This is the pdf version of Vaccines: The Week in Review 28 Macrh 2011 comprising all the posts below for this date:
WHO issued a progress report Towards universal access to diagnosis and treatment of MDR and XDR-TB by 2015 noting “progress is being made, but the response is far from sufficient given the MDR-TB threat facing the world. Two years on from the Beijing declaration – which was endorsed by all 27 high burden countries featured in this report – the commitments by some countries are too slow off the mark or simply stalled.” In relation to the 27 high burden MDR-TB countries, WHO reported:
– Funding: MDR-TB action plans exist in most of the 27 countries. Funding has increased, from $0.1b in 2009, to $0.5 billion in 2011. However, the estimated need in the Global Plan for MDR-TB worldwide in 2011 is $0.9b.
– Labs: Capacity has increased, but is still only adequate in 60% of the countries.
– Treatment: Only one-in-ten MDR-TB patients have access to treatment – and cure rates range widely from 25% to 82%.
– Drugs: The Global Drug Facility has more than doubled the number of finished pharmaceutical products for MDR-TB from 11 in 2008 to 25 today.
– Treatment capacity: If diagnostic capacity increases substantially in the next few months, the availability of second line drugs to treat all those diagnosed will be a challenge.
– TB infection control: In many countries this is still at a planning stage.
– Surveillance: Major progress has been made. By mid 2012, all 27 countries will have representative information on drug resistance.
World TB Day, 24 March 2011, Statement of Christine F. Sizemore, Ph.D., and Anthony S. Fauci, M.D., National Institute of Allergy and Infectious Diseases
National Institutes of Health.
“…Recent developments have created confidence that TB control strategies can be improved to stay abreast of the changing nature of the pandemic. For the first time in decades, a robust pipeline of candidate TB drugs, vaccines, diagnostics, and treatment and prevention strategies are being evaluated in clinical trials. WHO recently endorsed a diagnostic test that enables health care providers to identify drug-resistant TB directly from patient specimens within about two hours rather than waiting months for a conclusive diagnosis. Drugs are being developed that, when combined in novel ways, may significantly improve the way we treat patients with TB. Vaccines are being developed that may one day prevent the disease, even in persons who are already infected with Mtb….”
Full statement at: http://www.nih.gov/news/health/mar2011/niaid-21.htm
The Food and Drug Administration (FDA) approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older. Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research, commented, “The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease.” The FDA noted that approval “was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.”
The WHO announced a new report – The Abuja Declaration: Ten Years On. The report abstract notes: “In April 2001, heads of state of African Union countries met in Abuja, Nigeria and pledged to set a target of allocating at least 15% of their annual budget to improve the health sector. At the same time, they urged donor countries to “fulfil the yet to be met target of 0.7% of their GNP as official Development Assistance (ODA) to developing countries”. This drew attention to the shortage of resources necessary to improve health in low income settings.
“Only two African countries have reached that target. Overall, 27 have increased the proportion of government expenditures allocated to health and seven have reduced it since 2001. In the other 12, there is no obvious trend up or down. Current donor spending varies dramatically, from US$ 115 per person in one country, to less than US$ 5 per person in 12 others.”
Four page summary report at: http://www.who.int/entity/healthsystems/publications/abuja_10.pdf
The WHO posted an invitation to attend the Open Sessions of the first meeting of the Consultative Expert Working Group on Research and Development: financing and coordination (CEWG):
Place: WHO Executive Room, Geneva Switzerland
Date: 5-7 April 2011
“Members of the CEWG will meet to take forward the work of its predecessor, the Expert Working Group (EWG). They will deepen the analysis of the proposals considered by the EWG and consider further proposals for financing and coordination of research and development for diseases that disproportionally affect developing countries. To ensure transparency in the work of the CEWG, Member States and other stakeholders may attend the open sessions of the meeting. In particular Member States and other stakeholders may attend the following sessions subject to registration.
– Open Session on 5th April 2011, Tuesday, 9.30am to 3.30pm
– Open Forum on 6th April 2011, Wednesday, 9am to 6pm
– Open Session on 7th April 2011, Thursday, 5.30pm to 6pm
[Editor’s Note: We do not endorse the findings of or have any business relationships with market research firms which analyze the vaccines marketplace. But we do monitor new research and occasionally provide highlight, especially when such research provides insights into the scale or dynamics of the vaccines marketplace]
World Vaccines Market: Vaccine Segments Analysis, Vaccine Cases and Future Forecast
“…As growth in sales of vaccines has become higher than the traditional business all major pharmaceutical companies are eyeing the vaccine market as driver for their growth. Many mergers and acquisition have taken place in this space as consolidation has become the keyword for future growth. With companies consolidating they can focus better in the market and keep their profit margins high. Recently, pharmaceutical company Pfizer acquired Wyeth, Merck acquired Schering Plough and Sanofi acquired Shantha Biotechnics….”
“…Due to rising fear of terrorism Bio- Bio-protection vaccine future is also shinning. The Bio-protection vaccines market is expected to grow with a CAGR of 12.08% percent from 2009 to 2015…Seasonal flu vaccine market is forecasted to be more than US$ 7 billion by 2016…”
Research Highlights [selected]:
– World vaccines market will cross the mark of US$40 Billion by 2015
– Pediatric proprietary vaccine market is the biggest vaccine sector with more than US$6 Billion market in 2009
– In 2009 four companies (GSK, Sanofi-Aventis, Wyeth and Merck & Co.) together control 71% of the vaccines market worldwide
– Influenza vaccine market is expected to cross US$ 7 Billion market by 2015
– Bio-protection and Travel & Endemic vaccines market is expected to double by 2015 from their market in 2009
– US is the biggest vaccine market worldwide with more than US$10 Billion and its expected to lead the market till 2015
– Malaria vaccine market for public is expected to cross US$400 Million by 2025
– Cervical Cancer vaccine market is forecasted to cross US$4 Billion mark by 2012 and thereafter its year on year growth will slow down
– Prevner a Pfizer a product is expected to become the first vaccine to cross US$5 Billion mark by 2015
The Weekly Epidemiological Record (WER) for 25 March 2011, vol. 86, 13 (pp 113–128) includes: Working to overcome the global impact of neglected tropical diseases – Summary; WHO position statement on integrated vector management to control malaria and lymphatic filariasis; Monthly report on dracunculiasis cases, January 2011
The MMWR for March 25, 2011 / Vol. 60 / No. 11 includes:
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and by no means intended to be exhaustive.
@VaccinesToday view full profile →
Vaccines Today is an online platform, supported by the European Vaccine Manufacturers (EVM), for discussing vaccines and vaccination. http://www.vaccines-today.org
Clinical Infectious Diseases
Volume 52 Issue 7 April 1, 2011
Invited Articles: Vaccines
Paul Fine, Ken Eames, and David L. Heymann
“Herd Immunity”: A Rough Guide
Clin Infect Dis. (2011) 52(7): 911-916 doi:10.1093/cid/cir007
The term “herd immunity” is widely used but carries a variety of meanings [1–7]. Some authors use it to describe the proportion immune among individuals in a population. Others use it with reference to a particular threshold proportion of immune individuals that should lead to a decline in incidence of infection. Still others use it to refer to a pattern of immunity that should protect a population from invasion of a new infection. A common implication of the term is that the risk of infection among susceptible individuals in a population is reduced by the presence and proximity of immune individuals (this is sometimes referred to as “indirect protection” or a “herd effect”). We provide brief historical, epidemiologic, theoretical, and pragmatic public health perspectives on this concept.
Mar 26, 2011 Volume 377 Number 9771 Pages 1047 – 1124
Health care: an African solution
In 2006, WHO’s World Health Report detailed the perilous state of health-care provision in sub-Saharan Africa. The statistics are familiar to anyone with an interest in global health. Africa had only 2·3 health-care workers per 1000 population, compared with 18·9 in Europe, and this workforce had to deal with 24% of the global disease burden, with just 1% of the total global funding for health. Since published, these statistics have formed the introduction to many subsequent publications on health in Africa, but so far, practical solutions have been in short supply.
Volume 471 Number 7339 pp409-542 24 March 2011
Africa needs climate data to fight disease
Madeleine C. Thomson and colleagues call on climate and health researchers, policy-makers and practitioners to work together to tackle infectious diseases.
Volume 471 Number 7339 pp409-542 24 March 2011
Special Supplement: Cancer
Vaccines: Know your enemy
23 March 2011
Vaccines are arguably our greatest medical achievement. But to what extent can they help prevent cancer?
[Initial article language]
Cancer operates like a well-disguised saboteur. Occasionally it slips up by displaying unusual proteins, tripping immunological surveillance systems that are checking for abnormal growth. For decades now, scientists have tried to exploit this vulnerability with therapeutic vaccines — injections of tumour-associated proteins that essentially hang a ‘Wanted’ poster, helping immune cells recognize and kill cancer cells.
After a string of expensive and dispiriting defeats, therapeutic cancer vaccines recently registered their first big win. In April 2010, the US Food and Drug Administration (FDA) approved Provenge (sipuleucel-T) — a mixture of a patient’s own cells incubated with a protein expressed by 95% of prostate tumours. This was not an unequivocal victory, however. “On average, patients live about four months longer,” says Martin Kast, a cancer vaccine specialist at the Norris Comprehensive Cancer Center at the University of Southern California (USC) in Los Angeles. “It certainly measures up to many chemotherapeutics, but there’s still a long way to go.”
(Accessed 27 March 2011)
The BCG World Atlas: A Database of Global BCG Vaccination Policies and Practices
Alice Zwerling, Marcel A. Behr, Aman Verma, Timothy F. Brewer, Dick Menzies, Madhukar Pai Health in Action, published 22 Mar 2011
Despite nearly a century of use, the Bacille Calmette-Guérin (BCG) vaccine continues to be controversial, with known variations in BCG substrains and vaccine efficacy.
Because vaccination policies and practices vary across time and countries, we created the first searchable, online, open access database of global BCG vaccination policy and practices, the BCG World Atlas (http://www.bcgatlas.org/), which contains detailed information on current and past BCG policies and practices for over 180 countries.
The Atlas is for clinicians, policymakers, and researchers and provides information that may be helpful for better interpretation of tuberculosis (TB) diagnostics as well as design of new TB vaccines.
This is the pdf version of Vaccines: The Week in Review 21 March 2011 compiling all posts below for this date:
WHO said that the Tunisian Ministry of Public Health, supported by WHO, UNICEF and other health partners, started a vaccination campaign for an estimated 100 children under 5 years currently residing in Tunisia-Libya border camps. WHO noted that “strong winds and whirling sand are slowing down preparations, but the organizers are aware of the critical importance of vaccination.” Dr. Irshad Shaikh of the World Health Organization said, “As the number of families arriving at the camp incrementally rises, coupled with the fact that the length of stay of some of the families can get longer especially for those from Somalia and Eriteria (countries in conflict themselves), the risk for vaccine preventable illnesses in children inherently goes up.” The vaccination includes 7 antigens – diphtheria, tetanus, poliomyelitis, BCG, measles, whooping cough and hepatitis B. http://www.who.int/hac/crises/lby/releases/15march2011/en/index.html
PAHO/WHO, officials from Haiti’s Ministry of Public, UNICEF and other partners outlined a new plan to improve immunization services in Haiti over the next five years, including the introduction of three new vaccines. Ariel Henry of Haiti’s health ministry said, “We hope to start this multi-year immunization plan as soon as possible in order to save lives and protect Haitians. Diarrhea and pneumonia are the main causes of death in Haitian children, so we also plan to include rotavirus and pneumococcal vaccines in our strategic plan.” Dr. Ciro de Quadros of the Sabin Vaccine Institute, who chaired the meeting, said, “This plan shows the great work being done on immunization and the strong commitment to improve immunization services, and the international community backs the plan in Haiti.”
The U.S. Department of Health and Human Services released a report on “critical gaps which exist between older Americans who receive potentially lifesaving preventive services and those who do not.” Clinical prevention services examined in the report include vaccinations that protect against influenza and pneumococcal disease (e.g., bloodstream infections, meningitis, and pneumonia), screenings for the early detection of breast cancer, colorectal cancer, diabetes, lipid disorders, and osteoporosis, and smoking cessation counseling. The report was published by the Centers for Disease Control and Prevention, in partnership with HHS’ Administration on Aging, Agency for Healthcare Research and Quality, and Centers for Medicare and Medicaid Services.
Enhancing Use of Clinical Preventive Services Among Older Adults: Closing the Gap is available at: http://www.cdc.gov/aging/pdf/Clinical_Preventive_Services_Closing_the_Gap_Report.pdf
The Global Fund to Fight AIDS, Tuberculosis and Malaria announced that former President of Botswana Festus Mogae and former U.S. Health and Human Services Secretary Michael O. Leavitt “have agreed to lead a high-level panel of experts that will conduct an independent and thorough review of the Global Fund’s financial safeguards.” Michel Kazatchkine, Executive Director of the Global Fund, commented, “The appointment of this panel is part of the Global Fund commitment to ensuring our financial controls are the most robust possible, and that donor investments go directly to fighting AIDS, malaria and tuberculosis. Sound financial controls and anti-corruption protections are essential elements in our continued ability to save millions of lives, and to facilitating social and economic development in the more than 140 countries we support.” The panel “will assess the Global Fund’s current practices in financial oversight and implementation. The panel will also make recommendations where necessary to help strengthen the Global Fund’s fiscal controls and anti-corruption protections. This review is part of a broader set of measures that continue to be implemented to strengthen the Global Fund’s financial safeguards.”
The Bill & Melinda Gates Foundation announced Round 7 of Grand Challenges Explorations, its US$100 million grant initiative to encourage innovation in global health research. The initiative “offers scientists, inventors and entrepreneurs the opportunity to win $100,000 grants to pursue unconventional ideas that could transform health in developing countries, and focuses on research areas where creative, unorthodox thinking is most urgently needed.: The topics in this round are:
– The Poliovirus Endgame: Create Ways to Accelerate, Sustain and Monitor Eradication
– Create the Next Generation of Sanitation Technologies
– Create Low-Cost Cell Phone-Based Solutions for Improved Uptake and Coverage of Childhood Vaccinations
– Design New Approaches to Cure HIV Infection
– Explore Nutrition for Healthy Growth of Infants and Children
– Apply Synthetic Biology to Global Health Challenges
WHO highlighted deployment of a new “moving warehouse” in Senegal’s Saint Louis district yielding “the prospect of huge efficiencies in the supply of vaccines and medicines to health centres.” WHO said that through the system, insulated trucks deliver vaccines and other health products directly from regional warehouses to health centres, without interim stocking at district level. Products are delivered according to the needs indentified by the health centres, with delivery teams able to provide on-site supportive supervision and maintenance of equipment when deliveries are made. Stock management is computerized, with real-time, web-based information exchange between the moving warehouse, health centres, and regional and national storage facilities.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Burrill & Company published a report which notes that “America’s biopharmaceutical research companies invested a record $67.4 billion last year in the research and development of new medicines and vaccines – an increase of $1.5 billion from 2009…PhRMA member companies alone spent an estimated $49.4 billion on biopharmaceutical R&D last year, a 6.5 percent increase over 2009.”.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) published a new paper – Technology Transfer: A Collaborative Approach to Improve Global Health – the R&D Pharmaceutical Industry Experience – which “documents the growing trend of technology transfer in medicines and vaccines. It also identifies the critical enabling conditions which allow technology transfer to contribute successfully to global economic development and health.” IFPMA Director General Eduardo Pisani said, “Through technology transfer, R&D-based pharmaceutical companies are helping partner companies around the world to make advanced medicines and vaccines for their local markets. This is stimulating economic and social development, while also contributing to the health of recipient countries’ populations. With appropriate government encouragement and continued engagement by our members, the benefits of this approach could be extended to more countries. WHO Member States have asked us to share our best practice in this area, and this is what our new paper delivers.”
The IFPMA paper “identifies the risk of a ‘technology transfer gap’: while middle income economies are involved in a growing number of pharmaceutical technology transfer partnerships, low income countries may not be so attractive as partners, as they may lack many of the enabling conditions for successful technology transfer. The paper therefore recommends that low income country governments should help to improve local companies’ attractiveness as technology transfer partners, encourage them to focus initially on more accessible technologies and to create larger, regional markets through mutual recognition of medicine approvals with neighboring countries. High income countries can assist this process by technical means, such as giving low income countries greater access to international standard-setting bodies as a way of strengthening in-country competencies, as well as other forms of development assistance.”
The Weekly Epidemiological Record (WER) for 18 March 2011, vol. 86, 12 (pp 101–112) includes:
– Outbreak news (Meningococcal disease, Chad; Yellow fever, Sierra Leone)
– First meeting of the GPEI Independent Monitoring Board
– Progress in interrupting wild poliovirus circulation in countries with re-established transmission: Africa, 2009–2010
The MMWR for March 18, 2011 / Vol. 60 / No. 10 includes:
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and not intended to be exhaustive.
Annals of Internal Medicine
March 15, 2011; 154 (6)
Student Vaccination Requirements of U.S. Health Professional Schools: A Survey
Megan C. Lindley, Suchita A. Lorick, Jovonni R. Spinner, Andrea R. Krull, Gina T. Mootrey, Faruque Ahmed, Rosa Myers, Geraldine P. Bednash, Tyler C. Cymet, Rika Maeshiro, C. Fay Raines, Stephen C. Shannon, Henry M. Sondheimer, and Raymond A. Strikas
Ann Intern Med March 15, 2011 154:391-400; doi:10.1059/0003-4819-154-6-201103150-00004
The number of vaccines recommended for health care workers has increased over the past 2 decades, but national data on prematriculation vaccine policies of health professional schools were unavailable. This 2008–2009 survey of deans of 563 U.S. schools of medicine and nursing found that most schools’ policies adhere to the Advisory Committee on Immunization Practices recommendations for health care workers. However, exemption policies, measurement of titers to confirm vaccination, and payment mechanisms varied. In particular, nursing and osteopathic schools were less likely than allopathic medical schools to pay for influenza vaccination.
March 16, 2011, Vol 305, No. 11, pp 1061-1154
M. J. Friedrich
Oral cholera vaccination can help control cholera spread after an outbreak has begun, 2 new studies report.
Using existing data from a number of recent cholera outbreaks to simulate the number of cholera cases preventable by mass vaccination once an outbreak has occurred, researchers from the International Vaccine Institute (IVI) in Seoul, Korea, and other international institutions found that even a delayed response to vaccinate could be beneficial. (Reyburn R et al. PLoS Negl Trop Dis. 2011;5:e952).
In a separate case-control study, researchers from the IVI and the National Institute of Hygiene and Epidemiology in Hanoi, Vietnam, found that giving 1 to 2 doses of vaccine after a cholera outbreak began in Hanoi in 2007-2008 was 76% protective against cholera in this setting (Anh DD et al. PLoS Negl Trop Dis. 2011;5:e1006).
Recent outbreaks of the disease suggest that current global action plans against cholera are failing, but …
Journal of Infectious Diseases
Volume 203 Issue 7 April 1, 2011
Eradication of Poliovirus: Fighting Fire With Fire
J Infect Dis. (2011) 203(7): 889-890 doi:10.1093/infdis/jiq148
Endemic wild polioviruses have been eliminated from most of the world, and the number of human paralytic cases has been reduced by >99%, from an estimated annual incidence of >500,000 cases to <2000 cases [ 1– 3]. Circulating wild polioviruses remain endemic in only 2 major locations, Nigeria and a zone extending from northern India west to Pakistan and Afghanistan [ 1– 3]. Furthermore, wild-type 2 poliovirus has been eliminated altogether, with the last documented case reported in northern India in 1999 [ 4]. These remarkable accomplishments represent a triumph for oral poliovirus vaccine (OPV), composed of attenuated variants of the 3 poliovirus serotypes [ 5]. OPV is administered by mouth, induces mucosal and humoral immunity, and is relatively inexpensive to produce—attributes that have contributed to its widespread use even in regions with rudimentary health systems.
However, OPV has an Achilles heel. The attenuated variants in the vaccine are rapidly replaced by revertant mutants, even on a single passage through the human intestine [ 6]. …
Journal of Infectious Diseases
Volume 203 Issue 7 April 1, 2011
MAJOR ARTICLES AND BRIEF REPORTS
Steven Wassilak, Muhammad Ali Pate, Kathleen Wannemuehler, Julie Jenks, Cara Burns, Paul Chenoweth, Emmanuel Ade Abanida, Festus Adu, Marycelin Baba, Alex Gasasira, Jane Iber, Pascal Mkanda, A. J. Williams, Jing Shaw, Mark Pallansch, and Olen Kew
editor’s choice: Outbreak of Type 2 Vaccine-Derived Poliovirus in Nigeria: Emergence and Widespread Circulation in an Underimmunized Population
J Infect Dis. (2011) 203(7): 898-909 doi:10.1093/infdis/jiq140
Free Full Text (HTML)
Wild poliovirus has remained endemic in northern Nigeria because of low coverage achieved in the routine immunization program and in supplementary immunization activities (SIAs). An outbreak of infection involving 315 cases of type 2 circulating vaccine-derived poliovirus (cVDPV2; >1% divergent from Sabin 2) occurred during July 2005–June 2010, a period when 23 of 34 SIAs used monovalent or bivalent oral poliovirus vaccine (OPV) lacking Sabin 2. In addition, 21 “pre-VDPV2” (0.5%–1.0% divergent) cases occurred during this period. Both cVDPV and pre-VDPV cases were clinically indistinguishable from cases due to wild poliovirus. The monthly incidence of cases increased sharply in early 2009, as more children aged without trivalent OPV SIAs. Cumulative state incidence of pre-VDPV2/cVDPV2 was correlated with low childhood immunization against poliovirus type 2 assessed by various means. Strengthened routine immunization programs in countries with suboptimal coverage and balanced use of OPV formulations in SIAs are necessary to minimize risks of VDPV emergence and circulation.
The Pediatric Infectious Disease Journal
April 2011 – Volume 30 – Issue 4
Lessons Learned From A Measles Outbreak in Antwerp, Belgium: 2007–2008
Asnong, Carine; Van Herck, Koen; Lernout, Tinne; Theeten, Heidi; Van Damme, Pierre
Pediatric Infectious Disease Journal. 30(4):343-345, April 2011.
A 2007 to 2008 measles outbreak in Antwerp, Belgium, identified the orthodox Jewish communities as a new risk group. This study analyzes vaccination data of 949 school children of 4 belief systems to assess the completeness and timeliness of their measles-mumps-rubella vaccination. Orthodox Jewish children show a 4-fold lower chance of complete vaccination, a delayed start, and increased temporal spacing of childhood vaccinations. Not only belief issues but difficulties to access the regular vaccination program also seem to be the main reason.
April 1, 2011 – Volume 29 – Issue 4 pp: 269-359
Sensitivity Analysis in Cost-Effectiveness Studies: From Guidelines to Practice
Jain, Rahul; Grabner, Michael; Onukwugha, Eberechukwu
Pharmacoeconomics. 29(4):297-314, April 1, 2011.
Cost-effectiveness analysis (CEA) is one of the main tools of economic evaluation. Every CEA is based on a number of assumptions, some of which may not be accurate, introducing uncertainty. Sensitivity analysis (SA) formalizes ways to measure and evaluate this uncertainty. Specific sources of uncertainty in CEA have been noted by various researchers. In this work, we consolidate across all sources of uncertainty, discuss the imbalanced attention to SA across different sources, and discuss criteria for conducting and reporting SA to help bridge the gap between guidelines and practice.
Guidelines on how to perform SA have been published for many years in response to requests for greater standardization among researchers. Decision makers tasked with reviewing new health technologies also seem to appreciate the additional information conveyed by a robust SA, including the attention to important patient subgroups. Yet, past reviews have shown that there is a substantial gap between the guidelines’ suggestions and the quality of SA in the field. Past reviews have also focused on one or two but not all three sources of uncertainty. The objective of our work is to comprehensively review all different sources of uncertainty and provide a concise set of criteria for conducting and presenting SA, stratified by common modelling approaches, including decision analysis and regression models.
We first provide an overview of the three sources of uncertainty in a CEA (parameter, structural and methodological), including patient heterogeneity. We then present results from a literature review of the conduct and reporting of SA based on 406 CEA articles published between 2000 and mid-2009. We find that a minority of papers addressed at least two of the three sources of uncertainty, with no change over time. On the other hand, the use of some sophisticated techniques, such as probabilistic SA, has surged over the past 10 years. Lastly, we identify criteria for reporting uncertainty-robust SA and also discuss how to conduct SA and how to improve the reporting of SA for decision makers. We recommend that researchers take a more comprehensive view of uncertainty when planning SA for an economic evaluation.
(Accessed 20 March 2011)
The Challenge of Discharging Research Ethics Duties in Resource-Constrained Settings Jerome Amir Singh Perspective, published 15 Mar 2011
Linked Research Article
Jones-López EC, Ayakaka I, Levin J, Reilly N, Mumbowa F, et al. (2011)
Effectiveness of the Standard WHO Recommended Retreatment Regimen (Category II) for Tuberculosis in Kampala, Uganda: A Prospective Cohort Study. PLoS Med 8: e427. doi:10.1371/journal.pmed.1000427
Prospective evaluation of the effectiveness of the WHO-recommended standardized retreatment regimen for tuberculosis by Edward Jones-López and colleagues reveals an unacceptable proportion of unsuccessful outcomes.
The paper by Jones-López et al. in this week’s PLoS Medicine  (hereinafter “the Uganda study”) illustrates the challenge of conducting research in resource-constrained settings. At the time the study was proposed and initiated, the prevalence of multidrug resistant tuberculosis (MDR-TB) in Uganda was unknown. Further, second-line therapy for MDR-TB, available in other settings, was not available in the country. The Uganda study accordingly highlights at least two classic ethical conundrums: (1) should research be conducted in a setting if the existing standard of care for the health issue under investigation is “no treatment,” despite efficacious treatment existing elsewhere? and (2) should investigators introduce
The pdf version f Vaccines: The Week in Review 14 March 2011 is available here and comprises to posts below for this date:
The GAVI Alliance Board said it appointed Dr Seth Berkley as GAVI’s new CEO. Dr. Berkley is currently President, CEO and founder of the International AIDS Vaccine Initiative (IAVI). Dagfinn Høybråten, GAVI Alliance Board Chair, commented, “The GAVI Board is delighted to have attracted such a highly qualified and charismatic individual as Dr Berkley. (He) is an experienced leader in global public health with strong advocacy skills and is highly motivated to making vaccines available for all children. I am confident that, with Dr Berkley as the CEO, the Alliance will further increase its crucial role in providing cost effective immunisation for the world’s disadvantaged.” Dr Berkley is expected to take up his new role in August but will participate in several key GAVI meetings, including the Alliance’s first pledging conference on 13 June, which will be hosted by the UK government.
Dr Berkley commented, “I am very familiar with GAVI’s life-saving work and have great admiration for its successful track record. I am, therefore, honored and extremely excited to have been chosen to lead the Alliance as it works to deliver on an ambitious new strategy to introduce new vaccines including those against pneumococcal and rotavirus diseases, Meningitis A, HPV, rubella and Japanese encephalitis. I also look forward to the day when malaria and HIV will be added to this list.”
IFFIm’s first issue of “Vaccine Bonds” for 2011 was jointly announced by Daiwa Securities Group, the International Finance Facility for Immunisation Company (“IFFIm”), the GAVI Alliance, and the World Bank. The group said this is the fourth issue of IFFIm’s vaccine bonds arranged by Daiwa, and that, including previous, highly successful issues in March 2008, February 2009 and March 2010, the total amount of IFFIm’s vaccine bonds arranged by Daiwa is now over USD 1 billion equivalent. Alan Gillespie, the Chairman of the IFFIm Board, commented, “This transaction marks another milestone in our successful partnership with Daiwa. Daiwa’s work in placing over USD 1 billion equivalent of IFFIm’s bonds is having a meaningful impact in furthering IFFIm’s life-saving work through the GAVI Alliance.”
The WHO Strategic Advisory Group of Experts (SAGE) posted the draft agenda for its meetings scheduled for 5-7 April 2011 at:
Separately, WHO issued a call for experts to serve on WHO SAGE Working Group on Vaccination in Humanitarian Emergencies. WHO is establishing a new Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on Vaccination in Humanitarian Emergencies, and solicits proposals for experts to serve on this working group for which the terms of reference and needed expertise appear in the attached document. Proposals for nominations should be sent by email to SAGE Executive Secretary at email@example.com with curriculum vitae and indication of expertise no later than 23 March 2011.
The MMWR for March 11, 2011 / 60(09);276-278 includes:
Japanese Encephalitis in Two Children — United States, 2010
Japanese encephalitis virus (JEV) is the leading cause of vaccine-preventable encephalitis in Asia and the western Pacific. JEV is maintained in an enzootic cycle involving mosquitoes and amplifying vertebrate hosts, mainly pigs and wading birds. The virus is transmitted to humans primarily by Culex mosquitoes, which breed in flooded rice fields and pools of stagnant water and most often feed outdoors during the evening and night. JEV transmission occurs mainly in rural agricultural areas, but occasional human cases occur in urban areas. Japanese encephalitis (JE) in persons who have traveled or lived overseas is diagnosed infrequently in the United States, with only four cases identified from 1992 (when a JE vaccine was first licensed in the United States) to 2008 (1). This report describes the only cases diagnosed in the United States and reported to CDC since then. The first was a fatal case in a U.S. child who had visited relatives in the Philippines. The other occurred in a refugee who became ill while traveling from Thailand to the United States and whose diagnosis was complicated by concurrent neurocysticercosis. JE should be considered in the differential diagnosis for any patient with an acute neurologic infection who recently has been in a JE-endemic country. Travelers to JE-endemic countries should be advised of the risk for JE and the importance of personal protective measures to prevent mosquito bites (2). JE vaccine should be considered for travelers who might be at greater risk based on the season, location, and duration of their visit and their planned activities….
The Weekly Epidemiological Record (WER) for 11 March 2011, vol. 86, 11 (pp 93–100) includes: Antigenic and genetic characteristics of influenza A(H5N1) and influenza A(H9N2) viruses for development of candidate vaccines viruses for pandemic preparedness – February 2011.
A selection of items of interest this week from a variety of twitter feeds. This capture is highly selective and not intended to be exhaustive.
British Medical Bulletin
Volume 97 Issue 1 March 2011
Health outcomes in economic evaluation: who should value health?
Br Med Bull (2011) 97(1): 197-210 first published online January 31, 2011 doi:10.1093/bmb/ldr001
The valuation of health states is an integral part of economic evaluation studies. The source of these valuations (general public vs. patients) is surrounded by controversy. Health state values generated by the general public are often different compared with those of patients. General public values may not account for adaptation of the patients; patients’ values potentially incorporate self-interest. Decisions on the appropriate source of health values ultimately depend on the specific decision-making context and objectives of the evaluation. Differences in valuations and implications for decision-making should be explicitly addressed. Further research should systematically identify circumstances in which public and patients’ valuations diverge. There appears ground for development of methods that allow the simultaneous incorporation of patients and public preferences. Existing literature which discusses the issues around the health state valuation is summarized.
Health Economics, Policy and Law
Volume 6 – Issue 01
Eliminating drug price differentials across government programmes in the USA
Kalipso Chalkidou, Gerard F Anderson and Ruth Faden
Federal agencies in the USA pay significantly different prices for the same prescription drugs because each agency uses a different approach to derive the payment rate. Because we do not identify any economic rationale or socially accepted moral reasoning that would justify the current level of price variation, we suggest that the federal government should pay a uniform price for each drug. Laws and regulations that give certain federal agencies the ability to earn rebates, use formularies, or permit other special arrangements would need to be eliminated in order to have a single payment rate. This could make some government agencies worse off than others; however, a uniform payment rate would not need to affect beneficiaries’ current financial contributions, access to drugs, benefits or overall public expenditures. At the same time, having a single rate would permit the government to adopt a more effective approach to purchasing drugs and send a consistent message to pharmaceutical companies concerning which types of drugs the government wants them to develop for government beneficiaries. How this single price would be derived and how it would compare with the lowest or highest prices currently achieved by government agencies would depend on a variety of policy issues including the government’s desire to encourage pharmaceutical research and development and the need to control health care spending.
Volume 7, Issue 2 February 2011
NEWS, POLICY AND PROFILES
High time for GAVI to push for lower prices
Daniel Berman and Rohit Malpani
Beyond patents: The GAVI Alliance, AMCs and improving immunization coverage through public sector vaccine production in the global south
Anne-Emanuelle Birn and Joel Lexchin
The pilot AMC: The acceptance of policy evolution
Jim Dobbins, Lord Avebury and Hugh McKinney
Diverse tools needed to ensure affordable vaccines for the poor
Christopher J. Elias
Fixing GAVI’s cash crunch
Getting priorities straight
Richard T. Mahoney
The AMC is helping save children’s lives today
Why the AMC matters
March 9, 2011, Vol 305, No. 10, pp 969-1050
A Multifaceted Mandatory Patient Safety Program and Seasonal Influenza Vaccination of Health Care Workers in Community Hospitals
Edward J. Septimus, Jonathan B. Perlin, Scott B. Cormier, Julia A. Moody, Jason D. Hickok
To the Editor: Seasonal influenza is the leading cause of vaccine-preventable death in the United States. 1 Since health care workers can contribute to the spread of seasonal influenza among vulnerable patients, US national health objectives for 2010 included a target vaccination rate for health care workers of 60%. 2 However, reaching and exceeding this goal has been difficult.
Most health care institutions recognize their ethical and professional responsibility to protect patients from preventable nosocomial infections while accommodating employees’ needs. Accordingly, we developed a multifaceted patient safety program that required seasonal influenza vaccination of health care workers but accommodated declination for any reason. We assessed vaccination rates in a large, diverse health care system primarily comprised of community hospitals after implementing this program.
March 9, 2011, Vol 305, No. 10, pp 969-1050
Book and Media Reviews
Progress in Bioethics: Science, Policy, and Politics
Andrew R. Barnosky
With the increasing politicization of bioethics, the essays in Progress in Bioethics: Science, Policy, and Politics offer a persuasive perspective on the philosophy of the topic, with a respectful comparison with traditional conservative approaches in the ethics debate. The book is a valuable contribution to leading scholarship in the field, and its overarching message is consistent with the Latin phrase with which Howard Shapiro begins the foreword: “ audi alteram partem (hear the other side).”
The book, edited by Jonathan Moreno and Sam Berger, includes contributions from 16 prominent scholars, including Callahan, Caplan, Wolpe, Shapiro, and Lempert; all are civil and refined in their approaches. Whether readers consider themselves on the right or the left regarding ethical and political approaches to issues in the life sciences and medicine, it would be difficult after reading this book to not have an enhanced understanding of the differing philosophical approaches to these topics …
Mar 12, 2011 Volume 377 Number 9769 Pages 875 – 966
Incidence and clearance of genital human papillomavirus infection in men (HIM): a cohort study
Anna R Giuliano, Ji-Hyun Lee, William Fulp, Luisa L Villa, Eduardo Lazcano, Mary R Papenfuss, Martha Abrahamsen, Jorge Salmeron, Gabriella M Anic, Dana E Rollison, Danelle Smith
Human papillomaviruses (HPVs) cause genital warts and cancers in men. The natural history of HPV infection in men is largely unknown, and that information is needed to inform prevention strategies. The goal in this study was to estimate incidence and clearance of type-specific genital HPV infection in men, and to assess the associated factors.
Men (aged 18—70 years), residing in Brazil, Mexico, and the USA, who were HIV negative and reported no history of cancer were recruited from the general population, universities, and organised health-care systems. They were assessed every 6 months for a median follow-up of 27·5 months (18·0—31·2). Specimens from the coronal sulcus, glans penis, shaft, and scrotum were obtained for the assessment of the status of HPV genotypes.
In 1159 men, the incidence of a new genital HPV infection was 38·4 per 1000 person months (95% CI 34·3—43·0). Oncogenic HPV infection was significantly associated with having a high number of lifetime female sexual partners (hazard ratio 2·40, 1·38—4·18, for at least 50 partners vs not more than one partner), and number of male anal-sexual partners (2·57, 1·46—4·49, for at least three male partners vs no recent partners). Median duration of HPV infection was 7·52 months (6·80—8·61) for any HPV and 12·19 months (7·16—18·17) for HPV 16. Clearance of oncogenic HPV infection decreased in men with a high number of lifetime female partners (0·49, 0·31—0·76, for at least 50 female partners vs not more than one partner), and in men in Brazil (0·71, 0·56—0·91) and Mexico (0·73, 0·57—0·94) compared with the USA. Clearance of oncogenic HPV was more rapid with increasing age (1·02, 1·01—1·03).
The data from this study are useful for the development of realistic cost-effectiveness models for male HPV vaccination internationally.
National Cancer Institute.
Mar 12, 2011 Volume 377 Number 9769 Pages 875 – 966
US bioethics commission hears expert testimonies
The US Presidential bioethics commission, tasked with reviewing ethical guidelines to protect human trial participants, held its first public meeting on the topic last week. Nellie Bristol reports.
Medical Decision Making (MDM)
March/April 2011; 31 (2)
Jacob A. Udell and Donald A. Redelmeier
Patient Preferences and the Ironic Nature of Randomized Trials
Med Decis Making March/April 2011 31: 226-228, doi:10.1177/0272989X11399125
Randomized trials are an attractive form of medical research that often contains blemishes when examined carefully. One criticism relates to limited generalizability, because such studies typically include only a fraction of the available patients and often exclude the challenging individuals who have complex comorbidities. 1 Randomized trials can also fail because of practical issues such as insufficient recruitment (inadequate power bias), a limited duration of follow-up (brevity bias), or losses to follow-up (attrition bias). 2 Several other opportunities for misinterpretation arise if the study is not adequately blinded so that outcomes and co-interventions are managed in a slanted manner. 3 Furthermore, the large costs of a randomized trial (both financial and operational) create a potential conflict of interest for investigators and a worrisome reality that the research will not be repeated.
This issue of the journal describes a further blemish in randomized trials that is subtle, pervasive, and rarely mentioned. Specifically, such trials randomize the assignment of patients to treatments and thereby require each person to disregard his or her inherent preferences. Such a behavior style is remarkably strange for a sentient adult, does not occur in usual clinical settings, and typically must be maintained for an extended interval. 4, 5 Of course, patients sometimes feel conflicted when facing a choice, and such indecision may take time to resolve before a subsequent commitment. By definition, however, a randomized trial requires each patient to follow a treatment that has been randomly assigned with no basis. 6 …
Volume 471 Number 7337 pp135-260 10 March 2011
Vaccinate for the next H2N2 pandemic now
An old influenza strain still circulating in birds and swine could easily jump back to humans now that immunity to it has dropped, warn Gary J. Nabel and his colleagues.