FDA panel backs broader use of Edwards heart valve

A panel of heart experts said Wednesday that the government should expand approval of the first artificial heart valve designed to be implanted without major surgery, despite limited information about some long-term side effects.

The Food and Drug Administration's panel of outside cardiologists voted 11-0 with one abstention that the benefits of broader approval for Edwards Lifesciences' Sapien valve outweigh the risks.

The valve is currently approved for patients who aren't healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades.

If FDA follows the group's advice, the implant will be approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

The FDA is not required to follow the panel's advice, though it often does. A decision is expected later this year.

Edwards Lifesciences Corp. presented data from a pivotal trial showing that patients implanted with its heart valve survived about as long as those who underwent surgery. One year after the operation, 76 percent of patients implanted with the heart valve were still alive, compared with 73 percent of those who had undergone open-heart surgery.

The numbers were close enough to meet the study's goal of showing that Sapien's survival rate was at least as good as surgery. But panelists raised a number of concerns about the valve's side effects and the accuracy of the company's trial results.

Patients who got the Sapien valve had a higher rate of stroke immediately following the procedure when compared to surgery, though rates evened out over time. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber.

Elsewhere, panelists noted that the death rate among men was more than 3 percent higher than that for women with the Sapien valve.

In each case, panelists said more follow-up data would be needed to define the scope and severity of these issues.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA.

Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

Shares of Edwards Lifesciences Corp. fell 27 cents Wednesday to close at $90.54. They rose 59 cents to $91.13 in extended trading following news of the panel's vote.

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Rhode Island passes bill to guarantee rights of homeless people

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U.S. advisers back Edwards valve for wider group

Reuters – 4 hrs ago GAITHERSBURG, Maryland (Reuters) - An artificial heart valve from Edwards Lifesciences Corp that can be inserted without cracking open the chest for surgery won the support of U.S. advisers on Wednesday for use in a wider group of patients.

A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Sapien device outweigh its risks for people who need a new heart valve but face a higher risk of dying from open-heart surgery.

The FDA usually follows panel recommendations, although it is not required to, and will make a final decision in the future.

Shares of Edwards edged up 0.5 percent to $91 in post-market trading, as analysts said a positive recommendation had largely been factored into the share price before the meeting.

The valve is widely considered to be Edwards' most important new product, and was already approved last year for those deemed too sick to have the open-heart surgery.

Devices like Sapien, as well as sophisticated non-surgical techniques, are seen as the next frontier in the battle against heart disease as drugmakers produce fewer new medicines to fight the world's leading cause of death.

The Sapien device is meant for people with aortic stenosis, when the aortic valve that allows blood to leave the heart does not fully open, decreasing blood flow and potentially preventing it from reaching the brain and the rest of the body.

About 250,000 Americans have severe symptoms of the disease, and about two-thirds of them undergo surgery to treat it.

A bad aortic valve commonly requires open-heart surgery, during which the ribs are sawed open, the heart is stopped and a new valve is sewn in place. But thousands of people each year are considered too sick to get the surgery, or have other health conditions that make it risky.

With an Edwards' Sapien transcatheter heart valve -- the first such device in the United States -- a catheter guides the new valve to the heart through the femoral artery in the groin or a small incision between the ribs. The valve costs about $30,000 and is made of cow tissue and polyester supported with a stainless steel mesh frame.

Doctors say this and a similar device being developed by Medtronic Inc will eventually become the standard of care.

In pivotal clinical trials, Edwards said the Sapien led to a slightly lower death rate and dramatically shorter recovery times and hospital stays than chest-cracking open-heart surgery.

However, FDA advisers were concerned about higher stroke risk with the device compared to the traditional surgery, as well as an issue known as aortic leakage, when the valve does not seal properly and can send blood back into the heart.

"I think we are in belief that the totality of the data demonstrate a reasonable assurance of safety and efficacy," said Dr. Warren Laskey, the panel chair and a cardiologist at the University of New Mexico School of Medicine.

"There are questions that remain unaddressed, but they don't seem to impede our acceptance of the totality of the data."

The panelists were also worried about clinical trial data that showed people who had the device inserted through the ribs -- known as a transapical procedure -- had a higher mortality rate after one year compared to an insertion through an artery in the leg.

The advisory panel voted 10 to 2 that the device was safe, and 12 to 0 that it was effective.

Sapien is considered to be one of the most important growth drivers for Edwards, especially if the company gets approval for the broader use, potentially doubling the number of eligible patients, analysts say.

Analysts have pegged the worldwide market for transcatheter aortic valves at more than $2 billion a year.

"A broader indication for high-risk patients would enable multi-disciplinary heart teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option," Edwards' chairman and chief executive Michael Mussallem said in a statement.

(Reporting by Anna Yukhananov; Editing by Bernard Orr)

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Diabetes drug may help fight cancer, but no proof yet

Reuters – 1 hr 41 mins ago (Reuters) - A cheap and relatively safe diabetes drug, metformin, might have cancer-fighting properties, according to an international study - but findings fall short of proving it actually can stave off cancer.

Researchers, whose findings were published in the Journal of Clinical Oncology, found that women with diabetes who took the medication had a 25 percent lower risk of developing breast cancer over more than a decade of follow-up.

"Metformin use in postmenopausal women with diabetes was associated with lower incidence of invasive breast cancer," wrote lead researcher Rowan Chlebowski, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.

"These results can inform future studies evaluating metformin use in breast cancer management and prevention."

Metformin, also sold under the brand name Glucophage, has been on the market for many years and is generally considered safe, although five to 10 percent of patients experience side effects like nausea and bloating.

It is used by millions of type 2 diabetics every day to help control their blood sugar, and studies have shown it also shrinks lung and breast tumors in mice. Several reports show people taking it for diabetes appear to develop cancer less often.

The new study used data from about 68,000 postmenopausal women who took part in the U.S. government-funded Women's Health Initiative clinical trials.

Over nearly 12 years of observation, there were more than 3,200 new cases of breast cancer among the women.

Every year, 0.42 percent of women without diabetes developed breast cancer, compared to 0.40 percent of diabetics on metformin and 0.47 percent of diabetics taking other drugs.

After taking into account risk factors for breast cancer, the gap between women without diabetes and diabetics on drugs other than metformin vanished. But diabetics on metformin turned out to have a 25 percent lower cancer risk than their diabetes-free peers.

"This is an area of great excitement," said Pamela Goodwin, a breast cancer expert at Mount Sinai Hospital in Toronto, Canada, who wrote an editorial that appeared with the study.

"The evidence is coming together that metformin may actually have a clinically-relevant effect, but none of this is good enough to chance clinical practice just yet."

But she added that while the study is the best of its kind so far, it relies on observations instead of an actual experiment in which women are randomly selected to take metformin or not.

Goodwin and her colleagues are currently running a trial to test whether metformin can help ward off new tumors in women getting breast cancer treatment. Results are expected in three to four years. SOURCE: http://bit.ly/L86p7l

(Reporting from New York by Frederik Joelving at Reuters Health; editing by Elaine Lies and Bob Tourtellotte)

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FDA reviews safety of innovative heart valve

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Freezer damages brain samples used to study autism

A freezer malfunctioned at a Harvard-affiliated hospital that oversees the world's largest collection of autistic brain samples, damaging a third of the scientifically precious specimens and casting doubt on whether they can be used in research.

The director of the Harvard Brain Tissue Resource Center said the loss was "devastating," particularly in light of the increasing demand for brain samples among scientists searching for the cause of autism and potential treatments.

"Over the last 10 years, the autism tissue program has been working very hard to get the autism community to understand the importance of brain donation," Dr. Francine Benes said. Now many of those samples have been compromised.

The freezer failed sometime late last month at the center, which is housed at McLean Hospital in the Boston suburb of Belmont. At least 54 samples earmarked for autism research were harmed. Many of them turned dark with decay.

However, an initial review indicates that the DNA in the samples is intact and can still be used for genetic research. It's unclear, however, whether the samples could be used for the full range of neuroscience needs.

Thirty-two of the brains had been cut in half, with one side placed in a formaldehyde solution and the other placed in the freezer. The samples in the solution remain available for all research projects, the hospital said.

The frozen tissue samples are normally maintained at about minus 80 degrees Celsius, but the temperature had reached about 7 degrees

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Noisy hospitals need Rx for quiet as patients rest

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Stem cells can be harvested long after death: study

"Stem cells are fed at the University of Connecticut's Stem Cell Institute in 2010. Some stem cells can lay dormant for more than two weeks in a dead person and then be revived to divide into new, functioning cells, scientists in France say. (AFP Photo/Spencer Platt)" title

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Brazil claims successful test of parasite vaccine

"Photo illustration. Brazilian researchers say they have successfully tested a vaccine against schistosomiasis, a disease caused by parasitic worms that afflicts more than 200 million people worldwide. (AFP Photo/Saul Loeb)" title

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HIV may have returned in 'cured' patient: scientists

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Anti Aging Eye Merchandise

June 13, 2012 by admin

As a result of the eyes are lacking fat and oil glands, their creams are necessary to assist soften and nourish the skin round the eyes. Some eye creams improve the firmness and texture of the skin, as well as hydrate the skin. There are some creams that swish fine lines, scale back puffiness, and take away dark circles round the eyes. Quality anti aging creams contains vitamins A and D as these vitamins are diminished within the skin when there is increased exposure to the sun. Many of these eye creams also contain Vitamin E and Aloe Vera. These nutrients create the skin around the eyes healthier and younger looking.There are others that increase collagen that stimulates growth of recent skin cells as well as serving to to repair damaged skin. Quality vision creams for dark circles can normally contain such ingredients as Kojic acid, Vitamin K, and hydroquinone.

These ingredients help to prevent bruising and they conjointly lighten the skin. Eye creams that remove wrinkles and puffiness will normally have such ingredients as alpha-hydroxy acids (AHA), peptides, caffeine, retinol, and vitamin C. The ingredients stimulate collagen production and firm the skin. When targeting both wrinkles and dark circles below the eyes, it’s suggested that one uses a cream that targets a mixture of skin problems. There is a new ingredient known as Hylexin that has shown promising results in reducing dark circles underneath the eyes.Peptides are an necessary ingredient as they’re very effective at reducing wrinkles. Merchandise with a high concentration of peptides will be quite expensive. Another ingredient, Hyaluronic acid, that can be found in eye creams, is essential to firming and hydrating the skin. In addition, they containing the ingredient ‘escinine,’ a botanical with anti-inflammatory properties, and manganese, a mineral that increases circulation, can drastically decrease underneath eye puffiness.There are all natural eye creams which will embrace Vitamins and minerals, natural oils like nutmeg oil, sunflower oil, and sweet almond oil, and ocean weed extracts, water/aqua, Avocado oil, rose distillate, glycerin, alcohol, pineapple extract, Beeswax, peanut oil, rose petal extract, Jojoba oil, Mango butter, fragrance essential oil, Shea butter, and a lot of more.As we tend to age, our skin becomes a lot of vulnerable to damage. This is often especially true for the skin around the eyes that makes using anti aging eye creams a vital part of a daily skin care routine. One must first determine what eye problem they need such as wrinkles, puffiness, or dark circles beneath the eyes, and then decide the eye cream that best meets their skin needs. You will soon see improved, healthier, and younger trying skin.

Anti Aging

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Skin Care: 8 Simple Ways To Get Rid Of Acne Without Prescription Drugs And Products

June 13, 2012 by admin

So what causes acne? Acne occurs when there is a build up of dead skin cells or something (ie. Oil, dirt and dust) in the follicles (tiny little canals that are connected to your pores and glands) on your skin which interacts with bacteria producing a pimple, whitehead or blackhead. If not treated correctly, acne can leave to permanent skin scarring which can lead to lower self-confidence and self-esteem.

As part of a healthy lifestyle and diet, it is hence important that we have and ensure we maintain healthy skin. I have thus listed out 8 simple and very effective ways of improving your skin appearance and reducing your risk of acne breakouts and pimples.

1. Wash your face twice a day

Washing your face twice a day helps to get rid of all the bacteria, grime, oil and dirt that you have gathered throughout the day. Wash it gently once in the morning and again at night to ensure that your skin is free of dust, dirt, dead skin cells and bacteria which will reduce the possibility of clogging. However, the reason why I only suggested washing it twice a day is that it is actually not a good thing to wash your face too much. Washing your face excessively can actually strip your face of its natural oils which could result in drier/ weaker skin as your skin gets dehydrated.

When washing your face, use lukewarm water as hot water can strip your skin off its important nutrients. Make sure you pat dry your face and use a mild soap of cleanser to help prevent breakouts. I recommend finding a gentler cleaner that would not strip the skin of its natural moisturizers.

2. Reduce your stress levels

Studies have shown that there is a high correlation between levels of stress and the level of acne breakouts and blemishes. This is because when we undergo stress, our body undergoes a chemical reaction to produce stress hormones which consequently produces more oils. This oil, called seburn, is produced by facial glands inside hair follicles which will travel up the follicle canal and take along dead skin cells with it. Once the oil reaches the surface, it forms a protective coating, effective sealing in the dead skin cells, blocking the pores and creating breakouts.

Thus, it is important to try and reduce stress in order to prevent acne problems. However, with deadlines, social obligations, work commitments, projects, etc, reducing stress is understandably not an easy thing to do. This is why it is important to learn to live a balanced lifestyle and have a balanced diet to try and maximize your potential for a more stress-free life. A good idea is to read up on how to increase your energy levels naturally so you can get more out of your day, and how to eat right.

3. Reduce the amount of times you touch your face.

I know this sounds incredibly stupid and ridiculously easy. But many of us dont realize that we touch our faces a lot. We play with our ears, rub our eyes, lean our chin/cheeks against our hands, etc and it is thus probably one of the hardest thing to not do!

The problem with touching your face is that the surface of your hands contains plenty of bacteria from the day to day things you have come into contact with. You pick up bacteria every time you open the door, shake hands, touch your computer, handle money, pay for food, etc. Consequently, your hands are the highest source of dirt, oil, bacteria and even viruses. Once these things come into contact with your face, they start clogging up your pores and/or irritate your skin which can result in pimple development.

Hence, ensure that you wash your hands throughout the day especially before youre about to consciously touch your face (ie. to apply makeup). You will reduce the build up of bacteria, grime and grease and hence, the possibility of pimple breakouts.

4. Review your make up

The thing about makeup is: it doesnt cause breakouts but it really doesnt help in preventing them either. To reduce the possibility of breakouts, try going for oil-free and organic makeups that are free from additives that could irritate sensitive skin. However, if you feel that your current makeup brand/selection isnt causing you too much grief, it should be perfectly fine to stick with it. Unfortunately, for those who are experiencing some problems, switching and trying out new brands may be the only way of discovering which brand of makeup is best suited for you and your skin. Remember, this will take patience, but if you keep track on what works and what doesnt, it will be worth it in the end.

Lastly on this point, always remember to wash your makeup off every time before you go to bed. This will give your pores and skin a chance to breathe and remain healthy.

5. Increase your vitamin A, B, C, E and zinc intake

Studies have shown that a deficiency in these vitamins could result in higher chance of acne development and breakouts.

In particular, zinc and vitamin c are well known to be extremely effective in boosting your immune system which consequently helps cure acne and blemishes as it ensures that your body is operating at its optimum level. Furthermore, deficiencies in these particular nutrients have shown to actually cause acne. Thus, it is important to have a balanced diet to ensure youre are consume adequate amounts of vitamin A,B,C,E and zinc intake.

6. Reduce your intake of processed and fatty foods.

I know we have all heard about it before, but fatty and processed foods are really andtrulybad for you. Unfortunately, consuming too much of these type of foods can really affect the healthiness of your skin. Consuming oily/fatty foods (though extremely tasty) affects your immune system, promoting the production of oil on your skin surface which will hence increase your risk of acne breakouts and pimples.

Thus, it is important to try and reduce your intake of these type of foods and make sure that you try to wash your face twice a day with a facial wash to help remove access oils that may have built up over the day.

7. Eat foods that are rich in Omega-3

Omega-3 fatty acids are excellent in helping to prevent breakouts as they ensure that cell membranes remain healthy so that nutrients can be transported efficiently to the cells. Furthermore as acne is a skin inflammation reaction to excess sebum (oil/grease on your face), Omega-3s anti-inflammatory and antibacterial effects will assist in the reduction of skin inflammation which will result in a reduction of acne.

Foods that are rich in Omega-3 include fish, fish oil, olive oils, walnuts and tofu. Or alternately, if due to circumstances you cant seem to incorporate enough Omega-3 rich foods in your diet, you can use supplements that are high in Omega-3 fatty acids.

8. Exercise

I know youre probably wondering how on earth could exercise help with your skins health and appearance. The great thing about exercise is that it reduces your bodys stress levels. Stress increases your skins natural oils which in greater amounts, leads to the clogging of pores and mass breakouts. Thus, by exercising, youre reducing stress on your body which indirectly affects your facial appearance. Furthermore, sweating from exercise helps to clear out your pores so that your dead skin cells will be flushed to the top, allowing less clogging to occur.

One very important thing to remember though, please shower after you have exercised. As sweat clears the pores of dead skin cells and leaves it at the top, the accumulation of these skin cells (if left for long enough) can lead to blockages which will eventually block (again) your recently cleared pores. In addition to this, when sweat evaporates, it leaves behind salt on your skin which encourages pore blockages. A good post-exercise facial product would be a moisturizing cleanser to help clean all or the impurities from your face and to help replenish the moisture on your face that may have been lost during your work out.

So there you have it, 8 simple ways to healthier looking skin. Combating acne is really a case of looking after your skin and your body. Ensure that you are having a proper diet, drinking lots of water and living a balanced lifestyle and your skin, body and acne problems will look after themselves. The results may not be overnight, but in the long term it is the most effective way of improving your acne condition permanently.

Good Luck!

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