Genetics, Diagnosis, Treatment: NIH Takes On Sickle Cell Disease

Each year, some 150,000 children in Nigeria are born with sickle cell disease, the most common—and often life-threatening—inherited blood disorder in the world.

“I was not happy when I read that Nigeria will have the highest contribution to the global burden of sickle cell disease by 2050—if we continue at the present birth rate and the level of inactivity in newborn screening,” said hematologist Obiageli Nnodu, M.D., the lead researcher in Nigeria for the Sickle Pan African Research Consortium (SPARCo), funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. “As a country, we can do better than that. After all, this is a disease where children die undiagnosed, and largely from preventable causes such as bacterial infections.”

Sickle cell disease affects 20 million people worldwide, including at least 100,000 in the United States, mainly African Americans, but Hispanics and Asian-Americans, too. To help address the problem on a global scale, the NHLBI has been supporting programs in sub-Saharan Africa, where more than 75 percent of the sickle cell disease births worldwide occur. SPARCo, with a hub in Tanzania, and additional sites in Nigeria and Ghana, works to develop an infrastructure for sickle cell disease research, health care, education, and training to take place in Africa.

“We are showing that with effective partnerships, significant advances in health and biomedical science can be achieved,” said Tanzania-based Julie Makani, M.D., Ph.D., who leads the SPARCo consortium. SPARCo, in collaboration with the Sickle Africa Data Coordinating Center, led by Ambroise Wonkam, M.D., in South Africa, created  Sickle In Africa, which has a growing electronic registry of more than 10,000 individuals with sickle cell disease.

“The genetic diversity of Africa’s population allows scientific research that will increase our understanding of how a disease caused by a single gene can manifest in such different ways,” Makani explained.

Newborn screening, as Nnodu noted, is the first step to reduce mortality and suffering for these children, and for that, they need good tests readily available at the point of care. That’s why NHLBI supports research towards development of diagnostics, such as a new rapid result test that is relatively inexpensive, accurate, and can provide a timely diagnosis of sickle cell disease. The test does not require sophisticated laboratory equipment, electricity, refrigeration, or highly trained personnel—a critical advantage for countries with few resources.

On the treatment front, a large multinational NHLBI-funded clinical trial found that a daily hydroxyurea pill was safe and effective for young children living with sickle cell disease in sub-Saharan Africa. The NHLBI also has its sights on developing genetic therapies for the disease, as part of a newly announced NIH collaboration with the Bill & Melinda Gates Foundation. The goal of the partnership, which also addresses HIV, is to advance possible gene-based cures to clinical trials in the United States and relevant countries in sub-Saharan Africa within the next seven to 10 years.

“A person’s health should not be limited by their geographic location, whether it’s in rural America or sub-Saharan Africa,” said Gary H. Gibbons, M.D., director of the NHLBI. “Harnessing the power of science is needed to transcend borders if we want to improve health for all.”

National Sickle Cell Awareness Month Series:

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    U.S. Customs and Border Protection (CBP) has made progress testing and deploying facial recognition technology (FRT) at ports of entry to create entry-exit records for foreign nationals as part of its Biometric Entry-Exit Program. As of May 2020, CBP, in partnership with airlines, had deployed FRT to 27 airports to biometrically confirm travelers' identities as they depart the United States (air exit) and was in the early stages of assessing FRT at sea and land ports of entry. Facial Recognition Technology in Use at an Airport CBP has taken steps to incorporate some privacy principles in its program, such as publishing the legislative authorities used to implement its program, but has not consistently provided complete information in privacy notices or ensured notices were posted and visible to travelers. Ensuring that privacy notices contain complete information and are consistently available would help give travelers the opportunity to decline to participate, if appropriate. Further, CBP requires its commercial partners, such as airlines, to follow CBP's privacy requirements and can audit partners to assess compliance. However, as of May 2020, CBP had audited only one of its more than 20 airline partners and did not have a plan to ensure all partners are audited. Until CBP develops and implements an audit plan, it cannot ensure that traveler information is appropriately safeguarded. CBP has assessed the accuracy and performance of air exit FRT capabilities through operational testing. Testing found that air exit exceeded its accuracy goals—for example, identifying over 90 percent of travelers correctly—but did not meet a performance goal to capture 97 percent of traveler photos because airlines did not consistently photograph all travelers. A plan to improve the photo capture rate would help CBP better fulfill the program's mission of creating biometrically confirmed traveler departure records. Further, while CBP monitors air exit's performance, officials are not alerted when performance falls short of minimum requirements. The Transportation Security Administration (TSA) has conducted pilot tests to assess the feasibility of using FRT but, given the limited nature of these tests, it is too early to fully assess TSA's compliance with privacy protection principles. Within the Department of Homeland Security (DHS), CBP is charged with the dual mission of facilitating legitimate travel and securing U.S. borders, and TSA is responsible for protecting the nation's transportation system. For both CBP and TSA, part of their inspection and screening responsibilities includes reviewing travel identification documents and verifying traveler identities. Beginning in 1996, a series of federal laws were enacted to develop and implement an entry-exit data system, which is to integrate biographic and, since 2004, biometric records for foreign nationals. This report addresses (1) the status of CBP's deployment of FRT, (2) the extent to which CBP has incorporated privacy protection principles, (3) the extent to which CBP has assessed the accuracy and performance of its FRT, and (4) the status of TSA's testing and deployment of FRT and how TSA has incorporated privacy protection principles. GAO conducted site visits to observe CBP's and TSA's use of FRT, which were selected to include all three travel environments—air, land, and sea; reviewed program documents; and interviewed DHS officials. GAO is making five recommendations to CBP to (1) ensure privacy notices are complete, (2) ensure notices are available at locations using FRT, (3) develop and implement a plan to audit its program partners for privacy compliance, (4) develop and implement a plan to capture required traveler photos at air exit, and (5) ensure it is alerted when air exit performance falls below established thresholds. DHS concurred with the recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or gamblerr@gao.gov.
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  • Biofuel Fraudster Sentenced to Seven Years in Prison for Scamming Multiple Federal Agencies and Customers
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    The owner of a biofuel company was sentenced to seven years in prison followed by a three-year term of supervised release and ordered to pay $10,207,000 in restitution for defrauding multiple federal agencies and customers.
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    In Crime News
    The Justice Department's Civil Rights Division and the U.S. Attorney’s Office for the District of Massachusetts today concluded an investigation into conditions at the Massachusetts Department of Correction (MDOC).
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  • Rural Hospital Closures: Affected Residents Had Reduced Access to Health Care Services
    In U.S GAO News
    GAO found that when rural hospitals closed, residents living in the closed hospitals' service areas would have to travel substantially farther to access certain health care services. Specifically, for residents living in these service areas, GAO's analysis shows that the median distance to access some of the more common health care services increased about 20 miles from 2012 to 2018. For example, the median distance to access general inpatient services was 3.4 miles in 2012, compared to 23.9 miles in 2018—an increase of 20.5 miles. For some of the less common services that were offered by a few of the hospitals that closed, this median distance increased much more. For example, among residents in the service areas of the 11 closed hospitals that offered treatment services for alcohol or drug abuse, the median distance was 5.5 miles in 2012, compared to 44.6 miles in 2018—an increase of 39.1 miles to access these services (see figure). Median Distance in Miles from Service Areas with Rural Hospital Closures to the Nearest Open Hospital that Offered Certain Health Care Services, 2012 and 2018 Notes: GAO focused its analysis on the health care services offered in 2012 by the 64 rural hospitals that closed during the years 2013 through 2017 and for which data were available. For example, in 2012, 64 closed hospitals offered general inpatient services, 62 offered emergency department services, 11 offered treatment services for alcohol or drug abuse, and 11 offered services in a coronary care unit. To examine distance, GAO calculated “crow-fly miles” (the distance measured in a straight line) from the geographic center of each closed rural hospital's service area to the geographic center of the ZIP Code with the nearest open rural or urban hospital that offered a given service. GAO also found that the availability of health care providers in counties with rural hospital closures generally was lower and declined more over time, compared to those without closures. Specifically, counties with closures generally had fewer health care professionals per 100,000 residents in 2012 than did counties without closures. The disparities in the availability of health care professionals in these counties grew from 2012 to 2017. For example, over this time period, the availability of physicians declined more among counties with closures—dropping from a median of 71.2 to 59.7 per 100,000 residents—compared to counties without closures—which dropped from 87.5 to 86.3 per 100,000 residents. Rural hospitals face many challenges in providing essential access to health care services to rural communities. From January 2013 through February 2020, 101 rural hospitals closed. GAO was asked to examine the effects of rural hospital closures on residents living in the areas of the hospitals that closed. This report examines, among other objectives, how closures affected the distance for residents to access health care services, as well as changes in the availability of health care providers in counties with and without closures. GAO analyzed data from the Department of Health and Human Services (HHS) and the North Carolina Rural Health Research Program (NC RHRP) for rural hospitals (1) that closed and those that were open during the years 2013 through 2017, and (2) for which complete data generally were available at the time of GAO's review. GAO also interviewed HHS and NC RHRP officials and reviewed relevant literature. GAO defined hospitals as rural according to data from the Federal Office of Rural Health Policy. GAO defined hospital closure as a cessation of inpatient services, the same definition used by NC RHRP. GAO defined service areas with closures as the collection of ZIP Codes that were served by closed rural hospitals and service areas without closures as the collection of ZIP Codes served only by rural hospitals that were open. GAO provided a draft of this report to HHS for comment. The Department provided technical comments, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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    Desmond Logan, 35, a former officer with the Chattanooga Police Department (CPD), was sentenced by the Honorable Curtis L. Collier, U.S. District Court Judge in the Eastern District of Tennessee at Chattanooga.
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    The former president of Iron Workers Local 395 was sentenced today to 42 months in prison for his role in organizing a brutal assault on a group of non-union ironworkers in Dyer, Indiana.
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    Geraldine Hill and Clayton Hill, a California couple who operated a charity that purported to provide goods to the needy, were sentenced to prison for conspiracy to commit mail fraud and tax evasion. Geraldine Hill was sentenced to 15 months in in prison, and Clayton Hill was sentenced to 9 months in prison, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Robert S. Brewer, Jr. for the Southern District of California.
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  • Facing Long Post-Hurricane Recovery, Court in La. Gets Help From Friends
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    Hurricane Laura has left a lasting impact on the Western Louisiana community of Lake Charles, and the federal courthouse could be closed a year or more. Despite the disarray, courts in New Orleans, Texas, and even Alaska have reached out to support the court’s staff in getting back on their feet.  
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  • Three Additional States Ask Court To Join Justice Department Antitrust Suit Against Google
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    Today, the Attorneys General of Michigan and Wisconsin filed for permission to join the antitrust lawsuit filed by the United States and eleven other state Attorneys General against monopolist Google. This follows a similar recent motion by the California Attorney General to join the lawsuit on December 11, 2020.
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  • Weapon System Sustainment: Aircraft Mission Capable Rates Generally Did Not Meet Goals and Cost of Sustaining Selected Weapon Systems Varied Widely
    In U.S GAO News
    Mission Capable Rates for Selected Department of Defense Aircraft GAO examined 46 types of aircraft and found that only three met their annual mission capable goals in a majority of the years for fiscal years 2011 through 2019 and 24 did not meet their annual mission capable goals in any fiscal year as shown below. The mission capable rate—the percentage of total time when the aircraft can fly and perform at least one mission—is used to assess the health and readiness of an aircraft fleet. Number of Times Selected Aircraft Met Their Annual Mission Capable Goal, Fiscal years 2011 through 2019 aThe military departments did not provide mission capable goals for all nine years for these aircraft. Aggregating the trends at the military service level, the average annual mission capable rate for the selected Air Force, Navy, and Marine Corps aircraft decreased since fiscal year 2011, while the average annual mission capable rate for the selected Army aircraft slightly increased. While the average mission capable rate for the F-35 Lightning II Joint Strike Fighter showed an increase from fiscal year 2012 to 2019, it trended downward from fiscal year 2015 through fiscal year 2018 before improving slightly in fiscal year 2019. For fiscal year 2019, GAO found only three of the 46 types of aircraft examined met the service-established mission capable goal. Furthermore, for fiscal year 2019: six aircraft were 5 percentage points or fewer below the goal; 18 were from 15 to 6 percentage points below the goal; and 19 were more than 15 percentage points below the goal, including 11 that were 25 or more percentage points below the goal. Program officials provided various reasons for the overall decline in mission capable rates, including aging aircraft, maintenance challenges, and supply support issues as shown below. Sustainment Challenges Affecting Some of the Selected Department of Defense Aircraft aA service life extension refers to a modification to extend the service life of an aircraft beyond what was planned. bDiminishing manufacturing sources refers to a loss or impending loss of manufacturers or suppliers of items. cObsolescence refers to a lack of availability of a part due to its lack of usefulness or its no longer being current or available for production. Operating and Support Costs for Selected Department of Defense Aircraft Operating and support (O&S) costs, such as the costs of maintenance and supply support, totaled over $49 billion in fiscal year 2018 for the aircraft GAO reviewed and ranged from a low of $118.03 million for the KC-130T Hercules (Navy) to a high of $4.24 billion for the KC-135 Stratotanker (Air Force). The trends in O&S costs varied by aircraft from fiscal year 2011 to 2018. For example, total O&S costs for the F/A-18E/F Super Hornet (Navy) increased $1.13 billion due in part to extensive maintenance needs. In contrast, the F-15C/D Eagle (Air Force) costs decreased by $490 million due in part to a reduction in the size of the fleet. Maintenance-specific costs for the aircraft types we examined also varied widely. Why This Matters The Department of Defense (DOD) spends tens of billions of dollars annually to sustain its weapon systems in an effort to ensure that these systems are available to simultaneously support today's military operations and maintain the capability to meet future defense requirements. This report provides observations on mission capable rates and costs to operate and sustain 46 fixed- and rotary-wing aircraft in the Departments of the Army, Navy, and Air Force. How GAO Did This Study GAO was asked to report on the condition and costs of sustaining DOD's aircraft. GAO collected and analyzed data on mission capable rates and O&S costs from the Departments of the Army, Navy, and Air Force for fiscal years 2011 through 2019. GAO reviewed documentation and interviewed program office officials to identify reasons for the trends in mission capability rates and O&S costs as well as any challenges in sustaining the aircraft. This is a public version of a sensitive report issued in August 2020. Information on mission capable and aircraft availability rates were deemed to be sensitive and has been omitted from this report. For more information, contact Director Diana Maurer at (202) 512-9627 or maurerd@gao.gov.
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