Panel Recommends More Testing for Obesity Drugs

Obesity drugs should undergo clinical trials to ensure that they do not cause heart attacks, federal advisers said Thursday, a requirement that could make it harder for such drugs to gain approval.

An advisory committee to the Food and Drug Administration voted 17 to 6 to require such studies, even if there were no apparent signs that a drug increased cardiovascular risk.

“Given the checkered history of weight-loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, said at the end of the two-day meeting in Silver Spring, Md.

But some committee members warned that such a requirement would increase the time and cost of developing weight-loss drugs, discouraging pharmaceutical companies.

“If the F.D.A. follows through with this vote, you’ve just added another big disincentive for the drug companies to come up with obesity drugs, and we desperately need new drugs,” said Dr. Ed J. Hendricks, an obesity specialist in Sacramento, who voted with the minority. .

The F.D.A. usually follows the advice of its committees but it does not have to.

It was not immediately clear how, if at all, the committee vote would affect the fates of two obesity drugs awaiting approval from the F.D.A. — Qnexa from Vivus and Lorqess from Arena pharmaceuticals.

Because one-third of American adults are obese and another third are overweight, some obesity specialists and patient advocates say new drugs are needed. Xenical from Roche is the only drug approved for long-term use.

The F.D.A. has been cautious about the drugs, in part because they might be used by many people who, because of their obesity, are already at an increased risk of heart attacks and other cardiovascular problems.

Two drugs associated with the fen-phen diet pill combination were removed from the market in 1997 because of damage to heart valves. In 2010, the drug Meridia from Abbott Laboratories was withdrawn after a clinical trial showed it increased the risk of cardiovascular problems in patients.

The F.D.A. now requires makers of drugs for Type 2 diabetes to rule out an increased risk of cardiovascular problems. That has delayed approval of some drugs and discouraged investment in diabetes-related start-ups by venture capitalists.

Lou Tartaglia, acting chief executive of Ember Therapeutics, a start-up company developing obesity treatments, said the risks of drugs should be assessed on a case-by-case basis. “Just because it is diabetes or obesity doesn’t automatically mean that alarm bells should be going off for cardiovascular risk,” said Dr. Tartaglia.

Mindful of adding time and cost to drug development, most committee members said that some of the testing for cardiovascular risk could take place after a drug was approved.

They also said drug companies might not have to do special cardiovascular trials if they can adequately assess cardiovascular risk in the trials they already do to win approval.

The committee was asked to vote only for drugs with no “signal” of cardiovascular risk. The F.D.A. said during the meeting that it had already decided that cardiovascular risks must be ruled out for drugs that have such a signal, like raising blood pressure.

One drug with a signal is Contrave, which is being developed by Orexigen Therapeutics. It was rejected by the F.D.A. in 2011 because it raised blood pressure and pulse rate.

To rule out the possibility that Contrave raises the risk of cardiovascular problems, Orexigen is now embarking on a clinical trial that is expected to include 10,000 patients, cost tens of millions of dollars and take at least two years.

Qnexa from Vivus also raised heart rate, prompting some analysts to question whether that would be a signal that would delay approval.

However, Qnexa lowered blood pressure. The same advisory committee last month discussed potential heart risks and recommended approval of Qnexa by a vote of 20 to 2. Committee members seemed to agree that Vivus could do a cardiovascular trial after approval.

Vivus declined to comment on Thursday, saying it was in a quiet period before the F.D.A. decision, which is expected by April 17.

Lorqess by Arena Pharmaceuticals drug was rejected by the F.D.A. in 2010, mainly because the drug caused certain tumors in rats. The advisory committee will discuss Arena’s new application for approval in May.

www.nytimes.com

ArturoRodriguez, MD

md@thebariatric.com
http://www.thebariatric.com
http://www.bandstersforum.com
Phone: 011-52-81-8378-3177
Twitter: @bandagastrica
Facebook: http://www.facebook.com/banda.gastrica

Obesity and other targets of Children’s Museums

CHILDREN’S museums do not usually have exhibitions that involve crawling through a giant digestive system.

But such an installation — along with a play center where visitors learn the power of pedaling, bouncing and jumping and a place to meet superpowered vegetable heroes — is part of a larger effort by the Children’s Museum of Manhattan to help prevent childhood obesity.

While children’s museums are primarily known as activity centers to divert the younger set and to help form future museumgoers, they are increasingly focused on social outreach. “Part of our mission is to provide access,” said Andy Ackerman, executive director of the Children’s Museum of Manhattan. “Social issues, education, health and creativity — it’s all a continuum, and we can connect those domains and reinforce each of them.”

The Port Discovery Children’s Museum in Baltimore has adapted museum exhibits and programming for children with special needs. The Young at Art Museum in Davie, Fla., has an afterschool arts program for homeless students. The Providence Children’s Museum in Rhode Island helps children in foster care find permanent families. And the Children’s Museum of the Arts in Manhattan provides a place for foster-care children to reunite with their birth parents by making art together.

“As resources become more and more scarce, everybody’s looking to children’s museums to fill varying kinds of needs for children and families,” said Janet Rice Elman, executive director of the Association of Children’s Museums in Arlington, Va. “These are places where families can learn through play — from science to early literacy skills to parenting — in settings that are joyful.”

Many of these programs involve collaborations with other organizations that have specific expertise. The Children’s Museum of Manhattan on the Upper West Side, for example, developed its so-called EatSleepPlay effort with the National Institutes of Health and collaborates with the City University of New York on training at-home child-care providers in teaching literacy, math and science.

The Children’s Museum of the Arts in SoHo has joined with Henry Street Settlement’s Urban Family Center to bring free weaving, printmaking and sculpture to children living in transitional housing, culminating with a children’s art exhibition and a reception for families and friends. And the Boston Children’s Museum is joining with Head Start, Boston Public Schools and the City of Boston to prepare students for kindergarten.

“We want to be relevant to our communities,” said Jeri Robinson, the vice president for early childhood and family learning at the Boston museum.

Museums are also developing continuing relationships with outside experts. The Children’s Museum of Manhattan, for example, has worked closely with health advisers like Dr. Judith Owens, director of sleep medicine at the Children’s National Medical Center in Washington. Her research helped the museum develop the sleep section of the EatSleepPlay exhibition,  covering topics like preparing for sleep, what happens during sleep and how much sleep children need.

Rather than serving as just one more recreational option, children’s museums are recasting themselves as essential anchors in their communities — “the hub or the center,” Mr. Ackerman said.

“Educating through the arts,” he added. “That’s how you change behavior.”

The New-York Historical Society is seeking to educate with its new DiMenna Children’s History Museum, which opened last fall. Young visitors learn about prejudice by studying the life story of James McCune Smith, the first African-American to earn a medical degree. They learn about money and credit by visiting the Alexander Hamilton pavilion. “All of the exhibits we’ve developed are focused on teaching a skill or a behavior,” said Louise Mirrer, the president and chief executive.

The museums are also reaching beyond their walls to take their programming more aggressively into underprivileged neighborhoods. The Children’s Museum of Manhattan is replicating its exhibitions in East Harlem’s public housing. It sends two artists to Memorial Sloan-Kettering Cancer Center every week to work with children. And it is running health and literacy programs in the Bronx and New Orleans.

And children’s museums are making a concerted effort to draw specific groups of people who might otherwise not come through their doors. On Mondays, the Children’s Museum of Manhattan is open to children with autism and their families, as well as to school groups. “They need a quiet venue,” Mr. Ackerman said.

The ARTogether program at the Children’s Museum of the Arts brings foster children together with their biological parents to create art, led by a clinically trained, licensed art therapist. The museum recently expanded the effort to include families with children at risk of being placed in foster care. It has hired staff members who speak Mandarin and Cantonese.

“You can come to our space and participate alongside other folks who maybe aren’t having the same challenges,” said David Kaplan, the museum’s executive director. “You want to be supportive of families in the program but you want to be empowering them — you don’t want them to rely on you forever. Eventually you want them coming to the museum on their own terms and on their own time.”

In opening a larger space last fall, the Children’s Museum of the Arts hopes to generate more revenue to benefit children at risk, to provide a “nice, safe environment for people to come to,” Mr. Kaplan said.

Not only are children’s museums seeking to educate, they want their visitors to feel comfortable entering cultural institutions for many years to come and to see exhibitions that affirm their own experience. “The audiences who are living here want to be able to come here and see their lives reflected,” said Ms. Robinson of the Boston museum.

In some cases, the exhibits also take the visitors to places they have never been. The museum now features a Japanese silk weaver’s house that was a gift from Kyoto. “Many of our kids will never go to Japan,” Ms. Robinson said. “But they can have an authentic Japanese experience by coming to our house.”

www.nytimes.com

ArturoRodriguez, MD

md@thebariatric.com
http://www.thebariatric.com
http://www.bandstersforum.com
Phone: 011-52-81-8378-3177
Twitter: @bandagastrica
Facebook: http://www.facebook.com/banda.gastrica

The best way to control your weight

 

 

ArturoRodriguez, MD

md@thebariatric.com
http://www.thebariatric.com
http://www.bandstersforum.com
Phone: 011-52-81-8378-3177
Twitter: @bandagastrica
Facebook: http://www.facebook.com/banda.gastrica

LapBand: Truth or myth

I can’t have a Lap Band Surgery if I am not Super-Obese: Every day we do more Lap Band Surgeries in overweight and mildly obese patients, especially if they have a family history of co-morbidities such as Type 2 Diabetes, High Blood Pressure or High Cholesterol. The tendency world wide is that patients qualify for the Lap Band Procedures with BMI of 30 and above. The Lap band works also very well in patients who don’t want to gain weight but maintain in the weight they are and this is possible due to the Lap Band versatility to be adjustable to the patient’s needs.

You have to lose more than 10 pounds the first month after a Lap band Surgery: Yes, you do… The liquid diet should help you to lose much more than 10 pounds in the first month after surgery. When patients don’t reach this minimum it is because they are drinking many liquid calories and/or are not moving at all to burn the excess fat. Your goal after the first month of your surgery would be to lose at least 2 pounds per week and exercise will help you to reach this goal.

I am eating too much therefore I should go for a fill: Getting a lap band fill should not be based on the amount of food you are eating.  As long as you are losing weight or sizes, you won’t need a fill. If you are eating more, this could mean that you are moving or exercising more than you did before, or that you are making better choices about the foods that you are eating.  If you are in a plateau or gaining weight, then you should go for a fill. The purpose of the fill is to increase the restriction to food when you quit losing weight.

Should I expect to lose weight without exercising? You can lose weight without exercise if you are eating a very low calorie diet, but normally you will need some kind of exercise in addition to the diet to lose or maintain a healthy weight. Remember that the Lap band is a tool and you have to learn how to use it – this includes the change in the bad old habits.

I was expecting not to be dieting with the Lap Band Surgery.  The Lap Band procedure is a restrictive aid for treating excess weight and needs full cooperation from the patients in order to work as desired. Even in patients with a big fill, there are calories that will pass through easily, like ice cream or chocolates, and you can gain weight if you choose too many high-calorie foods. The key is: Follow a healthy, well-balanced, low-calorie food intake and also get active – do some kind of exercise to boost your health.

The Lap Band shows me when I am over eating and that is why I vomit all the time: History of vomiting is frequently found in patients that have to be de-banded because of Lap Band Erosion or Slippage. You have to learn to be satisfied before vomiting. If you are someone that vomits frequently, you may have developed a bad habit of over eating, not chewing well or eating too fast - and at some point you will end up hurting your stomach.

I don’t need fluoroscopy for a Lap Band fill: I recommend a fluoroscopic check-up done at least once a year.  Fluoroscopy helps us to detect early complications such as anatomical changes in your stomach and esophagus, and also the functional status of the Lap Band.

My friend has a very good fill with 3 cc and I do not: Stomachs differ in size from person to person, and everyone reacts differently to the Lap Band. You can’t compare yourself with anyone. That was Inamed’s big mistake: the Lap Band was made too short to fit all the patients’ stomachs, assuming that they were equal in size. This caused some patients to have complications such as disphagia (difficulty swallowing) after having the Lap Band for several months.

Support Groups and Message Boards are a waste of time: It is critical for the patients to have a supportive group if they truly want to succeed. I encourage all my Lap Band patients to join our Lap Band Message Boards where they can feel comfortable exchanging and sharing experiences in a friendly environment.

ArturoRodriguez, MD

md@thebariatric.com
http://www.thebariatric.com
http://www.bandstersforum.com
Phone: 011-52-81-8378-3177
Twitter: @bandagastrica
Facebook: http://www.facebook.com/banda.gastrica

I'm Fat! Please Help Me!

SAN FRANCISCO (AP) -- A morbidly obese California man whose tearful, videotaped plea for help became a YouTube sensation may be getting the support he wanted.

The "Dr. Phil" show reached out to Livermore resident Robert Gibbs, 23, after he posted his three-minute video last week.

Gibbs mentioned the program in his clip, which has been viewed more than a million times and inspired more than four dozen recorded responses from viewers offering diet tips and encouragement.

A crew from the "Dr. Phil" show was scheduled to come to his house and film him on Wednesday, Gibbs told The Associated Press.

On the YouTube video, which he made the day before his birthday last Friday, Gibbs did not specify what kind of help he needed - just that he hoped someone knowledgeable about weight loss would see it and get in touch with him.

He also said he feared he would not live long enough to see his nephew and niece grow up or to have a family of his own. He estimated his weight to be between 600 and 700 pounds,

"I'm making this video because I don't know what else to do," he said on the video. "For everyone who is just going to make fun of me I really don't care. It doesn't matter. This is my last chance, my last hope, one of them at least."

Gibbs declined to be interviewed by the AP because he said he had an exclusivity agreement with "Dr. Phil."

Along with suffering from diabetes, Gibbs has sores all over his body and cannot stand for more than a few minutes at a time, KCBS-TV said. He spends his days watching television.

Read more: http://www.wptv.com/dpp/news/health/robert-gibbs-on-youtube-obese-man-asks-for-help-and-dr-phil-show-responds#ixzz1oRMyC7MK

http://guide2herbalremedies.com

ArturoRodriguez, MD

md@thebariatric.com
http://www.thebariatric.com
http://www.bandstersforum.com
Phone: 011-52-81-8378-3177
Twitter: @bandagastrica
Facebook: http://www.facebook.com/banda.gastrica