/nutrition-2-1038.pdf. Study authors include Yanni Papanikolaou, Nutritional Strategies, Inc.; James Brooks, Pharmavite, LLC; Carroll Reider, Pharmavite, LLC; and Victor L. Fulgoni, III, Nutrition Impact, LLC.
A word of caution this study was funded by a supplement manufacturer but it does reach similar conclusions as older studies see: http://www.diabetesincontrol.com/
Graham
Graham
Ginger Fat Bombs - Low Carb and Gluten Free
Libby at 'Ditch the Carbs' Blog has made a few fat bomb recipes and these ginger fat bombs are her favourite. I too have always liked the taste of ginger. Have a look at this recipe idea and why not give it a try... it's another winner I think.
"Fat bombs will keep you fuller for longer, reduce your carb intake, and contain a healthy dose of coconut oil. Coconut oil is making a huge comeback for various reasons. It is high in lauric acid which is anti fugal and anti bacterial. It is also a great source of MCT (medium chain triglycerides) which are metabolised in the liver for rapid energy, and can produce ketones which have been shown to be therapuetic for brain function. Snacking on coconut oil to keep hunger away.
Use a combination of Coconut Butter and Coconut Oil. Coconut butter is similar to coconut oil but the butter still has some fibre and white meat from the coconut. It has a richer taste. The difference between them is similar to comparing peanut butter with peanut oil. There are some carbs in coconut butter, but most of it is fibre and it is great for those who do not like the texture of straight coconut oil.
If you like these, then why not take a look at the Chocolate Fat Bombs with walnuts or the Paleo Easter Eggs (just call them fat bombs any other time of the year). All are super simple recipes to make when you get hungry and want a quick snack."
INGREDIENTS Serves 10
75g/ 2.6oz coconut butter softened
75g/ 2.6oz coconut oil softened
25g/ 0.8oz shredded coconut (unsweetened)
1 (5ml) tsp granulated stevia or sweetener of choice, to taste
½ (5ml) tsp dried (powdered) ginger
INSTRUCTIONS
Mix all the ingredients in a pouring jug until the stevia is dissolved.
Pour into silicon moulds or ice block trays and refrigerate for minimum 10 minutes.
NUTRITION INFORMATION
Serving size: 1 Ginger Fat Bomb Calories: 120 Fat: 12.8g Carbohydrates: 2.2g Sugar: 0.1gFibre: 1.4g Protein: 0.5g
"Fat bombs will keep you fuller for longer, reduce your carb intake, and contain a healthy dose of coconut oil. Coconut oil is making a huge comeback for various reasons. It is high in lauric acid which is anti fugal and anti bacterial. It is also a great source of MCT (medium chain triglycerides) which are metabolised in the liver for rapid energy, and can produce ketones which have been shown to be therapuetic for brain function. Snacking on coconut oil to keep hunger away.
Use a combination of Coconut Butter and Coconut Oil. Coconut butter is similar to coconut oil but the butter still has some fibre and white meat from the coconut. It has a richer taste. The difference between them is similar to comparing peanut butter with peanut oil. There are some carbs in coconut butter, but most of it is fibre and it is great for those who do not like the texture of straight coconut oil.
If you like these, then why not take a look at the Chocolate Fat Bombs with walnuts or the Paleo Easter Eggs (just call them fat bombs any other time of the year). All are super simple recipes to make when you get hungry and want a quick snack."
INGREDIENTS Serves 10
75g/ 2.6oz coconut butter softened
75g/ 2.6oz coconut oil softened
25g/ 0.8oz shredded coconut (unsweetened)
1 (5ml) tsp granulated stevia or sweetener of choice, to taste
½ (5ml) tsp dried (powdered) ginger
INSTRUCTIONS
Mix all the ingredients in a pouring jug until the stevia is dissolved.
Pour into silicon moulds or ice block trays and refrigerate for minimum 10 minutes.
NUTRITION INFORMATION
Serving size: 1 Ginger Fat Bomb Calories: 120 Fat: 12.8g Carbohydrates: 2.2g Sugar: 0.1gFibre: 1.4g Protein: 0.5g
Link to Libby's original recipe here
All the best Jan
Sunday, 29 March 2015
Dr Jason Fung: Of Traitors and Truths
I was reading Dr. Eenfeldt interesting recent post on www.dietdoctor.com, about a clip of the great crusader Dr. Aseem Malhotra showed at the recent LCHF summit in Cape Town and was reminded of one of the great truths of our time. You cannot be betrayed by those whom you do not trust. While we often blame Big Food for obesity, we never really trusted them, so cannot really be betrayed.
But, we have been betrayed. By whom? The story is even worse then you suspect….
Big Food wants to make more money. That’s no secret. They created an entirely new category of food, called “snack food,” and promoted it relentlessly. They advertised on TV, print, radio and Internet.
But there was an even more insidious form of advertising called sponsorship and research. Big Food sponsors large organizations such as the Academy of Nutrition and Dietetics. Coca Cola General Mills, Kellogg Company and Pepsi are found among its “Premier” sponsors. At its annual meeting, a sponsor could hold a “nutritional symposia.” In 2014, for example, the Coca Cola Company would teach dieticians about Coaching Your Clients Toward Lasting Weight Loss.” The $50,000 Gold Sponsorship allowed the company to spread the message that sugar is not harmful to children. Thanks, Coca Cola.
Michele Simon, in her scathing report “And Now a Word from our Sponsors” uncovers how corporate giants like Coca Cola and McDonalds ‘educates’ health professionals.
And don’t forget the medical associations. In 1988, the American Heart Association decided that it would be a good idea to start accepting cash to put its Heart Check symbol on foods of otherwise dubious nutritional quality. The Center for Science in the Public Interest estimates that in 2002, the AHA received over $2 million from this program alone. Food companies paid $7,500 for one to nine products, but there was a volume discount for more than twenty-five products! Exclusive deals were, of course, more expensive. In 2009, such nutritional standouts as Cocoa Puffs and Frosted Mini-Wheats were still on the Heart Check list. The 2013 Dallas Heart Walk organized by the AHA featured Frito-Lay as a prominent sponsor. The Heart and Stroke Foundation in Canada was no better. As noted on Dr. Yoni Freedhoff’s weightymatters blog , a bottle of grape juice proudly bearing the Health Check contained ten teaspoons of sugar. The fact that these food were pure sugar seemed not to bother anybody.
The researchers and academic physicians were not to be ignored either. These were key opinion leaders in the medical community. In 2013, Dr. Allison wrote a prominent article in the prestigious New England Journal of Medicine entitled “Myths, Presumptions and Facts about Obesity”. Among his list of ‘facts’ of obesity, he writes, “Diets (i.e., reduced energy intake) very effectively reduce weight, but trying to go on a diet or recommending that someone go on a diet generally does not work well in the long-term”. Funny. How can a diet be effective, but generally not work? Isn’t that the very definition of ineffective? Also, Dr. Allison is declaring plainly that doctors should not even recommend diets. Forget about eating a whole, unrefined natural foods diet. Forget about reducing added sugars and refined starches like white bread.
Instead, his recommended treatments for obesity included meal replacement bars/ shakes, drugs and surgery. That’s certainly odd. Obesity is a dietary disease and requires a dietary cure. Instead, he favors meal replacements? These are amongst the last things that I would ever consider recommending.
Consider the ingredient list of a popular meal replacement shake “Ensure Plus”. This is the sort of ‘food’ that Dr. Allison feels is highly beneficial to you. It also happens to be a highly profitable item. The first five ingredients are: Water, Corn Maltodextrin, Sugar, Milk Protein Concentrate, Canola Oil. This nauseating blend of water, sugar and canola oil does not really meet my definition of healthy. Why would Dr. Allison strenuously recommend this garbage? Things become a little clearer when you read the financial disclosures. Dr. Allison reports receiving payment for:
Board membership from Kraft Foods; receiving consulting fees from Vivus, Ulmer and Berne, Paul, Weiss, Rifkind, Wharton, Garrison, Chandler Chicco, Arena Pharmaceuticals, Pfizer, National Cattlemen’s Association, Mead Johnson Nutrition, Frontiers Foundation, Orexigen Therapeutics, and Jason Pharmaceuticals; receiving lecture fees from Porter Novelli and the Almond Board of California; receiving payment for manuscript preparation from Vivus; receiving travel reimbursement from International Life Sciences Institute of North America; receiving other support from the United Soybean Board and the Northarvest Bean Growers Association; receiving grant support through his institution from Wrigley, Kraft Foods, Coca-Cola, Vivus, Jason Pharmaceuticals, Aetna Foundation, and McNeil Nutritionals; and receiving other funding through his institution from the Coca-Cola Foundation, Coca-Cola, PepsiCo, Red Bull, World Sugar Research Organisation, Archer Daniels Midland, Mars, Eli Lilly and Company, and Merck.
He was clearly not going to bite the hand that fed him. That he should be allowed to write in such an influential journal is criminal. But this is far from an isolated case.
Read more: http://intensivedietarymanagement.com/
Thanks to our friend Indy51 for the hat tip
Graham
Jimmy Moore - 'I Will No Longer'
Jimmy Moore has just put a great post up on his blog - well I think it's great. If you haven't yet read it, here are just two snippets from it below.
"That’s why I choose to be a light in the darkness giving people education, encouragement, and inspiration in their own personal health journey. "
"All I can be is Jimmy Moore. The moment I try to be anything other than that is the day I no longer exist. I am who I am and all that comes with that. Am I perfect? Nope and never claimed to be. But what you will always get from me is a real person with real struggles just like you who is a voracious self-educated empowered patient looking to help other people become better in their health and life. It’s who and what I am all about and I will never apologize for being that."
Thanks Jimmy and .....
All the best Jan
"That’s why I choose to be a light in the darkness giving people education, encouragement, and inspiration in their own personal health journey. "
"All I can be is Jimmy Moore. The moment I try to be anything other than that is the day I no longer exist. I am who I am and all that comes with that. Am I perfect? Nope and never claimed to be. But what you will always get from me is a real person with real struggles just like you who is a voracious self-educated empowered patient looking to help other people become better in their health and life. It’s who and what I am all about and I will never apologize for being that."
Link to Jimmy's article here
Thanks Jimmy and .....
All the best Jan
Paleo Easter Eggs - Low Carb and Gluten Free
Paleo Easter Eggs
" I have to say these are the easiest little things to make, and only takes 20 minutes until they are ready to eat. Paleo Easter Eggs are a tasty little treat with no added sugar, egg free, dairy free, grain free, nut free, gluten free little bundles of joy.
Easter eggs these days seem to go on sale almost as soon as the Christmas decorations get packed away, and I for one was guilty of buying them way too soon, then buying more, and more. This year the Easter Bunny will still call here, but will be bringing the best quality chocolate it could find and just on Easter Sunday, not for the months and months they have been selling in the stores.
Paleo Easter Eggs:
Ingredients:
75g/ 2.6 oz shredded coconut unsweetened
70g/ 2.5 oz coconut oil melted
3 tbs coconut cream
1 tbs granulated stevia, or sweetener of choice, to taste
½ tsp vanilla
Chocolate Coating:
60g/ 2.1 oz coconut oil melted
6 tsp cocoa powder
2 tsp granulated stevia, or sweetener of choice, to taste
Method - Instructions:
Mix all the ingredients together in a small bowl.
Refrigerate until solid enough to roll into egg shapes.
Roll small amounts into egg shapes and place in the fridge again to set completely.
Chocolate Coating:
Mix all the ingredients together in a small bowl.
Place 1 Paleo Easter Egg in the chocolate coating at a time. Using a spoon, turn the egg until completely covered.
Place the chocolate coated eggs on a plate.
Refrigerate until chocolate coating is set
NUTRITION INFORMATION
Serving size: 1 Paleo easter Egg Calories: 128 Fat: 13.4g Carbohydrates: 1.1g Sugar: 0.5g Fibre: 0.6g Protein: 0.9g "
Original recipe idea here
Can you believe Easter is so near now.
All the best Jan
Saturday, 28 March 2015
Itzhak Perlman Sarasate Zigeunerweisen
Another disabled musician, and out on the stratosphere of mega musicians. Does it get any better? That's my lot, have a great weekend. Eddie
Michel Petrucciani - Satin Doll
Please check this guy out. Born with severe physical disadvantages, but a musical giant. Eddie
Susan Boyle - You'll See
A few years ago Susan Boyle appeared on a UK talent show. A very plain looking Woman, a million miles away from a music recording artist. How wrong everyone was, a person truly gifted. Susan said her ambition was to sing like Elaine Page. Never ever judge a book by it's cover. Eddie
Michael Buble - Come Fly With Me - Saturday Night Is Music Night
Saturday Night Again ..... and I hope you are having a pleasant evening. Perhaps you've spent the day shopping or house cleaning, you may have enjoyed time with family, or even had a nice walk. If you are in the UK please do not forget to alter your clocks tonight - they Spring forward !
Anyway it's a well known fact, as all regular blog readers will know, that Ilike love Michael Buble - so without further ado ....... here he is. Come Fly With Me. All the best Jan
Anyway it's a well known fact, as all regular blog readers will know, that I
Monsanto lobbyist was offered a glass of Roundup weedkiller during an interview on Canal+ after claiming it was perfectly safe to drink !
Patrick Moore (no not that one) works on behalf of the company Monsanto and their weedkiller product Roundup.
He was being interviewed by the French language station in reference to the accusation made by the World Health Organisation (WHO) last week that the product was "probably carcinogenic to humans". Specifically this was in connection to reports that the product is causing cancer rates to increase in Argentina.
The active ingredient in question is glyphosate which is linked by the WHO to Parkinson’s disease, infertility and other health problems.
Monsanto, on the other hand, claim that is safe.
Going further than just denying the danger, lobbyist Dr Patrick Moore said: "You can drink a whole quart of it and it won’t hurt you."
His interviewer responded: "You want to drink some? We have some here."
The back and forth then continued:
Moore: "I'd be happy to actually. Not really, but..."
Interviewer: "Not really?"
Moore: "I know it wouldn't hurt me."
Interviewer: "If you say so, I have some glyphosate.."
Moore: "No, no I'm not stupid."
Interviewer: "Okay, so, you... so it's dangerous right?"
Moore: "No. People try to commit suicide with it and fail fairly regularly."
Interviewer: "Tell the truth. It's dangerous."
Moore: "It's not dangerous to humans. No. It's not."
Interviewer: "So are you ready to drink one glass of glyphosate?"
Moore: "No, I'm not an idiot."
Dr Moore then left, telling the interviewer he was a "complete jerk".
It's quite a splendid example of someone making a claim and being completely called out on it.
Link to story here. Eddie
Easter Gift For That Special Low Carber In Your Life !
However, if you should be looking for a special Easter Egg for the low carber in your life then this may be the answer. It is made from 75% Tanzania origin chocolate, so could well be suitable.
The one draw back is the price £33,000 !
But read on and find out why.
"Are you racking your brains for what you can buy for the Oligarch in your life this Easter? Or for that matter what's acceptable to give a footballer's wife, a lottery-winner, or anyone else who can afford more than two bedrooms in central London? Swanky website VeryFirstTo.com could have the answer to your Easter gift dilemma: a £33,000 chocolate bunny.
For your money you get slightly more than your typical £3 supermarket chocolate novelty. The bunny has been hand-carved by award-winning chocolatier Martin Chiffers.
It's made from 75% Tanzania origin chocolate and is 38 cm high. It weighs around 5 kg, and if you want to eat the lot yourself, you'll be consuming 548,000 calories. At the feet of the bunny are three solid chocolate eggs decorated with gold leaf.
The mega-rich recipient can decide whether to wolf the lot before breakfast, or to keep it as an ornament - as the makers estimate it will last at least two years - as long as it doesn't get hotter than about 16 degrees.
The chocolate is fairly spectacular, but the real attraction is the eyes of the chocolate novelty, which are made from two 1.70 carat diamonds - with a combined value of over £25,000.
When you finally demolish the rabbit, the company that provided the diamonds, 77 Diamonds, will create a bespoke piece of jewellery featuring them - free of charge.
Of course you might consider this a little self-indulgent, but you can salve your conscience with the fact that when the rabbit is sold, the website will make a £1,000 donation to The Prince's Trust.
How does it compare?
The price means it easily eclipses the cost of the most expensive non-jewelled egg in the world. That sold at auction in March 2012 for £7,000.
However, for sheer size, it falls short of the largest chocolate bunny ever made. That title goes to a 12-foot rabbit made by Duracell South Africa in 2010. It took four people three days to sculpt it, and the finished article weighed an impressive 3,010 kg.
And if you want to really impress your Oligarch this Easter, then nothing will be quite as good as their own FabergĆ© egg. The older ones hardly ever come to auction, but in 2007 the one made for the Rothschild family sold for £8.9 million.
If that's a bit rich for your blood, each year FabergƩ runs a Big Egg Hunt. It gets artists to design new eggs, and auctions them off for charity. The record for the most expensive one sold in recent years was broken by Jeff Koons last year, when the egg he designed sold for $900,000.
Original Story here
All the best Jan
Friday, 27 March 2015
Anyone For Breakfast - Baked Eggs and Ham
Looking for a quick and easy to follow recipe for a delicious breakfast, how about little ramekins of eggs baked with ham and cheese which will go down well with the whole family. They look really sophisticated but only take five minutes to prepare and 20 minutes in the oven.
Baked eggs:
Ingredients - Serves 4
4-6 slices good quality honey roast ham, cut into 5cm wide strips
8 eggs
100g cheddar cheese, grated
Cherry tomatoes, to garnish flat-leaf parsley, chopped to garnish
Method
1. Pre-heat the oven to 200C/180C fan/gas 6. Spray two ramekins with cooking oil and then line with strips of ham.
2. Carefully crack two eggs into each lined ramekin.
If you wanted to have them for lunch you could add an extra flavour dimension with a layer of chopped tomatoes and basil or spinach under the egg.
3. Scatter with cheese, season and then pop onto a baking sheet and cook in the oven for 15-20 minutes until the eggs are set. Give them a shake to see if they're done, if in doubt pull the cheese to one side with a knife to have a look underneath.
4. Garnish with cherry tomatoes, chopped flat-leaf parsley and serve.
Original Recipe Idea Here
All the best Jan
Interview With Jeremy Clarkson's Waiter on the night of the punch up.
This is a total scream very funny contains some swearing. Eddie
English raspberries on sale in March for first time ever !
Waitrose will stock the Chichester glasshouse-grown Diamond Jubilee berries from 26 March, claiming it is the first time consumers have been able to enjoy locally grown varieties in March.
The berries are grown in glasshouses by Harry Hall, who supplied the supermarket with the first strawberries of the season earlier this month.
Laurence Olins, chairman of industry body British Summer Fruits, said the berries were the result of a trial plot of the "very sweet" Diamond Jubilee berries planted by Mr Hall.
Just 200kg of the berries are expected this week, but there should be around a tonne produced every week afterwards.
Mr Olins said: "This is probably the earliest we've seen English raspberries."
The early delivery follows British-grown strawberries becoming available weeks earlier than previous years.
This is thanks to the weather this winter, which the Met Office has said was the sunniest since records began in 1929.
The figures for rainfall and temperature were average, but the number of sunny days was 125% of the long-term average.
Waitrose's raspberry buyer Nicki Baggott said: "This is the first time we've been able to offer British-grown raspberries so early in the year.
"It's incredibly unusual to have these ready in March, but a combination of growing techniques and the perfect weather have meant we can sell these juicy delights earlier than ever."
Raspberries were once regarded as a late summer crop, but British Summer Fruits said growers are using new varieties and innovative methods to extend the season.
Original article here
All the best Jan
Thursday, 26 March 2015
The War on Wheat - the fifth estate
It's a multi-billion dollar battle for your belly. Millions of people are joining the anti-wheat revolution.
Kellogg's, the world's largest cereal maker, has seen its biggest drop in sales since the 1970s. Food companies are selling off their struggling bread divisions. It's all because best-selling health evangelists say that wheat is causing everything from fat bellies to schizophrenia. But do they have science on their side? Mark Kelley takes a hard look at what's driving a movement that is dramatically changing the way we eat. http://www.cbc.ca/fifth/
Graham
Kellogg's, the world's largest cereal maker, has seen its biggest drop in sales since the 1970s. Food companies are selling off their struggling bread divisions. It's all because best-selling health evangelists say that wheat is causing everything from fat bellies to schizophrenia. But do they have science on their side? Mark Kelley takes a hard look at what's driving a movement that is dramatically changing the way we eat. http://www.cbc.ca/fifth/
Graham
Broccoli and Salmon Parcels with Spicy Moroccan Butter Sauce
"A sensational North African meal. Easier to make than you’d think but just as good to eat as you’d think. This is the simplest form of steaming and a good way to cook vegetables and fish keeping in all the flavour and nutrients. When you make a parcel, the white wine turns to steam and cooks the Tenderstem® broccoli and salmon to perfection in a delicious scented vapour.
Ingredients:
Serves Four
325g Tenderstem® Broccoli blanched, refreshed and drained
4 x 125g, boneless, skinless salmon fillets
1 shallot, finely chopped
Black pepper
1 orange, juice only
4 slices Parma ham
285ml white wine
1tbsp white wine vinegar
1-2tsp harissa paste
90ml double cream
55g unsalted butter, chilled and diced
4 x 36cm squares of baking paper or foil
Method:
4 x 125g, boneless, skinless salmon fillets
1 shallot, finely chopped
Black pepper
1 orange, juice only
4 slices Parma ham
285ml white wine
1tbsp white wine vinegar
1-2tsp harissa paste
90ml double cream
55g unsalted butter, chilled and diced
4 x 36cm squares of baking paper or foil
Method:
1. Pre heat the oven to 200C/400F/Gas mark 6/190C fan oven.
2. Divide the Tenderstem® Broccoli stems and place on one half of the paper/foil squares. Season with freshly ground black pepper and scatter over the shallots.
3. Squeeze a little orange juice over the salmon fillets and season well. Wrap each salmon fillet in a slice of Parma ham and place on top of the Tenderstem®. broccoli. Drizzle each with a tablespoon of white wine.
4. Fold the other half of the paper/foil over the fish and twist the edges together to form a seal.
5. Transfer to a baking tray and place in the oven for 12-14 minutes until the fish and Tenderstem® broccoli are just cooked through.
6. Meanwhile make the chilli butter sauce. In a small pan pour in the remaining white wine, vinegar and bring to the boil, simmer until the liquid has reduced by half. Add the harissa paste and cream and reduce a little further.
7. Turn down the heat and gently whisk in the chilled butter. Season with salt, pepper and a squeeze of orange juice.
8. Place each pack on its own serving plate, take to the table to open and eat! Serve with a good drizzle of spicy butter sauce. "
Original recipe idea here
Hope you enjoy it.
All the best Jan
Formula 1 Is it on the way out ?
After one race the outcome is already over. Short of WW3 Mercedes have already won the constructors championship and Lewis will be world champion, probably. Red Bull aren't going to get a look in, and are moaning like a bunch of whimps ha ha. Ferrari or Williams have an outside chance of picking up a race win or two, if they get lucky.
The cars sound like a knackered lawn mower, and checking race track lap records, records were set on some of the fastest tracks around ten years ago. In short, F1 has not been a sport for years, if the next races are like the Australian GP reading Duggie the divers blog will be more interesting.
Just for a larf check out the ticket prices for this years British GP at the link below, no wonder that geriatric dwarf Ecclestone is a billionaire. I asked Bernie for a comment before posting this, he replied swiftly. What larks as Dillinger would say. Eddie
The cars sound like a knackered lawn mower, and checking race track lap records, records were set on some of the fastest tracks around ten years ago. In short, F1 has not been a sport for years, if the next races are like the Australian GP reading Duggie the divers blog will be more interesting.
Just for a larf check out the ticket prices for this years British GP at the link below, no wonder that geriatric dwarf Ecclestone is a billionaire. I asked Bernie for a comment before posting this, he replied swiftly. What larks as Dillinger would say. Eddie
Link to the rip off here.
Well Can You Do It Properly - Most Brits Don't !
Well Can You Do It Properly ... make a cup of tea that is! According to this article, a new study has shown that "Most Brits Don't Know How To Make A Decent Cup Of Tea ..........
We Brits may be known for our love of tea, but according to a new study, the majority of us don't know how to make a decent cuppa.
Researchers from University College London (UCL) studied the tea-drinking habits of 1,000 Brits as part of British Science Week.
They found that while three quarters of the nation drink at least one cup of tea each day, 80% of us don't let our tea brew for long enough to achieve the optimum taste.
According to the researchers, tea should be brewed for between two and five minutes to release its full flavour.
But 37% of tea-drinkers brew their tea for significantly less time at one to two minutes on average.
"This may be controversial, but the British do not understand how to make tea! Or at least they're not doing it properly. And it's because they don't understand the variables," Mark Miodownik, Professor of Materials and Society at University College London and spokesperson for British Science Week, said in the study.
"Expediency is causing us to throw chemistry out of the window - we're not allowing our tea to brew for long enough, to release the flavours properly."
On the topic of which goes first, milk or tea, the study found that the majority of people believe if you are making tea in a mug you should add the milk after the boiling water.
Over two thirds (69%) of tea-drinkers add milk after the boiling water, with those aged 65 or over being more likely to add milk before.
The UCL study follows a guide on how to make 'The Perfect Cup of tea' which was released by the British Standard's Institution last month.
Although the guide has only just been brought to public attention it was developed in 1980 to help professional tea testers.
The guide states that tea should be left to infuse in a tea pot for six minutes, supporting the UCL finding that the majority of us are missing out on the perfect cuppa due to impatience."
Well readers will know I do like my cup of tea, especially with my LCHF breakfast, so do I need to 'fine-tune' my tea making skills. I'll just go and make one and see .....
All the best Jan
Wednesday, 25 March 2015
Study finds why drug for type II diabetes makes people fat
ATLANTA--Medication used to treat patients with type II diabetes activates sensors on brain cells that increase hunger, causing people taking this drug to gain more body fat, according to researchers at Georgia State University, Oregon Health and Science University, Georgia Regents University and Charlie Norwood Veterans Administration Medical Center.
The study, published on March 18 in The Journal of Neuroscience, describes a new way to affect hunger in the brain and helps to explain why people taking a class of drugs for type II diabetes gain more body fat.
Type II diabetes, the most common form of diabetes, affects 95 percent of diabetes sufferers. People with type I or type II diabetes have too much glucose, or sugar, in their blood. Type II diabetes develops most often in middle-aged and older adults and people who are overweight and inactive, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
The research team found that sensors in the brain that detect free circulating energy and help use sugars are located on brain cells that control eating behavior. This is important because many people with type II diabetes are taking antidiabetics, known as thiazolidinediones (TZDs), which specifically activate these sensors, said Johnny Garretson, study author and doctoral student in the Neuroscience Institute and Center for Obesity Reversal at Georgia State.
The study found peroxisome proliferator-activated receptor &Upsih; (PPAR&Upsih;) sensors on hunger-stimulating cells, known as agouti-related protein (AgRP) cells, at the base of the brain in the hypothalamus. Activating these PPAR&Upsih; sensors triggers food hoarding, food intake and the production of more AgRP. When AgRP cells are activated, animals become immediately hungry. These cells are so potent they will wake a rodent up from slumber to go eat, Garretson said.
TZDs help to treat insulin resistance, in which the body doesn't use insulin the way that it should. They help the body's insulin work properly, making blood glucose levels stay on target and allowing cells to get the energy they need, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
"People taking these TZDs are hungrier, and they do gain more weight. This may be a reason why," Garretson said. "When they're taking these drugs, it's activating these receptors, which we believe are controlling feeding through this mechanism that we found. We discovered that activating these receptors makes our rodent animal model eat more and store more food for later, while blocking these receptors makes them eat less and store less food for later, even after they've been food deprived and they're at their hungriest."
Graham
Four Steps To Successfully Cut Down Sugar In Your Diet
With all the talk, both in the press, and on our TV Screens .. in fact all over the place .. we are hearing more and more how sugar is having a detrimental affect on our health. The article I've linked to below talks about the average American adult, but I really think you could add the UK, Australia, France .. in fact almost any country plus include children too. We are eating too much sugar.
If you are trying to cut down on your sugar intake you may find the tips in the article helpful.
"The average American adult consumes the equivalent of about 32 teaspoons of sugar per day. Sugar is really the number one food additive: it is added to drinks, often in the form of high-fructose corn syrup, to bread, sauces, dressings, and to all kinds of processed foods including many low-fat products.
Cutting down sugar in your diet may be one of the best actions you can take to improve your health and your weight. And you don't need to have tremendous amounts of willpower or to go cold turkey (unless you want to do this, of course).
Here are four steps to help you cut down sugar in your diet. You'll want to follow the steps in order, except for step four which can be taken whenever you want.
1. Give yourself 30 days (or more)
There is mounting evidence that sugar can be addictive. But if you have strong cravings and you feel you're addicted to sugar, don't get discouraged.
Many people will try to convince you that breaking an addiction is very hard because of hormones and neurotransmitters in your brain, but this attitude can actually be quite disempowering. In fact, breaking an addiction is perfectly doable with the right approach. I have personally helped quite a few women do it with great success.
Your best bet is to use a gentle, step-by-step process that gives your body and your taste buds time to adapt. The mistake many people make when they decide to get off sugar is they want to be perfect from day one, so they go cold turkey and cut out sugar completely from the beginning.
While this may work for people with a very strong addiction, in my real-world practice with women who have a rather mild sugar addiction, I've seen that a compassionate, gentle approach works far better.
Start by believing that you can do it and make a commitment to give it all you've got over a period of time that feels realistic to you.
2. Identify your #1 source of sugar and start there
Think about everything you eat and drink and identify your main source of sugar. Usual suspects are sodas or other sweetened beverages, sugar you add yourself, and processed baked foods.
It may be you're drinking a lot of commercial fruit juices, carbonated sodas, or hot sweetened beverages. Or it may be you're adding four teaspoons of sugar to your tea or coffee and you eat sugary snacks, sweetened yogurt or dessert at every meal. Or it may be you're eating processed bread, cakes and cookies several times a day.
Once you know what to cut down, make a plan. If you've been adding three teaspoons of sugar to your tea or coffee, gradually reduce to two within a week, then one within the next two weeks.
If you are currently drinking at least two large bottles of soda a week, start by cutting down to one and a half bottle, then one bottle the next week, then half a bottle, and see if you are comfortable with cutting out soda entirely.
The key is to be excited about cutting down your consumption and not experiencing it as frustration and deprivation or making a point of reaching an imaginary level of perfection.
Once you've cut down your main source of sugar, you may already enjoy some improvement in your weight and your energy levels.
3. Eat more real food
Sure, the list of processed foods is a never-ending one. And sugar often hides in cakes, cookies, candy bars, ice cream, popcorn, pretzels, granola or fruit bars, energy bars, dressings, sauces, and condiments.
"Low-fat" or "no-fat" foods are often marketed as healthy but most of the time they have also been processed and fat has been replaced by hidden sugars or artificial sweeteners.
If you eat a lot of junk food and processed foods, start by replacing them with real food, one step at a time. If you cook and prepare your food yourself, you'll dramatically cut your sugar intake over time. Do this over thirty days or more, following the same gentle approach as mentioned earlier.
Once you've cut down processed foods, you may realize that your sugar cravings are gone and that you've even managed to kiss your sugar addiction goodbye.
4. Sleep your cravings away
Whenever someone tells me she needs to eat six times a day and she has strong sugar cravings, the first question I ask her is how many hours she sleeps at night. Many times, the answer is less than five or six hours.
So what would sleep have to do with cutting down sugar? Well, it will help by reducing your cravings for sugar as well as processed foods that contain sugar.
Different studies have found that sleep deprivation of two hours or more of the recommended seven to nine hours of sleep leads to overeating and junk food cravings.
Sleep deprivation also leads to sweet foods being more appealing to adolescents, with a consumption of sweet/dessert servings up to 52% higher, and to an increased intake of food in men as well as cravings for calorie-dense foods in adults.
This is why a proper amount of sleep can be a great way to curb cravings, which will also help you cut down sugar in your diet over time."
Article taken from here. For me the key point is number three 'eat more real food' what do you think?
All the best Jan
Jeremy Clarkson to be sacked by the BBC !
Jeremy Clarkson is to be sacked as Top Gear presenter after a BBC investigation concluded he did attack a producer on the programme.
Lord Hall, the Director General of the BBC, is expected to announce his decision on Wednesday after considering the findings of an internal investigation.
Clarkson, 54, will be thanked for his work on the hugely popular motoring show, but will be told such behaviour cannot be tolerated at the Corporation. More here.
An unnamed BBC insider said last night, we are looking for a replacement for Ckarkson. In order to maintain our stance on political correctness and minority promotion, we are looking to recruit a one legged Mongolian lesbian with a speech impediment and a glass eye.
Eddie
Tuesday, 24 March 2015
The Evidence for Low-Fat Diets Isn't Really There
Last week I talked to you about dietary cholesterol, and how the existing randomized controlled trials warned us that they wouldn’t work. Now, it appears those guidelines might be changed, decades later. Cholesterol isn’t the only recommendation that is controversial. So are the ones on fat. Prepare to get annoyed.
For those of you who want to read more, go here: http://theincidentaleconomist.com/
Graham
For those of you who want to read more, go here: http://theincidentaleconomist.com/
Graham
Jimmy Moore's Livin' La Vida Low-Carb with special guest Dietitian Franziska Spritzler
“If you follow a healthy diet and you take care of yourself, that beauty from within will come out. You can be beautiful at any age.” — Franziska Spritzler
We do not usually promote any product or service but Franziska is a friend of ours and so is Jimmy. We have met Franziska and she is just as she is on her new book cover, and is a truly charming and very knowledgeable lady. Check out her latest podcast with Jimmy Moore here.
Eddie
Cheryl Fernandez-Versini hits out at 'sexualisation' of women in the music industry !
Too right, and many Women have not hawked their arse to get to the top in the music business, they got to the top because they had real talent, and worked very hard, get my drift. Maybe someone could tell Cheryl, the less the talent, the more the arse hawking required.
Link to the bullshit here.
Eddie
Link to the bullshit here.
Eddie
Kiwi Fruit and Blackberry Clotted Cream Cake - Which Is Low In Carbs
Ingredients:
100 grams of ground almonds
1 teaspoon baking powder
2 large eggs
1 tablespoon of melted butter
2 tablespoons of double cream
One Kiwi fruit
100 grams of blackberries
125 grams of clotted cream
Method:
Mix all dry ingredients in a bowl.
Melt the butter in a Pyrex jug/dish, add the eggs, cream.
Add the dry ingredients and mix.
Pour mix into a 6" x 3" micro-wave safe glass dish.
Microwave in a 700watt for 4 minutes.
Allow to cool and cut in half.
Spread on extra thick clotted cream add the sliced kiwi fruit.
Place top on cake and cover with clotted cream and add the blackberries.
Tastes fantastic serves six.
Why not check out our lowcarb recipe blog here
All the best Jan
Monday, 23 March 2015
Rosuvastatin: winner in the statin wars, patients’ health notwithstanding
More is spent in the US on rosuvastatin than any other statin. Yet the evidence of its health benefits has always been weak and there is growing evidence of harmful side effects. Sidney Wolfe explains why he thinks the drug should have been withdrawn and why it should not be used
Last year, rosuvastatin (Crestor) was the most prescribed brand name drug in the US, with 22.3 million prescriptions filled and $5.8bn (£3.9bn; €5.5bn) in sales.1 Worldwide 2013 sales were $8.2bn, the third highest for any branded drug.2 Given the longstanding, continuing evidence of rosuvastatin’s comparative lack of clinical benefits and increasing evidence of risks, how did this happen? The short answer is that of statins still on the market, the milligram for milligram cholesterol lowering potency of rosuvastatin exceeds all others, a fact exploited in advertising campaigns. But what about actually improving health, preventing heart attacks and strokes?
Less evidence of clinical benefit since approval
When rosuvastatin was approved in the US in 2003 for lowering cholesterol, three other statins—simvastatin, pravastatin, and lovastatin—had already obtained additional Food and Drug Administration approval for use to reduce cardiovascular risk, and a fourth, atorvastatin, was found to have such clinical benefit in 2004.3
But rosuvastatin did not gain approval for cardiovascular risk until 2010, and then only for primary prevention of heart attacks and strokes. Approval was based on the results of the JUPITER study, which included only patients with both low density lipoprotein (LDL) cholesterol <130 mg/dL (3.4 mmol/L) and C reactive protein ≥ 2 mg/L (19 nmol/L)4 and thus has limited generalizability.
Other criticisms of the study include concern that the size of the treatment benefit could have been exaggerated because the study was stopped early.5 Simulations show that trials stopped early will consistently overestimate treatment effects. This is supported by a study comparing the size of the benefits in 91 randomized controlled trials that were stopped early or truncated with those in 424 non-truncated trials, matched for the same disease research questions. The pooled results showed that trials stopped early for benefit “systematically overestimate treatment effects for the outcome that precipitated early stopping,” especially with studies stopped with fewer than 500 clinical events.6 When JUPITER was stopped early because of benefit, the accrued number of clinical events was 393.2 The relatively larger effect seen in JUPITER than other statin trials is almost certainly at least partly because it was stopped early. A reduced benefit might be outweighed by the risks of rosuvastatin.
By the time rosuvastatin was approved for primary prevention in 2010, the three most prescribed statins had been approved for both primary and secondary prevention after multiple trials, including in patients with raised LDL cholesterol, had shown benefit (atorvastatin, four trials; pravastatin, three trials; and simvastatin, two trials).3
More evidence of risks
In addition to the evidence of clinical benefits for rosuvastatin being substantially less robust than for these three statins, there is increasing evidence that the drug also carries a higher risk of serious adverse effects. Prespecified outcomes in the JUPITER study2 included not only cardiovascular endpoints but also new onset diabetes. Ironically, the reason for including this “hopeful” endpoint was that an earlier study had found that pravastatin decreased new onset diabetes.7 8 In JUPITER, however, there was a significantly higher incidence (26%) of new onset diabetes in the rosuvastatin group compared with the placebo group.
A recent review of 17 randomized trials involving 113 394 patients comparing the risk of new onset diabetes for various statins corroborated this finding.9 Treatment with rosuvastatin, compared with placebo, was associated with a 25% relative increase in the risk of developing diabetes; pravastatin was associated with the lowest risk, a 7% increase. An earlier, observational study of 240 000 patients beginning statin treatment also found that rosuvastatin was associated with the highest increased risk of diabetes and pravastatin the lowest.10
The differences in new onset diabetes are probably caused by the differing metabolic effects of rosuvastatin and pravastatin. In another randomized study of patients with raised cholesterol, rosuvastatin significantly increased glycated hemoglobin (HbA1C) and fasting insulin levels, and decreased insulin sensitivity, whereas pravastatin significantly lowered HbA1C and fasting insulin levels, and increased insulin sensitivity.11 Further evidence of differing metabolic effects among statins has been recently reviewed.12
Rosuvastatin’s FDA approved labeling now says: “In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%).”13 The labeling for other statins merely states that “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.”
Other serious problems were identified before rosuvastatin’s approval. Public Citizen opposed approval of rosuvastatin in 2003,14 and in 2004 it asked the FDA to ban the drug because of two serious adverse reactions.15The first was rhabdomyolysis. Rosuvastatin is the only statin in which rhabdomyolysis was detected in randomized controlled clinical trials before the drug was approved. Even with cerivastatin, eventually banned because of rhabdomyolysis, no cases had occurred in the clinical trials before its approval. In a recent study of 641 703 patients in the UK prescribed different statins, those taking rosuvastatin had a significantly higher risk of an abnormally raised creatine phosphokinase activity than patients on large daily doses of other statins (simvastatin, pravastatin, or atorvastatin).16
The second serious concern seen during preapproval trials was renal problems. At the time, rosuvastatin was the only statin to have been associated with proteinuria and hematuria. According to FDA documents “in the subgroup of patients with dipstick [protein and blood] positive urine, the percentage of patients with an increase of serum creatinine of 30% over baseline was 14%, 16%, 24%, 33%, and 41% for 5 mg, 10 mg, 20 mg, 40 mg and 80 mg of rosuvastatin, respectively. . . These data suggest that some patients with greater levels of proteinuria and hematuria may progress to clinically relevant renal disease.”17
Although the FDA rejected our petition to ban rosuvastatin in 2005, the agency agreed that: “In addition, urine abnormalities, specifically proteinuria and hematuria, not previously noted in the review of other statin drug applications and not known to occur with this class, were observed sporadically in a small percentage of rosuvastatin-treated patients, with the highest incidence occurring at the 80-mg dose.”18
Further concerns about rosuvastatin’s renal effects were seen in an AstraZeneca funded randomized study comparing high dose rosuvastatin with atorvastatin in diabetic patients with progressive kidney disease.19 Although rosuvastatin lowered plasma lipid concentrations to a greater extent than atorvastatin, the study reported that “atorvastatin seems to have more renoprotective effects.” Urinary protein excretion was reduced during one year of treatment with atorvastatin 80 mg, with no significant changes in estimated glomerular filtration rate (eGFR). In patients given rosuvastatin 40 mg, however, “urinary protein excretion was not significantly different from baseline, but the patients did have a significant decrease from baseline in eGFR, and doubling of serum creatinine and acute renal failure were more common in this group.”19
Why the drug remains popular
Given the evidence of more serious risks and less clinical benefit than other statins how has the drug fared so well for so long?
A prescient answer can be found in an October 2003 Lancet editorial, “The statin wars: why AstraZeneca must retreat.”20 It stated that AstraZeneca’s chief executive, Tom McKillop, “has pledged to do whatever it takes to persuade doctors to prescribe rosuvastatin, including launching an estimated $1 billion first-year promotional campaign. ‘We’ve got to drive the momentum’, he [McKillop] said at a recent investors meeting. ‘You get one shot at launching a major new product. This is our shot.’” The editorial concluded, “Physicians must tell their patients the truth about rosuvastatin—that compared with its competitors, rosuvastatin has an inferior [clinical] evidence base supporting its safe use. AstraZeneca has pushed its marketing machine too hard and too fast. It is time for McKillop to desist from this unprincipled campaign.”
McKillop promptly responded, accusing the journal of not telling the truth, then stating “Crestor is an extensively studied and well tolerated drug with a safety profile comparable to other marketed statins combined with a greater ability to get patients to their cholesterol goals than any other single product.” Referring to the unmet need for adequate treatment with lipid lowering treatment, McKillop stated that “With this compelling medical need, it is unthinkable that we should desist from our efforts to make this medicine more widely available to physicians and patients.”21
Barely more than a year later, in December 2004 the US FDA had to send a letter to AstraZeneca demanding that it immediately stop an advertisement in the Washington Post containing false and misleading information about Crestor’s risks. The advert stated that “The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis,” citing the FDA website, which actually contained no such information.22
The advert was in response to a Washington Post article about Public Citizen’s campaign against the drug, discussing the safety concerns shared by us and the FDA.23 In the article Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, stated that the FDA “has been very concerned about Crestor since the day it was approved, and we’ve been watching it very carefully.” He further stated the agency is “concerned about the same issues with Crestor as Public Citizen.”
The FDA’s letter to AstraZeneca said, “The ‘patient safety’ print ad makes false or misleading safety claims that minimize the risks associated with Crestor, thereby suggesting that Crestor is safer than has been demonstrated by substantial evidence or substantial clinical experience.” The agency wrote to the company again the following year about “misleading superiority claims” for Crestor in other promotional materials.24
When patents expired for simvastatin, pravastatin, and atorvastatin, the rise in generic prescriptions quickly equaled or exceeded the sharp decreases in brand name prescriptions (IMS Health data). The patent for rosuvastatin expires in 2016, and with it AstraZeneca’s need to promote it. But for the sake of the public’s health, we must hope that the drug’s disadvantages will lead to a sharp decline in its use before next year.
Last year, rosuvastatin (Crestor) was the most prescribed brand name drug in the US, with 22.3 million prescriptions filled and $5.8bn (£3.9bn; €5.5bn) in sales.1 Worldwide 2013 sales were $8.2bn, the third highest for any branded drug.2 Given the longstanding, continuing evidence of rosuvastatin’s comparative lack of clinical benefits and increasing evidence of risks, how did this happen? The short answer is that of statins still on the market, the milligram for milligram cholesterol lowering potency of rosuvastatin exceeds all others, a fact exploited in advertising campaigns. But what about actually improving health, preventing heart attacks and strokes?
Less evidence of clinical benefit since approval
When rosuvastatin was approved in the US in 2003 for lowering cholesterol, three other statins—simvastatin, pravastatin, and lovastatin—had already obtained additional Food and Drug Administration approval for use to reduce cardiovascular risk, and a fourth, atorvastatin, was found to have such clinical benefit in 2004.3
But rosuvastatin did not gain approval for cardiovascular risk until 2010, and then only for primary prevention of heart attacks and strokes. Approval was based on the results of the JUPITER study, which included only patients with both low density lipoprotein (LDL) cholesterol <130 mg/dL (3.4 mmol/L) and C reactive protein ≥ 2 mg/L (19 nmol/L)4 and thus has limited generalizability.
Other criticisms of the study include concern that the size of the treatment benefit could have been exaggerated because the study was stopped early.5 Simulations show that trials stopped early will consistently overestimate treatment effects. This is supported by a study comparing the size of the benefits in 91 randomized controlled trials that were stopped early or truncated with those in 424 non-truncated trials, matched for the same disease research questions. The pooled results showed that trials stopped early for benefit “systematically overestimate treatment effects for the outcome that precipitated early stopping,” especially with studies stopped with fewer than 500 clinical events.6 When JUPITER was stopped early because of benefit, the accrued number of clinical events was 393.2 The relatively larger effect seen in JUPITER than other statin trials is almost certainly at least partly because it was stopped early. A reduced benefit might be outweighed by the risks of rosuvastatin.
By the time rosuvastatin was approved for primary prevention in 2010, the three most prescribed statins had been approved for both primary and secondary prevention after multiple trials, including in patients with raised LDL cholesterol, had shown benefit (atorvastatin, four trials; pravastatin, three trials; and simvastatin, two trials).3
More evidence of risks
In addition to the evidence of clinical benefits for rosuvastatin being substantially less robust than for these three statins, there is increasing evidence that the drug also carries a higher risk of serious adverse effects. Prespecified outcomes in the JUPITER study2 included not only cardiovascular endpoints but also new onset diabetes. Ironically, the reason for including this “hopeful” endpoint was that an earlier study had found that pravastatin decreased new onset diabetes.7 8 In JUPITER, however, there was a significantly higher incidence (26%) of new onset diabetes in the rosuvastatin group compared with the placebo group.
A recent review of 17 randomized trials involving 113 394 patients comparing the risk of new onset diabetes for various statins corroborated this finding.9 Treatment with rosuvastatin, compared with placebo, was associated with a 25% relative increase in the risk of developing diabetes; pravastatin was associated with the lowest risk, a 7% increase. An earlier, observational study of 240 000 patients beginning statin treatment also found that rosuvastatin was associated with the highest increased risk of diabetes and pravastatin the lowest.10
The differences in new onset diabetes are probably caused by the differing metabolic effects of rosuvastatin and pravastatin. In another randomized study of patients with raised cholesterol, rosuvastatin significantly increased glycated hemoglobin (HbA1C) and fasting insulin levels, and decreased insulin sensitivity, whereas pravastatin significantly lowered HbA1C and fasting insulin levels, and increased insulin sensitivity.11 Further evidence of differing metabolic effects among statins has been recently reviewed.12
Rosuvastatin’s FDA approved labeling now says: “In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%).”13 The labeling for other statins merely states that “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.”
Other serious problems were identified before rosuvastatin’s approval. Public Citizen opposed approval of rosuvastatin in 2003,14 and in 2004 it asked the FDA to ban the drug because of two serious adverse reactions.15The first was rhabdomyolysis. Rosuvastatin is the only statin in which rhabdomyolysis was detected in randomized controlled clinical trials before the drug was approved. Even with cerivastatin, eventually banned because of rhabdomyolysis, no cases had occurred in the clinical trials before its approval. In a recent study of 641 703 patients in the UK prescribed different statins, those taking rosuvastatin had a significantly higher risk of an abnormally raised creatine phosphokinase activity than patients on large daily doses of other statins (simvastatin, pravastatin, or atorvastatin).16
The second serious concern seen during preapproval trials was renal problems. At the time, rosuvastatin was the only statin to have been associated with proteinuria and hematuria. According to FDA documents “in the subgroup of patients with dipstick [protein and blood] positive urine, the percentage of patients with an increase of serum creatinine of 30% over baseline was 14%, 16%, 24%, 33%, and 41% for 5 mg, 10 mg, 20 mg, 40 mg and 80 mg of rosuvastatin, respectively. . . These data suggest that some patients with greater levels of proteinuria and hematuria may progress to clinically relevant renal disease.”17
Although the FDA rejected our petition to ban rosuvastatin in 2005, the agency agreed that: “In addition, urine abnormalities, specifically proteinuria and hematuria, not previously noted in the review of other statin drug applications and not known to occur with this class, were observed sporadically in a small percentage of rosuvastatin-treated patients, with the highest incidence occurring at the 80-mg dose.”18
Further concerns about rosuvastatin’s renal effects were seen in an AstraZeneca funded randomized study comparing high dose rosuvastatin with atorvastatin in diabetic patients with progressive kidney disease.19 Although rosuvastatin lowered plasma lipid concentrations to a greater extent than atorvastatin, the study reported that “atorvastatin seems to have more renoprotective effects.” Urinary protein excretion was reduced during one year of treatment with atorvastatin 80 mg, with no significant changes in estimated glomerular filtration rate (eGFR). In patients given rosuvastatin 40 mg, however, “urinary protein excretion was not significantly different from baseline, but the patients did have a significant decrease from baseline in eGFR, and doubling of serum creatinine and acute renal failure were more common in this group.”19
Why the drug remains popular
Given the evidence of more serious risks and less clinical benefit than other statins how has the drug fared so well for so long?
A prescient answer can be found in an October 2003 Lancet editorial, “The statin wars: why AstraZeneca must retreat.”20 It stated that AstraZeneca’s chief executive, Tom McKillop, “has pledged to do whatever it takes to persuade doctors to prescribe rosuvastatin, including launching an estimated $1 billion first-year promotional campaign. ‘We’ve got to drive the momentum’, he [McKillop] said at a recent investors meeting. ‘You get one shot at launching a major new product. This is our shot.’” The editorial concluded, “Physicians must tell their patients the truth about rosuvastatin—that compared with its competitors, rosuvastatin has an inferior [clinical] evidence base supporting its safe use. AstraZeneca has pushed its marketing machine too hard and too fast. It is time for McKillop to desist from this unprincipled campaign.”
McKillop promptly responded, accusing the journal of not telling the truth, then stating “Crestor is an extensively studied and well tolerated drug with a safety profile comparable to other marketed statins combined with a greater ability to get patients to their cholesterol goals than any other single product.” Referring to the unmet need for adequate treatment with lipid lowering treatment, McKillop stated that “With this compelling medical need, it is unthinkable that we should desist from our efforts to make this medicine more widely available to physicians and patients.”21
Barely more than a year later, in December 2004 the US FDA had to send a letter to AstraZeneca demanding that it immediately stop an advertisement in the Washington Post containing false and misleading information about Crestor’s risks. The advert stated that “The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis,” citing the FDA website, which actually contained no such information.22
The advert was in response to a Washington Post article about Public Citizen’s campaign against the drug, discussing the safety concerns shared by us and the FDA.23 In the article Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, stated that the FDA “has been very concerned about Crestor since the day it was approved, and we’ve been watching it very carefully.” He further stated the agency is “concerned about the same issues with Crestor as Public Citizen.”
The FDA’s letter to AstraZeneca said, “The ‘patient safety’ print ad makes false or misleading safety claims that minimize the risks associated with Crestor, thereby suggesting that Crestor is safer than has been demonstrated by substantial evidence or substantial clinical experience.” The agency wrote to the company again the following year about “misleading superiority claims” for Crestor in other promotional materials.24
When patents expired for simvastatin, pravastatin, and atorvastatin, the rise in generic prescriptions quickly equaled or exceeded the sharp decreases in brand name prescriptions (IMS Health data). The patent for rosuvastatin expires in 2016, and with it AstraZeneca’s need to promote it. But for the sake of the public’s health, we must hope that the drug’s disadvantages will lead to a sharp decline in its use before next year.
Graham
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