Is the EMA Poised to Make a Major U-turn on its Transparency Initiative?

In timing that highlights the importance of Clinical Trials Day and the AllTrials campaign, Peter Doshi and Tom Jefferson, two of the authors of the recent systematic review of Clinical Study Reports and summary of regulatory comments on Oseltamivir for influenza assess an alarming development in clinical trial transparency initiatives, which is also the subject of a public letter by the European Ombudsman.

Image Credit, Steven Depolo, Flickr

Image Credit, Steven Depolo, Flickr

Summary

The European Medicines Agency (EMA) appears poised to make a major U-turn on its transparency initiatives, reversing its principle of public access to clinical trial data as its sets up a system of controlled access similar to those independently established by industry. This is a stunning and surprising reversal, particularly as it comes after AbbVie dropped its lawsuit against EMA and after the passing of the European clinical trials legislation which will require public access to Clinical Study Reports. If finalized, the EMA’s new policy will prohibit a data requestor from even printing out a redacted Clinical Study Reports: they must instead read it in a so-called “view- on-screen-only” mode.


Continue reading »

Category: General | Comments Off

The MSF Scientific Day 2014 will be streamed live online on Friday 23rd May

PLOS Medicine and BioMed Central are proud to be co-sponsoring this year’s MSF Scientific Day and have co-written this joint blog on both the Speaking of Medicine and the BioMed Central blog to mark the occasion.

Image Credit: @TiffDahmash

Image Credit: @TiffDahmash

Streamed live on 23rd May 2014 from the Royal Society of Medicine (RSM) in London, MSF Scientific Day is a unique opportunity to showcase medical and scientific research carried out in MSF programmes around the world. MSF provides medical aid to populations in over 60 countries affected by armed conflicts, epidemics, famines, natural disasters and those excluded from healthcare. The MSF Scientific Day was a huge success last year with over 2000 people taking part, 1700 of them tuning in from 92 different countries, with a keynote speech by international health expert, Hans Rosling on the synergy and conflict between research and advocacy.


Continue reading »

Category: General, MSF | Tagged | Comments Off

Integrated Neglected Tropical Disease (NTD) Control: The Early Years

Peter J Hotez and the Global Network for Neglected Tropical Diseases discuss integrated control measures for NTDs.

Co-endemicity map in Burundi communes in 2009 for trachoma, onchocerciasis, schistosomiasis and soil transmitted helminth infections. Ndayishimiye  et al.

Co-endemicity map in Burundi communes in 2009 for trachoma, onchocerciasis, schistosomiasis and soil transmitted helminth infections.
Ndayishimiye et al.

Among the unusual and striking aspects of global integrated NTD control and elimination activities was the exceedingly quick timeline between the time when the concept of integrating NTDs was first proposed and when implementation was initiated.  The intellectual framework for a public policy for integrated mass drug administration campaigns that targeted the seven major NTDs simultaneously – ascariasis, trichuriasis, hookworm infection, schistosomiasis, lymphatic filariasis (LF), onchocerciasis, and trachoma – entered the biomedical literature in 2005.  Within months a public policy was launched, and expanded implementation of this approach begun.

This month PLOS Neglected Tropical Diseases published a detailed account of a four-year (2007-2011)-long integrated NTD program conducted in the nation of Burundi, a small, densely populated, and landlocked East African nation.  When the program began, Burundi had only recently emerged from more than a decade of civil conflict, yet the nation was one of the first few to employ integrated mass drug administration campaigns.  The project was launched through private support from the Legatum investment group channeled through the international philanthropy expert, Geneva Global, and ultimately the Global Network for Neglected Tropical Diseases (known previously as the GNNTDC or Global Network for NTD Control) for financial management.  SCI (Schistosomiasis Control Initiative) and CBM served as technical implementation advisors to the Ministry of Health (MoH) of Burundi.  Together with a parallel program in Rwanda, these two projects established proof-of-principle for successful private financial investments in NTD control, which ultimately led to the establishment of The END Fund.


Continue reading »

Category: General | Comments Off

Assessing Voluntary Medical Male Circumcision for HIV Prevention in a Unprecendented Public Health Intervention

PLOS launches a new collection, Voluntary Medical Male Circumcision for HIV Prevention: Improving Quality, Efficiency, Cost Effectiveness, and Demand for Services during an Accelerated Scale-up, which focuses on the challenges and opportunities of a large scale public health intervention. Dr. Emmanuel Njeuhmeli and Dr. Rhona MacDonald discuss the implementation and outcomes of the program so far.

Voluntary medical male circumcision (VMMC) – a surgical procedure that involves the complete removal of the foreskin by a trained medical professional – has been shown to be effective in the prevention of HIV transmission.

Image Credit: (left) Sgt. Adam Fischman, US Army Africa & (right) Sterling Riber, MFDI for Jhpiego/Tanzania

Image Credit: (left) Sgt. Adam Fischman, US Army Africa & (right) Sterling Riber, MFDI for Jhpiego/Tanzania

In 2007, WHO and the Joint United Nations Programme on HIV /AIDS  recommended that 14 priority countries with high HIV and low male circumcision prevalence in Southern and Eastern Africa consider implementing VMMC as a key intervention in their HIV prevention portfolio.

This massive public health intervention launched in 2009 with support from WHO/UNAIDS calling for 80% coverage of male circumcision by 2016. Although the growth of VMMC programs has dramatically increased over recent years, it appears that the coverage goal will be unattainable by 2016.
Continue reading »

Category: General | Tagged , | 2 Comments

Arboviruses and Sandwiches: April’s Lunch & Learn with Dr LaBeaud

Kathleen Luschek, PLOS staff member, shares April’s Lunch & Learn with Dr Desiree LaBeaud, as part of an ongoing program to further dialogue between PLOS and the broader open community.

Dr. Desiree LaBeaud, CHORI

Dr. Desiree LaBeaud, CHORI

On April 11, 2014, the PLOS head office in San Francisco hosted our fourth Lunch & Learn of the year. This month’s speaker was Dr. Desiree LaBeaud, a research scientist at Children’s Hospital Oakland Research Institute, who also serves as Deputy Editor for PLOS Neglected Tropical Diseases. Dr. LaBeaud spoke about her research on arboviruses, specifically Rift Valley fever virus, chikungunya, and dengue. While most of Dr. LaBeaud’s work takes place in Kenya, she spoke about the recent (within the last 20 years) resurgence of outbreaks around the world; she described the dramatic increase not only in geographic distribution, but also in scale and types, with one cause being globalization and increased air travel. She explained that despite the spread of these mosquito-borne viruses into the developed world, they are still very much Neglected Tropical Diseases. As with other NTDs, both socioeconomic status and lasting effects are important, and while there are mosquito vectors here in the U.S., the largest outbreaks continue to occur in developing nations, particularly across Africa. (For more on Dr. LaBeaud’s views on why arboviruses belong on the list of NTDs, see her Viewpoint here.)
Continue reading »

Category: Dengue, Neglected Diseases | Comments Off

Arboviruses and Sandwiches: April’s Lunch & Learn with Dr LaBeaud

Kathleen Luschek, PLOS staff member, shares April’s Lunch & Learn with Dr Desiree LaBeaud, as part of an ongoing program to further dialogue between PLOS and the broader open community.

Dr. Desiree LaBeaud, CHORI

Dr. Desiree LaBeaud, CHORI

On April 11, 2014, the PLOS head office in San Francisco hosted our fourth Lunch & Learn of the year. This month’s speaker was Dr. Desiree LaBeaud, a research scientist at Children’s Hospital Oakland Research Institute, who also serves as Deputy Editor for PLOS Neglected Tropical Diseases. Dr. LaBeaud spoke about her research on arboviruses, specifically Rift Valley fever virus, chikungunya, and dengue. While most of Dr. LaBeaud’s work takes place in Kenya, she spoke about the recent (within the last 20 years) resurgence of outbreaks around the world; she described the dramatic increase not only in geographic distribution, but also in scale and types, with one cause being globalization and increased air travel. She explained that despite the spread of these mosquito-borne viruses into the developed world, they are still very much Neglected Tropical Diseases. As with other NTDs, both socioeconomic status and lasting effects are important, and while there are mosquito vectors here in the U.S., the largest outbreaks continue to occur in developing nations, particularly across Africa. (For more on Dr. LaBeaud’s views on why arboviruses belong on the list of NTDs, see her Viewpoint here.)
Continue reading »

Category: Dengue, Neglected Diseases | Comments Off

Launch of the PLOS Pediatric Medicine Collection

PLOS Medicine Editors Rhona MacDonald and Amy Ross on the launch of the new PLOS Pediatric Medicine Collection and the upcoming Pediatric Academic Societies and Asian Society for Pediatric Research Meeting, where PLOS will be in attendance.

pediatric_medicine

Image credits (clockwise from top left): Matt Erasmus, Flickr.com; D.C. Atty, Flickr.com; Frank Douwes, Flickr.com; U.S. Air Force photo/Staff Sgt Eric T. Sheler, Wikimedia Commons

To coincide with PLOS Medicine’s participation in the Pediatric Academic Societies and Asian Society for Pediatric Research joint meeting (PAS/ASPR 14) in Vancouver on May 3-6, PLOS is delighted to announce the launch of a new collection on pediatric medicine. This collection collates key research and commentary relating to the health of children that has been published across the PLOS journals over the past year.

The Pediatric Medicine Collection covers children of all ages, includes those living in high, middle, and low-income countries, and covers the main conditions affecting children world-wide.
Continue reading »

Category: Collections, Conference news, General, Maternal Newborn and Child Health | Comments Off

Chikun—what?

Kristy Murray urges preventative action in the United States against Chikungunya, a dangerous virus spread by mosquitoes which has already reached the Caribbean.

It’s best to start learning how to pronounce the word “Chikungunya” (chik-en-gūn-ya): this crippling virus that is spread by mosquitoes could soon be making landfall to a city near you.

Chikungunya Vector Aedes Aegypti Image Credit: James Gathany (PHIL, CDC) [Public domain], via Wikimedia Commons

Chikungunya Vector Aedes aegypti
Image Credit: James Gathany (PHIL, CDC) [Public domain], via Wikimedia Commons

Chikungunya virus can cause a very severe disease in people, with fevers, headaches, and painfully debilitating joint pain that can last for months to years.  The word “chikungunya” is African (Makonde) in origin and translates to “that which bends up.”  People infected with this virus are literally bent up from the extreme joint pain they experience.  The virus is spread from person to person through Aedes species mosquitoes -  very aggressive day feeders that are widespread throughout the Americas.

This virus was originally identified in Africa more than 50 years ago.  During the first decade of the millennium, the virus began to spread rapidly to India, islands throughout the Indian Ocean, and other parts of Asia.  In 2007, it took only one infected person to travel from India to Italy to create a major outbreak, sickening more than 200 people.
Continue reading »

Category: General | 1 Comment

Advances in HIV Mucosal Immunology: Challenges and Opportunities

Florian Hladik from the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle, USA, explains why recent research on how to study the rectal and genital mucosa – featured in the new PLOS Collection Advances in HIV Mucosal Immunology: Challenges and Opportunities will be key to developing an effective HIV vaccine.

Image Credit: Artistic rendition of immune cells and potential HIV targets in the rectal mucosal. Yang, Ochoa, Preza & Anton, 2014

Image Credit: Artistic rendition of immune cells and potential HIV targets in the rectal mucosal. Yang, Ochoa, Preza & Anton, 2014

People most often become infected with HIV through sexual transmission; accordingly, their initial exposure to the virus is in their genital or rectal mucosa. Consequently, the best opportunity to prevent HIV transmission is through interventions that affect the mucosa. For example, new HIV infections could be prevented by reducing the amount of virus in the genital fluids of infected people or by stopping HIV from establishing productive infections in the genital or rectal mucosa of uninfected people. In order to design HIV interventions that work this way, we must first understand how best to study the mucosa so that we can determine whether test interventions are effective.
Continue reading »

Category: Collections, HIV | Tagged , , , , | 1 Comment

Malaria Control in Emergencies: Time for Action

Estrella Lasry, Tropical Advisor to MSF, on measures taken by the organisation to predict and prevent malaria outbreaks in emergency situations.

Credit: Anna Surinyach/MSF

Credit: Anna Surinyach/MSF

A lunar landscape, cracked earth and scorching heat. 4,000 rudimentary tents made from wooden poles and plastic sheeting. And people everywhere, 95% of them women and children, according to camp authorities, and a few men, hoping at least to find safety and security, and perhaps even to make a first step towards  a new life. It’s another day at one of the refugee camps where Médecins Sans Frontiéres (MSF) is working in Ethiopia, and “home” to thousands of South Sudanese people fleeing the latest wave of violence in their country. Any day now the rainy season will begin, bringing floods and creating endless breeding sites for mosquitoes, and with them a new spike in malaria.
Continue reading »

Category: MSF | Comments Off