Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

India's pharmaceutical industry: hype or high tech take-off?

India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fullyfledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets.

Health consumer organizations and the pharmaceutical industry : is transparency the answer?

This book examines the important role of consumer activism within health policy in different national contexts. In an age of shifting boundaries between state and civil society, consumer groups are potentially drivers of democratization in the health domain. The expert contributors explore how their activities bring new dynamics to relations between service providers, the medical profession, government agencies, and other policy actors. This book is unique in comprehensively analysing the opportunities and dilemmas of this type of activism, including ambiguous partnerships between consumer groups and stakeholders such as the pharmaceutical industry. These themes are explored within an internationally comparative framework, with case studies from various countries. Students and researchers in the fields of health policy and sociology, public policy and social movements will find this relevant and path-breaking book enlightening. It will also prove invaluable for participants and activists in patient and health consumer organizations.

The politics of the pharmaceutical industry and access to medicines : world pharmacy and India

The Pharmaceutical Industry presents one of India’s most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals.

The Politics of the Pharmaceutical Industry and Access to Medicines: World Pharmacy and India examines this important industry from different economic, social and political perspectives. Topics covered include the implications of TRIPS-compliant intellectual property rights, the role of flexibilities under TRIPS, the market regulation system, the role of Indian firms in exporting HIV/AIDS medications to Africa, the issue of free trade agreements, the power and reach of foreign pharmaceutical multinationals in India’s domestic market, and the sustainability of India as a major generics supplier.

The Pharmaceutical Industry and Access to Medicines in India

Pharmaceutical policy in India as elsewhere is shaped by conflicting economic and social interests and opposing values and priorities. Tensions can be understood as revolving around the contradiction between use value and exchange value in the production of medicinal drugs as commodities, as per Marx’s original analysis. The use value of medicines – if safe and efficacious, of good quality, and prescribed and consumed appropriately – is the prevention, cure or alleviation of ill-health and disease. Health policy is – or should be – aimed at optimising the use value of medicines. For this purpose government agencies administer regulatory oversight of the manufacturing, marketing and distribution of medicines. Drugs made available to patients are expected to meet adequate safety, quality and efficacy standards, but regulation to ensure such standards is subject to controversy in most countries. This is a domain where definition and interpretation of scientific-technological principles and criteria is infused by partiality and bias grounded in social and material interests, as evidenced by recurrent debates about industry ‘capture’ of regulatory agencies, including the world’s most regulator, the US Food and Drug Administration (Angell 2005; Law 2006). In India, a Parliamentary Committee Report in 2012 depicted the Central Drugs Standard Control Organisation (CDSCO) as dysfunctional and influenced inappropriately by the exchange value perspective of manufacturers (Parliamentary Standing Committee on Health and Welfare 2012). The clash between use and exchange value perspectives is starkly illustrated by cases of products known to cause more harm than good, particularly common in poorly regulated markets such as India’s, as shown by Srinivasan & Phadke.

The pharmaceutical industry, intellectual property rights and access to medicines in Pakistan

The pharmaceutical industry in Pakistan is worth around US$ l.18 billion, with annual growth in 2010 approaching 10 per cent (Khan, 2012). There are more than 650 registered companies, including 31 multinationals, which in 2006 had a market share in value terms of 53.3 per cent, with national firms controlling the remaining 46.7 per cent (IMS Health, 2007). In 2007 medicines worth about US$100 million were exported. Medicines are a vital component of healthcare, and Pakistan spends around three-quarters of its healthcare budget on medicines (WHO, 2004). This chapter provides an overview, from a public health perspective, of the national pharmaceutical market and the development of drug policies and regulation. Pakistan adopted a Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant patent regime in 2000, and the intersection between patents and public health is a central policy challenge. This chapter highlights key issues related to intellectual property, Free Trade Agreements (FTAs), and production and access to medicines.

Open Innovation in the pharmaceutical industry

O objetivo desse estudo é discutir a estratégia de inovação aberta adotada pelas quarto maior companhias farmacêuticas norte-americanas nos último quarto anos. A inovação tem sido reconhecida como uma fonte essencial de vantagem competitiva de uma firma. A partir do momento em que empresas começam a expandir e interagir em escala global, sua estratégia de inovação começa a mudar, e adquire um aspecto mais integrado, intensificando seu relacionamento com atores externos e recursos. Essa mudança tem como objetivo reduzir o custo da inovação e aumentar sua eficiência, e tem impacto nos resultados da empresa. Essa pesquisa realiza uma pesquisa exploratória usando dois modelos de inovação aberta como referência, Lichtenthaler (2008) e Lazzarotti-Manzini-Pellegrini (2010). Entender como firmas aplicam estratégias de inovação aberta é o primeiro passo para avaliar seu impacto na estratégia geral da mesma na nova conjuntura internacional.

Non-conventional applications of computerized tomography: Analysis of solid dosage forms produced by pharmaceutical industry

X-ray computed tomography (CT) refers to the cross-sectional imaging of an object measuring the transmitted radiation at different directions. In this work, we describe a non-conventional application of computerized tomography: visualization and improvements in the understanding of some internal structural features of solid dosage forms. A micro-CT X-ray scanner, with a minimum resolution of 30 μm was used to characterize some pharmaceutical tablets, granules, controlled-release osmotic tablet and liquid-filled soft-gelatin capsules. The analysis presented in this work are essentially qualitative, but quantitative parameters, such as porosity, density distribution, tablets dimensions, etc. could also be obtained using the related CT techniques. © 2010 American Institute of Physics.