NEWS NOW

Friday, October 29, 2010

F.D.A. Rejects Qnexa, a Third Weight-Loss Drug

The Food and Drug Administration rejected another new diet pill on Thursday, the latest setback in the quest to develop treatments for overweight Americans amid the nation’s obesity epidemic.


The rejected drug, called Qnexa, is the third weight loss medicine to run into trouble this month because of concerns about safety. Last week, the F.D.A. declined to approve another new drug, lorcaserin, because it caused tumors in rats. And earlier in the month it forced the withdrawal of Meridia from the market after 13 years, citing the risk of heart attacks and strokes for certain patients.

“It looks pretty bleak out there for anyone trying to get a drug approval for weight loss,” said Dr. Ken Fujioka, director of the center for weight management at the Scripps Clinic in San Diego.

Vivus, the developer of Qnexa, said late Thursday in a statement on its Web site that the F.D.A. had requested that the company provide a thorough evaluation of the drug’s potential for causing birth defects and heart problems.

The company, based in Mountain View, Calif., said it was confident it could provide this information to the F.D.A. in about six weeks. If the F.D.A. were to be satisfied, the drug could win approval sometime next year.

There has been no new prescription diet pill approved since Roche’s Xenical in 1999. Xenical is now the only drug approved for long-term use in managing weight.

“It’s tough to be a doctor and try to do something about the biggest problem in the U.S.,” said Dr. Fujioka, who is a consultant to some drug companies, including Vivus.

Some drug companies shied away from the diet market, after part of the popular fen-phen diet combination was removed from the market in 1997 because it damaged heart valves. The debacle resulted in huge legal settlements.

The F.D.A.’s decision on Qnexa was not unexpected, given that an advisory committee to the agency had voted 10 to 6 against approval in July.

But it is nonetheless disappointing to some specialists because Qnexa produced about twice as much weight loss as other diet pills. In clinical trials, patients on the highest dose of Qnexa lost an average of 10.6 percent of their weight after one year, compared with 1.7 percent for those taking a placebo.

Qnexa is a combination of two existing drugs — phentermine, a stimulant that is approved for short-term use as a weight loss drug, and topiramate, an epilepsy and migraine drug sold by Johnson & Johnson under the name Topamax.

An F.D.A. advisory committee in December will consider another diet drug, called Contrave, developed by Orexigen Therapeutics. But if that one also is not approved, some experts say it would discourage already wary pharmaceutical companies from working on drugs for obesity.

“It’s going to put the brakes on all obesity drug development for a decade,” said Dr. W. Timothy Garvey, chairman of the department of nutrition sciences at the University of Alabama at Birmingham, who was an investigator in the clinical trials of Qnexa.

Morgan Downey, an advocate for obese people who also consults for pharmaceutical companies, said the F.D.A. appeared to believe that a very effective drug would be used so much that unanticipated side effects would show up, while less effective drugs were not worth any risk.

“The F.D.A. has gotten itself into a real knot,” said Mr. Downey, who describes himself as obese and edits the Downey Obesity Report Web site. “They can’t approve a very effective drug and they can’t approve a modest drug.”

The F.D.A. does not comment or publicly release its reasons for turning down a drug.

Dr. John Jenkins, director of the agency’s office of new drugs, told reporters this month that the agency was “committed to working toward approval” of new obesity drugs, “so long as they are safe and effective for the population for which they are intended.”

Diana Zuckerman, president of the National Research Center for Women and Families, said the diet drugs that have made it to market are not very effective, so the F.D.A. should pay close attention to safety. “The vast majority of people taking them don’t stay on them long enough to get any health benefit,” she said.

About a third of Americans are obese and another third merely overweight. Obesity contributes to many other health problems like diabetes, heart disease and cancer.

So an effective diet pill could help cut medical costs over all and should, at least in theory, become a blockbuster.

“This is the biggest field, bigger than statins potentially,” Jack Lief, chief executive of Arena Pharmaceuticals, the developer of lorcaserin, said a year ago, referring to the popular cholesterol-lowering drugs like Lipitor.

Yet no diet pill has ever become a true blockbuster. COmbined sales of all prescription obesity drugs in the United States have been falling over the last few years and totaled only $154 million in 2009, according to IMS Health, a health care information company.

That is mainly because they generally produce a weight loss of only 5 percent or so. The body has so many mechanisms to maintain weight that any one drug is not likely to have much effect, scientists say.

A study published in the journal Obesity in January that used insurance records found that fewer than 1 percent of adults used obesity pills despite the considerable number of obese people. And only 11 to 18 percent of the users stayed with the drugs for longer than three months, a far greater dropout rate than for statins.

“With a statin, patients rely on their doctor to tell them whether they should be taking it or not,” said John A. Tucker, a pharmaceutical industry consultant in San Diego. “With an obesity drug, they can judge for themselves,” and many are disappointed in the weight loss they achieve.

The difficulties, and safety setbacks, have already soured many pharmaceutical companies on obesity drugs. When two drugs used in the fen-phen diet pill combination were withdrawn from the market in 1997 for damaging heart valves, their manufacturer Wyeth, now part of Pfizer, was left with more than $20 billion in liability.

Three years ago, the F.D.A, citing the risk of suicidal thoughts and depression, declined to approve rimonabant from Sanofi-Aventis. Merck and Pfizer then abandoned development of drugs that worked in the same way.

Dr. Fujioka said another reason obesity drugs were not more popular is that many physicians “have a bias against obese patients and don’t want to give them the easy way out.”

Unlike advocates for patients with, for example, AIDS or cancer, those who are obese may be more reluctant to pressure an agency like the F.D.A., because overweight people often view their condition as a sign of a lack of willpower.

“Most people feel it is their personal responsibility, so they are uncomfortable to go out and make a claim on society for additional help,” Mr. Downey said.

Dr. Caroline Apovian, director of the center for nutrition and weight management at Boston University Medical Center, who has consulted for drug companies, said, “We’ve shown over and over again that it’s very difficult for anyone to lose weight and keep it off through diet and exercise alone.” When that approach is successful, she said, it often requires intensive coaching, which is impractical for medical offices to provide on a large scale.

Despite the setbacks, there are still diet drugs under development. The next generation will probably not be pills but rather injections of synthetic versions of hormones the body already uses to control weight.

Bariatric surgery, which can reduce weight far more than pills, is now restricted for use in severely obese people because of risks and costs. In December, an F.D.A. advisory committee will consider a proposal from Allergan to lower the weight threshold for use of its Lap-Band gastric banding system.

There are also devices in development that do not require invasive surgery. Still, no surgical approach is likely to be as practical for a huge population as drugs.

“We have over 50 antihypertensive agents on the market,” Dr. Apovian said. “We have lots of drugs on the market for diabetes. With the epidemic of obesity, how is it possible that we have only two drugs on the market?”

Thursday, October 14, 2010

BEACH COMMUNITIES FALL SHORT IN EDUCATION

The United Nations Basic Millennium Development Goal of universal education and the Free Compulsory Universal Basic Education (FCUBE) system has come to a stand-still in sea-shore communities in Accra.
The inhabitants of these deprived societies, which include Chorkor, Jamestown and Teshie-Nungua, are mostly unemployed, fishermen or fishmongers who lack quality education and good livelihood.
They therefore adheres no importance to education and seek after their individual daily breads only.
The children, mostly found loitering at the beaches refuses to attend school on grounds of lack of money by parents, neglection, lost of passion for education and several non-educational accessibility problems.
The Chorkor suburb, a decade ago, was blessed with an education-free-no-paying educational academy through Alpha and Omega Academy.
The educational unit was established by Madam Gertrude Quartey in 1997, then a fibroid patient, who had been operated upon at the Tema General Hospital.
Believed to have established the educational unit under the directives of God Almighty, Madam Quartey, explains that God had a purpose for saving her life after several doctors proposal of surgery with fear of death, of which the very last was a success.
The school now serves 360 pupils, five voluntary youths in tuition, and has only one roofed-building and an attached hole-in canopy classroom for learning and administrative works.
The Christian schools close-by, was no substitute as educational minded families in the community could not afford the tuition fees.
Madam Quartey explained that the inhabitants of the suburb, needs education, not only in the classroom for children but social livelihood as well.
She explained that total negligence and laziness exemplified by most parents in the community, hinders educational development in the fishing community.
She also stated that most children avoid going to school due to financial difficulties.
“The children take it upon themselves to seek and sell charcoals among other small manual works for their meals in a day”, she added.
Alpha and Omega Academy was however registered as an association due to the immense support and intellectual development given to the children the deprived society.
Surprisingly, since the inception of the academy seven years ago, pupils do not pay tuition fee, except a feeding fee of 30pesewas a day of which 30 orphans are exempted.
The teachers receive monthly pay of ¢50 a month each, with no pay for the founder and principal of the school, Madam Quartey.
Madam Quartey outlined that the suburb was hostile to the educational academy.
She said, “Even inhabitants who offer services to us charges triple the price and landlords increase rent greatly”.
She stated that the current location of the academy is the fifth since inception seven years ago.
She however appealed for assistance to maintain Alpha and Omega Academy.
She as well prayed for education among sea-shore communities and change in mentality among the inhabitants.
The Academy is as well taking care of three teenage pregnant girls to ensure safety in their lives since they have been neglected by their families.
Characteristically of deprived communities, teenage pregnancy has greatly rose high in the sea-shore communities, leaving most of the young mothers live in danger.
The story at Christ the King of Kings Academy at Jamestown depicted no different fate.
The Academy, a three minute walk from the beach occupies the former GAPOHA warehouse building for children’s daily classroom activities.
Their classroom is demarcated by wood barns to differentiate various academic classes.
The principal, Mr. Emmanuel Ashie a physically challenged person, explained that, he established the school to help develop the fishing community children and to help curb risk faced by children at the beach.
He proclaimed that the school was a non-fee-paying school but one cedi is paid for feeding and teachers allowance.
He added that most families could not afford the cedi payment daily and decided to stop their children from attending but rather, join them either in selling or fishing at the beaches.

JAPAN EMBASSY SUPPORTS DORMAA VOCATIONAL TRAINING CENTRE

Japan has committed $103,388 to support the construction of a female hostel for the Dormaa Vocational Training Centre(DVTC) in Accra.
The amount will also be used to provide other ancillary facilities in the Dormaa West municipality.
An agreement to pave the way for the release and disbursment of the funds was signed at a ceremony in Accra.
The Japanese Ambassador to Ghana, Mr Keiichi Katakami signed on behalf of Japan while Mr Richard Addo-Gyamfi, the Centre Manager of DVTC, initialled for the centre.
Addressing the ceremony, Mr Katakami said the amount was provided by the Japanese Government under the Japanese Grant Assistance for Grassroots Human Security Projects Scheme (GGHSP).
He stated that girl-child empowerment had been a key to the holistic to national development and his country was proud to associate itself to such developments.
He added that the completion of the project would significantly increase female enrolment in the municipality.
He said that the recipient of the grant was mandatory to the judicious utilisation of the amount for the project.
The centre manager of DVTC, Mr Richard Addo-Gyamfi, who received the grant on behalf of DVTC, expressed profound gratitude to the Japan government for its approval of the project.
He, however, stated that a well-structured vocational training could equip the youth with employable skills.
He also expressed joy in the increased intake of girls for the centre, from in and outside the environs of Dormaa upon completion of the project.
The Dormaa West Municipal Chief Executive, Mr Vincent Oppong Asamoah, gave the assurance that the assembly would work to implement the project as designed.

Rt. Rev. Dr. Kwaku Asamoah-Okyere inducted as new Methodist Church Admistrative Bishop

Story: Stephen Bonsu
The first and current general director of the board of ministries of the Methodist church Ghana, Rt. Rev. Dr. Kwaku Asamoah-Okyere, has been inducted into office as the Administrative Bishop of the church in Accra.
Rev. Asamoah-Okyere, who earlier served on acting basis of his current position, from October 2009 to September 2010, was elected to serve on a six-year term of office, which begun on October 1st, 2010.
The Presiding Bishop of the church, The Most Rev. Professor Emmanuel Kwaku Asante, inducting the new administrative bishop into office called on Rev. Asamoah-Okyere to be steadfast and humble before the Almighty Father irrespective of his already established long, calm and dedicative services of high prestige.
He added, “This is not just an appointment, but a call to graciousness of God and as such, begin from simplicity to heavenly favours as exemplified by Simone Peter upon his first encounter with Christ Lord”.
He however, prayed for God’s strength and power for the Bishop in performance of his duties as streamlined by the Methodist constitutional doctrine.
Responding to the call to servitude, Rev. Asamoah-Okyere said, “I am so persuaded and I am so determined by Gods Grace”.
He expressed gratitude to the Almighty and all wishers and prayed for continuous support of prayer
The new Administrative Bishop further outlined that the ministry is a holistic church that seeks to support its members in social, economic and spiritual needs and health.
He also noted out that the Christian ministry will initiate a strategic plan to create good relationship, nearness to and feeling of the presence of God among the Christian family under their protectorate.
He explained that the strategic plan will seek to guide the ministers of the church in leading the members spiritually, socially and economically.
He added that it will as well create an enabling environment for the church members to be in ministering.
Rev. Asamooah-Okyere added, “We the Methodist church, we talk about priesthood of all believers. It is for us to create the necessary atmosphere, for every member to feel obliged to preach the gospel”.
He called out to all Christians for teamwork as the principles of the Methodist church was never built on individuality but togetherness, which maps-up the Methodist church and its dioceses.
The induction ceremony, however, witnessed the attendance of several bishops across the country, converging at the Wesley Cathedral in Accra to give substantial support and pay homage to their new Administrative Bishop.

Saturday, October 2, 2010

Conform To Covenant On Force Evictions-Amnesty International, Ghana Warns

Story: Stephen Bonsu

Amnesty International, Ghana Section, has hinted to the Ghanaian government of its non-conformity to and breach of the United Nations (UN) covenant on ‘the right to adequate housing due to the government’s frequent deployment of forced evictions in the Accra Metropolis.
Article 11 (1) of the covenant noted out by UN stipulates that special attention should be paid to, “undertaking major clearance operations and should take place only when conservation and rehabilitation are not feasible and relocation measures are made”.
Also in the global strategy for shelter from 1988 to the year 2000, the general assembly adopted in its resolution 43/181, that, the fundamental obligation (of Governments) is to protect and improve houses and neighborhoods, rather than damage or destroy them.
The director of Amnesty International, Ghana Section, Mr. Lawrence Amesu, addressing the media, stated that “Government has not ensured full compliance with Ghana’s international and regional human right obligations and commitment as explicitly set-out in the treaties has rectified”.
With reference to Abuja and CMB forcible eviction, the director said that the action possibly deprives residence of their homes, including women and children, and in most cases with their means of earning their living.
He added that the eviction was done without enough notification or compensation or an alternative means such as relocation with accommodation.
“Forced evictions are un-tolerable under the UN treaty and as such, government must go through the rightful means of property eviction for national development”, he added.
He beckoned on the government to conform to the covenant and seek to redress its mode of eviction of homes for possible development as it is a violation of affected victim’s internationally enshrined humanitarian right.
He however added that Ghana has not yet committed itself fully to the abolition of the death sentencing penalty as agreed internationally.
Mr. Amesu therefore, questioned the reasons behind the detention of death sentenced inmates of the Ghanaian prisons since 1973, and further called on the government to incorporate the total abolition of the death penalty in the on-going constitutional review for full compliance of the treaty.
He also called on the government to ensure fast, free and fair prosecution of detained prisoners whose warrant card and document of arrest and prosecution has expired, cannot presently be traced or have no genuine evidence against, yet serving unspecified remand jail terms.
The Growth and Activism Coordinator, Frank Kwaku Doyi also added that “As with other rights, if the right to adequate housing is not being respected, protected or fulfilled by governments , then it is considered to be a human rights violation”.
He further noted out that informal settlers or squatters may not be forcibly evicted even if they are illegally occupying a land.
He explained that under normal circumstances, notifications must be made 90 days with frequent notification and alternative provision of accommodation before destruction of an individual’s property.
Although he reckoned the inability of the government to provide houses for every individual, Mr. Doyi added that the governed voted the government into power to prong them into development and improvement in future livelihood, but not problems of forceful evictions.
He added that, forced evictions through demolishing, mainly victims unaware, more often leaves victims with loss of valuables upon perpetrators invading their premises with an aim of helping out during the exercise.

Agbogbloshie Exotic vegetable Group Donates to Osu Childrens Home

Story: Stephen Bonsu

THE Agbogbloshie Co-operative Exotic Vegetables Farmers and Marketing Society Limited, has donated non-perishable foods and exotic vegetables amounting to ¢800 to the Osu Children’s Home in Accra.
The association, which has the widest exotic vegetable market in West Africa comprised of farmers and root producers of their products, hence, deemed the kind gesture as their widow’s mite to the poor.
The donated food items included two bags of 25kg rice, a gallon of oil, baskets of cucumbers, carrots, cabbages, yellow melon, green beans, squash, pepper, cauliflowers and spring onions among others.
Briefing Daily Graphic after the donation, the chairman of the Agbogbloshie Co-operative Exotic Vegetable Farmers and Marketing Society Limited, Mr. George Opare Asante explained that the donation calls on the general public to see it as a responsibility to help the vulnerable especially the orphans in the society.
“This is what we sell and produce and helping others like donations at least, helps advertise and bring us out to the world aside other undeniable benefits”, he added.
The chairman was also of the view that the food items will help develop and supplement the children with a balanced diet for healthy growth.
He noted out that the producers of the exotic vegetables are given enough education in their cultivation of their farm produce for human consumption.
The Head Supervisor of the Osu Children’s Home, Mrs. Sharon Abbey, who received the donation, expressed sincere gratitude to the donors for their kind gesture.
Mrs. Abbey, however, recalled the excitement in receiving such balanced nutritional food supplements for the home as several donations had always comprised of non-perishable foods and items.
She added, “In order to prepare a balanced diet for the children, we need to box the mills with fresh vegetables and these vegetable donations will immensely support us“.
The Head Supervisor further called on all and sundry to come to the children’s homes aid as government’s aid to them is limited.