Senate votes to protect medical research at DoD

Researchers at the Durham University in the United Kingdom have received a US$100,000 grant from the Bill & Melinda Gates Foundation to test the feasibility of training dogs to detect malaria. Dogs have been trained to use their keen sense of smell to detect other diseases, including certain cancers, and studies suggest that malaria infection causes a distinct odor, and that unique chemicals can be found on the breath of patients. The team plans to recruit 400 children in the Gambia, including many who are currently infected with malaria. The children will wear nylon socks for 24 hours, which will then be used to train the dogs to identify malaria based on odors in the sweat and skin. If successful, this approach to malaria testing would be quick and cheap, and would not require any equipment or a laboratory setting. A new, commercially-available diagnostic can predict premature births, a critical tool as half of all preterm births occur in women without known risk factors. Between 2011 and 2013, the Utah-based Sera Prognostics enrolled more than 5,500 pregnant women at 11 sites across the United States, and confirmed that the quantity of two proteins in the blood can indicate risk for preterm birth. The test can be administered at 19 or 20 weeks into the pregnancy; pregnancy normally lasts 40 weeks and delivery before 37 weeks is considered preterm. The test—PreTRM®—tells a woman her percentage risk, and currently costs $945, however, Sera Prognostics is working with the Bill & Melinda Gates Foundation to develop tools more suitable for low-income countries. Startup NextGen Jane is developing a “smart tampon” that would collect menstrual blood each month and test for a range of diseases and conditions, including sexually transmitted infections, endometriosis, polycystic ovarian syndrome, uterine fibroids, cervical cancer, and more. Many of these conditions are asymptomatic, and consequently go undetected until significant damage has been done. The team at NextGen Jane has a working prototype—a device that siphons menstrual blood from tampons—and is conducting clinical trials for several of the diagnostics themselves, which identify biomarkers for different conditions in menstrual blood. The tool will connect to a database, allowing women to analyze the data and track their reproductive health over time. The team anticipates having a complete product—combined diagnostics and the delivery mechanism—within the next year, which will be commercially available within three to four years.

As happens every May, the World Health Organization’s (WHO) highest governing body, the World Health Assembly (WHA), met last week for its 69th annual meeting in Geneva, Switzerland. The agenda was the most packed in recent memory, consisting of more than 70 discussion items, many of which were controversial. As a result, the agenda did not conclude until the eleventh hour on Saturday, May 28. Despite the lengthy agenda and difficult conversations, the WHA made two key decisions impacting global health research and development (R&D). This post will focus on those agenda items then GHTC will publish a full report covering the entire WHA R&D debate the week of June 6.   In the meantime, you can watch a recording of the panel discussion and webinar hosted by GHTC and the Geneva Centre for Security Policy on May 23, which provides a broad overview of many of the R&D issues discussed at WHA. Framework of engagement with non-State actors (FENSA) Discussions around revising WHO’s policies and procedures for engaging with non-State actors (any group other than a member state) have been highly contentious. Advocates for the proposed framework have argued that WHO needs to insulate its normative functions from undue influence by outside groups, while others have argued that the unintended consequences of the pre-WHA draft framework could be dramatic for some of WHO’s partners by inappropriately categorizing some partnerships as commercial entities. The intensive negotiation process at WHA resulted in a compromise decision that addresses concerns previously discussed by GHTC regarding FENSA’s impact on product development partnerships, while also maintaining some of the more stringent restrictions on how WHO engages with for-profit companies. As such, FENSA will move forward into implementation with the following key adjustments:   Assessments of any proposed engagement with non-State actors will be guided by an implementation guide prepared by the WHO Director-General, which lays out clear criteria and guidelines. Evaluation of new engagements will be conducted by a specialized risk assessment staff to remove as much of the burden as possible from program staff. Ongoing or repetitive engagements can be classified as low-risk and subjected to a streamlined evaluation process, so long as a full risk assessment has been conducted on a substantively similar project in the past. The private sector is prohibited from providing staff secondments to WHO and is dramatically restricted in how it can provide in-kind or financial contributions.  Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) The CEWG is a continuation of the Expert Working Group (EWG), which was convened more than a decade ago to chart how WHO could better support R&D for neglected diseases. This WHA marked an opportunity for the global health community to approve the plan set forth by the WHO Special Programme for Research and Training in Tropical Diseases (TDR) to create a pooled fund to support R&D and a global health R&D observatory to develop and recommend global research priorities. After extensive negotiations, the WHA’s decision calls on the WHO to:    Expedite the further development of a global health R&D observatory. Develop terms of reference and a costed work plan for the observatory for consideration at the 70th WHA. Develop an operational plan for a voluntary pooled fund for consideration at the 70th WHA. Advocate for sustainable funding for the new mechanisms. Convene a series of expert working groups to inform the new mechanisms’ policies and procedures. In combination, these directives make clear the concern that many member states shared regarding TDR’s ability to raise the additional funding needed to support its ambitious proposals, as well as a desire to better understand how the observatory would prioritize research project recommendations across the global health R&D portfolio. Given the debate regarding these two items, the WHA declined to give it the green light at this year’s assembly, preferring instead to ask for more detailed operational proposals for consideration next year.   Given all of the unanswered questions on both CEWG and FENSA heading into WHA, it was important to see compromises come out of the discussion; both processes will go forward, but in a measured fashion to allow the development of concrete workplans and guidelines to shape their implementation. GHTC will continue following both processes closely, and looks forward to helping ensure that the concerns of the global health R&D community are front and center in both initiatives.