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Kaiser Daily Global Health Policy Report

In The News

GSK To Seek Marketing Approval For Malaria Vaccine From European Medicines Agency

“British drugmaker GlaxoSmithKline [GSK] will seek marketing approval for the world’s first malaria vaccine next year after trial data showed the shot significantly cut cases of the disease in African children,” Reuters reports. “The vaccine known as RTS,S was found, after 18 months of follow-up, to have almost halved the number of malaria cases in young children in the trial, and to have reduced by around a quarter the number of malaria cases in infants,” the news agency writes (Kelland, 10/7). “Although the vaccine doesn’t appear to work as well as originally hoped, both Glaxo and the charitable group helping fund the vaccine trial, the PATH Malaria Vaccine Initiative, said it could still be a useful tool against a disease that kills about 660,000 people a year — mostly children in Africa,” according to the Wall Street Journal (Whalen, 10/7). “Sir Andrew Witty, chief executive of GSK, said the company was very encouraged by the latest results and would now apply for a regulatory license for its use in Africa under a special provision of the European Medicines Agency,” The Guardian notes. “While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” Witty said, according to the newspaper (Boseley, 10/7).

“Results for the Phase III stage of the closely-followed RTS,S vaccine were unveiled at a conference in Durban, South Africa, gathering experts on malaria in Africa,” Agence France-Presse writes, adding, “The research was carried out at 11 centers in seven African countries, covering more than 15,000 infants and children” and “78 percent of children and 86 percent of infants in the trial” used bed nets. “GSK said that, if it gets the green light for RTS,S, the vaccine would probably be distributed through agencies such as UNICEF and the GAVI Alliance, a public-private health partnership,” AFP notes (10/8). In a joint statement, the company and the PATH initiative “said that the hope now is that the [WHO] may recommend the use of the RTS,S vaccine from as early as 2015 if EMA drugs regulators back its license application,” BBC News states (10/8).

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PBS NewsHour Reports On Pakistan's Polio Vaccination Campaign Setbacks

PBS NewsHour on Monday aired a video report on setbacks in the polio vaccination campaign in Pakistan, “where there have recently been a series of attacks on those trying to administer vaccines.” Special correspondent Fred de Sam Lazaro reports the country’s polio campaign began to stall “thanks to epic floods, political turmoil, and religious extremists who have fought the polio campaign with guns and rumors.” Lazaro also says the CIA’s use of a vaccination campaign as a cover to obtain more information on Osama bin Laden’s whereabouts in Pakistan has engendered distrust of the efforts, according to the video transcript. In response, “the vaccination campaign recently enlisted prominent mainline religious leaders,” Lazaro reports, though “such reassurances haven’t made life any safer for vaccinators. At least 22 have been gunned down in the past year or so.” In addition, “there’s one more complication … a seeming public indifference,” Lazaro reports. The video report features a neighborhood in Pakistan where “[t]here’s no clean drinking water, no sanitation, no schools. For millions of Pakistanis who live in conditions like these, polio is hardly the most pressing concern” (10/7).

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AVAC Analysis Examines AIDS 'Tipping Point' In Hard-Hit Countries

Although “[a]bout a dozen countries hit hard by AIDS have reached a ‘tipping point’ that means they are winning their battles against the disease … the world as a whole — and Africa in particular — is still losing the fight,” according to a new analysis (.pdf) from AVAC, the New York Times reports. The analysis “compares the number of people in each country who are newly infected with HIV each year to the number of infected being put on treatment for the first time,” the newspaper notes. Rwanda, Botswana, South Africa, and Haiti, among other countries, are in the “winning” column, while Nigeria and India, two of the world’s most populous countries, “are doing so badly that they keep the world as a whole in the ‘losing’ column,” the newspaper writes. According to the New York Times, AVAC Executive Director Mitchell Warren said, “We wanted to find a mechanism that could chart the progress over time, and use it as a management tool, and to make comparisons between countries that are doing the right things and the others” (McNeil, 10/7).

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Bill And Melinda Gates Discuss Public Health Issues In New York Times Interview

The New York Times features a conversation with Bill and Melinda Gates, co-chairs of the Bill & Melinda Gates Foundation. In the interview, they discuss the foundation’s family planning advocacy, support for research to find an AIDS vaccine, and efforts to create what Bill Gates refers to as “a toilet cheap enough to deploy in all the world’s slums and that has the same positive characteristics of a flush toilet” (Dreifus, 10/7).

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Bono Compliments U.S. For Leadership In AIDS Response

Appearing on Sunday on CNN’s “Fareed Zakaria GPS,” musician and anti-poverty activist Bono discussed the AIDS response, saying, “The AIDS stuff — the United States is so far out in front. … 10 million people owe their lives to the U.S., left and right. George Bush started it. President Obama is finishing it.” According to a video clip from the show, Bono added, “This tiny little virus that’s wreaked so much havoc in so many people’s lives — the greatest health crisis in 600 years is on the run because of American leadership. That’s important” (Miks, 10/5).

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Editorials and Opinions

CDC Working To Eradicate Polio Amid Partial Government Shutdown

Noting how the U.S. government’s partial shutdown is affecting the CDC — closing eight of 10 global disease detection centers worldwide — Washington Post columnist Michael Gerson writes in an opinion piece, “Fortunately, the CDC’s polio eradication effort has been largely exempted from the shutdown.” He continues, “It is part of one of the most ambitious medical enterprises in history — attempting to eliminate a highly contagious virus from the wild. This has been achieved only twice before, with smallpox and rinderpest. The end of polio transmission is a few hundred yearly cases away. Even a brief pause would risk losing ground.”

“More than 99 percent of poliovirus transmission has been stopped over the past few decades. But the final bit is the hardest,” Gerson states. He notes the virus remains endemic in Afghanistan, Pakistan, and Nigeria. “Now a virus originating in Nigeria has caused an outbreak in Somalia, which has spread some cases to Kenya and Ethiopia,” Gerson writes. “Polio eradication is an enterprise now conducted at the frontiers of medicine and war — introducing vaccination into places that have never seen Western medicine and sometimes requiring negotiations with warlords and militias,” he states, concluding, “But these are struggles near the finish line of a landmark scientific achievement. And for those who doubt that any purpose of government can be essential, the daring, humane work of the CDC is a corrective” (10/7).

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Conservatives Should Support Family Planning Programs

Saying conservatives historically supported family planning programs but recently have argued against contraception, John Seager, president of Population Connection, writes in a U.S. News & World Report opinion piece, “But what if I told you that there are a number of really good conservative arguments for supporting and even increasing family planning funding — particularly internationally — even in a tight fiscal environment?” He presents “four reasons why conservatives should rekindle a romance with birth control.” Seager says “birth control saves money,” noting “expanding access to contraception is a crucial step toward achieving all eight of the Millennium Development Goals, according to a report produced by a panel of 53 experts and international agencies.” He adds that “birth control boosts economies” and “stabilizes nations,” using international case studies from Thailand, the Philippines, Nigeria, and Pakistan as support. Finally, he says “birth control reduces human suffering” by reducing the incidence of maternal and infant mortality, as well as abortion.

“An estimated 222 million women around the world who want to delay or end childbearing don’t have access to contraception,” Seager writes, adding, “In fact, we’re spending 30 percent less in inflation-adjusted dollars on international family planning now than we did in 1995.” He continues, “I know that I’ll never persuade some conservatives that international family planning deserves their support. But when a single investment can save money, boost economies, stabilize nations and reduce human suffering, thoughtful people of all political persuasions should give it a second look” (10/7).

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Recent Releases

UNESCO, Partners Release Report On Youth Health, Education In Eastern, Southern Africa

Last week, UNESCO, UNAIDS, UNFPA, UNICEF, WHO and other bilateral partners launched a report (.pdf) focused on youth in Eastern and Southern Africa, titled “Young People Today: Time for Action Now,” a UNESCO press release states. The report shows “adolescents and young people — especially young women — face a wide range of challenges that compromise their life chances,” according to the press release. The report examines HIV/AIDS prevalence, access to health services, child marriage, teenage pregnancy and maternal health, and gender-based violence, the press release notes. UNESCO and partners also “launched a region-wide campaign to highlight the rights and education/health needs of adolescents and young people,” the press release states (10/4).

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New Database Provides Access To Countries' Clinical Regulatory Requirements

The new Global Health Regulatory Requirements Database “provides consolidated access to country-level regulatory requirements, thereby aiding product developers, multilateral organizations, and advocates with getting products through clinical trial approval and designing programs to strengthen regulatory capacity,” Global Health Technologies Coalition (GHTC) Regulatory Associate Tricia Aung writes in the organization’s “Breakthroughs” blog. The tool, developed by GHTC, also can help “identify opportunities to provide technical assistance at the country level to strengthen the capacity of regulatory authorities, and encourage harmonization and policy reform,” Aung adds (10/7).

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