Weight Loss News: Carrie Fisher’s weight loss is no joke

2011-08-25 / Weight Loss & Obesity / 2 Comments

Carrie Fisher’s weight loss is no joke

Back in December, writer and actress Carrie Fisher began a long journey to shed pounds, hiring on as a celebrity spokeswoman for weight loss company Jenny Craig and targeting 30 lbs. She did far better.

On Wednesday, the woman who in her twenties made many a young man swoon as “Star Wars” Princess Leia in her metal bikini, revealed that she’d lost 50 lbs.

Fisher, now 54, has used her sly wit to write seriously about her life’s struggles growing up in a celebrity family, daughter of Debbie Reynolds and Eddie Fisher. One book, “Wishful Drinking,” morphed into a one-woman stage show. Here, she reveals how she went from a chubby 180 lbs to a fit 130.

Q: Everyone always wants to know, what’s the secret?

A: “It is better to not do it all by yourself, so I had the consultant that Jenny Craig provides. You can vent any frustration to that person, and it’s good to have someone cheering for you when you don’t feel like cheering for yourself, and to keep you focused on the positive.”

Q: When you think back, just before you decided to diet, what did you think about yourself?

A: “I was ashamed. I knew also what the weight implied — that you’re saying ’screw it’ to your health. I have a daughter; I can’t afford to risk my health anymore. But it was just like, ‘no one’s going to see me, and I’m too old anyway and what am I doing trying to fit into a bathing suit and trying to get picked up in a bar in Acapulco.’ The bottom line is: I was really embarrassed, and didn’t think I could do it.”

Q: Had you tried other weight loss programs?

A: “I hadn’t really done a lot of them. I’d always tried myself, but nothing had worked for me in the last four years. I’d always had excuses like I was on the road…It was getting annoying that my mother was thinner than I was! And, of course, my daughter — that’s where my old body is, she has it. Now, I wear one size higher than she.”

Q: A big problem people have with dieting is that it feels like they are denying themselves all the foods they want? Or, at least, what they are accustomed to eating.

A: “There’s not a lot of room for (denial) in the Jenny Craig system, so you don’t. The food is good enough that you don’t feel denied…You have to stay focused on that. You are getting results, and that is the good thing about having someone else help you keep your eye on the prize.”

Q: I asked you what you thought about yourself when you started the program. How about now? How do you see yourself?

A: “I can’t even believe I did it. It’s amazing. I really did think, ‘I’m never going to look good again, so screw it.’ I never did think I looked that good, even when I was cute.”

Q: In May, you reached your target of losing 30 lbs, but you kept going to take off the additional 20. Why?

A: “Because it looks better, because as you do it, you get on a roll and it’s not a fat roll! It’s going well, so you’re reassured because you have results…I lost the 30 lbs kind of comparatively easy. The last 20 were hard. It was not easy, but it is fun to be able to focus your rage at the consultant.”

Q: And, I’d guess, it gave you new material for a book.

A: “Yes, a new chapter called ‘Wishful Shrinking.’”

Medical Minute 8-24: Weight Loss Procedure Curing Diabetes

He was the personal chef for millionaire Donald Trump.

And now, Tom Haynes is responsible for bringing students into the Institute of Culinary Education.

“I’ve had the great pleasure of working with tens of thousands of students,” said Tom Haynes, Chef.

But he’s most proud of what he did for his health.

Weighing in at 285, Tom was diabetic for 10 years.

“I had to stab myself 13 times a day with insulin.”

Today, Tom is insulin- and medication-free — all because of a side effect of bariatric surgery.

“Some patients who take insulin for type 2, they have an operation, and very often, we don’t put them back on insulin,” said Francesco Rubino, M.D., New York-Presbyterian/Weill Cornell.

Doctor Francesco Rubino is spearheading the studies of gastric bypass surgery and its effects on type-two diabetes. It started back in 1999 when he noticed an unexpected side effect to the surgery he was performing on morbidly obese patients.

“I noticed some patients had diabetes remission as early as days or weeks after the operation.”

Once a surgery only used for people with body mass indexes over 35, now a new clinical trial at New York-Presbyterian is using gastric bypass for people suffering from diabetes with BMI as low as 26.

“I thought changing the gut anatomy, you change the way the way the gut speaks to the body.”

And the way the pancreas creates insulin, which doesn’t work properly for people with type-two diabetes. But why this surgery sends diabetes into remission is still a mystery.

“It’s totally changed my life.”

Miranda Kerr’s Weight Loss ‘Secret’ Is a Sham

Victoria’s Secret supermodels tend to look like they came from a completely different universe of beautiful, so it’s no wonder that when one of them spills the details of how she stays slim and gorgeous, many women cling to every word. And it’s really not all that surprising that women on both sides of the pond and Down Under are fascinated by new mom and wife to Orlando Bloom, Miranda Kerr. After all, she did just drop her baby weight like it was nothing. How the heck did she do it?

Well, apparently, coconut oil plays a major role in her beauty and weight maintenance regimen. She revealed last month that she’s been taking four tablespoons a day of the “healthy fat” (diluted in green tea or drizzled on salads) since she was 14, and it’s the one thing she “can’t live without.” She attributed her svelte body, clear skin, and glossy hair to the supplement. Then, surprise, surprise, within weeks, sales of coconut oil SOARED!

Oh man, are we all that gullible?

Don’t get me wrong. I’m pleased to hear Miranda’s touting a natural supplement that probably doesn’t cause any harm, and may do a body good, but is it a magic bullet for weight loss? Uhm … doubtful.

Some quick myth-busting: The medium-chain triglycerides (MCTs) in coconut oil have been said to boost metabolism and promote weight loss. I know we all wish this was really true (myself included!), but the fact of the matter is that preliminary human studies haven’t really shown weight loss effects from MCTs. And the evidence is slim on other “heart-healthy benefits.” Bummer.

That said, it’s totally annoying that so many of us are so hard up for beauty and weight loss fast fixes that we’re not even curious about what the research shows. We just think, “Miranda Kerr likes it? Sign me up!” failing to remember that uh … the supermodel is only 27 years old with fab genes, and also follows a hardcore regimen of daily yoga, light jogging, steamed veggies, fresh fruit, and fish. Coconut oil probably doesn’t hurt, but I’m sure it’s not doing the heavy lifting when it comes to keeping Miranda looking fit and gorgeous. Any woman who buys into the hype will probably just end up looking foolish.

Does Miranda Kerr’s love for coconut oil make you want to try it?

The Only Weightloss Is Essex: Kirk Norcross appears to have shed pounds over heartbreak of splitting from Lauren Pope

He might have recently had a nose job to thin the bridge after it was broken boxing – but it appears there’s a whole lot less of Kirk Norcross all round at the moment.

The 23-year-old Only Way Is Essex star appeared to have slimmed down drastically in these pictures taken yesterday as the ’scripted reality’ show was filming.

Perhaps his drastic weightloss is in a bid to impress his slender on-off DJ girlfriend Lauren Pope – or perhaps he’s been on the heartbreak diet.

The Only Way Is Essex couple have already split and reconciled twice, and earlier this month, they were said to be trying to give their troubled love affair a third try.

Lauren, 27, and Kirk, 23, split in June but according to sources close to the pair they want to give themselves one last go.

A source told the MailOnline: ‘It’s clear how much Kirk and Lauren love each other but the timing’s not right. The pressure of being in the public eye certainly put a strain on things.

‘We all think they will get back together as he can’t be without her. ‘

A bereft Lauren was said to have lost weight and became unhealthily skinny over their split – but fortunately, she has since regained much of the weight she lost and looks great.

However, now it looks like it’s Kirk’s turn to drop the pounds, having previously been so buff, he featured on the front cover of Attitude magazine.

The source said: ‘They both want to be together but it’s hard for them right now.’

Lauren and Kirk started dating last November when Kirk hired the model-turned-DJ to appear at his club Sugar Hut in Brentwood, Essex.

However, Sugar Hut promoter Kirk was minus Lauren today – and revealed on his Twitter he was on a day trip to Drayton Manor theme park in Tamworth with porn star Gemma Massey.

The 26-year-old was apparently a dental nurse before she got into adult modelling and films.

It’s not known how long she has known Kirk or what they’re relationship is.

Still, spending the day on rollercoasters is one way to forget about the ups and downs of his love life.

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Gout Treatment News: Gout drug may help some with few treatment options

2011-08-21 / Health News / 1 Comments

Gout drug may help some with few treatment options

A new drug that’s injected intravenously may help some very sick gout patients who don’t get better with usual treatment, according to a new study.

The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa, or pegloticase.

Patients taking the drug had fewer gout symptoms a few months after starting treatment than those who got a sham treatment — but they were also more likely to have a serious reaction to the injections.

The researchers say most gout patients don’t have very severe disease and should not be using the drug.

“The progression in these individuals is extreme,” study author Dr. Michael Becker, from the University of Chicago, told Reuters Health. The patients in the study had “gone on to have really severe — on average disabling — (gout), poor quality of life (and) lots of pain.”

“This is not a medication to be undertaken in a much larger group of patients,” he added.

Of 5 or 6 million people in the U.S. with gout, about three percent do not get better with typical gout drugs, such as Lopurin and Zyloprim, or they can’t take the medication for another reason, Becker and colleagues note in the Journal of the American Medical Association. Last year, the U.S. Food and Drug Administration approved Krystexxa — given by injection every other week — for use in those patients.

Gout is a form of arthritis that occurs when uric acid — generally passed out of the body in the urine — accumulates in joints and forms crystals, causing swelling and pain. Krystexxa works by breaking that uric acid down into a form that’s more easily passed through the body.

The current report combines data from two drug trials involving 212 patients with chronic gout. Study participants who got the drug injection every two weeks for six months were compared to a group that received injections once a month and a group that got only drug-free placebo injections.

The majority of patients were men — in their fifties, on average.

Krystexxa caused uric acid levels to fall quickly — but that response didn’t always last. Forty-two percent of patients in the biweekly group and 35 percent in the monthly group still had lowered uric acid six months after starting treatment.

On average, patients who received the drug had a bigger improvement in their general physical function and quality of life compared to those who only got the drug-free injections. And those who got the most frequent drug injections also reported the least pain.

However, more than nine out of ten patients reported at least one “adverse event” — including painful gout flare-ups or reactions to the injections, including a few cases of breathing problems. Those reactions were more common in patients taking Krystexxa.

Some patients also reported headaches and nausea.

Becker said doctors could test which patients had stopped responding to the drug and halt treatment to avoid unnecessary risks in people whose gout isn’t getting any better.

Krystexxa costs about $5,000 per month. Becker said patients whose symptoms improved with the injections could probably go back on cheaper medications — but it’s not clear yet how long most patients would have to get the injections first.

Most patients in the study also had heart conditions, or at least the risk factors for heart disease. Gout often occurs together with obesity and high blood pressure.

Becker said patients who don’t respond to Lopurin and Zyloprim have a couple of other medication options (including Uloric, approved by the FDA in 2009), but gout drugs can take up to several years to really kick in — and some patients with severe disease can’t wait that long. For a number of those patients, Krystexxa may be worth the risks and cost.

“When you have seriously ill people who have no options, 40 percent (of patients getting better) is pretty good,” he said. “Gout can be a really serious and disabling disease. With this and other (drugs) that are coming into line for treatment, we can do a good job in virtually all these people, including the sickest.”

Pegloticase an Option in Patients With Refractory Gout

Adults with severe chronic gout refractory to conventional urate-lowering therapy may respond to treatment with pegloticase (Krystexxa; Savient Pharmaceuticals, Inc), with reductions in uric acid levels, as well as improved physical function and quality of life.

The findings were based on 2 company-sponsored studies published in the August 17 issue of the Journal of the American Medical Association.

Long-term urate-lowering therapy is the mainstay of treatment of gout, John S. Sundy, MD, PhD, of Duke University Medical Center, Durham, North Carolina, and colleagues note in their study.

In roughly 3% of patients, conventional oral urate–lowering agents fail to achieve target uric acid levels of less than 6.0 mg/dL. Pegloticase was developed for this group of patients.

The drug was approved by the US Food and Drug Administration in September 2010 based in part on the results of the 2 randomized controlled trials reported in the Journal of the American Medical Association.

In comments to Medscape Medical News, Daniel Furst, MD, professor of rheumatology at the University of California, Los Angeles, and member of the American College of Rheumatology, said that pegloticase “clearly has a place as second- or third-line” therapy for refractory gout.

It fulfills an unmet need, but one that “is not yet fully characterized,” said Dr. Furst, who was not involved in these studies of pegloticase.

Parallel Randomized Controlled Trials With Similar Results

The 2 studies, known as C0405 and C0406, were conducted between June 2006 and October 2007 at 56 rheumatology practices in the United States, Canada, and Mexico. The studies lasted 6 months and involved a total of 225 patients: 109 in trial C0405 and 116 in trial C0406.

Study participants received 12 biweekly intravenous infusions of either pegloticase 8 mg at each infusion (biweekly treatment group), pegloticase alternating with placebo at successive infusions (monthly treatment group), or placebo.

One week before the first infusion and throughout the study, all participants received prophylaxis for gout flare with either colchicine (0.6 mg once or twice daily) or a nonsteroidal anti-inflammatory drug.

The primary endpoint was a plasma uric acid level of less than 6.0 mg/dL measured at months 3 and 6. A responder was defined as a patient with a plasma uric acid level of less than 6.0 mg/dL for 80% of the time or longer during months 3 and 6.

The investigators say plasma uric acid levels normalized within 24 hours of the first infusion in all patients receiving pegloticase. Some patients subsequently lost the urate-lowering response, whereas others maintained uric acid levels of less than 6.0 mg/dL throughout the trial.

When analyzed separately by dose, patients treated with biweekly pegloticase experienced response rates of 47% (20/43; 95% confidence interval [CI], 31% – 62%) and 38% (16/42; 95% CI, 24% – 54%) in the 2 trials.

Patients treated with monthly pegloticase had response rates of 20% (8/41; 95% CI, 9% – 35%) and 49% (21/43; 95% CI, 33% – 65%) in the 2 trials. Response rates were 0% in both placebo groups in the 2 trials.

When data from the 2 trials were pooled, response rates were 42% in the biweekly pegloticase group (36/85; 95% CI, 32% – 54%), 35% in the monthly pegloticase group (29/84; 95% CI, 24% – 46%), and 0% the placebo group.

The proportion of responders in both pegloticase treatment groups was significantly greater vs the placebo group in the pooled analysis (P < .001 for both), the investigators report.

They also note that average plasma uric acid levels were substantially below the 6.0-mg/dL target for the entire 6-month study period.

Forty percent of patients in the biweekly pegloticase group and 21% in the weekly pegloticase group had complete resolution of 1 or more tophi (a secondary endpoint) by the final visit vs 7% of patients in the placebo group (P = .002 and P = .20, respectively). Compared with placebo, both pegloticase doses were associated with significant improvements in physical function, quality of life, and pain on standard instruments.

Potential Adverse Events With Pegloticase

One or more adverse events occurred in more than 90% of participants in each treatment group. Serious adverse events were more common in patients treated with biweekly pegloticase (24%) and monthly pegloticase (23%) vs patients treated with placebo (12%).

Despite gout flare prophylaxis, roughly 80% of patients across the 3 pooled study groups experienced gout flare; it was the most common adverse event.

Infusion-related reaction was the second most common adverse event, occurring in 26% and 42% of patients receiving pegloticase biweekly and monthly, respectively, and in 5% of those receiving placebo. Ten percent of patients receiving pegloticase biweekly and 13% receiving it monthly dropped out of the study because of infusion-related reactions.

“Infusion-related reactions, including some cases fulfilling criteria for anaphylaxis, were the most common adverse events causing withdrawal from these trials,” the study authors note.

Although all of these reactions resolved “promptly and without sequelae, minimizing the risk for infusion-related reactions is important for the safe administration of pegloticase in clinical practice,” they advise.

Seven deaths occurred between randomization and the end of the study (4 in the pegloticase group and 3 in the placebo group).

Summing up, Dr. Sundy and colleagues say that these parallel, 6-month, placebo-controlled trials of pegloticase treatment indicate sustained uric acid reductions and significant clinical improvements in “a substantial proportion of patients with chronic gout and refractoriness to, or intolerance of, conventional urate-lowering therapy.”

Dr. Furst commented that the 2 studies have several limitations, including, but not limited to, the “small numbers, short duration and no cost effectiveness analysis.” He also said that the “generalizability” of the results “needs further work.”

The 2 studies were sponsored by Savient Pharmaceuticals. Four study authors were employees of Savient at the time of conception and performance of the studies. A complete description of disclosures can be found in the original article.

Dr. Furst discloses that he is an investigator in a trial of febuxostat (Uloric) and serves on a task force panel that is developing guidelines for treatment of gout. He has been on a number of national committees concerned with rheumatic therapeutics, including being a member and fellow in the American College of Rheumatology and the American Society of Clinical Pharmacology and Therapeutics.

Eisenhower Rheumatology Clinic uses new diagnostic tools, treatments to tackle rising gout incidences

Gout, a painful form of arthritis, has become an increasingly common problem in the United States. Gout is now the most common inflammatory joint disease in men of all ages, and in older women. Gout is caused by high levels of the chemical uric acid in the body, which is deposited into the joints as microscopic crystals. The crystals cause episodes of intense joint swelling and pain as the body’s immune system attempts to attack and break them down. Large studies in the United States indicate that the prevalence of gout nearly doubled from 2.9 to 5.2 cases per 1000 people from 1990 to 1999.

This significant increase in gout is generally attributed to negative lifestyle trends in the U.S. population. Obesity, diabetes, high blood pressure, and the consumption of red meat, alcohol and foods sweetened with fructose have been identified as risk factors for gout. Certain medications, medical conditions such as chronic kidney disease, and genetic factors influence an individual’s risk of gout as well. Pre-menopausal women have a low rate of gout due to the protective effects of estrogen. However, after menopause the rate of gout rises and is influenced by the same risk factors affecting men.

Fortunately, new diagnostic tools and treatments are being deployed to fight the growing epidemic. The traditional diagnosis of gout requires identifying gout crystals by removing them from an affected joint with a needle and syringe. This approach is not only painful, but is technically difficult in certain joints. Eisenhower’s Rheumatology Clinic is employing a new diagnostic tool in the form of high-frequency ultrasound scanning to identify gout crystals within the joint. The scan is quick and painless and can be performed during a routine office visit. In addition, blood testing and X-rays are often performed to determine the severity of gout and to guide treatment.

Once diagnosed, many patients require a medication to treat their gout. Failure to treat gout typically results in progressive disease severity over time and may lead to irreversible joint damage. Some severe gout flares mimic serious infections and may result in unnecessary hospitalizations and antiobiotic treatments. Until recently, treatment options were limited due to a relative dearth of clinical and research interest in gout. Allopurinol, an oral medication that lowers blood levels of uric acid, has long been the mainstay of gout treatment. However, for patients allergic or intolerant to this medication, until recently there was no equally effective alternative.

Physicians now have two additional treatment options. Febuxostat, an oral medication similar to allopurinol, is available for patients who fail or cannot tolerate allopurinol. Pegloticase, an intravenous medication given as an outpatient infusion, is available for cases that fail oral treatment. For many, gout treatment is managed by a primary care physician such as an Internal Medicine or Family Medicine physician. Complicated cases may be referred to a Rheumatologist.

The importance of modifying lifestyle-related risk factors to reduce gout cannot be over-emphasized. Reducing consumption of red meats, alcohol, and fructose-sweetened foods such as soft-drinks is recommended. Consumption of low-fat dairy products has been found to reduce the risk of gout, and therefore is encouraged. Finally, maintaining an ideal body weight through healthy diet and regular aerobic exercise directly reduces the risk of gout, with the added indirect benefit of reducing high blood pressure and kidney disease. A strategy that encompasses nutritional education and lifestyle changes as well as medication management offers the best chance of success in treating and preventing gout.

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Diabetes Treatment News: The American Diabetes Association Announces New Editors for Diabetes Care

2011-08-16 / Diabetes / 0 Comments

The American Diabetes Association Announces New Editors for Diabetes Care

The American Diabetes Association announces the appointment of William T. Cefalu, MD, of the Pennington Biomedical Research Center and the Louisiana State University Health Science Center (LSUHSC) School of Medicine, as the Editor-in-Chief of Diabetes Care. Diabetes Care is the Association’s premier peer-reviewed journal dedicated to diabetes care, prevention, and treatment.

The Association also announced the appointment of the following Associate Editors to the editorial team of Diabetes Care:
George Bakris, MD, University of Chicago Medical Center
Lawrence Blonde, MD, FACP, Ochsner Clinic and Alton Ochsner Medical Foundation
Andrew J. M. Boulton, MD, University of Manchester and the University of Miami
Mary de Groot, PhD, Indiana University School of Medicine
Eddie L. Greene, MD, Mayo Clinic
R. Robert Henry, MD, VA San Diego Healthcare System and the University of California, San Diego
Sherita Hill Golden, MD, MHS, FAHA, Johns Hopkins University
Frank Hu, MD, MPH, PhD, Harvard School of Public Health
Derek LeRoith, MD, PhD, Mount Sinai School of Medicine
Robert G. Moses, MD, South Eastern Sydney & Illawarra Area Health Service
Eric Ravussin, PhD, Pennington Biomedical Research Center
Stephen Rich, PhD, University of Virginia
Matthew C. Riddle, MD, Oregon Health & Science University
Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center
William V. Tamborlane, MD, Yale Center for Clinical Investigation
Katie Weinger, EdD, RN, Joslin Diabetes Center
Judith Wylie-Rosett, EdD, RD, Albert Einstein College of Medicine

The team will serve a three-year term, for the 2012 to 2014 volume years, with an optional two-year extension.

As the incoming Editor-in-Chief of Diabetes Care, Cefalu brings a wealth of professional and scholarly experience to the journal. Cefalu is Director of the Joint Diabetes, Endocrinology and Metabolism Program of the LSUHSC School of Medicine and Pennington Biomedical Research Center, as well as the Douglass L. Manship Sr., Professor of Diabetes at Pennington Biomedical Research Center.

The American Diabetes Association, the Pennington Biomedical Research Center, and the LSUHSC are proud to come together to support Cefalu and the publication of high-impact diabetes-related research in Diabetes Care.

“The appointment of Dr. Cefalu brings great honor to the Pennington Biomedical Research Center,” said Steven Heymsfield, MD, Executive Director. “The peer-reviewed Diabetes Care will continue under his editorship to provide timely, insightful, in-depth information on this profoundly important health topic.”

Likewise, Steve Nelson, MD, Dean of the LSUHSC School of Medicine, applauds the appointment of Cefalu as the next Editor-in-Chief of Diabetes Care. “This is well-deserved recognition for the stature that Dr. Cefalu has attained professionally. He is an accomplished physician scientist. We are proud to have him on our LSU School of Medicine faculty and honored that our school will be working closely with the American Diabetes Association in the dissemination of the latest in research findings for the care of patients with diabetes.”

Cefalu’s research is active at both the clinical and basic levels. On a clinical level, he is interested in clinical interventions to improve the metabolic state of individuals with insulin resistance and type 2 diabetes. On a basic level, he is interested in cellular mechanisms for insulin resistance. In addition, Cefalu also serves as Director for a National Institutes of Health-funded Center for the Study of Botanicals and Metabolic Syndrome at Pennington Biomedical Research Center.

Cefalu has published widely in journals, books, and book chapters and has edited several textbooks on the management of diabetes. He is a past Associate Editor for Diabetes Care and is currently an Associate Editor for Diabetes. He lectures both nationally and internationally.

Cefalu and his editorial team will succeed current Editor-in-Chief Vivian A. Fonseca, MD, and his current editorial team, which convened in July 2006 and will complete its term at the end of 2011:
Edward J. Boyko, MD
Antonio Ceriello, MD
Charles M. Clark, Jr., MD
Samuel Dagogo-Jack, MD, FRCP
Lawrence Fisher, PhD
Todd P. Gilmer, PhD
Carla J. Greenbaum, MD
James B. Meigs, MD, MPH
Richard E. Pratley, MD
Aaron I. Vinik, MD
Ruth S. Weinstock, MD, MPH
Bernard Zinman, MD

Current Associate Editors Andrew M. Boulton, MD; Robert G. Moses, MD; Katie Weinger, EDD, RN; and Judith Wylie-Rosset, EDD, RD, will continue with Cefalu’s team.

“My colleagues and I are extremely excited to oversee the future editorial direction of Diabetes Care, the top clinical journal for diabetes care and management in the world,” stated Cefalu. “Our goal is to ensure the journal continues to address the changing health care and research landscape, as well as provide health care professionals with the information they need to better manage people with diabetes.”

Diabetes Care is the highest-ranked journal devoted exclusively to diabetes prevention and treatment. The journal publishes original research about topics that are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals. Diabetes Care is published 12 times a year and is received by American Diabetes Association Category I Professional Members.

How fatty food triggers diabetes: Scientists believe discovery paves way for Type 2 ‘cure’

Fatty food trips a genetic switch in the body that can trigger diabetes, a study has found.

Understanding the biological pathway could lead to a potential cure for the disease, say scientists.

The discovery helps explain why Type 2 diabetes is so often linked to obesity.

n studies of mice and humans, researchers found that high levels of fat disrupted two key proteins that turn genes on and off.

The ‘transcription factors’ FOXA2 and HNF1A activate a pancreatic enzyme that in healthy people prevents diabetes developing.

When the proteins stop working, the enzyme is shut down, which in turn upsets the ability of insulin-secreting beta cells in the pancreas to monitor blood sugar levels. Without this glucose sugar-sensing mechanism, blood sugar cannot be regulated properly.

Study leader Dr Jamey Marth, from the Sanford-Burnham Medical Research Institute in the U.S., said: ‘Now that we know more fully how states of over-nutrition can lead to Type 2 diabetes, we can see more clearly how to intervene.

‘The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment.

‘This may be accomplished by beta cell gene therapy or by drugs that interfere with this pathway in order to maintain normal beta cell function.’

The research is published in the journal Nature Medicine.

Experiments in mice showed that preserving the function of the enzyme affected by FOXA2 and HNF1A blocked the onset of diabetes, even in obese animals.

Diminished glucose sensing by beta cells was an important factor in both the development and severity of the disease.

Dr Marth and his team are now looking at ways to augment the enzyme’s activity in humans.

More than two million people in the UK have Type 2 diabetes, the most common form of the disease.

Insulin-dependent, or Type 1 diabetes is a quite different condition caused by an autoimmune disorder.

Leon Medical Centers Earns Coveted American Diabetes Association Certification for Centro de Diabetes Education* Program

Leon Medical Centers, a leading healthcare service provider for the Medicare community in Miami-Dade County, has earned the prestigious American Diabetes Association (ADA) Education Recognition Certificate for its quality diabetes self-management education program. This Recognition was recently awarded to the LMC’s “Centro de Diabetes” at Flagler Center on July 6, 2011 for offering high-quality education* that is essential for effective diabetes treatment.

“It is an honor to be recognized by such a prestigious association because the process gives professionals a national standard by which to provide patients with comprehensive quality education”

The ADA Education Recognition effort for LMC which begun in the fall of 2010, is a voluntary process, which assures that approved education programs have met the National Standards for Diabetes Self-Management Education Programs. These Standards were developed and tested under the auspices of the National Diabetes Advisory Board in 1983 and were revised by the diabetes community in 1994, 2000 and 2007. Programs that achieve Recognition status have a staff of knowledgeable health professionals who can provide comprehensive information about diabetes management for participants. Education Recognition status is verified by an official certificate from ADA and awarded for four years.

“The American Diabetes Association Certification reinforces Leon Medical Centers’ commitment to continually enhance care to our patients and the community. By providing a level of care that meets the highest national standards we are able to maintain patients’ health and improve their quality of life,” said Rafael Mas, M.D., Chief Medical Officer, Leon Medical Centers.

Self-management education is an essential component of diabetes treatment. By meeting the National Standards we ensure greater consistency in the quality of education offered to people with diabetes. Assuring high-quality education for patient self-care is one of the primary goals of the Education Recognition program. Unnecessary hospital admissions and some of the acute and chronic complications of diabetes may be prevented through self-management.

According to the ADA, there are 25.8 million people or 8.5% of the population in the United States who have diabetes; 11.8% are Hispanics. While an estimated 18.8 million have been diagnosed, unfortunately, 7.0 million people are not aware that they have the disease. Each day approximately 5,205 people are diagnosed with diabetes. Many will first learn that they have diabetes when they are treated for one of its life-threatening complications – heart disease and stroke, kidney disease, blindness, nerve disease and amputation. About 1.9 million new cases of diabetes were diagnosed in people aged 20 years or older in 2010 in the US. Diabetes contributed to 231,404 deaths in 2007, making it the seventh leading cause of death in the US. Overall, the risk of death among people with diabetes is about twice that of people of similar age but without diabetes.

“It is an honor to be recognized by such a prestigious association because the process gives professionals a national standard by which to provide patients with comprehensive quality education,” said Janet Martinez, ARNP, BC, Director of Disease Management, Leon Medical Centers.

About Leon Medical Centers:

Leon Medical Centers, established in 1996, is a healthcare service provider that offers medical services exclusively to Medicare patients in Miami-Dade County. LMC operates seven Super Medical Centers located in Miami, Westchester, East Hialeah, Bird Road, West Hialeah, Kendall and Flagler and offers state-of-the-art technology such as CT scan, Digital X-rays, Ultrasound, Echocardiogram, and other diagnostics, in addition to a range of medical services that includes primary care, specialties, dental, on-site pharmacy, vision, hearing, physical therapy and laboratory.

Fat ‘disrupts sugar sensors causing type 2 diabetes’

US researchers say they have identified how a high-fat diet can trigger type 2 diabetes, in experiments on mice and human tissue.

Writing in the journal Nature Medicine, they say that fat interferes with the body’s sugar sensors.

The authors argue that a deeper understanding of the processes involved could help them develop a cure.

Diabetes UK said the study was interesting and a “theory worth investigating further”.

One of the main risk factors for type 2 diabetes is being overweight – rising obesity levels have contributed to a doubling of diabetes cases in the last 30 years.
Fat and sugar

Sugar in the blood is monitored by pancreatic beta cells. If sugar levels are too high then the cells release the hormone insulin, which tells the body to bring the levels back down.

Key to this is the enzyme GnT-4a. It allows the cells to absorb glucose and therefore know how much is in the blood.
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The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment”
Dr Jamey Marth
Lead researcher

Researchers at the University of California and the Sanford-Burnham Medical Research Institute say they have shown how fat disrupts the enzyme’s production.

Experiments on mice showed that those on a high-fat diet had elevated levels of free fatty acids in the blood.

These fatty acids interfered with two proteins – FOXA2 and HNF1A – involved in the production of GnT-4a.

The result: fat effectively blinded cells to sugar levels in the blood and the mice showed several symptoms of type 2 diabetes.

The same process also took place in samples of human pancreatic cells.

Lead researcher Dr Jamey Marth said: “The observation that beta cell malfunction significantly contributes to multiple disease signs, including insulin resistance, was unexpected.”

He suggested that boosting GnT-4a levels could prevent the onset of type 2 diabetes: “The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment.

“This may be accomplished by beta cell gene therapy or by drugs that interfere with this pathway in order to maintain normal beta cell function.”

Dr Iain Frame, Director of Research at Diabetes UK, said: “This is a well-executed study into possible factors responsible for the events that lead to type 2 diabetes.

“The researchers have linked their results in mice to the same pathways in humans and although they did not show they could prevent or cure type 2 diabetes they have shown it is a theory worth investigating further.

“We will watch this with great interest and hope this early work will eventually lead to some benefit to people with type 2 diabetes.”

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Wellness Today: Shelves and health

2011-08-14 / Wellness / 0 Comments

San Jose Medical Marijuana Collective Elemental Wellness Hosts Free Weekly Grow Workshops

For those who have tried to grow their own medical marijuana only to end up blowing tons of money on grow equipment and guidebooks that don’t deliver on their promise-Elemental Wellness Center, a San Jose cannabis dispensary, has the answer. The San Jose cannabis club hosts a series of ongoing workshops called Crop Circle Grow Club every Sunday at 3pm.

Although many people grow marijuana, an extraordinary amount of knowledge and experience is required to produce high quality medicine.

Grow room guru, Josh Jones, owner of See Your Green, provides in depth instruction on everything from seed to harvest, and weekly help troubleshooting problems. “Club members are able to bring their questions to group and get immediate answers,” said Jones, who discloses his proven techniques to help turn brown thumbs to green ones-and budding botanists to master growers.

“We like to describe our intimate group as a grow club think tank,” said Jones. “It’s an opportunity for growers to share their own experiences and wisdom.”

Member-growers are essential to the San Jose medical marijuana collective, which operates in a “closed loop” system. In the organization members are encouraged to cultivate medicine, and provide it back to the collective, so it is available to other patients who cannot grow. This model helps ensure everyone has access to the medicine they need.

“We carry over 15 varieties of clones,” said Jones. “Many patients want to take a plant home, but don’t know how to start a garden. From expensive lights to complicated irrigation systems and CO2 dispensers to fertilizers, they are concerned about getting all of the right gear. In my workshop, Crop Shop, I discuss the variety of products on the market and guide patients through the design process of building their grow rooms,” said Jones.

For the more seasoned grower, Crop Circle is a forum for the exchange of grow tips and genetics. “Diversity is good when it comes to cannabis,” said Robert Nia, Inventory Manager at Elemental Wellness. Strain swaps help keep the gene pool flush with boutique and rare strains. “Every strain contains different proportions of THC, CBD and CBN-and that delicate balance is responsible for how the plant affects you,” explained Nia.

Josh provides a formal agenda and uses handouts, show-and-tell, and live demonstrations to springboard discussions. Students are invited to bring in photos of their gardens at different stages, and all club members engage in lively debates about the best way to solve various grow problems. Since the club was formed ten months ago, attendance itself has grown from 3 to 35 regular participants.

“Josh brings years of experience to the table. He has been featured in High Times and Mother Jones magazines,” said Nia. “It’s rewarding to have patients leaving testimony on our Facebook page about how much they like the club and Josh.”

Each month’s workshop series is dedicated to a new subject with coverage of usually three weekly subtopics followed by a review at the end of the month. Crop Circle workshops have included: “Grow Room Design on a Dime,” “Crop Shop” (how to choose the right equipment), “This Old Greenhouse,” and “The War on Bugs” (how to fight pests and bacteria, disease, molds and mildews safely).

August Topic: “Seeds & Planting”

Aug 7 – Phenotypes & Genetics
Aug 14 – Germination (methods & timing)
Aug 21 – Transplanting (when & how)
Aug 28 – Review: Seeds & Planting

September Topic: “The Growing Plant”

Sep 4 – Light cycle & ventilation
Sep 11 – Nutrients & N:P:K Ratio
Sep 18 – Watering & feeding schedule (nutrient calendar)
Sep 25 – Review: The Growing Plant

“I love teaching Crop Circles,” said Jones. “It gives me a chance to help each grower change their focus from quantity to quality.”

Shelves and health

Take a yoga class, learn how to caramelize onions, or set off for a group hike.

The offerings, which sound like they should be on a spa schedule, will be featured at the Whole Foods supermarket in Dedham starting on Monday.

Whole Foods Market Inc., based in Austin, Texas, has chosen its largest New England store to debut the grocery store chain’s first Wellness Club – a concept that combines health with commerce.

“This isn’t about weights and scales and measures,’’ said Whole Foods’ Heather Hardy, who is overseeing what Whole Foods bills as a lifestyle club. “It’s about empowering people to make healthier choices.’’

Access to that empowerment comes at a price: It costs $199 to become a member of the Wellness Club, and monthly dues are $45.

As at a gym, club members check in at a front desk, but in this case it’s steps from the salad bar, near the fish. Inside the glassed-in, 950-square-foot space – with sage-colored walls and fresh-cut flowers – they can access a reference library, undergo a lifestyle evaluation, or take a cooking class.

Part of the concept is to learn how to prepare a dish – such as mango quinoa porridge – from a chef in a sleek kitchen, and then head out into the store to find, and buy, the ingredients.

“The key is what you are eating,’’ said Alona Pulde, a Los Angeles doctor who helped shape the concept for Whole Foods. “It’s the how and why,’’ behind a healthy lifestyle, Pulde said.

Help from visiting nutritionists, lectures on how to handle late-night cravings, and even day trips to leaf peep are part of the club’s offerings. A personal coach can create an eating plan and club members can sign up for one-on-one cooking session with chef Ryan Parker at an additional cost.

“Since it’s located in an actual grocery store people can take the practical knowledge learned and put it into practice when they shop,’’ said Whole Foods founder John Mackey in an e-mail.

A thousand products that meet the club’s code of health – whole foods, plants, nutrient-dense foods, and healthy fats -have been tagged with the Wellness Club seal of approval.

Club members receive a 10 percent discount on those items, from produce to the bulk aisle. It helps shoppers “cut though all the marketing hype,’’ said Jeff Novick, a Florida dietitian overseeing the launch. “People are saying ‘I just want someone to help me,’ ’’ Novick said.

Heidi Feinstein, a Boston nutritionist and holistic therapist, called the concept “brilliant’’ and said it is “exactly what consumers want and need.’’

Mayo Clinic opening high-tech outpost at Mall of America

Mayo Clinic is making its debut in the Twin Cities health marketplace Thursday with a high-tech health-and-wellness display at the Mall of America.

The internationally known medical center based in Rochester gave reporters a peek at its “Create Your Mayo Clinic Health Experience” the day before its opening. The facility sports three-dimensional computer monitors, kiosks for the casual shopper and “navigator” specialists to help people assess their health and map out a wellness program.

“We consider this a lab as we try to decide what we want to offer in a permanent facility, if we do that,” said Dr. David Hayes, medical director for the mall project.

The idea is to gather customer and patient opinion to guide development of a facility Mayo would like to build in the Phase II expansion of Mall of America, officials said.

Mayo has been creeping closer to the Twin Cities market in recent weeks. Last month, Mayo Clinic Health System, which has 70 medical facilities in the Minnesota, Iowa and Wisconsin, acquired the former Queen of Peace Hospital in New Prague. That Scott County hospital has three branch clinics in Belle Plaine, Le Sueur and Montgomery.

Also in July, Mayo opened a $10 million oncology treatment center in Northfield, near the campus of Northfield Hospital.

The Twin Cities market already has big health care providers, including Allina Hospitals and Clinics, Fairview Health Services, which includes University of Minnesota Medical Center, and Park Nicollet Health Services.

But Mayo says its strategy is different.

“We are not competing,” said John La Forgia, Mayo’s chief marketing officer and a project strategist. “We have something unique. This is about health and wellness, not the kind of service provided by a hospital. … We are not developing a major new hospital.”

But anyone stopping at the mall can easily connect with Mayo doctors and resources in Rochester, Hayes said. Mayo has a two-year lease on its first-floor space and on a more traditional office nearby.

Standing by a computer monitor in one of the three traditional exam rooms, Hayes explained the Rochester connection. By using video technology, doctors in Rochester can get the pulse or blood pressure of a patient in the mall medical office. The doctors can see video of a skin lesion or other symptoms and diagnose conditions with some assistance from a medical worker at the mall office, he said.

La Forgia declined to put a price tag on the mall project cost or what kinds of revenue its expects to generate there. Patients would typically pay for mall services out of pocket, he said.

Mayo has a letter of intent with the Mall of America giving the clinic first choice of a space in the upcoming mall expansion, he added.

“We would like to do it, but there is no commitment that we will definitely do it,” he said.

Mayo has retained the Campbell Mithun advertising agency to publicize its new venture, La Forgia said. Mayo is also the only provider allowed to offer health fairs or any other health-related activity at the mall for two years, Hayes said.

The “Health Experience” space is based on extensive market research over nearly two years. Mayo interviewed mall shoppers and held focus groups from a wide age range of people in Minneapolis, Chicago, San Francisco and London. The goal is to find out what kind of health care and delivery vehicle people want going into the 21st century.

“This is a global destination,” La Forgia said of the mall. “We think of ourselves globally.”

He noted that London was chosen because England sends more people to the Mall of America than most other nations.

Mayo’s Health Experience is sandwiched between a teddy bear store and the American Girl doll shop.

The kiosks and wellness experts offer shoppers a convenient way to move health care delivery away from hospitals and doctor’s offices. The space offers quick access to as much or little medical information and service as consumers desire.

“We talk to people at the mall and at other malls and ask, ‘What would you want?’” Hayes said. “This is a lab to find out what will work in this space [and] to keep Mayo relevant and give people more information about their health and wellness using high quality materials.”

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Hypertension Treatment News: Device Promising for Resistant Hypertension

2011-08-09 / Other / 0 Comments

Device Promising for Resistant Hypertension

Although a baroreflex activation therapy device designed to treat resistant hypertension lowered blood pressure, it failed to meet two of five coprimary endpoints in a pivotal trial, researchers found.

The trial did not meet endpoints regarding short-term systolic blood pressure response and safety of the procedure to implant the device, according to John Bisognano, MD, PhD, of the University of Rochester in New York, and colleagues.

It did, however, show a benefit on sustained response, safety of baroreflex activation therapy, and safety of the device, the researchers reported online in the Journal of the American College of Cardiology.

The findings were originally reported at the American College of Cardiology meeting in April.

The authors noted that all five of the coprimary endpoints needed to be met to establish the overall efficacy and safety of the Rheos device.

However, they wrote, “the weight of the overall evidence suggests that over the long-term, baroreflex activation therapy can safely reduce systolic blood pressure in patients with resistant hypertension. Future clinical trials will address the limitations of this study and further define the therapeutic benefit of [the therapy].”

They added that “new technology for delivering baroreflex activation therapy that involves a less invasive implant procedure has been developed by [Rheos manufacturer] CVRx and is currently undergoing confirmatory study in Europe.”

The Rheos system is targeted to the 20% to 30% of patients with hypertension who are resistant to treatment, defined as a failure to achieve a blood pressure less than 140/90 mm Hg with maximally tolerated doses of at least three antihypertensives, including a diuretic.

The system involves leads strung from a pulse generator implanted in a patient’s chest to each carotid sinus. The electrical impulses stimulate the baroreceptors there, reducing sympathetic activity and increasing parasympathetic activity, which causes the blood vessels to open and heart rate and blood pressure to drop.

In the current phase III trial, 265 patients with resistant hypertension — who were taking an average of 5.2 antihypertensives at baseline — were implanted with the device, which was turned off.

After one month, they were randomized 2:1 to have the device turned on for 12 months (181 patients) or to have the device turned off for the first six months and then turned on for the last six months (84 patients).

At six months, the mean decrease in systolic blood pressure was greater in the group with the device turned on, although the difference did not reach statistical significance (16 versus 9 mm Hg, P=0.08).

By 12 months, when both groups had had the device turned on for at least six months, the mean reduction in systolic blood pressure from baseline was 25 mm Hg in both groups.

The trial failed to meet two of the five coprimary endpoints:
The percentage of patients who achieved at least a 10 mm Hg drop in systolic pressure from baseline at six months was not significantly greater in the group with the device on (54% versus 46%, P=0.97).
The percentage of patients in both groups who remained free of serious procedure- or system-related adverse events 30 days after implantation (74.8%) did not exceed the goal of 82%. Most events were related to lead placement and involved transient or permanent nerve injury in 4.4 to 4.8% of patients.

The trial did meet the other three endpoints:
The percentage of patients who had the device turned on for the entire 12-month study who had a significant blood pressure response at six months and who maintained that response at one year (88%) exceeded the goal of 65%.
The percentage of patients who remained free of adverse events related to baroreflex activation therapy from 30 days to six months post implantation did not differ between the groups by more than 15% (91.7% with the device on for 12 months versus 89.3% in the other group). That met criteria for noninferiority (P<0.001).
The percentage of patients in both groups who remained free of hypertension-related and serious device-related adverse events from 30 days to 12 months post implantation (87.2%) exceeded the goal of 72%.

A prespecified ancillary analysis showed that a greater percentage of patients who had the device turned on achieved a systolic blood pressure of 140 mm Hg or less at six months (42% versus 24%, P=0.005), although the proportion was about 50% in both groups by one year.

Researchers admitted that certain assumptions had to be made that could not be verified beforehand because of the novelty of the device.

Also, variability in blood pressure measurements could have been reduced if the trial design had allowed for several qualifying measurements.

Pluristem stem-cell out-license comes into effect

The license that Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) awarded to United Therapeutics Corporation (Nasdaq: UTHR) to use of its PLacental eXpanded (PLX) cells to develop and commercialize a cell-based product for the treatment of pulmonary hypertension came into effect yesterday. Pluristem awarded the license on June 19, after obtaining permission from the Office of the Chief Scientist.

United Therapeutics paid Pluristem a down payment of $4 million when the agreement was signed, and it will make up to $55 million in milestone payments, and cover the costs of development and clinical trials for this indication. If the product is commercialized, United Therapeutics will also pay royalties.

Pluristem’s share price fell 5.7% on Nasdaq yesterday to $3.15, giving a market cap of $131 million, but rose 1.3% premarket trading today, but fell 2.8% by mid-afternoon on the TASE today to NIS 10.89.

JIPMER to test genes for personalised treatment

PUDUCHERRY: At a time when the world is looking towards personalised medicine, the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) has taken the lead among government hospitals in the country by introducing pharmacogenomics testing of genes to provide personalised treatment.

Initially, the testing would be done for CYP2C9, CYP2C19 and VKORC1 genes which would promote personalised treatment of patients with epilepsy, peptic ulcer, diabetes, hypertension, stroke, cardiac diseases, deep vein thrombosis and patients undergoing valve therapy, said Dr C Adithan, professor and head , department of pharmacology, JIPMER. He added that it was the first step towards personalised medicine.

The idea behind the pharmogenomic testing is to understand the genetic make up of an individual associated with drug metabolism and treatment response to drugs. Pharmocogenomics stems from the concept that one drug doesn’t fit all. Instead of the patient undergoing a ‘trial and error’ of various drugs, all it takes is one DNA test to analyse one’s genes which are the code for drug metabolising enzymes.

Knowing the patient’s genetic constitution would enable the physician to prescribe more confidently the appropriate drug. One could do away with the adverse drug reaction (ADR) or non-response. He added that there was no accounting for the cost effectiveness in the long run.

The testing would be done in the PCR laboratory of JIPMER. After the logistics are put in place, the testing would begin in the next three to six months and thereafter testing of other genes would be introduced in a phased manner, he said.

The department of pharmacology, JIPMER, also has a drug information centre, where on an average 70 area reports are received on ADR.

Symposium on Hepatitis B

A symposium on ‘hepatitis B-resolving the dilemma’ was held at JIPMER on Saturday.

Dr Sankaranarayanan from Chennai KK trust hospital who spoke on hepatitis in children emphasised on the importance of hepatitis B vaccination in high risk groups. The methods of testing used to diagnose acute and chronic hepatitis B were elaborated by Dr George Kurien.

Dr Piramanayagam from Apollo hospital, Chennai, spoke on hepatitis B and pregnancy and Dr Thomas Alexander from Pondicherry Institute of Medical Sciences on hepatitis B in adults.

Dr Biju Pottakkat from JIPMER who spoke on liver cancer detailed the various therapeutic options in liver cancer associated with Hepatitis B. Dr Lakshmi and Dr Amit Goel, gastroenterologists from JIPMER, outlined several aspects to prevent hepatitis B in adults and children.

The symposium urged the delegates to increase the awareness among health workers and public about hepatitis B and its complications.

Dangers of hypertension

Hypertension sharply increases the risk of heart attack, stroke, heart failure, and kidney failure

Hypertension is one of the most common medical problems in the US; at present, one of every American adults has high blood pressure. It’s a shame since many, if not most, cases could be prevented by simple lifestyle measures such as dietary salt restriction, weight control, and moderate exercise.

Hypertension is also one of the most important medical problems in America; it sharply increases the risk of heart attack, stroke, heart failure, and kidney failure. That’s also a shame, since excellent drugs are available to lower blood pressure and prevent these deadly complications.

You don’t have to bring your pressure down to normal (below 120/80 millimetres of mercury) to get the benefit of treatment. Simply lowering an elevated blood pressure to modest treatment targets (below 140/90 for people without certain complicating conditions; below 130/80 for those with diabetes, kidney disease, heart failure, or atherosclerosis) can cut the risk of heart attack and stroke by about 34 per cent and 21 per cent, respectively.

But the biggest shame of all is that only about 44 per cent of hypertensive patients reach these goals.

There are many explanations for these sorry results. A study highlights one of the most important reasons: poor adherence to medication regimes.

The study

Researchers in Italy obtained information from 400 primary care physicians to identify 18,806 patients ages 35 and older who were first diagnosed with hypertension during 2000 and 2001. None of the patients had been diagnosed with coronary artery disease, heart failure, or cerebrovascular disease when they entered the study; the scientists followed the patients for an average of 4.6 years to track the onset of these complications.

All patients in the study received prescriptions for one or more effective antihypertensive medications. Based on how often they filled their prescriptions, the patients were classified into three adherence levels: high (pills on at least 80 per cent of days), medium (40 per cent to 79 per cent), or low (below 40 per cent).

At the start of the study, only 8 per cent were in the high-adherence group; by the end of the study, 19 per cent achieved this level. Intermediate adherence fell from 41 per cent to 32 per cent, and low adherence was stubbornly high, declining only minimally from 51 per cent to 49 per cent.

Did adherence matter? It sure did. As compared with their low-adherence counterparts, the high-adherence patients enjoyed a 38 per cent lower risk of acute cardiovascular events during the study period.

Perspectives

Although previous research has demonstrated that good adherence to medication results in lower blood pressure readings, fewer hospitalisations, and lower medical costs, the study is one of the first to document reduced cardiovascular events. Curiously, though, the study did not provide information on blood pressure readings, nor did it rate the patients according to their adherence to the lifestyle changes that can also lower blood pressure. Despite these limitations, the research serves to emphasize the importance of compliance with medication.
In randomised clinical trials of anti-hypertensive therapy, only 5 per cent to 10 per cent of motivated, supervised volunteers discontinue their medications over the course of a year, but in real world clinical practice, discontinuation rates can be 50 percent or higher within just six months. But why?

Doctors often blame their patients, but physicians who fail to explain the importance of continually taking medication, long-term lifestyle changes, and careful blood pressure monitoring and follow-up surely deserve some of the blame. And patients are often discouraged by complex medication schedules, expensive drugs, or both.

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Heart Disease News: Technique Stimulates Growth of New Blood Vessels of Heart Disease Patients

2011-08-03 / Health News / 0 Comments

Technique Stimulates Growth of New Blood Vessels of Heart Disease Patients

New method could be used to treat heart disease

University of Pittsburgh researchers have developed a new method for regrowing blood vessels with growth factor, which could be used to treat heart disease.

Yadong Wang, study leader and University of Pittsburgh professor, along with co-authors Johnny Huard, Hunghao Chu and Chien-Wen Chen, have found a minimally invasive technique for transferring growth factor into mice via injection, which stimulates the growth of new blood vessels.

The human body has growth factors that control activities like cell proliferation, differentiation and migration. These potent molecules can even cause cell suicide and promote cell growth. The problem is that the body strictly controls growth factor, and the body will destroy “free-floating” growth factor.

But now, Wang and his team have created a method that overcame this problem. Despite the half-life for most growth factor (injected under the skin) being a half hour or less, researchers decided to inject the growth factor under the skin of mice directly onto a molecule called heparin, which bonds growth factor to its receptor on the cell’s surface. As the receptor and the growth factor bind to heparin, the activity of growth factor is increased and stabilized.

This may have solved the problem associated with growth factor duration, but it also caused another road block: bonding heparin to growth factor results in a water-soluble substance, which is a problem because a majority of the human body is made up of water.

But this issue didn’t stop the University of Pittsburgh team for long. They found a positively charged molecule, called polycation, which possesses many positive charges to counter heparin’s many negative charges. This neutralized the heparin and brought it out of solution into a coacervate, which is an aggregate of small oil droplets.

The team was able to successfully deliver fibroblast growth factor-2 as a result of the conversion of heparin/growth factor complexes into coacervates. Using only one growth factor, the researchers injected the compound under the skin of mice, which caused new blood vessels to grow. In addition, the blood vessels were still in place over a month later.

“We had structures that resembled arterioles — small arteries that lead to a network of capillaries,” said Wang.

The procedure is minimally invasive because the coacervate is not very viscous, meaning that you can use a thin needle to inject the growth factor through tissue and the damage created in small. It could also be used through a catheter, meaning that the chest wouldn’t need to be opened up for open-heart surgery.

The idea behind this discovery is to use growth factor to help the heart heal itself after a heart attack without negative results, like dilating ventricles until they become too large. The growth factor would be injected right after the heart attack to help the heart repair itself.

“Our hope would be to reduce scarring, keep as much of the muscle alive as possible, and induce quick blood vessel formation to bring as many nutrients as possible in order to reestablish an environment for muscle growth,” said Wang.

The team will use a disease model next to test this method before moving on to human clinical trials. If all goes well, the final step will be to commercialize the treatment.

Study: Heart procedures driven by profit, not science

Heart disease kills more Americans than anything else. While the statistics cause great concern, some providers see this is as an opportunity to cash in by marketing expensive, unnecessary heart procedures to healthy patients.

A recent investigation by Consumer Reports Health indicates that the practice of healing hearts has become a money-making machine that too often favors profits over science.

“We’re concerned that some people are having too many tests and too many treatments as a result, and some of that’s driven by profits, not good science,” reiterated Dr. John Santa, director of the Consumer Reports Health Ratings Center.

Most patients would say that my heart is very important and there’s no amount of money that would preclude me from getting some type of test to make sure that my heart is healthy, “Early Show” co-anchor Chris Wragge points out.

While Dr. Santa recognizes this concern, he says, “There are good and inexpensive tests and many of those aren’t being used as often. It’s frustrating because many tests that are expensive potentially dangerous and aren’t effective are being used.”

What are some of the tests that indicate people are overdoing it?

“We did a survey of almost 1,200 healthy (people) 40 to 60 years old, no disease, no symptoms and no risk factors and found 44 percent were getting ineffective tests, like EKGs, stress tests or ultrasound of the carotid arteries,” he adds.

According to Santa, there are negative effects, aside from the costs. “These tests aren’t precise when it comes to detecting early disease so they can be false positives, you get a cascade of additional tests and sometimes treatment including angioplasty, you could end up with a metal stent in your coronary artery for the rest of your life and may not need it,” he explains.

Are doctors giving bad advice?
“In some cases, unfortunately they are,” he said. “Most doctors are emphasizing the big five tests: blood pressure, cholesterol, diabetes, taking small doses of aspirin and stopping smoking. Those are the big five, but obviously doctors are, in some cases, recommending tests that aren’t very effective, and in some cases treatment that isn’t.”

What advice can Dr. Santa offer to patients who trust their doctor for the most part?

“They need to do research and use tools like we’re offering that offer ratings of these tests, also offering ratings of heart surgery groups, so that they can more easily sort out who are the best heart surgeons to have their surgery,” he said.

Exactly what goes into the whole ratings system?

“It’s a three-star system, 323 heart surgery groups across the country have released this data. Eighty-one of the groups are three-star, very good performance information, 238 are average and five below average,” he explained. “The important thing for patients to know, almost all heart surgeons have this information. Ask them for it. And if they aren’t willing to give it to you, maybe you should look for another surgeon. Do your research. Don’t just take the advice of your doctors.”

Sunshine Heart Appoints New US Board Member

Sunshine Heart, Inc. (asx:SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced the appointment of Gregory Waller as an independent non-executive director. Mr. Waller brings more than 30 years of financial management and industry experience to Sunshine Heart with an established history of serving on the boards of several successful medical device companies. He is the second US-based board member to be appointed this year following the appointment of Paul Buckman in January.

Mr. Waller was with the public company, Sybron Dental Specialties, for 25 years until he retired as Chief Financial Officer in 2005. During his career with Sybron, Mr. Waller contributed to the company’s growth from $10 million to $750 million in sales. Serving in a variety of operational and financial management positions, he was instrumental in closing multiple rounds of financing for the company. In addition, he oversaw Sybron’s initial public offering and its acquisition of more than 30 companies worldwide until its eventual sale to Danaher Corporation in 2006 for $2.6 billion (representing a $2.1 billion gain to shareholders).

“Few industry veterans have taken a company to the success that Gregory Waller has and we are honored to welcome him onto our board,” said Nick Callinan, Sunshine Heart’s Chairman. “Mr. Waller has an outstanding track record on the boards of fast growing medical technology businesses, many of which have now become established public companies. His vast experience with the cardiovascular market will also be extremely valuable to us.”

Mr. Waller currently serves on the board of Endologix Inc., which develops and manufactures minimally invasive treatments for vascular disease. He helped develop the strategic direction for Endologix, assisted in the development of the audit committee procedures and processes and helped raise substantial capital, taking Endologix’s market cap from $175M to $470M.

In addition, he has previously held board positions with Alsius, Inc., Cardiogenesis Inc., Clarient, Inc., and SenoRx, Inc., where he played an instrumental role in each company’s acquisition or IPO.

“It is a privilege to join the board of Sunshine Heart as I believe the Company has an exciting future ahead of it,” said Mr. Waller. “The unique C-Pulse system has the potential to become a leading treatment for Class III heart failure, representing a tremendous opportunity in the cardiovascular heart failure market. I am particularly looking forward to working with Dave Rosa, CEO of Sunshine Heart, to help navigate the continued financial success of the Company.”

Mr. Waller has been a featured speaker for the Center of Corporate Governance as well as a panelist at the Forum for Corporate Directors meetings.

“The diversified expertise that Mr. Waller brings in financial management, corporate governance, auditing and fundraising will support Sunshine Heart’s growth and the continued achievement of our corporate goals,” Mr. Callinan added. “These include securing additional capital to complete a U.S. FDA pivotal trial for our C-Pulse Heart Assist system, to support regulatory approvals outside the U.S., as well as to fund continued enhancements to the C-Pulse system.”

This press release does not and shall not constitute an offer to sell or the solicitation of any offer to buy any of the securities. The shares of Sunshine Heart have not been registered under the Securities Act of 1993 (US Securities Act) and may not be offered, sold or delivered in the United States, or to, or for the account or benefit of, any US Person, as such term is defined in Regulation S of the US Securities Act. In addition, hedging transactions with regard to the shares may not be conducted unless in accordance with the US Securities Act.

About the C-Pulse(R) Heart Assist System The C-Pulse Heart Assist System utilizes the proven scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient’s bloodstream, the novel extra-aortic approach of the C-Pulse technology offers greater flexibility allowing patients to disconnect as necessary or desired. The C-Pulse system’s potential benefits may help reverse the heart failure process or maintain the patient’s current condition, thereby preventing the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.

About Sunshine Heart(R) Sunshine Heart is a global medical device company committed to the commercialization of the C-Pulse Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. C-Pulse relieves the symptoms of heart failure through the use of counter-pulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart’s pumping load. The Company has completed enrolment of an approved US Food and Drug Administration (FDA) 20patient U.S. clinical trial with the C-Pulse System. Sunshine Heart is a Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004.
Forward-Looking Statements

This announcement contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations with respect to the progress of, and presentation of data related to, product development and commercialization efforts, results of clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities, ultimate clinical outcomes and benefit of the Company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility the FDA does not accept our regulatory application or approve the marketing of the C-Pulse(R) Heart Assist System in the U.S., the possibility the Company may be unable to raise the funds necessary for the development and commercialization of its products, the possibility the Company may be unable to successfully list its securities on a U.S. securities exchange, and those described in our filings with the ASX. We may update our risk factors from time to time in our filings with the ASX.

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Obesity Treatment News: EnteroMedics to Present at the Canaccord Genuity Annual Growth Conference

2011-08-01 / Weight Loss & Obesity / 0 Comments

EnteroMedics to Present at the Canaccord Genuity Annual Growth Conference

EnteroMedics Inc. ETRM
+0.38% , the
developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., Chief Executive Officer, is scheduled to present at the Canaccord Genuity Annual Growth Conference in Boston, MA on Thursday, August 11, 2011 at 9:00 am ET. Dr. Knudson will provide an overview of the Company and an update on its VBLOC(R) vagal blocking therapy development program.

The presentation will be webcast live and may be accessed by visiting EnteroMedics’ website at www.enteromedics.com . A replay of the webcast will also be available immediately after the conclusion of the presentation. Investors can access the webcast under “Press Room” in the “Investors” section of EnteroMedics website.

About VBLOC(R) Therapy

EnteroMedics developed VBLOC(R) vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC(R) Therapy is delivered via the Maestro(R) System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC(R) Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

About EnteroMedics Inc.

EnteroMedics is a development stage medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity and other gastrointestinal disorders. EnteroMedics’ proprietary neuroblocking technology, VBLOC(R) vagal blocking therapy, is designed to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. These electrical impulses are delivered by a neuroregulator, EnteroMedics’ Maestro(R) System, which is powered by an integrated rechargeable battery. For more information, visit www.enteromedics.com .

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro(R) System for the treatment of obesity in the United States or in any foreign market other than the European Community; our preliminary findings from our EMPOWER(TM) pivotal trial; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC(R) vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 7, 2011. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Caution – Investigational device. Limited by Federal (United States) law to investigational use.

The implantation procedure and usage of the Maestro(R) System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.

School Obesity-Prevention Curriculum Can Reduce Medical Costs

Teaching middle-school children about nutrition and exercise and encouraging them to watch less TV can save the health care system a substantial amount of money, suggests an economic analysis from Children’s Hospital Boston and the Centers for Disease Control and Prevention.

Using data from a randomized, controlled study conducted at 10 Massachusetts middle schools, five of which adopted the obesity prevention curriculum Planet Health, the researchers created a model projecting a net savings of $14,000 for the 254 girls receiving the curriculum, by averting the costs of treating obesity and eating disorders. They project that expanding the program to even just 100 schools could save the health care system $680,000.

The study, published in the August issue of the Archives of Pediatrics & Adolescent Medicine, was led by S. Bryn Austin, ScD, an epidemiologist in Children’s Hospital Boston’s Division of Adolescent Medicine, and CDC health economist Li Yan Wang.

Planet Health, developed at the Harvard School of Public Health, is a curriculum for academic, physical education and health education teachers to guide middle-school students in choosing healthy foods, increasing physical activity and limiting TV and other screen time. It provides teacher training, lesson plans, materials and FitCheck, a self-assessment tool for students.

In an earlier study of 10 middle schools, half offering the Planet Health program and half offering regular programs (schools were matched by town, school size and ethnic composition), obesity prevalence declined in the schools with Planet Health but increased in control schools over the two years of follow-up. In addition, overweight girls in Planet Health schools were twice as likely as girls in control schools to return to a healthy weight over the two years.(Gortmaker SL et al, 1999). Unexpectedly, girls in Planet Health schools were also less than half as likely as girls in control schools to begin purging or using diet pills to control their weight (Austin SB et al, 2005); this study was later replicated in a separate group of middle schools (Austin SB et al, 2007). The effects were not statistically significant for boys.

“We were really surprised and encouraged to see how protective Planet Health was for eating disorder symptoms in girls,” says Austin, the study’s senior author. “When we found the same protective effect – cutting the risk for girls in half — in a different set of middle schools several years later, we knew we were on to something important.”

Bulimia typically develops in adolescence, and often begins with a few behaviors, such as using diet pills or purging to control weight. Full-blown bulimia is a life-threatening disorder that carries a variety of medical complications such as electrolyte imbalances, dehydration, metabolic alkalosis (an imbalance in the body’s acid/base balance), heart rhythm disturbances, tooth erosion and bowel dysfunction.

“Eating disorders cause an enormous amount of suffering,” says Austin. “They can also be chronic and expensive to treat, which is often a big financial burden on individuals, their families, and society. That’s what led us to want to do the economic study.”

In their economic analysis, Austin and Wang first estimate that 3.4 percent of girls receiving the Planet Health intervention would be prevented from developing disordered weight-control behaviors by the age of 13 1/2, based on numbers from the original randomized study (7 of 254 girls in the Planet Health schools, or 2.8 percent, developed these behaviors, versus 14 of 226 controls, or 6.2 percent). Based on current knowledge about the progression of eating disorders, they calculate that, in turn, 1 case of bulimia would be prevented by the age of 17 among the 254 girls.

Factoring in typical treatment costs — which can be tens of thousands of dollars over a decade — and known rates of remission and relapse, Austin and Wang estimate that an average of $34,000 would be saved by preventing one girl in the five Planet Health study schools from developing bulimia nervosa. Adding Wang’s previous finding of $27,042 in savings resulting from prevention and reduction of obesity in the same schools (Wang LI et al, 2003), the program would yield a net savings of $14,238 after subtracting the $46,803 cost of offering Planet Health in those schools.

“Because eating disorders can be so expensive to treat, preventing even one case in the five Planet Health schools translated into reducing medical costs by $34,000,” says Austin. “But if we scale up our calculations to include, say, 100 middle schools in Massachusetts, the medical costs reduced by preventing bulimia increase to over half a million dollars. And if we scale up nationwide, to say 1,000 schools, the potential reduction in the medical cost burden is sizable.”

Austin notes that obesity prevention programs that stigmatize obesity or create a sense of blame can actually contribute to eating disorders. “We need to be smart about choosing obesity prevention strategies that, at the same time, can prevent eating disorders,” she says. “Our study shows that when we do both, we substantially increase the benefits, both in terms of health and reducing medical costs.”

The study was funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration. Lauren Nichols of the Division of Adolescent and Young Adult Medicine at Children’s Hospital Boston was coauthor.

Lannett gets FDA approval for anti-obesity treatment

Lannett has received the US Food and Drug Administration (FDA) approval for the abbreviated new drug application (ANDA) of Phentermine Resin Extended-Release Capsules, 15mg and 30mg.

Lannett’s Phentermine Resin Extended-Release Capsules, 15mg and 30mg is the generic version of UCB’s Ionamin Capsules, 15mg and 30mg.

Phentermine Resin is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction.

Cody Laboratories, the pain management subsidiary of Lannett, is responsible for producing the active pharmaceutical ingredient (API) of the product.

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