Elsevier

The Lancet

Volume 360, Issue 9343, 2 November 2002, Pages 1405-1409
The Lancet

Series
The pharmaceutical industry as an informant

https://doi.org/10.1016/S0140-6736(02)11394-8Get rights and content

Summary

The pharmaceutical industry spends more time and resources on generation, collation, and dissemination of medical information than it does on production of medicines. This information is essential as a resource for development of medicines, but is also needed to satisfy licensing requirements, protect patents, promote sales, and advise patients, prescribers, and dispensers. Such information is of great commercial value, and most of it is confidential, protected by regulations about intellectual property rights. Through their generation and dissemination of information, transnational companies can greatly influence clinical practice. Sometimes, their commercially determined goals represent genuine advances in health-care provision, but most often they are implicated in excessive and costly production of information that is largely kept secret, often duplicated, and can risk undermining the best interests of patients and society.

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

References (44)

  • Anon

    Cost of development soars to $802 million per drug

    Scrip

    (2001)
  • McKee M, Mossialos E, Baeten R. The impact of EU law on health care systems: work and society, vol 39. Brussels: Peter...
  • Drug and therapeutics bulletin and the national prescribing centre

    Medicines and the NHS: a guide for directors, book 2—how medicines get to market

    (1997)
  • Chief medical officer

    Withdrawal of an oral polio vaccine: analysis of events and implications

    (2002)
  • Practical guide number 1, practical guide to medical publishing. Pharmaceutical Marketing, November,...
  • JM Stern et al.

    Publication bias: evidence of delayed publication in a cohort study of clinical research projects

    BMJ

    (1997)
  • RA Davidson

    Source of funding and outcome of clinical trials

    J Gen Intern Med

    (1986)
  • JM Kemmeren et al.

    Third generation oral contraceptives and risk of venous thrombosis: meta-analysis

    BMJ

    (2002)
  • LL Kjaegard et al.

    Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the

    BMJ. BMJ

    (2002)
  • WA Ray et al.

    Evaluating drugs after their approval for clinical use

    N Engl J Med

    (1993)
  • PA Rochon et al.

    A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis

    Arch Intern Med

    (1994)
  • DG Altman et al.

    The revised CONSORT statement for reporting randomized trials: explanation and elaboration

    Ann Intern Med

    (2001)
  • Cited by (97)

    • Drug information by public health and regulatory institutions: Results of an 8-country survey in Europe

      2017, Health Policy
      Citation 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].

    View all citing articles on Scopus
    View full text