Analysis

Patients and the public deserve big changes in evaluation of drugs

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b1025 (Published 31 March 2009) Cite this as: BMJ 2009;338:b1025
  1. Silvio Garattini, director1,
  2. Iain Chalmers, editor, James Lind Library2
  1. 1Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy
  2. 2Summertown Pavilion, Oxford OX2 7LG
  1. Correspondence to: S Garattini garattini{at}marionegri.it
  • Accepted 24 November 2008

Silvio Garattini and Iain Chalmers argue that ending the secrecy surrounding drug trials would benefit all parties

The drug industry has an image problem, and big changes are needed to restore public confidence. The reasons why it has got itself a bad name are well rehearsed. They include research agendas distorted by priorities that are important to industry but not to patients1; inappropriately restricted study populations that exclude patients with multiple health problems2 and children3; uninformative trial designs that fail to assess whether new drugs are better than existing treatment options4; outcome measures that ignore the effects of treatments on morbidity and mortality or on the quality of life5; biased under-reporting and over-reporting, not only of whole studies,6 7 8 but also of outcomes within published reports of research9; and specious promotion of drugs, including disease mongering.10

Industry makes much of the expense of bringing a new drug to market. In fact, directly and indirectly, the public provides most of the support for developing and evaluating new drugs.11 The public provides most of the academic infrastructure supporting much of the relatively high risk basic research underpinning drug development. It donates to medical research charities that fund much of this basic research and subsidises charities because charities attract tax relief. And through taxes, health insurance premiums, and direct payments for medicines, the public reimburses industry for its costs in a situation in which a true market does not exist. We believe that patients and health services are getting a poor return on this investment. If they are to reap better dividends in terms of better health at lower cost, major changes are needed in the way that drugs are evaluated.

Whose interests?

In countries where drug manufacturers are major …

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