Global Health & Public Private Partnerships (PPP)

90.10 Gap, Drugs for all, Global burden of disease, Patient Bill of Rights

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Abstract

With over 100 PPPs active in single or multiple global diseases the impact on outcome and metrics is discussed. The global impact of PPPs is difficult to evaluate due to lack of validated measurable objective parameters. Overview of rationale for PPP formation and growth is discussed. PPP provide better focus, objectives and resource mobilization and have contributed to increased R&D in tropical and neglected diseases of the poor. Disease burden of the poor and developing countries remains a major barrier to economic prosparity and global peace. The mission statements, objectives and achievements of some of these PPPs and charitable foundations are similar. It is elimination of a single or multiple diseases to increase prosperity, productivity and peace. None of the PPP is set up in countries with high disease burden. Control of high operating costs and wastage is required. In 2007 the total funding for global health was 22 billion out of which 7 billion was by PPP and foundations.

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Introduction

Global health is derived from public health and evolved from hygiene and tropical medicine. It has become an essential component of foreign policy, a target of philanthropic action and a media darling. Global health is defined as study, research and practise on improving and equity in health for all persons worldwide.

Towards a common definition of global health

Jeffrey P Koplan , T Christopher BondMichael H MersonK Srinath Reddy, Mario Henry Rodriguez, Nelson K Sewankambo, Judith N Wasserheit, for the Consortium of Universities for Global Health Executive Board

The Lancet, Volume 373, Issue 9679, Pages 1993 – 1995, 6 June 2009

doi:10.1016/S0140-6736(09)60332-9

 

 

World Health Organization  WHO  to tackle global health problems and eradicate diseases was formed in Geneva on 7 April, 1948 during the meeting of World Health Assembly. To raise awareness of issues of global health concern, the first World Health Day was declared on 7 April 1950.

This knol is dedicated to the  World Health Day 2009 

World Health Day – 7 April 2010

1000 cities 1000 lives logo
 
CDC PHIL ID 10701 Transmission electron Micrograph of West Nile Virus

PHIL Image 10701
CDC PHIL ID 10816    Transmission Electron Micrograph of Ebola Virus
PHIL Image 10816
 

Table 1. Global Burden of Disease   WHO Data (updated  June 2009)

Millions of patients are sick, suffering and dying while waiting for safe, affordable and effective drugs from the Industry, Research Establishment, NGO, Health Charities, Foundations, WHO and Governments.

These global citizens are tired of excuses from the healthcare establishment and international and national rulers.

Help poor patients by faster approval of new drugs, low cost manufacture and distribution of affordable drugs.

Disease
Incidence/yr   millions
Deaths/yr   million
Type and associated Diseases
Infections
3000

Malaria, Tuberculosis, AIDS
Neglected Diseases
1200

Hepatitis, Leishmania, Filariasis, dengue, STD, Leprosy, Viral, bacterial and fungal infections, Drug resistance
Cardiovascular
300
17.5
Hypertension, lipid disorders, obesity

Rheumatic heart, CHF

Diabetes
336 4.6 Obesity, Hypertension, Lipid disorders

                                             Retinopathy, Foot Ulcers, Lactic acidosis, Nephropathy, Neuropathy

Cancer
100
7.6
Prostate, Breast, Lung, Colon
 Respiratory

 300 Asthma

210 COPD

 4.2 Tobacco, Pollution
Neurological
80

Epilepsy, Parkinson’s disease, Depression

                                               Alzheimer’s Disease, Schizophrenia

Infant Mortality
112 underweight
9
Malnutrition, poor sanitation
Maternal Health

0.5 during childbirth
2.7 million new cases
AIDS
40
2.9

Malaria
500
0.8

Tuberculosis

2200 infected persons
(9.4 million new cases 2008)


 

1.8
Drug Resistant TB 0.44 million,
HIV-TB co-infection
DOTS-6 m treatment costs $20, MDRTB costs $500 and 2 years to cure
India, China, Russia

 

 

World Health day in turn led to naming and celebration of specific days like AIDS day, malaria day, heart day to concentrate and raise awareness of disease burden and focus attention on tackling a specif disease. Other health related days concern stop Smoking /No tobacco, violence against women, children, food, migration, environment, refugees and children.
 
WHD 2010:  Theme Urbanization and Health
 
People cycle at the city centre in Brussels, Belgium on a car-free street day.
 
After first mention of Health days here , hundreds of knols were created to different days.
 
AVERT
 
 

World Mental Health Day

http://www.wfmh.org/index.html

 

http://www.worlddiabetesday.org/

www.worldheart.org/what-we-do/worldheartday/

www.worldcancercampaign.org/

 
Scanning Electron Micrograph of Mycobacterium     CDC Phil ID 11033

PHIL Image 11033
       
Mycobacterium tuberculosis CDC PHIL 9997
PHIL Image 9997

 

WHO Map and Data  Global Burden of Tuberculosis 

About 2.2 infected persons, fall in GDP of 1-3 trillion $ from poor countries (upto 7% of GDP) , no new drug during the past 40 years, half a million cases of multidrug resistant TB each year, leading killer of AIDs patients, evry second 1 person dies due to TB.
 

 
Top 10 countries with TB patients
Country
TB Incidence
India 1961 820
China 1305 770
Indonesia 528 060
South Africa 460 600
Nigeria 460 150
Bangladesh 353 100
Ethiopia 314 270
Pakistan 297 110
Philippines 255 080
Democratic Republic of Congo 245 330

 
WHO was the first international body to focus on diseases and health problems of developing countries. The early years were the period of new drug discoveries, antibiotics and the donor nations of the West and WHO. It was assumed that they had the means and drugs in hand to eradicate most of the tropical disease like malaria and TB. Most of these top driven early efforts ordered by donor countries of the West failed. The Rockefeller Foundation had funded and started the first global campaign to eradicate malaria by spraying of insecticide DDT and bednets to keep mosquitos out. The programme was successful in some European countries. The impact in developing countries was mixed. The newly formed WHO promptly adopted the malaria eradication as its top priority in early 1960s. The eradication campaign ran for almost 15 years and was a failure in most developing countries. The concerns about the evironmental impact of widespread use of chlorinated pesticides and the high cost(almost 30% of WHO budget) with poor results led to the demise of the second global malaria eradication project.  
 
 

By mid 1970s units were formed within WHO to deal with Tropical Disease Research (TDR) , Vaccines and Child and Maternal Health. TDR initiated and started global efforts to eradicate and eliminate malaria, smallpox and tuberculosis without local input or involvement. Lack of funds and the use of low cost drug treatment led once again to failure of such campaigns and development of drug resistance. Although choroquine had become ineffective (drug resistance) it was used until 2001 because it was cheap and alternatives were  more expensive. Use of artimisinin was recommended in 2001, it costs more and requires monitoring for cardiotoxicity. Ridley and Fletcher have discussed the history and achievements of TDR and how to deal with future challenges (http://www.who.int/tdr/about/pdf/nature_reviews_micro1899.pdf).  TDR timelines of key achievements is available at http://www.who.int/tdr/about/pdf/anniversary_book_timeline.pdf.

Global Alliance for Vaccines and Immunization GAVI at WHO (http://www.gavialliance.org/) was launched in 2000.

http://www.searo.who.int/en/Section1243/Section2448.htm

AIDS outbreak in early 1990s led to the formation of a special unit within WHO to tackle the disease on a global basis. Clash of personalities, priorities, politics and donor push for quick action led to the formation of UNAIDS in 1994 (http://www.unaids.org/en/).
WHO regularly updates data and maps about the Global Burden of Disease and Global mortalitity and cause of death.
 
 
CDC PHIL  ID  178          Electron Micrograph of Rotavirus
PHIL Image 178
 
 
 
 
The global burden of disease, malaria and TB prevalence and distribution is available at
 

. WHO Data and map : http://rbm.who.int/wmr2005/html/map1.htm

http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_part4.pdf

http://www.who.int/tb/publications/2009/airborne/background/map.JPG

 

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Transmission Electron micrograph of AIDS virus   CDC PHIL 11279

  Transmission Electron micrograph of Hepatitis B Virus  CDC PHIL ID 11755


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Public Private Partnerships

 

The formation of TDR, GAVI and UNAIDS can be considered as the foundation and role model for Public Private Partnerships PPP advocated by  healthcare charities and Jeffry Sachs of Earth Institute at Coumbia University.The rationale was that a specialist organization  functioning like a virtual company model and disease focus with defined objectives and priorities It was Sachs study published in Lancet in mid 1990s that showed the lack of foreign aid money to fight AIDS in Africa was showing any reduction in mortality.

This led to the formation of Global Fund to fight AIDS, Tuberculosis and Malaria ((http://www.theglobalfund.org/en) under UN system in Geneva. However critics in an editorial in NYT and articles in PLoS Medicine allege that UNO, WHO have mislead public by setting specific disease targets and outcomes which are difficult to measure. Sustained cause and disease specific campaigns with clearly defined objectives and timelines funded by public private partnerships had better chances of success than be part of WHO. PPPs can mobilize resouces from a variety of donor like governments, charities, companies, foundations and private wealthy persons. Global Fund to fight AIDS, Tuberculosis and Malaria (http://www.theglobalfund.org/en). Global fund has spent billions to provide AIDs triple therapy at low cost to patients in poor and developing countries, nets, insecticides and TB and malaria treatments.
 
 
The Global Fund logo

Most of these PPPs are set up in Geneva, Europe or USA and none has been set up in Africa, Asia or Latin America. The operating costs of these PPPs are relatively high and there is lot of travel (business class), 5* hotel stay, meetings, conferences, advisory boards and glossy prints out of books, monographs and papers. Thus travel and entertainment budgets are relatively high. PPPs are dependant on local third parties for execution, action, delivery and outcome measures. There is little or no attempt to discontinue or terminate projects. Projects once started continue forever. A few years ago UNAIDS wasted millions of doolars on glossy monograph to highlight the achievements of 10 years of its departing chief and founder director Peter Piot.

The following factors can derail or disrupt any disease eradication campaign

Civil wars

Natural disasters

Climate change

Shifting local or political priority

Limited resources

Corruption

Diversion to other emerging diseases like SARS, Avian and Swine Influenza.
 
 UNITAID Together to heal
 
 
UNITAID:  A new Agency for duplicative work
 

UNITAID’s mission is to contribute to scaling up access to treatment for HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available.

UNITAID was established to support existing efforts to achieve the United Nations Millennium Development Goals – in particular Goals 4 – Child Health, 5 – Maternal Health, 6 – Combating HIV and other diseases. UNITAID’s funds are disbursed to international partners working in global health and health commodities procurement, such as the William J. Clinton HIV/AIDS Initiative (CHAI) and UNICEF.

Book Jacket POWER IN NUMBERS 
UNITAID, INNOVATIVE FINANCING, AND THE QUEST FOR MASSIVE GOOD
PHILIPPE DOUSTE-BLAZY AND DANIEL ALTMAN
WITH A PREFACE BY PRESIDENT BILL CLINTON

 

Innovation in global health

A spoonful of ingenuity

Jan 7th 2010 | NEW YORK
From The Economist print edition



The Global Drug Facility (GDF) is a mechanism to expand access to, and availability of, high-quality anti-TB drugs and diagnostics to facilitate global DOTS expansion or maintenance to support the Stop TB Strategy.

 
Foundation for Innovative New Diagnostics
 
 

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NIH

The Foundation for the National Institutes of Health identifies and develops opportunities for innovative public-private partnerships involving industry, academia, and the philanthropic community (www.fnih.org). There were over 100 public private partnerships funded with over $ 1 billion with over 100 active R&D projects for vaccines and drugs for tropical and neglected diseases by the end of 2008.  Developments in the area of neglected diseases have opened up new opportunities for licensing by universities and companies. These public-private partnerships (PPPs) support development of drugs, vaccines and diagnostics to address diseases that predominantly afflict the poor or to make drugs available to patients in poor countries and operate on the virtual company model .

The Biomarkers Consortium http:/www.biomarkersconsortium.org.

The aim is to develop biomarkers to detect and diagnose disease and monitor disease treatment and outcome. Biomarkers can be used as surrogate endpoints to gain new drug approvals. Reduction in levels of cholesterol results in reducing risk of cardiovascular deaths. Similarlarly levels of glycosylated hemoglobin HbA1c can be used to monitor efficacy of antidiabetic drugs. 

The Foundation for Innovative New Diagnostics http://www.finddiagnostics.org has similar objectives (not related to NIH).

The declining R&D productivity coupled with increasing costs and reduced number of new drug approvals led to the FDA initiated CPI. The aim is to increase R&D productivity and find innovative ways to speed up introduction of safe and effective drugs. Critical Path Initiative

There is no drug to block and reverse the progression of Osteoarthritis despite advances in knowledge. Most of the treatments provide symptomatic relief. Osteoarthritis is very common disease and contributes to reduced mobility and morbidity with high economic costs. http://www.niams.nih.gov/Funding/Funded_Research/Osteoarthritis_Initiative/default.asp.

The Grand Challenge for Global Health awards grants for selected global projects. The current topics are

To develop low cost diagnostic tests, Induce mucosal immunity, develop vaccines for HIV, malaria, TB, Pneumonia, diarrrhea and new tools for eradication of malaria.http://www.gcgh.org.


The genome project is deveoted to development of all types of genomic research. http://www.genome.gov/19518664.

The Alzheimer disease Neuroimaging Initiative is to develop and validate imaging of the brain and predict disease outcome and efficacy of new drugs in clinical trials. http://www.nia.nih.gov/NewsAndEvents/PressReleases/PR20041013ADNI.htm

PPPs

Pharmaceutical and biotechnology industry has no interest in developing vaccines and treatments for the tropical and neglected diseases like AIDS, Chagas’ Disease , Contraception , Dengue, Diarrhea, Leprosy, Leishmaniasis, Lymphatic filariasis, Malaria, Malaria, Onchocerciasis, Schistosomiasis , Trypanosomiasis, Tuberculosis and Sexually transmitted diseases. Because once these medicines were developed after considerable R&D expenses, international organizations were not ready to pay higher prices of new medicines. Industry was expected to donate or supply these new drugs at cost basis only. Since there was no profit or payback in such R&D, these projects were terminated. International and national organizations like WHO failed to develop new medicines for tropical diseases and lacked sufficient resources. Universities or research institutes were not able to attract interest from the industry for promising leads and companies terminated their own R&D leads because of lack of profits or commercial success.  Glaxo Smith Kline and Astra Zeneca have R&D laboratories in Asia dealing with tropical diseases(outside Japan). There are no industrial R&D labs in Africa.

The 90-10% gap refers to the fact that 90% of drug discovery is directed towards diseases of the Western World with only 10% of the global disease burden. Tropical and developing and poverty related diseases accounting for 90% of world disease burden receive only 10% resources for R&D. It was noted that previous international efforts to vaccination and tropical disease eradication had failed to make any significant impact due to lack of funds, objectives and strong local opposition in some cases. Global Forum for Health Research  http://www.globalforumhealth.org/Site/000

 

Aeras, Global TB Vaccine Foundation (Aeras) (http://aeras.org)

Tuberculosis has infected 2 billion persons worldwide and kills 1.8 million patients every year. The tB vaccine protects mainly against pediatric infections and is not effective against adult strains. Despite its widespread use, the BCG vaccine has failed to prevent the spread of the disease which infects one new victim every second. The coinfection of TB with HIV poses a new serious threat to global health. Current medicinal treatment of TB lasts 6-9 months, is considred too long by many patients who drop out or are lost to followup. These patients develop multi drug resistance which raises the cost of treatment. The need for a safer and more cost effective TB vaccine is championed by Aeras Foundation and funded by several other partners like Gates Foundation.

The widely used BCG vaccine is only effective against pediatric TB infections.The TB vaccine has no efficacy/impact on a looming TB pandemic. Co infection with HIV is even more deadly. Global Alliance for TB Drug Development (www.tballiance.org) has several projects in its R&D pipeline. However some of these projects were terminated by the industry.

Tuberculosis By  Charles Daley

Rubin EJ. The Granuloma in Tuberculosis — Friend or Foe? New Eng J Med,  360:2471-2473, 2009.


When the world richest person Bill Gates set up his fondation, now works full time, is now joined by the second richest man Warren Buffett and started donating billion for selected healthcare causes on a global basis, the effect has been real transformational and like a paradigm shift. With the presence of Nobel Prize winners in the advisory board and predefined measurable outcomes and deadlines. Ford Foundation and Rockfeller Foundation have been active in issues of global health for several decades. These foundations have served as models for newer foundations as benchmarks. 
 Bill & Melinda Gates Foundation
 

Bill and Melinda Gates Foundation (www.gatesfoundation.org/GlobalHealth/InfectiousDiseases/)

Science and technology have great potential to improve lives worldwide. Gates foundation funds and shape global agenda and goals and relies onpartners to act, implement and deliver. The foundation has a clear focus to proritize neglected diseases. The objective is to discover new insights to fight disease and health problems all over the world. Gates funds efforts to develop effective and affordable vaccines and medicines and deliver proven health care solutions to poor contries and communities. Malaria, AIDS, Diarrhea, Polio, Pneumonia, Neglected Diseases, Nutrition, Maternal and Child Health are current priorities of the foundation.
 
Gates Foundation has distributed $10 billion in grants and R&D funding during the past 10 years. Only 20 organizations accounted for 65% of all grants. The Global Fund for Aids, Tuberculosis and Malaria and GAVI alliance together received 25% of the grants. Most of the grants were going to the USA and Europe and for development of new drugs and vaccines for HIV, AIDS, Malaria and tropical and neglected disease. The foundation is now the top donor to WHO.
 
McCoy, D, Kembhavi, G., Patel, J., Luintel, A. The Bill& melinda Gates foundation grant making programme for global health. The Lancet 373, 1645-1653, 2009.

Bill & Melinda Gates Foundation

The MMV was the first PPP formed in 1999 and since then has developed an R&D portfolio of over 60 projects. MMV was founded by WHO, International Federation of Pharmaceutical Manufacturers Association, IFPMA, Global Forum for Health GFHR, Rockefeller Foundation, The World Bank, ABPI, The Wellcome Trust and Swiss Agency for Development. The development of vaccine for malaria led to the formation of MVI by PATH. Malaria kills over 1 million patients each year and infects over 300-500 million persons resulting in a $12 billion loss of productivity in Afrian countries. The disease can be prevented, diagnosed rapidly and treated by insecticides spays to control mosquitos, bednets to prevent mosquito biting human victims and rapid field test for Plasmodium falciparum infections. The cheap drugs chloroquine/sulphadoxine are not effective due to drug resistance and artimisin based treatment costs much more and requires monitoring. Phase III trials with vaccine show only 30% efficacy (only 1 out of 3 person is protected by the vaccine). such a vaccine if approved can still save over 300,000 deaths each year at relativly low cost and simple treatment. there are 16 malaria vaccines in clinical trials.

At the end of World war II, the disease was endemic all over the world, it has now been eradicated in most of the Western World and over 100 countries. Development of resistance to insecticides, environmental concerns, lack of funds, political will for sustained campaign, high cost of artimisin based treatment regiment and long duration of treatment have derailed several past and current eradication campaigns.  

Malaria Vaccine Initiative (MVI). (http://www.malariavaccine.org)

Medicine for Malaria Venture (www.mmv.org).
 

                                       

Dengue vaccine trials are described in PDVI web site

Pediatric Dengue Vaccine Initiative http://www.pdvi.org
 
 
Institute for One World Health http://www.oneworldhealth.org
 

This is a private company based approach has resulted in marketing of some drugs in India at affordable prices has reduced the incidence of Leishmaniasis

International AIDS Vaccine Initiative (http://www.iavi.org/)

Several  AIDS vaccines have failed in late stage clinical trials but there are many other candidate vaccines ready or testing.

 

Program for Appropriate Technology in Health http://www.path.org

The main objective is to adopt Western developed technolgy and health solution to local conditions in poor countries and make it suitable for use by local communities

The New York based PPP has tested several microbiocides to prevent transmission of AIDS and other sexually transmitted diseases with mixed results. Most of the products tested failed to pass efficacy criteria in Phase III trials
 
International Partnership for Microbicides

International Partnership for Microbicides http://www.ipm-microbicides.org

Medecins Sans Frontiers

Drugs for Neglected Diseases Initiative (www.dndi.org)

The award of the Nobel peace prize to Medicine Sans Frontier (Doctors without borders, MSF) led to the formation of this virtual PPP. The high human cost of the neglected diseases (Trypanosomiasis or sleeping sickness, Leishmaniasis, Chagas Disease and Malaria) is due to lack of new drugs to treat patients.

Médecins Sans Frontières MSF, Institut Pasteur, Indian Council of Medical Research,

Oswaldo Cruz Foundation (FIOCRUZ),  TDR, and Health Ministry in Malaysia joined to develop new drugs. There were 21 projects in the R&D portfolio of DNDI.

Trypanosomiasis infects 50,000-150000 persons each year. Available treatments are costly, difficult to administer and are not effective in drug resistant strains. Another form of of Trypanosomiasis, Chagas Disease infects 8 million persons each year in Latin America. Current treatment Benznidazole (requires 60 days with 50% efficacy) and Nuffutiniox with reduced efficacy and high cost lead to bvery high drop out rates resulting in development of drug resistant parasites.

The parasite Leishmaniasis (Kala Azar in India) affects 0.5 million persons each year. Availability of low cost drugs like amphotericin B nanoparticles, miltefosine and paromomycin has made great impact in reducing mortality and morbidity in India. However the route of administration, long treatment period and relative high cost of treatment has limited impact in Africa.

Foundations

Nippon Foundation

The Nippon Foundation believes in bringing together world’s wisdom to transform society and world as one family. The foundation has contributed during the past 30 years to eradicate poverty, starvation and sickness. One active recent project was to provide free drugs for leprosy in India and to raise awareness to eliminate disease based discrimination.

http://www.rotary.org/en/Pages/ridefault.aspx

Rotary club has been very active through its member in campaigns for vaccination,

awareness and education in many poor or disease endemic countries.

PATHwww.path.org/  is a non profit international organization involved in providing health care solutions to emerging and existing infections, vaccines, reproductive and maternal health

www.arc.asso.fr/  ARC is a French charity for promotion of cancer research and treatment
Association pour la recherche sur le cancer (ARC)

Robert Wood Johnson Foundation http://www.rwjf.org/ is involved in improving healh care for all Americans.
 

 
PHRMAhttp://www.phrma.org/

USA Industry: Presription Drug Assistance Programs for poor and uninsured patients (https://www.pparx.org/ViewCompanies.php)

IFPMA   International Federation of Pharmaceutical Manufacturers Association

www.ifpma.org/


Wellcome Trust (UK) spended $ 1 billion in 2008 to promote top international and UK medical scientists and research and is Europe largest health charity. Its online e-grant system to fund research in neuroimaging, medical history and bioethics, trackdown fake antimalarials and awards to top biomedical scientists.

Wellcome Trust http://www.wellcome.ac.uk/

Aga Khan Development Network (Switzerland). http://www.akdn.org/

Aga Khan Foundation. http://www.akdn.org/akf

The Geneva based charity has been active in healthcare activities in Asia, Africa and Eastern Europe and funds universities and hospitals.

Robert Bosch Stiftung (Germany) 47 million

Aetna Foundation. www.aetna.com/foundation/

Provides grants in healthcare by improving healthcare delivery to low income. poor patients irrespective of race, religion and ethnic origin.

The Berlex Foundation. www.berlexfoundation.org/

Funds innovative research in reproductive medicine

The Charles Dana Foundation New York http://www.dana.org/

Supports medical research in cognition and immunology


Glasser Family Foundation. www.glaserfoundation.org/

Supports and funds global AIDS/HIV efforts

 
Aga Khan Foundation (AKF)Aga Khan Foundation
 

Provides comprehensive information about medicaid, medicare, uninsured coverage, prescription drugs , healthcare and insurance costs and health benefits and ongoing reforms in the USA.

 
 

 

Electron Micrograph of 1918 Spanish influenza Virus  CDC PHIL 11098
PHIL Image 11098

 
 

 


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Global Health TV Show – November 2009

Tuesday, 1st December is World Aids Day. In this special program we talk to Dr Steve Patterson from Imperial College, London about his team’s recent research in to the STEP vaccine trials in to HIV/AIDS with researchers from King’s College London and Royal Holloway, Uni. of London.

Combating Neglected Tropical Diseases

Major Report on Child Vaccines

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