By Lisa Richwine

ADELPHI, Maryland (Reuters) – Arena Pharmaceuticals Inc urged U.S. advisers on Thursday to back its proposed prescription weight-loss pill, arguing the medicine was safe for people despite tumors in lab rats.

Winning the panel’s support would move the drug, lorcaserin, closer to the U.S. market. The medicine is crucial to the small San Diego-based drugmaker, which was founded in 1997 and has no approved products.

Arena began its pitch by directly challenging concerns about cancerous tumors seen in rats. The company said the findings did not apply to people because the rat tumors resulted from high doses or biological mechanisms specific only to rodents.

“Lorcaserin does not pose a cancer risk to humans at the recommended therapeutic doses,” Dr. Gary Williams, a public health professor at New York Medical College who spoke for Arena, told the panel.

He also pointed to nine medicines that were approved with evidence of the same types of rat tumors seen with lorcaserin.

Food and Drug Administration reviewers highlighted the cancer issue as a key concern in an initial analysis released

on Tuesday. Investors fled the stock, sending the company’s shares down 45 percent since Monday’s close.

Industry analysts said ahead of the meeting Arena could have a tough time reassuring the panel the drug would not raise cancer risk in people.

“We suspect that the vote will likely be a close one going against approval of lorcaserin prior to additional trials to rule out the risk of cancer,” BMO Capital Markets analyst Jason Zhang said in a research note.

Consensus forecast data from Thomson Reuters shows analysts expect Arena’s drug could reach peak annual sales of $822 million if it reaches the market. Japan‘s Eisai Co holds U.S. marketing rights to lorcaserin.

Drugmakers have failed for decades to produce a pill to help people shed a significant number of pounds without serious side effects. Risks of current options were highlighted on Wednesday when U.S. advisers agreed tougher action was needed on Abbott Laboratories Inc’s diet drug Meridia but split on whether the drug should be banned.

Two other companies, Vivus Inc and Orexigen Therapeutics Inc, have weight-loss pills under FDA review this year. All three companies are trying to launch the first new prescription diet drug in a decade.

While the current U.S. obesity drug market is small — prescription and over-the-counter diet pills took in $381.5 million in 2009, according to data from IMS Health — some analysts have said a new product could more than double that.

EFFECTIVE ‘BY A SLIM MARGIN’

Arena’s lorcaserin was designed to block appetite signals in the brain in a similar way to the now-withdrawn fenfluramine in the fen-phen diet drug cocktail. The Arena drug is more selective in the receptors it affects, and the company says studies have not found any of the heart-valve problems with lorcaserin that were linked to fenfluramine.

FDA reviewers, in 270 pages of analysis prepared for Thursday’s advisory panel, said they would ask the outside experts to consider data on heart-valve disease, psychiatric and memory problems and cancerous tumors in rats.

They also said one of the doses Arena tested met agency criteria for effectiveness “by a slim margin.” In company studies, patients who took 10 milligrams of lorcaserin twice daily for a year lost about 5.8 percent of their body weight on average. Placebo patients lost 2.5 percent.

The advisory panel is expected to vote Thursday afternoon on whether to recommend approval of lorcaserin. The FDA usually follows panel advice and is due to make a final decision by October 22. The drug’s proposed brand name is Lorqess.

Arena is developing other drugs for treatment of blood clots, sleep disorders and pulmonary arterial hypertension, but all are in early testing.

(Reporting by Lisa Richwine; Editing by Tim Dobbyn, Dave Zimmerman)

The infant survived for an entire week without food or water.

-April Daniels Hussar

In a true miracle, rescuers discovered a 15-day-old baby alive in the rubble of her home a full week after the earthquake in Haiti destroyed the house.

Her mother, 22-year-old Michelene Joassaint, said she had put baby Elisabeth down for a nap on the second floor of her house and was on the first floor when the quake struck. She tried to get upstairs but had to flee the house as it fell around her. Joassaint was sure her daughter has perished in the disaster, but the search and rescue team sent to demolish the remains of the house found the baby alive, in her bed that had fallen from the second floor to the first.

“It was the mercy of God,” said Joassaint, who was staying in a homeless camp  on a soccer field when she learned the news. “I cried and then ran to the baby.”

There have been many dramatic rescues in Haiti, both by official search and rescue teams and by everyday citizens working to free their fellow people.

“The search and rescue has been a fantastic success this time,” said Sir John Holmes, the United Nations Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator. “They’ve pulled out more people than is normally the case.” (WSJ.com)

The actress doesn’t enjoy the pressures placed on the female population.  -Carolyn French

Cutie pie Reese Witherspoon finds it rather challenging to be a woman. Like, join the club, right?

Reese feels somewhat boxed in by society’s view of how a female should act, and she knows that at the end of the day it all comes down to garnering support from your besties.

“It’s tough being a woman,” she recently stated. “You are supposed to be self-sufficient, but we all need our sisters. I have three women friends who will drop anything to help me and I will do the same for them. I believe in those female bonds, because a lot of stuff happens with men and marriage and divorce, but family and friends are paramount.”

True that. And although we wholeheartedly agree, it must be pretty darn sweet being Ms. Reese Witherspoon! (Showbiz Spy)

Honestly, I don’t know whether to be horrified by this new iPhone App, or run out and buy an iPhone just so I can use the App. What is it? Why, it’s the iSurgeon, “an innovative App … which combines personal image modification with high tech gaming features.” Huh?

Basically, it does two things: One, it lets you see what you would look like with plastic surgery: a new nose, bigger boobs, even smaller ears. Two, it lets you “play plastic surgeon” and perform procedures on “patients.” It even comes with “realistic sound effects.” (I got a little woozy when I read that, I don’t handle blood and stuff well to begin with, I don’t need to hear skin being scalpeled, ewwww.)

It was created by an actual plastic surgeon, Dr. Michael Salzhauer, who’s also written a children’s book that explains Mommy’s plastic surgery (awww, isn’t that sweet?).

While it would be cool to see what I’d look like slightly modified, since I don’t think I have the guts to ever do it for real, the idea of performing surgery is beyond my scope of a good time.

What do you think? Are you downloading the App as you read this? Or will your phone be a surgery-free zone?

• I wonder if these celebs would have re-thought their procedures if they had this App, hmmm …
• Does that plastic surgery game sound fun? Then wait until you check out this one. Or this one.
• Not going anywhere near a scalpel? You can still transform your face with these makeup tips.

“A-PLUS” ran the headline of a Post story the other day that cheered a fashion magazine’s decision to run pictures of overweight models. So. Hooray for fatties, right? Or maybe we are expected to praise the magazine’s path-breaking and revolutionary decision to be only the ten thousandth magazine to do a (the singular is apt) spread on fat women.

Back when I worked for a women’s magazine, we’d do the Fat-Is-In cover story every six months. (Surprise! Not that many actresses and models wanted to participate. Emme Jacob was to us what Obama’s birth certificate is to Lou Dobbs.) Other stories we’d do every six months: “Inside the Obesity Epidemic,” “Secrets of the Star Who Lost All That Weight” and (in recent years) “Check Out This Chick Who Got Her Stomach Stapled.”

Over at V magazine (Just V? I am reminded of the Woody Allen line, from the story collection “Without Feathers”: “Should I marry W? Not if she won’t tell me the other letters in her name”), the most recent save-the-whales picture layout features a herd — sorry, group! — of semiclad plus-sized models.

The V spread is blissfully meaningless as a trend. The magazine will soon go back to featuring girls built like praying mantises. It’s been about 20 years since glossy magazines first started trying to figure out a way to deal with the larding of America and the issues that weigh down the other side of the scale: feminism, political correctness and skyrocketing sales of pieces of cloth that used to be labeled “pup tents” but now are sold as clothing in the “Real Woman” department, or the “Robust Female” section, or the “Judgment Free Zone,” or whatever the current term is. But in that same 20 years, fashion models have gotten even skinnier.

Surely there must be a way for magazines to sell fat-folk clothes, appease feminists (“James Gandolfini is sexy, so why isn’t Roseanne?”) and express tender tolerance for those who are (as a press release I got the other day put it) “suffering from obesity”?

No. There isn’t. Because fashion magazines are run for the pleasure of upscale advertisers, and advertisers sell aspiration. If you want to sell reality, that’s a completely different and less lucrative advertising category — dubious fat-burning potions, sad little nutri-snacks, grim stretchy exercise belts that harness your gut to the doorknob. Ralph Lauren doesn’t want his ads next to the Thighslammer. And nobody at W or anywhere else wants to descend the social ladder. You know the name of the editor of Vogue. Tell me, who’s the editor of Weight Watcher’s mag?

Writers who praise the V decision to go all “Norbit” seem to think that relief would rain down on today’s high-strung women if only fashion magazines would stop forcing them to buy their monthly package of starved waifery. Aren’t these models driving women into deadly anorexia and punishingly low self-esteem?

Actually, the opposite problem is the case. There are a lot more women “suffering from” obesity, which is prevalent in practically every demographic group, than anorexia, a scourge of school-aged upper-middle-class white girls, the kind of tortured souls you pick up at a party by slipping in a line like, “Are you a writer? There’s something of the old soul in your eyes” and who spend their formative years telling boys pretending to listen, “I think I might be a . . . Wiccan” or “. . . lesbian” or — something really ghastly — “. . . vegetarian.”

In fashion magazines staffed by upper-middle-class white women, the death of millions from obesity-related causes don’t count. What sets off their alarms is the death of one coked-up rice-cake-eating model who starved herself to the grave.

There is a one-word answer to obesity in this country, and you would think fashion-book editors would understand, since it is one of their favorite nouns. Acceptance? Tolerance? Self-esteem? No, Paris.

The average American lard lady would, if sent to Paris, find herself slimming down instantly. Paris is, literally and figuratively, built for the tiny and lithe. American giantesses wouldn’t be able to squeeze into a subway seat or through the closely-arranged tables of a 5th arrondissement cafe, and, if they tried, they’d be subject to mutters of disapproval and rude stares. Shame — the certain knowledge that you have given those around you ample reason to disapprove — is a powerful societal weapon. See how well it worked on cigarette smokers and drunk drivers? Importing a little Parisian attitude to America would vastly benefit the tubby. Obesity has now surpassed smoking in America as a health threat, according to a new 15-year study conducted by City College and Columbia University.

Tolerance is the enemy of shame. With more and more fat acceptance — like that encouraged by V — there will be more and more fat people.

Nobody is born 300 pounds. Nobody “suffers from” obesity. She chooses it, one milkshake at a time.

In New York, as the fatty next to us in coach buries the armrest with his flab or unrolls across two seats in the subway, we think, “Musn’t be intolerant of the horizontally uninhibited!” Fat people harm themselves and take up space for which you paid. They drive up everyone’s insurance costs. If we can’t make them feel shame in this country, then maybe skinny models are our last resort.

If the fashionably starved are the only thing keeping the final 40% of us from turning into human zeppelins, they’re not as useless as you think.

The other day I received an email from Mary Ellen, the Executive Director at Ophelia’s Place in upstate NY asking me if I’d model in her upcoming fashion show on February 7th.

She calls the fashion show “A Radical Fashion Show to Benefit Ophelia’s Place.”  The show will be hosted by Joy Nash featuring models of all shapes, genders, sizes and colors.

The show is truly radical since all of the clothes worn by the models are from Target and local thrift shops. Leave it to Mary Ellen to come up with a great idea like that. She says it’s all about thrift and recycling.

I’d do anything for Mary Ellen, so I agreed to be in the show.

I have 2 goals with the show;

1. Support Mary Ellen and Ophelia’s Place.
2. Try not to not embarrass myself too much. I’m sure they’re will be a stumble here and there, but my goal is to not have people engaging in hardy laughter. 

The first goal will be easy, the second one not so much.

I went to a local store to try on clothes and get a general feel for walking. You know what they say – practice makes perfect!

- “AMERICA THE BEAUTIFUL” DVD
- SCREENING IN DALLAS
- PEABODY ESSEX MUSEUM SCREENING
- BEAUTIFUL PERSON OF THE WEEK
- UPCOMING SCREENINGS

- PEABODY ESSEX MUSEUM

If you haven’t already seen “America the Beautiful,” here are some of the ways that you can:

You can order the PG-13 or R rated version in either the Home Use, Educational or Organizational version off of our website.

The Educational and Organizational version comes with a 1 time public performance license to screen the film for an audience either with free admission or charging an admission.

BUY DVD NOW

if that link doesn’t work, go to:
www.americathebeautifuldoc.com/buy

The basic difference between the R Rated version and the PG-13 version:

- 4 swear words are missing

- Some images from the plastic surgery scene have been removed

- Also the Eve Ensler scene where she talks about doctors that perform Vagina rejuvenation surgery is gone.

You can also order “America the Beautiful” on Video on Demand through your local cable provider.

“America the Beautiful” is now available in 50 million homes ( Video on Demand) through cable outlets like:

Time Warner Cable, COX, Cablevision, Charter, Verizon, AT&T, RCN, Insight, Mediacom, Suddenlink, Rogers Cable (Canada), Cogeco (Canada).

You can watch the film on Amazon Video on Demand by clicking here:

Amazon Video on Demand

You can watch the film on ITunes by clicking here:

WATCH OR BUY ON ITUNES

- BEAUTIFUL PERSON OF THE WEEK

While I was at the Peabody Essex Museum, I got a chance to interact with Jennifer Evans, the Director of Special Events at the museum.

After talking to her about 15 minutes, I told her she rocked and asked her if she’d be my “Beautiful Person of the Week” and she said yes.

I’m proud to introduce all of you to Jennifer.

In Jennifer’s own words, this is why she’s a beautiful person:

I believe that each person is born with a special gift and our job is to discover that gift within ourselves, develop it and give it back to the world. My gift is music and when I sing or perform music and share it with others, I feel the most fulfilled and most beautiful.

Another beauty – I have a good heart and feel great empathy toward others. For many, many years I thought there was something wrong with me because sometimes I would be so taken with another’s emotional state that I couldn’t concentrate on what was being said in a small group or even in one-on-one situations. I would feel overwhelmed by someone else’s emotional pain, insecurities or even their anger – though they might be smiling – and would clam up. Over time, I have learned to better balance this intuitive understanding with steady verbal skills so that I can participate more comfortably in the world around me and, hopefully, make others more comfortable when we speak. Now, instead of seeing this understanding of others as a curse, I see it was a gift because it allows me to reach out to those around me.

- UPCOMING SCREENINGS

Here is a partial list of  some of the screenings set up for 2010. I will be at all of the screenings listed below and conducting a Q&A afterwards. I will list additional  screenings soon:

January 23, 2010 – Dallas, TX
Elizabeth Hughes Screening

February 1, 2010 – Chicago, IL (NOT CONFIRMED)
University of Illinois – Chicago

February 3, 2010 – Clinton, NY
Hamilton College

February 4, 2010 – Brooklyn, NY
Brooklyn Public Library

February 7, 2010 – Liverpool, NY
Ophelia Place Fashion Show

February 18, 2010 – Champaign-Urbana, IL
University of Illinois – Champaign

February 22, 2010 – Evanston, IL
Northwestern University

February 23, 2010 – Daluth, MN
University of Minnesota

February 24, 2010 – Hoffman Estates, IL
Alexian Brothers

February 27, 2010 – Long Beach, CA
Shoreline Treatment Center

February 28,2010 – Reno, Nevada
University of Nevada – Reno

March 2, 2010 – LaCrosse, WI
University of Wisconsin – LaCrosse

March 3, 2010 – Normal-Bloomington, IL
Illinois State

March 4, 2010 – Poughkeepsie, New York
Marist College

April 16, 2010 – Austin, TX
University of Texas – Austin

May 25, 2010 – Manhattan, NY
Hosting Fashion Show and Auction for ROAED

October 1, 2010 – Chicago, IL
Child and Adolescent Psychiatry Meeting

In case you haven’t noticed, the blonde bombshell has made a habit out of going under the knife.  -Carolyn French

At the end of November reality star/singer Heidi Montag continued her quest to become “the best me” by hopping on an operating table to receive 10 plastic-surgery makeovers (in one day).

The 23-year-old Hills beauty opens up about her dramatic transformation – which included a chin reduction, breast enlargement and nose job – in the latest issue of People.

Read Hollywood’s Worst Boob Jobs

“For the past three years, I’ve thought about what to have done,” she admits. “I’m beyond obsessed.”

Ya think?

Get the skinny on Heidi’s alterations by snagging a copy of People, available today! (People)

How to Wear Winter Florals!

Anything Chanel seems to garner the sort of attention that results in immediate obsession and desire. The latest is a collection of transfer tattoos that first appeared on their spring/summer 2010 runway. For all of us who want a tattoo, but can’t stomach the needles or the permanence, Chanel has graciously provided us with a chic alternative. The tattoos contain floral designs, dangling chains, and the signature Chanel logo, just in case you forgot exactly who you were wearing. The transfer tattoo is likely to bring out your fashionista rocker side, so if you feel the need to head bang or walk with some attitude, carry on; you are, after all, wearing a Chanel tattoo. The tattoos will be sold at Selfridges starting on March 1, so if you were debating getting a real tattoo, save it. This one might be better.

Chanel not really your style? Here are some of our other favorite tattoos that were showcased on the Spring/Summer 2010 runway.

1. Rodarte

Rodarte went tribal for their spring/summer 2010 runway, as models had their exposed body parts painted over in bold tribal-like tattoos. Enticing and alternative, it makes you look at tribal wear in a whole new way.

Our Favorite New Accessory for Spring, Here!

2. Jean Paul Gaultier

Jean Paul Gaultier brought a surprising gangster air to his spring/summer 2010 runway. Models wore tattoos everywhere from their chests to their faces. The tattoos gave the petite models a tough look as if given the opportunity, they would beat any annoyances to a pulp.

A Real Woman’s Adventures With Eyelash Extensions

3. Marchesa

For those who don’t have the patience for temporary tattoos, Marchesa has just the thing. As part of their spring/summer 2010 collection, Marchesa brings tattoo hosiery to the masses. All the look of a real or temporary tattoo, minus the mess.