Christian Hunter

I don't think there is a cooler artform today than this:

2013-05-14T11:07:00.001-05:00

I'll just go ahead and acknowledge straight-away the fact that there's a bigger universe of possible television or movies for you to watch (other than this film) tonight than there has ever been in the history of our species, even more available tomorrow night. So why would you watch internationally acclaimed and cult-artist Banksy's documentary "Exit Through the Giftshop"? Well I'm not saying you should.

However, if you dig street art, even a tiny little bit, then odds are you're going to be really glad you chose to watch this fantastic film:

First, a little background on my own personal preference: I like art. Now I don't go totally bananas when Claude [insert super Euro 14th century last name] blah blah's lithographs find their way into town under armed guard. Hard pass.

To me there's something far more more interesting, compelling, and relevant to me about an artist who, well, who's actually seen a car in his or her life, and who has something to say about their experiences in this very alien world we now live in today. That's all even more true when that artists principal motivation isn't fame or money, but pride in their work.

The guys and gals whose exhausted bodies are compelled, from a rare nights sleep, up out of bed and into the streets to not only work for free, but to do it because they LOVE it! They thrive on breathing life into the cold edges of our cookie-cutter urban sprawl, and care far more about impacting hurried passers by than some alien critic, they want to "wow" their involuntary constituency, create a moment, however fleeting, and use it as an opportunity to challenge the observer, to disturb them, or even something as good natured as reminding them that beauty is all around is if they just keep an eye out for it.

A good mix of artists from the totally obscure to internationally famous can be found in this spectacular documentary; I got a chance to watch again recently and it was even better the second time.

"Exit Through the Giftshop" follows a loosely networked collection of artists, each seemingly equally adept at holding your interest. A bit surprising is how, as vanguards of contemporary urban/graffiti art today, these artists remain so impossibly modest, especially true given the fact that most of them are also every bit as eccentric, fascinating, and thoughtful as you would expect them to be...watch them dive, duck, and hide in plain view all the while seemingly fearless; buckets of paint in each arm, and an ambition to discover a new and unique canvas to make quick jaw-droppingly cool masterpiece out of.

This is an interesting and entertaining little gem of a movie that's perfect for anyone who loves urban and defiance art, and also desires to learn more about the still largely enigmatic artists who have no qualms with routinely risking their freedom (as well their very life and limb); to conjure into overnight-existence their increasingly sought after and sophisticated art, and field it on the frontlines of some of the most heavily fought for asset in the world: a share of your attention: http://j.mp/DefianceArt

Enjoy,

Christian Hunter

Austin, TX

Arrested Development show will release in May 2013!

2013-04-10T14:43:00.004-05:00

Insanely good news for all fans of the Arrested Development show:

Netflix is leading a truly fascinating revolution in the way television content is produced and consumed. As part of their strategy, they made a bold and unprecedented move to resurrect the cult tv show Arrested Development – which won high praise from critics, but never realized meaningful ratings from viewers.

Fox cancelled the show due to its lackluster performance at the end of its 3rd season, all the way back in 2006! Still, despite the significant time and stardom that have accumulated since then, Netflix successfully brought back all the main characters of the show and are picking up where the last episode left off.

The program is still in filming and set to release all its fifteen brand new episodes simultaneously on Netflix.com this May 26, 2013. Yep, ALL 15 episodes are being released at once! This follows the apparently successful binge-watching model that "House of Cards", Netflix's most recent successful release of its own content, has demonstrated.

Wonderful news for fans of the Arrested Development show like me, who (other than a dim hope for seeing the full cast come together for a potential movie) held little hope of ever seeing the Bluth family return to television.

BRAVO NETFLIX!

Christian Hunter

Austin, TX

Film edited in bedroom on a Macbook wins Oscar!

2013-02-25T09:28:00.001-06:00

The magic between these two is remarkable

QUESTION: What do you get when you combine a quickly written screenplay shot in 7 days with a 3 person crew (each publicly unrecognizable), then edit the film from your bedroom on a retail application (Final Cut 7) using an ordinary Macbook?

ANSWER: You get an Oscar!

Or at least Shawn Christensen did. Shawn Christensen is the writer and director of the film "Curfew" (and, as of last night, is also an Oscar winner having snagged "best live action short" film award for the 19-minute long gem). Shawn Christensen has a very bright future! A bright future indeed!

Having chosen Curfew to watch on a whim, I was immediately taken-in by how well-done it appeared. This gripping drama and a fascinating aesthetic piece also affected a curious empathy in me from the first frame; I believe the director intended this, and wisely entrusted its preservation to the deft acting performance of the films few central characters.

In Curfew, Shawn Christensen expertly couples just the right mix of cinematography with a captivating tight-as-a-drum script, expert cinematography (despite his editing the film in his room on a Macbook Pro!), absolutely first rate acting, and a frighteningly perfect musical score.

And then there was the dance scene.

It was this films own little slice of Travolta and Thurman, and it was nothing short of film magic. In fact, it's scenes like that one in Curfew which serve as the contemporary cinephile's raison d'être. Films like Curfew do so much to sustain our faith.

Shawn Christensen and his acting mates Fatima Ptacek and Kim Allen delivered up so much up in such a small package. This film is a wonderful way to spend 19 minutes, and is a wonderfully deserving recipient of the Oscar award last night!

You're not going to die today.

2012-12-21T08:50:00.002-06:00

It's 6:43am on Friday December 21st, and as many of you know, today we're all supposed to die.

Or at least that's what the Mayans would have us believe.

Those wild and crazy Mayans – unsuccessful apparently at predicting the demise of their own society – have enjoyed incredible success post vitam in convincing many that today will be their last.

Some apparently are taking their prediction so far as to take their own life in anticipation of the "inevitable". Or, as in the case of this complete ding-dong, plan on dying tonight so that he may spare the rest of us from certain planet-destroying death. How? That's simple. He plans on flinging himself off a huge rock in Sedona: http://j.mp/hesprobablynotgoingtojump

Media coverage leading up to this day has been frenetic. We all know that the news industry can't help themselves but go positively berserk for sticky news stories like this one, fueled by good ol' fashioned coal-fired-fear.

Print, television, and every media distributor between them count fear-based story lines such as this Mayan prediction among their favorite types of "news"; and why shouldn't they, it's dirt cheap to produce, can hold the public's increasingly finicky attention span for days, weeks, months, or longer. And best of all, where a product of good journalism typically requires expensive legwork in the field, all a media producers need do now is play a few clips or quotes of convincing fear salesmen, then pan to their proverbial audience, hysterical and wide-eyed with fear...mmm, cheap ratings!

Yep, you'd be hard-pressed to find a more successful story type than those which scare the daylights out of their own audience.

So, as an exercise in rational thought, I thought it'd be fun to post research showing just how unique these types of large-scale predictions of death and apocalyptic destruction really are, and also shed some light on the types of glue-huffing half-wits that were successful in getting their 15 minutes as it were in the apocalyptic limelight.

Here below is an incomplete (but completely entertaining) list of end-of-days predictions which, for obvious reasons, didn't quite materialize as expected.

Egg, meet face, face, egg.

Enjoy:

Should Austin develop a social-centric traffic management system?

2012-11-19T23:58:00.001-06:00

I submitted a proposal to the Austin Dept of Transportation (http://j.mp/AustinTraffic) a somewhat far-out alternative to traditional traffic management strategies (road-widening, etc). In it, I loosely outlined a plan to create a government regulated social-transportation and traffic management platform; one designed to relieve Austin's intensifying traffic problem by radically increasing the human density of each Passenger Car Equivalent "PCE" on IH-35 and similarly congested Austin roadways. Of course this system, to the extent it has merit, could be of equal use to any metropolitan area besieged by traffic.

I proposed the development of an online utility to incentivize and simplify the conversion of vehicles – specifically the exceedingly large percent of single-driver vehicles congesting our roadways – into a marketplace of fast-moving micro-shuttles.

While no small undertaking, the relative cost to develop this network would be negligible in contrast with traditional stopgap measures employed by cities like our own, most notably the undertaking of centi-million dollar roadway expansions.

One might be tempted to immediately dismiss the following proposal overview as a glorified ridesharing scheme. I would suggest however that while this proposal does bear some similarity to such a program, advances in technology have rendered the topographical landscape of opportunity in the rideshare vector almost indistinguishable from any contemplated and/or deployed in the past. This plan, quite simply, would not have been technologically feasible even a short five years ago.

Success of a government sponsored traffic mitigation network would hinge upon factors such as compelling incentive(s) to both driver and passenger, an extremely high-degree of participatory safety, network usage simplicity (for both driver and passenger), as well as sufficiently ubiquitous public awareness and participation in the system upon launch.

There are a number of means by which to incentivize a driver to pickup a passenger, and a similar number that could compel individuals to participate as a passengers, including the following:

Economic - for most, the idea of offsetting costs of fuel as well as wear-and-tear on their vehicles is an attractive one

Social - a novel program incentive would be the result of an intelligent vehicle-grouping model, one that contemplates doing away with the traditional "stiffs" and strangers that comprise the stigmatized rideshare or carpooling passenger. Instead, through the use of highly sophisticated modeling (based upon the systems knowledge of each participant, their publicly disclosed preferences, privately disclosed ones, behavioral analysis, and other variables), the system could autonomously select and tune its passenger grouping in real-time, with the goal of creating dynamic, interesting, fun, and valuable driving companions which consistently pose a more attractive alternative to driving alone.

Environmental - fewer single passenger (or severely underutilized passenger carrying capacity) on the road means fewer resources expended and corresponding – potentially significant – environmental benefits to be had.

Obligational - the most controversial of incentives (but worth considering) is one that would tie-in local law-enforcement and the proposed system to allow for (at the discretion of the offender) offsets of monetary penalties for traffic and/or parking related violations through participation as driver or passenger on the network.

Any consideration paid for transportation, or "fares", transacted between passenger and driver would benefit greatly from a friction-free system which autonomously tabulates each fare and seamlessly exchanges payment (in whatever form(s) ultimately decided upon) with little or no effort required by either party.

From a technological "how to" perspective, I believe mashing-up existent technological infrastructure to comprise the super-majority of the network is more than a possibility, it's now practical. I envision using geofencing technology, accelerometers, and wireless payment technologies (be they "near field", "RFID", or other even simpler technology) among other technology already embedded in present-day mobile phones to comprise the hardware-backbone of this proposed system.

Should a plan like this find success, funding to incentivize passengers (to the extent required) could in theory require no public participation. However, as a practical matter, the enormous public savings realized in radically increasing more efficient use of existent infrastructure could almost certainly provide sufficiently compelling financial incentive in the form of fully funded or partially subsidized fares to encourage broad participation amongst both driver and passenger.

Should this concept find traction, questions such as "do we measure fare-increments in feet, miles, or minutes", or "should the quality of a vehicle be modifier to fare-increments", and all such matters I'll leave to be debated by those more qualified than myself.

From an elevated view however, the proposition is uniquely Austin in that it leverages and enhances the city's technological sophistication, its open-mindedness, and our public desire to retain a small-town interconnectedness against a significant and ever-mounting problem as the city grows. Best of all, it promises to do so without expending any additional resources or further taxing our environment.

While this is clearly a niche topic, I'd appreciate any thoughts and input you may have.

Christian Hunter

Austin, Texas

Despite controversy, Stacey Dash's following surges.

2012-10-09T20:40:00.004-05:00

Stacey Dash braves racist backlash

One Twitter named "Brooke" asked this of "Clueless" star Stacey Dash:

“You ready to head back the fields, jigaboo”

This angry and racist tweet was in response to a Twitter post by Dash late Sunday night to “Vote for Romney. The only choice for your future”

Dash, 46, accompanied the post with a patriotic photo of herself clad in a red bathing suit and almost immediately it unleashed a torrent of racist rage from Obama supporters. Within minutes those supporters, and a number of detractors, began flooding the web with angry posts:

“She’s an indoor slave, you know that,”

said Sherrick W., who tweets as @SimplySher. She herself as a black woman in a different tweet.

Another tweeted: “We’ve been letting you slide for years! It's OVER.”

What has yet to catch mainstream attention however is the fact that since posting the controversial tweet Sunday night, the subsequent two days saw Stacey's online Twitter following surge by over 20,000 users Monday, and is now over 302,000 as of Tuesday evening (this according to Twitter stats site: TwitterCounter.com):

It would appear that users have been flocking to support Ms. Dash despite all the negativity.

As of just now, she's got one more follower in me.

Christian Hunter

Austin, TX

Apple's new topographic maps defy criticism

2012-09-25T22:58:00.001-05:00

The press gets a huge collective "FAIL" in my opinion for neglecting to cover one of the most, if not "the most" important features ever released on the iPhone! A feature which, incidentally, is embedded in Apple's new and much complained-about topographic maps system. The feature? How about the fact that Apple's new voice guided topographic maps system will doubtlessly save lives!

Depth perception and voice nav!

Anyone who's "chased the blue dot" while driving and using Google maps to guide them on the iPhone (don't give me that look, you know you've done it!) knows that using Google maps for guidance while driving is DOWNRIGHT DANGEROUS!

I live in Austin, Texas and have used the new Apple topographic maps a number of times. In each instance it worked not only flawlessly, but in a way that didn't require me to look down at it (except for the occasional glance to marvel at how accurately its 3-D positional guidance feature was working) unlike when using Google maps.

Clearly there are some areas affected by insufficient or erroneous Apple maps data coverage on iPhone's new topographic maps. That sucks, I feel for those folks, and suggest they go back to using Google maps for now. But let's remember that they're in the minority and it's Apple we're talking about here. Yeah, they get plenty wrong, but they tend to correct quickly and not make similar mistakes again.

I think those Google maps users who haven't used the new Apple topographic maps system on the iPhone are going to be very pleasantly surprised. I also think, far more importantly, by using them they'll be safer.

Enjoy,

Christian Hunter

Austin, TX

iPhone 5 Release Video

2012-09-12T08:41:00.000-05:00

Here you'll find a leaked video describing the key features of the iPhone 5:

Some of the researched improvements to the iPhone 5 not featured in this video are its exact screen dimensions. Here below are the exact measurements of the iPhone 5 screen:

iPhone 5 dimensions:

3.567 inches length
2.058 inches width

iPhone 4S dimensions:
3.023 inches length
2.044 inches width

iPhone 5 screen thickness:
.091mm screen thickness

iPhone 4S screen thickness:
1.01mm screen thickness

The iPhone 5 screen is also remarkably scratch proof! In a side-by-side scratch test using a key the iPhone 4 showed considerable scratching whereby the iPhone 5 showed none!

A full detail of all the changes made to the iPhone 5 should be made today at 1pm Pacific Standard Time.

Scratchproof iPhone 5 Screen

iPhone 5 and 4S side-by-side comparison of dimensions

Congresswoman Yvette Clarke drops cognitive deuce on Colbert Report

2012-09-04T23:48:00.000-05:00

Congresswoman Yvette Clarke demonstrated heart-stopping ignorance this evening during her Colbert Report interview. To paraphrase the most outrageous parts of the interview: when asked by Colbert essentially what the 11th District Congresswoman from New York would say if she could be transported via time machine back to Brooklyn in the year 1898, she said that she'd proclaim to her captors "let me go!".

Somewhat confused by what the Congresswoman was referring to, Ms. Clarke made sure Colbert knew she'd demand the state of slavery that existed in 1898 come to an immediate end...35 years after we fought the whole Civil War thing that ended it!

Somewhat shocked (as all but Colbert's most profoundly idiotic viewers were) Colbert asked who exactly (as a black woman) she would demand to win her hypothetical freedom from...and this is where it got far weirder: the Congresswoman replied "the Dutch" [insert gasps, and various iterations of "holy shit" made audible by those watching...in my home anyway].

Here's a link to the full video of Yvette Clarke on the Colbert Report

Almost as though on Repo Games, Colbert served up numerous "are you suuuure..." type looks and pauses in an effort to free Congresswoman Yvette Clarke (pun intended) from the heart-stoppingly ignorant display she was putting on (or at least keep her congressional seat from being repo'd). But no, the Congresswoman would have nothing of it. Instead she denied Colbert every opportunity afforded her to escape the interview without looking as shit-brainingly idiotic as possible, insisting that in 1898 it was about time those sneaky Dutch and their slaveholding ways came to an end!

If Colbert really wanted to decimate her he'd ask when the Dutch no longer held political control over New York and it became a state, you know, the one she represents in Congress!? We have at least one member of the House who, among other things, doesn't know that the United States has been around a bit longer than 114 years!

The Congresswoman is proud of her interview

Even after the interview, just two short hours ago, on Congresswoman Yvette Clarke's Twitter account, she was advertising the interview as though proud of it!?

Can someone tell me how this woman was elected?

If not, at least offer me some hope that this will end her career as a member of our Congress?

Is the United States now owned by China?

2012-09-03T11:37:00.002-05:00

Paranoia over China's increasing worldwide dominance and rapidly growing economic might comes at a time when the federal government of the United States can't get comfortable with our budget deficit (no matter its percent of GDP) yet continue to sell our bonds into the seemingly insatiable appetite for it amongst the Chinese.

Most in the US view China's rapidly growing manufacturing might and increasing ownership of our public debt not as benefits (in that the former has dramatically lowered our cost of living – keeping domestic inflation in check; and their long-view on the US in financing our national debt works similarly, whilst also lowering our cost to borrow and finance our significant budget deficit); yet these developments are feared as threats.

I disagree. In fact, I believe we have China just where we've been moving (both politically and commercially) to put them in for decades. Going back to Nixon, it was clear that the Chinese, while communist in name, were quite different then their comrades to the north (for which they too held a distrust that rivaled our own...and still do to this day). Nixon understood that the Chinese have been capitalists for thousands of years, and at the core of their Marxist push was a steely-cold and calculating plan; one that recognized no iteration of Jeffersonian democracy would leapfrog the better part of a billion people over the craggy and risk-ridden transition to industrialization with nary a scratch. Anyone who's had the chance to take a gander at the sheer awesome and democratically-impossible scope of the Three Gorge Dam (and the near 1.5 million people it displaced) can sympathize with the fact that sometimes tough and wildly unpopular decisions have paved the way to more than one democracy (or republic as the case may be).

Today's China is, in some respects, less socialistic than much of Western Europe with its moth-eaten social safety-net and seemingly unbridled tendency towards free-market capitalism.

Yet fears of Chinese hegemony is increasingly influencing public opinion in the United States, fears of imminent Chinese dominance that harken back to the 1980's when, prompted by the fear-mongering media, many Americans believed Japan would surely overtake the US economically (then no doubt have their revenge for that whole World War 2 thing!). Japanese xenophobia climaxed with the purchase of the Rockefeller Center and Radio City Music Hall in New York...what was next, The White House!?

Well, not many years would pass when, much like the Japanese economy, the very same company that triumphantly plunked down $900 million to own Rockefeller Center would walk away, selling their ownership for what they paid out of concern that it was a "losing investment" (its value today is in the many billions).

Fast forward to present day and, much like the insatiable appetite the Japanese were reported to have for United States real estate, the Chinese can't seem to get enough of buying up our national debt: one can hardly make it through the day without being warned by the same alarmist media that "the United States is drowning in debt, that the Chinese government is buying it all, ergo, China owns the United States!"

Well just like in the 80's, the media's go it wrong on so many levels! Yet like so many other xenophobia-stuffed lies sold to sloth-minded viewers, they tend to live on way past their expiration date and grow increasingly bloated in their impact. Today proclamations of America's inevitable demise still gets public attention as cheaply as it did 25 years ago, and every decade before then.

As a consequence, a significant percent of America's public today believe we have a dangerous reliance on China, oft citing Chinese and, to a lesser extent Japanese, purchases of America's nearly $16 trillion in our national debt as their chief concern.

But there's one little problem with that conventional wisdom: it's just not true. While yes, the Chinese, Japanese and plenty of other foreigners do own meaningful percentages of US national debt, it's actually Americans themselves who own most it.

Below is a fascinating breakdown of who actually "owns America" (in terms of how much US national debt is owned by foreigners) as of 2007 and, well, it sure isn't the Chinese:

Hong Kong: $121.9 billion (0.9%)

Caribbean banking centers: $148.3 (1%)

Taiwan: $153.4 billion (1.1%)

Brazil: $211.4 billion (1.5%)

Oil exporting countries: $229.8 billion (1.6%)

Mutual funds: $300.5 billion (2%)

Commercial banks: $301.8 billion (2.1%)

State, local and federal retirement funds: $320.9 billion (2.2%)

Money market mutual funds: $337.7 billion (2.4%)

United Kingdom: $346.5 billion (2.4%)

Private pension funds: $504.7 billion (3.5%)

State and local governments: $506.1 billion (3.5%)

Japan: $912.4 billion (6.4%)

U.S. households: $959.4 billion (6.6%)

China: $1.16 trillion (8%)

The U.S. Treasury: $1.63 trillion (11.3%)

Social Security trust fund: $2.67 trillion (19%)

So out of the $15+ trillion in national debt (which is a fraction of America's net worth), America owes foreigners about $5 trillion of it…the other $10+ trillion is owned by Americans.

The Great Pen Meltdown at Kickstarter!

2012-09-02T05:05:00.000-05:00

Like thousands of others, a little over a year ago I placed an order from what may have been the cutest and sweetest couple to ever start a Chinese pen manufacturing company together.

Of course it was a lot more than that, yet as the weeks and months went by with no product, I let myself become momentarily irritated at you guys over the seemingly incessant delays to your Pen Type-A; that is until I began to read some of the other posts and realize just how vitriolic and frenzied an assault that adorable couple at CW&T (Che-Wei and his girlfriend Taylor) at Kickstarter had become.

So this note is from one soon to be owner of your Pen Type-A); and my best effort to empathize with your nightmareish situation, and register my own brief apology:

Seeing the kind of challenges you had endured really gave me pause, and after giving it some thought, I realized that my own frustration was super-amateur, instinctual, and something I felt bad karmically about. So I wanted to share some of my thoughts, at least as partial penance (pun intended).

Of course it's pretty easy to be frustrated with the way things have turned out thus far with the pen, but if one were to pause as I did and allow themselves just a minute or two to imagine what they would do if put in your shoes (and I mean from the very start to present-day), it becomes awfully difficult to stay mad.

Just walking through this whole ordeal chronologically: you guys had a great idea to develop this very interesting pen; you were obviously very passionate about it, and it seemed a simple enough project to execute against (this is probably a good place to remind ourselves that this admittedly new product run called for only 40 or so orders for the new pen, not over 4,000!). So based on what you believed your subscription would be (which you "hoped" would reach $2,500, not nearly $300,000 for *'s sake!), as well as your rightful confidence in the basic resources and staff you had to fulfill what you expected would be a small beta-order, you very reasonably opted to test demand on (a then still-novel) Kickstarter platform.

I was around for your launch; I ordered and then marveled at how quickly interest in the Pen Type-A seemed to pile-on! The time-lapse between putting your toes in the proverbial water and finding yourselves pulled under, buried by a torrent of unrelenting demand wasn't a gradual one, it happened practically overnight!

There was absolutely massive (and I believe unprecedented at the time) oversubscription to your offering. Now I'm not sure if you could have put on the breaks from a technical standpoint (using the Kickstarter system to shut-down or even reverse demand?), but even if you could, how many of us would ourselves slam those money doors shut? I wouldn't.

So you rolled up your sleeves and went all-out to build an excellent pen, and quickly satisfy that enormous demand. Unfortunately you ran head-on almost immediately with your first of many setbacks with Chinese manufacturers – who themselves may speak broken-english but are often quite fluent in the language of over-promising.

From there, in my view, you've done a heroic job of keeping thousands of us updated on Kickstarter (27 times in 12 months), and in not letting however many nervous breakdowns you guys may have had affect your progress. All the while you've managed to admirably continue to chip away at the problem and delivery more and more of the Pen Type-A product (to seemingly delighted customers!).

So, if assigning blame is what drove a customer to this page on Kickstarter, then I suppose they'll be happy to learn you've swallowed your collective pride, held your noses, have taken full and unconditional responsibility for ALL the problems that have haunted your beleaguered pen project (despite the fact that your production problems could have been anticipated by a very select few experts out there with many years of experience in the world of Chinese manufacturing).

However, I bring blame up for another reason; I think all of us participants should bear in mind that Kickstarter is about helping fund "startup projects" from a unique vector and unique stage of gestatory development. As I see it, dollars from Kickstarter are basically pre-seed and pre-angel funding! As such, expectations for a "smooth anything" are themselves errors in participant thinking...ergo, a customer participant blaming only you guys would be a failure on their behalf to take their own share of the blame in recognizing (before ordering) that their very small investment at a typically wildly risky stage of a new operation might not go flawlessly for them.

Alright, enough of all that. Keep at it you guys, you're almost there. I hope next time you won't let fear of unknown variables preclude you from displaying the same volume of courage, or slow that all important early inertia that earned you such incredible early success with the Pen Type-A. As an quasi-investor/customer of yours that'd be my only concern for you. Remember:

Skepticism, good.

Cynicism, bad.

You'll be through this soon enough, and I for one hope for an opportunity to participate in your next project.

Best,

Christian Hunter
www.facebook.com/ideajunkie
www.linkedin.com/in/christianhunter
www.twitter.com/christianhunter

New Gov Think Tank Recruits Nations Brightest!

2012-08-06T08:57:00.002-05:00

In a fascinating effort by the Federal Gov't to open up American policy-making to the people, Expert Labs (now known as "Think Up") was born.

This contemporary think tank is gathering a diverse array of world-class private-sector experts to leverage what's now being called “cloud expertise”.

The purpose, simple: enlist citizen experts to inform and shape public policy through the social networks they already use.

I look forward to watching this revolutionary effort develop in coming years. I should say it's certainly off to an impressive start with some of the biggest guns in the private sector signing-on to lend their insights and proven problem-solving abilities to help navigate us through some of the countries most pressing and critical issues. Juggernauts like:

Caterina Fake, Founder Flickr.com, Hunch, and guided as Chairwoman Etsy.com

Anil Dash, founder StackExchange.com

Andy Baio, co-founder Kickstarter.com

And partnering with the little know guys like, well, Craig Newmark (the Founder of Craigslist.com). Sheesh, these guys are serious!

The organization has debuted with a fascinating utility that aggregates, analyzes, and graphs your communication across all channels. Here's a description on youtube.

Here's an excellent Wired article on the coming-together of Expert Labs.

Enjoy,

Christian Hunter
Austin, Texas
August, 6, 2012

iTunes movies and shows failing to download:

2012-08-02T09:37:00.001-05:00

As stated in my GetSatisfaction post about iTunes download failures, below is a back-and-forth between myself and a couple of technical support agents at iTunes concerning iTunes continuing to abort movie and TV downloads despite having plenty of bandwidth and storage.

As it turns out, Apple and iTunes knew why I was continuing to be frustrated (for months) with an inability to reliably rent or download movies or shows: they just didn't feel like sharing "why" with their high-volume customers!

I've learned that Apple continues to allow high-volume users like myself to slam right into the same technical support problem-wall: where downloads stop completing as a result of hitting some internal limit of movies and/or TV shows in my download queue.

Those are movies and shows that I don't want to download (I have over 440 shows and movies that I'd rather download ONLY if I want to watch them ever again vs. Apple probably wanting me to pay to hold those downloads in my memory storage instead of entirely available on demand as their "Purchased" button on the iTunes homepage allows) but apparently only iTunes agents have the power to actually delete a download queue, we're not allowed to delete our own!

Here are my most recent emails to-and-from Apple support:

Hello [Apple agent],

Thank you for your attempts at resolving this matter. On my side, unfortunately, I've been confounded and for the most part paralyzed by your request that I do the following (the second request):

- your permission to remove all 441 items from your pending downloads
- the order numbers and titles of the items you have been unable to download

To the first request, "yes", you have permission to delete all 441 (I only see "362") items from my download queue. A point of note that might be interesting for you guys to know: Yesterday night I called in and spent nearly an hour being coached by an agent in Apple Macbook Air support on how to delete my download queue; your agents at Apple aren't aware (he's the second agent I had a similar experience with) that the option to delete a customer queue isn't the option of the customer, that it has to be done by an agent at iTunes.

With respect to the second request however, frankly I was hoping that you at iTunes would be able to at least identify the countless number of aborted and prematurely failed downloads of various media and to refund that. The idea that I should pour over purchase receipts, and with each piece of media first ask the question: "did it download as it should have?", and then second, assuming I suspect it didn't, I have to thne remember the context in which I purchased the media in order to ascertain whether or not the download did in fact complete.

That's a sad state of affairs at Apple if my assumptions are in fact correct, and iTunes is burden-shifting a basic reconciliation of iTunes' ability to work to its beleaguered users.

Please let me know if I did read your requests correctly, and I suppose we'll take it from there.

Thanks,

Hi Christian,

My name is [Apple agent], I am a senior advisor for the iTunes Store Customer Support and I have taken over this request to ensure your issue is handled in a timely manner.

To acquaint myself with the situation, I have reviewed all previous correspondences with [other Apple agent], and I understand that Xx_Issue_xX (<-----I THINK APPLE FORGOT TO FILL-IN THIS PART OF THE TEMPLATE! LOL!). I can certainly appreciate your desire to resolve this issue and I will be more than happy to continue to assist you where [other Apple agent] left off.

First and most importantly, I would like to extend a thank you for your patience and understanding while we try to resolve the issue you have encountered, Christian.

In reviewing your account I noticed that there are 441 items awaiting download. Some of these items date back to 08/07/2009.

On occasion, if there are items that are located in the download queue of an account that have been removed, this can prevent you from downloading your recent purchases. With that said, I would like to have your permission to remove all of the items that are in your pending downloads.

Once I have done this, I will then repost a new copy of the items that you have been having an issue with downloading. In order for me to do this, I will need you to reply back with the following:

- your permission to remove all 441 items from your pending downloads
- the order numbers and titles of the items you have been unable to download

You can find the order numbers on your email receipts or in your Purchase History (this is the best place to look if you do not keep your purchase receipts). iTunes Store order numbers begin with the letter "M". If you need to review your Purchase History, follow the steps in this article:

http://support.apple.com/kb/HT2727

I look forward to hearing back from you with the requested information. Once I receive your reply I will promptly resume working towards resolving the issue you reported. I will have your request flagged for higher priority over the next few days to ensure I receive any replies from you.

You are a valued iTunes Store customer, I appreciate your patience and understanding in this matter. I wish you the best and hope you have an excellent day, Christian!

Sincerely,

[Apple agent]
Senior Advisor
iTunes Store/Mac App Store Customer Support

Thank you for allowing me the opportunity to assist you.

First Name : Christian
Last Name : Hunter
Email :
Lang_Country : en_US
Product : iTunes Store
Support Subject : Connecting & Downloading
Sub Issue : Downloads from iTunes store incomplete or interrupted
GCRM Case ID : 329847164
See additional info below
What device did you use to connect to the store? Mac computer
Which operating system is installed? Mac OS X v10.7.x
What version of iTunes is installed on your computer? iTunes 10.6
Choose the iTunes Store or App Store for your country: United States
Describe the alert message you received: "There was a problem downloading "Movie name". An unknown error occurred (-50). I'm completely fed up with these incessant problems on both my Macbook Air and Pro! I've had dozens of aborted media downloads that I'd try downloading in multiple media formats (such as SD vs. HD) and am really annoyed that I have to play technician on Apple's cheap quasi-self-help system when I'm buying $4,000+ in media every year, and failing to run it on multiple versions of your own platforms! What gives?
Details:
I spend $4,000+ every year on your media and have for years. I think you should know that I'm completely pissed off and plan on letting others know that Apple can't run their media on their own new platforms.

https://getsatisfaction.com/apple/topics/secret_itunes_internal_policy_causing_download_failures_apple_calls_them_unknown_errors?rfm=1

Boomerang: A killer productivity utility for GMail

2012-07-04T12:00:00.000-05:00

For those of you who wish you had a means by which to effortlessly reschedule the email you receive until a better time, or need a simple means to quickly schedule the sending of an email to a future date and time, then the Boomerang app for GMail may be for you.

Boomerang is a must-have alternate to the ever-increasing creep of Gmail "inbox pollution" from ill-timed emails, or to the crowding (and frequent loss) of highly-important emails in my GMail inbox by the torrents of relatively unimportant mail we all typically sort through each day. I should also add that Boomerang is vastly superior to every other system I've tested thus far, whether GMail or browser based, that promised (using one method or another), to help reign in out of control inbox noise but ultimately fell short.

Boomerang was of instant and high-utility for me and having used it for several months now have confirmed it so helpful that I felt compelled to pen a brief review and make others aware of this new service. I'm not sure whether it's considered an application "app", an extension, or plugin, but I do know that Boomerang is super-lightweight (with barely any measurable resource usage of my system) and has quickly become the most effective productivity tool I use for both personal and business email and task management.

I highly recommend their "Personal" service plan, and just now upgraded myself to their "Professional" plan in order to get access to the mobile version of Boomerang, which is available only to subscribers of their (presently-priced at $14.95) top of the line "Professional" offering. That said, my proverbial jury has just gone out on the question of whether or not the Pro offering is of relative value to the Personal service level (I'll check back in a few weeks with my findings on that question); but again, being able to effortlessly reschedule the handling of various GMail emails until such time as is ideal for me to re-receive and deal with them is an enormous boon to my personal productivity. In addition, the ability to schedule the exact delivery date and time of my emails (using natural language such as "in 1 hour", etc) each now invaluable capabilities I use throughout my typical day.

I know they have a free test version at Boomerang; check it out.

BTW: The above sounds really salesy, so I want to make clear that I am not an employee, stakeholder, etc., nor do I even know anyone at the company...I'm just a raving evangelist for their product!

Best,

Christian Hunter

Austin, TX

Belviq may not make you thin, but may get you high!

2012-06-27T13:26:00.003-05:00

Today, around 1pm EST, the FDA approved Belviq for super-fat people in the US. It's the first weight loss drug to gain such approval in a mere 13 years! That being the case, it's no wonder our pill-loving society have all become a bunch of fatties! In fact it's probably a miracle we're not all dead by now...though this Belviq drug may just change all that.

Just kidding. It's not deadly...

Anyhow, excited by the news of a potential blockbuster drug, I was utterly shocked by the anorexic (pun intended) amount of information available on this drug, so I decided to do some research on my own and at least find out whether or not Belviq is something to be excited about?

Well the long and the short of that whole "should the nations fatties be excited?" question is: "No, not so much to be excited about if you're a chubster...HOWEVER, if you're into getting high, well then Belviq may be for you!".

It's no secret that many in the US abuse Ambien for its euphoric and sedative properties, that's why I was shocked to learn that in clinical trials, Belviq proved to be more abuse prone and addictive at high doses than Ambien! And by 35%+!. The only drug in their research that they scored as more abuse prone than Belviq was Ketamine!

Stoners, no stoners, DOWN!

Here are some highlights from what I read below. My findings are not those of a doctor and shouldn't be relied upon for any reason, etc:

The Year 1 placebo-adjusted weight loss achieved in patients treated with BELVIQ was 3.3 kg., so about 6lbs is what you get (on average) for sticking with it a year.

In a sub-study of 154 patients, data showed a nearly 10% reduction in fat mass among those taking Belviq, though if you continue reading their literature (below), they'll explain that the placebo group lost a average of 4.6%, for a net-placebo-adjusted reduction in fat mass achieved by those on BELVIQ of 5.3%.

Lorcaserin "Belviq" is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors. This vector is likely why the addictive potential comes into play.

TIME TO PARTY! Er, I meant, time to lose a little weight.

I pulled this segment from Section 9 (below). Very interesting in that it appears to get users "higher" than Ambien (zolpidem):

In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of Belviq (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo. These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13-16%), but less than the incidence following ketamine administration (50%). The duration of euphoria following lorcaserin administration persisted longer (> 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.

Here for your own reading is the drug research. Enjoy!

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BELVIQ safely and effectively. See full prescribing information for BELVIQ.
BELVIQ (lorcaserin hydrochloride) tablets, for oral use Initial U.S. Approval: 2012
INDICATIONS AND USAGE
BELVIQ is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

30 kg/m2 or greater (obese) (1) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes) (1)
Limitations of Use:
- The safety and efficacy of coadministration with other products for
  weight loss have not been established (1)
- The effect of BELVIQ on cardiovascular morbidity and mortality
  has not been established (1)
  DOSAGE AND ADMINISTRATION
- One tablet of 10 mg twice daily (2)
- Discontinue if 5% weight loss is not achieved by week 12 (2)
  DOSAGE FORMS AND STRENGTHS
  10 mg film-coated tablets (3)

• Cognitive Impairment: May cause disturbances in attention or memory. Caution with use of hazardous machinery when starting BELVIQ treatment (5.3)
• Psychiatric Disorders, including euphoria and dissociation: Do not exceed recommended dose of 10 mg twice daily (5.4)
• Monitor for depression or suicidal thoughts. Discontinue if symptoms develop. (5.4)
• Use of Antidiabetic Medications: weight loss may cause hypoglycemia. Monitor blood glucose. BELVIQ has not been studied in patients taking insulin. (5.5)
• Priapism: Patients should seek emergency treatment if an erection lasts >4 hours. Use BELVIQ with caution in patients predisposed to priapism. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (greater than 5%) in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are hypoglycemia, headache, back pain, cough, and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
DRUG INTERACTIONS
Serotonergic drugs (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John’s Wort): use with extreme caution due to the risk of serotonin syndrome. (7.1)
USE IN SPECIFIC POPULATIONS
• Nursing Mothers: Discontinue drug or nursing. (8.3)
• Pediatric Use: Safety and effectiveness not established and use
not recommended. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Pregnancy (4)

CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)- like Reactions: The safety of coadministration with other serotonergic or antidopaminergic agents has not been established. Manage with immediate BELVIQ discontinuation and provide supportive treatment. (5.1)
Valvular heart disease: If signs or symptoms develop consider BELVIQ discontinuation and evaluate the patient for possible valvulopathy. (5.2)
FULL PRESCRIBING INFORMATION: CONTENTS*
1. 1 INDICATIONS AND USAGE
2. 2 DOSAGE AND ADMINISTRATION
3. 3 DOSAGE FORMS AND STRENGTHS
4. 4 CONTRAINDICATIONS
5. 5 WARNINGS AND PRECAUTIONS
  1. 5.1 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
  2. 5.2 Valvular Heart Disease
  3. 5.3 Cognitive Impairment
  4. 5.4 Psychiatric Disorders
  5. 5.5 Potential Risk of Hypoglycemia in Patients with Type 2
    Diabetes Mellitus on Anti-diabetic Therapy
  6. 5.6 Priapism
  7. 5.7 Heart Rate Decreases
  8. 5.8 Hematological Changes
  9. 5.9 Prolactin Elevation
  10. 5.10 Pulmonary Hypertension
6. 6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS
1. 7.1 Use with Other Agents that Affect Serotonin Pathways
2. 7.2 Cytochrome P450 (2D6) substrates
8 USE IN SPECIFIC POPULATIONS

Revised: 06/2012

Reference ID: 3151563

8.1 Pregnancy
8.3 Nursing Mothers 8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment 8.7 Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:

 30 kg/m2 or greater (obese), or
 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition
(e.g., hypertension, dyslipidemia, type 2 diabetes) [see Dosage and Administration (2)]
Limitations of Use:
-  The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established
-  The effect of BELVIQ on cardiovascular morbidity and mortality has not been established

2 DOSAGE AND ADMINISTRATION
The recommended dose of BELVIQ is 10 mg administered orally twice daily. Do not exceed recommended dose [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].
BELVIQ can be taken with or without food.
Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment [see Clinical Studies (14)].
BMI is calculated by dividing weight (in kg) by height (in meters) squared. A BMI chart for height in inches and weight in pounds is provided below:

Reference ID: 3151563

Table 1. BMI Conversion Chart
(lb) 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 205 210 215 220 225 (kg) 56.8 59.1 61.4 63.6 65.9 68.2 70.5 72.7 75.0 77.3 79.5 81.8 84.1 86.4 88.6 90.9 93.2 95.5 97.7 100.0 102.3

Weight
Height (in) (cm) 58 147.3
59 149.9 60 152.4 61 154.9 62 157.5 63 160.0 64 162.6 65 165.1 66 167.6 67 170.2 68 172.7 69 175.3 70 177.8 71 180.3 72 182.9 73 185.4 74 188.0 75 190.5 76 193.0

26 27 28 29 30 31 32 34 35 36 37 38 39 40 41 42 43 44 45 46 47 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 43 44 45 46 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 23 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 38 39 40 41 22 23 24 25 26 27 28 28 29 30 31 32 33 34 35 36 36 37 38 39 40 22 22 23 24 25 26 27 28 28 29 30 31 32 33 34 34 35 36 37 38 39 21 22 23 23 24 25 26 27 28 28 29 30 31 32 33 33 34 35 36 37 38 20 21 22 23 23 24 25 26 27 27 28 29 30 31 32 32 33 34 35 36 36 20 20 21 22 23 24 24 25 26 27 27 28 29 30 31 31 32 33 34 35 35 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 34 34 18 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 33 18 19 19 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 32 32 17 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 31 17 18 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 17 17 18 19 19 20 20 21 22 22 23 24 24 25 26 26 27 28 28 29 30 16 17 17 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28 29 16 16 17 18 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28 15 16 16 17 18 18 19 20 20 21 21 22 23 23 24 24 25 26 26 27 27

3 DOSAGE FORMS AND STRENGTHS

BELVIQ is provided as blue, film-coated, 10 mg tablets. The tablets are round, biconvex, debossed with “A” on one side and “10” on the other side.

4 CONTRAINDICATIONS
 Pregnancy [see Use in Specific Populations (8.1)]

5 WARNINGS AND PRECAUTIONS
5.1 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
BELVIQ is a serotonergic drug. The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements such as St. John’s Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination [see Drug Interactions (7.1)].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g.,

Reference ID: 3151563

hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
The safety of BELVIQ when coadministered with other serotonergic or antidopaminergic agents, including antipsychotics, or drugs that impair metabolism of serotonin, including MAOIs, has not been systematically evaluated and has not been established.
If concomitant administration of BELVIQ with an agent that affects the serotonergic neurotransmitter system is clinically warranted, extreme caution and careful observation of the patient is advised, particularly during treatment initiation and dose increases. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated [see Adverse Reactions (6.1) and Drug Interactions (7.1)].
5.2 Valvular Heart Disease
Regurgitant cardiac valvular disease, primarily affecting the mitral and/or aortic valves, has been reported in patients who took serotonergic drugs with 5-HT2B receptor agonist activity. The etiology of the regurgitant valvular disease is thought to be activation of 5-HT2B receptors on cardiac interstitial cells. At therapeutic concentrations, BELVIQ is selective for 5-HT2C receptors as compared to 5-HT2B receptors. In clinical trials of 1-year duration, 2.4% of patients receiving BELVIQ and 2.0% of patients receiving placebo developed echocardiographic criteria for valvular regurgitation at one year (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation): none of these patients was symptomatic [see Adverse Reactions (6.1) see Clinical Pharmacology (12.1)].
BELVIQ has not been studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease. Preliminary data suggest that 5HT2B receptors may be overexpressed in congestive heart failure, Therefore, BELVIQ should be used with caution in patients with congestive heart failure.
BELVIQ should not be used in combination with serotonergic and dopaminergic drugs that are potent 5-HT2B receptor agonists and are known to increase the risk for cardiac valvulopathy (e.g., cabergoline).
Patients who develop signs or symptoms of valvular heart disease, including dyspnea, dependent edema, congestive heart failure, or a new cardiac murmur while being treated with BELVIQ should be evaluated and discontinuation of BELVIQ should be considered.
5.3 Cognitive Impairment
In clinical trials of at least one year in duration, impairments in attention and memory were reported adverse reactions associated with 1.9% of patients treated with BELVIQ and 0.5% of patients treated with placebo, and led to discontinuation in 0.3% and 0.1% of these patients, respectively. Other reported adverse reactions associated with BELVIQ in clinical trials included confusion, somnolence, and fatigue [see Adverse Reactions (6.1)].
Since BELVIQ has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ therapy does not affect them adversely [see Patient Counseling Information (17)].

Reference ID: 3151563

5.4 Psychiatric Disorders
Events of euphoria, hallucination, and dissociation were seen with BELVIQ at supratherapeutic doses in short- term studies [see Adverse Reactions (6.1), Drug Abuse and Dependence (9.2), and Overdosage (10)]. In clinical trials of at least 1-year in duration, 6 patients (0.2%) treated with BELVIQ developed euphoria, as compared with 1 patient (<0.1%) treated with placebo. Doses of BELVIQ should not exceed 10 mg twice a day.
Some drugs that target the central nervous system have been associated with depression or suicidal ideation. Patients treated with BELVIQ should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue BELVIQ in patients who experience suicidal thoughts or behaviors [see Adverse Reactions (6.1)].
5.5 Potential Risk of Hypoglycemia in Patients with Type 2 Diabetes Mellitus on Anti- diabetic Therapy
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas); hypoglycemia was observed in clinical trials with BELVIQ. BELVIQ has not been studied in combination with insulin. Measurement of blood glucose levels prior to starting BELVIQ and during BELVIQ treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for anti-diabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia. If a patient develops hypoglycemia after starting BELVIQ, appropriate changes should be made to the anti-diabetic drug regimen [see Adverse Reactions (6.1)].
5.6 Priapism
Priapism (painful erections greater than 6 hours in duration) is a potential effect of 5-HT2C receptor agonism.
If not treated promptly, priapism can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.
BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease). There is limited experience with the combination of BELVIQ and medication indicated for erectile dysfunction (e.g., phosphodiesterase type 5 inhibitors). Therefore, the combination of BELVIQ and these medications should be used with caution.
5.7 Heart Rate Decreases
In clinical trials of at least 1-year in duration, the mean change in heart rate (HR) was -1.2 beats per minute (bpm) in BELVIQ and -0.4 bpm in placebo-treated patients without diabetes and -2.0 beats per minute (bpm) in BELVIQ- and -0.4 bpm in placebo-treated patients with type 2 diabetes. The incidence of HR less than 50 bpm was 5.3% in BELVIQ and 3.2% in placebo-treated patients without diabetes and 3.6% in BELVIQ and 2.0% in placebo-treated patients with type 2 diabetes. In the combined population, adverse reactions of bradycardia occurred in 0.3% of BELVIQ and 0.1% of placebo-treated patients. Use with caution in patients with bradycardia or a history of heart block greater than first degree.

Reference ID: 3151563

5.8 HematologicalChanges
In clinical trials of at least one year in duration, adverse reactions of decreases in white blood cell count (including leukopenia, lymphopenia, neutropenia, and decreased white cell count) were reported in 0.4% of patients treated with BELVIQ as compared to 0.2% of patients treated with placebo. Adverse reactions of decreases in red blood cell count (including anemia and decreases in hemoglobin and hematocrit) were reported by 1.3% of patients treated with BELVIQ as compared to 1.2% treated with placebo [see Adverse Reactions (6.1)]. Consider periodic monitoring of complete blood count during treatment with BELVIQ.
5.9 Prolactin Elevation
Lorcaserin moderately elevates prolactin levels. In a subset of placebo-controlled clinical trials of at least one year in duration, elevations of prolactin greater than the upper limit of normal, two times the upper limit of normal, and five times the upper limit of normal, measured both before and 2 hours after dosing, occurred in 6.7%, 1.7%, and 0.1% of BELVIQ-treated patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients, respectively [see Adverse Reactions (6.1)]. Prolactin should be measured when symptoms and signs of prolactin excess are suspected (e.g., galactorrhea, gynecomastia). There was one patient treated with BELVIQ who developed a prolactinoma during the trial. The relationship of BELVIQ to the prolactinoma in this patient is unknown.
5.10 Pulmonary Hypertension
Certain centrally-acting weight loss agents that act on the serotonin system have been associated with pulmonary hypertension, a rare but lethal disease. Because of the low incidence of this disease, the clinical trial experience with BELVIQ is inadequate to determine if BELVIQ increases the risk for pulmonary hypertension.

6 ADVERSE REACTIONS
The following important adverse reactions are described below and elsewhere in labeling:

6.1

       

Serotonin Syndrome or NMS-like Reactions [see Warnings and Precautions (5.1)] Valvular Heart Disease [see Warnings and Precautions (5.2)]
Cognitive Impairment [see Warnings and Precautions (5.3)]
Psychiatric Disorders [see Warnings and Precautions (5.4)]
Hypoglycemia [see Warnings and Precautions (5.5)]
Heart Rate Decreases [see Warnings and Precautions (5.7)] Hematological Changes [see Warnings and Precautions (5.8)] Prolactin Elevation [see Warnings and Precautions (5.9)]
Clinical Trials Experience

In the BELVIQ placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks, 11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969 patients were exposed to BELVIQ 10 mg twice daily for 1 year and 426 patients were exposed for 2 years.
In clinical trials of at least one year in duration, 8.6% of patients treated with BELVIQ prematurely discontinued treatment due to adverse reactions, compared with 6.7% of placebo-treated patients. The most

Reference ID: 3151563

common adverse reactions leading to discontinuation more often among BELVIQ treated patients than placebo were headache (1.3% vs. 0.8%), depression (0.9% vs. 0.5%) and dizziness (0.7% vs. 0.2%).
Most Common Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions for non-diabetic patients (greater than 5% and more commonly than placebo) treated with BELVIQ compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and constipation. The most common adverse reactions for diabetic patients were hypoglycemia, headache, back pain, cough, and fatigue. Adverse reactions that were reported by greater than or equal to 2% of patients and were more frequently reported by patients taking BELVIQ compared to placebo are summarized in Table 2 (non-diabetic subjects) and Table 3 (subjects with type 2 diabetes mellitus).

Table 2. Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients without Diabetes Mellitus

BELVIQ 10 mg BID N=3195

264 (8.3)
207 (6.5)
186 (5.8)
169 (5.3)
122 (3.8)

229 (7.2)

439 (13.7)
414 (13.0)
207 (6.5)

201 (6.3)
65 (2.0)

537 (16.8)
270 (8.5)

136 (4.3)
111 (3.5)
93 (2.9)

67 (2.1)

Adverse Reaction
Gastrointestinal Disorders
Nausea
Diarrhea
Constipation
Dry mouth
Vomiting
General Disorders And Administration Site Conditions
Fatigue
Infections And Infestations
Upper respiratory tract infection
Nasopharyngitis
Urinary tract infection
Musculoskeletal And Connective Tissue Disorders
Back pain
Musculoskeletal pain
Nervous System Disorders
Headache
Dizziness
Respiratory, Thoracic And Mediastinal Disorders
Cough
Oropharyngeal pain
Sinus congestion
Skin And Subcutaneous Tissue Disorders
Rash

Number of patients (%)
Placebo N=3185
170 (5.3)
179 (5.6)
125 (3.9)
74 (2.3)
83 (2.6)
114 (3.6)
391 (12.3)
381 (12.0)
171 (5.4)
178 (5.6)
43 (1.4)
321 (10.1)
122 (3.8)
109 (3.4)
80 (2.5)
78 (2.4)
58 (1.8)

Reference ID: 3151563

Table 3. Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients with Type 2 Diabetes Mellitus

BELVIQ 10 mg BID N=256

24 (9.4)
7 (2.7)

19 (7.4)
12 (4.7)

8 (3.1)

29 (11.3)
23 (9.0)
8 (3.1)

75 (29.3)
7 (2.7)
6 (2.3)

30 (11.7)
12 (4.7)

37 (14.5)
18 (7.0)

9 (3.5)
9 (3.5)
7 (2.7)
6 (2.3)

21 (8.2)

13 (5.1)

Adverse Reaction
Gastrointestinal Disorders
Nausea
Toothache
General Disorders And Administration Site Conditions
Fatigue
Peripheral edema
Immune System Disorders
Seasonal allergy
Infections And Infestations
Nasopharyngitis
Urinary tract infection
Gastroenteritis
Metabolism And Nutrition Disorders
Hypoglycemia
Worsening of diabetes mellitus
Decreased appetite
Musculoskeletal And Connective Tissue Disorders
Back pain
Muscle spasms
Nervous System Disorders
Headache
Dizziness
Psychiatric Disorders
Anxiety
Insomnia
Stress
Depression
Respiratory, Thoracic And Mediastinal Disorders
Cough
Vascular Disorders
Hypertension
Other Adverse Reactions

Number of patients (%)
Placebo N=252
20 (7.9)
0
10 (4.0)
6 (2.4)
2 (0.8)
25 (9.9)
15 (6.0)
5 (2.0)
53 (21.0)
2 (0.8)
1 (0.4)
20 (7.9)
9 (3.6)
18 (7.1)
16 (6.3)
8 (3.2)
6 (2.4)
3 (1.2)
5 (2.0)
11 (4.4)
8 (3.2)

Serotonin-associated Adverse Reactions
SSRIs, SNRIs, bupropion, tricyclic antidepressants, and MAOIs were excluded from the BELVIQ trials. Triptans and dextromethorphan were permitted: 2% and 15%, respectively, of patients without diabetes and 1% and 12%, respectively, of patients with type 2 diabetes experienced concomitant use at some point during the trials. Two patients treated with BELVIQ in the clinical program experienced a constellation of symptoms and signs consistent with serotonergic excess, including one patient on concomitant dextromethorphan who reported an event of serotonin syndrome. Some symptoms of possible serotonergic etiology that are included in the criteria for serotonin syndrome were reported by patients treated with BELVIQ and placebo during clinical trials of at least 1 year in duration. In both groups, chills were the most frequent of these events (1.0% vs. 0.2%, respectively), followed by tremor (0.3% vs. 0.2%), confusional state (0.2% vs. less than 0.1%), disorientation (0.1% vs. 0.1%) and hyperhidrosis (0.1% vs. 0.2%). Because serotonin syndrome has a very low incidence, an

Reference ID: 3151563

association between BELVIQ and serotonin syndrome cannot be excluded on the basis of clinical trial results [see Warnings and Precautions (5.1)].
Hypoglycemia in Patients with Type 2 Diabetes
In a clinical trial of patients with type 2 diabetes mellitus, hypoglycemia requiring the assistance of another person occurred in 4 (1.6%) of BELVIQ-treated patients and in 1 (0.4%) placebo-treated patient. Of these 4 BELVIQ-treated patients, all were concomitantly using a sulfonylurea (with or without metformin). BELVIQ has not been studied in patients taking insulin. Hypoglycemia defined as blood sugar less than or equal to 65 mg/dL and with symptoms occurred in 19 (7.4%) BELVIQ-treated patients and 16 (6.3%) placebo-treated patients.
Cognitive Impairment
In clinical trials of at least 1-year duration, adverse reactions related to cognitive impairment (e.g., difficulty with concentration/attention, difficulty with memory, and confusion) occurred in 2.3% of patients taking BELVIQ and 0.7% of patients taking placebo.
Psychiatric Disorders
Psychiatric disorders leading to hospitalization or drug withdrawal occurred more frequently in patients treated with BELVIQ (2.2%) as compared to placebo (1.1%) in non-diabetic patients.
Euphoria. In short-term studies with healthy individuals, the incidence of euphoric mood following supratherapeutic doses of BELVIQ (40 and 60 mg) was increased as compared to placebo [see Drug Abuse and Dependence (9.2)]. In clinical trials of at least 1-year duration in obese patients, euphoria was observed in 0.17% of patients taking BELVIQ and 0.03% taking placebo.
Depression and Suicidality. In trials of at least one year in duration, reports of depression/mood problems occurred in 2.6% BELVIQ-treated vs. 2.4% placebo-treated and suicidal ideation occurred in 0.6% BELVIQ- treated vs. 0.4% placebo-treated patients. 1.3% of BELVIQ patients vs. 0.6% of placebo patients discontinued drug due to depression-, mood-, or suicidal ideation-related events.
Laboratory Abnormalities
Lymphocyte and Neutrophil Counts. In clinical trials of at least 1-year duration, lymphocyte counts were below the lower limit of normal in 12.2% of patients taking BELVIQ and 9.0% taking placebo, and neutrophil counts were low in 5.6% and 4.3%, respectively.
Hemoglobin. In clinical trials of at least 1-year duration, 10.4% of patients taking BELVIQ and 9.3% taking placebo had hemoglobin below the lower limit of normal at some point during the trials.
Prolactin. In clinical trials, elevations of prolactin greater than the upper limit of normal, two times the upper limit of normal, and five times the upper limit of normal, occurred in 6.7%, 1.7%, and 0.1% of BELVIQ-treated patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients, respectively.
Eye disorders.
More patients on BELVIQ reported an eye disorder than patients on placebo in clinical trials of patients without diabetes (4.5% vs. 3.0%) and with type 2 diabetes (6.3% vs. 1.6%). In the population without diabetes, events of blurred vision, dry eye, and visual impairment occurred in BELVIQ-treated patients at an incidence greater than that of placebo. In the population with type 2 diabetes, visual disorders, conjunctival infections, irritations, and inflammations, ocular sensation disorders, and cataract conditions occurred in BELVIQ-treated patients at an incidence greater than placebo.

Reference ID: 3151563

Echocardiographic Safety Assessments
The possible occurrence of regurgitant cardiac valve disease was prospectively evaluated in 7794 patients in three clinical trials of at least one year in duration, 3451 of whom took BELVIQ 10 mg twice daily. The primary echocardiographic safety parameter was the proportion of patients who developed echocardiographic criteria of mild or greater aortic insufficiency and/or moderate or greater mitral insufficiency from baseline to 1 year. At 1 year, 2.4% of patients who received BELVIQ and 2.0% of patients who received placebo developed valvular regurgitation. The relative risk for valvulopathy with BELVIQ is summarized in Table 4. BELVIQ was not studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease [see Warnings and Precautions (5.2)].

Table 4.

Incidence of FDA-Defined Valvulopathy at Week 52 by Treatment Group1
Study 3
Placebo N=209
1 (0.5)
5.97 (0.73, 49.17)

Study 1

Study 2

BELVIQ N=210

6 (2.9)

BELVIQ N=1278

Placebo N=1191

BELVIQ N=1208

Placebo N=1153

FDA-defined Valvulopathy, n (%)
Relative Risk (95% CI)
Pooled RR (95% CI)

1.16 (0.81, 1.67)

34 (2.7)

28 (2.4)

24 (2.0)

23 (2.0)

1.13 (0.69, 1.85)

1.00 (0.57, 1.75)

1
echocardiogram; ITT-intention-to-treat; LOCF-last observation carried forward

7 DRUG INTERACTIONS
7.1 Use with Other Agents that Affect Serotonin Pathways
Based on the mechanism of action of BELVIQ and the theoretical potential for serotonin syndrome, use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to, triptans, monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI), selective serotonin reuptake inhibitors (SSRIs), selective serotonin- norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John’s Wort [see Warnings and Precautions (5.1)].
7.2 Cytochrome P450 (2D6) substrates
Use caution when administering BELVIQ together with drugs that are CYP 2D6 substrates, as BELVIQ can increase exposure of these drugs [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy
Pregnancy Category X.
Risk Summary
BELVIQ is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Maternal exposure to lorcaserin in late pregnancy in rats resulted in lower body weight in offspring which persisted to adulthood. If this drug is used during pregnancy, or if the patient

Patients without valvulopathy at baseline who received study medication and had a post-baseline

Reference ID: 3151563

becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.
Clinical Considerations
A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.
Animal Data
Reproduction studies were performed in pregnant rats and rabbits that were administered lorcaserin during the period of embryofetal organogenesis. Plasma exposures up to 44 and 19 times human exposure in rats and rabbits, respectively, did not reveal evidence of teratogenicity or embryolethality with lorcaserin hydrochloride.
In a pre- and postnatal development study, maternal rats were dosed from gestation through post-natal day 21 at 5, 15, and 50mg/kg lorcaserin; pups were indirectly exposed in utero and throughout lactation. The highest dose (~44 times human exposure) resulted in stillborns and lower pup viability. All doses lowered pup body weight similarly at birth which persisted to adulthood; however, no developmental abnormalities were observed and reproductive performance was not affected at any dose.
8.3 Nursing Mothers
It is not known whether BELVIQ is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
8.4 Pediatric Use
The safety and effectiveness of BELVIQ in pediatric patients below the age of 18 have not been established and the use of BELVIQ is not recommended in pediatric patients.
8.5 Geriatric Use
In the BELVIQ clinical trials, a total of 135 (2.5%) of the patients were 65 years of age and older. Clinical studies of BELVIQ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Since elderly patients have a higher incidence of renal impairment, use of BELVIQ in the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Elderly patients with normal renal function should require no dose adjustment.
8.6 Renal Impairment
No dose adjustment of BELVIQ is required in patients with mild renal impairment. Use BELVIQ with caution in patients with moderate renal impairment. Use of BELVIQ in patients with severe renal impairment or end stage renal disease is not recommended [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Dose adjustment is not required for patients with mild hepatic impairment (Child-Pugh score 5-6) to moderate hepatic impairment (Child-Pugh score 7-9). The effect of severe hepatic impairment on lorcaserin was not

Reference ID: 3151563

evaluated. Use lorcaserin with caution in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

9 DRUG ABUSE AND DEPENDENCE
9.2 Abuse
In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of lorcaserin (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo. These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13-16%), but less than the incidence following ketamine administration (50%). The duration of euphoria following lorcaserin administration persisted longer (> 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.
Overall, in short-term studies with healthy individuals, the rate of euphoria following oral administration of lorcaserin was 16% following 40 mg (n = 11 of 70) and 19% following 60 mg (n = 6 of 31). However, in clinical studies with obese patients with durations of 4 weeks to 2 years, the incidence of euphoria and hallucinations following oral doses of lorcaserin up to 40 mg was low (< 1.0%).
9.3 Dependence
There are no data from well-conducted animal or human studies that evaluate whether lorcaserin can induce physical dependence, as evidenced by a withdrawal syndrome. However, the ability of lorcaserin to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggests that lorcaserin may produce psychic dependence.
10 OVERDOSAGE
No experience with overdose of BELVIQ is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with BELVIQ were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of BELVIQ caused euphoria, altered mood, and hallucination in some subjects. Treatment of overdose should consist of BELVIQ discontinuation and general supportive measures in the management of overdosage. BELVIQ is not eliminated to a therapeutically significant degree by hemodialysis.

11 DESCRIPTION
BELVIQ (lorcaserin hydrochloride) is a serotonin 2C receptor agonist for oral administration used for chronic weight management. Its chemical name is (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. The empirical formula is C11H15Cl2N·0.5H2O, and the molecular weight of the hemihydrate form is 241.16 g/mol.
The structural formula is:

Reference ID: 3151563

NH HCl
0.5 H2O

Lorcaserin hydrochloride hemihydrate is a white to off-white powder with solubility in water greater than 400 mg/mL. Each BELVIQ tablet contains 10.4 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 10.0 mg anhydrous lorcaserin hydrochloride, and the following inactive ingredients: silicified microcrystalline cellulose; hydroxypropyl cellulose NF; croscarmellose sodium NF; colloidal silicon dioxide NF, polyvinyl alcohol USP, polyethylene glycol NF, titanium dioxide USP, talc USP, FD&C Blue #2 aluminum lake, and magnesium stearate NF.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action
Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus. The exact mechanism of action is not known.
Lorcaserin at the recommended daily dose selectivity interacts with 5-HT2C receptors as compared to 5-HT2A and 5-HT2B receptors (see Table 5), other 5-HT receptor subtypes, the 5-HT receptor transporter, and 5-HT reuptake sites.
Table 5. Lorcaserin Potency (EC50) and Binding Affinity (Ki) to Human 5-HT2A, 5-HT2B, and 5-HT2C Receptor Subtypes
Serotonin Receptor Subtype Ki, nM
5HT2C 13 5HT2B 147 5HT2A 92
12.2 Pharmacodynamics
Cardiac Electrophysiology. The effect of multiple oral doses of lorcaserin 15 mg and 40 mg once daily on QTc interval was evaluated in a randomized, placebo- and active- (moxifloxacin 400 mg) controlled four-treatment arm parallel thorough QT study in 244 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo adjusted, baseline- corrected QTc based on individual correction method (QTcI) was below 10 ms, the threshold for regulatory concern.

EC50, nM

2380

553

Reference ID: 3151563

12.3 Pharmacokinetics
Absorption
Lorcaserin is absorbed from the gastrointestinal tract with peak plasma concentration occurring 1.5 - 2 hours after oral dosing. The absolute bioavailability of lorcaserin has not been determined. Lorcaserin has a plasma half life of ~11 hours; steady state is reached within 3 days after twice daily dosing, and accumulation is estimated to be approximately 70%.
Effect of Food. Twelve adult volunteers (6 men and 6 women) were given a single 10 mg oral dose of BELVIQ in a fasted state and after administration of a high fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800–1000 calories) meal. The Cmax increased approximately 9% and exposure (AUC) increased approximately 5% under fed conditions. Tmax was delayed approximately 1 hour in the fed state. BELVIQ can be administered with or without food.
Distribution
Lorcaserin distributes to the cerebrospinal fluid and central nervous system in humans. Lorcaserin hydrochloride is moderately bound (~70%) to human plasma proteins.
Metabolism
Lorcaserin is extensively metabolized in the liver by multiple enzymatic pathways. After oral administration of BELVIQ, the major circulating metabolite is lorcaserin sulfamate (M1), with a plasma Cmax that exceeds lorcaserin Cmax by 1- to 5-fold. N-carbamoyl glucuronide lorcaserin (M5) is the major metabolite in urine; M1 is a minor metabolite in urine, representing approximately 3% of dose. Other minor metabolites excreted in urine were identified as glucuronide or sulfate conjugates of oxidative metabolites. The principal metabolites exert no pharmacological activity at serotonin receptors.
Elimination
Lorcaserin is extensively metabolized by the liver and the metabolites are excreted in the urine. In a human mass balance study in which healthy subjects ingested radiolabeled lorcaserin, 94.5% of radiolabeled material was recovered, with 92.3% and 2.2% recovered from urine and feces, respectively.
Specific Populations
Renal Impairment. The disposition of lorcaserin was studied in patients with varying degrees of renal function. Creatinine clearance (CLcr) was calculated by Cockgroft-Gault equation based on ideal body weight (IBW). Impaired renal function decreased Cmax of lorcaserin, with no change in AUC.
Exposure of lorcaserin sulfamate metabolite (M1) was increased in patients with impaired renal function by approximately 1.7-fold in mild (CLcr = 50-80 mL/min), 2.3-fold in moderate (CLcr = 30-50 mL/min) and 10.5-fold in severe renal impairment (CLcr = <30 mL/min) compared to normal subjects (CLcr >80 mL/min).
Exposure of the N-carbamoyl-glucuronide metabolite (M5) was increased in patients with impaired renal function by approximately 1.5-fold in mild (CLcr = 50-80 mL/min), 2.5-fold in moderate (CLcr = 30-50 mL/min) and 5.1-fold in severe renal impairment (CLcr = <30 mL/min) compared to normal subjects (CLcr >80 mL/min).
The terminal half-life of M1 is prolonged by 26%, 96%, and 508% in mild, moderate, and severe renal impairment, respectively. The terminal half-life of M5 is prolonged by 0%, 26%, and 22% in mild, moderate,

Reference ID: 3151563

and severe renal impairment, respectively. The metabolites M1 and M5 accumulate in patients with severely impaired renal function.
Approximately 18% of metabolite M5 in the body was cleared from the body during a standard 4-hour hemodialysis procedure. Lorcaserin and M1 were not cleared by hemodialysis. Lorcaserin is not recommended for patients with severe renal impairment (CLcr <30 mL/min) or patients with end stage renal disease [see Use in Specific Populations (8.6)].
Estimate Ideal Body Weight (IBW) in (kg)
Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet. Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet.
The Cockroft-Gault calculation using the IBW:
female:
GFR (mL/min) = 0.85 x (140-age) x ideal body weight (kg)
72 x serum creatinine (mg/dL)
male:
GFR (mL/min) = (140-age) x ideal body weight (kg)
72 x serum creatinine (mg/dL)
Hepatic Impairment. The disposition of lorcaserin was evaluated in patients with hepatic impairment and subjects with normal hepatic function. Lorcaserin Cmax was 7.8% and 14.3% lower, in subjects with mild (Child-Pugh score 5-6) and moderate (Child-Pugh score 7-9) hepatic impairment, respectively, than that in subjects with normal hepatic function. The half-life of lorcaserin is prolonged by 59% to 19 hours in patients with moderate hepatic impairment. Lorcaserin exposure (AUC) is approximately 22% and 30% higher in patients with mild and moderate hepatic impairment, respectively. Dose adjustment is not required for patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on lorcaserin was not evaluated [see Use in Specific Populations (8.7)].
Gender. No dosage adjustment based on gender is necessary. Gender did not meaningfully affect the pharmacokinetics of lorcaserin.
Geriatric. No dosage adjustment is required based on age alone. In a clinical trial of 12 healthy elderly (age greater than 65 years) subjects and 12 matched adult patients, lorcaserin exposure (AUC and Cmax) was equivalent in the two groups. Cmax was approximately 18% lower in the elderly group, and Tmax was increased from 2 hours to 2.5 hours in the elderly group as compared to the non-elderly adult group.
Race. No dosage adjustment based on race is necessary. Race did not meaningfully affect the pharmacokinetics of lorcaserin.
Drug-Drug Interactions
Lorcaserin inhibits CYP 2D6-mediated metabolism. In a clinical trial in 21 CYP 2D6 extensive metabolizers, concomitant administration of lorcaserin (10 mg BID for 4 days) increased dextromethorphan peak concentrations (Cmax) by approximately 76% and exposure (AUC) by approximately 2-fold [see Drug Interactions (7.2)].

Reference ID: 3151563

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Mutagenesis
Lorcaserin hydrochloride was not mutagenic in an in vitro bacterial mutation assay (Ames test), was not clastogenic in an in vitro chromosome aberration assay in Chinese hamster ovary cells, and was not genotoxic in an in vivo micronucleus assay in rat bone marrow.
Carcinogenesis
The carcinogenic potential of lorcaserin hydrochloride was assessed in two-year carcinogenicity studies in mice and rats. CD-1 mice received doses of 5, 25 and 50 mg/kg. There were no treatment-related increases in the incidence of any tumor in mice at doses that produced plasma exposure in males and females of 8 and 4-times the daily human clinical dose, respectively.
In the rat carcinogenicity study, male and female Sprague-Dawley rats received 10, 30, and 100 mg/kg lorcaserin hydrochloride. In females, mammary adenocarcinoma increased at 100 mg/kg, which was associated with plasma exposures that were 87-times the daily human clinical dose. The incidence of mammary fibroadenoma was increased in female rats at all doses with no safety margin to the clinical dose. The increases in adenocarcinomas and fibroadenomas may be associated with lorcaserin hydrochloride-induced changes in prolactin homeostasis in rats. The relevance of the increased incidence of mammary adenocarcinomas and fibroadenomas in rats to humans is unknown.
In male rats, treatment-related neoplastic changes were observed in the subcutis (fibroadenoma, Schwannoma), the skin (squamous cell carcinoma), mammary gland (adenocarcinoma and fibroadenoma), and the brain (astrocytoma) at greater than or equal to 30 mg/kg (plasma exposure 17-times human clinical dose). At higher exposure, liver adenoma and thyroid follicular cell adenoma were increased but were considered secondary to liver enzyme induction in rats and are not considered relevant to humans. Human brain exposure (AUC24h,ss) to lorcaserin at the clinical dose is estimated to be 70-fold lower than brain exposure in rats at the dose at which no increased incidence of astrocytoma was observed. Excluding the liver and thyroid tumors, these neoplastic findings in male rats are of unknown relevance to humans.
Impairment of Fertility
Potential effects on fertility were assessed in Sprague-Dawley rats in which males were dosed with lorcaserin hydrochloride for 4 weeks prior to and through the mating period, and females were dosed for 2 weeks prior to mating and through gestation day 7. Lorcaserin hydrochloride had no effects on fertility in rats at exposures up to 29 times the human clinical dose.

14 CLINICAL STUDIES
The safety and efficacy of BELVIQ for chronic weight management in conjunction with reduced caloric intake and increased physical activity were evaluated in 3 randomized, double-blind, placebo-controlled trials with durations ranging from 52 to 104 weeks. Two trials in adults without type 2 diabetes mellitus (Study 1 and Study 2) and one study in adults with type 2 diabetes mellitus (Study 3) evaluated the effect of BELVIQ 10 mg twice daily. The primary efficacy parameter in these studies was weight loss at 1 year, which was assessed by percent of patients achieving greater than or equal to 5% weight loss, percent of patients achieving greater than or equal to 10% weight loss, and mean weight change. All patients received one-on-one instruction for a

Reference ID: 3151563

reduced-calorie diet and exercise counseling that began with the first dose of study medication and continued every four weeks throughout the trial.
Study 1 was a 2-year study that enrolled 3182 patients who were obese (BMI 30-45 kg/m2), or who were overweight (BMI 27-29.9 kg/m2) and had at least one weight-related comorbid condition such as hypertension or dyslipidemia. In Year 2, placebo patients were continued on placebo and BELVIQ patients were re- randomized in a 2:1 ratio to continue BELVIQ or to switch to placebo. The mean age was 44 (range 18-65); 83.5% were women. Sixty-seven percent were Caucasian, 19% were African American and 12% were Hispanic. Mean baseline body weight was 100.0 kg and mean BMI was 36.2 kg/m2.
Study 2 was a 1-year study that enrolled 4008 patients who were obese (BMI 30-45 kg/m2) or were overweight (BMI 27-29.9 kg/m2) with at least one comorbid condition such as hypertension or dyslipidemia. The mean age was 44 (range 18-65); 80% were women. Sixty-seven percent were Caucasian, 20% were African American and 11% were Hispanic. Mean baseline body weight was 100.2 kg and mean BMI was 35.9 kg/m2.
Study 3 was a 1-year study that enrolled 604 adult patients with BMI greater than or equal to 27 kg/m2 and inadequately controlled type 2 diabetes (HbA1c range 7-10%) being treated with metformin and/or a sulfonylurea. Mean age was 53 (range 21-65); 54% were women. Sixty-one percent were Caucasian, 21% African American and 14% were Hispanic. Mean BMI was 36 kg/m2 and mean HbA1C was 8.1%.
A substantial percentage of randomized subjects withdrew from each study prior to week 52: 50% in Study 1, 45% in Study 2 and 36% in Study 3.
One-Year Weight Management in Patients without Diabetes Mellitus
Weight loss at 1 year in Studies 1 and 2 is presented in Table 6. The pooled data are reflective of the individual study results.
Statistically significantly greater weight loss was achieved with BELVIQ compared to placebo at week 52. The Year 1 placebo-adjusted weight loss achieved in patients treated with BELVIQ was 3.3 kg by ITT/LOCF analysis. The time course of weight loss with BELVIQ and placebo through week 52 is depicted in Figure 1.
Patients who did not lose at least 5% of baseline body weight by week 12 were unlikely to achieve at least 5% weight loss at week 52.

Reference ID: 3151563

Table 6. Weight Loss at 1 Year in Studies 1 and 2 Combined

BELVIQ 10 mg BID N=3098

100.4 (15.7)
-5.8 (0.1)
-3.3** (-3.6, -2.9)
-5.8 (0.1)
-3.3** ( -3.6, -3.0)
47.1
24.5** (22.2, 26.8)
22.4
13.8** (12.0, 15.5)

Weight (kg)
Baseline mean (SD)
Change from baseline (adjusted mean1) (SE) Difference from placebo (adjusted mean1)
(95% CI)
Percent change from baseline (adjusted mean1) (SE) Difference from placebo (adjusted mean1)
(95% CI)
% of Patients losing greater than or equal to 5% body weight
Difference from placebo (95% CI)
% of Patients losing greater than or equal to 10% body weight
Difference from placebo (95% CI)
SD=Standard Deviation; SE=Standard Error; CI=Confidence Interval

Placebo N=3038
100.2 (15.9)
-2.5 (0.1)
-2.5 (0.1)
22.6
8.7

Intent to Treat Population using last observation carried forward method; All patients who received study medication and had a post-baseline body weight. Forty-four percent (44%) of patients in Belviq and 51% in placebo dropped out before the 52-week endpoint.
1Least squares means adjusted for baseline value, treatment, study and treatment by study interaction. **p<0.001 compared to placebo. Type 1 error was controlled across the three endpoints.

Figure 1. Longitudinal Weight Change (kg) in Completer Population: Studies 1 and 2

Reference ID: 3151563

Two-Year Weight Management in Patients without Diabetes Mellitus
The safety and efficacy of BELVIQ for weight management during 2 years of treatment were evaluated in Study 1. Of the 3182 patients who were randomized in Year 1, 1553 (48.8%) were randomized in Year 2. Patients in all three Year 2 patient groups (BELVIQ Year 1/ BELVIQ Year 2, BELVIQ Year 1/placebo Year 2, and placebo Year 1/placebo Year 2) regained weight in Year 2 but remained below their Year 1 mean baseline weight (Figure 2).

Figure 2. Body Weight Changes during Study 1 in the Completers Population
Effect of BELVIQ on Cardiometabolic Parameters and Anthropometry
Changes in lipids, fasting glucose, fasting insulin, waist circumference, heart rate, and blood pressure with BELVIQ are shown in Table 7.
In a substudy of 154 patients conducted as part of Study 2, DEXA analysis showed a 9.9% reduction in fat mass from a baseline of 45.0 kg in patients treated with BELVIQ compared to a 4.6% reduction from a baseline of 44.5 kg in patients treated with placebo. The placebo-adjusted reduction in fat mass achieved on BELVIQ was -5.3%. Reductions in lean body mass were 1.9% and 0.3% from baseline values of 48.0 kg and 51.0 kg, respectively, for BELVIQ- and placebo-treated patients.

Reference ID: 3151563

Table 7.
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
Triglycerides
Systolic blood pressure (mmHg)
Diastolic blood pressure (mmHg)
Heart Rate (bpm)
Fasting glucose (mg/dL) Fasting insulin2 (μIU/mL)
Waist Circumference (cm)

Mean Changes in Cardiometabolic Parameters and Waist Circumference in Year 1 of Studies 1 and 2
BELVIQ minus Placebo (LSMean)
-1.2*
-1.3*
1.2*
-4.8*
BELVIQ minus Placebo (LSMean)
-0.7*
-0.6*
-0.8
-0.8
-2.1*
-2.5

BELVIQ N=3096		Placebo N=3039
Baseline mg/dL	% change from Baseline (LSMean1)	Baseline mg/dL	% change from Baseline (LSMean)
194.4	-0.9	194.8	0.4
114.3	1.6	114.1	2.9
53.2	1.8	53.5	0.6
135.4	-5.3	137.0	-0.5
Baseline	change from Baseline (LSMean)	Baseline	change from Baseline (LSMean)
121.4	-1.8	121.5	-1.0
77.4	-1.6	77.7	-1.0
69.5	-1.2	69.5	-0.4
92.1	-0.2	92.4	0.6
15.9	-3.3	15.8	-1.3
109.3	-6.6	109.6	-4.0

1 Least squares means adjusted for baseline value, treatment, study and treatment by study interaction
2 Measured in Study 1 only (n=1538)

* Statistically significant versus placebo based on the pre-specified gatekeeping method for controlling Type I
error in key secondary endpoints.
One-Year Weight Management in Patients with Type 2 Diabetes Mellitus
Weight loss among patients with type 2 diabetes mellitus who were treated with BELVIQ was statistically significantly greater than that among patients treated with placebo (Table 8).

Reference ID: 3151563

Table 8. Weight Loss at 1 Year in Study 3 (Type 2 Diabetes Mellitus)

BELVIQ 10 mg BID N=251

103.5 (17.2) -4.7 (0.4) -3.1** (-4.0, -2.2)

-4.5 (0.4) -3.1** (-3.9, -2.2)

37.5 21.3** (13.8, 28.9)

16.3 11.9** (6.7, 17.1)

Weight loss (kg)
Baseline mean (SD)
Change from baseline (adjusted mean1) (SE) Difference from placebo (adjusted mean1)
(95% CI)
Percent change from baseline (adjusted mean1) (SE) Difference from placebo (adjusted mean1)
(95% CI)
% of Patients losing greater than or equal to 5% body weight
Difference from placebo (95% CI)
% of Patients losing greater than or equal to 10% body weight
Difference from placebo (95% CI)
SD=Standard Deviation; SE=Standard Error; CI=Confidence Interval

Placebo N=248
102.3 (18.0) -1.6 (0.4)
-1.5 (0.4)
16.1
4.4

Intent to Treat Population using last observation carried forward method; All patients who received study medication and had a post-baseline body weight. Thirty-four percent (34%) of patients in Belviq and 38% in placebo dropped out before the 52-week endpoint.
1Least squares means adjusted for baseline value, baseline HbA1c stratum and prior antihyperglycemic medication stratum.
**p<0.001 compared to placebo. Type 1 error was controlled across the three endpoints.
Effect of BELVIQ on Cardiometabolic Parameters and Anthropometry in Patients with Type 2 Diabetes Mellitus
Patients in Study 3 were taking either metformin and/or a sulfonylurea at study start, and had inadequate glycemic control (HbA1c range 7-10%). Changes in HbA1c and fasting glucose with BELVIQ use are shown in Table 9.

Reference ID: 3151563

Table 9. Mean Changes in Cardiometabolic Parameters and Waist Circumference in Patients with Type 2 Diabetes Mellitus

BELVIQ N=256		Placebo N=252
Baseline	Change from Baseline (LSMean1)	Baseline	Change from Baseline (LSMean)
8.1	-0.9	8.0	-0.4
163.3	-27.4	160.0	-11.9
126.6	-0.8	126.5	-0.9
77.9	-1.1	78.7	-0.7
72.3	-2.0	72.7	-0.4
Baseline	% Change from Baseline (LSMean)	Baseline	% Change from Baseline (LSMean)
173.5	-0.7	172.0	-0.1
95.0	4.2	94.6	5.0
45.3	5.2	45.7	1.6
172.1	-10.7	163.5	-4.8
115.8	-5.5	113.5	-3.3

HbA1C (%)
Fasting glucose (mg/dL)

BELVIQ minus Placebo (LSMean)
-0.5*
-15.5*

Systolic blood pressure (mmHg) 0.1
Diastolic blood pressure (mmHg) -0.4
Heart Rate (bpm) -1.6
BELVIQ minus Placebo (LSMean)
Total Cholesterol (mg/dL) -0.5
LDL Cholesterol (mg/dL) -0.8
HDL Cholesterol (mg/dL) 3.6
Triglycerides (mg/dL) -5.9
Waist Circumference (cm) -2.2
Intent to Treat Population using last observation carried forward method; All patients who received study medication and had a post-baseline measurement.
* Statistically significant versus placebo based on the pre-specified gatekeeping method for controlling Type I error in key secondary endpoints.
1Least squares means adjusted for baseline value, baseline HbA1c stratum and prior antihyperglycemic medication stratum.
16 HOW SUPPLIED/STORAGE AND HANDLING
BELVIQ 10-mg tablets are supplied as blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:

NDC 62856-529-10 Bottle of 100
NDC 62856-529-51 Blister pack of 10
Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).

BELVIQ is indicated for chronic weight management only in conjunction with a reduced-calorie diet and increased physical activity.
Patients should be instructed to discontinue use of BELVIQ if they have not achieved 5% weight loss by 12 weeks of treatment.
Patients should be informed of the possibility of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions with the combined use of BELVIQ with other serotonergic drugs, including selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), triptans, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors

Reference ID: 3151563

[MAOIs]), dietary supplements such as St. John’s Wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.

Patients who develop signs or symptoms of valvular heart disease, including dyspnea or dependent edema should seek medical attention.
Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ therapy does not affect them adversely.
Patients should be instructed to seek medical attention in the event of emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Patients should be cautioned not to increase their dose of BELVIQ.
Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.
Patients should be instructed to avoid pregnancy or breastfeeding while undergoing BELVIQ therapy and to talk to their prescribing physician should they get pregnant or decide to breastfeed.
Patients should tell their healthcare provider about all the medications, nutritional supplements and vitamins (including any weight loss products) that they may take while taking BELVIQ.
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH, Zofingen, Switzerland Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

Reference ID: 3151563

PATIENT INFORMATION BELVIQ® (BEL-VEEK) (lorcaserin hydrochloride) tablets
Read the Patient Information that comes with BELVIQ before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about BELVIQ, talk to your doctor or pharmacist.
What is BELVIQ?
BELVIQ is a prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.
BELVIQ should be used with a reduced calorie diet and increased physical activity.
It is not known if BELVIQ is safe and effective when taken with other prescription, over-the- counter, or herbal weight loss products.
It is not known if BELVIQ changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if BELVIQ is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).
It is not known if BELVIQ is safe and effective in children under 18 years old.
Who should not take BELVIQ? Do not take BELVIQ if you:
• are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby. What should I tell my healthcare provider before taking BELVIQ?
Before you take BELVIQ, tell your doctor if you:

have or have had heart problems including:  congestive heart failure
 heart valve problems
 slow heart beat or heart block
have diabetes
have a condition such as sickle cell anemia, multiple myeloma, or leukemia
have a deformed penis, Peyronie’s disease, or ever had an erection that lasted more than
4 hours
have kidney problems

Reference ID: 3151563

have liver problems
are pregnant or plan to become pregnant.
are breast feeding or plan to breastfeed. It is not known if BELVIQ passes into your breastmilk. You and your doctor should decide if you will take BELVIQ or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
BELVIQ may affect the way other medicines work, and other medicines may affect how BELVIQ works.
Especially tell your doctor if you take medicines for depression, migraines or other medical conditions such as:

 triptans, used to treat migraine headache
 medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin uptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or antipsychotics
 cabergoline
 linezolid, an antibiotic
 tramadol
 dextromethorphan, an over-the-counter medicine used to treat the common cold or cough
 ver-the-counter supplements such as tryptophan or St. John’s Wort
 medicines to treat erectile dysfunction
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know all the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take BELVIQ?
-  Take BELVIQ exactly as your doctor tells you to take it.
-  Your doctor will tell you how much BELVIQ to take and when to take it.
  • Take 1 tablet 2 times each day.
  • Do not increase your dose of BELVIQ.
  • BELVIQ can be taken with or without food.
- Your doctor should start you on a diet and exercise program when you start taking BELVIQ. Stay on this program while you are taking BELVIQ.
- Your doctor should tell you to stop taking BELVIQ if you do not lose a certain amount of weight within the first 12 weeks of treatment.

 If you take too much BELVIQ or overdose, call your doctor or go to the nearest emergency room right away.
What should I avoid while taking BELVIQ?
• Do not drive a car or operate heavy machinery until you know how BELVIQ affects you.
BELVIQ can slow your thinking.

Reference ID: 3151563

What are the possible side effects of BELVIQ?
BELVIQ may cause serious side effects, including:
 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions.
BELVIQ and certain medicines for depression, migraine, the common cold, or other medical problems may affect each other causing serious or life-threatening side effects. Call your doctor right away if you start to have any of the following symptoms while taking BELVIQ:

mental changes such as agitation, hallucinations, confusion, or other changes in mental status
coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
restlessness
racing or fast heart beat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity (stiff muscles)

Valvular heart disease. Some people taking medicines like BELVIQ have had problems with the valves in their heart. Call your doctor right away if you have any of the following symptoms while taking BELVIQ:
- trouble breathing
- swelling of the arms, legs, ankles, or feet
- dizziness, fatigue, or weakness that will not go away
- fast or irregular heartbeat
Changes in your attention or memory.
Mental problems. Taking BELVIQ in high doses may cause psychiatric problems such as:
- hallucinations
- feeling high or in a very good mood (euphoria)
- feelings of standing next to yourself or out of your body (disassociation)

 Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking BELVIQ and while you take BELVIQ.
Painful erections (priapism). The medicine in BELVIQ can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using BELVIQ and call your doctor or go to the nearest emergency room right away.

Reference ID: 3151563

Slow heart beat. BELVIQ may cause your heart to beat slower. Tell your doctor if you have a history of your heart beating slow or heart block.
Decreases in your blood cell count. BELVIQ may cause your red and white blood cell count to decrease. Your doctor may do tests to check your blood cell count while you are taking BELVIQ.
Increase in prolactin. The medicine in BELVIQ may increase the amount of a certain hormone your body makes called prolactin. Tell your doctor if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.
The most common side effects of BELVIQ include:
- headache
- dizziness
- fatigue
- nausea
- dry mouth
- constipation
- cough
- low blood sugar (hypoglycemia) in patients with diabetes
- back pain
  Tell to your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BELVIQ. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
How do I store BELVIQ?
Store BELVIQ at room temperature between 59°F to 86°F (15°C to 30°C). Safely throw away medicine that is out of date or no longer need.
Keep BELVIQ and all medicines out of the reach of children. General information about the safe and effective use of BELVIQ.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BELVIQ for a condition for which it was not prescribed. Do not give BELVIQ to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about BELVIQ. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BELVIQ that is written for health professionals.
For more information, go to www.BELVIQ.com Website or call 1-888-274-2378.

Reference ID: 3151563

What are the ingredients in BELVIQ? Active Ingredient: lorcaserin hydrochloride
Inactive Ingredients: silicified microcrystalline cellulose; hydroxypropyl cellulose NF; croscarmellose sodium NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C Blue #2 aluminum lake; and magnesium stearate NF.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Rx Only
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH, Zofingen, Switzerland Manufactured by Arena Pharmaceuticals GmbH, Untere Brϋhlstrasse 4, CH-4800, Zofingen, Switzerland
Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

Reference ID: 3151563

Learn You With The Myers Briggs Personality Test

2012-05-12T04:01:00.003-05:00

I've taken many different assessment tests, some that determine my IQ, others my spacial competency, etc. However, no test can compare the the Myers Briggs test in helping understand those meta-traits and attributes that make you, well, you....

Visit this site to take the test for free:

http://j.mp/myersbriggsquicktest

The test itself shouldn't take longer than 10 minutes to complete, and when you're done you'll be assigned a four character "personality type". There are sixteen different personality types, and I'll eat my left hand if your jaw isn't on the floor when you read about who the Myers Briggs system thinks you are. Let me know your personality type, I'm also interested in hearing from anyone who doesn't believe the test represented their personality closely (if not spot-on!). Enjoy

Christian Hunter
Austin, TX

BTW: Here's my test result FYI:

A Distorted View of Privatization

2012-04-30T08:43:00.000-05:00

As a longtime supporter of public school privatization, "A Very Pricey Pineapple", by Ms. Gail Collins, is a sobering editorial which describes a creeping danger to the privatization initiative: monopoly.

What's most worrying about this article is the implication that the doings of an apparent monopoly are to be construed as those of a privatized system. I disagree. The privatization movement she describes seems more a post-Soviet land-grab than an organized transfer of responsibility away from government bureaucrats, and into a highly-competitive marketplace of choice driven by economic incentive.

I think most every supporter of privatization envisioned something different from that which Ms. Gail Collins describes; specifically, privatization should involve the application of free-market principles to a bloated, wildly expensive, and increasingly ineffective socialist-style public education system. Nowhere in the brochure did it mention anything about super-monopolies and no-bid style contracts. That's not privatization, that's plunder.

Have a read for yourself here: j.mp/priceypineapple

"How do i get a reality show" you ask?

2012-03-31T22:36:00.001-05:00

If you've ever asked yourself "how do i get a reality show", perhaps you should be asking Ryan Seacrest.

It was Ryan Seacrest who was behind the wildly popular reality show Keeping Up With the Kardashians, and while not behind the Jersey Shore, Ryan Seacrest's latest reality show on the Bravo Network has been dubbed a Persian version of Jersey Shore", and the comparison is spot on!

My girlfriend came out to the kitchen, Shahs of Sunset was on in the background, and when one of the characters of the show declared her sympathy with the poor in saying she "feels bad for people who don't fly private", conversation quickly turned to the TV, where she refused to believe it wasn't Jersey Shore, she kept laughing and pointing at the scantily clad characters doing the typical Jersey shore style fist pumping around the pool to house music. It took my pointing out the Shahs of Sunset and Bravo Network logo at the bottom left of the screen to get her to believe. I laughed to myself thinking that the cast of the Shahs of Sunset would recoil in disgust at the comparison, but what's really funny is that the cast of the Jersey Shore would be equally disgusted!

I like being like everyone else!

How could characters so similar to each other in their own strange way take such offense at a comparison? Probably because each show features their own sad gaggle of hyper-prejudiced, wildly insecure, and xenophobic trolls. I'm guessing that's the Bravo Network and Ryan Seacrest formula: they scout out serious freaks who should themselves be highly sensitive to prejudice, but instead are about as ruthlessly prejudice as you could get. That certainly makes for an outrageous reality show, you want to yell out at the TV, after all, on the Shahs of Sunset you have a gay guy, a fat girl, a fat dude, and a haggard older lady. How in the world could a group so different and unique act so prejudice toward the rest of the world? Well, that's the attention getter: t he cast of the reality show Shahs of Sunset look down their noses at everyone around them with pity, or more likely with disgust, as though they're the only normal ones in the room, one of them pointing out "there are two things I hate, ants, and ugly people". LOL! It makes for an outrageous reality show, but is in fact a really sad commentary on what happens to people when they stick to their own, stay overprotected, revel in bigotry, and never themselves ask perhaps the toughest question of all: namely, "could it be possible that we are the biggest freaks in the room?".

So if Ryan Seacrest and The Bravo Network were to honestly answer your question how do I get a reality show, they'd say be like the weirdos on Shahs of Sunset. Be ignorant to the point of hilarity, ignore your own issues and inadequacies but be expert at locating what you find unattractive about others. Oh, and it'd be an extra bonus if you could make an entire class look like a bunch of reprehensible buffoons by exemplifying and exaggerating every stereotype ever leveled against it, whether Italian American, Persian, Rich, fit, gay, or a housewife, the uglier you could portray a class, the better.

So for those without access to Ryan Seacrest or an "in" at the Bravo Network, that still want to know "how do i get a reality show", now you know. The question is, do you really want what it takes to be on one?

Newest Social Network is giving its shares away to first users.

2012-03-26T14:37:00.001-05:00

Could the next Facebook be built by giving the company away?

The new ultra-viral invite-only Zurker.com thinks so, and its CEO is betting the company on it! To get an invitation to join, and claim your name in its URL (this helps your name's SEO rank), then click here:

http://j.mp/zurkerinvite

Nick Oba, Zurker.com's founder, really believes in users. In fact, this serial entrepreneur, whose user-content driven online magazine failed to takeoff in 2010, decided to up the ante with his next company, Zurker.com and this time, instead of catering to the venture capital crowd chock full of some of the richest in the world to build support for his upstart, he's instead betting the company on a novel system to get the company the mass it needs: he's giving the company away to its early users, for free.

The logic goes something like this: Facebook.com and other social networks like it spend upwards of $20 per user in marketing fees alone. Nick Oba believes that if the Zurker platform is great, and and its users had just the extra incentive to pass word along after giving it the thumbs up, then Zurker can skip the Seed and Angel round of investing entirely. Typically social networks like Zurker give away most of their company selling stock to early investors in order to raise the millions of dollars typically needed; money that's used to build a large enough user-base. Once that base is built, it's usually leveraged to attract even more venture investors and cash (where then the company needs to sell even more shares, albeit typically for a far higher price per share).

Zurker's bold plan will instead offer that first big chunk of the company to its users in the form of "vShares", each share representing a contract of ownership interest in the underlying company. This, in Zurker's CEO's mind, will give its users enough incentive to keep perpetuating word about the company, allowing Zurker to reach the critical mass of users it needs to raise big money cheaper, and altogether bypassing the need to raise cash at what is typically the most expensive time: the very beginning.

According the the numbers published on Zurker's site, valuations of these initial 1,000,000 "founders shares", once they reach just 500,000 users, could be equivalent to $10 per share. The numbers get even more interesting however when you compare the potential values of Zurker to companies like Myspace (in which case Zurker vShares would worth roughly $580/share), or Bebo.com, which would value vShares at roughly $800.

If allowed to fantasize, what would the valuation of Zurker be if it were the next Facebook? Try roughly $50,000 per share!

So what happened?

Well, as of the last week in March 2012, we still have to wait and see. The company is presently in it's "Alpha stage, pre-issuance"; which means as soon as the full one million vShares purposed for users have been given away, then "Zurker will be restructured as a public corporation and vShares will become real shares" Zurker explains on its vShares page. A copy of the vShares page can also be found below.

If that weren't bold enough, Zurker has gone so far as to create a system that grants full access to the company's books. This is available to vShares stakeholders and the public alike on Zurker's "Open Books" page.

Zurker's CEO, Nick Oba, is implementing a very bold and innovative idea whose time may have come. If he's right, then that could mean the obscene fortunes made by New York and Silicon Valley in their dominance over Seed and Angel Financing stages (of once fledgling companies like Google and Facebook) are in decline. And if Nick Oba is right, then Zurker will likely soon have about a million owners with many reasons to be glad he is.

The 15 best obscure and mainstream shows on TV

2012-01-15T21:15:00.002-06:00

Fairly Obscure:

My top 15 list of the best obscure and mainstream television shows on recently:

1. Party Down

2. Arrested Development

3. Worst Week

4. Head Case

5. Shameless

6. Terriers

7. Caprica

8. Perfect Couples

9. Back to You

10. Better off Ted

11. Lovespring International

12. The Hard Times of RJ Berger

13. The Life & Times of Tim

14. The Increasingly Poor Decisions of Todd Margaret

15. Lights Out

Mainstream:

1. Friday Night Lights

2. How I Met Your Mother

3. It's Always Sunny in Philadelphia

4. Modern Family

5. Grey's Anatomy

6. 30 Rock

7. Battlestar Gallactica

8. Californication

9. Lost

10. House

11. Lie to Me

12. Royal Pains

13. Nip/Tuck

14. Private Practice

15. Happy Endings

Getting it done with good ol' fashioned failure.

2011-11-20T14:26:00.001-06:00

Now one can get into a good debate as to whether or not austerity in these uncertain economic times globally is in fact the right direction for this country, but I believe it's difficult to debate the sheer political genius in how this nation's version of austerity is being implemented. I'll explain:

I think it's pretty clear that the super committee is going to fail to come to any sort of agreement, however, I believe – despite not hearing a single similar opinion in the press, or blogosphere – that impasse was part of the political plan to begin with.

Sure, the inability to come to agreement will look like failure in the eyes of the public. But I believe to those architects of the joint select committee as part of the Budget Control Act of 2011, "failure" will, in actuality indicate to them that their plan has succeeded.

Am I mad in thinking this entire concept of a super committee may well be one of the most ingenious political devices to come around in years? I mean, it's happening right before our eyes: $1 trillion in cuts to the federal budget and not a single member of our government will be hated for it!

I suspect this first go may just be a test, one that we'll likely see repeated, and ultimately designed to level those fiscal albatrosses that truly threaten the long term economic stability of the United States: the sacred budgetary allocations whose mere mention of cutting would be tantamount to political suicide. They're now exposed, for the first time in a long time, to this "zero responsibility" scheme.

This "Super Committee", which involves a relatively small and obscure (to the majority of the public anyway) number; being six of each opposing party, can now indignantly storm out of whatever chamber they've been ensconced in, nodding their heads, furiously pointing their fingers and, as usual, off to collect ever-more money from their impassioned base whilst espousing ever-more extreme and inflammatory allegations against their opposition. It would seem just another day in Washington but for the fact that, by default, they just came to agreement on cutting a trillion dollars from our budget!

So Congress just keep doing-nothing, but now they do it in order to get things done!

No political power is lost, if anything it'll be gained, and $1 trillion gets gutted from our budget. It's the new Alice in Wonderland political environment we live in, but I'm encouraged by what I assume is evidence that pragmatism of this structure which predicted failure, in fact embraced failure as the centerpiece of its newly found political super-weapon.

Gmails new look, & a fix for its annoying "feedback" button!

2011-11-03T22:39:00.000-05:00

If you're just looking for the fix to the annoying "feedback" popup on the new Gmail look, then skip to the bottom. There you'll find the solution in boldface-type...

Anyhow, not sure if you've been invited to switch to the new Gmail look; but if not, or if you've postponed it, I thought I'd give you a link to upgrade yours: http://j.mp/uF5uqj

or here: https://mail.google.com/mail/help/intl/en/newlook.html

The link also contains a compact and helpful tutorial which outlines some of the improvements to the system that go beyond looks alone.

You'll probably notice there's more to this change in Gmail's look than looks alone: there are also some interesting improvements to functionality as well. I believe the most significant change of all — and perhaps the most significant change implemented by Google to one of their systems in a while — is their first implementation of a truly "dynamic UI" in Gmail.

Of course you'll continue be able to specify how you want the UI to appear, but in this particular instance, the dynamic UI enables a type of functionality in Gmail that automatically responds to and manipulates its interface and screen layout in response to how YOU use it! This all works in an effort to better accommodate your unique preferences and particular use-idiosyncrasies without your having to take the time or thought to specify them yourself.

I LOVE this genre of technology and am really excited to see it deployed on Gmail. Anyhow, the main reason I decided to write about it was to get you thinking about how you too can use this type of technology in the near future. Specifically, you might be able to leverage you may already know about your users to adapt your service(s) automatically in better accommodating them.

This of course is all in contrast to how it's been done since the dawn of commercialism, which has been to put the burden of "accommodating" (to a product or service) entirely on the user in forcing them to "accommodate to" the product or service they wanted to use.

The attitudes of conventional static (vs. "dynamic") deployments of products and services have caused us as consumers to expect to be instructed by the company on the proper use of their wares. That's in stark contrast to the possibilities that automated-change which allows us to instruct our product or service on our preferred method(s) of use by simply using it.

Typically companies tell us that we need to:

"...click this button to make our widget do X", or "if you need to change X, then pickup the phone and call 800-xxx-xxxx..."

In the coming shift to dynamic and automated usage-based change, the examples above will transition from "the way it's always been to the way things were" very quickly. Instead of being forced to follow rigid use instructions, companies will initially offer choice-sets or modes of use to their customers; and will remain flexible while they listen to and watch for hints users leave to their particular preferences. Then, based on the data they collect from the user in response to that flexibility, they'll ultimately organize their product/UI/service/etc to the exact preferences of each individual user.

The concept of dynamic auto-customization (which may be dubbed "mass customization" or "mass personalization"...) that I'm trying to articulate in this post will soon be a reality, and I'm all but certain will be one that will significantly favor those businesses that adopt it earlier than their competition!

Something to think about...

Anyhow, it's a bit ironic, but in this new deployment I found myself being ritually haunted by a persistent button that pops up on the bottom of the screen begging me to learn “about the new look | send feedback”...grrr! I kept swatting its "X" close button only to have it persist...even after I yielded and input my thoughtful feedback...the thing kept coming after me like some senile zombie, begging FEEDBACK!!!

Enough was enough, and thanks to Jabba Laci's post the solution was simple:

So, if you too have been annoyed by the constant “about the new look | send feedback” button popup that came along with the new Gmail look, then you can stop it by downloading adblockplus.

For Firefox it can be found here: http://j.mp/vSdOfZ

or here:

http://download.cnet.com/Adblock-Plus-for-Mozilla-Firefox/3000-11745_4-10636539.html

once downloaded, simply add this filter:

mail.google.com##div[class="GcwpPb-MEmzyf GcwpPb-bEO5kc"]

For Google Chrome you'll find the add-on here: http://j.mp/tOmZg9

and there you have it, no more requests for feedback popups!

Enjoy,

Christian Hunter

Austin, Texas

Shareholders beg Netflix to: "Turn It Off!"

2011-10-26T05:51:00.000-05:00

Netflix (NFLX) got into content recently, at least proverbially, in producing a horror flick that's got its shareholders begging management to "turn it off"!

Many of you who own shares already know, and those 20+ million of you with a Netflix subscription will find out (if you haven't already) that the company arbitrarily split its two service types (its conventional DVD's by mail, and its new and expanding bank of movies and shows available by streaming) which were both sold for a combined $9.99 and backed them down to $7.99 each, or $15.98 total. While not a devastatingly significant amount of money for those who actively use the service, the arbitrary and ham-fisted methods used were resented by even the most rabid Netflix Evangalists.

These price hikes were not without consequence either. However, I thought it worth mentioning that this stock is now trading at $77. It was $300 just this last July!

Barf Indeed!

So post-bloodbath the contrarian in me is immediately interested. I've always been attracted to this kind of panic selling and understanding the underlying story driving this type of capitulation. This isn't to say I believe there'll be an immediate sharp rebound in the company's stock price, but whenever there's an abrupt rush to a limited number of exits, you're typically dealing with a glut of especially "weak hands" willing to sell at nearly any price.

The stock was priced to perfection, but now however, considering its 40% year-over-year top-line growth and what appears to be a new emphasis on bottom-line directed from the top (in perhaps the most inept fashion I've seen from a company with the kind of good-faith Netflix has in a long time!) this company is looking to be an speculative play worthy of a second look by those with strong stomachs.

Of course, if I were to intent on building a position in Amazon, I wouldn't do so right away, but instead would "leg in", and buy in thirds over the next couple of months or so while the realities of the recent panic are digested, and the actual performance dynamic of the company in this all-important holiday season are better understood.

As a parting thought, I was fortunate enough to have Marc Randolph, co-founder of Netflix, serve on the board of directors of one of my businesses for a couple of years, and in that time I routinely found myself left slack-jawed by his brilliance! He'd occasionally drop the answer to a complex problem...not an idea or clue that might get us to the answer...the whole thing w/ a bow on it! I count Marc among the most naturally gifted businessmen I've ever had the pleasure of working with. Now I don't know Reed Hastings, but from what I'm told he's running that place with similar cognitive firepower...so, these guys, while clearly not immune to mistakes, are some really smart SOB's with a damn good track record and a over 20 million subscribers in a high-growth industry! The company is certainly worthy of a closer look...

Christian Hunter
Austin, Texas

Google thinks I look like Meryl Streep...and a Japanese schoolgirl

2011-09-18T02:43:00.000-05:00

Google took another brave step to seal its position as info-overlord when it launched its "Google Image Search". It took me a second to register, but yeah, they're talking about using images, not text, to perform searches on their engine!

I needed a picture, and of course it wasn't but 2 seconds later that a picture of my own grill was streaking across the screen in a show of subconscious vanity, to be shoved into this new visual hive-mind:


What? I needed a pic...

I don't know what I expected, but the results were impressive...

All was well with the world, I had a new tool to find my own face with, and Google....well Google decided to do what apparently my friends, family, hell even my own girlfriend were too afraid to tell me all these years....that I look like almost 50% female, about 10% baby'esque, and the balance a hybrid between Simon Cowell, Meryl Streep, some totally random dudes and chicks, oh, and a seductive Japanese schoolgirl:

Now having had some time to digest this all, I think what really hurts the most isn't so much looking like a totally awesome baby, but that I find myselves so much more attractive in how Google sees me than I do in the mirror...

Now might be the right time (only you can know when you're ready) to learn the honest truth about what you really look like...if you're ready, check it out through this shortcut: j.mp/ndNkI7

And if you're up for some honest sharing, let me see a pic of what your friends and family have been hiding from you all these years...

2011-09-18T02:02:00.000-05:00

Case Mate "accidentally" revealed iPhone case by mistake!

So iPhone case vendor Case Mate "accidentally" throttled its own website traffic by leaking pictures which revealed the shape and form of the wildly anticipated Apple iPhone 5. They pulled down the page, and replaced it with what I have to admit may be the best published list of rumors on the phone I have yet read.

Among Case Mate's list of "rumored new features", they assert that the new iphone 5 will take on a completely different form than its predecessors (um, I'm gonna guess less of a speculation seeing as they were given the physical specs by Apple?), believing it to be even thinner than the 4, and wide enough to accommodate a large 4 inch screen.

Outfitted with an 8 megapixel camera, and an A5 dual processor (like what's in the iPad2), it should also be capable of storing movies, pictures, and sound files in Apples' iCloud.

Perhaps the coolest speculated attribute will be its ability to charge using a wireless system (similar to this). Consensus is we're very likely a week or less away from its announced ship date, which most believe will be mid-October.

Christian Hunter
Austin, Texas

CaseMate accidentally throttles pre-orders for its cases