FDA To Reconsider Once-Rejected Diet Drug

February 17th, 2012

 

ABC News

 

By: Carrie Gann

 

In the search for treatments to fight obesity, regulators are turning their attention to a diet drug that has already failed to receive government approval as a weight loss treatment.

Next week, a panel of advisors to the U.S. Food and Drug Administration will consider whether or not to recommend the diet drug Qnexa for approval. The move is the latest attempt to give new tools to patients and doctors to fight the obesity that currently plagues one-third of Americans. It also fans a fiery debate about the search for a “magic bullet” alternative to difficult lifestyle changes to help obese people lose weight.

Qnexa was rejected by the FDA in 2010 over concerns about potentially dangerous side effects, such as cardiovascular problems and birth defects. Now, the FDA will consider whether or not the drug’s manufacturer, Vivus, should do a larger clinical trial to investigate the potential for cardiovascular side effects.

But some obesity specialists are, in effect, already giving the drug to their patients by prescribing Qnexa’s two major ingredients, phentermine and topiramate. The practice, called off-label prescribing, is not prohibited by the FDA. Doctors who have prescribed this combination say it has helped patients shed pounds when many other paths to weight loss have failed.

Dr. Ken Fujioka, director of the Center for Weight Management at Scripps Clinic in San Diego, said he often sees obese patients who have changed their diets, started exercising more and still have not been able to lose more than a few pounds. Though bariatric surgery is a lasting, effective option for long-term weight loss, many patients either aren’t morbidly obese enough to qualify for the surgery or are reluctant to resort to such a drastic measure to lose weight. For about 30 of these patients, Fujioka has prescribed low doses of phentermine and topiramate.

“The weight loss with this combination rivals bariatric surgery and I see using these meds in the seriously obese patient as an alternative,” Fujioka said.

Dr. Jana Klauer, a New York City-based doctor specializing in weight management, said her patients lost an average of 40 pounds when taking the drugs along with improved diet and exercise plans.

“The drug combination gives great results, providing diet and exercise are part of the plan,” she said.

Vivus, the company that developed Qnexa, said in a statement that the drug is a combination of low doses of both drugs and it is intended for use in combination with improvements in diet and exercise. Vivus said it does not support the off-label use of phentermine and topiramate.

The drugs work by suppressing appetite, and both have been approved by the FDA for other uses. Phentermine, a stimulant, is already approved for weight loss, but only for short-term use. Topiramate is an anticonvulsant, for which weight loss is a side effect.

But a laundry list of side effects has many experts concerned about the safety of the drugs, if taken over a long period of time. Topiramate creates feelings of mental fogginess, memory lapses and a lack of concentration.

Phentermine, one of drugs that made up the failed diet drug Fen-Phen, can lead to a range of cardiovascular side effects, such as high blood pressure, heart attacks and heart palpitations. Dr. David Katz, co-founder of the Yale University Prevention Research Center, noted that these side effects are the very problems caused by obesity.

Dr. Charles Clark, a professor of pharmacology and toxicology at Indiana University, said the potential side effects are enough to keep him from prescribing phentermine and topiramate to his patients, particularly in light of the failure of Fen-Phen, which was withdrawn from the market in 1997 after causing fatal blood pressure and heart valve problems in patients.

“Given our experience with Fen-Phen, we should be cautious in our use of these agents until larger and longer-term trials are completed,” Clark said.

Others say concerns about side effects of both drugs and their offspring Qnexa are legitimate, but could be managed or avoided if doctors carefully monitor patients while they’re taking the drug. For example, the FDA’s concerns about potential birth defects caused by Qnexa could be resolved by not prescribing the drug to women who could get pregnant. Many doctors say the risks of these drugs may be outweighed by the benefits for some patients with disabling health problems caused by obesity.

In the past 20 years, a parade of diet drugs have come before the FDA, representing an effort by drug companies to give obese patients and their doctors alternatives to difficult, often unsuccessful lifestyle changes. Most of the drugs have failed to meet the agency’s standards for safety and effectiveness. Many come with a list of embarrassing side effects, such as anal leakage, and only one, Alli, is approved for long-term use. A handful of drugs, such as Metabolife and Meridia, were removed from the market because of heart safety concerns.

Some doctors say there is no evidence that Qnexa will perform better than the diet drugs that have already flopped.

“I have made selective use of some weight loss drugs, but have not to date found much reason for enthusiasm for any of them,” Katz said. “I don’t have much for Qnexa.”

Others are more hopeful that Qnexa is different, including Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Clinic Foundation in New Orleans. He cites evidence from previous clinical trials that Qnexa helps patients lose a modest amount of weight, which improves their risk factors for diabetes, high blood pressure and other cardiovascular problems. He said cardiovascular and birth defect risks that the FDA cited in its first look at the drug were very slight and “clinically unimportant.”

“Considering the dismal results that many experience with attempted weight loss with diet and exercise, which is always the first choice, and the explosion in the need and use of bariatric surgery, this combination drug should be a major advance, and I hope that it gets approved this time by the FDA,” Lavie said.

 

For The Full Report Go To ABC News

 

Fructose Is Found To Increase Cardiovascular And Diabetes Risk In Adolescents

February 16, 2012

Natural News

By John Phillip

Researchers at the Medical College of Georgia at Georgia Health Sciences University have published evidence that cardiovascular disease and diabetes risk is present in the blood fractions of adolescents who consume a lot of fructose, a scenario that worsens in the face of excess belly fat. Published in theJournal of Nutrition, scientists determined that high dietary fructose consumption results in lower levels of cardiovascular protectors such as HDL cholesterol and adiponectin, due in part to how the body metabolizes the fruit-based mega-sweetener at the cellular level. Excess body fat accumulated around the mid-section, a rapidly growing problem in adolescents, compounds the problem when compared to those with less visceral fat deposits. A wealth of scientifically validated research studies now highlight the importance of eliminating fructose in all its forms from the diets of both adults and children alike to dramatically reduce risk of diabetes and heart disease.

The study detailed an analysis of 559 adolescents, aged 14 to 18 and detailed cardiovascular risk factors including high blood pressure, fasting glucose, insulin resistance and blood inflammatory factors. Excess fat around the midsection was found to exacerbate the identified risk factors, as compared to those with generalized fat right beneath the skin known as subcutaneous fat, where an association was not evident.

Click here for the full report from Natural News

Fructose Is Found To Increase Cardiovascular And Diabetes Risk In Adolescents

February 15, 2012

Natural News

By John Philip

“You would think that school would stop selling soda to the students after reports like this. But nope, they get too much money from Coke.” –KTRN

Researchers at the Medical College of Georgia at Georgia Health Sciences University have published evidence that cardiovascular disease and diabetes risk is present in the blood fractions of adolescents who consume a lot of fructose, a scenario that worsens in the face of excess belly fat. Published in the Journal of Nutrition, scientists determined that high dietary fructose consumption results in lower levels of cardiovascular protectors such as HDL cholesterol and adiponectin, due in part to how the body metabolizes the fruit-based mega-sweetener at the cellular level. Excess body fat accumulated around the mid-section, a rapidly growing problem in adolescents, compounds the problem when compared to those with less visceral fat deposits. A wealth of scientifically validated research studies now highlight the importance of eliminating fructose in all its forms from the diets of both adults and children alike to dramatically reduce risk of diabetes and heart disease.

The study detailed an analysis of 559 adolescents, aged 14 to 18 and detailed cardiovascular risk factors including high blood pressure, fasting glucose, insulin resistance and blood inflammatory factors. Excess fat around the midsection was found to exacerbate the identified risk factors, as compared to those with generalized fat right beneath the skin known as subcutaneous fat, where an association was not evident.

Click here for the full report.

A Daily Aspirin May Cause Internal Bleeding

January 10, 2012

SkyNews

A daily aspirin may not be worth the risk for people with no existing heart condition.

A study of more than 100,000 people by St George’s, University of London, found that an aspirin a day could reduce heart risks by 10%.
But long-term there is a 30% increase in the risk of life-threatening or debilitating internal bleeding.
Aspirin, which thins the blood and helps prevent clotting, is a standard treatment for patients recovering from heart attacks or strokes.
Many doctors have also prescribed regular aspirin as a precaution to healthy people who may be at increased risk due to their medical and family history.
For every 120 people treated with aspirin for around six years, one cardiovascular event was averted.

Click here for the full report from SkyNews.

FDA Alert : Multaq (Dronedarone) Increased Risk Of Death / Cardiovascular Problems

December 20, 2011

Medical News Today

By MNT

“Here is yet ANOTHER pharmaceutical drug that causes … death!  When did someone die from taking too much vitmain D3? H ow bout never.” –KTRN

The drug Multaq, from Sanofi-Aventis, is used to treat cardiac arrhythmias, however the FDA has issued a warning today stating that in further trials it has shown a serious risk of cardiovascular problems, including death.

More specifically the FDA states that Multaq must now carry the warning :

“Healthcare professionals should not prescribe Multaq to patients with Permanent Atrial Fibrillation who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.”

Click here for the full report.

Find Out More About The Amazing Nutrient CoQ10

October 27, 2011

Natural News

By Paul Fassa

Coenzyme Q10, known as CoQ10, is highly regarded as a super antioxidant. But is it for real? CoQ10 gets a lot of good press, but it’s not cheap. So to buy and try or not to buy and try is the question. Not all supplements live up to their reputation, and not all supplements are right for everyone. Let’s examine CoQ10 a bit.

What it is and isn’t
CoQ10 is not a magic bullet. It is an important compound that our bodies produce, but production declines as we age. It functions best in conjunction with a decent diet and other quality supplements. Foods such as organic organ meats, oily fish, spinach, peanuts, and whole grains provide some CoQ10.

It likes to lodge in the parts of our cells that produce energy, and is instrumental for producing the molecule adenosine-5-triphosphate (ATP). ATP is a major source of cellular energy, and it’s involved with several metabolic processes within the cell, including protein production.

Beside its antioxidant capabilities, which scavenge damaging free radicals that cause cellular damage, it appears able to repair oxidative damage. CoQ10 prevents problematic blood clotting. All these qualities have made it a favorite for increasing cardiovascular health and for preventing heart diseases or recovering rapidly from heart problems.

In addition to hundreds of reports from Japanese doctors on CoQ10′s positive effects with heart patients, Dr. Denton Cooley found that most of his heart disease patients were CoQ10 deficient. His finding corroborates discoveries from Karl Folker, Ph.D, who had originally researched CoQ10 in the west.

For athletic types or those who are involved in strenuous activities, CoQ10 offers rapid recovery times from spent energy and muscular stress as well as additional energy too for competing athletically or completing arduous physical tasks.

Click here for the full report from Natural News.

Chocolate Reduces Stroke Risk In Women, Study Finds

October 26, 2011

Natural News

By Mary West

Swedish researchers have contributed the latest glad tidings to a growing number of studies indicating chocolate is beneficial for the cardiovascular system. According to a study published in the Journal of the American College of Cardiology, scientists found that women, who ate the most chocolate, had a 20 percent reduction in their stroke risk: USA Today reports. In this case, the quantity consumed was approximately two candy bars per week.

Author Susanna Larsson explains that the healthful components of cocoa are compounds called flavonoids, which have antioxidant activity and the ability to impede the harmful oxidation of low-density lipoprotein (LDL), known as “bad cholesterol.” Since the oxidation of LDL leads to the formation of plaque that causes cardiovascular disease, the hindrance of this process reduces the risk of stroke. In addition to this advantage, previous studies have shown dark chocolate consumption can lower blood pressure and insulin resistance, as well as help prevent the formation of blood clots.

In spite of the positive findings, Larsson cautions against eating too much chocolate. She advises that it be consumed in moderation, due to its high content of calories, fat and sugar. Larsson also states that dark chocolate is superior to milk chocolate because it has more cocoa and less sugar.

The researchers at Karolinska Institute studied 33,000 women between the ages of 49 and 83 over a 10-year period. Scientists compared data from the participants’ questionnaires about their chocolate consumption with their stroke risk to determine if a correlation existed. Results revealed the more chocolate the women consumed, the less stroke incidence they incurred. The findings were significant because those who ate 2.3 ounces of chocolate per week had a 20 percent reduced stroke incidence compared to those who seldom ate chocolate.

Although the study does not prove chocolate was responsible for the reduced incidence, after controlling for other stroke risk factors, the results persisted: Larsson relayed to CBS News. Additionally, she expects the results to apply to men also. Regardless of the suggested benefit, experts are advising people to keep the results in perspective and not substitute chocolate for vegetables.

Click here for the full report from Natural News.

New Research Says Increasing Salt Decreases Heart Attacks

October 20, 2011

The Great Fitness Experiment

By Charlotte Hilton Andersen

Pop quiz time! Salt: life-giving nutrient or heart attack in a ceramic shaker? If you grew up like I did then you probably think of salt as a no-no for a healthy lifestyle but research is now saying that not only does salt not cause heart attacks like we’ve all been told for the past 20 years, but that slashing salt intake increases incidence of cardiovascular death. Surprised? You shouldn’t be – this ”new” research that’s been making headlines over the past few weeks is based on studies over 20 years old. And yet one of the first things people generally do when they’re trying to get healthy is cut back on sodium. Whole diet programs are based almost solely around this one principle.

Me being me, I took this advice to heart and removed almost all salt from diet several years ago. I never added even a smidgen of salt to foods and if a recipe called for it I just omitted it (yet another reason my cookies turned out like turds?). My self righteousness knew no bounds as I handed the salt shaker back to the waiter telling him we wouldn’t be needing that murderous mineral at our table.

So imagine my surprise when during my Great Over-Exercising Debacle Where I Suppressed My Thyroid, Gained Ten Pounds and Lost My Freaking Mind one of the first things my doctor told me to do was to eat more salt. Her recommendation was based on the fact I needed more iodine – a nutrient commonly added to table salt – to support my floundering thyroid but when I told her I’d cut all salt out of my diet years before, her jaw dropped. “Why would you do that?” she gasped. “You need salt!”

I should have known that salt wasn’t all evil when my infant son used to get super excited to see me after a hard workout – so he could lick the salty sweat off my shoulder and neck. Yeah, my 10-lb baby boy that I pushed out my nethers and therefore owes me big time for the rest of my life, only loved me as a salt lick. Babies may shoot poop up their backs but they’re not dumb, especially when it comes to feeding. Humans need some salt.

But like anything in nature, salt doesn’t operate in a vacuum. (When I was a kid I thought the adage was “Nature whores a vacuum” which if you’ve ever seen a Kirby Vacuum sales presentation, is kinda true.) Sodium needs to be balanced with potassium for our bodies to function properly on a cellular level. This is the idea behind those “electrolyte replacement” drinks sweaty exercisers are pushed to drink and all the banana-pimping at races (wow, could I have made that sound any worse?). Note: while bananas are a good source of potassium they’re not dietary rockstars in that nutrient. Apricots, tomato puree, raisins and figs take top honors with apricots containing more than 3 times the amount of potassium.

And yet, research still shows that salt can increase blood pressure and that some people are genetically sensitive to the white stuff. In addition, conventional medical wisdom still advises all adults to cut sodium intake. Plus salt makes you bloat and that’s the last thing we girls need. Even more confusing are all the different types of salt with their different medicinal properties and how table salt is processed into impotency. So which is it? And if we do eat salt, what kind? And how much? And isn’t it kinda gross and unhygienic to let your baby lick you after a workout?

For myself I have decided that salt has long been considered essential for humans and I’m going to eat it and not worry about limiting it in my foods. I also make sure to eat plenty of potassium as well. My only caveat is that I try to only eat salt I add myself rather than buying sodium laden processed foods. I trust my Celtic sea salt. I don’t trust that can of soup giving me the evil eye on aisle 13.

What’s your opinion on salt? Were you as surprised by these findings as I was? Anyone want to educate me on which type of salt I should be using?

Click Here For The Full Report

Optimism May Help You Live Longer

March 3rd, 2011

AOL Health

By: Catherine Donaldson Evans

A positive outlook may help guard against heart disease and increase the chances of a long life, a new study suggests, bolstering previous findings.

Researchers from Duke University Medical Center followed 2,800 patients who’d been hospitalized with heart disease. Those with the most optimistic attitudes about making a full recovery were more likely to live longer than their pessimistic counterparts, according to lead author John Barefoot.

Specifically, the upbeat heart patients had a 30 percent greater chance of survival after 15 years than the negative ones.

“Our research shows better physical recovery and a higher likelihood of survival is linked to attitude — personal beliefs about their illness,” Barefoot, a professor emeritus at Duke, told USA Today.

The team of scientists asked the cardiac patients being treated for coronary artery disease to fill out a questionnaire while they were in the hospital being diagnosed. The survey asked them how they felt about their recovery and their outlook on resuming their normal way of life.

They were told to “agree” or “disagree” with statements including “I expect my lifestyle will suffer;” “I can still live a long, healthy life;” and “I doubt that I’ll ever fully recover,” according to Barefoot.

The researchers tracked the patients for about 15 years after their treatment and accounted for a wide range of factors, including age, gender, seriousness of condition, depression and income level, the paper said. They still found that optimism was linked with longevity and better health.

Though it isn’t known exactly why a positive attitude seems to be correlated with good health, Barefoot theorizes it may be because optimistic people handle illness better, are less likely to give up hope, are more adept at problem solving, have less of a physiological reaction to stress and exercise more regularly.

“I think those kinds of things need to be investigated in much more detail,” he said.

There could be other explanations for the results, however.

Dr. Steven E. Nissen, department chair of cardiovascular medicine at the Cleveland Clinic, told ABC News that patients “with a ‘positive’ attitude may simply be healthier than patients with a negative attitude. In fact, their ‘attitude’ may reflect their health status.”

The optimistic participants may also have been getting higher-quality medical treatment than the pessimistic ones.

“Cardiovascular providers [might] give better care to patients with a positive outlook — perhaps spending more time with them or being more conscientious,” Dr. James Kirkpatrick, assistant professor of medicine at the University of Pennsylvania, told ABC.

Click here for the full report from AOL Health

Diet Soda Linked to Heart Attack and Stroke Risk

February 10th, 2011

ABCNews.com

By: Kate Moisse

New research that links diet soda consumption with an increased risk of heart attack and stroke has doctors urging caution about the controversial and preliminary results.

According to a study of more than 2,500 people presented today as a poster at the American Stroke Association International Stroke Conference in Los Angeles, people who drank diet soda daily had a 61 percent increased risk of cardiovascular events compared to those who drank no soda, even when accounting for smoking, physical activity, alcohol consumption and calories consumed per day.

“This study suggests that diet soda is not an optimal substitute for sugar-sweetened beverages, and may be associated with a greater risk of stroke,” Hannah Gardener of the University of Miami and her colleagues reported at the conference.

But the questionnaire-based study garnered criticism by experts in diet, nutrition and vascular disease.

“This study has major flaws and should not change anyone’s diet soda consumption,” said ABC News Chief Health and Medical Editor Dr. Richard Besser.

The researchers used data obtained though the multi-ethnic, population-based Northern Manhattan Study to examine risk factors for stroke, heart attack and other vascular events such as blood clots in the limbs. While 901 participants reported drinking no soda at the start of the study, 163 said they drank one or more diet sodas per day.

“One of the many flaws here is that participants were asked about soda intake at only one point in time, when they entered the study,” Besser said. “It is difficult to imagine that people’s intake of soda is constant during that period.”

Association, Not Causation
Connie Diekman, a registered dietician and director of University Nutrition at Washington University in St Louis, said, “Population-based studies provide some ‘food for thought’ but shouldn’t be used as the basis of nutrition guides for individuals. This study would be another one that indicates more controlled studies are needed.”

Drinking regular or diet soda has previously been linked to diabetes and metabolic syndrome, a precursor to diabetes. Surprisingly, Gardener and colleagues failed to detect an increased cardiovascular risk among daily drinkers of regular soda.

“Unfortunately, it may be that individuals with poor dietary habits do resort in some kind of calorie balancing and continue to eat high-calorie sweet foods but reduce their guilt by drinking diet soda,” said Dr. Howard Weintraub, clinical director of the New York University Center for the Prevention of Cardiovascular Disease, explaining the propensity to wash down a high-fat meal with low-cal soda.

Although the authors went on to control for metabolic syndrome (a component of which is obesity), peripheral vascular disease and cardiac disease history later in their analysis — lowering the magnitude of increased risk to 48 percent — they did not account for variations in eating habits.

“In my 20 years of clinical practice, patients who consume diet soda tend to have more of a sweet tooth; to get more sweet cravings; to eat more foods with added sugar; and to like and eat more processed food than patients who avoid both regular and diet soda,” said Dr. David Katz, director of Yale University’s Prevention Research Center.

Click here for the full report from ABCNews.com

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