FDA clears first new weight-loss pill in 13 years

This photo provided by Food and Drug Administration shows Arena Pharmaceutical's anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. (AP Photo/Food and Drug Administration)

This photo provided by Food and Drug Administration shows Arena Pharmaceutical's anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. (AP Photo/Food and Drug Administration)

WASHINGTON (AP) ? The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said FDA's drug center director, Dr. Janet Woodcock, in a statement.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.

In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.

The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.

Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the idea that lifestyle changes alone are not enough to treat obesity.

"This is good news because it tells us that the FDA is indeed treating obesity seriously. On the other hand, it's not the answer to the problem ? or even a big part of the answer," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq.

Even if the effects of Belviq are subtle, experts say it could be an important first step in a new line of treatments that attack the underlying causes of obesity.

"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.

Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.

Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.

Shares of San Diego-based Arena Pharmaceuticals Inc. jumped $2.54, or 28.7 percent, to close at $11.39. Shares of Mountain View, Calif.-based Vivus rose $1.94, or 7.4 percent, to $28.33.

Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. On average patients lost just 3 to 3.7 percent of their starting body weight over a year. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more.

The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Patients are unlikely to see any significant weight loss by staying with the drug.

Side effects with the drug include depression, migraine and memory lapses.

In May a panel of expert advisers to the FDA voted 18-4 to recommend approval of Arena's drug, concluding that its benefits "outweigh the potential risks when used long term" in overweight and obese people.

Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight.

While several drugs are available for short-term weight loss, until Wednesday there was only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche, which is seldom prescribed because of unpleasant digestive side effects and modest weight loss. Belviq is the first new prescription drug approved to treat obesity since Xenical's approval 13 years ago.

Other safety failures for diet pills have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.

Associated Press

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Ephron blazed trail in male-dominated industry

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How the Brain Views Race

Liz Phelps was one of the first researchers to tackle how the brain responds to people of different racial groups. Image: NYU

In this groundbreaking adventure into the worlds of psychopaths, the renowned psychologist Kevin Dutton argues that there is a fine line between a brilliant...

Read More??

From Nature magazine

How the brain responds to and processes images of people from different racial groups is an emerging field of investigation that could have major implications for society. Psychologist Elizabeth Phelps of New York University, in New York, who in 2000 led one of the first studies in this area, tells Nature what her latest review of the field reveals about the neuroscience of race.

What does psychology tell us about race?
Social psychologists differentiate between the attitudes that people express and their implicit preferences. This can be studied using the implicit association task, which measures initial, evaluative responses. It involves asking people to pair concepts such as black and white with concepts like good and bad. What you find is that most white Americans take longer to make a response that pairs black with good and white with bad than vice versa. This reveals their implicit preferences.

What did your review of the neuroscience literature show?
My colleagues and I found that there?s a network of brain regions that is consistently activated in neuroimaging studies of race processing. This network overlaps with the circuits involved in decision-making and emotion regulation, and includes the amygdala, fusiform face area (FFA), anterior cingulate cortex (ACC) and dorsolateral prefrontal cortex (DLPFC).

What did your previous work show?
Our 2000 study was the first to link race preference to brain activity. We measured the eye-blink startle, a reflex response that people display when they hear a loud noise, for example. A lot of studies have shown that this reflex is potentiated [enhanced] when people are anxious or in the presence of something they think is negative. We found that implicit preferences were correlated with potentiated startle, and that both were correlated with the amount of amygdala activation.

How does the neuroscience fit with the psychological model?
Activity in the FFA isn?t surprising, because all of these studies use photos of faces. The amygdala is involved in emotions, and might be linked to the automatic evaluations we make when we see people from other racial groups. We think that the ACC and DLPFC are involved in more complex functions. People tend to show unintentional indications of race bias, even when they are motivated to be non-prejudiced, so the ACC may be involved in detecting these conflicts. You can have an implicit bias and choose not to act on it, and the DLPFC may be trying to regulate the emotional responses that conflict with our egalitarian goals and beliefs.

What about people who are overtly prejudiced?
Finding differences in people with extreme views wouldn?t be too surprising, but I?m not sure we?d see anything more than an exaggerated [emotional] response. We?re more interested in ?normal? people. Those who are more internally motivated to be non-prejudiced show greater ACC activity, whereas those who hold extreme views obviously have explicit, intentional race bias and don?t care about controlling their emotional responses.

What are the societal implications of this research?
Most white Americans we studied show an implicit preference for their own group. They don?t have bad intentions, but because they?ve associated black people with, say, criminality so many times, their decisions are infused with that association, whether or not they believe it?s accurate. There?s evidence of unintentional race bias at every stage of the legal process. Despite the fact that it aims to be egalitarian, sentencing is vastly different for African Americans. The bias is also there in employment.

How should this research progress?
We need to investigate how our implicit preferences are linked to the choices and decisions we make. We want to use this knowledge to reduce the unintended consequences of race bias ? the things we do that aren?t consistent with our beliefs. One problem is the lack of funding for this type of work. It?s very hard to fund this kind of research because it?s not really relevant to health. One way to go would be to apply the sophisticated tools of neuroeconomics to investigate how unintentional bias affects our decision making. The research could also be linked to emerging work on controlling emotions.

This article is reproduced with permission from the magazine Nature. The article was first published on June 26, 2012.

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Higgs boson buzz goes through ups and downs

CERN / CMS Collaboration

A computer graphic shows a typical Higgs boson candidate event, including two high-energy photons whose energy (depicted by red towers) is measured in the Compact Muon Solenoid's electromagnetic calorimeter. The yellow lines are the measured tracks of other particles produced in the collision. The pale blue volume represents the CMS' crystal calorimeter barrel.

By Alan Boyle

A week ago, sources started passing the word that physicists were "fired up" about further evidence for the existence of the Higgs boson, the last undiscovered particle predicted by the Standard Model and the main quarry for the $10 billion Large Hadron Collider.

That blaze of buzz reached a high point this week, when Columbia mathematician Peter Woit reported "reliable rumors"?that the confidence level for a detection of the Higgs' signature in the mass range of around 125 billion electron-volts, or 125 GeV, was increasing.

"CERN will soon have to decide how to spin this: will they announce discovery of the Higgs, or will they wait for some overwhelmingly convincing standard to be met, such as 5 sigma in at least one channel of one experiment?" Woit wrote.

---

"Sigma" refers to the statistical confidence that a given result is more than a fluke, with 5 sigma serving as the gold standard for a discovery. If you're a Higgs-watcher, you'll be hearing a lot about sigma in the next couple of weeks, leading up to the International Conference on High-Energy Physics, or ICHEP, in Australia from July 4 to 11. That's when the LHC's teams are due to provide a status report on the search for the Higgs.?

The Higgs hunt is hot because physicists have hypothesized about the boson for 40 years as part of the mechanism by which some particles acquire mass while others don't. The Higgs is so fundamental to the frontier of physics that Fermilab's Leon Lederman once called it the "God Particle"?? a term that most other physicists positively hate.?Finding it in the mass range where it's expected to be would serve as solid confirmation for the Standard Model, one of the most successful theories in the history of science. Not finding it would be more interesting: Physicists would have to consider some other mechanism, outside the Standard Model, to explain particle mass. And there's nothing theorists love more than a challenge like that.

In December, the teams behind the ATLAS and CMS detectors reported "tantalizing hints" of a Higgs detection at 125 GeV, with confidence levels of 3.6 sigma for ATLAS and 2.6 sigma for CMS. If the additional observations made since then show the same sorts of hints, those sigma levels should go up?? and that's been the gist of the buzz over the last week or so. For science geeks, that's a big deal, or at least a big meme: so big that the hashtag #HiggsRumors was for a time on top of Twitter's trending list, Discovery News' Jennifer Ouelette noted.

A lot of that trending took place because of the in-jokes spawned by the original buzz ??which has now fallen to a steady hum, thanks to a string of reality checks.

"Please do not believe the blogs," ATLAS spokeswoman Fabiola Gianotti told The New York Times. "I am very surprised that rumors appear on a subject that is really evolving daily," CMS spokesman Guido Tonelli told Science News. "The experimenters can't possibly have their data in presentable form yet, so the rumors can't be correct in every detail," Rutgers theoretical physicist Matt Strassler observed on his blog.

Union College physicist Chad Orzel, the author of "How to Teach Relativity to Your Dog," said the celebrity-level hype was?"the price of success":

"I mean, it?s not an accident that there?s a lot of excitement about the maybe-sorta-kinda discovery of the Higgs. This is the product of years of relentless hype from the particle physics community. They've been talking about this goddamn particle for longer than I've been running this blog, and it's finally percolated out into the general public consciousness enough that buzz about it can trend on Twitter. Complaining that your persistent effort to get people to care about particle physics esoterica has led to people being excited about particle physics esoterica seems more than a little churlish.

"So, lighten up. Revel in the success of your hype machine. God knows, if there were a Twitter trending topic about Bose-Einstein Condensation or anything else in atomic physics, I?d do the Happy Dance all the way down the hall. You?ve worked hard to make your elusive particle a celebrity, now reap the rewards."

The true reaping will come in a couple of weeks.?As Reuters' Robert Evans reported, the most recent readings from ATLAS and CMS are being analyzed in isolation, so that one team's conclusions don't influence the other team. Until the ICHEP actually takes place, hype is just about all we'll hear about. But in the meantime, get ready for the real news by reviewing these resources:

Update for 1 p.m. ET June 22: Europe's CERN particle-physics center just announced that the big update on the Higgs search will come on July 4, during a seminar at 3 a.m. ET that's tied to the start of the ICHEP conference.?

"We now have more than double the data we had last year," CERN's director for research and computing, Sergio Bertolucci, was quoted as saying. "That should be enough to see whether the trends we were seeing in the 2011 data are still there, or whether they?ve gone away. It?s a very exciting time."

CERN said that if a new particle is discovered, the ATLAS and CMS teams will need more time to ascertain whether it's the Higgs.

"It's a bit like spotting a familiar face from afar," CERN Director General Rolf Heuer explained. "Sometimes you need closer inspection to find out whether it?s really your best friend, or actually your best friend's twin."

CERN said physicists at the conference in Melbourne will be able to join the seminar via a live two-way link. The seminar will be followed by a news conference at CERN. There'll be a webcast available via?http://webcast.cern.ch. Stay tuned...

---

Alan Boyle is msnbc.com's science editor. Connect with the Cosmic Log community by "liking" the log's Facebook page, following @b0yle on Twitter and adding the?Cosmic Log page?to your Google+ presence. You can also check out?"The Case for Pluto,"?my book about the controversial dwarf planet and the search for new worlds.

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Most popular cities in the world to visit

George Rose / Getty Images

A view looking down The Mall toward Buckingham Palace and Victoria Memorial in London.

By Deborah L. Jacobs, Forbes.com

In choosing a vacation spot this year, will you follow your heart or follow the crowd?

To come up with its second annual list of the 20 most visited cities in the world,?MasterCard?followed the money. The company's?Global Destination Cities Index for 2012?ranks Istanbul as the fastest growing destination, putting it No. 5 on the list after London, Paris, Bangkok and Singapore.

Slideshow: See the most visited cities in 2012

?Despite sluggish economic growth around the world, the number of people traveling abroad continues to increase,? the report states. London leads the world in the two key criteria MasterCard considered: as both the most popular destination city for overseas travelers (they?re expecting 16.9 million foreign visitors this year), and in the average amount each visitor spends (their total spending there is projected to be $21.1 billion). Whether drawn by business or as tourists, London?s visitors from?New York?are the ones that travel the furthest and spend the most.

---

New York still ranks second by visitor spending (after London), which may explain all the foreign languages one hears while shopping at the?Gap.

In the Asia/Pacific region, Bangkok leads in the total number of visitors and visitor spending and is expected to displace Paris as the third-ranking city by visitor spending. Dubai retains its rank as No. 1 of the top 10 destination cities in the Middle East and Africa.

Glitz trumps history in the People?s Republic of China, with Shanghai ahead of Beijing by five ranks. And though to many minds Barcelona outcharms Madrid, Spain?s capital remains the more popular destination.

Although?Rome?hasn?t lost any of its charm, it has slipped in popularity as a tourist destination, falling below?Seoul, Kuala Lumpur, Frankfurt and Dubai. Perhaps economic forces are at play.

Still undecided about your next destination? Check out the slideshow to help decide.

Deborah L. Jacobs, a lawyer and journalist, is the author of Estate Planning Smarts: A Practical, User-Friendly, Action-Oriented Guide. You can follow her on Twitter.

More from Forbes.com

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100,000 Downloads Later, TC Disrupt Finalist Open Garden Launches Update, Improves User Experience

Open Garden?was definitely one of the most interesting and ambitious startups to?launch?at TechCrunch Disrupt in New York last month. The service, which helps you share and crowdsource your mobile connectivity, was one of the Startup Battlefield finalists?and even though it lost to Uberconference, the company got a lot of momentum out of its launch. Today, Open Garden's CEO and co-founder?Micha Benoliel?told me that the company's Android and desktop apps (Mac and Windows) have now been downloaded over 100,000 times. In addition, Open Garden is launching an update today that will greatly improve the user experience for new users and add a few new features for existing users.

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The Photographic Tricks That Make McDonald's Burgers Look Good [Video]

If you've ever wondered how McDonalds manages to make its burgers look so much more appetizing in the pictures than they do in real life, wonder no more. This video takes a peek behind the scenes at a McDonald's photo shoot to explain some of the tricks that are used to make you crave a Quarter Pounder. Amazingly, the ingredients in the two are exactly the same—though they do look very, very different by the end of the process. [YouTube via PetaPixel] More »

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