An influential group of cancer experts has warned that the high
prices charged by pharmaceutical companies for cancer drugs are
effectively condemning patients to death.The group of more than 100 leading cancer physicians from around the
world, including nine from the UK, accuse the drug industry of
“profiteering” – making a profit by unethical methods such as by raising
the cost of grain after a natural disaster. Of the 12 drugs
approved by the Food and Drug Administration in the US in 2012, 11 were
priced above $100,000 (£65,000) per patient per year. In addition the
price of existing drugs of proven effectiveness has been increased by up
to threefold. The specialists say: “What determines a morally
justifiable ‘just price’ for a cancer drug? A reasonable drug price
should maintain healthy pharmaceutical industry profits without being
viewed as ‘profiteering’.
One of the best known – imatinib, whose brand name is Glivec – has
proved so successful in chronic myeloid leukaemia that patients who a
decade ago survived for a few years can now look forward to a
near-normal life expectancy.
But the cost of Glivec has risen from
£18,000 per patient per year to around £21,000 in the UK, and from
$30,000 to $92,000 in the US. This is despite the fact that all research
costs were covered by the original price, and the number of patients
treated and the length of time they are on the drug have both vastly
increased because of the drug’s success.
More on this story here.
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Monday, 29 April 2013
Sunday, 28 April 2013
The Drinking Man's Diet
Did you ever hear of a diet which was fun to
follow? A diet which would let you have two martinis before lunch, and a
thick steak generously spread with Sauce BĂ©arnaise, so that you could
make your sale in a relaxed atmosphere and go back to the office without
worrying about having gained so much as an ounce? A diet which allows
you to take out your favorite girl for a dinner of squab and broccoli
with hollandaise sauce and Chateau Lafitte, to be followed by an evening
of rapture and champagne?"
So starts a jaunty little pamphlet titled The Drinking Man's Diet that first appeared in 1964. It was published by an equally jaunty San Francisco bon vivant, Robert Cameron, who priced it at $1. (Cameron used noms de plume--first Gardner Jameson and Elliott Williams, later Jeffrey W. Roberts.) In two years, he sold 2.4 million copies in 13 languages. Now Cameron, 93, still jaunty, still a bon vivant and still admirably trim from following his own diet, is reissuing this classic.
Like Atkins, whose own low-carb diet followed Drinking Man nine years later, Cameron proposes healthful weight loss by reducing one's intake of carbohydrates. As far as it goes, that's fine, since what Cameron's book terms "man-type" food (also "aesthetic" and "gourmet" food) is mercifully low in carbs: well-marbled steaks, thick slabs of fish, salads strewn with Roquefort.
More here
So starts a jaunty little pamphlet titled The Drinking Man's Diet that first appeared in 1964. It was published by an equally jaunty San Francisco bon vivant, Robert Cameron, who priced it at $1. (Cameron used noms de plume--first Gardner Jameson and Elliott Williams, later Jeffrey W. Roberts.) In two years, he sold 2.4 million copies in 13 languages. Now Cameron, 93, still jaunty, still a bon vivant and still admirably trim from following his own diet, is reissuing this classic.
Like Atkins, whose own low-carb diet followed Drinking Man nine years later, Cameron proposes healthful weight loss by reducing one's intake of carbohydrates. As far as it goes, that's fine, since what Cameron's book terms "man-type" food (also "aesthetic" and "gourmet" food) is mercifully low in carbs: well-marbled steaks, thick slabs of fish, salads strewn with Roquefort.
More here
Saturday, 27 April 2013
Wilson Pickett - It's A Groove
Another stellar record, a great late night sound, lights down low, you’ve got the picture. Check out the guitar playing.
Saturday night is music night !
An absolute classic from one of the best singers that ever drew breath. Has the sax solo ever been bettered ? Eddie
Low-Carb Trend Still Packs Punch: NMI
AVENTURA, Fla. -- The low-carb trend is alive and well, despite arguments from some quarters that it's run out of steam, according to Steve French, managing partner, Natural Marketing Institute.
"A lot of people think low carb is gone and dead," he said during a session at the American Bakers Association Convention here. "It's not dead at all."
About half of American adults say they have used low-carb food and beverages over the past year, according to NMI survey data. That finding indicates the trend has staying power, he said.
"That's a move into consumers understanding more about the types of grains in terms of sustained energy and single versus complex carbs," he said.
It manifests itself in the elimination of items like potatoes or rolls from meals, he added.
"The industry needs to be cognizant on how this affects consumption patterns."
French also said it's too early to tell whether the gluten-free phenomenon will have staying power, as NMI research shows an unusual pattern in its development.
Typically a health trend begins with early adopters, which NMI refers to as the "well beings," the households most engaged in health and wellness, he said. From that group it usually flows into the mainstream.
"But that's not happening with gluten free," he said.
In this category usage is highest among the "fence sitters," a healthy-wannabes, younger consumer segment more likely to have children. That may indicate a connection to concerns about allergies and tolerances, he said. These facts make it harder to predict the course of gluten free.
"So is it a fad diet?" French asked. "The jury is still out on whether it's a fad or a trend."
http://supermarketnews.com/bakery/low-carb-trend-still-packs-punch-nmi#ixzz2RcJZLNsE
Graham
Thursday, 25 April 2013
Senior Focus: Should older adults take statins?
I heard an interesting discussion at the recent American College of Cardiology meeting, led by Dr. Michael Rich, a professor of cardiology and colleague at Washington University in St. Louis. He raised the question of whether heart patients who are very old need to take statins.
The conclusion was that in the majority of cases the answer was no, though statins might be appropriate in some cases.
Statins have a number of side effects that reduce their benefit in older adults. They can damage muscles, which can lead to aches and increase the likelihood of falls.
A recent study implicated statins in causing older adults to become fatigued, which is a major cause of frailty. It also showed that in some people, statins caused functional decline.
The Food and Drug Administration has issued a “black box” warning that statins may worsen memory problems in older people. There are even cases showing that stopping statins may seem to “cure” dementia.
On the flip side, some data — not overwhelmingly strong, in my opinion — indicates that middle-aged people may be protected from developing vascular dementia if they take a statin.
So, should you take a statin if you are elderly? If you are in your mid-70s and on a statin, have your physician measure your small, dense and large, fluffy LDL cholesterol. If you have mainly large, fluffy LDL, you probably don’t need a statin.
Also, if you feel your memory is slipping, work with your doctor to make sure the statin isn’t to blame. Have your physician check your memory using a test like the St. Louis University Mental Status Examination. You can then stop your statin and have your doctor re-measure it in a few months. If your score is better, you should not go back on a statin.
For some elderly patients, the benefits of taking a statin outweigh the disadvantages. For instance, patients who have had a number of heart attacks or a recent heart attack probably need to take a statin. However, I’ve found little evidence that an expensive statin is more effective than a cheap, $4 a month statin.
The bottom line is that while there are exceptions, most people who get to old age would never have gotten there if they needed a statin. So talk to your doctor.
SLUCare physician John Morley is director of geriatrics at St. Louis University and a geriatrician at St. Louis University and Des Peres hospitals. Email him at morley@slu.edu.
Graham
Doug’s delight !
We have posted this item quite a few times, it’s a lowcarb masterpiece and our friend Doug and his family love it, as do all our team.
Melt the butter I used a Pyrex jug, add the eggs and cream, then add the dry ingredients and mix thoroughly. Add some lowcarb fruits, blueberries, raspberries and strawberries to the mix and spoon into a baking container. I used a silicone bread mould. Microwave in a 700watt for 6 minutes. Take out of the mould, if still damp place upside down on four layers of kitchen paper and microwave for a further one minute. Allow to cool then spread on a layer of extra thick cream, then add fruits to the top. A little tip, allow to cool on four or five layers of kitchen paper to remove any excess moisture. Serve in a bowl with some double cream. Serves eight.
The small one
The big one
Ingredients:
200g ground almonds
2 heaped teaspoons baking powder
3 medium eggs
200g ground almonds
2 heaped teaspoons baking powder
3 medium eggs
2 tablespoons of butter
2 tablespoons double cream
Strawberries, raspberries and blue berries
Strawberries, raspberries and blue berries
Method:
Mix all dry ingredients in a bowl.
Melt the butter I used a Pyrex jug, add the eggs and cream, then add the dry ingredients and mix thoroughly. Add some lowcarb fruits, blueberries, raspberries and strawberries to the mix and spoon into a baking container. I used a silicone bread mould. Microwave in a 700watt for 6 minutes. Take out of the mould, if still damp place upside down on four layers of kitchen paper and microwave for a further one minute. Allow to cool then spread on a layer of extra thick cream, then add fruits to the top. A little tip, allow to cool on four or five layers of kitchen paper to remove any excess moisture. Serve in a bowl with some double cream. Serves eight.
The small one
Ingredients:
100g ground almonds
1 teaspoon baking powder
2 large eggs
1 tablespoon of melted butter
2 tablespoons of double cream
100g ground almonds
1 teaspoon baking powder
2 large eggs
1 tablespoon of melted butter
2 tablespoons of double cream
Half a tub of clotted cream
A handful of fresh Strawberries
Method:
Mix all dry ingredients in a bowl.
Melt
the butter I used a Pyrex jug, add the eggs, cream, then add the dry
ingredients and mix. Microwave in a 700watt for 3 minutes. Allow to cool
and cut in half. Spread on extra thick clotted cream and some sliced
strawberries. Serves four to six. Less than five carbs per portion.
Eddie
Diabetes warning over soft drinks !
Drinking one or more cans
of sugary soft drinks a day is linked to an increased risk of diabetes
in later life, a study suggests. A can a day raises the relative risk of diabetes by about a
fifth, compared with one can a month or under, say European scientists. The report in the journal Diabetologia mirrors previous US findings.
A diabetes charity recommends limiting sugary foods and drinks as they are calorific and can cause weight gain.The latest research was carried out in the UK, Germany, Denmark, Italy, Spain, Sweden, France and the Netherlands.Some 350,000 individuals were questioned about their diet, as part of a large European study looking at links between diet and cancer.
"The consumption of sugar sweetened soft drinks increases your risk of diabetes - so for every can of soft drinks that you drink per day, the risk is higher," lead researcher Dora Romaguera from Imperial College London told BBC News.She called for clearer public health information on the effects of sugary soft drinks.
A diabetes charity recommends limiting sugary foods and drinks as they are calorific and can cause weight gain.The latest research was carried out in the UK, Germany, Denmark, Italy, Spain, Sweden, France and the Netherlands.Some 350,000 individuals were questioned about their diet, as part of a large European study looking at links between diet and cancer.
"The consumption of sugar sweetened soft drinks increases your risk of diabetes - so for every can of soft drinks that you drink per day, the risk is higher," lead researcher Dora Romaguera from Imperial College London told BBC News.She called for clearer public health information on the effects of sugary soft drinks.
"Given the increase in sweet
beverage consumption in Europe, clear messages on its deleterious effect
on health should be given to the population," Dr Romaguera and
colleagues conclude in their research paper.
More on this story here.
Wednesday, 24 April 2013
Blood Sample Mismatch Leads 'Anguished' Authors To Retract Three Lipitor Papers
Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants.
The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The trial supported the increasingly aggressive use of statins and helped to solidify the enormous commercial success of atorvastatin (Lipitor, Pfizer).
The 3 newly-retracted substudies do not appear to affect the main finding of TNT. Two papers were published in the Journal of the American College of Cardiology. The third was published in the American Heart Journal. (TheAHJ retraction notice has not yet been published, but the editors have confirmed the retraction.) Here are the 3 retracted articles:
Plasma PCSK9 Levels and Clinical Outcomes in the TNT (Treating to New Targets) Trial: A Nested Case-Control Study
Roeland Huijgen, MD; S. Matthijs Boekholdt, MD, PhD; Benoit J. Arsenault, PhD; Weihang Bao, PhD; Jean-Michel Davaine, MD; Fatiha Tabet, PhD; Francine Petrides, BSc; Kerry-Anne Rye, PhD; David A. DeMicco, PharmD; Philip J. Barter, MD, PhD; John J.P. Kastelein, MD, PhD; Gilles Lambert, PhD
J Am Coll Cardiol. 2012;59(20):1778-1784. doi:10.1016/j.jacc.2011.12.043
Roeland Huijgen, MD; S. Matthijs Boekholdt, MD, PhD; Benoit J. Arsenault, PhD; Weihang Bao, PhD; Jean-Michel Davaine, MD; Fatiha Tabet, PhD; Francine Petrides, BSc; Kerry-Anne Rye, PhD; David A. DeMicco, PharmD; Philip J. Barter, MD, PhD; John J.P. Kastelein, MD, PhD; Gilles Lambert, PhD
J Am Coll Cardiol. 2012;59(20):1778-1784. doi:10.1016/j.jacc.2011.12.043
Prediction of Cardiovascular Events in Statin-Treated Stable Coronary Patients by Lipid and Nonlipid Biomarkers
Benoit J. Arsenault, PhD; Philip Barter, MD, PhD; David A. DeMicco, PharmD; Weihang Bao, PhD; Gregory M. Preston, PhD; John C. LaRosa, MD; Scott M. Grundy, MD, PhD; Prakash Deedwania, MD, PhD; Heiner Greten, MD; Nanette K. Wenger, MD; James Shepherd, MD; David D. Waters, MD; John J.P. Kastelein, MD, PhD
J Am Coll Cardiol. 2011;57(1):63-69. doi:10.1016/j.jacc.2010.06.052
Benoit J. Arsenault, PhD; Philip Barter, MD, PhD; David A. DeMicco, PharmD; Weihang Bao, PhD; Gregory M. Preston, PhD; John C. LaRosa, MD; Scott M. Grundy, MD, PhD; Prakash Deedwania, MD, PhD; Heiner Greten, MD; Nanette K. Wenger, MD; James Shepherd, MD; David D. Waters, MD; John J.P. Kastelein, MD, PhD
J Am Coll Cardiol. 2011;57(1):63-69. doi:10.1016/j.jacc.2010.06.052
Vitamin D levels do not predict cardiovascular events in statin-treated patients with stable coronary disease
Vera Bittner, MD, MSPH, Nanette K. Wenger, MD, David D. Waters, MD, David A. DeMicco, PharmD, Michael Messig, PhD, John C. LaRosa, MD
American Heart Journal, Volume 164, Issue 3 , Pages 387-393, September 2012
Vera Bittner, MD, MSPH, Nanette K. Wenger, MD, David D. Waters, MD, David A. DeMicco, PharmD, Michael Messig, PhD, John C. LaRosa, MD
American Heart Journal, Volume 164, Issue 3 , Pages 387-393, September 2012
Here is the main text of the retraction:
TNT investigator John Kastelein, an author of two of the papers, toldRetraction Watch:"The main findings of the TNT Trial were published in 2005 (1). Since that time, members of the Steering Committee and other investigators have published 32 papers based upon additional analyses of TNT. The data for these papers were derived from analyses of the TNT clinical database, managed by Pfizer. The clinical database has been crosschecked many times and the data in it is valid. During the trial, blood samples were drawn from the patients at regular intervals for subsequent analysis. We performed a nested case-control study that included 507 patients who experienced a CV event and 1,020 control patients in the main biomarker analysis, and 496 patients who experienced a CV event and 1,117 control patients in the PCSK9 analysis. The biomarker database was separate from the clinical database. An anonymization code was run in 2007 to link patients from one database to the other.In late 2012, the TNT frozen blood samples were integrated into a large automated biobank that includes samples from other Pfizer trials. At that time discrepancies were noted among the samples, indicating that an error had occurred when the samples were anonymized in 2007. Further investigation revealed that the code created to manually anonymize the data was accidentally run twice. During the first run, anonymized subject identifiers were successfully assigned to both biosamples and clinical data. However, after this first run had passed quality control checks, the anonymization code was re-run inadvertently, replacing the first correct set of identifiers with a random and incorrect set. We do not understand how or why the code was re-run. The study team, who were blinded as to patient identity, thus reported on mismatched clinical and biomarker data. The investigators of the biomarkers study were puzzled that none of the 18 biomarkers were predictive of cardiovascular events. However we were reassured because on-treatment LDL-cholesterol, HDL-cholesterol and triglyceride levels were all strongly predictive of events, and we reported this in the paper. These lipid levels were part of the clinical database, and thus were not subject to the error that occurred with the biomarkers. In the PCSK9 analysis, PCSK9 levels were predictive of events in the atorvastatin 10-mg group (p = 0.039) but not in the 80-mg group. This finding, which we now realize is totally spurious, was not unexpected and raised no red flags. Similarly, the failure of vitamin D levels to predict events, as reported in the AHJ paper, was not surprising.Since the error was discovered, we have created a new anonymized clinical and biomarker database by restoring the original set of anonymized identifiers. We are currently reanalyzing the data according to our original study plans. However, the nested case-control feature of the original study design has been lost because the patient selection for biomarker sampling was random. Only approximately one tenth of patients now had an event, compared to one third in the original study design. Thus, the power to detect a difference in the level of a biomarker between patients with and without events has been attenuated.All authors of these manuscripts are anguished to have made this mistake and publishing incorrect information."
http://www.forbes.com/sites/larryhusten/2013/04/16/blood-sample-mismatch-leads-anguished-authors-to-retract-three-lipitor-papers/Since the retraction was the result of a sample mix up and the results of our analysis were negative with regards to the predictive ability of the biomarkers in question, I, in fact, do hope that with the corrected sample labels and a new analysis we will be able to make better sense of the data.
Graham
Death of medical student Sarah Houston after taking banned slimming drug Dinitrophenol highlights dangers of buying pills online, warns Government
Slimming pills which led to the death of a medical student will claim
more lives unless regulators launch an urgent crackdown, campaigners
warned yesterday as it emerged that a legal loophole has allowed the
hazardous tablets to remain on sale.
Jim Dobbin, a microbiologist who is also the Labour and Co-operative MP for Heywood and Middleton, called for a review of the law concerning DNP (2,4-dinitrophenol) – an unregulated weight-loss product taken by the Leeds University student Sarah Houston. It was linked to 62 deaths around the world in a study published last year in The Journal of Medical Toxicity.
“It is unacceptable that lives are being put at risk by ineffective legislation and control of internet trade in potentially lethal products,” Mr Dobbin said.
More on this story here.
Jim Dobbin, a microbiologist who is also the Labour and Co-operative MP for Heywood and Middleton, called for a review of the law concerning DNP (2,4-dinitrophenol) – an unregulated weight-loss product taken by the Leeds University student Sarah Houston. It was linked to 62 deaths around the world in a study published last year in The Journal of Medical Toxicity.
“It is unacceptable that lives are being put at risk by ineffective legislation and control of internet trade in potentially lethal products,” Mr Dobbin said.
More on this story here.
Anyone want to buy my house ?
London home set to smash property price record by going on sale for a staggering £250m The house, which is on Carlton House Terrace, enjoys views of St James's Park and is 30 times bigger than a typical London family house. A London home is set to smash the record for the most expensive property in Britain by going on sale for a staggering £250?million. The Grade I listed Regency property in central London would cost potential buyers 700 times more than the £370,000 average property value in the capital.
Eddie
Eddie
More here.
Tuesday, 23 April 2013
Low-glycemic diet seen to reverse diastolic dysfunction of diabetes !
Vienna, Austria - A diet that was short on carbohydrates and long on protein, given to diabetic patients engaged in a supervised exercise and weight-loss program, appeared not only to cut proinsulin levels and postprandial glucose and triglyceride levels, it seemed to improve LV diastolic function [1].
Laboratory and echo changes in overweight/obese diabetic patients assigned to low-glycemic (n=16) and low-fat (n=16) diets
In the study that compared the "low-carb" diet to a traditionally recommended low-fat diet, the one designed to flatten out resulting insulin and glucose curves also allowed them to take far fewer oral diabetes medications and apparently cut both systolic and diastolic pressures. The low-fat diet had no apparent effect on diastolic function or med use or on blood pressures.
On the other hand, the two diets led to about the same declines in weight and waist circumference and lipoprotein-cholesterol levels, reported Prof Helene von Bibra (Technical University Munich, Germany) here at the Prediabetes and the Metabolic Syndrome 2013 Congress.
Many patients with insulin resistance, diabetes, or both have subclinical diastolic dysfunction, with severe prognostic implications if it becomes symptomatic, von Bibra reminded heartwire. About 65% of the 32 patients in the study had abnormal diastolic function as defined echocardiographically by low early diastolic myocardial velocity. That measure in most cases nearly normalized after the low-carb diet, but not after the low-fat diet, she said.
Of 32 overweight or obese diabetic patients (mean body-mass index, 34) without cardiac disease who were engaged in a "rehabilitation program in order to lose weight" that included two hours of supervised aerobic exercise per day, half followed a low-glycemic diet (25% carbohydrate, 45% fat, 30% protein) and the other half a low-fat diet (55% carbohydrate, 25% fat, and 20% protein) for three weeks. The diets provided the same amount of calories. Those on the low-fat diet then switched to the low-glycemic diet for an additional two weeks. Cardiac function by echo and metabolic parameters were assessed daily before and after a 400-kcal breakfast.
From baseline to three weeks, patients on the low-carb diet reduced their use of conventional oral antidiabetic medication by 86%. Those on the low-fat diet reduced them by only 6% by the end of three weeks, but intake went down another 57% by the end of their two-week low-glycemic diet phase. "And still they had improvements in glucose," von Bibra said. Medications other than oral ones for diabetes, such as antihypertensive drugs, were not changed in anyone during the study.
In the low-glycemic-diet group, mean systolic blood pressure declined from 127 mm Hg to 118 mm Hg (p<0.002) after three weeks; diastolic pressures also fell (p<0.04). Neither changed after three weeks for those initially on the low-fat diet, but both "improved in the same direction" as those in the low-glycemic group after two weeks on the low-glycemic diet, von Bibra said.
Initial assigned diet | Baseline | 3 wk | 2 wk after crossover to low-carb | p |
Low-glycemic | ||||
Triglycerides (mg/dL) | 150 | 111 | — | <0.005 |
Postprandial glucose (mg/dL) | 141 | 125 | — | <0.04 |
E' (cm/s) | 9.5 | 10.4 | — | <0.03 |
Low-fat | http://www.theheart.org/article/1531861.do | |||
Triglycerides (mg/dL) | 208 | 194 | 138 | <0.003 vs 3 wk, <0.004 vs baseline |
Postprandial glucose (mg/dL) | 168 | 137 | 127 | <0.008 vs baseline |
E' (cm/s) | 10.8 | 10.7 | 11.4 | <0.02 vs 3 wk |
E'=early diastolic myocardial velocity by tissue-Doppler echocardiography
The gains in diastolic function probably were not independently related to the associated blood-pressure reductions; rather, she proposed, they reflected improvements in myocardial energy utilization on the low-glycemic diet. Insulin resistance can lead to diastolic dysfunction via several pathways, she noted, but the most prominent seems to be myocardial energy deficiency secondary to microvascular dysregulation and mitochondrial imbalances of glucose vs fat oxidation.
http://www.theheart.org/article/1531861.do (free registration)
Graham
Sunday, 21 April 2013
Troubling New Signals? Diabetes Drugs & Adverse Event Reports !
For the past two months, there has been rising controversy over the extent to which certain diabetes drugs called GLP-1 inhibitors may cause pancreatitis and pancreatic cancer. Although links to pancreatitis are actually not new, one of two recent papers suggested pre-cancerous cell growth may be cause for concern, prompting both the FDA and the European Medicines Agency to start investigations.
Now, a watchdog group is calling for a reassessment of the entire class of drugs after analyzing adverse events data that was reported to the FDA and finding distinctly higher odds that GLP-1 drugs are generating reports for these illnesses compared with a control group consisting of older drugs, such as metformin, that are used to treat diabetes.
Specifically, the analysis found the odds were roughly 25 times higher for the following drugs: Merck’s Januvia (MRK), which is the biggest seller in this group; Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also marketed by Bristol-Myers; the Tradjena treatment sold by Eli Lilly (LLY) and Boehringer Ingelheim, and Novo Nordisk’s Victoza.
“I think the future of the whole class is in question,” says Thomas Moore, senior scientist for drug safety and policy with the Institute for Safe Medication Practices, which published the data in its QuarterWatch report. While he says further study should be undertaken, “if results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”
In reaching this conclusion, ISMP examined 1,723 serious adverse events reported to the FDA between July 1, 2011, and June 30, 2012 for all five of the GLP-1 drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production. There were 831 cases of pancreatitis; 105 case of pancreatic cancer; 32 cases of thyroid cancer and 101 cases indicating a hypersensitivity reaction.
When breaking down the adverse event reports, ISMP found that after adjusting for differences, the odds that a report would be filed indicating pancreatitis was 28.5 times higher for the two injectable drugs – Byetta and Victoza – compared with older diabetes meds. By contrast, the odds of such a report being filed in connection with the pills were 20.8 times higher.
Overall, the odds the GLP-1 drugs would cause an adverse event report of pancreatitis to be filed was 25.6 times higher than for the metformin or sulfonulyreas. Similarly, the injectable drugs were associated with reports of thyroid cancer, while the pills were not, according to ISMP. Athough all of the GLP-1 yielded hypersensitivity reports, the odds that Victoza would do so was nearly 8 times higher than the older meds and the only one to show a statistically significant difference.
“There are some important signals here,” says Moore, who maintains the analysis is the most comprehensive analysis to date of adverse events for this class of drugs. “The hypersensitive issue needs more than AE reports to validate, but it’s a pretty big signal. And our analysis also provides preliminary evidence of the risks of the (injectables) could be higher than the oral agents” (here is the ISMP report).
He added that the results “build on” what was seen in the recent studies that prompted regulatory probes. In one study, which was published in Diabetes, researchers found the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. However, the study was small – researchers examined the pancreas of 20 deceased human organ donors with type 2 diabetes.
The other study, which was published in JAMA Internal Medicine, examined insurance records for more than 2,500 diabetics between February 2005 and December 2008, and found that patients hospitalized with pancreatitis were twice as likely to have taken either Januvia or Byetta than a control group of type 2 diabetics who did not have pancreatitis. The other drugs were not analyzed (read more here and here is another interesting angle).
This study generated considerable pushback from not only the drugmakers, but also Wall Street analysts and the American Association of Endocrinologists and the American Diabetes Association over concerns that physicians may change treatment practices and objections to the study design. They also noted pancreatitis was not a new issue.
But when the next study appeared in Diabetes, the dissension was muted, although the Public Citizen watchdog group called for the FDA to ban the class of drugs (read here). Not surprisingly, several of the drugmakers last night defended their medicines and noted the ISMP analysis had limitations, since the FDA adverse event reporting system does not demonstrate causality.
The FDA database is “subject to reporting biases and (is) often limited by a lack of information concerning important variables such as confirmation of diagnosis, specific patient characteristics and co-morbidities, duration of a patient’s disease, prior drug exposures, and concomitant medication use. The authors themselves caution that their analysis ‘should be interpreted in light of the known limitations of a reporting system that does not collect data systematically,’ “ a Bristol-Myers spokesman writes us.
He adds that “direct comparison of event rates of different agents generated from this type of analysis should be interpreted with caution, as the authors themselves acknowledge. These data need to be put into context with data from clinical trials and epidemiology studies, which are better suited to assess risk.”
And a Novo Nordisk spokesman sent us this: “We have reviewed the totality of safety information available to us, and remain confident in the safety profile of Victoza. We continue to work closely with the FDA to provide an on-going assessment of Victoza’s risk-benefit profile.”
And a Boehringer spokeswoman wrote this: "Numerous factors can increase spontaneous adverse event reporting. Comparison of reporting rates across products is not methodologically supported due to biases that cannot be adequately controlled... The FDA’s Adverse Event Reporting System specifically states that data should not be used to compare findings across compounds. Products may be approved for different indications in patient populations that are inherently different, and therefore, the outcomes across these patients may also be different."
"...It is not appropriate to compare new users of a product with patients who have been treated with a product for a longer period of time as it introduces critical bias due to depletion of susceptibles (healthy survivor bias); the initially treated group of patients has a higher risk of adverse events than that after some years of market presence because patients with side effects may, for example, discontinue treatment," she adds.
Think I'll stick with LowCarb !
Graham
Largest Manhunt in History Finds Great Dietition !
After the largest manhunt in history, conducted by detectives from the FBI to Interpol, assisted by intelligence operatives from MI5 to Mossad, an informed and clued up dietition has been found. At a press conference today FBI Special Agent Jimmy (Popeye) Doyle stated "we never really thought we would find a dietition that knew what they were talking about. The hunt to find a dietition not on the payroll of big pharma or junk food outfits was thought to be a lost cause, but this find justifies the years of work and $billions spent" Franziska Spritzler, RD, CDE was left stunned, when Doyle informed her how long the search had taken. Seriously folks check out this great site. A taster.
Eddie
"While doing research for my ADA low-carb article, I read many studies on carb restriction for diabetes and weight management, but I didn't consider the beneficial effects of ketosis. At the time, I was still consuming close to 100 net grams of carbs a day and wasn't ready to try anything as extreme as a ketogenic diet. But after having looked into the research on VLCKDs and experiencing their effects first hand, I'd like to see more obese and otherwise metabolically challenged people try them. Improved lipid profiles, slowing down of the aging process, and improvements in mood and cognition are just a few of the potential benefits attributed to ketogenic diets, along with weight loss and blood glucose control. In addition to the studies, I've read countless online accounts of how ketosis has changed people's lives for the better. And I plan to continue eating this way indefinitely unless I develop problems, at which point I would make adjustments as needed. That's how I got here in the first place, after all.
Now, as enthusiastic as I am about VLCKDs, do I realistically think that all dietitians, nurses, doctors, and other health professionals will come on board in the near future? Probably not, considering most of them think ketosis is unhealthy and that we need at least 130 grams (and preferably a lot more) of carbs at a minimum to support the needs of the central nervous system. But I am cautiously optimistic that the tide is starting to turn as practitioners begin to look at the research and listen to their patients' accounts of success -- or perhaps even test their own postprandial blood sugars. Carb restriction may not be appropriate in every case, but I defy anyone to objectively look at the evidence and deny how beneficial it's been for so many, especially those who have struggled with weight and blood sugar issues for years."
More great information here.
Eddie
"While doing research for my ADA low-carb article, I read many studies on carb restriction for diabetes and weight management, but I didn't consider the beneficial effects of ketosis. At the time, I was still consuming close to 100 net grams of carbs a day and wasn't ready to try anything as extreme as a ketogenic diet. But after having looked into the research on VLCKDs and experiencing their effects first hand, I'd like to see more obese and otherwise metabolically challenged people try them. Improved lipid profiles, slowing down of the aging process, and improvements in mood and cognition are just a few of the potential benefits attributed to ketogenic diets, along with weight loss and blood glucose control. In addition to the studies, I've read countless online accounts of how ketosis has changed people's lives for the better. And I plan to continue eating this way indefinitely unless I develop problems, at which point I would make adjustments as needed. That's how I got here in the first place, after all.
Now, as enthusiastic as I am about VLCKDs, do I realistically think that all dietitians, nurses, doctors, and other health professionals will come on board in the near future? Probably not, considering most of them think ketosis is unhealthy and that we need at least 130 grams (and preferably a lot more) of carbs at a minimum to support the needs of the central nervous system. But I am cautiously optimistic that the tide is starting to turn as practitioners begin to look at the research and listen to their patients' accounts of success -- or perhaps even test their own postprandial blood sugars. Carb restriction may not be appropriate in every case, but I defy anyone to objectively look at the evidence and deny how beneficial it's been for so many, especially those who have struggled with weight and blood sugar issues for years."
More great information here.
More women than men suffer heart disease !
The stereotype of the overweight, unfit bloke as a heart attack in waiting masks a deadly fact. In fact, more young women suffer from cardiovascular problems than men, heart experts warn. Across the UK, there are 710,000 women, aged 16-44, living with heart disease compared to 570,000 men, according to British Heart Foundation (BHF) research.
Professor Peter Weissberg, BHF medical director, said clear signs of
heart complaints are going unnoticed by women. “There’s a great tendency
for women to ignore symptoms because they think of it as a man’s
problem. Women are affected by heart disease and sometimes more than
men.”
More on this story here.
More on this story here.
Saturday, 20 April 2013
Saturday night is music night.
As good as it gets JOE BONAMASSA & BETH HART ..... "I'D RATHER GO BLIND"
Welcome to the crazy world of dietitions.
I know I am stating the obvious, but it seems to me, most people become interested in lowcarb, for the weight loss benefits. It is a fact there are many more overweight people than there are diabetics, let’s hope it stays that way. A diabetic going lowcarb 50 carbs a day or less, has a huge incentive to stay lowcarb. Less medication, for many type two diabetics nil medication, to hold stable non diabetic blood glucose numbers.
The over weight non diabetic may wait weeks, or even months to see a substantial reduction in weight, the diabetic sees a massive change in their fight to reduce the risk of blindness, limb amputation and kidney failure, in a matter of a few days. Very high and very dangerous BG numbers, are very often reduced to non diabetic in less than a week. This is very important, because many type two diabetes medications are close to useless, expensive, and many banned for killing and maiming people. Actos and Avandia two well known examples. The benefit of weight loss is of secondary importance for most type two diabetics. Weight loss is still an important issue for around 80% of type two’s because excessive weight brings about insulin resistance for many.
So, the type two has great incentives to go and stay lowcarb, what about the non diabetic over weight person. Many people believe, including some medical professionals that a diabetic runs high BG numbers because of a lack of insulin. This is true for some diabetics such as type one’s. It comes as a great surprise to many, when I tell them at diagnosis, a heavily overweight diabetic can be running plasma insulin levels of three times higher than a slim non diabetic.
Insulin is often referred to by biochemists as the fat building hormone. In fact, the body cannot make body fat without insulin. It is very unusual to find an overweight individual who doesn’t also have elevated insulin levels. Insulin also inhibits the body’s use of stored fat as a source of fuel. Lowering insulin levels is extremely important, perhaps essential, for weight loss to succeed. This is one reason why low carb diets are particularly successful in weight loss since the fewer the carbs, the less insulin is required. Some may also find that they consume fewer calories without feeling hungry, because their fat metabolism begins to work properly once more, allowing the body access to energy reserves in fat stores which were previously inaccessible.
So, if you are a non diabetic, but heavily overweight, the last thing you need is to be awash with excess insulin. Insulin has a measurable impact on blood vessels by narrowing them, with increased cardiovascular risks. Insulin has often been called the aging hormone. Not enough is bad, too much is also bad. I am sure most people who visit this site know, carbohydrates have a large impact on blood glucose levels, protein much less, and fats have little if any effect. The $64000 question is, if you have not been diagnosed as a diabetic, do you know what your BG numbers are ? Most do not. I would recommend if you are heavily over weight or type two diabetes runs in your family, invest around £10 in a BG meter. It will come with ten test strips. Check your BG one and two hours after a typical meal, you may not be happy with the BG numbers you see, but you will know where you stand.
I once asked a medical professional, why don’t you BG test every over weight person or people that have type two diabetes running through their family’s. She replied the cost would be astronomical. I said the cost of a test strip won’t break the NHS. She replied you are right, but we would find so many diabetics the system could not cope ! Meanwhile most dietitions and healthcare professionals, are telling not only diabetics, but also non diabetics, to base their meals on starchy carbs. Welcome to the crazy world of dietitions.
Eddie
The over weight non diabetic may wait weeks, or even months to see a substantial reduction in weight, the diabetic sees a massive change in their fight to reduce the risk of blindness, limb amputation and kidney failure, in a matter of a few days. Very high and very dangerous BG numbers, are very often reduced to non diabetic in less than a week. This is very important, because many type two diabetes medications are close to useless, expensive, and many banned for killing and maiming people. Actos and Avandia two well known examples. The benefit of weight loss is of secondary importance for most type two diabetics. Weight loss is still an important issue for around 80% of type two’s because excessive weight brings about insulin resistance for many.
So, the type two has great incentives to go and stay lowcarb, what about the non diabetic over weight person. Many people believe, including some medical professionals that a diabetic runs high BG numbers because of a lack of insulin. This is true for some diabetics such as type one’s. It comes as a great surprise to many, when I tell them at diagnosis, a heavily overweight diabetic can be running plasma insulin levels of three times higher than a slim non diabetic.
Insulin is often referred to by biochemists as the fat building hormone. In fact, the body cannot make body fat without insulin. It is very unusual to find an overweight individual who doesn’t also have elevated insulin levels. Insulin also inhibits the body’s use of stored fat as a source of fuel. Lowering insulin levels is extremely important, perhaps essential, for weight loss to succeed. This is one reason why low carb diets are particularly successful in weight loss since the fewer the carbs, the less insulin is required. Some may also find that they consume fewer calories without feeling hungry, because their fat metabolism begins to work properly once more, allowing the body access to energy reserves in fat stores which were previously inaccessible.
So, if you are a non diabetic, but heavily overweight, the last thing you need is to be awash with excess insulin. Insulin has a measurable impact on blood vessels by narrowing them, with increased cardiovascular risks. Insulin has often been called the aging hormone. Not enough is bad, too much is also bad. I am sure most people who visit this site know, carbohydrates have a large impact on blood glucose levels, protein much less, and fats have little if any effect. The $64000 question is, if you have not been diagnosed as a diabetic, do you know what your BG numbers are ? Most do not. I would recommend if you are heavily over weight or type two diabetes runs in your family, invest around £10 in a BG meter. It will come with ten test strips. Check your BG one and two hours after a typical meal, you may not be happy with the BG numbers you see, but you will know where you stand.
I once asked a medical professional, why don’t you BG test every over weight person or people that have type two diabetes running through their family’s. She replied the cost would be astronomical. I said the cost of a test strip won’t break the NHS. She replied you are right, but we would find so many diabetics the system could not cope ! Meanwhile most dietitions and healthcare professionals, are telling not only diabetics, but also non diabetics, to base their meals on starchy carbs. Welcome to the crazy world of dietitions.
Eddie
Friday, 19 April 2013
Black OP’s outfits and their pay masters.
Reading the excellent DietDoctor.com blog today, I found several articles showing how dietitions and medical professionals, are being turned into shills for the Coca-Cola company. Was I surprised, not in the least ! Big pharma and junk food outfits have a grip on just about every organisation involved in health advice in the UK. One neat trick is call yourself a charity, of make your organisations name sound like a Government Institution. Big pharma and junk food spends $billions every year on their propaganda, far too many healthcare professionals have either swallowed the lies hook, line and sinker, or are on the payroll. Meanwhile, we have to rely on a relatively small (but growing) number of honest and informed HCP’s and bloggers. A David versus Goliath situation for sure. Check out these black OP’s outfits and their pay masters.
DUK The diabetes charity.
Abbott Bayer Boehringer Ingelheim Bristol Myers Squibb Bupa Bunzl Everyclick First Capital Connect Flora pro.activ Kodak Lilly Lloyds Pharmacy Menarini Merck Serono Morphy Richards Merck Sharp & Dohme Limited Novartis Novo Nordisk Nursing Times PAL Technologies Ltd Pfizer Rowlands Pharmacies Sanofi-aventis SplendaTakeda Tesco Diets
HEART UK -The Nation’s Cholesterol Charity
Abbott Healthcare Alpro UK AstraZeneca BHR Pharma Cambridge Weight Plan Cereal Partners UK (Sh Wheat) Food & Drink Federation Fresenius Medical Care (UK) Limited Genzyme Therapeutics Hovis Kellogg’s (Optivita) Kowa Pharmaceutical Europe Co Limited L.IN.C Medical Systems Limited Merck Sharpe & Dhome PlanMyFood Pfizer Premier Foods Progenika Biopharma s.a. Roche Products Limited Unilever (Flora) Welch’s (Purple Grape Juice)
The British Nutrition Foundation
However, the organisation's 39 members, which contribute to its funding, include – beside the Government, the EU – Cadbury, Kellogg's, Northern Foods, McDonald's, PizzaExpress, the main supermarket chains except Tesco, and producer bodies such as the Potato Council. The chairman of its board of trustees, Paul Hebblethwaite, is also chairman of the Biscuit, Cake, Chocolate and Confectionery Trade Association.
The European Food Information Council
Current EUFIC members are: AB Sugar, Ajinomoto Sweeteners Europe, Bunge, Cargill, Cereal Partners, Coca-Cola, Danone, DSM Nutritional Products Europe Ltd., Ferrero, Kraft Foods, Mars, McDonald's, Nestlé, PepsiCo, Pfizer Animal Health, Südzucker, and Unilever.
The British Heart Foundation
Unilever Flora margarine.
Eddie
More on HEART UK and AstraZeneca:
http://www.yourstatin.co.uk/
DUK The diabetes charity.
Abbott Bayer Boehringer Ingelheim Bristol Myers Squibb Bupa Bunzl Everyclick First Capital Connect Flora pro.activ Kodak Lilly Lloyds Pharmacy Menarini Merck Serono Morphy Richards Merck Sharp & Dohme Limited Novartis Novo Nordisk Nursing Times PAL Technologies Ltd Pfizer Rowlands Pharmacies Sanofi-aventis SplendaTakeda Tesco Diets
HEART UK -The Nation’s Cholesterol Charity
Abbott Healthcare Alpro UK AstraZeneca BHR Pharma Cambridge Weight Plan Cereal Partners UK (Sh Wheat) Food & Drink Federation Fresenius Medical Care (UK) Limited Genzyme Therapeutics Hovis Kellogg’s (Optivita) Kowa Pharmaceutical Europe Co Limited L.IN.C Medical Systems Limited Merck Sharpe & Dhome PlanMyFood Pfizer Premier Foods Progenika Biopharma s.a. Roche Products Limited Unilever (Flora) Welch’s (Purple Grape Juice)
The British Nutrition Foundation
However, the organisation's 39 members, which contribute to its funding, include – beside the Government, the EU – Cadbury, Kellogg's, Northern Foods, McDonald's, PizzaExpress, the main supermarket chains except Tesco, and producer bodies such as the Potato Council. The chairman of its board of trustees, Paul Hebblethwaite, is also chairman of the Biscuit, Cake, Chocolate and Confectionery Trade Association.
The European Food Information Council
Current EUFIC members are: AB Sugar, Ajinomoto Sweeteners Europe, Bunge, Cargill, Cereal Partners, Coca-Cola, Danone, DSM Nutritional Products Europe Ltd., Ferrero, Kraft Foods, Mars, McDonald's, Nestlé, PepsiCo, Pfizer Animal Health, Südzucker, and Unilever.
The British Heart Foundation
Unilever Flora margarine.
Eddie
More on HEART UK and AstraZeneca:
Developed in
partnership between HEART UK and AstraZeneca
Graham
GlaxoSmithKline accused of market 'abuse' !
GlaxoSmithKline (GSK) has been accused of market "abuse" by the consumer watchdog, the Office of Fair Trading (OFT).
Alpharma, Generics UK and Norton Healthcare all received money not to enter the market with their copies of Seroxat, it said.
The generic drug makers were attempting to supply the UK market with their versions of paroxetine, which GlaxoSmithKline brands as Seroxat, the OFT said. Seroxat is used to treat depression. GSK accused them of infringing its patent, so to resolve this dispute Glaxo effectively paid the three companies off, according to the OFT.
"The paroxetine supply agreements under investigation were terminated in 2004," GSK said. If proven, the allegations would be an infringement on the part of all the parties of competition law and on the part of GlaxoSmithKline an abuse of its dominant place in the market.
More on this story here.
Thursday, 18 April 2013
No fish tonight.
Yes, yes I KNOW some may call this processed food, but Eddie was supposed to go fishing today and catch us dinner BUT he chickened out! No I jest. Anyway I‘d seen this at our local Morrisons Supermarket and thought mmnnn this would be ok for an emergency meal….. and it was. Morrison Bistro Beef Bourguignon with shallots, button mushrooms, carrots and bacon, all cooked in a French red wine sauce, just 9.2 carbs per half pack, so not a bad carb content for an emergency meal. I already had some swede, which I mashed with lots of butter and some white cabbage, which I cooked gently on the hob. Add to that some broccoli micro-waved with some double cream and seasoning and it all tasted extremely good, and the important point, all of this for less than 20 Carbs each for the meal. Some may think I’m heathen at having the broccoli and cream with what really is a gravy type dish but what the heck! My philosophy is if you like it and the carbs are low enough go for it.
Jan
Give ‘em an inch and they take a mile !
No, I am not talking about the lowcarb antis I take on, I never give them an inch, I’m talking about my wife. She joins our crew and she is posting all over the blogosphere like a banshee on speed. I have lost count of the times she has said to me today, did you know, or look at this !, she is driving me nuts. Don’t expect to see much of me in the future, she has nicked our internet computer and I am relegated to housework and cooking. Weather not up to some decent fishing today, high winds and showers. The way things are going I might start decorating our place. Being a lowcarb militant is not all it's cracked up to be.
Eddie
Don Mitchello The Cod Father LOL
Eddie
Scientist Steven Eaton jailed for falsifying drug test results !
A scientist who faked research data for
experimental anti-cancer drugs has been jailed for three months for
falsifying test results.
Eaton, 47, was working at the Edinburgh branch of US pharmaceutical firm Aptuit in 2009 when he came up with the scam.
If it had been successful, cancer patients who took the drug could have been harmed, the court was told.
Edinburgh Sheriff Court heard how Eaton had manipulated the results of an experiment so it was deemed successful when it had actually failed.
Speaking after the case, Gerald Heddell, the Medicines and Healthcare Products Regulatory Agency's director of inspection, enforcement and standards, said he welcomed the conviction. He added: "This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."
More on this story here.
Wednesday, 17 April 2013
The science of obesity: what do we really know about what makes us fat? An essay by Gary Taubes
Since the 1950s, the conventional wisdom on obesity has been simple: it is fundamentally caused by or results from a net positive energy balance—another way of saying that we get fat because we overeat. We consume more energy than we expend. The conventional wisdom has also held, however, that efforts to cure the problem by inducing undereating or a negative energy balance—either by counselling patients to eat less or exercise more—are remarkably ineffective.
Put these two notions together and the result should be a palpable sense of cognitive dissonance. Take, for instance, The Handbook of Obesity, published in 1998 and edited by three of the most influential authorities in the field. “Dietary therapy,” it says, “remains the cornerstone of treatment and the reduction of energy intake continues to be the basis of successful weight reduction programs.” And yet it simultaneously describes the results of such dietary therapy as “poor and not long-lasting.”1
Rather than resolve this dissonance by questioning our beliefs about the cause of obesity, the tendency is to blame the public (and obese patients implicitly) for not faithfully following our advice. And we embrace the relatively new assumption that obesity must be a multifactorial and complex disorder. This makes our failures to either treat the disorder or rein in the burgeoning epidemics of obesity worldwide somehow understandable, acceptable.
Another possibility, though, is that our fundamental understanding of the aetiology of the disorder is indeed incorrect, and this is the reason for the lack of progress. If this is true, and it certainly could be, then rectifying this aetiological misconception is absolutely critical to future progress.
Read the full essay here: http://www.bmj.com/content/346/bmj.f1050
Graham
Jan our latest lowcarb team member.
For those who may not have guessed, Jan is my wife. In almost every way the total opposite of me. They say opposites attract, who am I to argue. Jan started lowcarbing the same day as me, almost five years ago. Jan is an ex PE teacher and never a pound overweight in her life. After five years of supporting me and my friends, she wants to take an active part in the cause. From the start she understood, a diet based on sugar and carbs made no sense, for anyone.
With the weather warming up and offers of the photographic work I find interesting, I am standing back somewhat. Please cut her some slack, she is very new to the world of blogs, as for me, I intend to spend my days fishing and photographing nature, a man could do worse.
Good health and good luck to you and yours.
Eddie
With the weather warming up and offers of the photographic work I find interesting, I am standing back somewhat. Please cut her some slack, she is very new to the world of blogs, as for me, I intend to spend my days fishing and photographing nature, a man could do worse.
Good health and good luck to you and yours.
Eddie
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