Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health

2018 ◽  
Vol 44 (2-3) ◽  
pp. 329-341
Author(s):  
Michael S. Sinha ◽  
Nina Jain ◽  
Thomas Hwang ◽  
Aaron S. Kesselheim
Keyword(s):  
Public Health ◽  
Research And Development ◽  
Neglected Tropical Diseases ◽  
Financial Incentive ◽  
Priority Review ◽  
Neglected Diseases ◽  
Pharmaceutical Manufacturer ◽  
Global Public Health ◽  
Public Health Importance ◽  
Voucher Program

The U.S. federal government awards a priority review voucher (“PRV”) to a pharmaceutical manufacturer after the Food and Drug Administration (“FDA”) approves a product for one of a list of voucher-eligible indications. The voucher, which can be transferred or sold, allows the company to accelerate the review timeline of another product for any indication. The PRV program was proposed in 2006 as an incentive for research and development for neglected diseases, such as dengue and leishmaniasis.Neglected tropical diseases (“NTDs”) predominantly affect the world’s poorest populations and are associated with significant morbidity and mortality. Despite their global public health importance, neglected diseases were estimated to account for less than 1% of pharmaceutical research and development expenditures. The voucher program was intended to address this gap between investment and disease burden: “[t]he major obstacle to stimulating the R&D of new medicines for neglected diseases is lowincome nations' inability to pay for such medicines.” The voucher would provide an additional financial incentive to fund clinical development of these products without requiring additional appropriations from Congress.

The efficacy of a single oral dose of albendazole against soil-transmitted helminthiasis in Ogun State, Nigeria

2021 ◽  
Vol 42 (2) ◽  
pp. 360-365
Author(s):  
S.O. Sam-Wobo ◽  
Amadou D. Garba ◽  
J. Vlaminck ◽  
B. Levecke ◽  
O.N. Adekunle ◽  
...  
Keyword(s):  
Drug Administration ◽  
Neglected Tropical Diseases ◽  
Infected Individual ◽  
Primary School Children ◽  
Global Public Health ◽  
Public Health Importance ◽  
Ogun State ◽  
Fecal Egg Count ◽  
Stool Samples ◽  
Study Participants

Soil Transmitted Helminths (STHs) are Neglected Tropical Diseases of global public health importance. This study evaluated the efficacy of albendazole (ALB) amongst primary school children aged 6 – 16 years in STH-endemic communities in Ogun State, Nigeria. Demographic characteristics were obtained and stool samples were collected and analysed by Kato-Katz at baseline and 15 and 21 days post-treatment. All study participants were treated with a single ALB 400 mg tablet. A total of 282 participants were screened at baseline, of which 151 were found to be excreting STH (51.4%) of which A. lumbricoides was the most prevalent STH (n = 137, 48.6%), followed by hookworm (n = 60 children, 21.3%) and T. trichiura (n = 3; 1.1%). The prevalence across the four schools varied from 31.3% to 73.9% for A. lumbricoides, from 6.8% to 56.3% for hookworm, and from 0.0% and 2.2% for T. trichiura  infections. Of the 151 children excreting any STH infection at baseline, 131 (86.8%) provided a stool sample 15 and 21 days after treatment. The mean fecal egg counts across these complete cases at baseline was 5,096 (± 13,735) eggs per gram (EPG) for A. lumbricoides, 2,202 (±7,849) for hookworms and 288 (±375) for T. trichiura. Fifteen days after drug administration the therapeutic efficacy, measured as the reduction in mean fecal egg count (FEC) following drug administration (ERR), was 99.7% (95CI: 99.4-99.9) for A. lumbricoides and 69.2% (95CI: 28.7-92.8) for hookworms. The hookworm ERR at day 14 was reduced due to the continued high egg output of one highly infected individual. One week later, 21 days following drug administration, ERR for hookworm also reached satisfactory levels (99.4% (95CI: 98.7-99.8)). This study highlights that ALB still shows satisfactory efficacy to Ascaris and hookworm infections in Ogun State, Nigeria.

Private support of public health

2021 ◽  
pp. 751-758
Author(s):  
Quarraisha Abdool Karim ◽  
Roger Detels
Keyword(s):  
Public Health ◽  
Private Investment ◽  
Emerging Diseases ◽  
Substantial Contribution ◽  
Neglected Diseases ◽  
Global Public Health ◽  
Private Funding ◽  
Treatment Services ◽  
Bill Gates ◽  
Public Health Challenges

Private funding of public health is well established. These additional resources have historically made a substantial contribution by focusing attention and catalysing investments to build public health capacity globally. Private investment has been pivotal in increasing access to available vaccines, treatment services, and innovations in otherwise neglected diseases that contribute to substantial morbidity and mortality rates in resource-constrained settings. The increase in public–private sector partnerships highlight emerging novel approaches to advancing global public health through innovation in research and product development and service delivery for new and re-emerging diseases. Recently a new group of billionaire philanthropists such as Mark Zuckerberg and Bill Gates, still young and giving while they are alive, have changed the character and scope of giving. However, some giving can inadvertently be associated with negative consequences for the recipients. This chapter provides an overview of the history and current practices and impact of private giving, reflects on the benefits and challenges, and suggests how private investments could more effectively contribute to address the public health challenges of the twenty-first century and beyond.

scholarly journals Dengue fever and chikungunya virus infections: identification in travelers in Uganda – 2017

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
John T. Kayiwa ◽  
Annet M. Nankya ◽  
Irene Ataliba ◽  
Charity A. Nassuna ◽  
Isaac E. Omara ◽  
...  
Keyword(s):  
Public Health ◽  
Dengue Fever ◽  
Chikungunya Virus ◽  
Clinical Manifestations ◽  
Febrile Illness ◽  
Final Diagnosis ◽  
Differential Diagnoses ◽  
Global Public Health ◽  
Emerging Viruses ◽  
Public Health Importance

AbstractArboviruses are (re-) emerging viruses that cause significant morbidity globally. Clinical manifestations usually consist of a non-specific febrile illness that may be accompanied by rash, arthralgia and arthritis and/or with neurological or hemorrhagic syndromes. The broad range of differential diagnoses of other infectious and non-infectious etiologies presents a challenge for clinicians. While knowledge of the geographic distribution of pathogens and the current epidemiological situation, incubation periods, exposure risk factors and vaccination history can help guide the diagnostic approach, the non-specific and variable clinical presentation can delay final diagnosis. This case report summarizes the laboratory-based findings of three travel-related cases of arbovirus infections in Uganda. These include a patient from Bangladesh with chikungunya virus infection and two cases of dengue fever from Ethiopia. Early detection of travel-imported cases by public health laboratories is important to reduce the risk of localized outbreaks of arboviruses such as dengue virus and chikungunya virus. Because of the global public health importance and the continued risk of (re-) emerging arbovirus infections, specific recommendations following diagnosis by clinicians should include obtaining travel histories from persons with arbovirus-compatible illness and include differential diagnoses when appropriate.

scholarly journals The history of the neglected tropical disease movement

2021 ◽  
Vol 115 (2) ◽  
pp. 169-175
Author(s):  
David H Molyneux ◽  
Anarfi Asamoa-Bah ◽  
Alan Fenwick ◽  
Lorenzo Savioli ◽  
Peter Hotez
Keyword(s):  
Public Health ◽  
Rockefeller Foundation ◽  
Tropical Disease ◽  
World Health ◽  
Neglected Diseases ◽  
Neglected Tropical Disease ◽  
Global Public Health ◽  
Enabling Factors ◽  
History Of ◽  
Health Organization

Abstract The history of the neglected tropical disease movement is seen through the lens of authors who worked during the last 4 decades in different roles and in different settings, from Western-based laboratories to clinical roles in endemic countries and in critical policy roles in the World Health Organization (WHO). The authors seek to identify key players from the introduction of the word ‘neglected’ by the late Kenneth Warren in his Rockefeller Foundation–supported Great Neglected Diseases of Mankind movement through to the more recent developments after the London Declaration of 2012. The role of the various actors—endemic countries, major pharmaceutical companies, the WHO, non-government development organizations, bilateral donors and academia—are discussed. The critical events and decisions are highlighted that were essential enabling factors in creating a viable and successful movement and with a resultant massive global public health and antipoverty impact. The importance of advocacy is emphasized in creating the momentum to establish a globally recognized public health ‘brand’ as a target in the United Nations Sustainable Development Goals.

scholarly journals Title: COVID-19Predict - Predicting Pandemic Trends.

2020 ◽  
Author(s):  
Jurgen Bosch ◽  
Austin Wilson ◽  
Karthik O'Neil ◽  
Pater A Zimmerman
Keyword(s):  
Public Health ◽  
Health Care Providers ◽  
County Level ◽  
Global Public Health ◽  
Care Providers ◽  
Time Data ◽  
Short Term ◽  
Mortality Trends ◽  
Public Health Importance ◽  
National State

Background Given the global public health importance of the COVID-19 pandemic, data comparisons that predict on-going infection and mortality trends across national, state and county-level administrative jurisdictions are vitally important. We have designed a COVID-19 dashboard with the goal of providing concise sets of summarized data presentations to simplify interpretation of basic statistics and location-specific current and short-term future risks of infection. Methods We perform continuous collection and analyses of publicly available data accessible through the COVID-19 dashboard hosted at Johns Hopkins University (JHU github). Additionally, we utilize the accumulation of cases and deaths to provide dynamic 7-day short-term predictions on these outcomes across these national, state and county administrative levels. Findings COVID-19Predict produces 2,100 daily predictions [or calculations] on the state level (50 States x3 models x7 days x2 cases and deaths) and 131,964 (3,142 Counties x3 models x7 days x2 cases and deaths) on the county level. To assess how robust our models have performed in making short-term predictions over the course of the pandemic, we used available case data for all 50 U.S. states spanning the period January 20 - August 16 2020 in a retrospective analysis. Results showed a 3.7% to -0.2% mean error of deviation from the actual case predictions to date. Interpretation Our transparent methods and admin-level visualizations provide real-time data reporting and forecasts related to on-going COVID-19 transmission allowing viewers (individuals, health care providers, public health practitioners and policy makers) to develop their own perspectives and expectations regarding public life activity decisions.

scholarly journals Newly discovered viruses

2020 ◽  
pp. 951-957
Author(s):  
Susannah J.A. Froude ◽  
Harriet C. Hughes
Keyword(s):  
Public Health ◽  
Global Public Health ◽  
Emerging Pathogens ◽  
Emerging Viruses ◽  
Public Health Importance ◽  
Viral Pathogens ◽  
New Hosts ◽  
Vector Borne ◽  
Almost All ◽  
Severe Fever

Although humans are affected by an enormous range of microorganisms, almost all newly discovered emerging pathogens are viruses that are often zoonotic or vector-borne. These emerging viruses often have high baseline mutation rates, allowing them to adapt relatively easily to new hosts and enabling them to take advantage of new epidemiological opportunities provided by the changing environment. A range of apparently new human viral pathogens has been reported increasingly in international outbreak information over the last few years. How they will influence global public health remains to be seen. Emerging viruses that might be of particular global public health importance include, respiratory coronaviruses, Zika virus, and severe fever and thrombocytopenia syndrome virus. Other emerging viruses of importance include bocavirus, Bufavirus, PARV4, human parechovirus, Itaya, Heartland, and Bourbon virus. The human pathogenicity of other emerging viruses is less certain.

Endophytic Fungi in the Fight Against Neglected Tropical Diseases

2020 ◽  
Vol 20 (16) ◽  
pp. 1683-1693
Author(s):  
Maria Beatriz Silva Costa ◽  
Camila Martins de Oliveira
Keyword(s):  
Endophytic Fungi ◽  
Neglected Tropical Diseases ◽  
Public Health Problem ◽  
Neglected Diseases ◽  
Tropical Diseases ◽  
Global Public Health ◽  
Mortality And Morbidity ◽  
Underdeveloped Countries ◽  
Causes Of Mortality ◽  
Global Eradication

Neglected tropical diseases are a serious global public health problem and they are one of the main causes of mortality and morbidity, especially in underdeveloped countries. These diseases have several implications for health and they are considered a priority in global eradication programs for disease control. The aim of this mini-review is to report recent studies on the fight against neglected diseases, namely dengue fever, chikungunya, zika, malaria protozoa, Chagas disease, leishmaniasis, schistosomiasis helminths, filariasis, and tuberculosis bacteria using extracts and isolated substances of endophytic fungi based on their bioactivity profiles in relation to these diseases.

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