she is indeed living the dream of showbiz by showbiz critic, BBWRITEZ.
He tipped her a s a professional artiste who knows what she wants and how to get it.
"I just like her and her creativity. Think what you want to worry your brains about but this is showbiz for crying out loud, Ghana", he said.
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Saturday, June 16, 2012
MZBEL GOES NAKED
she is indeed living the dream of showbiz by showbiz critic, BBWRITEZ.
He tipped her a s a professional artiste who knows what she wants and how to get it.
"I just like her and her creativity. Think what you want to worry your brains about but this is showbiz for crying out loud, Ghana", he said.
Wednesday, November 2, 2011
Friday, May 13, 2011
YOUTH PRODUCE COMPOST FROM ORGANIC WASTE
A set of youth engaged by two non-governmental organizations, CHF International Ghana (CHF) and Nimba Community Support Service (NIMCOSS) have produced the first volume of matured organic compost from waste in Accra.
The 230 kilograms total weight compost, produced from organic waste collected by the youth from some households in the Avenor Community in the Okaikoi South Sub-Metro of the Accra Metropolitan Assembly weighs approximately 20 kilograms each, and has been approved by the Ghana Standards Board for farmers’ usage.
Some farmers have already expressed interest in the organic manure with one farmer purchasing the first 230 kilogram compost, bagged in eleven sacks for an undisclosed amount.
This, however, stipulates that the woes of waste collection is over since the AMA can create wealth out of the over 60 per cent of waste collected which happens to be organic.
The programs Manager of NIMCOSS, Mr. Yaw Duah, in an interview with Daily Graphic, expressed joy that after months of work with the youth and the Avenor Community, some tangible results had been realized.
He said, “Waste is not valueless, and the attitude towards waste in many residents in many parts of Accra, including Avenor is a contributing factor to the perennial flooding in the city.”
He added that the maturation of the compost marked the realization of an aspect of the goal of the Youth Engagement in Service (YES) delivery project being funded by CHF International Ghana and implemented by NIMCOSS in partnership with AMA.
The project, he recalled, was to create a scalable and integrated waste management system in Avenor through effective waste collection and value addition innovations.
Mr. Duah, explained that the project begun with a distribution of two waste bins to 720 households that applied for it to undertake source separation of household waste, with two females and four males equipped with tricycles, branded uniforms and safety kits to undertake door-to-door waste collection in the community.
“The few households that separated their households had it sent to a simple aerobic compost facility constructed near one public latrine in Avenor, where another set of five youth processed the organic waste into compost with supervision and tutelage from Mr. Joseph Awuye, Compost Technical Engineer from the AMA’s Waste Management Department,” he continued.
He further explained that the organic waste, matured after nearly three months of organic waste shredding, piling, turning, drying, sieving and bagging.
Mr. Duah, however, expressed regret to some youth abandoning the program due to poor attitude and stigmatization from friends and relations as the program was geared towards equipping them with work for a salary.
He as well noted out that, over 90 youths had benefited from various capacity- building training programs with about half the number enjoying start-up support to manage their own enterprises through NIMCOSS and its associated partners.
The 230 kilograms total weight compost, produced from organic waste collected by the youth from some households in the Avenor Community in the Okaikoi South Sub-Metro of the Accra Metropolitan Assembly weighs approximately 20 kilograms each, and has been approved by the Ghana Standards Board for farmers’ usage.
Some farmers have already expressed interest in the organic manure with one farmer purchasing the first 230 kilogram compost, bagged in eleven sacks for an undisclosed amount.
This, however, stipulates that the woes of waste collection is over since the AMA can create wealth out of the over 60 per cent of waste collected which happens to be organic.
The programs Manager of NIMCOSS, Mr. Yaw Duah, in an interview with Daily Graphic, expressed joy that after months of work with the youth and the Avenor Community, some tangible results had been realized.
He said, “Waste is not valueless, and the attitude towards waste in many residents in many parts of Accra, including Avenor is a contributing factor to the perennial flooding in the city.”
He added that the maturation of the compost marked the realization of an aspect of the goal of the Youth Engagement in Service (YES) delivery project being funded by CHF International Ghana and implemented by NIMCOSS in partnership with AMA.
The project, he recalled, was to create a scalable and integrated waste management system in Avenor through effective waste collection and value addition innovations.
Mr. Duah, explained that the project begun with a distribution of two waste bins to 720 households that applied for it to undertake source separation of household waste, with two females and four males equipped with tricycles, branded uniforms and safety kits to undertake door-to-door waste collection in the community.
“The few households that separated their households had it sent to a simple aerobic compost facility constructed near one public latrine in Avenor, where another set of five youth processed the organic waste into compost with supervision and tutelage from Mr. Joseph Awuye, Compost Technical Engineer from the AMA’s Waste Management Department,” he continued.
He further explained that the organic waste, matured after nearly three months of organic waste shredding, piling, turning, drying, sieving and bagging.
Mr. Duah, however, expressed regret to some youth abandoning the program due to poor attitude and stigmatization from friends and relations as the program was geared towards equipping them with work for a salary.
He as well noted out that, over 90 youths had benefited from various capacity- building training programs with about half the number enjoying start-up support to manage their own enterprises through NIMCOSS and its associated partners.
Sunday, December 19, 2010
DEMOLISHING OF AGBOGBLOSHIE RAILWAY SLUM IS A VIOLATION OF THEIR RIGHTS AS CITIZENS-AMNESTY INTERNATIONAL BLURTS OUT
Amnesty International Ghana has nullified the Ghana Government and the Accra Metropolitan Assembly’s (AMA) plan to demolish structures within 50 meters along the railways at Agbogbloshie slums for redevelopment of the railway systems as a gross violation of the inhabitants’ fundamental human rights.
On 7 December, the AMA announced on their website that structures along the railway lines would be demolished as part of a nationwide plan to redevelop Ghana’s railway system, and proceeded immediately with an action of announcing and marking of the likely to be demolished structures in the Agbogbloshie slum with a vacate notification date of December 14, 2010 as the deadline for the slum dwellers.
The Director of Amnesty Ghana, Mr. Lawrence Amesu who addressed the slum dwellers explained that, forced evictions are a violation of human rights of which the Government is obliged to prohibit and prevent.
He said, “Under International Human Rights Laws, evictions may be carried out only as a last resort, once all other feasible alternatives to evictions have been explored and genuine consultation has taken place with the communities”.
He added that the action to be taken was built on no maximum consultation and no alternative accommodation given, which will render the inhabitants homeless or vulnerable to other human rights violation, which ought to have been considered as a required duty to protect and prevent by the Government.
Mr. Amesu, however, reckoned the positivity in the Government and the Railway Company for the plans and concrete efforts made for rehabilitating and modernizing the railway system, but were more emphatic on the consequences of the action on the 1000’s of rural urban immigrants living along the railways.
The consequences he outlined, included increased school drop-outs as parents are traumatized and also lost the sources of income, making them lose capability of catering for their children’s education; increased social vices such as prostitution, cyber fraud and increased vulnerability to sexually transmitted diseases; and increased streetism and its attendant social vices.
He added that the plan to evict the Agbogbloshie railway dwellers will also contradict and defeat the Millennium Development Goal Seven (7) which states that, “Have achieved by 2020 a significant improvement in the lives of at least 100 million slum dwellers”.
The Director further reminded the Ghanaian government of its party terms to the International Covenant on Economic, Social and Cultural Rights, with a surety to respect, protect and fulfill its provisions at all levels, thus, adequate alternative provisions should be made before embarking on the intended demolishing plan for development.
He also recalled the government’s avowed commitment to slum upgrading spelt out in the page 85 of its 2008 manifesto and prayed the yet to be taken plan would be well considered a second thought by the government.
The 2008 manifesto page 85 vow of the government, he stated, recognized the fact that slum existence is the results of rural-urban migration limited supply of land and regulatory framework that fail to address the needs of urban poor, of which the railway dwellers are no exception.
“It will be of no use if a project which is intended to improve the lives of the masses of Ghanaians tends to make ‘others’ very poor and destitute,:” he explained.
He stressed out that women and children bear the brunt of traumatized and dislocated communities and as such, called on the government to be conscious of its intended action of forcefully evicting residents along the rails if they fail to vacate the area by December 14.
The director of Women in Slums Economic Empowerment (WISEEP) Frederick Opoku also disclosed that the children is the property of the government and must be protected from such inhumanities which happen to be another form of a disaster.
He added that a good enumeration carried out for quality in citizen’s livelihood planning could be another solution to prevent this type of disaster.
He prayed to the government to help use an alternative solution to the issue as the implementations of the plan will plunge the youth into several social vices.
The yet to be displaced Agbogbloshie slum inhabitants and concerned groups are however, appealing to Authorities to make provisions for relocation of and compensation for the affected victims as part of the rehabilitation of the railway project.
On 7 December, the AMA announced on their website that structures along the railway lines would be demolished as part of a nationwide plan to redevelop Ghana’s railway system, and proceeded immediately with an action of announcing and marking of the likely to be demolished structures in the Agbogbloshie slum with a vacate notification date of December 14, 2010 as the deadline for the slum dwellers.
The Director of Amnesty Ghana, Mr. Lawrence Amesu who addressed the slum dwellers explained that, forced evictions are a violation of human rights of which the Government is obliged to prohibit and prevent.
He said, “Under International Human Rights Laws, evictions may be carried out only as a last resort, once all other feasible alternatives to evictions have been explored and genuine consultation has taken place with the communities”.
He added that the action to be taken was built on no maximum consultation and no alternative accommodation given, which will render the inhabitants homeless or vulnerable to other human rights violation, which ought to have been considered as a required duty to protect and prevent by the Government.
Mr. Amesu, however, reckoned the positivity in the Government and the Railway Company for the plans and concrete efforts made for rehabilitating and modernizing the railway system, but were more emphatic on the consequences of the action on the 1000’s of rural urban immigrants living along the railways.
The consequences he outlined, included increased school drop-outs as parents are traumatized and also lost the sources of income, making them lose capability of catering for their children’s education; increased social vices such as prostitution, cyber fraud and increased vulnerability to sexually transmitted diseases; and increased streetism and its attendant social vices.
He added that the plan to evict the Agbogbloshie railway dwellers will also contradict and defeat the Millennium Development Goal Seven (7) which states that, “Have achieved by 2020 a significant improvement in the lives of at least 100 million slum dwellers”.
The Director further reminded the Ghanaian government of its party terms to the International Covenant on Economic, Social and Cultural Rights, with a surety to respect, protect and fulfill its provisions at all levels, thus, adequate alternative provisions should be made before embarking on the intended demolishing plan for development.
He also recalled the government’s avowed commitment to slum upgrading spelt out in the page 85 of its 2008 manifesto and prayed the yet to be taken plan would be well considered a second thought by the government.
The 2008 manifesto page 85 vow of the government, he stated, recognized the fact that slum existence is the results of rural-urban migration limited supply of land and regulatory framework that fail to address the needs of urban poor, of which the railway dwellers are no exception.
“It will be of no use if a project which is intended to improve the lives of the masses of Ghanaians tends to make ‘others’ very poor and destitute,:” he explained.
He stressed out that women and children bear the brunt of traumatized and dislocated communities and as such, called on the government to be conscious of its intended action of forcefully evicting residents along the rails if they fail to vacate the area by December 14.
The director of Women in Slums Economic Empowerment (WISEEP) Frederick Opoku also disclosed that the children is the property of the government and must be protected from such inhumanities which happen to be another form of a disaster.
He added that a good enumeration carried out for quality in citizen’s livelihood planning could be another solution to prevent this type of disaster.
He prayed to the government to help use an alternative solution to the issue as the implementations of the plan will plunge the youth into several social vices.
The yet to be displaced Agbogbloshie slum inhabitants and concerned groups are however, appealing to Authorities to make provisions for relocation of and compensation for the affected victims as part of the rehabilitation of the railway project.
Saturday, November 6, 2010
CLIMATE CHANGE LEADS
Human beings are exposed to climate change through changing weather patterns (for example, more intense and frequent extreme events) and indirectly through changes in water, air, food quality and quantity, ecosystems, agriculture, and economy.
Evidence is gathering that human activities are changing the climate. This 'climate change' could have a huge impact on our lives.
At this early stage the effects are small but are projected to progressively increase in all countries and regions. Given the complexity of factors that influence human health, assessing health impacts related to climate change poses a difficult challenge
In the context of climate variation, anthropogenic factors are human activities that change the environment.
In some cases the chain of causality of human influence on the climate is direct and unambiguous (for example, the effects of irrigation on local humidity), while in other instances it is less clear.
Various hypotheses for human-induced climate change have been argued for many years. Presently the scientific consensus on climate change is that human activity is very likely the cause for the rapid increase in global average temperatures over the past several decades.
Consequently, the debate has largely shifted onto ways to reduce further human impact and to find ways to adapt to change that has already occurred.
Of most concern in these anthropogenic factors is the increase in CO2 levels due to emissions from fossil fuel combustion, followed by aerosols (particulate matter in the atmosphere) and cement manufacture. Other factors, including land use, ozone depletion, animal agriculture and deforestation, are also of concern in the roles they play - both separately and in conjunction with other factors - in affecting climate, microclimate, and measures of climate variables.
CLIMATE EFFECTS ON HUMAN HEALTH/MORTALITY
Climate-Sensitive Disease
Climate change may increase the risk of some infectious diseases, particularly those diseases that appear in warm areas and are spread by mosquitoes and other insects. These "vector-borne" diseases include malaria, dengue fever, yellow fever, and encephalitis. Also, algal blooms could occur more frequently as temperatures warm — particularly in areas with polluted waters — in which case diseases (such as cholera) that tend to accompany algal blooms could become more frequent.
AIR QUALITY
Climate change is expected to contribute to some air quality problems. Respiratory disorders may be exacerbated by warming-induced increases in the frequency of smog (ground-level ozone) events and particulate air pollution.
Ground-level ozone can damage lung tissue, and is especially harmful for those with asthma and other chronic lung diseases. Sunlight and high temperatures, combined with other pollutants such as nitrogen oxides and volatile organic compounds, can cause ground-level ozone to increase. Climate change may increase the concentration of ground-level ozone, but the magnitude of the effect is uncertain. For other pollutants, the effects of climate change and/or weather are less well studied and results vary by region .
1.General Impacts
The impact of temperature on morbidity and mortality can be assessed at both the seasonal and daily level. The variability in occurrence of numerous illnesses is linked to somewhat predictable seasonal trends in temperature (Persinger, 1980), although sig significant year-to-year differences do occur. Medical disorders such as bronchitis, peptic ulcer, adrenal ulcer, glaucoma, goiter, eczema, and herpes zoster are related to seasonal variations in temperature (Tromp, 1963). Heart failure (most often myocardia l infarction) and cerebrovascular accidents represent two general mortality categories that have been correlated many times with ambient monthly temperatures (Persinger, 1980). Complications from these disorders can be expected at higher temperatures sinc e the body responds to thermal stress by forcing blood into peripheral areas to promote heat loss through the skin. This increases central blood pressure and encourages constriction of blood vessels near the core of the body. However, increases in heart d isease are also noted at very cold temperatures as well. Strong negative correlations have been found between winter temperature and deaths in certain North American, northern Asian, and European countries (Persinger, 1980).
2Weather has a profound effect on human health and well-being. It has been demonstrated that weather is associated with changes in birth rates, and sperm counts, with outbreaks of pneumonia, influenza and bronchitis, and is related to other morbi dity effects linked to pollen concentrations and high pollution levels.
3. Hot weather extremes appear to have a more substantial impact on mortality than cold wave episodes. Most research indicates that mortality during extreme heat events varies with age, sex, and race. Factors associated with increased risk from hea t exposure include alcoholism, living on higher floors of buildings, and the use of tranquilizers. Factors associated with decreased risk are use of air conditioning, frequent exercising, consumption of fluids, and living in shaded residences. Acclimatiza tion may moderate the impact of successive heat waves over the short term.
4.Humidity has an important impact on mortality since it contributes to the body's ability to cool itself by evaporation of perspiration. It also has an important influence on morbidity in the winter because cold, dry air leads to excessive dehydr ation of nasal passages and the upper respiratory tract and increased chance of microbial and viral infection.
Evidence is gathering that human activities are changing the climate. This 'climate change' could have a huge impact on our lives.
At this early stage the effects are small but are projected to progressively increase in all countries and regions. Given the complexity of factors that influence human health, assessing health impacts related to climate change poses a difficult challenge
In the context of climate variation, anthropogenic factors are human activities that change the environment.
In some cases the chain of causality of human influence on the climate is direct and unambiguous (for example, the effects of irrigation on local humidity), while in other instances it is less clear.
Various hypotheses for human-induced climate change have been argued for many years. Presently the scientific consensus on climate change is that human activity is very likely the cause for the rapid increase in global average temperatures over the past several decades.
Consequently, the debate has largely shifted onto ways to reduce further human impact and to find ways to adapt to change that has already occurred.
Of most concern in these anthropogenic factors is the increase in CO2 levels due to emissions from fossil fuel combustion, followed by aerosols (particulate matter in the atmosphere) and cement manufacture. Other factors, including land use, ozone depletion, animal agriculture and deforestation, are also of concern in the roles they play - both separately and in conjunction with other factors - in affecting climate, microclimate, and measures of climate variables.
CLIMATE EFFECTS ON HUMAN HEALTH/MORTALITY
Climate-Sensitive Disease
Climate change may increase the risk of some infectious diseases, particularly those diseases that appear in warm areas and are spread by mosquitoes and other insects. These "vector-borne" diseases include malaria, dengue fever, yellow fever, and encephalitis. Also, algal blooms could occur more frequently as temperatures warm — particularly in areas with polluted waters — in which case diseases (such as cholera) that tend to accompany algal blooms could become more frequent.
AIR QUALITY
Climate change is expected to contribute to some air quality problems. Respiratory disorders may be exacerbated by warming-induced increases in the frequency of smog (ground-level ozone) events and particulate air pollution.
Ground-level ozone can damage lung tissue, and is especially harmful for those with asthma and other chronic lung diseases. Sunlight and high temperatures, combined with other pollutants such as nitrogen oxides and volatile organic compounds, can cause ground-level ozone to increase. Climate change may increase the concentration of ground-level ozone, but the magnitude of the effect is uncertain. For other pollutants, the effects of climate change and/or weather are less well studied and results vary by region .
1.General Impacts
The impact of temperature on morbidity and mortality can be assessed at both the seasonal and daily level. The variability in occurrence of numerous illnesses is linked to somewhat predictable seasonal trends in temperature (Persinger, 1980), although sig significant year-to-year differences do occur. Medical disorders such as bronchitis, peptic ulcer, adrenal ulcer, glaucoma, goiter, eczema, and herpes zoster are related to seasonal variations in temperature (Tromp, 1963). Heart failure (most often myocardia l infarction) and cerebrovascular accidents represent two general mortality categories that have been correlated many times with ambient monthly temperatures (Persinger, 1980). Complications from these disorders can be expected at higher temperatures sinc e the body responds to thermal stress by forcing blood into peripheral areas to promote heat loss through the skin. This increases central blood pressure and encourages constriction of blood vessels near the core of the body. However, increases in heart d isease are also noted at very cold temperatures as well. Strong negative correlations have been found between winter temperature and deaths in certain North American, northern Asian, and European countries (Persinger, 1980).
2Weather has a profound effect on human health and well-being. It has been demonstrated that weather is associated with changes in birth rates, and sperm counts, with outbreaks of pneumonia, influenza and bronchitis, and is related to other morbi dity effects linked to pollen concentrations and high pollution levels.
3. Hot weather extremes appear to have a more substantial impact on mortality than cold wave episodes. Most research indicates that mortality during extreme heat events varies with age, sex, and race. Factors associated with increased risk from hea t exposure include alcoholism, living on higher floors of buildings, and the use of tranquilizers. Factors associated with decreased risk are use of air conditioning, frequent exercising, consumption of fluids, and living in shaded residences. Acclimatiza tion may moderate the impact of successive heat waves over the short term.
4.Humidity has an important impact on mortality since it contributes to the body's ability to cool itself by evaporation of perspiration. It also has an important influence on morbidity in the winter because cold, dry air leads to excessive dehydr ation of nasal passages and the upper respiratory tract and increased chance of microbial and viral infection.
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?”
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?”
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