European Court is on the Wrong Side on Patient Safety

Síle Lane from Sense About Science discusses the recent European Court injunction on clinical trial data.

AllTrials logo for website (2)The European General Court has issued an injunction to prevent the European medicines regulator from releasing information from clinical trials conducted by AbbVie and InterMune at the request of the two companies. While yesterday’s ruling pertains to two particular cases it has ramifications for all.

The Court’s decision puts the European Medicines Agency into conflict with its own policy, announced in 2012, to proactively release data from clinical trials supporting the authorisation of medicines being used by patients all over Europe. The Clinical Study Reports that EMA has made available since last year were one of the few ways that researchers could access otherwise withheld material. Their release was instrumental in spotting serious flaws in the evidence for Roche’s drug Tamiflu, for example, which the UK government alone spent £500m on in one year.

More importantly the Court’s decision at the request of AbbVie and InterMune puts it into conflict with the interests of patients. When GSK joined the AllTrials campaign and promised to publish all the CSRs available since its formation as a company they said that they owe this to the patients who have taken part in their trials. Two hundred other organisations including more than 100 patient groups and 50,000 people have signed up to the campaign calling on regulators worldwide to do everything they can to secure registration and publication of the results of clinical trials.

So we’re on the brink. Patients and researchers all over the world have started pushing for historic change. GSK has shown that it’s not beyond the reach of pharma companies to agree to that change. The EMA has tried going some way to delivering on that change.

But, EMA now has to decide if the European Court’s ruling will divert them from their policy to publish trial information. We will be sending the EMA the AllTrials petition. We will be asking them to continue their fight for transparency and showing them that tens of thousands of people are asking why they don’t have access to the evidence behind the medicines they use, prescribe and research. Will you help us today at www.alltrials.net? Please, ask your colleagues and friends to add their voices and ask them to forward this to others when they have.

The European Court has indicated that it is on the wrong side of history. The EMA now has to show that arguments in favour of secrecy no longer hold.

Síle Lane is director of campaigns at Sense About Science

 

Category: Access, General | Tagged , , , , | 8 Comments

Q&A with Pamela Collins – lead author of new series in PLOS Medicine on integrating mental health

2066_Columbia_Collins_20070711In the latest installment of the Speaking of Medicine series of Q&A blog posts, we hear from Pamela Collins, the corresponding author of a series of Policy Forum articles in PLOS Medicine that provides a global perspective on integrating mental health.  Pamela Collins M.D., M.P.H., is the Director of the Office for Research on Disparities and Global Mental Health at the National Institute of Mental Health (NIMH). I asked her about some of the topics discussed in the new series, which will be published in PLOS Medicine weekly for the  next five weeks, starting with the publication today of a Policy Forum article discussing integration in research, policy, and practice.

1. Why is the integration of mental health care so important?

Integration of mental health care is important on several levels. First, there is a need to integrate mental health concerns into the broader discussions in global public health because of the tremendous disability and suffering that mental disorders cause around the world. Mental disorders are global problems which, untreated, result in increased morbidity and mortality, as well as increased health system and societal costs.  Second, we know that mental disorders co-occur with many other medical conditions, including cardiovascular disease, diabetes, and HIV-related disease.  Depression is a good example. When depression co-occurs with these conditions, the risk of poor outcomes, including death, increases.  Third, integration of mental health interventions into other areas of routine care (e.g. primary care or maternal health care) has the potential for improving access to needed services, enabling health care providers to deliver holistic care.  Establishing access to evidence-based, effective care for depression in settings where women receive routine health services may increase the likelihood that women with depression receive the care they need.

2. What were your main motivations for initiating the series?

NIMH and its partners completed the priority setting initiative, the Grand Challenges in Global Mental Health, in 2011. One of the Grand Challenges identified by the group of international stakeholders was to “redesign health systems to integrate mental, neurological, and substance use (MNS) disorders with other chronic disease care, and create parity between mental and physical illness in investment to research, training, treatment and prevention.”  Notably, meeting this challenge requires the cooperation of stakeholders within and outside of the mental health arena.  It is timely, too.  Much of the global health community is now focused on how to leverage resources efficiently in order to achieve the best health outcomes for populations in need. Integrating mental health services that build on existing platforms may be one way to introduce efficiency.

3. How did you get interested in this area of research?

My past research focused on the intersection of mental health care and HIV-related care in high-, middle-, and low-income country settings.  I entered this arena of integration while first working to reduce the risk of HIV infection among women with schizophrenia, bipolar disorder, and depression in New York City in the 1990s, and I subsequently began to work with providers in South Africa and Rwanda around similar issues.  People with severe mental illnesses have a much higher prevalence HIV infection in the United States. Yet, this is not a population that we usually hear about in public health efforts to prevent HIV and care for people with HIV.  But the risk for HIV infection is not solely a high-income country phenomenon.  Studies from sub-Saharan Africa also show a high prevalence of HIV infection among people hospitalized in psychiatric facilities. This population also has higher rates of mortality and earlier mortality from non-communicable diseases.  These findings point to the possibility of integrated care as a means of insuring that people with mental illnesses gain access to the prevention and care they need for other health conditions.  At the same time people who develop a mental illness while being treated for other health conditions need access to services where the symptoms of mental illness will be recognized and treated appropriately.

4. What are the main barriers to moving this field forward?

One critical barrier is the inequity in human resources for health care around the world. There is a dearth of mental health care providers in many parts of the world. The 2011 WHO Mental Health Atlas tells us that nearly half of the world’s population lives in a setting with one psychiatrist or less serving 200,000 people. But, barriers also provide opportunities.  The mental health community has long experimented with using non-specialists to deliver mental health services including community health workers, nurses, or primary care doctors. We now have a growing number of rigorous studies that provide evidence that effective mental health interventions can be delivered by non-specialists in settings where the specialist workforce is simply insufficient.

5. What further research is needed in this area?

Given that the resources allocated for mental health care are limited in many settings, we need to understand the best methods of equipping available health care providers to deliver evidence-based mental health services, in tandem with interventions for other disorders, in a variety of health system environments.  We have tools, through the WHO Mental Health Gap Action Programme, to assist with screening for some MNS disorders, but we need more understanding of how disease processes interact to affect the course of illness.  As we will see in the concluding paper in the series, Vikram Patel and colleagues argue that at  the systems level, we have more to learn about how and where to integrate services for people with different kinds of mental illnesses, such as chronic psychosis, dementia, or childhood mental disorders.  Furthermore, most of the studies that provide the evidence base for integrating mental health services into other delivery platforms have been carried out in high-income countries, so we need more data from settings with fewer resources that show how best to provide these services. Last year NIMH published a funding opportunity announcement called “Grand Challenges in Global Mental Health: Integrating Mental Health into Chronic Disease Care Provision in Low- and Middle-Income Countries.”  We hope the studies to be funded through this initiative will answer some of these questions.


Category: Mental Health | 1 Comment

This Week in PLOS Medicine: Global Access to Health Information, Integrating Mental Health, Upper GI Bleeds, & Cinacalcet

Image Credit: Flickr Moving Mountains Trust

Image Credit: Flickr Moving Mountains Trust

This week PLOS Medicine offers a global perspective on access to health information and integrating mental health. New research articles on mortality after upper GI bleeding and cinacalcet for chronic kidney disease are also featured.

In April’s editorial, the PLOS Medicine Editors reflect on the critical need for access to high quality health information across the globe and a recent analysis suggesting that governments have a legal responsibility to ensure access to health information for their citizens and health workers.

In the first article of a five-part weekly series providing a global perspective on integrating mental health, Pamela Collins and colleagues set the scene for why mental health care should be combined with priority programs on maternal and child health, non-communicable diseases, and HIV, and how this might be done. Forthcoming papers in the series will examine the specific instances of integrating mental health with maternal health, HIV, and non-communicable disease care, and a final paper will address cross-cutting issues.

Colin Crooks and colleagues examine patient outcomes in the 5 years after a non-variceal upper gastrointestinal bleed and found an increased risk of all causes of death, over half of which were due to non-gastrointestinal causes, particularly malignant tumors and cardiovascular disease.

Giovanni Strippoli and colleagues report findings of a systematic review and meta-analysis examining the benefits and harms of calcimimetic therapy in adults with chronic kidney disease (CKD). The routine use of cinacalcet therapy in people with CKD does not appear warranted; benefits may be limited to preventing parathyroidectomy in the small number of patients for whom surgery is contraindicated.

Remember you can comment on, annotate and rate any PLOS Medicine article and see the views, citations and other indications of impact of an article on that articles metrics tab.

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This Week in PLOS NTDs and Pathogens: Advancing Neurocysticercosis Research; Ivermectin vs. Onchocerciasis; Rhoptries Revealed; and HCV-Induced Liver Disease

Figure 3. Malhotra S, Yen JY, Honko AN, Garamszegi S, Caballero IS, et al. (2013) Transcriptional Profiling of the Circulating Immune Response to Lassa Virus in an Aerosol Model of Exposure. PLoS Negl Trop Dis 7(4): e2171. doi:10.1371/journal.pntd.0002171


Malhotra S, Yen JY, Honko AN, Garamszegi S, Caballero IS, et al. (2013) Transcriptional Profiling of the Circulating Immune Response to Lassa Virus in an Aerosol Model of Exposure. PLoS Negl Trop Dis 7(4): e2171. doi:10.1371/journal.pntd.0002171

The following new articles are publishing in PLOS NTDs this week:

Neurocysticercosis (NCC) is the most common cause of adult acquired epilepsy worldwide and one the most frequent parasitic infections associated with chronic morbidity encountered in the United States, but study of the disease remains underfunded. Here Dr. Theodore Nash and colleagues discuss the importance of NCC as a preventable and treatable infection, as well as advancements, goals, reasons for lack of material support and a roadmap for advancement.

Studies in Mali, Nigeria and Senegal have shown contradictory results concerning the efficacy of long-term ivermectin distribution for onchocerciasis elimination. Dr.

Hugo Turner and colleagues explore how assumptions regarding aspects of treatment effects can affect temporal projections of infection load and prevalence in highly endemic African savannah settings.

Despite the significant public health issues and potential biodefense risks posed by the Lassa virus (LASV) little is known of the human immune response to this hemorrhagic fever. Dr. Shikha Malhotra and colleagues outline here an unbiased genomics approach to map the temporal host response in the peripheral blood mononuclear cells of non-human primates exposed to LASV. Their results provide a picture of the host’s circulating immune response to LASV exposure and demonstrate that gene expression patterns correlate with specific stages of disease progression.

The following new articles are publishing in PLOS Pathogens this week:

As with many intracellular infectious agents, the protozoan Toxoplasma gondii has a quiver of effectors that it uses to co-opt host cell functions including several from a paralogous family of protein kinases and pseudokinases that are injected into the host cell from the apical secretory organelles known as rhoptries (ROPs). In this Pearl, Dr. John Boothroyd presents how these ROPs were found and the current state of knowledge about their function.

Hepatic inflammation during chronic HCV infection is considered to be the primary catalyst for progressive liver disease and development of liver cancer but the underlying molecular mechanisms are not well understood. The results from Dr. Amina Negashand and colleagues identify HCV-induced IL-1b production by hepatic macrophages as a critical and central process that promotes liver inflammation and disease.

Emerging evidence suggests that the p65 family of guanylate-binding proteins (GBPs), which is upregulated by interferon gamma, play an important role in host defense against intracellular pathogens. Dr. Elizabeth Selleck and colleagues provide findings that demonstrate that Gbp1 plays an important role in the IFN-c-dependent, cell-autonomous control of toxoplasmosis and predict a broader role for this protein in host defense.

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Malaria: Targets and Drugs for All Stages

More drugs for malaria: time to expand the antimalarial portfolio

Malaria is an ancient enemy. Its treatments predate modern drug discovery, most notably the use of the Qinghao plant in ancient China (2nd century BC to 340 CE) and Peruvian bark in the early 17th century, the medicines from which are now known to be artemisinin and quinine respectively. Calls for the eradication of malaria have brought renewed focus on tools to control malaria.  Yet, although disease burdens have been lowered in the last five years, malaria remains endemic in over 100 countries and, with an estimated seven hundred thousand deaths in 2010, is still a leading cause of mortality and morbidity worldwide.

Drug research in malaria often focuses on blood stage parasites because they are responsible for the symptoms of the disease and are easier to manipulate in the laboratory.   The assembled PLOS Collection describes multiple parasite and host processes engaged in infection in blood, the blocking of which could stop human illness. However, control and eradication of malaria will also require the development of drugs against stages responsible for mosquito transmission and those that remain latent in the liver, also summarized in the collection. Although these selected papers represent significant research at the highest levels, they are only a fraction of the malaria drug discovery literature.

Despite research, a significant historical hurdle was the market failure of the pharmaceutical industry to invest in the discovery and development of new antimalarials.  Thus new partnerships have arisen that bring together academic and pharmaceutical work.  For example, the not-for-profit product development partnership Medicines for Malaria Venture (MMV) was established in 1999 to discover, develop and deliver new antimalarials in collaboration with both the public and private sector.  They are joined by the Bill and Melinda Gates Foundation , multiple agencies including the National Institutes of Health , the Wellcome Trust, Medical Research Council and others. Never before have philanthropic, public and large Pharma resources been better integrated for antimalarials, progressing research in early stages to testing drugs in humans, subsequent registration and delivery to patients.
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Category: Collections, General | 4 Comments

Seasonal Malaria Chemoprevention: Good News in a Year Marked by Malaria Emergencies

Estrella Lasry from Médecins Sans Frontières reflects on the roll out of seasonal malaria chemoprevention in Mali and Chad.

In 2012, MSF projects in several countries saw an important increase in cases of malaria, a prolonged peak in areas of seasonal transmission, and more than 6 emergency interventions were launched to fight this increase.

Image Credit: Estrella Lasry/MSF

Image Credit: Estrella Lasry/MSF

While the past decade has seen drastic improvements in the response to malaria (rapid diagnostic tests, affordable artemisinin-based combination therapies, and strategies relying on trained community health care workers) this 2012 experience showed that several challenges remain, including the scaled-up use of injectable artesunate for severe cases, outbreak response, and addressing malaria in areas of high seasonal transmission.

In the latter case, recent studies in West Africa have shown how seasonal malaria chemoprevention (SMC) can be effective at reducing cases of both simple and severe malaria.
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Should the Alcohol Industry Inform Evidence-Based Health Policy?

In a Policy Forum article published in this week’s PLOS Medicine Jim McCambridge and colleagues analyze submissions made by Alcohol Industry actors to the Scottish Government’s 2008 consultation on ‘Changing Scotland’s relationship with alcohol.’ The Scottish Government’s report was significant because it was the first government report within the UK to adopt a whole population approach to alcohol policy rather than considering alcohol misuse simply as an individual choice, and it included measures to introduce minimum unit pricing.

In their PLOS Medicine article Jim McCambridge and colleagues found that submissions to the Scottish Government’s consultation that were included in their case study, “ignored, misrepresented, and otherwise sought to undermine the content of the international evidence base on effective policies in order to influence policy” and they concluded “we suggest that the public interest is not served by industry actors’ involvement in the interpretation of research evidence.”

Speaking on BBC Radio 4’s Today programme Dr McCambridge noted, “What is very striking about the submissions made in this case is
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Eliminating Neglect and Neglected Tropical Diseases

PLOS NTDs Editor-in-Chief, Peter Hotez, highlights progress in the elimination of neglected tropical diseases through mass drug administration and other measures.

This month, a landmark paper was published in PLOS Neglected Tropical Diseases.  A group of scientists and public health experts from the ministry of health of Togo and Togo’s Université de Lomé, together with Norway’s Health & Development International and the Georgia-based Mectizan Donation Program, Rollins School of Public Health at Emory University, and the United States Centers for Disease Control and Prevention (CDC), reported that Togo will soon become the first sub-Saharan African country to eliminate lymphatic filariasis [1]. Their approach to elimination relied on mass drug administration (MDA) with ivermectin and albendazole donated by Merck & Co. and GlaxoSmithKline, respectively, together with programs of morbidity management – lymphedema management and hydrocele surgeries – and monitoring and evaluation [1].

The importance of the paper stems from the fact that it provides further proof of principle that sub-Saharan African nations are building on their previous successes in elimination or eradication of selected neglected tropical diseases (NTDs) including dracunculiasis (guinea worm) in most of the region, onchocerciasis (river blindness) in two countries, and human African trypanosomiasis (sleeping sickness) in more than a dozen countries. In addition, the article highlighted the roles of morbidity management alongside MDA and essential financial support for the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) [1].

I previously reviewed the success stories achieved to date for eliminating 11 of the high prevalence NTDs using MDA and other measures [2], which can now be updated to include information from the World Health Organization’s (WHO’s) 2020 Roadmap on NTDs included in the Second WHO Report on NTDs [3], together with new information on eliminating onchocerciasis in Guatemala and southern Mexico [4] and trachoma elimination [5]. The six diseases listed in Table 1 are those specifically targeted for elimination in 2012 by a London Declaration on NTDs in collaboration with a consortium of donors and industrial partners [6].
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Category: General, Global Health Metrics, Neglected Diseases, Policy | 3 Comments

This Week in PLOS Medicine: Atherosclerosis & Air Pollution, Non-melanoma Skin Cancer, & the Scottish Alcohol Industry

Image Credit: Flickr Jennifer Barnard

Image Credit: Flickr Jennifer Barnard

This week PLOS Medicine published articles ranging from research on the link between air pollution and atherosclerosis to a case study of the Scottish alcohol industry’s effect on public policy.

In a prospective cohort study, Sara Adar and colleagues found that decreasing levels of fine particulate matter in multiple US urban areas are associated with slowed progression of intima-medial thickness, a surrogate measure of atherosclerosis. Nino Künzli contextualized these findings as some of the first human evidence for the impact of air pollution on the development of atherosclerosis.

In a prospective study, Jiali Han and colleagues found a modestly increased risk of subsequent malignancies among individuals with a history of non-melanoma skin cancer, specifically breast and lung cancer in women and melanoma in both men and women.

Jim McCambridge and colleagues analyzed industry submissions to a Scottish Government consultation on whole population approaches to alcohol policy. The authors noted that studies of the nature of alcohol industry and other corporate influences on public policies can be informed by work already conducted on the tobacco industry.

In honor of the WHO’s World Immunization Week, the PLOS Medicine homepage features a selection of recent research and policy articles on vaccination.

Remember you can comment on, annotate and rate any PLOS Medicine article and see the views, citations and other indications of impact of an article on that articles metrics tab.

 

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Vaccines in Developing Countries: Why the High Prices?

Kate Elder and Jennifer Cohn from Médecins Sans Frontières question why new vaccines are so expensive. 

Global health leaders will gather in Abu Dhabi on April 24-25 for a Vaccine Summit to discuss recent accomplishments and seek ways to expand the impact of childhood vaccination under the Decade of Vaccines (DoV), an initiative for collective action announced by Bill Gates at the 2010 World Economic Forum.  Promoting greater affordability and accessibility—key tenets for increasing immunization coverage—should be at the top of the agenda.

The past few years have brought many positive developments, with childhood vaccination now saving an estimated 2-3 million lives each year. But huge gaps remain. In 2011, over 22 million children—20% of the global birth cohort—did not receive the full WHO-recommended package of basic vaccines. Teams from Doctors Without Borders/Médecins Sans Frontières (MSF) see the consequences of these gaps every day in the children we treat—among refugee populations, people caught in conflict, or in more routine settings of maternal and child health clinics.

Leaders in Abu Dhabi will call for funding the DoV at approximately US$57 billion over the next ten years, almost half of it for purchasing the vaccines.

While vaccines are often called a ‘best buy’ in public health, the overall cost of the vaccines package has skyrocketed in the past decade
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