FDA Scrutinizes Weight Loss Pill from Orexigen

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Scientists for the Food and Drug Administration said Friday a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn't meet all the criterion set forth by the agency.

The FDA's review, posted online Friday, also raised questions about the pill's effects on the heart, a perennial issue for weight loss drugs that have been plagued by safety issues.

Orexigen's pill Contrave is the third weight loss pill to be reviewed by the FDA this year. FDA officials have acknowledged the need for new weight loss drugs amid an epidemic of U.S. obesity, though the agency rejected the two other medications due to safety concerns.

Shares of Orexigen Therapeutics Inc. fell 62 cents, or 11.3 percent, to $4.84 in morning trading.

The FDA said Friday four studies conducted by Orexigen showed patients taking its drug lost, on average, 4.2 percent more weight than patients taking a placebo. However, the results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.

The drug did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight. FDA guidelines published in 2007 state that a drug can be considered effective if it meets this requirement.

The FDA will ask a panel of experts to vote on the drug's efficacy and safety on Tuesday. The vote is non-binding, though the FDA often follows the guidance of its panelists.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.

But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Earlier this year Abbott Laboratories' Meridia weight loss pill was pulled from the market after regulators said it increased the risk of heart attack and stroke.

In reviewing Contrave, FDA scientists complained that the company enrolled few elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug's safety in patients at risk for heart attack and stroke.

Contrave is a combination pill, mixing the antidepressant bupropion with the anti-addiction drug naltrexone. FDA reported higher rates of side effects already linked to the drugs, including high blood pressure, dizziness and insomnia.

The quest for a blockbuster weight loss drug has been plagued for decades by safety issues. Doctors and patients had hoped a new wave of treatments submitted to the FDA would prove safer than older therapies. But in October the FDA rejected two drugs in one week: Qnexa from Vivus Inc. and lorcaserin from Arena Pharmaceuticals Inc.

Qnexa had shown significant weight loss in trials but was linked to potential heart problems and birth defects. In lorcaserin's case, the FDA raised concerns about cancerous tumors seen in rats who took the drug.


source : articles.sfgate.com

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Video Game to Choose Healthier Diet

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A candidate from Georgia Tech College of Computing has shown that playing health-related video games on a mobile device can help adults learn to live more healthfully by making smart diet choices.

OrderUP! Includes "exergames," in which players get a genuine workout while playing. It educates players about how to make healthy eating choices in situations nearly everyone encounters regularly in their lives.

By casting players as virtual restaurant servers, Order UP! forces players to make healthy—and fast—menu decisions for a group of demanding, impatient customers.

"The most important finding from the OrderUP! project was how the game was integrated into conversations players had with other players and non-players about things that they had learned, particularly things that confronted their assumptions about healthy choices," said Beki Grinter, the project's principal investigator and associate professor in Georgia Tech's School of Interactive Computing.

How the game works: virtual 'customers' are offered three possible food choices like a fried chicken thigh, a jerk chicken breast or gumbo. They're then asked to make the healthiest choice, with only a few moments to pick before the customer gets impatient and leaves.

Players start with 1,000 health points, and as they make unhealthy choices for their customers (or as the customers get tired of waiting and leave) their health points drop. The object of the game is to continue serving food as long as possible.

"All health games, or any kind of ''serious'' game with a purpose beyond entertainment, always have the challenge of making the game fun versus getting across the information you want to get across," said the game's creator, Andrea Grimes Parker, a student in Human-Centered Computing in Georgia Tech's School of Interactive Computing.

"In particular, we found that people learned how to make healthier choices when eating out, reassessed the healthiness of their current eating habits, began having productive conversations about healthy eating with people in their social network and, finally, actually started introducing healthier foods into their diet," said the game's creator, Andrea Grimes Parker, a student in Human-Centered Computing in Georgia Tech's School of Interactive Computing.

"One finding that was a bit surprising was just how much people translated what they saw in the game to their own lives. Another surprise was that players wanted more detailed information about nutrition values," Parker said.

Future development of OrderUP! will include a longer study to measure player behaviour change over an extended period of time, as well as an expanded game with more levels, more food choices and more nutritional information available to the player.

The finding is published in the paper, Let's Play! Mobile Health Games for Adults, recently presented at Ubicomp 2010 in Copenhagen, Denmark.

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The Effects of Stress

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While there's a wealth of information available about the effects of stress, it can be stressful trying to wade through it all! Here are 10 important facts about the effects of stress that can go a long way in helping you understand stress and its role in your life. This can help you quickly and easily learn more about the effects of stress and find some effective stress management techniques to incorporate into your life right now.

1. The Wrong Attitude Significantly Increases Your Stress Level
We all experience stress, but the pessimists, perfectionists, and those with 'type A' personalities (to name a few) greatly increase the level of stress they experience in a given event, and even bring more stressful events into their lives with their self sabotage thought and behavior patterns. If you have some of these tendencies, you can significantly reduce the level of stress you experience with these resources on stress and self sabotage.

2. Some Types of Stress Can Be Beneficial
A certain type of stress, eustress, is actually necessary and beneficial for a balanced and exciting life. Eustress is the type of stress you experience when you're riding a roller-coaster (if you enjoy fast rides), are playing a fun game, or are falling in love. Eustress makes us feel vital and alive. (Chronic stress, however, is another story!) If you're interested in learning more about the different types of stress and how they affect your health, read this article on stress and health.

3. You Can Stop Your Stress Reaction Right Now
When you experience stress, all manner of physiological changes occur to get you in top physical shape to fight or run. Unfortunately, if you don't calm yourself down relatively quickly, you could remain in this altered state for too long, and it could take a toll on your health. Practicing stress relievers like breathing exercises and meditation can calm you down quickly, returning your body to normal. Read more on how to calm down quickly.

4. Even Small Amounts of Stress Can Affect Your Health
You may be aware that months spent in a stressful life situation can leave you vulnerable to illness, but did you know that relatively short periods of stress can also compromise your immune system, elevating your risk of illness? Sadly, it's true. Learn more about the ways that stress, especially job stress, can impact your health.

5. The Wrong Attitude Can Make You Sick
Negative thought patterns and emotional stress can lead to psychosomatic illness, a condition that's caused at least in part by stress, but has physical symptoms that need to be treated as any other illness does. If you're concerned about your thoughts and emotions taking a physical toll, read more on psychosomatic illness and staying healthy.

6. You Can Prevent A Significant Amount Of Stress In Your Life From Occurring
Some stress is inevitable, but you can structure your life in ways that buffer you from stress and stressful events. For example, maintaining a healthy diet, getting regular exercise, and having at least a few close friendships are all important ways to relieve stress and stay healthy. Find more ways to relieve daily stress in your life, and prevent some of your stress from ever occurring!

7. Stress can age you prematurely in many ways
It may be surprising, but stress can be more of a factor in determining your physical age than the number of candles you blow out each year. Stress actually speeds up wear and tear on many, many areas of your body and at all levels, inducing many of the changes we refer to when we talk about 'aging'. Read more about recent research on this here.

8. Not Everyone Experiences Stress In The Same Way
Certain inborn personality traits and learned thought patterns can cause two people who live through the same event to experience it very differently, with one person finding it extremely stressful and the other finding it only mildly stressful or not at all. Some of these traits you can't change, but others you can alter to a large degree. Read more about mental traits contributing to burnout and stress, and find resources for altering your experience of stress.

9. Some 'Stress Relievers' Actually Cause More Stress
Most of us have a few less-than-healthy ways of dealing with stress. Unfortunately, most of these 'bad habits' that feel so good at the time can really cause much more stress in the long run. If you smoke, drink in excess, spend too much, or handle stress in a way you know may not be good for you, find resources for understanding how you're affecting your stress levels right now, and find resources for healthier coping.

10. By Imagining Your Stress Gone, It Can Be
Certain mental stress relief techniques, such as affirmations, guided imagery and visualizations, involve imagining that your stress is gone. And they work! Learn more about these and other mental stress relievers, and see which one works best for you.

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What is Stress?

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Stress is a feeling that's created when we react to particular events. When you sense danger – whether it’s real or imagined – the body's defenses kick into high gear in a rapid, automatic process known as the “fight-or-flight” reaction, or the stress response.When people feel stressed by something going on around them, their bodies react by releasing chemicals into the blood. These chemicals give people more energy and strength, which can be a good thing if their stress is caused by physical danger.

The stress response is the body’s way of protecting you. When working properly, it helps you stay focused, energetic, and alert. In emergency situations, stress can save your life – giving you extra strength to defend yourself, for example, or spurring you to slam on the brakes to avoid an accident.

The stress response also helps you rise to meet challenges. Stress is what keeps you on your toes during a presentation at work, sharpens your concentration when you’re attempting the game-winning free throw, or drives you to study for an exam when you'd rather be watching TV.

the stress response can also cause problems when it overreacts or fails to turn off and reset itself properly.


stress stops being helpful and starts causing major damage to your health, your mood, your productivity, your relationships, and your quality of life.

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