A new Pacific-Rim Trade Agreement threatens future access to medicines

• Renin-Angiotensin System (RAS) blockers alone or in combination have similar effects on cardiovascular and renal outcomes in patients with diabetes

• Length-of-stay in health facilities after childbirth is too short in many low- and middle-income countries

• A New Pacific-Rim Trade Agreement Threatens Future Access to Medicines

Renin-Angiotensin System (RAS) blockers alone or in combination have similar effects on cardiovascular and renal outcomes in patients with diabetes

Angiotensin-Converting Enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARBs) alone or in combination have similar effects on cardiovascular and renal outcomes in patients with diabetes, according to a study published by Ferrán Catalá-López and colleagues from the University of Valencia/CIBERSAM and INCLIVA Health Research Institute, Spain, and the Ottawa Hospital Research Institute, Canada, in this week's PLOS Medicine.

A collaboration of researchers from Canada, USA, Italy and Spain combined data from 71 published and unpublished randomized controlled trials (total of 103,120 participants) that tested the effects of renin-angiotensin system (RAS) blockers alone or in combination with other high blood pressure treatments in adults with diabetes. Using a novel analytic approach called network meta-analysis, the researchers found no significant differences in the risk of major cardiovascular outcome between ACE inhibitors, and either ARBs or a combination of ACE inhibitors plus ARBs. Similarly, for the risk of progression of renal disease, no significant differences were detected between ACE inhibitors and any of the remaining therapies, such as ARBs or a combination of ACE inhibitors plus ARBs. They also found that no RAS blocker strategy was superior to ACE inhibitors with respect to all-cause mortality, cardiovascular mortality, heart attacks, end-stage renal disease, or doubling serum creatinine.

While the findings suggest that any single ACE inhibitor or ARB was equally effective as any other, and just as effective as any drug combination, there were not enough data comparing direct renin (DR) inhibitors with ACE inhibitors or ARBs to allow strong conclusion, therefore additional research might be warranted. Furthermore, the analyses did not consider the costs of any particular drug, or any side effects that were not relevant to the outcomes measured.

The authors say: "Clinicians should discuss the balance between benefits, costs, and potential harms with individual diabetes patients before starting treatment."

Research Article

Funding:

FCL and RTS are partially funded by Generalitat Valenciana (PROMETEOII/2015/021). RTS is also funded by INCLIVA and Institute of Health Carlos III (PI14/00894)/CIBERSAM. BH is supported by a New Investigator Award from the Canadian Institutes of Health Research and the Drug Safety and Effectiveness Network. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests:

BH has previously received funds for methodologic advice from Amgen Canada and Cornerstone Research Group for the provision of advice related to systematic reviews and meta-analysis. None of the advice is related to the content of this manuscript. All the other authors have declared that no competing interests exist.

Citation:

Catalá-López F, Macías Saint-Gerons D, González-Bermejo D, Rosano GM, Davis BR, Ridao M, et al. (2016) Cardiovascular and Renal Outcomes of Renin-Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses. PLoS Med 13(3): e1001971. doi:10.1371/journal.pmed.1001971

Author Affiliations:

Department of Medicine, University of Valencia/INCLIVA Health Research Institute, Valencia, Spain

Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain

Centre for Clinical and Basic Research, Department of Medical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana, Rome, Italy

The University of Texas School of Public Health, Houston, Texas, United States of America

Instituto Aragonés de Ciencias de la Salud, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Zaragoza, Spain

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Salud Pública), Valencia, Spain

Spanish Council for Scientific Research (CSIC), Barcelona, Spain

Area of Budgetary Stability, Ministry of Finance and Public Administrations, Madrid, Spain

School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada

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Contact:

Ferrán Catalá-López
Senior Researcher
34679519973
ferran_catala@hotmail.com
University of Valencia
Department of Medicine
Avda Blasco Ibañez 15
Valencia, 46010
SPAIN

Length-of-stay in health facilities after childbirth is too short in many low- and middle-income countries

Length-of-stay in health facilities following childbirth is highly variable across 92 countries and inadequate for a substantial proportion of women, according to a study published by Oona Campbell and colleagues from the London School of Hygiene & Tropical Medicine, United Kingdom, in this week's PLOS Medicine.

The researchers compiled data on length-of-stay after facility births from databases and recent health surveys covering 92 countries. Data were obtained from Demographic and Health Surveys (DHS), Multiple Indicator Cluster Surveys (MICS), the US Centers for Disease Control and Prevention Reproductive Health Survey (CDC-RHS), and databases compiled by the Organisation for Economic Co-operation and Development (OECD). Across countries, they estimated that the mean length-of-stay ranged from 0.5 days (in Egypt) to 6.2 days (in Ukraine) for singleton (i.e. single baby, not twins or multiplets) vaginal births (data available for 71 countries) and from 2.5 days to 9.3 days for caesarean-section deliveries (data available for 30 countries). The United Kingdom was the high-income country with the shortest length-of-stay for singleton vaginal births (mean 1.5 days). Across the 30 low- and middle-income countries with data from DHS, the proportion of women with vaginal deliveries who stayed too short (<24 h) ranged from 0.1% to 83.2%, while the proportion with cesarean-section deliveries who stayed too short (<72 h) ranged from 1.0% to 75.3%.

While the findings suggest that many women and their newborns are not receiving adequate postnatal care, there are several limitations to the analysis. For many countries, the researchers were unable to find information on postnatal length-of-stay, and additional research is warranted. The postnatal lengths-of stay reported vary widely between countries and are likely influenced by national norms and health system features in addition to specific needs of mothers and newborns. Moreover, in several countries, the percentage of births in health facilities is low, suggesting that many countries still need to increase facility births.

The authors say: "Substantial proportions of women stay too short to receive adequate postnatal care. We need to ensure that facilities have skilled birth attendants and effective elements of care, but also that women stay long enough to benefit from these."

Research Article

Funding:

No funding was received for this work.

Competing Interests:

The authors have declared that no competing interests exist.

Citation:

Campbell OMR, Cegolon L, Macleod D, Benova L (2016) A Cross-Sectional Description of Length of Stay after Childbirth in 92 Countries and an Analysis of Associated Factors in 30 Nationally Representative Surveys in Low- and Middle-Income Countries. PLoS Med 13(3): e1001972. doi:10.1371/journal.pmed.1001972

Author Affiliations:

Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom

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Professor Oona Campbell
44(0)2079272802 / press@lshtm.ac.uk
London School of Hygiene and Tropical Medicine
Keppel Street
WC1E 7HT
London, UK
Via the London School of Hygiene & Tropical Medicine press office:

FROM THE PLOS MEDICINE MAGAZINE:

A New Pacific-Rim Trade Agreement Threatens Future Access to Medicines

The recently negotiated Trans Pacific Partnership Agreement contains provisions that would dramatically and negatively impact access to affordable medicines in the United States and elsewhere if it is ratified, according to Brook Baker, from the Northeastern University School of Law, Boston, United States, in a new Essay published in this week's PLOS Medicine.

The Trans-Pacific Partnership Agreement finally reached a draft agreement in October, 2015 and was signed in February 2016. The next stage of implementation for the agreement is ratification by signatory countries which may take up to 2 years.

In his Essay Prof. Baker outlines how provisions in the Intellectual Property chapter of the agreement lengthen, broaden, and strengthen patent-related monopolies on medicine and erects new monopoly protections on regulatory data as well. He describes dangerous terms in the Investment Chapter that define intellectual property rights as investments and that allows foreign entities to use investor-state-dispute-settlement private arbitration provisions to challenge IP-related decisions and policies that adversely impact their expectations of profits. He also outlines how an annex to the agreement's Transparency chapter addressing transparency and procedural fairness for pharmaceutical products and medical devices, gives companies multiple opportunities to intercede in decisions to list products for reimbursement.

Prof. Baker argues, "[intellectual property] maximization in the [Trans Pacific Partnership Agreement] will harm access to more affordable medicines in both in the US and its trading partners. Policy space on both sides of the Pacific will be reduced while opportunities for excessive pricing will increase dramatically with predictable adverse consequence for the right to health. Armed with knowledge about the details of the [Trans Pacific Partnership Agreement's] anti-access provisions, there is still time for health advocates to convince the US Congress and [Trans Pacific Partnership Agreement] partners that the [Trans Pacific Partnership Agreement's] monopoly- enhancing measures must be rejected."

Essay

Funding:

No funding was received for this work.

Competing Interests:

The author has declared that no competing interests exist.

Citation:

Baker BK (2016) Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere. PLoS Med 13(3): e1001970. doi:10.1371/journal.pmed.1001970

Author Affiliations:

Northeastern University School of Law, Program on Human Rights and the Global Economy, Boston, Massachusetts, United States of America

University of KwaZulu Natal, Durban, South Africa

Health Global Access Project, New York, New York, United States of America

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Contact:

Professor Brook Baker
16173733217
b.baker@neu.edu
Northeastern University
School of Law
416 Huntington Ave
Boston, MA 02115
UNITED STATES

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