SeriesThe pharmaceutical industry as an informant
Section snippets
Information to steer the search for new products
Transnational companies plan their research programmes for new drugs in accordance with predictions on future markets and the potential for creation of lucrative products. Such programmes, which industry presently estimates cost an average of around US$800 million for each drug6 (see paper in this series by Henry and Lexchin, to be published in The Lancet on Nov 16), typically take around 10–12 years to complete. Planning of the programmes relies crucially on having data about present
Information required by regulators
Regulatory authorities in industrialised countries set out in detail the information—and so the type and content of research-they require in the application for a product to be manufactured, sold, supplied, or promoted. Such requirements have in the past varied from country to country. Now, however, standardised positions have been agreed throughout the EU, and between the USA, the EU, and Japan, by development of the International Conference on Harmonisation of Technical Requirements for
Assessment of the validity of information submitted
Assessing the basis for licensing decisions is difficult, not least because the full marketing submission is only seen by the applicant and the relevant regulatory authority or those working on behalf of the authority. Only a limited amount of data are made public—eg, in published reports of clinical trials, as a product's summary of characteristics or Patients' Information Leaflet, as the European Public Assessment Report for medicines licensed centrally by the EU, and as various expert US
Information published in the medical press
Drug companies recognise the enormous value of publishing clinical trial reports about their products in medical journals, especially when the journal is prestigious.10 Such publications are important because they raise awareness of products. However, to improve sales, it is also crucial that the published report shows the company's product in a favourable light. Publication is especially helpful if the article is published around the time of the product's launch. Echoing these aspirations,
Generation of information and wider research implications
The pharmaceutical industry is the single largest sponsor of medical research—and thus the largest generator of related information—in, for example, Canada,29 the USA,30 and the UK,31 and in some countries it is the only realistic source of such support. Industry-funded research is overwhelmingly drug-oriented, so it could distort a country's research effort by, for instance, diverting resources and personnel away from non-drug interventions or other aspects of health care. Moreover, as
Impartial information provided by companies to users
In many industrialised countries, it is standard for drug companies to provide impartial information about their products to health-care professionals and patients (see section on information required by regulators). Such information includes summaries of product characteristics, packaging and labelling details, and Patients' Information Leaflets. This material, which is drafted, published, paid for, and distributed by the company, is usually required by law, has legal status, and is mainly
Promotional information
By announcing a medicine's availability and its potential use, advertising can be valuable to prescribers and patients. It is also an important component of drugcompany business, with, for instance, much more money spent on promotion than on research and development,36 or on provision of impartial information. In the UK (one of the few places where advertising spend is capped), adherence to the Pharmaceutical Price Regulation Scheme (PPRS) means that for every pound spent by the industry on
When promotional information distorts
There is no doubt that medicines offer enormous health benefits; however, a crucial issue for patients and society at large is that treatment choices are made rationally, with patients receiving the best available medicines given in such a way that fullest advantage is ensured. These goals are unlikely to be met if the reasons for prescription are distorted, and end up tipping the balance away from patients' interests and towards those of the pharmaceutical industry. The more effective the
Conclusions
The pharmaceutical industry—and in particular large transnational companies—generates and collates vast amounts of information. Much of this material remains secret or is shared exclusively with regulatory authorities. A small proportion is publicly available, mainly as published clinical trials, promotional material, and impartial treatment advice directed to prescribers and patients. Through their investment in research, transnational companies have an important effect on the direction of
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Cited by (97)
Drug information by public health and regulatory institutions: Results of an 8-country survey in Europe
2017, Health PolicyCitation Excerpt :Transparency of regulatory decisions, making assessments of benefits and risks of medicines available, is also a relevant issue. Medicines producers know how to promote access to and uptake of information related to their drugs, regardless of its quality [7,8]. Drug information from the public health side falls clearly behind, as there is no comparable system of selecting relevant and updated information and of bringing it to the desk of physicians and decision-makers: few of the experiences described in the scientific literature seem to be routinely implemented within health services at the moment, although geographical variability may exist as some countries have more experience in this regard [9].
Análisis del Proceso de Actualización de Medicamentos en el Cuadro Básico y Catálogo de Insumos del Sector Salud
2013, Value in Health Regional IssuesMedicalization I. 'Disease labeling: All business.'
2013, Atencion Primaria