In a reversal, an FDA advisory committee backs the weight-loss drug Qnexa despite health risks after its maker, Vivus, promises strict oversight
A panel of medical experts voted overwhelmingly Wednesday to endorse the controversial weight-loss drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity medication for the first time since 1999.
The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees.
The 20-2 vote in favor of Qnexa was a surprising reversal from 2010, when the same advisory committee decided that the drug's risks of heart problems and birth defects outweighed its weight-loss benefits.
In a clinical trial involving 4,323 people, Qnexa — a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine — led to an average loss of about 10% of total body weight in the first year of use. Many users also saw improvements in blood pressure.
But the trials also found that that the drug caused a slight increase in heart rate, which can boost the odds of a heart attack or stroke. In addition, researchers detected an increased risk of birth defects — typically cleft lip — in women who became pregnant while taking the drug.
Vivus Inc., the drug's manufacturer, addressed those concerns by proposing a tightly controlled system for prescribing Qnexa. To prevent birth defects, patients who take the drug will have to undergo monthly pregnancy testing and healthcare providers will get special training on the medication's risks and benefits. Vivus will also restrict distribution of the drug to registered pharmacies, among other measures.
"We will know who the prescribers are. We will know who has been trained," Dr. Barbara Troupin, Vivus' senior director of global medical affairs, told the advisory committee. "We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients."
According to the clinical trial data and previous studies, the risk of having a baby with a cleft lip is two to five times greater in women who took topiramate.
"The simple reality is, if you're pregnant or planning on getting pregnant, it's not the right drug for you," said Joe Nadglowski, chief executive of the Obesity Action Coalition, a patient advocacy group based in Tampa, Fla., that supports approval of Qnexa.
Vivus, based in Mountain View, Calif., proposed a similar program to monitor heart risks in patients. Several panel members strongly encouraged the company to conduct a post-marketing study to help identify the potential cardiovascular risks.
At the panel's daylong meeting Wednesday in Silver Spring, Md., several members of the Endocrinologic and Metabolic Drugs Advisory Committee said they worried about Qnexa's side effects but believed the benefits outweighed the risks.
More than 35% of American adults are obese, including about 5% who are morbidly obese, and an additional 33% are overweight, according to the Centers for Disease Control and Prevention in Atlanta. Those extra pounds are more than just a cosmetic issue; they also increase one's risk of diabetes, heart disease, stroke, osteoarthritis, certain types of cancers and possibly dementia.
"The most encouraging thing is that just about every member really heard the message about the need to treat obesity," said Ted Kyle, the advocacy committee chairman of the Obesity Society. "Obesity is not a trivial disease."
Only one prescription diet drug is available in the United States. That drug, orlistat, blocks absorption of fat and is sold under the trade name Xenical. Qnexa appears to work by suppressing appetite and increasing feelings of fullness.
It's not clear why the medication raises heart rate, but such an increase is typically viewed as a marker of cardiovascular risk, said Dr. Michael S. Lauer, director of the division of cardiovascular sciences at the National Heart, Lung and Blood Institute and a member of the advisory panel.
Lauer cast one of the two votes against approval, saying that the FDA should first ask Vivus to complete a study that provided detailed cardiovascular risk data. Otherwise, he said, FDA approval "would be a decision based on hopes, surrogates and suppositions."
"We have seen many cases in medicine where we thought we understood the pathology of disease … and we turned out to be wrong," Lauer said. "With an epidemic as serious as obesity, we need to do this right."
If approved by the FDA, Qnexa would be targeted for people with a body mass index of 30 or above, or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes or sleep apnea. A BMI of 25 to 29 indicates a person is overweight, and 30 or greater is considered obese.
The vote sent Vivus shares soaring to more than $21 in after-hours trading, double the official closing price of $10.55.
Friday, February 24, 2012
Monday, February 20, 2012
Lent defination and Lent 2012 shedule
What is Lent?
Lent is a Christian Festival. In the past it was a long, strict religious fast when people gave up all rich food. The day before Lent starts is known as Shrove Tuesday.
Lent is the time when Christians prepare for the greatest of the Christian festivals known as Easter, by thinking of things they have done wrong.
It was a time for spring-cleaning lives, as well as homes.
What happens during Lent today?
The Christian church no longer imposes a strict fast. Lent is a time when some Christians try to overcome their own faults because they believe that it was man's sin which led Jesus to be crucified.
Some Christians try to follow the example of Jesus in the desert by giving up luxuries and practising self-discipline. And they try to put aside more time to prayer and religious acts so that they can really let God into their lives.
Bible Study
Many churches hold special Lent services. In some towns the churches of different denominations join together in groups to discuss and share their Christian faith.
When does Lent begin?
Lent begins with Ash Wednesday and lasts for six and a half weeks.
Lent is a moveable feast which means the date changes from year to year. We explain more on our Easter main page.
In 2012 Ash Wednesday is on 22 February
2009 — 25 February
2010 — 17 February
2011 — 9 March
2012 — 22 February
2013 — 13 February
2014 — 5 March
2015 — 18 February
2016 — 10 February
2017 — 01 March
2018 — 14 February
2019 — 06 March
2020 — 26 February
2021 — 17 February
2022 — 02 March
When does Lent end? When is Lent over?
Lent ends at Easter when Christians remember the execution of Jesus and then celebrate his rising from death.
The last week of Lent begins with Palm Sunday, which celebrates the day Jesus entered Jerusalem and the people lay down palms at his feet. The last day of Lent is Holy Saturday, the day before Easter Sunday (Easter Day)copyright of projectbritain.com
In the Roman Catholic Church, Lent officially ends at sundown on Holy Thursday (Maundy Thursday), with the beginning of the mass of the Lord's Supper.
The period of forty fast days and Sundays before Easter are known as Lent.
image: 2010 calendar showing 40 days
Calendar 2010
Why are Sundays not counted in the 40 days?
Sundays are always a day of celebration in the Christian church and so they cannot be included in the 40 fast days of Lent. Sundays commemorate the Resurrection. c
Why does Lent last for 40 days?
Lent is a time when Christians remember the 40 days and nights Jesus spent alone in the desert without food being tempted by the Devil. Jesus used this time to prepare for His work by fasting and praying.
Luke's Gospel says:
'Jesus, full of the Holy Spirit, returned from the Jordan and was led by the Spirit in the desert, where for forty days he was tempted by the devil. He ate nothing during those days, and at the end of them he was hungry.'
So, as in the Bible, Christians spend forty days in preparing themselves to rejoice at the resurrection of Jesus Christ at Easter.
Interesting fact
The number 40 is a special number in the Bible. It signifies preparation for something special:
* The rain lasted for 40 days in the mighty flood - Noah
* Moses stayed on the Mount Sinai forty days (Ex 24:18)
* Jonah gave the people of Ninevah forty days to repent (Jon 3:4)
* Jesus, before starting his ministry, spent forty days in the desert in prayer and fasting (Matt 4:2)
Source :http://www.woodlands-junior.kent.sch.uk/customs/lent.html
Lent is a Christian Festival. In the past it was a long, strict religious fast when people gave up all rich food. The day before Lent starts is known as Shrove Tuesday.
Lent is the time when Christians prepare for the greatest of the Christian festivals known as Easter, by thinking of things they have done wrong.
It was a time for spring-cleaning lives, as well as homes.
What happens during Lent today?
The Christian church no longer imposes a strict fast. Lent is a time when some Christians try to overcome their own faults because they believe that it was man's sin which led Jesus to be crucified.
Some Christians try to follow the example of Jesus in the desert by giving up luxuries and practising self-discipline. And they try to put aside more time to prayer and religious acts so that they can really let God into their lives.
Bible Study
Many churches hold special Lent services. In some towns the churches of different denominations join together in groups to discuss and share their Christian faith.
When does Lent begin?
Lent begins with Ash Wednesday and lasts for six and a half weeks.
Lent is a moveable feast which means the date changes from year to year. We explain more on our Easter main page.
In 2012 Ash Wednesday is on 22 February
2009 — 25 February
2010 — 17 February
2011 — 9 March
2012 — 22 February
2013 — 13 February
2014 — 5 March
2015 — 18 February
2016 — 10 February
2017 — 01 March
2018 — 14 February
2019 — 06 March
2020 — 26 February
2021 — 17 February
2022 — 02 March
When does Lent end? When is Lent over?
Lent ends at Easter when Christians remember the execution of Jesus and then celebrate his rising from death.
The last week of Lent begins with Palm Sunday, which celebrates the day Jesus entered Jerusalem and the people lay down palms at his feet. The last day of Lent is Holy Saturday, the day before Easter Sunday (Easter Day)copyright of projectbritain.com
In the Roman Catholic Church, Lent officially ends at sundown on Holy Thursday (Maundy Thursday), with the beginning of the mass of the Lord's Supper.
The period of forty fast days and Sundays before Easter are known as Lent.
image: 2010 calendar showing 40 days
Calendar 2010
Why are Sundays not counted in the 40 days?
Sundays are always a day of celebration in the Christian church and so they cannot be included in the 40 fast days of Lent. Sundays commemorate the Resurrection. c
Why does Lent last for 40 days?
Lent is a time when Christians remember the 40 days and nights Jesus spent alone in the desert without food being tempted by the Devil. Jesus used this time to prepare for His work by fasting and praying.
Luke's Gospel says:
'Jesus, full of the Holy Spirit, returned from the Jordan and was led by the Spirit in the desert, where for forty days he was tempted by the devil. He ate nothing during those days, and at the end of them he was hungry.'
So, as in the Bible, Christians spend forty days in preparing themselves to rejoice at the resurrection of Jesus Christ at Easter.
Interesting fact
The number 40 is a special number in the Bible. It signifies preparation for something special:
* The rain lasted for 40 days in the mighty flood - Noah
* Moses stayed on the Mount Sinai forty days (Ex 24:18)
* Jonah gave the people of Ninevah forty days to repent (Jon 3:4)
* Jesus, before starting his ministry, spent forty days in the desert in prayer and fasting (Matt 4:2)
Source :http://www.woodlands-junior.kent.sch.uk/customs/lent.html
Friday, February 17, 2012
The Mardi gras 2012 schedule
Krewe of NOMTOC : Date: Sunday, Feb 19, 2012 | Location: Uptown | Time: 9:00am
Krewe of Iris : Sunday, Feb 19, 2012 | Location: Uptown | Time: 10:00am
Krewe of Okeanos : Sunday, Feb 19, 2012 | Location: Uptown | Time: 11:00am
Krewe of Napoleon : Sunday, Feb 19, 2012 | Location: Metairie | Time: 5:30pm
Krewe of Bacchus : Sunday, Feb 19, 2012 | Location: Uptown | Time: 5:15pm
Krewe of Thoth : Sunday, Feb 19, 2012 | Location: Uptown | Time: 12:00pm
Krewe of Mid City : Sunday, Feb 19, 2012 | Location: Uptown | Time: 11:45am
- Krewe of NOMTOC : - Founded in 1951, The Krewe of NOMTOC (New Orleans Most Talked Of Club) began parading on the Westbank (Orleans Parish) in 1971. This all-black krewe is comprised of 400 male and female riders, 17 floats, 12 equestrian units and marching bands. Their sponsor, The Jugs Social Club has a rich heritage of civic activism, regularly donating generous amounts to local schools, youth groups, and social programs. Each year a group of academic honor students is selected as guest riders in the parade. Throws include ceramic medallion beads, jug banks and their signature Jug Man dolls..
- Krewe of Iris : - Founded in 1917, The Krewe of Iris first stated parading in 1959, and it is the oldest and largest all-female krewe in New Orleans. Named for the Goddess of the Rainbow and Messenger to the Gods, the krewe sticks to strict Carnival traditions, wearing full length masks and white gloves. The Krewe of Iris has 900 riders, 32 floats, 12 equestian units and marching bands. Throws include emblem cups, medallion beads, ceramic Iris beads, dolls and doubloons. The Krewe Captain thows her own special doubloon which is a popular item each year.
- Krewe of Okeanos :- Founded in 1949, the Krewe of Okeanos is named for the Greek god of oceans and fertile valleys.Formed by more than 250 male and female riders, Okeanos is known for its elaborately-costumed captain and king
- Krewe of Napoleon : - The Krewe of Napoleon was created in 1980 to give Jefferson Parish an excitingly different approach to the Mardi Gras season. From the very beginning, the Corps de Napoleon's primary goal has been to honor the French heritage of New Orleans and its surrounding parishes. This differs from other krewes and organizations who mostly choose Greek or Roman mythological figures as their names. The Corps de Napoleon instead selected France's greatest hero as its namesake.
- Krewe of Bacchus :- Early in 1968, the Krewe of Bacchus broke with Carnival tradition by staging a Sunday night parade with bigger and more spectacular floats than anything previously seen in Carnival. They then decided to have a national celebrity king lead its parade, breaking ranks with 113 years of Carnival tradition.
- Now, with more than 1,000 members and 31 animated super-floats, the Krewe of Bacchus is revered as one of the most spectacular krewes in Carnival history.
- Bacchus is the most innovative and imitated krewe this century. Owen "Pip" Brennan Jr. and a group of 13 friends decided to form Bacchus in 1968 to put spark back into the celebration of Mardi Gras.
- The krewe's large signature floats, Rendezvous supper dance with Las Vegas-type entertainment, and national celebrity monarchs are just a few of the tradition-breaking moves that set the Krewe of Bacchus apart.
- Bacchus, the Greek god of wine, has been portrayed by celebrities including Raymond Burr, Bob Hope, Dom DeLuise, Charlton Heston, William Shatner and Kirk Douglas, and Dick Clark.
- The parade's more than 25 floats include several super floats such as the Bacchagator, Bacchasaurus, and Baccha-Whoppa. The Krewe of Bacchus holds its parade on the Sunday before Mardi Gras Day ... drawing crowds of several hundred thousands every year.
- The Bacchus parades through the streets of New Orleans with its massive floats, marching bands, and ceremonial escort groups... ending up inside the Convention Center for their black-tie Rendezvous party of over 5000 guests from all over the country, featuring celebrity entertainment before and after the parade.
2012 Mardi Gras News - Actor / comedian Will Ferrell (Step Brothers, Anchorman, Saturday Night Live) will serve as Bacchus XLIV in this year's parade.
- Krewe of Thoth : - Founded in 1947, the Krewe of Thoth is named for the Egyptian Patron of Wisdom and Inventor of Science, Art and Letters. The krewe's original parade route was designed specifically to serve people that were unable to attend other parades in the city. The route passed in front of 14 institutions that cared for people with disabilities and illnesses.
- Today's Krewe of Thoth includes over 1,200 riders and 40 floats, and the krewe still makes it a point to provide a Mardi Gras parade for some of the same healthcare facilities as they did in the early days.
- Among Thoth's throws are 3-D die-cut metallic necklaces, 6" stuffed polar bears and many varieties of specialized doubloons.
- Krewe of Mid City :- Founded in 1933, the Krewe of Mid-City is the 5th oldest continuously parading organization of the New Orleans Mardi Gras season. Often called "The best day parade in Mardi Gras," Mid-City has gained a reputation for having themes dedicated to children and for having some of the best bands in Mardi Gras from all over the country.
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