Syria among 'most dangerous places on Earth' for children - UNICEF
UNITED NATIONS (Reuters) - The number of children affected by the civil war in Syria has more than doubled over the past year, with hundreds of thousands of young Syrians trapped in besieged parts of the country, the United Nations Children's Fund said on Monday.
"After three years of conflict and turmoil, Syria is now one of the most dangerous places on earth to be a child," said the UNICEF report. "In their thousands, children have lost lives and limbs, along with virtually every aspect of their childhood."
"They have lost classrooms and teachers, brothers and sisters, friends, caregivers, homes and stability," it said. "Instead of learning and playing, many have been forced into the workplace, are being recruited to fight, or subjected to enforced idleness."
UNICEF said the child casualty rates were the highest recorded in any recent conflict in the region. It cited U.N. figures that at least 10,000 children have been killed in the Syrian war but noted that the real number is probably higher.
The opposition Syrian Observatory for Human Rights has said that more than 136,000 have been killed since a revolt against President Bashar al-Assad began in March 2011.
"The dangers for children go beyond death and injury," UNICEF said. "Boys as young as 12 have been recruited to support the fighting, some in actual combat, others to work as informers, guards, or arms smugglers."
The UNICEF report said 2 million children needed some form of psychological support or treatment while a total of 5.5 million children were affected by the conflict - some of them inside Syria and others living abroad as refugees.
This is more than twice the number of children affected by the conflict in March 2013, when UNICEF estimated it had impacted 2.3 million young Syrians.
The number of children displaced inside Syria has risen to nearly 3 million from 920,000 a year ago. Meanwhile, UNICEF said the number of child refugees has grown to 1.2 million from 260,000 since last year - 425,000 of them under 5 years old.
"The decline in Syrian children's access to education has been staggering," the report said. "Today, nearly 3 million children in Syria and in neighbouring countries are unable to go to school on a regular basis. That's about half of Syria's school-age population."
UNICEF said there were 323,000 children under 5 years of age in besieged or areas that are hard for humanitarian aid workers to access.
The UNICEF report comes after Save the Children, an international advocacy group that promotes children's rights, issued an assessment of Syria's collapsing healthcare system.
The UNICEF report said Syrian children are being been forced to grow up faster than any child should - one in 10 Syrian refugee children is now working while one in every five Syrian girls in Jordan is forced into early marriage.
"This war has to end so that children can return to their homes to rebuild their lives in safety with their family and friends," said UNICEF director Anthony Lake. "This third devastating year for Syrian children must be the last."
(Reporting by Louis Charbonneau; Editing by Cynthia Osterman)
Brazil starts HPV vaccination program
Brazilian President Dilma Rousseff on Monday said the country was rolling out a vaccination program to protect five million 11-to 13-year-old girls against the human papilloma virus (HPV), which can cause cause cervical cancer.
"The state has an obligation to protect all girls," Rousseff said as she inaugurated the program in Sao Paulo.
Brazil intends over five years to produce a vaccine in conjunction with biomedical research center Butantan Institute and US pharmaceutical company Merck Sharp & Dohme (MSD) via a $480 million investment, making available 41 million doses over that time frame until Brazil's labs can produce their own.
The first year of the program will see 15 million doses -- three per child -- administered. The government hopes to reach at least 80 percent of Brazil's 5.2 million girls in the targeted age group.
The World Health Organization says cervical cancer is the second most common form of the disease in women worldwide, each year bringing 250,000 deaths and 500,000 new cases.
Exclusive - Germany OKs Northwest Bio brain cancer drug, shares soar
By Ransdell Pierson
(Reuters) - Germany has granted Northwest Biotherapeutics Inc special permission to sell its experimental brain cancer drug in the country, the company said, and its stock jumped as much as 36 percent.
The tiny U.S. biotech received a special "hospital exemption" in Germany, allowing Northwest to sell the injectable drug for five years even though it has not completed its late-stage trial of the immunotherapy, Chief Executive Officer Linda Powers said in an interview. She said the company, which would also have the right to seek renewal of the exemption after five years, has not yet requested or received formal marketing approval for its product.
Even before Monday's announcement, Northwest Biotherapeutics shares had surged 60 percent. Wall Street is closely watching the company, which has reported promising results for its DCVax-L drug in a tiny cadre of patients. But sceptics have questioned whether they will be borne out in a larger population.
Northwest has attracted the interest of large institutional players such as Goldman Sachs, while some investors have taken short positions in the stock, at around 9 percent of its shares as of February 14.
The exemption in Germany allows Northwest to sell DCVax-L through hospitals and their outpatient clinics for patients with all severities of cancer that begin in the brain, even though it is only being tested in patients newly diagnosed with the most severe form of the disease, called Glioblastoma multiforme
It is the first hospital exemption in Germany for a product never previously on the market, Powers said. She hopes it will encourage other European nations to look favourably on DCVax-L.
The European Union has encouraged member countries to create the hospital exemptions as a way of fostering use of breakthrough biotechnology drugs that have not yet won formal marketing approval.
Patients taking DCVax-L in small informal trials, along with standard care, lived 2.5 times as long as typically seen with patients taking standard treatment alone.
The German regulator, known as the Paul-Ehrlich-Institute (PEI), said DCVax-L can be used after patients receive the standard care for brain cancer, which consists of surgery, radiation and treatment with Merck & Co Inc's Temodar chemotherapy.
Interim data from a late-stage trial of DCVax-L had been expected last month, but has not yet become available, causing concern among investors. The company declined to say when it will provide the interim data on the drug's safety and effectiveness. On Friday, it said an independent data safety monitoring board had recommended the trial continue, based on its safety review.
At least 3,000 cases of GBM are seen in Germany each year, Powers estimated. She added that many other patients have lower- grade brain tumours that will also be eligible for treatment with DCVax-L.
Northwest Biotherapeutics plans to begin selling its drug in the next few months in Germany, and to ramp up production at its manufacturing plant in Leipzig, Powers said.
Separately, Germany's centralized government reimbursement authority has authorized Northwest Biotherapeutics to negotiate reimbursement for DCVax-L, Powers said. She added that six major hospital centres in Germany have applied to be eligible for reimbursement for the product, anticipating the hospital exemption.
Powers, through different investment entities that include venture capital firm Toucan Partners LLC and drug manufacturer Cognate BioServices Inc, owns 33 percent of Northwest Biotherapeutics' 51 million shares. Other major shareholders include Franklin Advisers Inc, The Vanguard Group and Goldman Sachs.
THE CASE FOR A PREMIUM PRICE
Northwest Biotherapeutics is pushing ahead following two high-profile disappointments of dendritic cell-based therapies from ImmunoCellular Therapeutics Ltd and Dendreon Corp .
Industry analysts say DCVax-L could potentially be worth more than a billion dollars in annual sales if it eventually wins full marketing approval in Europe and the United States.
Germany's regulator apparently opened the door to DCVax-L because data from the small earlier trials suggested advantages over standard treatments that offer little help to patients, Powers said.
"They realize we're still in our Phase III trial, but appear satisfied with the underlying biology of DCVax-L and the glimpses of effectiveness that were seen in early-stage trials," she said.
DCVax-L initially could be priced higher than Temodar, which costs about $65,000 to $70,000 a year. Powers said the price for DCVax-L was warranted because of signs of effectiveness seen in the informal early-stage trials.
"When you add Temodar to surgery and radiation you get an additional 2.5 months of survival," Powers said, allowing the average patient to survive 14.5 months.
By contrast, the average patient taking DCVax-L plus standard treatment in the smaller Phase I/II trial survived three years, without additional serious side effects. But data from that study, which involved 20 patients with newly diagnosed GBM, were not considered statistically significant because of the small size and informal nature of the trial.
DCVax-L is among an emerging new crop of drugs that coax the body's immune system to track down and kill cancer cells. More specifically, it harnesses dendritic cells, or master cells of the immune system that give marching orders to its soldiers, including t-cells and b-cells, which make antibodies.
The treatment consists of an individual patient's immature dendritic cells being drawn from the blood and mingled in a laboratory dish with dozens of antigens, or proteins, from brain tumour tissue of the patient obtained in surgery.
When purified and injected back into the patient, DCVax-L is meant to prompt t-cells and b-cells to leave the lymph nodes and fan out through the body, seeking and attacking cells having the target antigens.
(For a graphic, click: http://link.reuters.com/cex86v)
Northwest Biotherapeutics expects to report complete data from its formal late-stage trial of DCVax-L in 2015, Powers said. The Phase III study, which began in 2008 and is being conducted in Europe and the United States, involves 312 patients who were newly diagnosed with GBM and received standard therapies.
"If we meet the goals of the trial, we would plan to apply for marketing approval in Europe and the United States," Powers said.
At least 12,000 patients a year develop GBM in the United States, along with a similar number in Europe, Powers said.
(Reporting by Ransdell Pierson; Editing by Michele Gershberg, Jeffrey Benkoe and David Gregorio)
Drunken groom fights with bride on jet, forces emergency landing
By Peter Polack
GEORGE TOWN, Cayman Islands (Reuters) - A groom on his honeymoon got into a drunken argument with his bride aboard a flight form Atlanta to Costa Rica, forcing the Delta Air Lines aircraft to make an emergency landing on Grand Cayman island on Sunday night, authorities said.
The U.S. citizen was escorted from the flight after it landed by Cayman Islands police and was being held in custody on a charge of drunk and disorderly conduct, according to Royal Cayman Islands Chief Inspector Raymond Christian.
The bride remained aboard for the flight to San Jose, Costa Rica, he said. He did not name the bride or the groom involved in the incident other than to say the groom was a U.S. citizen.
The removed passenger could face further charges under the international air law, according to Christian.
Delta spokeswoman Lindsay McDuff confirmed on Monday that a "disruptive customer" prompted the crew of flight 901 to divert to Grand Cayman. "The flight landed without incident and the customer was met by local authorities," McDuff said.
It was the second time in recent weeks that the airline had reportedly performed an emergency landing because of drunken behaviour by a passenger. On February 7 a Delta flight from Baltimore to Salt Lake City was diverted due to an unruly female passenger who was described by officials as intoxicated.
(Editing by David Adams and David Gregorio)
Northeast Syria faces food crisis, but access eases elsewhere: WFP
By Stephanie Nebehay
GENEVA (Reuters) - Three northeastern provinces of Syria face an "alarming" food crisis, although access to relieve the impact of civil war has improved somewhat elsewhere, a U.N. aid agency said on Monday.
Western powers and U.N. human rights investigators have accused the Syrian government of a policy of "starvation until submission" to punish tens of thousands of civilians in rebel-held areas. Opposition forces are besieging two Shi'ite Muslim villages with a total of 45,000 people in Aleppo province.
Days before the Syrian conflict enters its fourth year, the World Food Programme (WFP) said the hardest areas to reach were the northeastern provinces of Raqqa, Deir al-Zor and Hassaka.
"We don't have total absolute numbers on deaths due to starvation. There are no massive indications of that. But there are certainly widespread (and) what I would call alarming nutritional indicators," Amir Abdulla, the U.N. agency's deputy executive director, told a news briefing in Geneva.
"The high levels of acute malnutrition are in the besieged areas or areas that we have been unable to access," he said.
Fighting and restrictions still hinder aid deliveries in parts of 12 of Syria's 14 provinces, WFP said in a statement.
"There has been a certain degree of increased access. But I stress that sporadic or one-off convoys, whilst providing temporary relief, don't provide the sort of sustained access and assistance that the people in those areas need," Abdulla said.
Access has eased since a unanimous U.N. Security Council resolution on February 22 told all sides to boost aid and threatened "further steps" in case of non-compliance, Abdulla said.
But he said much remained to do, citing Homs and Aleppo as two areas where the United Nations was pushing for more access.
In February, WFP food rations failed to reach half a million of the 4.2 million Syrians who need them.
But the agency said it had delivered rations for the first time in months to 71,500 people living in four limited-access areas in Idlib, Deraa, Deir-al Zor and the Damascus countryside.
Locally-negotiated truces enabled convoys to reach parts of Deraa and the Damascus countryside, the statement said.
In recent days, the WFP delivered food to 20,000 people in Houla in rural Homs for the first time since May. Trucks with rations for 20,000 people arrived in Raqqa province for the first time in six months. Food aid also reached 17,500 displaced people living in camps in Harem, north of Idlib.
But Raqqa, the only province completely under rebel control and where nearly 285,000 people need aid, remained largely inaccessible for the fourth straight month, WFP said.
Humanitarian conditions in Deir-al-Zor are "rapidly worsening" amid food shortages and soaring market prices that put more than 550,000 people "at risk of food insecurity".
Deliveries in Deir al-Zor were a fraction of those planned due to fighting and the presence of armed groups on access roads.
Abdulla said shifting front lines and the need to negotiate with diverse combatants complicated WFP's aid efforts.
"There are certain groups who basically have stated that they do not want international humanitarian organisations to come into their areas. And in some of those areas, humanitarian workers, basically their lives are under threat, and we're not able to operate there," he said.
The WFP programme, which also feeds some 2 million Syrian refugees in neighbouring countries, costs $40 million a week.
(Reporting by Stephanie Nebehay; Editing by Alistair Lyon)