Roche drug works in early-stage breast cancer

The Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease before surgery.

In documents posted online, FDA scientists said women who received the drug Perjeta as initial treatment for breast cancer were more likely to be cancer-free at the time of surgery than women who received older drug combinations. Although the results come from mid-stage trials of the drug, FDA scientists recommended accelerating approval of the drug.

That step is reserved for groundbreaking drugs to treat life-threatening diseases.

Perjeta was first approved last summer to treat women with a subtype of breast cancer that has already spread to other parts of the body. But Roche’s Genentech unit is now seeking approval to use the drug at a much earlier stage of the disease: after diagnosis and before surgery to remove the tumor.

Surgery to remove tumors is the first step in treating virtually all forms of cancer. If approved, Perjeta would be the first cancer drug approved for use as a pre-surgical step. Using cancer drugs before surgery is still experimental, but doctors hope the approach could help shrink tumors to make them easier to remove. In some breast cancer cases, a tumor that is easier to operate on could allow women to keep their breasts, rather than having them surgically removed.

On Thursday, the FDA will ask an outside panel of cancer specialists whether Perjeta’s benefits outweigh its risks for treating early-stage breast cancer. Among other questions, the experts will be asked whether the preliminary results reported by Genentech are likely to result in longer overall survival for patients. The government agency isn’t required to follow the group’s advice, though it often does.

The panel will review a 417-woman study comparing Perjeta in different combinations against older breast cancer treatments. When Perjeta was combined with Herceptin, another Genentech drug, and standard chemotherapy, 39 percent of women saw their cancer reach undetectable levels. Only 21 percent of women experienced the same results from taking Herceptin and chemotherapy alone. After drug treatment all the women received standard breast surgery to remove any cancerous tumors. Genentech says this surgery allowed researchers to confirm the presence or absence of cancer.

Last year the FDA released guidelines for studying breast cancer drugs in the pre-surgical setting, with the aim of accelerating approval of promising therapies. Perjeta is the first drug to undergo FDA review since those recommendations were released. If approved, it could encourage more drugmakers to study cancer drugs for early-stage use.

“Despite advances in systemic therapy of breast cancer, there remains a need to expedite drug development and approval of highly effective therapies for patients with high-risk early-stage breast cancer,” the FDA states in its review.

Like Herceptin, Perjeta only works in a subset of about 20 percent of breast cancer patients who have tumors that overproduce a protein known as HER-2, which makes cancer cells rapidly divide and grow.

Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute. About 6,000 to 8,000 deaths per year are attributed to the HER-2 form of the disease.

FDA scientists stress in their review that Genentech’s results are preliminary and will have to be confirmed in future trials. The company only measured the patients’ immediate response to the drug, and did not submit follow-up data showing whether the cancer returned or whether women ultimately lived longer. But agency scientists said the company’s approach “is reasonably likely to predict clinical benefit,” and noted that Genentech is already enrolling patients in a late-stage trial that could confirm the results.

Since the early 1990s the FDA has granted accelerated approval to dozens of drugs based on promising early results, on the condition that their effectiveness is confirmed in later studies. That policy has been praised by patients with HIV, cancer and other deadly diseases where access to experimental treatments can mean life or death.

But the flipside of the program means removing drugs from the market if their initial promise isn’t confirmed by later studies. In 2011 the FDA was criticized by some cancer patients when it revoked breast cancer approval for another Genentech drug, Avastin. The FDA concluded that the drug did not help breast cancer patients live longer or bring enough other benefit to outweigh its dangerous side effects. The drug is still approved to treat colon cancer and other forms of the disease.

The FDA is scheduled to make a decision on whether to approve Perjeta for early-stage breast cancer by Oct. 31.

Source: Fox news


9 ways to eliminate sugar cravings

According to the American Heart Association, the average American consumes approximately 16 teaspoons more added sugar than is recommended per day.

Sugar stimulates the brain to release serotonin, the “feel good” chemical, which provides a natural high. The endorphins released after eating sugar calm and relax us, leaving us wanting more. Eliminating a sugar addiction can be difficult, but following these steps can greatly reduce cravings and make it easier to kick the habit for good.

Nix the artificial sweeteners.  Artificial sweeteners have not been proven to curb sugar cravings. The taste, artificial or real, will have the same effect on the body creating the same cycle of wanting more and more.

Eat protein. Protein deficiency can contribute to sugar cravings as the body searches for a quick energy source. Adding protein to every meal ensures that the body always has fuel to access and maintains a steady blood sugar level, preventing any spikes and crashes.

Eliminate or reduce processed foods. The amount of sugar in processed food is usually underestimated. Something as seemingly innocent as whole-wheat crackers can have as much as 4 grams of sugar per serving. Always read the label to double check the sugar content, or steer clear of packaged foods altogether.

Eat a balanced diet. Eating too much of one flavor profile can create extreme cravings for the opposite flavor. A diet high in salty foods tends to create cravings for sweet foods. Listen to your body and take note of what you’re eating to find balance with a variety of flavors.

Sweeten up with vegetables. Sweet vegetables such as carrots, sweet potatoes, podded peas, beets and sweet bell peppers can provide you with a quick burst of energy when you need a pick me up. By regularly incorporating these sweet flavors you can more easily keep intense sugar cravings away since you’ll be satisfying the need for sweet flavors.

Season with sweet spices. Spices such as coriander, cinnamon, nutmeg, clove and cardamom will naturally sweeten foods without the need for added sweeteners, working wonders to reduce cravings.

Check your mineral levels. Magnesium is used in the regulation of glucose, insulin, and the neurotransmitter dopamine; a deficiency can manifest in the form of intense sugar cravings, especially for chocolate. Zinc is needed for proper insulin and glucose utilization; a deficiency can also lead to sugar cravings.

Supplement with L-glutamine. This amino acid has been found to help reduce, and even eliminate, cravings by helping to steady blood sugar. Add 500 milligrams three times a day with meals and an extra dose when a craving hits. Taking as little as a quarter teaspoon at the onset of a sugar craving should stop it in its tracks.

Get moving, and then rest. Being overtired will create a craving for a quick energy source, such as sugar, to counteract exhaustion. Instead, get plenty of sleep and move your body daily to reduce tension boost energy and diminish your chances of needing a quick sugar rush.

When a craving hits and feels uncontrollable remember that it won’t last for more than 20 minutes. Distract yourself until it passes. The more you resist the easier quicker your cravings will disappear.

Source: Fox news


Inducing labor linked with lower C-section rate

Pregnant women who are near their due date or have just passed it can have labor induced with drugs or other medical procedures — or they can simply wait for labor to start on its own.

Sometimes, there is a medical reason to induce labor, such as a woman having gestational diabetes, but in other cases, women undergo elective induction, when labor is induced without a medical reason. Now, a new study suggests that women who elect to induce labor are less likely to wind up having a cesarean section (or C-section) compared with women who give labor a longer chance to begin naturally.

Among women in the study who had previously had a baby, the odds of having a C-section for their current pregnancy were cut by about half in those who underwent elective induction. About 3 percent of these women who were induced wound up having a C-section, while about 7 percent of those who waited for labor to start on its own had the surgery, said study researcher Blair G. Darney, an obstetrics and gynecology researcher Oregon Health & Science University.


Girl with fatal brain infection is now discharged from hospital

A 12-year-old Arkansas girl who survived a rare and often fatal infection caused by a brain-eating amoeba says she is lucky to be alive.

 

A 12-year-old Arkansas girl who survived a rare and often fatal infection caused by a brain-eating amoeba says she is lucky to be alive.

Kali (KAY’-lee) Hardig, her parents and doctors spoke to reporters Wednesday before she was to be released from Arkansas Children’s Hospital.

Kali says she has missed playing with her dog and seeing friends after being hospitalized in July.

The girl was diagnosed with an infection caused by a brain-eating amoeba. Health officials say there were 128 reported infections in the United States between 1962 and 2012. Before Kali, doctors could only point to one known survivor in the U.S. and another in Mexico.

Health officials believe Kali became sick after a trip to an Arkansas lake. The amoeba is often found in warm, fresh water.

This article is appeared in fox news

 


5 habits of naturally slim people you should steal

If there’s one thing I’ve learned in more than 15 years of private practice, it’s that weight management is about far more than calories in, calories out. In addition to genetics, there are dozens of patterns that day after day, week after week, influence our shapes and sizes. Many of the habits of seemingly “naturally slim” people aren’t deliberate, but you can consciously adopt them. Over time, they’ll soon become second nature, and work for you too. Here are five I notice often, and how they can lead to diet-free weight loss.

Be fidgety

Research shows that people who move more burn as many as 350 extra calories a day, the equivalent of talking a daily 60 minute walk at 4 miles per hour. If you’re not one of those people who is always tapping your toe, moving around in your chair, or talking with your hands, start building some purposeful non-workout activity into your day. Stand up while you talk on the phone or brainstorm, get up from your desk every hour on the hour to sip water, stretch , or just walk around the room, park in the furthest spot on the lot, and take escalators and stairs every chance you get. It may seem forced at first, but stick with it, and it will soon feel odd not to do these things. For one of my clients, this change not only resulted in weight loss, but also a surge in creativity, which makes sense, since movement enhances circulation. That may be why one recent study found that sitting less slashes the risk of chronic diseases , including cancer, heart disease, and type 2 diabetes .

Eat without distractions

We’ve become a nation of multi-taskers, including eating while driving, working, reading, walking, and well, just about any activity. The other day, I saw a woman strolling through Target, placing items into her card, while simultaneously eating and talking on the phone. While it may be efficient to do several things at once, people who eat mindfully and without distractions tend to eat less and feel more satisfied. Do you remember being a kid, eating an ice cream cone, and being so into it you couldn’t help letting out an “Mmmmmmm” as you savored every spoonful? Some adults maintain that kind of awareness, and according to the research, relearning it can result in naturally eating 300 fewer calories a day, enough to drop two sizes in a year’s time. start, commit to noshing without doing anything else, even just once a day. Take a few deep, relaxing breaths, then eat, while drawing all of your attention to the aromas, flavors, and textures of your food. Much like yoga  and meditation, this daily exercise can boost your overall awareness, a benefit that will likely translate to curbing your intake, and boosting your enjoyment.

Order unapologetically

I waited tables in college and grad school, so I appreciate kindness to servers, but these days, customizing your order when dining out is the norm, and in my experience, it’s a major habit of naturally slim people. The key is, they modify meals not to save calories, but to get what they really want, and to eat in a way that intuitively makes them feel best. I remember one regular customer who, long before carbs were considered evil, always ordered her turkey burgers bunless. She’d say things like, “If I have that bun, I won’t have room for popcorn at the movies” or “If I don’t skip the bun, I’ll feel like napping rather than shopping!” To her, ditching the bun wasn’t about dieting, it just made sense, and I advise my clients to take the same approach. One exercise I give clients is this: recall a recent meal that left you feeling stuffed and sluggish, then write down how you would modify your order to result in what I call the “Goldilocks effect” – not too little, not too much, just right. One hundred percent of the time, the imagined do-over meals are more balanced, far lower in calories, and much more “sensible.” Apply that logic every time you dine out, and you’ll end restaurant eater’s remorse.

Rethink waste

Through keeping food journals, one of my clients recently discovered that she nearly always finished her kids’ leftovers. When we talked about why (e.g. what was she thinking and feeling while doing this?), she realized it was because she couldn’t let the food go to waste. This mindset also resulted in frequently eating until she was uncomfortably full. She marveled at how thin people can push a plate away with food still on it, and take one bite of a free sample, then toss the rest in the trash. She knew this “rule” was ingrained in her as a child, and as an adult, she still felt bad about breaking it. But when I asked her to make a list of the pros and cons of continuing to follow this directive, it hit her like a ton of bricks that overeating, just to avoid throwing food away was even more wasteful. Not only would it not help others in need, but by eating more than her body needed, she was gaining “waste weight,” which she had to carry around 24 hours a day. That powerful realization led to paying attention to her body, eating when hungry, stopping when full, preparing more appropriate portions for the whole family, and effortlessly shedding pounds and inches.

Forego what’s so-so

One of the biggest insights many of my clients gain is just how often they eat things they don’t even really like, something naturally slim people rarely do. When you begin to eat more mindfully, the experience of eating something that’s not flavorful, or unsatisfying, is such a let down, it doesn’t make sense to keep eating. And eating something that doesn’t really do it for you often leads to overeating or prolonged eating, in an attempt to become satisfied, which typically results in feeling stuffed–and still unsatisfied. One of my clients recently experienced this while out to dinner with her hubby. They ordered a dessert that looked amazing, but after one bite she realized it was just meh. She put down her spoon, and decided to have a few squares of dark chocolate when she got home instead. This was not a restrictive move, but an it’s-not-worth-it-when-it’s-not-worth-it shift that has changed the way she eats, and resulted in a diet-free body transformation.

This article is originally appeared in Fox News


Are egg yolks good or bad for your health?

egg received a bad reputation with regard to cardiovascular health, as one large egg contains approximately 187 milligrams of cholesterol.

California stores of the supermarket chain unveiled a brand new product called Beyond Eggs – artificial eggs made with ground-up peas, sorghum and other plant ingredients.

 

According to Hampton Creak, the company that created the product, the main motivation behind the chicken-less egg was to provide a plant-based alternative for developing countries, in order to help increase their food supply.  And as global demand for eggs continues to increase, the manufacturers claim that more land and water are being used to raise chickens, therefore they wanted to find a way of reducing the environmental footprint created by egg production.

 

While the chicken-less egg was mostly created to address international food shortage concerns, the product is also potentially appealing to vegans, who don’t eat any animal-based products, and other consumers who are concerned that eggs are too high in cholesterol.

 

But are these concerns actually valid?  The nutritional value of the egg and its yolk has been debated by nutritionists for years.  Originally, the egg received a bad reputation with regard to cardiovascular health, as one large egg contains approximately 187 milligrams of cholesterol.

 

However, most research has shown that cholesterol found in foods isn’t fully to blame for increased LDL cholesterol in the body.

 

“Eggs are an animal product, and they do contain cholesterol,” Lisa Cimperman, a registered dietician for UH Case Medical Center, told FoxNews.com.  “But actually, cholesterol in foods doesn’t affect our blood cholesterol as much as saturated fat does.  Cholesterol in food, in general you do want to avoid, but it’s not necessarily the main culprit of high cholesterol.”

 

Compared to other animal products, the average egg actually contains relatively low amounts of saturated fats – approximately 1.6 grams per egg yolk.  Additionally, various studies from the Harvard School of Public Health and the British Nutrition Foundation have found that eggs have clinically insignificant effects on blood cholesterol, and are not associated with an increased risk of cardiovascular disease.

 

Regardless, many consumers are still concerned over the yolk’s fatty content, so rather than eat the full egg, they often eat the egg’s albumin – more commonly referred to as the egg white.  Since egg whites are considered pure protein, this dietary decision isn’t a bad move.  However, some dieticians argue it’s important to consume both the egg’s fat and protein, as the combination can have positive health benefits when it comes to blood sugar.

 

“You want the fat, because it not only satiates you, but also slows the absorption of your food,” Laura Cipullo a registered dietician in New York City, told FoxNews.com.  “So you stay fuller longer, and it won’t increase blood sugar.  A lot of people have toast with just egg whites, but it’s giving them a quicker rise in their blood sugar. But if you have the yolk with it or a different form of fat like avocado, your blood sugar won’t rise as quickly, because it takes longer to break (the food) down.”

 

Of course, all fat must be consumed in moderation, which is why many dieticians recommend eating only a few egg yolks each week.  And for patients with a history of vascular disease, keeping track of the eggs they eat each week is critical to their health.  A recent study from the National Institutes of Health found that patients with an increased risk for cardiovascular disease should limit their cholesterol intake from foods to about 200 milligrams a day.

 

“What I typically recommend for individuals who I see who have had heart disease or have high cholesterol, I recommend they eat no more than three egg yolks per week and then as much of the egg white as they want,” Cimperman said.  “Being conscious of the quantity they’re eating can be helpful.”

 

Despite their fat and cholesterol content, egg yolks are good source of vitamin A and iron, along with a host of other nutrients.

 

“Eggs, in general, are also good sources of B vitamin, thiamine is one example, and selenium, which is an antioxidant,” Cimperman said.  “And folate is a good vitamin, particularly for pregnant women.”

 

Cimperman noted that although eggs contain many health properties, egg preparation is critical, since the way an egg is made can completely alter its nutritional value. An egg fried in butter, for example, will wreak more havoc on a person’s blood cholesterol than a hardboiled egg.

 

But as long as consumers are conscientious about how many eggs they consume and the way they’re consuming them, they shouldn’t be overly concerned about their cardiovascular health.

 

“Even if you’re eating something like a nut – that also has saturated fat in it,” Cipullo said. “You have to look at the benefits, and the benefits of eggs providing overall protein and vitamins and being easy to eat, that outweighs the fact that it has a few grams of saturated fat.”

 

Read more : Fox News/health


Women advised to have babies before turning 35

Experts have suggested that women should aim to have children before turning 35.

During British Science Festival in Newcastle, a panel of doctors said that a woman should aim to start her family before the age of 35, as fertility declines sharply after this point, the Scotsman reported.

Experts warned that many women wrongly believe that procedures such as IVF could prolong fertility, saying that there was no way of reversing declining fertility.

Mary Herbert, professor in reproductive biology at the University of Newcastle, advised all women to think about family planning in the context of not just preventing pregnancy but also in the context of having their babies at a time when they still have their reproductive fitness.

The experts said that women are born with a pool of one to two million eggs that shrinks until, at the menopause, the eggs effectively run out.

However, it was also noted that is not only the number but the quality of eggs that is reduced by the passing years.

 


Tea made from mamala tree may help fight AIDS

The prostratin compound shows both preventing HIV from infecting human cells and awakening dormant HIV viruses that are hiding inside human

A compound found in a medicinal tea brewed from the bark of a tree could help fight AIDS, scientists have found.

The tea used by tribal healers on the South Pacific island of Samoa to treat hepatitis contains the compound prostratin, extracted from the bark of the mamala tree.

Scientists have found a way to isolate the compound and synthesise it so it is 100 times more potent.
The new version of prostratin shows promise in laboratory tests for both preventing HIV from infecting human cells and awakening dormant HIV viruses that are hiding inside human latently infected cells.

Latent HIV cell reservoirs are untouchable by today`s antiviral medicines. Antiviral medicines reduce active virus levels in patients` blood and keep patients healthy.
But when patients stop the medication, the hibernating HIV in reservoirs awakens to resupply active virus. Prostratin flushes HIV out of its cellular sanctuaries so that antiviral drugs can attack and hopefully eradicate the HIV from the body.

Speaking at the American Chemical Society`s meeting in Indianapolis, Paul A Wender from Stanford University described efficient new ways of making prostratin.
Wender and colleagues first developed a way to make the tea ingredient, prostratin, in large amounts from readily available ingredients.

He described how that initial synthesis broke down a major barrier to probing prostratin`s antiviral effects. Until then, scientists had to extract prostratin from the bark of the Samoan mamala tree, and only tiny and variable amounts were so obtained.

Samoa is where another scientist, Paul Cox, in 1987 heard a native healer praise mamala bark tea as a remedy for viral hepatitis. It led scientists at the National Cancer Institute to analyse the bark and identify prostratin as a key ingredient.
Wender`s synthesis of prostratin opened the door to research on the substance and enabled his team to change prostratin`s architecture.

“We now have made synthetic variants of prostratin, called analogs, that are 100 times more potent than the natural product,” Wender said.

Wender`s group also synthesised bryostatin, a substance that occurs naturally in sea creatures called bryozoans, and appears even more effective for AIDS and have applications for Alzheimer`s disease and cancer.

“Bryostatin has shown great promise in laboratory experiments as the basis for development of potentially transformative medicines for cancer, Alzheimer`s disease and the eradication of HIV/AIDS,” Wender said.

Researchers have designed simpler and more readily synthesised analogs of bryostatin which are up to 1,000-fold more potent in flushing HIV out of its hiding places than prostratin.

Source Zee News/health


FDA receives 89 reports of illness from Chobani yogurt

 The Food and Drug Administration reports at least 89 people have reported getting sick after eating Chobani Greek yogurt manufactured in Twin Falls, Idaho.

FDA spokeswoman Tamara Ward told The Times-News on Monday that some have described nausea and cramps.

No link has been confirmed between the illnesses and the yogurt. However, Ward says the FDA is working with Chobani to hasten its voluntary recall.

Chobani last week told grocery stores to destroy 35 varieties of yogurt reported to have been contaminated by a mold associated with dairy products. The affected yogurt cups have the code 16-012 and expiration dates between Sept. 11 and Oct. 7.

Health officials have said the yogurt is not a public health threat, but the company said last week the “mold can act as an opportunistic pathogen for those with compromised immune systems.”

Read more: http://www.foxnews.com/health/2013/09/10/fda-receives-8-reports-illness-from-chobani-yogurt/#ixzz2eYvVt6qM


Learning and memory disorders could soon become history

 Researchers have created new, specific memories by direct manipulation of the brain that could help understand and potentially resolve learning and memory disorders.

Research led by senior author Norman M. Weinberger, a research professor of neurobiology and behaviour at UC Irvine, and colleagues has shown that specific memories can be made by directly altering brain cells in the cerebral cortex, which produces the predicted specific memory.

The researchers say this is the first evidence that memories can be created by direct cortical manipulation.

During the research, Weinberger and colleagues played a specific tone to test rodents then stimulated the nucleus basalis deep within their brains, releasing acetylcholine (ACh), a chemical involved in memory formation. This procedure increased the number of brain cells responding to the specific tone.

The following day, the scientists played many sounds to the animals and found that their respiration spiked when they recognized the particular tone, showing that specific memory content was created by brain changes directly induced during the experiment. Created memories have the same features as natural memories including long-term retention.

The study has been published in Neuroscience.