ICYMI: My Q&A during a Senate Armed Services Committee hearing about Iran with Secretary Kerry, Secretary Carter, and General Dempsey. WATCH:
Posted by Senator Tom Cotton on Wednesday, July 29, 2015
Thursday, July 30, 2015
Senator Tom Cotton, thank you for going the extra mile
Tuesday, March 31, 2015
Evidence Based Medicine vs Individualized Patient Care: What happens when they are out of sync?
For years I have worked in the medical education industry, plus have the pleasure of having a family of physicians and many physician friends. I've used the term "Evidence-based" in so many titles of so many activities to the point where I started wondering if evidence-based medicine is replacing the art of medicine. Lack of evidence does not always = lack of efficacy, and physician personal experience with particular therapies or treatment approaches, as well as looking at the patient as an individual, is very important.
Guidelines evolve, and in some cases, do a 360 when "new evidence" replaces old evidence. And then some guidelines are changed because of lack of funding for clinical trials to provide the evidence, even when physicians are in disagreement with the change.
I've seen patients be treated against "evidence-based" guidelines with great success. In addition, insurers seem to dictate treatment based on evidence, and I would hate to see patient care suffer because a physician had to follow a protocol they strongly felt was futile in a certain patient. And by following the protocol, or step-wise approach, are patients suffering the consequences of delayed efficacious treatment?
Guidelines evolve, and in some cases, do a 360 when "new evidence" replaces old evidence. And then some guidelines are changed because of lack of funding for clinical trials to provide the evidence, even when physicians are in disagreement with the change.
I've seen patients be treated against "evidence-based" guidelines with great success. In addition, insurers seem to dictate treatment based on evidence, and I would hate to see patient care suffer because a physician had to follow a protocol they strongly felt was futile in a certain patient. And by following the protocol, or step-wise approach, are patients suffering the consequences of delayed efficacious treatment?
Monday, March 30, 2015
MISLEADING TITLE!!!!! Based on This Study, an Alzheimer's Disease Cure Could Be Around the Corner (BIIB)
Based on This Study, an Alzheimer's Disease Cure Could Be Around the Corner (BIIB)
Misleading main stream media article - around the corner in title? Studies to date are in mice, larger animals in 2017? I've seen this article posted on numerous social media outlets with people very excited...not quite understanding the drug development process and that mice don't = humans. I hope this proves to be a great treatment, but don't lead on people who are worried for themselves or loved ones.
Misleading main stream media article - around the corner in title? Studies to date are in mice, larger animals in 2017? I've seen this article posted on numerous social media outlets with people very excited...not quite understanding the drug development process and that mice don't = humans. I hope this proves to be a great treatment, but don't lead on people who are worried for themselves or loved ones.
Wednesday, December 11, 2013
Tuesday, March 19, 2013
A Dallas woman has been sentenced to 16 years in prison for the neglect-related death of her diabetic 9-year-old daughter.
Reported by the Associated Press
A Dallas woman has been sentenced to 16 years in prison for the neglect-related death of her diabetic 9-year-old daughter.
A judge in Dallas on Monday sentenced 31-year-old Georgia Jones. Jones pleaded guilty to felony injury to a child in the May 2008 death of Chastity Butler. The death was ruled natural due to diabetic complications.
The Dallas Morning News reports the girl died on her mother's bed next to a bag of candy and a half-eaten cupcake. The family was celebrating a relative's birthday at the time of the death.
Investigators say Chastity's diabetes was not properly monitored and that caused the girl to be constantly sick. Police say the mother did not show up for a diabetes-care class after her daughter was diagnosed.
Read more: http://www.beaumontenterprise.com/news/article/Dallas-mom-gets-16-years-for-daughter-s-4366874.php#ixzz2O0zlvvw3
A Dallas woman has been sentenced to 16 years in prison for the neglect-related death of her diabetic 9-year-old daughter.
A judge in Dallas on Monday sentenced 31-year-old Georgia Jones. Jones pleaded guilty to felony injury to a child in the May 2008 death of Chastity Butler. The death was ruled natural due to diabetic complications.
The Dallas Morning News reports the girl died on her mother's bed next to a bag of candy and a half-eaten cupcake. The family was celebrating a relative's birthday at the time of the death.
Investigators say Chastity's diabetes was not properly monitored and that caused the girl to be constantly sick. Police say the mother did not show up for a diabetes-care class after her daughter was diagnosed.
Read more: http://www.beaumontenterprise.com/news/article/Dallas-mom-gets-16-years-for-daughter-s-4366874.php#ixzz2O0zlvvw3
Monday, March 18, 2013
Childhood Depression Linked To Teenage Smoking, Obesity
Supports my personal theory that in many cases obesity and smoking are more alike
because of the depression link.
Childhood Depression Linked To Teenage Smoking, Obesity
March 16, 2013
redOrbit Staff & Wire Reports – Your Universe Online
Children who are suffering from depression have a higher risk of developing cardiovascular disease later on in life, according to new research presented at the annual meeting of the American Psychosomatic Society, in Miami, Florida on Friday.
The study, which was prepared by scientists at the Washington University School of Medicine in St. Louis and the University of Pittsburg, reports teenagers who suffered clinical depression when they were children were more likely than other people their age to smoke cigarettes, suffer from obesity, or lead sedentary lives.
Furthermore, that likelihood was present even if the teens had overcome their depression. The findings suggested depression, even at a young age, could increase the risk that heart problems will eventually surface, they added.
“Part of the reason this is so worrisome is that a number of recent studies have shown that when adolescents have these cardiac risk factors, they’re much more likely to develop heart disease as adults and even to have a shorter lifespan,” first author Robert M. Carney, PhD, a professor of psychiatry at Washington University, explained.
“Active smokers as adolescents are twice as likely to die by the age of 55 than nonsmokers, and we see similar risks with obesity, so finding this link between childhood depression and these risk factors suggests that we need to very closely monitor young people who have been depressed,” Carney added in a statement.
While medical experts have long known adults suffering from depression were more likely to have a heart attack or related cardiac event, it has not yet been established when other risk factors for these ailments – including smoking, obesity and sedentary lifestyle – combine with depression to increase the risk for heart problems.
“We know that depression in adults is associated with heart disease and a higher risk of dying from a heart attack or having serious complications,” Carney says. “What we didn’t know is at what stage of life we would begin to see evidence of this association between depression and these cardiac risk factors.”
The Washington University professor and his colleagues looked at children who had taken part in a 2004 study of the genetics of depression. The study investigators surveyed 201 children with a history of clinical depression and 195 siblings with no such history, as well as 161 unrelated age- and gender-matched children with no history of depression. The average age of the participants was nine at the time of the study.
Seven years later, the researchers surveyed the subjects once again, focusing specifically on the rates of smoking, obesity and physical activity in all three groups. According to Carney, 22 percent of the depressed youngsters were obese by age 16 versus just 17 percent for their siblings and just 11 percent in the unrelated children. He said he and his colleagues discovered similar patterns in the other categories as well.
“A third of those who were depressed as children had become daily smokers, compared to 13 percent of their nondepressed siblings and only 2.5 percent of the control group,” he said. Likewise, the teens who had struggled with depression were also the least physically active, followed by their siblings.
The members of the third, control group were the most active, they discovered.
Further analysis and the use of statistical methods eliminated other possible causes for the increased smoking and obesity rates, strengthening their belief depression was the cause of the phenomenon.
Depressed children were 2.5 times more likely than their siblings to smoke, and heart disease risk factors were also more common in children who had been depressed – whether or not they still suffered from the symptoms at an advanced age.
“Depression seems to come first,” Carney said. “It’s playing an important, if not a causal, role. There may be some related genetic influences that give rise to both depression and to heart disease, or at least to these types of cardiac risk behaviors, but more study will be required before we can draw any firm conclusions about that.”
Children who are suffering from depression have a higher risk of developing cardiovascular disease later on in life, according to new research presented at the annual meeting of the American Psychosomatic Society, in Miami, Florida on Friday.
The study, which was prepared by scientists at the Washington University School of Medicine in St. Louis and the University of Pittsburg, reports teenagers who suffered clinical depression when they were children were more likely than other people their age to smoke cigarettes, suffer from obesity, or lead sedentary lives.
Furthermore, that likelihood was present even if the teens had overcome their depression. The findings suggested depression, even at a young age, could increase the risk that heart problems will eventually surface, they added.
“Part of the reason this is so worrisome is that a number of recent studies have shown that when adolescents have these cardiac risk factors, they’re much more likely to develop heart disease as adults and even to have a shorter lifespan,” first author Robert M. Carney, PhD, a professor of psychiatry at Washington University, explained.
“Active smokers as adolescents are twice as likely to die by the age of 55 than nonsmokers, and we see similar risks with obesity, so finding this link between childhood depression and these risk factors suggests that we need to very closely monitor young people who have been depressed,” Carney added in a statement.
While medical experts have long known adults suffering from depression were more likely to have a heart attack or related cardiac event, it has not yet been established when other risk factors for these ailments – including smoking, obesity and sedentary lifestyle – combine with depression to increase the risk for heart problems.
“We know that depression in adults is associated with heart disease and a higher risk of dying from a heart attack or having serious complications,” Carney says. “What we didn’t know is at what stage of life we would begin to see evidence of this association between depression and these cardiac risk factors.”
The Washington University professor and his colleagues looked at children who had taken part in a 2004 study of the genetics of depression. The study investigators surveyed 201 children with a history of clinical depression and 195 siblings with no such history, as well as 161 unrelated age- and gender-matched children with no history of depression. The average age of the participants was nine at the time of the study.
Seven years later, the researchers surveyed the subjects once again, focusing specifically on the rates of smoking, obesity and physical activity in all three groups. According to Carney, 22 percent of the depressed youngsters were obese by age 16 versus just 17 percent for their siblings and just 11 percent in the unrelated children. He said he and his colleagues discovered similar patterns in the other categories as well.
“A third of those who were depressed as children had become daily smokers, compared to 13 percent of their nondepressed siblings and only 2.5 percent of the control group,” he said. Likewise, the teens who had struggled with depression were also the least physically active, followed by their siblings.
The members of the third, control group were the most active, they discovered.
Further analysis and the use of statistical methods eliminated other possible causes for the increased smoking and obesity rates, strengthening their belief depression was the cause of the phenomenon.
Depressed children were 2.5 times more likely than their siblings to smoke, and heart disease risk factors were also more common in children who had been depressed – whether or not they still suffered from the symptoms at an advanced age.
“Depression seems to come first,” Carney said. “It’s playing an important, if not a causal, role. There may be some related genetic influences that give rise to both depression and to heart disease, or at least to these types of cardiac risk behaviors, but more study will be required before we can draw any firm conclusions about that.”
Tuesday, March 12, 2013
Incentives/Penalties with Medical Insurance for Obesity
So recent data was presented at ACC demonstrating monetary incentives work well to get people to lose weight. In addition, the data demonstrated monetary penalties worked even better. So what does this mean for the future of health insurance in the U.S.? Life and disability insurance have underwriters that take into account BMI, smoking, and other diseases when writing a policy and determining a premium if they decide to issue the policy. However, medical insurance, at least commercial (not self-insured employer plans) have community rates that do not take into account BMI, smoking, excessive alcohol or illicit drug use. And the Americans with Disabilities Act recognizes obesity and alcohol addiction as disabilities and employers are not to discriminate. I am interested in where our National Healthcare Plan will take us over the next few years and wonder whether more litigation will be ahead of us if penalties are put in place.
Cleveland Clinic has a policy not to hire smokers - even if they do not smoke at work. Smoking is highly correlated with mental illness, so one could say that it is discrimination, but the policy stands. Actually overeating/obesity is also correlated with mental illness. If someone consumes too much alcohol off-hours it will impact their job performance - or even if they just stay up all night having sex or playing Words with Friends :). Smoking, drinking, overeating, and not exercising are all modifiable risk factors that impact a person's health. It is apples to apples if looking at absenteeism, negative impact on health, and loss of productivity.
However our country voted for this, so if we accept government issued healthcare, we will be required to play by the rules set forth in the legislation. If the government is accepting the risk and requiring health insurers to accept the risk without pre-existing conditions, it is reasonable to think that they should have the right to make sure the insured (general public) are doing everything they can to prevent illness so we can reduce costs and provide coverage for everyone.
And on a final note, what's good for one should be good for all. If small businesses and individuals are required to follow the rules set forth in ObamaCare, then government workers, unions, and large employers should be as well - the "get out of jail free cards" being issued to appease groups that voted for our president and for the congress and senate that signed the bill are atrocious. Healthcare reform is needed. But our corrupt government practices that exempt corporations, unions, and those who passed the healthcare reform legislation are indefensible.
Cleveland Clinic has a policy not to hire smokers - even if they do not smoke at work. Smoking is highly correlated with mental illness, so one could say that it is discrimination, but the policy stands. Actually overeating/obesity is also correlated with mental illness. If someone consumes too much alcohol off-hours it will impact their job performance - or even if they just stay up all night having sex or playing Words with Friends :). Smoking, drinking, overeating, and not exercising are all modifiable risk factors that impact a person's health. It is apples to apples if looking at absenteeism, negative impact on health, and loss of productivity.
However our country voted for this, so if we accept government issued healthcare, we will be required to play by the rules set forth in the legislation. If the government is accepting the risk and requiring health insurers to accept the risk without pre-existing conditions, it is reasonable to think that they should have the right to make sure the insured (general public) are doing everything they can to prevent illness so we can reduce costs and provide coverage for everyone.
And on a final note, what's good for one should be good for all. If small businesses and individuals are required to follow the rules set forth in ObamaCare, then government workers, unions, and large employers should be as well - the "get out of jail free cards" being issued to appease groups that voted for our president and for the congress and senate that signed the bill are atrocious. Healthcare reform is needed. But our corrupt government practices that exempt corporations, unions, and those who passed the healthcare reform legislation are indefensible.
Monday, February 25, 2013
Large Trial Shows Cardiovascular Benefits Of Mediterranean Diet
Large Trial Shows Cardiovascular Benefits Of Mediterranean Diet - Larry Husten, Forbes
A large new trial offers powerful evidence that a Mediterranean diet can reduce the risk for cardiovascular disease. Results of the PREDIMED (Prevención con Dieta Mediterránea) study were published online in the New England Journal of Medicine.
Investigators in Spain randomized 7447 people at high risk for cardiovascular disease to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts, or a control diet for which people were advised to lower their intake of dietary fat. The diets were designed not to restrict calories but to change the composition of the diet.
The trial was stopped early in July 2011 by the data and safety monitoring board when the benefits in the Mediterranean diet groups crossed a predetermined boundary. After 4.8 years of follow-up a primary endpoint event (the composite of MI, stroke, and death from CV causes) occurred in 3.8% of patients in the Mediterranean diet extra-virgin olive oil group, 3.4% in the Mediterranean diet with nuts group, and 4.4% of patients in the control group. After adjusting for small differences among the groups, the hazard ratios for the two Mediterranean diet groups were 0.70 (95% CI, 0.54-0.92) and 0.72 (95% CI, 0.54-0.96). The benefit in favor of the Mediterranean diet groups occurred early in the trial and continued throughout the follow-up period. The results were consistent across a broad range of subgroups.
Given that the results appear consistent with those from previous smaller trials and observational studies, the authors said that “a causal role of the Mediterranean diet in cardiovascular prevention has high biologic plausibility. The results of our trial might explain, in part, the lower cardiovascular mortality in Mediterranean countries than in northern European countries of the United States.”
The authors said the benefits of the Mediterranean diet may be explained by several different factors, including moderate alcohol consumption, low consumption of meat, and high consumption of vegetables, fruits, nuts, legumes, fish, and olive oil.
One PREDIMED investigator, Emilio Ros, told CardioBrief that he believes the results of the trial mean that current recommendations regarding dietary fat should be changed to reflect that a “high fat, high vegetable fat diet is optimal for cardiovascular health.” Another study investigator, Ramón Estruch, said that “a major problem with low-fat diets is their low potential for long-term sustainability.” He said that the results clearly demonstrate “the superiority of the Mediterranean diets.”
Investigators in Spain randomized 7447 people at high risk for cardiovascular disease to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts, or a control diet for which people were advised to lower their intake of dietary fat. The diets were designed not to restrict calories but to change the composition of the diet.
The trial was stopped early in July 2011 by the data and safety monitoring board when the benefits in the Mediterranean diet groups crossed a predetermined boundary. After 4.8 years of follow-up a primary endpoint event (the composite of MI, stroke, and death from CV causes) occurred in 3.8% of patients in the Mediterranean diet extra-virgin olive oil group, 3.4% in the Mediterranean diet with nuts group, and 4.4% of patients in the control group. After adjusting for small differences among the groups, the hazard ratios for the two Mediterranean diet groups were 0.70 (95% CI, 0.54-0.92) and 0.72 (95% CI, 0.54-0.96). The benefit in favor of the Mediterranean diet groups occurred early in the trial and continued throughout the follow-up period. The results were consistent across a broad range of subgroups.
Given that the results appear consistent with those from previous smaller trials and observational studies, the authors said that “a causal role of the Mediterranean diet in cardiovascular prevention has high biologic plausibility. The results of our trial might explain, in part, the lower cardiovascular mortality in Mediterranean countries than in northern European countries of the United States.”
The authors said the benefits of the Mediterranean diet may be explained by several different factors, including moderate alcohol consumption, low consumption of meat, and high consumption of vegetables, fruits, nuts, legumes, fish, and olive oil.
“Perhaps there is a synergy among the nutrient-rich foods included in the Mediterranean diet that fosters favorable changes in intermediate pathways of cardiometabolic risk, such as blood lipids, insulin sensitivity, resistance to oxidation, inflammation, and vasoreactivity.”One limitation, acknowledged by the authors, is that the reduction in total fat intake in the control group was small. In addition, although people in the Mediterranean diet groups ate more fish and legumes, they did not substantially alter other aspects of their diet. The authors speculated that the consumption of the recommended olive oil and nuts, which were distributed for free to patients in the Mediterranean diet groups, may have been “responsible for most of the observed benefits of the Mediterranean diets.”
One PREDIMED investigator, Emilio Ros, told CardioBrief that he believes the results of the trial mean that current recommendations regarding dietary fat should be changed to reflect that a “high fat, high vegetable fat diet is optimal for cardiovascular health.” Another study investigator, Ramón Estruch, said that “a major problem with low-fat diets is their low potential for long-term sustainability.” He said that the results clearly demonstrate “the superiority of the Mediterranean diets.”
Thursday, February 21, 2013
Looking forward to the American College of Cardiology
The American College of Cardiology Scientific Sessions are March 9-11 in San Francisco, CA. I am very much looking forward to the cutting-edge scientific data that will be presented - it is an amazing scientific forum.
Can't wait to see everyone soon! Dina
Can't wait to see everyone soon! Dina
Wednesday, February 20, 2013
From the infamous Dr. Sharma's Obesity Notes...
Obesity Fact #1 Heritability is Not Destiny
Now that we have discussed the myths and presumptions,
it is time to turn to what the authors of the New England
Journal of Medicine paper consider to be “facts”.
These are statements about obesity, which the authors consider facts because there is sufficient evidence to consider them empirically proven.
As one may expect, “conclusive” evidence can only come from experimental studies (ideally, consistent findings from several well-designed randomised controlled trials, which constitute the highest level of evidence). Thus, it should come as no surprise that most of the facts identified by the authors pertain to issues that lend themselves to examination in such trials.
Obesity Fact #1 is that,
This finding is neither new nor limited to obesity. After all, even severe monogenic inborn errors of metabolism (like phenylketonuria) respond to changes in the environment (like elimination of phenylalanine in the diet).
However, it is important to remember that achieving lower weights for someone with a strong genetic disposition for obesity will always be so much harder than for someone without that genetic risk.
Thus, while environmental changes, which affect everyone, can perhaps reduce the average weight in a population, they will still leave the biggest people the biggest (albeit at a lower weight).
Just how big and feasible such environmental changes would need to be to significantly reduce obesity will remain to be seen.
At the individual level we have a fair idea that, for some people, this effort is likely to be substantial (readers may recall the recent series on Mark, Julie, Gertrude and Janice).
At an individual level there is certainly no doubt that some people are going to have to work much harder at trying to lose weight or keeping it off than others - so much at least, will always be destiny.
AMS
Edmonton, AB
These are statements about obesity, which the authors consider facts because there is sufficient evidence to consider them empirically proven.
As one may expect, “conclusive” evidence can only come from experimental studies (ideally, consistent findings from several well-designed randomised controlled trials, which constitute the highest level of evidence). Thus, it should come as no surprise that most of the facts identified by the authors pertain to issues that lend themselves to examination in such trials.
Obesity Fact #1 is that,
“Although genetic factors play a large role, heritability is not destiny; calculations show that moderate environmental changes can promote as much weight loss as the most efficacious pharmaceutical agents available.”This fact is based on several studies that have shown that it is indeed possible to “modulate” genetic risk by changes to the environment (i.e. diet and exercise).
This finding is neither new nor limited to obesity. After all, even severe monogenic inborn errors of metabolism (like phenylketonuria) respond to changes in the environment (like elimination of phenylalanine in the diet).
However, it is important to remember that achieving lower weights for someone with a strong genetic disposition for obesity will always be so much harder than for someone without that genetic risk.
Thus, while environmental changes, which affect everyone, can perhaps reduce the average weight in a population, they will still leave the biggest people the biggest (albeit at a lower weight).
Just how big and feasible such environmental changes would need to be to significantly reduce obesity will remain to be seen.
At the individual level we have a fair idea that, for some people, this effort is likely to be substantial (readers may recall the recent series on Mark, Julie, Gertrude and Janice).
At an individual level there is certainly no doubt that some people are going to have to work much harder at trying to lose weight or keeping it off than others - so much at least, will always be destiny.
AMS
Edmonton, AB
Aspirin No Help for Stroke Outcomes
Aspirin No Help for Stroke Outcomes
Low-dose aspirin might help ward off transient ischemic attacks (TIAs), but it didn't reduce overall incidence of stroke or improve outcomes following a stroke, an analysis of the Women's Health Study showed.There was no significant difference in total stroke incidence between women randomized to 100 mg of aspirin every other day and those randomized to placebo (OR=0.86, 95% CI 0.72 to 1.04), according to Pamela M. Rist, ScD, of Brigham and Women's Hospital in Boston, and colleagues.
Nor was the use of aspirin associated with significantly better functional outcomes in terms of total stroke, ischemic stroke, or hemorrhagic stroke (although outcomes tended to be worse for hemorrhagic stroke), they reported in the February issue of Stroke: Journal of the American Heart Association.
The odds ratios for experiencing a modified Rankin score (mRs) of 2-3, for example, were 0.94 for total stroke and 0.90 for ischemic stroke, but 1.66 for hemorrhagic stroke (all nonsignificant).
For an mRs of 4-6, the odds ratios were 0.94 for total stroke and 0.63 for ischemic stroke, but 1.47 for hemorrhagic stroke (all nonsignificant).
The fact that there was no benefit for aspirin for total stroke incidence is was most likely due to a nonsignificant increase in hemorrhagic stroke (OR=1.30, 95% CI 0.86 to 1.97), the authors wrote. Those taking aspirin did have a significantly decreased risk for TIA (OR=0.77, 95% CI 0.63 to 0.94) and a significant reduction in ischemic stroke (OR 0.90, 95% CI 0.65 to 0.98).
"This underscores the importance of using primary prevention methods, for example, aspirin or blood pressure-lowering treatment to reduce stroke incidence and its associated morbidity," Rist and colleagues wrote.
They also noted the importance of reducing "the morbidity burden" in women because they tend to have "worse functional outcomes after stroke compared with men."
Although aspirin has been validated as a means to prevent ischemic stroke in women, its impact on stroke morbidity is less well known.
However, an observed lower risk of TIA associated with aspirin in a previous analysis of the Women's Health Study might translate into a reduction of the "risk of stroke with a mild functional impairment," they said.
To accumulate more evidence for aspirin's effect on outcomes, Rist and colleagues analyzed participants from the Women's Health Study who had reported a stroke or TIA in the preceding year: 460 confirmed strokes (366 ischemic, 90 hemorrhagic, and four unknown), and 405 confirmed TIAs. Mean follow-up was 10 years. They compared stroke patients against study participants who had not reported a stroke.
The original Women's Health Study randomized nearly 40,000 healthy female healthcare professionals to receive 600 IU vitamin E or placebo, and low-dose aspirin or placebo on alternate days. The primary endpoint was cardiovascular disease or cancer.
The results, reported in 2005, showed vitamin E supplements did not protect women against heart attacks and stroke, nor did the vitamin have an effect on total cancer or the most common cancers in women -- breast, lung, and colon cancers, according to the study published July 6 in the Journal of the American Medical Association.
A subanalysis of the Women's Health study last year concluded that vitamin E was no help in preventing heart failure.
There was some functional benefit to those taking aspirin who did not smoke compared with placebo nonsmokers, but only in reducing TIA (OR 0.71, 95% CI 0.58 to 0.89) and having an mRs of 0-1 (OR 0.67, 95% CI 0.43 to 0.93).
"Whereas randomized assignment to 100 mg of aspirin every other day may reduce the risk of ischemic cerebral vascular events, especially TIA, we did not observe differential effects on functional outcomes from stroke," Rist and colleagues concluded.
Researchers did not have information on pre-stroke disability, and the results may not be generalizable to men, they said.
Tuesday, February 19, 2013
My favorite Online-Only Retail Boutiques...
My tried and true...favorite online boutiques....free shipping, free returns, amazing selection. Of course there are many nice department store sites for high end designer brands, etc, but for unique items...
Shopbop.com
Revolveclothing.com
And best coupons...
retailmenot.com
Shopbop.com
Revolveclothing.com
And best coupons...
retailmenot.com
Did we need to research this?? Smoking & Obesity combined reducing lifespan of young adults??
(HealthDay)—Young adults and teens who smoke, are obese and have high blood sugar levels may be more likely to die before they reach their 55th birthday, new government research suggests.
The findings are concerning when viewed in context of the rising rates of childhood obesity in the United States. Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 years, according to the U.S. Centers of Disease Control and Prevention. As a result, diseases and conditions previously only seen in adults are increasingly being diagnosed in children. These include high blood pressure, high cholesterol and type 2 diabetes.
"Given the numbers of youth who are obese, this is a concern," said the study's author, Dr. Sharon Saydah, a CDC senior scientist. "Any time somebody dies before age 55, it has an overall societal impact."
The average life expectancy in the United States is 78.7, according to the CDC.
The report was published online Feb. 18 and will be in the March print issue of the journal Pediatrics.
Saydah and her colleagues analyzed data on close to 9,250 people who took part in the third National Health and Nutrition Examination Survey.
Participants were aged 12 to 39 when the study was conducted. Of these, more than 15 percent were obese, and 30 percent were smokers. Overall, 298 of the participants died before they turned 55.
Those who smoked between the ages of 12 and 39 had an 86 percent greater risk of dying before 55, compared with those who did not, the data showed. Those who were obese when they were young had a 39 percent higher likelihood of dying before 55, compared with those not obese during these early years. In addition, the risk of dying before 55 tripled among those with high blood sugar levels between the ages of 12 to 39, the study showed. High blood pressure and high cholesterol levels, however, did not affect the risk of dying before age 55.
So, what can parents do today to help their kids live longer, healthier lives?
"There is not one specific thing we can recommend," Saydah said. "There is a need for more effective strategies to try and prevent obesity and smoking, and improve the overall health of the younger population."
This starts with encouraging healthier eating, a more active lifestyle and smoking cessation, she added.
Dr. Nazrat Mirza, an attending pediatrician in the Goldberg Center for Community Pediatric Health at Children's National Medical Center in Washington, D.C., said the new study confirms other findings and does so using nationally representative data.
"It's another wake-up call that obesity is associated with a higher risk of early death," she said. And this risk starts to build early in life.
"The stakes are very high," she added. "If these current trends continue, we won't become extinct, but it will affect our workforce and our defense."
Prevention is the key, Mirza said, adding, "Parents must set the stage very early in life by teaching and modeling healthy behaviors that will track into adolescence and early adulthood."
One expert noted that, as a doctor, she planned to do more to get the message across to adolescents.
"The poignancy of the study is the fact that these risks affect us at an earlier age," said Dr. Lisa Ipp, an assistant professor in pediatrics at Weill Cornell Medical College in New York City, who added she may turn the volume up on her usual healthy living messages as a result of these findings.
"Adolescents are a challenging group and we try our best to do risk reduction counseling and get them to get out of harm's way," she said. "But based on this data, we will certainly push a little bit harder."
The findings are concerning when viewed in context of the rising rates of childhood obesity in the United States. Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 years, according to the U.S. Centers of Disease Control and Prevention. As a result, diseases and conditions previously only seen in adults are increasingly being diagnosed in children. These include high blood pressure, high cholesterol and type 2 diabetes.
"Given the numbers of youth who are obese, this is a concern," said the study's author, Dr. Sharon Saydah, a CDC senior scientist. "Any time somebody dies before age 55, it has an overall societal impact."
The average life expectancy in the United States is 78.7, according to the CDC.
The report was published online Feb. 18 and will be in the March print issue of the journal Pediatrics.
Saydah and her colleagues analyzed data on close to 9,250 people who took part in the third National Health and Nutrition Examination Survey.
Participants were aged 12 to 39 when the study was conducted. Of these, more than 15 percent were obese, and 30 percent were smokers. Overall, 298 of the participants died before they turned 55.
Those who smoked between the ages of 12 and 39 had an 86 percent greater risk of dying before 55, compared with those who did not, the data showed. Those who were obese when they were young had a 39 percent higher likelihood of dying before 55, compared with those not obese during these early years. In addition, the risk of dying before 55 tripled among those with high blood sugar levels between the ages of 12 to 39, the study showed. High blood pressure and high cholesterol levels, however, did not affect the risk of dying before age 55.
So, what can parents do today to help their kids live longer, healthier lives?
"There is not one specific thing we can recommend," Saydah said. "There is a need for more effective strategies to try and prevent obesity and smoking, and improve the overall health of the younger population."
This starts with encouraging healthier eating, a more active lifestyle and smoking cessation, she added.
Dr. Nazrat Mirza, an attending pediatrician in the Goldberg Center for Community Pediatric Health at Children's National Medical Center in Washington, D.C., said the new study confirms other findings and does so using nationally representative data.
"It's another wake-up call that obesity is associated with a higher risk of early death," she said. And this risk starts to build early in life.
"The stakes are very high," she added. "If these current trends continue, we won't become extinct, but it will affect our workforce and our defense."
Prevention is the key, Mirza said, adding, "Parents must set the stage very early in life by teaching and modeling healthy behaviors that will track into adolescence and early adulthood."
One expert noted that, as a doctor, she planned to do more to get the message across to adolescents.
"The poignancy of the study is the fact that these risks affect us at an earlier age," said Dr. Lisa Ipp, an assistant professor in pediatrics at Weill Cornell Medical College in New York City, who added she may turn the volume up on her usual healthy living messages as a result of these findings.
"Adolescents are a challenging group and we try our best to do risk reduction counseling and get them to get out of harm's way," she said. "But based on this data, we will certainly push a little bit harder."
Wednesday, February 13, 2013
Conflict Of Interest Is A Complex Issue
Robert McKinnon Califf, MD and Harlan M. Krumholz, MD, SM
In a recent editorial in the Journal of the American College of Cardiology, Robert Califf discusses a few of the many complex questions related to the conflict of interest issue. Here CardioExchange’s Harlan Krumholz further explores the issue with Califf.
CardioExchange: Do you think that conflict of interest issues are mostly an issue about optics and not substance – or are you concerned that relationships with funders sometimes influence the science in ways that are not favorable to society?
Califf: I believe that financial conflict of interest has real substance, but that focusing exclusively on the medical products industry and failing to consider other sources of conflict of interest is a huge mistake and leads to sensationalism that then engenders reactive rules that add to bureaucracy rather than addressing the real issues. Yes, relationships with funders (medical products industry, NIH, foundations) have a huge influence on science as do professional rivalries, egos and desire to appear in the press (fame).
CardioExchange: One concern is that many trials are not under the control of the principal investigator– do you think that the profession should insist on trials that are not under the control of the funder?
Califf: I do not believe that a human experiment should be “under the control” of any single individual. Every aspect of a clinical trial is a compromise and no one gets everything they want. In fact a despotic, egotistical principal investigator can be just as dangerous as a controlling funding organization. Like our constitution, trials need a balance of power: PI, executive committee, steering committee, investigators, DMC, regulators, funders—all have a role to play. Yes, the PI ultimately is responsible, just as Hillary Clinton and Barack Obama were responsible for the security of our embassies—but there are many players. People understand this, and we should think of trials the same way. Indeed, one of the biggest influences on trials will now be the participants themselves,who are rightly becoming invovled in design, conduct and interpretation of trials.
CardioExchange: Even when the trial is not under the control of the funder, there may be other types of control. Should the PI and investigators always have full control of the data?
Califf: For now, I believe the sponsor and the trialists should both have the data under a set of rules agreed to before the trial starts. The biggest issue here is that most academic institutions are incapable of correctly managing complex trial data or analyzing it, so the PI’s are dependent on analyses from the sponsor or a CRO (clinical research organization) hired by the sponsor. I DO BELIEVE THAT INVESTIGATORS SHOULD ANALYZE THE DATA INDEPENDENTLY WITH ACCESS TO THE FULL DATA SET.
CardioExchange: What is the best path forward with conflict of interest, assuming that disclosure is not enough (since it is hard to interpret)?
Califf: The best path forward is transparency and public access to the data so that many people can analyze and interpret. This will take time. Importantly, my interpretation of the available information is that:
Academic analyses have more major errors and are not as reproducible as industry analyses. The oversight and punishment of bad behavior by FDA is important.
Bias in choosing the question is a much bigger issue than lying about the data.
In industry-sponsored trials, lying about the data is rare. Lying by omission (not looking at aspects of the data) is much more common
Tuesday, February 12, 2013
S.C. health officials consider food stamp soda ban in obesity battle
S.C. health officials consider food stamp soda ban in obesity battle
Joey Holleman
The State (Columbia, S.C.)
Seeking to slow the childhood obesity epidemic, South Carolina health leaders would like to limit the purchase of sugar-filled drinks with food stamps. Catherine Templeton, director of the Department of Health and Environmental Control, and Lillian Koller, director of the Department of Social Services, have exchanged thoughts on the subject.
Seeking to slow the childhood obesity epidemic, South Carolina health leaders would like to limit the purchase of sugar-filled drinks with food stamps.
Catherine Templeton, director of the Department of Health and Environmental Control, and Lillian Koller, director of the Department of Social Services, have exchanged thoughts on the subject. They agree that cutting the intake of sugary drinks could improve the health of the state’s children, but they are struggling with how to use the food stamp program as a tool in that effort, and especially with whether the federal government will allow it.
Several similar efforts, most notably by New York City, have failed to gain approval from the U.S. Department of Agriculture, which runs the Supplemental Nutrition Assistance Program, commonly referred to as food stamps. The feds told New York in 2011 that they agree with the goal of limiting intake of sugary drinks, but the city’s proposal had operational challenges and impacted too many people. They suggested a test program on a smaller scale.
Might South Carolina, or several counties in the state, be the right size for a test case? The state has plenty of SNAP recipients (about 875,000) and way too many obese people (about 1.6 million, based on estimates that one-third of the state is obese).
Templeton would like to see the state try something to reduce the intake of sugary beverages. She says the state and federal governments are ultimately “feeding” the obesity epidemic on the front end through the SNAP program and then spending billions on the back end in treatment for the health issues caused by obesity.
Templeton recognizes she will face opposition from the beverage industry and from people who resist any effort by the government to be food police. She isn’t trying to prevent people from buying soft drinks, just trying to stop paying for those drinks with public dollars.
“You treat your body the way you want to treat your body,” Templeton said. “But the government shouldn’t be subsidizing it.”
Templeton contacted Koller, whose agency handles the SNAP program in the state, for help with breaking the cycle of increasing obesity and increasing health care costs.
“I am charged with finding ways to address the obesity epidemic in South Carolina,” Templeton said. “One way is by reducing the poor quality of nutrition available under the SNAP program.”
Koller pointed out that the state would have to get a waiver from USDA to allow for changes in the SNAP regulations. The state would have to come up with some more focused plan than those tried by previous states. Koller suggested targeting only households with children in them.
Templeton suggested narrowing the scope with trial runs in only a few counties. She has been working to bring more state resources to anti-obesity efforts in three poor counties with high rates of obesity and few anti-obesity programs – Bamberg, Fairfield and Lee. Those counties, with about 17,000 SNAP recipients, could be test cases for a ban on using SNAP funds for sugary drinks.
Koller also brought up the idea of a two-pronged approach, discouraging sweetened drinks while encouraging healthier food. Some advocates have pushed for doubling the amount of SNAP funds when people use them for purchasing healthy foods such as fruits and vegetables. That’s already done at some local farmers markets in a program approved by the USDA.
Templeton agrees with that goal, but she said it might be better to focus only on sugary drinks for a test case. Limiting the scope of any waiver would seem to be a key to gaining approval. The USDA’s response to New York City noted it would impact hundreds of thousands of households. “A change of this significance should be tested on the smallest scale appropriate to minimize any unintended negative effects,” the response noted.
New York City called for banning use of SNAP funds for any drink with more than 10 calories per eight ounces, with exceptions for 100 percent fruit juices and milk. That would have ruled out using SNAP funds to pay for most nondiet soft drinks, as well as many energy drinks and sports drinks.
The USDA also noted the challenges in getting retailers to implement the restrictions and the need to collect health data to make sure the effort is working.
South Carolina has no shortage of researchers who would get behind such a project. Templeton already has broached the subject with University of South Carolina president Harris Pastides. USC in Columbia and MUSC in Charleston have multiple ongoing obesity-related studies.
Teresa Moore, who teaches about nutrition in USC’s Arnold School of Public Health, would like to see progress on the effort to slow the intake of sugary drinks. “I think we should limit them,” she said. “They are empty calories.”
But she noted it’s difficult to convince people to cut intake of sugary beverages when they are much less expensive than beverages that are healthier for children, such as juices and milk. Limiting use of SNAP funds for sugary beverages could change that equation for the state’s poor.
Read more here: http://www.miamiherald.com/2013/02/01/v-print/3211725/sc-health-officials-consider-food.html#storylink=cpy
Joey Holleman
The State (Columbia, S.C.)
Seeking to slow the childhood obesity epidemic, South Carolina health leaders would like to limit the purchase of sugar-filled drinks with food stamps. Catherine Templeton, director of the Department of Health and Environmental Control, and Lillian Koller, director of the Department of Social Services, have exchanged thoughts on the subject.
Seeking to slow the childhood obesity epidemic, South Carolina health leaders would like to limit the purchase of sugar-filled drinks with food stamps.
Catherine Templeton, director of the Department of Health and Environmental Control, and Lillian Koller, director of the Department of Social Services, have exchanged thoughts on the subject. They agree that cutting the intake of sugary drinks could improve the health of the state’s children, but they are struggling with how to use the food stamp program as a tool in that effort, and especially with whether the federal government will allow it.
Several similar efforts, most notably by New York City, have failed to gain approval from the U.S. Department of Agriculture, which runs the Supplemental Nutrition Assistance Program, commonly referred to as food stamps. The feds told New York in 2011 that they agree with the goal of limiting intake of sugary drinks, but the city’s proposal had operational challenges and impacted too many people. They suggested a test program on a smaller scale.
Might South Carolina, or several counties in the state, be the right size for a test case? The state has plenty of SNAP recipients (about 875,000) and way too many obese people (about 1.6 million, based on estimates that one-third of the state is obese).
Templeton would like to see the state try something to reduce the intake of sugary beverages. She says the state and federal governments are ultimately “feeding” the obesity epidemic on the front end through the SNAP program and then spending billions on the back end in treatment for the health issues caused by obesity.
Templeton recognizes she will face opposition from the beverage industry and from people who resist any effort by the government to be food police. She isn’t trying to prevent people from buying soft drinks, just trying to stop paying for those drinks with public dollars.
“You treat your body the way you want to treat your body,” Templeton said. “But the government shouldn’t be subsidizing it.”
Templeton contacted Koller, whose agency handles the SNAP program in the state, for help with breaking the cycle of increasing obesity and increasing health care costs.
“I am charged with finding ways to address the obesity epidemic in South Carolina,” Templeton said. “One way is by reducing the poor quality of nutrition available under the SNAP program.”
Koller pointed out that the state would have to get a waiver from USDA to allow for changes in the SNAP regulations. The state would have to come up with some more focused plan than those tried by previous states. Koller suggested targeting only households with children in them.
Templeton suggested narrowing the scope with trial runs in only a few counties. She has been working to bring more state resources to anti-obesity efforts in three poor counties with high rates of obesity and few anti-obesity programs – Bamberg, Fairfield and Lee. Those counties, with about 17,000 SNAP recipients, could be test cases for a ban on using SNAP funds for sugary drinks.
Koller also brought up the idea of a two-pronged approach, discouraging sweetened drinks while encouraging healthier food. Some advocates have pushed for doubling the amount of SNAP funds when people use them for purchasing healthy foods such as fruits and vegetables. That’s already done at some local farmers markets in a program approved by the USDA.
Templeton agrees with that goal, but she said it might be better to focus only on sugary drinks for a test case. Limiting the scope of any waiver would seem to be a key to gaining approval. The USDA’s response to New York City noted it would impact hundreds of thousands of households. “A change of this significance should be tested on the smallest scale appropriate to minimize any unintended negative effects,” the response noted.
New York City called for banning use of SNAP funds for any drink with more than 10 calories per eight ounces, with exceptions for 100 percent fruit juices and milk. That would have ruled out using SNAP funds to pay for most nondiet soft drinks, as well as many energy drinks and sports drinks.
The USDA also noted the challenges in getting retailers to implement the restrictions and the need to collect health data to make sure the effort is working.
South Carolina has no shortage of researchers who would get behind such a project. Templeton already has broached the subject with University of South Carolina president Harris Pastides. USC in Columbia and MUSC in Charleston have multiple ongoing obesity-related studies.
Teresa Moore, who teaches about nutrition in USC’s Arnold School of Public Health, would like to see progress on the effort to slow the intake of sugary drinks. “I think we should limit them,” she said. “They are empty calories.”
But she noted it’s difficult to convince people to cut intake of sugary beverages when they are much less expensive than beverages that are healthier for children, such as juices and milk. Limiting use of SNAP funds for sugary beverages could change that equation for the state’s poor.
Read more here: http://www.miamiherald.com/2013/02/01/v-print/3211725/sc-health-officials-consider-food.html#storylink=cpy
Monday, February 11, 2013
Authors' Self-Declared Financial Conflicts of Interest Do Not Impact the Results of Major Cardiovascular Trials
Authors' Self-Declared Financial Conflicts of Interest Do Not Impact the Results of Major Cardiovascular Trials
Ashish Aneja, MD; Ricardo Esquitin, MD; Kshitij Shah, MD; Rupa Iyengar, MPH; Rosane Nisenbaum, PhD; Magda Melo, MSc; Shiny Matthewkutty, MD; Sanjum S. Sethi, MD; Muhammad Mamdani, PharmD; Michael E. Farkouh, MD, MSc
[+-] Author Information
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Reprints requests and correspondence: Dr. Michael E. Farkouh, The Cardiovascular Institute, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1074, New York, NY 10029
Copyright 2013, American College of Cardiology Foundation. All Rights Reserved.
J Am Coll Cardiol. 2013;():. doi:10.1016/j.jacc.2012.10.056
Published online
ArticleFiguresTablesReferencestext A A A
Abstract Abstract | Methods | Results | Discussion | References
Objectives This study assessed whether the results of major, potentially practice-altering cardiovascular trials were influenced by the authors' self-declared financial conflicts of interest (FCOI). Secondary objectives included assessment of trial outcomes by source of funding, by FCOI subtype, and by trial end points.
Background Financial conflicts of interest, ubiquitous in cardiovascular medicine because of significant investigator-industry collaborations, potentially can influence trial outcomes.
Methods A MEDLINE search was performed using the MeSH term cardiovascular disease limited to randomized controlled trials and clinical trials published from January 1, 2000, through April 15, 2008, in 3 high-impact journals. Two reviewers independently abstracted data from the published article. Chi-square tests, Fisher exact tests, and multivariate logistic regression were used to assess the associations between FCOI and study characteristics and between FCOI and trial outcomes.
Results Of the 550 articles reviewed, 51.1% satisfied FCOI criteria, including at least one of the following: stock ownership, employee, speaker's bureau, and consultant). Of the 538 articles providing sponsorship information, 34.6% reported funding solely by nonprofit organizations, 48.3% reported funding solely by industry, and 17.1% reported funding by a combination. Prevalence of FCOI significantly increased with level of industry funding: 21.5% (none), 50.0% (shared), 75.0% (industry solely, n = 281, p < 0.0001). However, no differences in reporting of favorable results were detected when articles were analyzed by self-declared FCOI (60.5% vs. 59.5% in those with and without, odds ratio: 1.04, p = 0.81). This result was upheld in multivariate analysis.
Conclusions Authors' self-declared FCOI and source of funding do not seem to impact outcomes in major cardiovascular clinical trials.
Ashish Aneja, MD; Ricardo Esquitin, MD; Kshitij Shah, MD; Rupa Iyengar, MPH; Rosane Nisenbaum, PhD; Magda Melo, MSc; Shiny Matthewkutty, MD; Sanjum S. Sethi, MD; Muhammad Mamdani, PharmD; Michael E. Farkouh, MD, MSc
[+-] Author Information
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Reprints requests and correspondence: Dr. Michael E. Farkouh, The Cardiovascular Institute, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1074, New York, NY 10029
Copyright 2013, American College of Cardiology Foundation. All Rights Reserved.
J Am Coll Cardiol. 2013;():. doi:10.1016/j.jacc.2012.10.056
Published online
ArticleFiguresTablesReferencestext A A A
Abstract Abstract | Methods | Results | Discussion | References
Objectives This study assessed whether the results of major, potentially practice-altering cardiovascular trials were influenced by the authors' self-declared financial conflicts of interest (FCOI). Secondary objectives included assessment of trial outcomes by source of funding, by FCOI subtype, and by trial end points.
Background Financial conflicts of interest, ubiquitous in cardiovascular medicine because of significant investigator-industry collaborations, potentially can influence trial outcomes.
Methods A MEDLINE search was performed using the MeSH term cardiovascular disease limited to randomized controlled trials and clinical trials published from January 1, 2000, through April 15, 2008, in 3 high-impact journals. Two reviewers independently abstracted data from the published article. Chi-square tests, Fisher exact tests, and multivariate logistic regression were used to assess the associations between FCOI and study characteristics and between FCOI and trial outcomes.
Results Of the 550 articles reviewed, 51.1% satisfied FCOI criteria, including at least one of the following: stock ownership, employee, speaker's bureau, and consultant). Of the 538 articles providing sponsorship information, 34.6% reported funding solely by nonprofit organizations, 48.3% reported funding solely by industry, and 17.1% reported funding by a combination. Prevalence of FCOI significantly increased with level of industry funding: 21.5% (none), 50.0% (shared), 75.0% (industry solely, n = 281, p < 0.0001). However, no differences in reporting of favorable results were detected when articles were analyzed by self-declared FCOI (60.5% vs. 59.5% in those with and without, odds ratio: 1.04, p = 0.81). This result was upheld in multivariate analysis.
Conclusions Authors' self-declared FCOI and source of funding do not seem to impact outcomes in major cardiovascular clinical trials.
Wednesday, February 6, 2013
Rising Childhood Obesity Rates Lead to the First-Ever Guidelines for Treating Kids with Type 2 Diabetes
At the 2013 Cardiometabolic Health Congress (CMHC), Drs. Jay Skyler, Sonia Caprio, and David Ludwig will provide in-depth guidance on how to manage diabetes, obesity and cardiovascular disease in the pediatric population. For more information on the CMHC contact Dina Kouveliotes at info@cardiometabolichealth.org or 877.571.4700 or visit www.cardiometabolichealth.org
For information on the new American Academy of Pediatric Guidelines, see website address below:
http://health.usnews.com/health-news/news/articles/2013/01/28/first-ever-guidelines-issued-for-treating-type-2-diabetes-in-kids
For information on the new American Academy of Pediatric Guidelines, see website address below:
http://health.usnews.com/health-news/news/articles/2013/01/28/first-ever-guidelines-issued-for-treating-type-2-diabetes-in-kids
U.S. Food and Drug Administration (FDA) Approves KYNAMRO™ (mipomersen) for Homozygous Familial Hypercholesterolemia (HoFH)
Developed by Isis Pharmaceuticals and marketed by Genzyme, A SANOFI COMPANY under the name “KYNAMRO™”, this once-weekly injection works with other lipid-lowering medications and diet to prevent the rise of LDL-C. KYNAMRO™ (mipomersen) is now one of two FDA approved treatments for HoFH. The 2012 CMHC featured a continuing medical education (CME) symposium on Familial and Severe Hypercholesterolemia – watch the symposium for detailed information on practical approaches for screening, diagnosis and management of patients with HoFH at www.cmhc-online.com. For more information on the Cardiometabolic Health Congress contact Dina Kouveliotes at info@cardiometabolichealth.org / 877.571.4700 or visit www.cardiometabolichealth.org
Read FDA press release below...
FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder
The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).
HoFH, an inherited condition that affects about one out of every one million people in the United States, occurs when the body is unable to remove LDL-C, often called “bad” cholesterol, from the blood causing abnormally high levels of circulating LDL-C. For those with HoFH, heart attacks and death often occur before age 30. Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide) to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.
“Kynamro, an injection given once a week, works with other lipid-lowering medications and diet to impair the creation of the lipid particles that ultimately give rise to LDL-C,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research.
The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH. On average, levels of LDL-C fell by about 25 percent during the first 26 weeks in those receiving the drug. Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use.
The FDA approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription.
The most common adverse reactions in the clinical trial included injection site reactions, flu-like symptoms, nausea, headache and elevations in liver enzymes (serum transaminases).
The FDA is requiring four postmarketing studies for Kynamro: the development of a sensitive assay that binds double-stranded (ds) DNA; a study to assess for the presence of antibodies to ds-DNA in patients treated with Kynamro; a long-term registry of patients with HoFH to determine the long-term safety of Kynamro; and an enhanced pharmacovigilance program to monitor reports of malignancy, immune-mediated reactions, and hepatic abnormalities in patients treated with Kynamro.
A new report by Johns Hopkins Bloomberg School of Public Health finds many physicians feel under qualified to treat obesity.
To meet this educational need, a huge portion (pun intended) of the 2013 Cardiometabolic Health Congress (CMHC) is dedicated to obesity management. Obesity experts including Drs. Robert Eckel, Ken Fujioka, W. Timothy Garvey, Samuel Klein, Robert Kushner, I-Min Lee, David Nathan, Francesco Rubino and Arya Sharma will offer practical strategies to effectively manage patients who are overweight or obese and have, or are at risk of, cardiovascular/metabolic disease and related comorbidities.
For more information on the Cardiometabolic Health Congress contact Dina Kouveliotes at 877.571.4700/ info@cardiometabolichealth.org or visit www.cardiometabolichealth.org
Follow link below to read the article about the Bloomberg School of Public Health report.
www.jhsph.edu/news/news-releases/2012/bleich_physician_training.html
How reporting on obesity and car crashes turned into a data journalism train wreck
How reporting on obesity and car crashes turned into a data journalism train wreck
Rebecca Goldin, Ph.D., February 4, 2013
Data analysis is the new big thing in journalism; but it’s the little details that count
carcrashTo the list of risks associated with being obese, we must – if we are to believe recent news reports in USA Today and Fox News – add dying in an automobile accidents.
The source for this claim is a new study published by the Emergency Medicine Journal of the BMJ group, and therefore seems authoritative. But one of the hazards of reporting “new studies” – especially those with alarming findings – without referring back to the research that has been already undertaken on the topic is, one might say, science reporting’s equivalent of driving while under the influence.
So, if we leap back a year, we find that there was a similar study published in the American Journal of Emergency Medicine with conflicting results.
First, some qualification so we know what the media’s claim actually is about: It’s not that you are more likely to die from an accident if you are obese – it’s that if you are in a serious car accident, you are more likely to die from that accident if you are obese (though the claims are not so immediate in the scientific literature – see the caveats below). In particular, there is no evidence presented that obese people are more likely to be involved in a serious car accident than non-obese people.
And so, according to the news, the EMJ study found that among people involved in traffic collisions, obese people were more likely to die of their injuries than non-obese people. USA Today pointed out that underweight people are also at risk.
Except that this is not really what the study found. Obesity is defined as having a body mass index (BMI) level of over 30 in adults. In a comparison with death rates for people with normal BMI rates of 18.5 to 24.9, the EMJ in looking at just under 7,000 people, found no correlation between obese BMI levels of 30-34.5 and increased death (RR of 1.21 with 95% CI 0.98 to 1.49); no correlation with overweight people with BMI 25-29.9 and increased death (RR of 0.94 with 95% CI .82 to 1.09); and no correlation with underweight people with BMI less than 18.5 and increased death (RR=1.19, 95% CI 0.86 to 1.63).
Instead, the authors of the EMJ study found a correlation only among the severely obese, those with a BMI 35-39.9 (RR= 1.51, CI 1.10 to 2.08) and the morbidly obese, those with a BMI greater than 40 (RR= 1.80, CI 1.15 to 2.84). When broken down into gender-specific deaths, only women who were severely obese (but not that who were morbidly obese with a BMI over over 40, strangely) were found to have a statistically significant elevated risk (RR= 2.2, 95% CI 1.27 to 3.81). Remember that a result is considered statistically significant only if the CI (confidence interval) does not include the value 1.0.
In other words, the media accounts of what the study said were largely inaccurate. And this is before we examine the study in light of previous contrasting evidence.
Thus, the American Journal of Emergency Medicine study published in January, 2012, found less depressing results for overweight folk, using data from a much larger sample of over 155,000 people involved in traffic accidents. The odds ratios (similar to the relative risk) suggested a statistically significant benefit for overweight people. The adjusted risk of death reported as the odds ratio compared with normal weight people was OR, .952 (95% CI .911-.995). There was no statistically significant benefit or risk to being obese (BMI 30-34.9). In this study, the risk seemed to be localized to those who are underweight (OR =1,115, 95% CI 1.035-1201), severely obese (OR 1.212, 95% CI 1.28-1.302) and morbidly obese (OR 1.559; 95% CI 1.402-1.734).
So if one wanted to report the news accurately, the headlines should have said, “Car accidents and severe obesity may be a deadly mix: New study confirms risk” – perhaps with a subhead, “Previous benefit to overweight drivers and risk to underweight drivers is unconfirmed.”
The American Journal of Emergency Medicine study refers BMI levels of 35-39.9 “moderately obese” but for consistency with the Emergency Medicine Journal, we use “severely obese” for these levels in order to make appropriate comparisons.
Rebecca Goldin, Ph.D. is the Director of Research at STATS.org.
For information on the Cardiometabolic Health Congress contact Dina Kouveliotes at 877.571.4700 or visit www.cardiometabolichealth.org
Thursday, August 2, 2012
Can Surgery Reverse Type 2 Diabetes in Obese Patients?
2012 CMHC speaker Francesco Rubino has been in the news lately. His recent New England Journal of Medicine study, reported on by CBS News and other news outlets, suggests that bariatric surgery can reverse type 2 diabetes in morbidly obese patients.
Dr. Rubino’s provocative keynote address for Thursday afternoon, October 11, 2012 at the CMHC is titled Are We Ready for Bariatric Surgery as the Treatment of Choice for T2DM? Dr. Rubino, director of The Diabetes Surgery Center at New York-Presbyterian Hospital/Weill Cornell Medical Center, will discuss his own clinical data and other high-profile studies on the topic.
As always at the CMHC, this keynote address will focus on the practical, clinical implications of the information presented. Clinical issues that Dr. Rubino will cover in his talk include the following:
• The various available bariatric surgical approaches and what is known about the metabolic effects of each.
• How to identify obese patients with type 2 diabetes who would be good candidates for bariatric surgery.
• How clinicians can find surgeons with solid experience in bariatric surgical techniques.
• A cost-benefit analysis of surgical intervention in obese patients with type 2 diabetes.
“I’m really anticipating Francesco’s presentation,” said CMHC co-chair Robert Eckel, MD. “The bariatric approach for diabetes management is an option these days for us, but is this research or clinical care? How should patients be selected? Can we afford it? So many questions and Dr. Rubino is in a great position to address them.”
This entry was posted in Diabetes, Obesity by Jeff Minerd. Bookmark the permalink.
Wednesday, April 11, 2012
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