“U.S. government officials say they expect to put the finishing touches this month on new rules designed to help funding agencies identify and regulate especially problematic H5N1 studies before they begin,” which would allow influenza researchers “to lift a year-old, self-imposed moratorium on certain kinds of potentially dangerous experiments,” Science reports. “The two developments would essentially end a long and bruising controversy over the risks and benefits of H5N1 research,” the magazine notes, adding the debate was initiated by two research teams that lab-engineered H5N1 strains to be transmissible among mammals. “The issue has been especially sensitive for the U.S. government, because its National Institutes of Health (NIH) funded the two studies and is one of the world’s biggest funders of H5N1 research,” Science writes. The magazine discusses the moratorium’s impact on research worldwide and summarizes differing views about its effects (Malakoff, 1/4).
The January issue of the WHO Bulletin features an editorial examining universal health coverage and the right to health, a public health news roundup, a research article examining research priorities for adolescent sexual and reproductive health in low- and middle-income countries, and a systematic review examining the integration of antiretroviral therapy into antenatal care and maternal and child health settings, among others (January 2013).
“The U.S. Food and Drug Administration [on Monday] approved Johnson & Johnson’s drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally,” the Wall Street Journal reports. “The drug, Sirturo, will treat patients with multidrug-resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people worldwide who can’t be cured with existing therapies alone,” the newspaper notes (Walker/Tadena, 1/2).
The U.S. Food and Drug Administration’s approval of the tuberculosis (TB) drug Sirturo, also known as bedaquiline, “appears to be just the first step in an exciting renaissance for TB drug development,” Mark Harrington, executive director of Treatment Action Group (TAG), writes in the Bill & Melinda Gates Foundation’s “Impatient Optimists” blog. “Another new drug, delamanid, is currently in late clinical trials and has been submitted to the European Medicines Agency for review as a treatment for [multidrug-resistant (MDR)] TB,” he notes. Harrington concludes, “It’s an exciting time for TB treatment, but much more needs to be done and more resources are needed. We need to focus not only on the discovery and development of new drugs, but also on ensuring that news drugs are delivered to those who need them and in combinations that can prevent the emergence of new types of drug resistance” (12/28).
In a joint post in the Center for Global Development’s (CGD) “Global Health Policy” blog, Amanda Glassman, director of global health policy and a senior fellow at the CGD; research assistant Denizhan Duran; and Kate McQueston, program coordinator to the global health policy team, recap major global health events in 2012, linking to previous coverage of highlighted issues. “The global health legacy of 2012 will be twofold, a year of both increased commitments to health and flat lining budgets,” they write, adding, “While these are all great news, it is still uncertain as to who will pay for these ambitious goals: biggest donors are already scaling down their health aid budgets, and there remains a tremendous resource gap to reach the end of AIDS” (12/20).
“Scientists say the cholera outbreak that struck more than 7,000 people in Guinea this year was caused by a more toxic and more contagious generation of the bacteria,” and they “suspect the same strain killed nearly 300 people and struck more than 22,000 others in neighboring Sierra Leone,” VOA News reports. “Through genetic sequencing of the cholera bacteria found in Guinea, epidemiologists working with the United Nations Children’s Fund [UNICEF] have identified them as atypical variants of the O1 El Tor strain,” the news service writes. Francois Bellet, a member of UNICEF’s regional office for West and Central Africa, “said this discovery raises the alert level, requiring stronger epidemiological surveillance, preparedness and response to cholera outbreaks in Guinea and throughout the region,” according to VOA (Palus, 12/20). “This type of strain was present in Zimbabwe in 2009, in the Lake Chad Basin in 2009, and is found in Haiti currently,” IRIN notes (12/18).
Nick Chapman, a policy analyst at Policy Cures, writes in a guest post on the Global Health Technologies Coalition’s “Breakthroughs” blog about “the results of the latest G-FINDER survey on global funding of [research and development (R&D)] for neglected diseases.” He discusses several findings and trends from the report, including the impact of the global financial recession on R&D funding; the relatively stable level of U.S. funding; the concentration of pharmaceutical company funding to “a limited number of diseases with some commercial overlap, such as dengue fever, bacterial pneumonia and meningitis, and tuberculosis (TB)”; the shift away from product development funding from public funders; and the effect of these trends on product development partnerships (PDPs) (Lufkin, 12/19).
Following the conclusion of a two-day meeting at the National Institutes of Health (NIH) this week — meant “to gather feedback from flu researchers, others in the science community, and the public on its draft framework for funding H5N1 gain-of-function studies and to continue an international dialogue on issues related to benefits and risks of the research” — “experts anticipated that a voluntary moratorium on work with lab-modified strains that have increased transmissibility might end soon,” CIDRAP News reports (Schnirring, 12/18). “That’s because officials at the National Institutes of Health say they will be moving swiftly to finalize a new process for deciding whether or not to fund proposed experiments that could potentially create more dangerous forms of the bird flu virus H5N1,” NPR’s “Shots” blog notes.
Seattle Times Examines Partnership Between Hutchinson Cancer Research Center, Uganda Cancer Institute
The Seattle Times examines a partnership between the Fred Hutchinson Cancer Research Center and the Uganda Cancer Institute (UCI). In 2008, “the two institutes formally agreed to collaborate on clinical care and research projects, and more recently a major building project at Uganda’s only cancer-research center,” the newspaper writes. Corey Casper, director of the UCI/Fred Hutchinson Research Center Cancer Alliance, “says [the partnership] has the potential to demonstrate ‘that you can do first-rate research that can alter the impact of cancer care in the developing world, and that the craft of oncology can be practiced as well in Africa as it is in the developed world, just like it is with HIV,'” according to the Seattle Times (Silberner, 12/16).
CIDRAP News reports on a two-day meeting at the National Institutes of Health during which “researchers, biosecurity experts, and others” discussed the “crafting [of] a framework for funding H5N1 avian influenza gain-of-function studies.” The meeting “is the latest chapter in an intense scientific controversy that was triggered by the publication of two recent studies involving lab-engineered H5N1 strains that showed signs of being transmissible in mammals,” according to the news service. “The global scientific community is closely watching the framework discussions, because the U.S. Department of Health and Human Services (HHS) is one of the world’s biggest funders of H5N1 research, including the two studies that sparked the controversy,” CIDRAP writes, adding, “Studies on H5N1 are considered a key pandemic preparedness step, and research findings have been used to help governments guide the development of vaccine and antiviral countermeasures.” According to the news service, “The HHS will post a summary and video of the meeting at a later date for those who weren’t able to attend, and it is encouraging people to submit written comments by Jan 10, 2013” (Schnirring, 12/17).