New England Journal of Medicine
May 5, 2011  Vol. 364 No. 18
http://content.nejm.org/current.shtml

Perspective
Statistics in Medicine: Pragmatic Trials — Guides to Better Patient Care?
J.H. Ware, M.B. Hamel

[no abstract, first 100 words…]
Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients’ and clinicians’ actual questions about a given treatment. For example, placebo-controlled trials of a new migraine medication help to establish its efficacy, but they may not help clinicians and patients choose between the new medication and other available treatments. Moreover, since most randomized clinical trials are efficacy trials, researchers enroll a homogeneous patient population, define treatment regimens carefully and require that they be . . .

New England Journal of Medicine
May 5, 2011  Vol. 364 No. 18
http://content.nejm.org/current.shtml

Listening to Provenge — What a Costly Cancer Treatment Says about Future Medicare Policy
J.D. Chambers, P.J. Neumann

Free Full Text

PLoS Medicine
(Accessed 8 May 2011)
http://www.plosmedicine.org/article/browse.action?field=date

Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview
Su Golder, Yoon K. Loke, Martin Bland Research Article, published 03 May 2011
doi:10.1371/journal.pmed.1001026

Abstract 
Background
There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of meta-analyses aimed to assess the level of agreement or disagreement in the estimates of harm derived from meta-analysis of RCTs as compared to meta-analysis of observational studies.

Methods and Findings
Searches were carried out in ten databases in addition to reference checking, contacting experts, citation searches, and hand-searching key journals, conference proceedings, and Web sites. Studies were included where a pooled relative measure of an adverse effect (odds ratio or risk ratio) from RCTs could be directly compared, using the ratio of odds ratios, with the pooled estimate for the same adverse effect arising from observational studies. Nineteen studies, yielding 58 meta-analyses, were identified for inclusion. The pooled ratio of odds ratios of RCTs compared to observational studies was estimated to be 1.03 (95% confidence interval 0.93–1.15). There was less discrepancy with larger studies. The symmetric funnel plot suggests that there is no consistent difference between risk estimates from meta-analysis of RCT data and those from meta-analysis of observational studies. In almost all instances, the estimates of harm from meta-analyses of the different study designs had 95% confidence intervals that overlapped (54/58, 93%). In terms of statistical significance, in nearly two-thirds (37/58, 64%), the results agreed (both studies showing a significant increase or significant decrease or both showing no significant difference). In only one meta-analysis about one adverse effect was there opposing statistical significance.

Conclusions
Empirical evidence from this overview indicates that there is no difference on average in the risk estimate of adverse effects of an intervention derived from meta-analyses of RCTs and meta-analyses of observational studies. This suggests that systematic reviews of adverse effects should not be restricted to specific study types.

Science                                                
6 May 2011 vol 332, issue 6030, pages 625-752
http://www.sciencemag.org/current.dtl

EDITORIAL
Indigenous Genomics
Vanessa Hayes
Science 6 May 2011: 639

Summary
Studies of indigenous peoples are a crucial part of genomic research, not only to define the extent of human diversity but to provide medical benefit to all people. There are more than 370 million indigenous people living in almost half the countries of the world. Exploding interest in indigenous genomics and global population structure has raised debate about issues of informed consent and community benefit. As was evident in March 2011 during the African and Southern African Society of Human Genetics Meeting in Cape Town, South Africa, the inclusion of indigenous people in future genomic research is paramount, but ethical guidelines must address local concerns. Scientific practices and values must be integrated with indigenous governance so that such genomic research can continue, with the benefits fully realized by all.

Vaccine
Volume 29, Issue 22 pp. 3827-3930 (17 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Letters
Cost-effectiveness of Ontario’s pandemic vaccine program
Page 3829
Elizabeth Rolland-Harris, Martin Tepper

Vaccine
Volume 29, Issue 22 pp. 3827-3930 (17 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Regular Papers
Barriers to early uptake of tetanus, diphtheria and acellular pertussis vaccine (Tdap) among adults—United States, 2005–2007  Original Research Article
Pages 3850-3856
Brady L. Miller, Katrina Kretsinger, Gary L. Euler, Peng-Jun Lu, Faruque Ahmed

Abstract
Background
The tetanus, diphtheria and acellular pertussis vaccine (Tdap) was recommended by the Advisory Committee on Immunization Practices (ACIP) for U.S. adults in 2005. Our objective was to identify barriers to early uptake of Tdap among adult populations.

Methods
The 2007 National Immunization Survey (NIS)-Adult was a telephone survey sponsored by the Centers for Disease Control and Prevention (CDC). Immunization information was collected for persons aged ≥18 years on all ACIP-recommended vaccines. A weighted analysis accounted for the complex survey design and non-response.

Results
Overall, 3.6% of adults aged 18–64 years reported receipt of a Tdap vaccination. Of unvaccinated respondents, 18.8% had heard of Tdap, of which 9.4% reported that a healthcare provider had recommended it. A low perceived risk of contracting pertussis was the single most common reason for either not vaccinating with Tdap or being unwilling to do so (44.7%). Most unvaccinated respondents (81.8%) indicated a willingness to receive Tdap if it was recommended by a provider.

Conclusions
During the first two years of availability, Tdap uptake was likely inhibited by a low collective awareness of Tdap and a low perceived risk of contracting pertussis among U.S. adults, as well as a paucity of provider-to-patient vaccination recommendations. Significant potential exists for improved coverage, as many adults were receptive to vaccination.

Vaccine
Volume 29, Issue 22 pp. 3827-3930 (17 May 2011)
http://www.sciencedirect.com/science/journal/0264410X

Mumps outbreaks in four universities in the North West of England: Prevention, detection and response  Original Research Article
Pages 3883-3887
D. Kay, M. Roche, J. Atkinson, K. Lamden, R. Vivancos

Abstract
Evidence suggests that primary and secondary vaccine failure have contributed to recent university-based mumps outbreaks. We describe the epidemiology and public health management of two such outbreaks that occurred simultaneously in two areas of the North West of England, affecting four universities, using data from routine surveillance, serology testing, and telephone interviews and electronic questionnaires. Vaccination status was obtained from GP records. Cases were predominantly first year students living in university halls of residence. Public health response involved active surveillance, isolation advice and targeted vaccination clinics. Many students lack natural immunity and mumps vaccination. Factors hindering the public health response include delayed notifications, inability to readily define the ‘at risk’ population, low vaccine uptake, and lack of an evidence-based, cost effective strategy.

The pdf version of  Vaccines: The Week in Review  2 May 2011, comprising the posts below for this date is here:

Vaccines_The Week in Review_2 May 2011

    The Government of Rwanda, QIAGEN N.V. and Merck announced “the launch of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.” Rwanda “is the first nation in Africa to offer a comprehensive prevention program that incorporates both HPV vaccination and HPV testing.” Rwanda has a population of 2.72 million women ages 15 years and older. Cervical cancer ranks as the most frequent cancer in women of all ages in Rwanda. Dr. Richard Sezibera, Rwanda’s Minister of Health, commented, “It is our goal to create a comprehensive, coordinated program that includes HPV vaccination, cancer screening with HPV DNA testing, and treatment in order to address the nation’s unmet needs for cervical cancer-related health services. This vaccination and screening program brings us one step closer to reaching our goal of protecting the girls and women in our country. We are pleased to have the support of Merck and QIAGEN on this important government initiative.”

Merck “will provide more than two million doses of GARDASIL to the Government of Rwanda at no cost, while QIAGEN will provide 250,000 HPV screening tests at no cost along with all necessary equipment and training to successfully perform the tests. Thereafter, the Government of Rwanda will continue routine vaccination of appropriate 12 year old girls, and Merck will provide GARDASIL at a discounted access price that is made available for national vaccination programs in GAVI-eligible countries. Similarly, QIAGEN will make its HPV tests accessible under a tiered-market pricing structure designed to enable developing countries to establish and maintain the use of HPV testing within national cervical cancer screening and treatment programs.”

http://www.businesswire.com/news/home/20110425005622/en/Rwanda-Merck-QIAGEN-Launch-Africa’s-Comprehensive-Cervical

Caliber Biotherapeutics, “a fully-integrated biopharmaceutical company,” announced the opening of the world’s largest plant-made pharmaceutical manufacturing facility in Bryan, Texas, “with the capability of producing 10-100 million doses of vaccines per month,” and hundreds of thousands of doses of protein biotherapeutics such as monoclonal antibodies. Caliber “will also develop a proprietary product pipeline for cancer and infectious diseases utilizing cell- and microbial-based production systems. The end result will be new, more effective and affordable vaccines and biotherapeutics for patients – delivered in a time frame in which they are needed.” http://www.prnewswire.com/news-releases/new-biopharmaceutical-company-to-accelerate-delivery-of-vaccines-and-protein-therapeutics-120619094.html

“We need to make rotavirus vaccines available to all children”

Statement by the GAVI Alliance interim CEO, Helen Evans

Geneva, 28 April 2011 – Rotavirus disease continues to be a significant global health problem. As illustrated in newly released surveillance data by WHO and CDC, globally, 36% of children’s hopitalisation for diarrhoea are due to rotavirus infection.

But while the global rotavirus disease burden remains high, encouraging and growing evidence suggests that the introduction of rotavirus vaccines substantially reduce severe and fatal diarrhoea in young children.

Recognising the enormous potential impact of rotavirus vaccines on reducing child mortality, GAVI added rotavirus vaccines to its portfolio of vaccines for the poorest countries around the world. To date, four GAVI eligible countries have introduced the vaccine: Nicaragua, Honduras, Bolivia and Guyana. Sudan will be the first African country to introduce rotavirus vaccines before the end of the year.

GAVI is committed to working with its partners to accelerate the introduction of rotavirus vaccines in poor countries, and demand for rotavirus vaccines from GAVI-eligible countries is high.

With such life-saving tools within our reach, GAVI counts on the support of policymakers and donors to help accelerate the introduction of new and underused vaccines to the poorest children of the world. A successful outcome of GAVI’s Pledging Conference on 13 June will allow another 4 million lives to be saved.

http://www.gavialliance.org/media_centre/statements/rotavirus.php

The Weekly Epidemiological Record (WER) for 29 April 2011, vol. 86, 18 (pp 173–176) includes: Outbreak news – Measles outbreaks in Europe; Rotavirus surveillance worldwide – 2009
http://www.who.int/entity/wer/2011/wer8618.pdf

Twitter Watch

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.

GAVIAlliance GAVI Alliance
News Update: We need to make rotavirus vaccines available to all children http://ow.ly/1cpEki
29 Apr

gatesfoundation Gates Foundation
Stories, videos, and photos from European #Immunization Week: http://gates.ly/kGSxKg

AIDSvaccine IAVI
We’re pleased to announce the launch of IAVI’s Fellowship Program in #AIDS #Vaccine #Research & Dev http://bit.ly/j2oX0L #globalhealth #HIV

USAIDGH USAID
Polio Immunization Efforts Showing Positive Results in Southern Sudan. Read more here: http://go.usa.gov/bb0

GAVIAlliance GAVI Alliance
Malaria vaccine development: Marking progress and impact http://ht.ly/4GXeM

PATHtweets PATH
Elias: Malaria drug resistance is a growing threat. We need to keep investing in new tools to stay ahead of the parasite. #WorldMalariaDay

MalariaVaccine PATH MVI
Interview: MVI’s Dr. Christian Loucq discusses his life-long passion for #vaccines one.org/blog/2011/04/2… #malaria

Emerging Infectious Diseases
Volume 17, Number 5–May 2011
http://www.cdc.gov/ncidod/EID/index.htm

Perspective
Vector-borne Infections
R. Rosenberg and C.B. Beard

Abstract
Infections with vector-borne pathogens are a major source of emerging diseases. The ability of vectors to bridge spatial and ecologic gaps between animals and humans increases opportunities for emergence. Small adaptations of a pathogen to a vector can have profound effects on the rate of transmission to humans.

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Editorial
The worldwide epidemic of multidrug-resistant tuberculosis
The Lancet Infectious Diseases

WHO estimates that a third of the world’s population is infected with Mycobacterium tuberculosis. In 2009, there were almost 9 million new cases of tuberculosis and the disease killed almost 1 million people around the world. Since the discovery of the BCG vaccine, and the development of new antibiotics in the 1950s, the incidence of tuberculosis has fallen substantially. From 1995 to 2009, about 49 million people received treatment for the disease, 41 million of whom were cured, saving up to 6 million.

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Comment
Jeddah declaration on mass gatherings health
Ziad A Memish, Abdullah A Alrabeeah

Planning of events attended by millions of people is a daunting undertaking, and all too often it is done on an ad-hoc basis or via general operations oversight that includes health care along with a multitude of other responsibilities. Recognition that mass gatherings need a coordinated medical infrastructure is not new. What is new and different is an improved understanding of infectious diseases that originate and then disseminate from mass gatherings. Containment of this risk is a global priority.

The Lancet Infectious Disease
May 2011  Volume 11  Number 5  Pages 333 – 416
http://www.thelancet.com/journals/laninf/issue/current

Newsdesk
Vaccines and public health in Europe
Raffaella Bosurgi

The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference on the Impact of Vaccines on Public Health was held in Prague, Czech Republic (April 1–3, 2011), with support from The Lancet Infectious Diseases. The conference shared expert insights and scientific evidence about a diverse range of topics including human papillomavirus (HPV) and women’s health, vaccines for infants and elderly people, the pipeline for malaria vaccines, vaccination for HIV, and the big challenges of the 21st century.

Science                                                          <
29 April 2011 vol 332, issue 6029, pages 501-624
http://www.sciencemag.org/current.dtl

News & Analysis – Infectious Diseases
‘Breakthrough’ Deal on Flu Strains Has Modest Provisions
Martin Enserink

When exhausted negotiators in Geneva finally reached a deal about the global sharing of influenza viruses early in the morning on Saturday, 15 April, the World Health Organization (WHO) was quick to call it a “landmark agreement.” WHO chief Margaret Chan hailed the 45-page document as “a very significant victory for public health.” But the most significant breakthrough may be that, after 4 years of complex and often contentious negotiations, there is a deal at all. The actual text of the agreement—which promises developing countries certain benefits in return for sharing their flu viruses with the world—contains mostly “soft” language that’s not legally binding.