Everything You Always Wanted to See about Sex in Leishmania

Geneviève Lanotte (retired), Jean-Antoine Rioux (retired), and Jérémy Bouyer from CIRAD recount that cellular fusion in Leishmania was filmed in the 80s and provide the sex movie to the scientific community.

The title of our comment refers to the humorous title of the Review by Rougeron et al. (2010) on the sexuality of Leishmania: Everything You Always Wanted to Know about Sex (but Were Afraid to Ask)” in Leishmania after Two Decades of Laboratory and Field Analyses. In this paper, the authors present recent works challenging the dogmatic hypothesis of “dominant and ancient clonal reproductive mode”. Amazing animations already exist to illustrate the clonal reproduction cycle of Leishmania. Rougeron et al. (2010) refer to population genetics and experimental works but point out the “lack of clear evidence (experimental or biological confirmation) of sexuality in Leishmania parasites” and suggest using high-resolution imaging to capture a mating event. But what if a sex movie was already available?

Figure1

The sexuality of Leishmania: from fornicomastigotes (on the left) to a zygomastigote (on the right), recorded in the late 80s by Lanotte & Rioux. The full video is provided for the first time at the end of this comment.

Before satisfying our curiosity, let’s revisit some concepts.
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Category: General, Leishmaniasis | Tagged , , , , | 1 Comment

An Open Letter to the EMA from the AllTrials Steering Committee

AllTrials

AllTrials campaign
c/o Sense About Science
14A Clerkenwell Green
London EC1R 0DP

alltrials@senseaboutscience.org

 

Professor Guido Rasi
Director, European Medicines Agency
7 Westferry Circus
Canary Wharf
London E14 4HB

2nd June 2014

 

Dear Professor Rasi

Re: Draft Publication and access to clinical-trial data policy (EMA/240810/2013)

Hundreds of supporters of the AllTrials campaign contributed last year to the Agency’s consultation on its draft policy “Publication and access to clinical-trial data.” We welcomed the EMA’s proposals which would have seen Clinical Study Reports published proactively and openly in line with an Agency policy that the information in those reports should not generally be considered commercially confidential. We are now concerned that the most recent draft of the policy as shared with some stakeholders at meetings this month introduces barriers that will make it all but useless to independent researchers.

We understand that there are four areas of particular concern:

1. Clinical Study Reports will only be available for viewing on screen and cannot be saved, downloaded, printed, copied, annotated or shared in any way. This will make it nearly impossible for researchers to usefully scrutinise the documents. CSRs often contain thousands of pages of complex information. Research teams need to be able to share information and researchers have to be able to print or copy information such as outcome definitions, to make valid comparisons across studies. Your policy on access to CSRs as initially proposed could have made a genuine contribution to medical research. It now risks becoming a superficial and practically useless gesture.

2. The wording of the draft “Redaction Principles” policy is ambiguous, and where there is ambiguity, there is likely to be excessive redaction. For example, “statements/descriptions relating to objectives that are not supportive of a label claim and do not contribute to the overall benefit/risk evaluation” may be redacted. This would appear to suggest that any information on off-label uses of drugs will not be made available. While the Agency’s own use of these documents may be limited to a decision on one specific use of a treatment, in everyday clinical practice these same treatments are routinely and legally used by clinicians outside their marketing authorisation. This prescribing is based on published evidence that may be particularly vulnerable to dissemination bias, since evidence on off-label uses is frequently excluded from even voluntary codes of practice.

3. The “Redaction Principles” policy asks sponsors to submit two versions of a CSR from each trial: a standard version (CSR(a)) and a redacted version (CSR(b)). While this might be driven by a desire to lower the costs of transparency for the Agency, it puts primary responsibility for redacting in the hands of sponsors. How close CSR(a) is to CSR(b), and which parts are missing, may never be known to researchers granted access to CSR(b). Will there be an audit to explore whether redactions are proportionate or risk patient safety, and penalties for excessive redactions?

4. The Terms of Use contract contains clauses that seem to prioritise trial sponsors’ legal rights over researchers’ need to scrutinise and use information from CSRs to improve the evidence base for patient care. These supposed rights given to sponsors have never been established in law and are currently being debated in court cases in which the Agency is involved. Of greater concern, researchers will be asked to agree to a clause that allows trial sponsors to take direct legal action against the researcher for possible violation of the terms of use. Individual researchers are therefore being made vulnerable to protracted legal battles with large companies for infractions to these cumbersome rules. Since the rules themselves are poorly specified, these cases are likely to involve lengthy legal discussion. They will therefore introduce a new and unpredictable risk of high legal costs into routine academic work, effectively chilling researchers’ ability to use information relevant to patient care.
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Category: General | 1 Comment

The Failures and Futures of the Peer Review Process

Elspeth K. Ritchie from Newcastle University’s Biopharmaceutical Bioprocessing Technology Centre reflects on discussions between academic journal editors and writers after attending the Voice of Young Science “Peer Review: Nuts & Bolts” workshop, which was supported by several organisations including PLOS.

The words “peer review process” mean different things throughout a scientist’s career. For the established professor, it may be a well worn path. Meanwhile, it strikes terror into those preparing to submit for the first time. For those wanting to manage that fear by better understanding the process, events such as the Voice of Young Science “Peer Review: The Nuts & Bolts” workshop are highly recommended.

Image Credit: Justin Taylor, Flickr

Image Credit: Justin Taylor, Flickr

Peer Review: Nuts & Bolts

Assembled at Guy’s Campus, King’s College London was a varied cross‑section of persons involved in peer review. A guest panel of editors represented nearly all aspects in the post‑submission peer review process: Dr Elizabeth Moylan, Professor John Gilbert, and Alice Ellingham.


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A Boon or Curse? Status of the Elderly in Rural India

Praveen Aivalli presents some reflections about the neglected status of the elderly in India, and the need for an organised health system response to tackle this issue.

Image Credit: Adam Jones, Flickr

Image Credit: Adam Jones, Flickr

A hundred and two year old man lying helpless in the corner of a house like an animal raised a question in my mind about the situation of Indian elderly in rural India. I came across this old man at a village of south Indian state Karnataka. The man was once the head of the family, and its sole breadwinner, and today he lies in a corner of the house, abandoned by his family. A man who had built this house, provided for his children, played his role in society and perhaps never imagined that he will be spending his last days in a cow shed he made, just waiting the end.

I visited his village as part of a research team collecting data on access to medicines for rural poor.  While I was talking with his family members, he turned his head towards me and waved his hand. Out of interest I went inside the room to see his condition. He only noticed my presence through my voice; I saw that he was feeling things around him with his hands, and continued waving his hands in my direction. I was unable to understand his gestures. I peered closely only to notice his glazed eye caused by hyper-mature cataract; I wondered how long he had been blind. I couldn’t talk to him as he was unable to hear me and I was unable to understand his expressions, but one thing I heard very clearly “maatrekodi” (“give me medicine” in Kannada, the local language). He was asking me for the tablets for his body ache.
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Category: General | 1 Comment

Classic Ethnographies

Trisha Greenhalgh discusses classic ethnography texts and their applicability to health services research.

Ethnography is, traditionally, the remit of anthropologists. Think mud huts and pith helmets: months or years living among the ‘natives’, immersed in the strangeness of a distant culture and producing what Clifford Geertz called thick description [1]. More recently, ethnography has been appropriated by both management academics and health services researchers to study the culture of organisations [2-4].

In general, doctors are not trained in anthropology – or indeed in other interpretive methods. The methodology has become distorted and over-rationalized by medically trained researchers whose criteria for excellence have been appropriated from the randomized controlled trial. They may wrongly equate rigour with the use of structured checklists of what to observe, how, and for how long – or for two researchers to make independent observations of the same phenomenon on the assumption that they should both come out of the experience with the same set of ‘facts’. In reality, ethnography draws extensively on subjective methods and rigour is as much about reflexivity (self-questioning) and criticality (considering alternative explanations) as about accuracy or reproducibility of measurement [5].

Image Credit: Fotos GOVBA, Flickr

Image Credit: Fotos GOVBA, Flickr


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Category: General | 4 Comments

When 2 Become 1: Integrating the Health Care needs of Mothers and Infants, the New MHTF-PLOS Collection on Maternal Health

In November 2013, PLOS Medicine and the Maternal Health Task Force (MHTF) called for submissions to Year 3 of the MHTF-PLOS Collection on Maternal Health. Today we launch the Year 3 Collection and include 10 research articles recently published by PLOS.

Image credit: Jack Zalium, Flickr

Image credit: Jack Zalium, Flickr

The continuing collaboration between the MHTF at Harvard School of Public Health and PLOS Medicine is reflected in this latest collection highlighting the theme, “Integrating Health Care to Meet the Needs of the Mother–Infant Pair”. Our shared commitment to increasing the evidence base for approaches to improving maternal health has built a platform of research and commentary articles as featured in the preceding Year 1 & Year 2 Collections.
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Category: Collections, General, HIV, Maternal Newborn and Child Health | 1 Comment

EMA’s Proposed Data Release Policy: Promoting Transparency or Expanding Pharma Control over Data?

Trudo Lemmens of the University of Toronto critiques the recently distributed draft EMA Clinical Trials Data Release Policy.  

Image Credit: r2hox, Flickr Commons

Image Credit: r2hox, Flickr Commons

Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and Intermune’s Esbriet, which had stalled EMA’s data release approach. Shortly after, Abbvie withdrew the Humira lawsuit. Then in April 2014, the European Parliament approved the new Clinical Trials Regulation that introduced a requirement to register all clinical trials and make all clinical study reports in relation to EMA approved drugs publicly available. These developments put EMA again in the driver’s seat for the further implementation of its promised prospective data release policy.

Yet, when EMA recently distributed the draft policy to participants of its Clinical Trials Data Policy advisory groups, scientists and patient advocacy groups were dismayed, and the European Ombudsman sent a letter to inquire about EMA’s apparent shift: the proposed “Terms of Use” (TOU) and “Redaction Principles” impose various technical restrictions on data access, which would make it practically impossible to conduct decent research. If it were only technicalities, further discussions with the scientific community could fix the problems. But in the fracas around the technicalities, the legal booby-traps hidden in the (admittedly still draft) TOU received little attention. I therefore sent a letter to EMA’s executive director Guido Rasi outlining several legal concerns. Combining these with the technical restrictions suggests a problematic legal hijacking by industry of the transparency agenda.
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Category: General | 2 Comments

The Blue Marble Health Collection: Redrawing Boundaries that Disease has Already Crossed

Peter J. Hotez, Co-Editor-in-Chief of PLOS Neglected Tropical Diseases, and Larry Peiperl, Chief Editor of PLOS Medicine, on a new PLOS Collection that highlights a shift in current thinking about global health.

This week PLOS Neglected Tropical Diseases and PLOS Medicine have joined forces to launch Blue Marble Health: the mismatch between national wealth and population health, the most recent PLOS Collection.

Two key PLOS papers, each published in the fall of 2013, stimulated the genesis of this Blue Marble Health Collection.

The poor living among the wealthy.

Major areas of poverty in the G20 nations and Nigeria, where most of the world’s NTDs occur.
doi:10.1371/journal.pntd.0002570.g001

The first, from PLOS NTDs - ”NTDs V.2.0: ‘Blue Marble Health’—Neglected Tropical Disease Control and Elimination in a Shifting Health Policy Landscape” –  found that while some NTDs such as river blindness, loiasis, African sleeping sickness and schistosomiasis are largely or exclusively diseases of sub-Saharan Africa, paradoxically many of the world’s highest concentration of NTDs occur in the 20 wealthiest economies – the group of 20 (G20) countries – especially in the mostly hidden pockets of extreme poverty that can be found in the big middle-income nations, such as Indonesia or in areas of the  BRICS countries, including northeastern Brazil, northern India, and southwestern China.  Moreover, the disease burden from NTDs is alarmingly high in the southern United States, especially in Texas and the Gulf Coast, in areas of Australia with large Aboriginal populations such as the Northern Territories, and Eastern Europe.

A parallel editorial in PLOS Medicine - Poor Health in Rich Countries: A Role for Open Access Journals - noted that relative poverty within a society is a stronger predictor of health than aggregate measures of economic power such as GNP or per-capita income. For example, tens of millions of Americans living in poverty, including many people of color, “experience levels of health that are typical of middle-income or low-income countries.” The editorial concluded that, for many issues that affect the health of people of lower socioeconomic status, clear-cut distinctions between “domestic” and “cross-border” research are becoming increasingly difficult to draw.


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Category: General, NCDs, Neglected Diseases | 1 Comment

New Statistics on ‘Modern-day Slavery’ Reveal a Shameful and Profitable Business

Jocalyn Clark analyses the ILO’s shocking recent report that ‘modern-day slavery’ generates billions of dollars globally each year.

Image credit: Bark, Flickr

Image credit: Bark, Flickr

When updated estimates increase three-fold, one tends to take notice. This is what happened to many I suspect when the International Labour Office (ILO) reported last week that forced labour, child labour, and sexual exploitation generate a massive US$150 billion each year, three times its previous estimate in 2005. Nearly two-thirds of the estimated profits come from sexual exploitation, including prostitution and pornography.

Twenty-one million men, women and children around the world are economically and sexually exploited by employers, trafficked, held in debt bondage or work in slave-like conditions, according to the report. Female victims are usually trafficked in commercial sex and domestic work, and men typically in forced labour in the agriculture, construction and mining sectors. That these victims are said to “generate billions of profits annually” is interesting use of language – of course, these modern-day slaves are generating profits for others and doing so under the forced and exploitative direction of others. Worse, this illegal activity helps fuel the world’s economy.
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Scientific Day 2014: The Role of Evidence in Humanitarian Aid

Sarah Venis and Philipp du Cros reflect on the theme of this year’s MSF scientific day which will be streamed live online on May 23rd.

SCIENTIFICDAY_FINAL_LOGOSThis year marks the 20th anniversary of the Rwandan Genocide in which between 500,000 and a million people were brutally killed. The international community failed to act and MSF concluded that “you can’t stop genocide with doctors”. The aftermath of the genocide included analysis of the failures of humanitarian aid and led to moves to improve its quality and accountability. But how far has humanitarian aid moved since then? In the past year, the bloody conflicts in Central African Republic (CAR), South Sudan and Syria have reached unspeakable levels of violence that have tested the limits of humanitarian assistance. Last month, three MSF colleagues were among 16 people killed during a meeting at the MSF hospital in Boguila CAR. MSF activities have been scaled down in the area as a result. In 2013, unable to guarantee the safety of its staff, MSF took the difficult decision to leave Somalia after 22 years. And, last week, five MSF staff were finally released after being kidnapped in Syria in January; again resulting in MSF having to withdraw medical assistance from populations in dire need.
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Category: General, MSF | 2 Comments