A debate at Prescrire’s annual “Pilule d’Or” (“Golden Pill”) awards ceremony, which took place in Paris on 26 January 2012, explored how independently funded clinical trials can become a reality.
The Mediator° (benfluorex) scandal in France has led to the adoption of new medicines legislation. But large-scale development of more independent drugs research is still lacking, in France and elsewhere.
Pharmaceutical companies control the clinical trials of their drugs, and therefore their evaluation. Even if regulatory agencies were to better manage conflicts of interest with the experts they call upon, delivery of marketing authorisations would still depend on data supplied by pharmaceutical companies.
Clinical trials financed independently of pharmaceutical companies are not an impossible utopia. Major, publicly funded clinical trials, most notably in the United States of America, have strongly contributed to a better understanding of the harm-benefit balance of certain drugs.
The present system of inciting healthcare-related research and development is based on market demand. A current of thought has arisen around the world in the past few years, in favour of inventing a system more oriented towards health needs.
The existing system is broken, with few new drugs reaching the market, most often providing no comparative advantage, and sometimes resulting in more harms than benefits — and yet often sold at extravagant prices. The question of finding alternate funding for research and development is therefore a timely one.
For its annual “Pilule d’Or” (“Golden Pill”) awards ceremony, Prescrire invited three experts to contribute to a conference-debate on this topic.
- Marc-André Gagnon, Assistant Professor at Carleton University (Canada) and researcher at Harvard University (USA), pointed out that drug regulatory agencies rely upon data supplied by pharmaceutical companies in order to grant or refuse marketing authorisations. Therefore pharmaceutical companies, whose future sales depend upon getting new drugs onto the market, include clinical trials in their marketing plans, with frequent publication of positive results, while concealing negative results, and when necessary intimidating researchers, etc. Companies' research is in large degree financed by the public, most notably in the form of tax credits: yet another reason to require research practices that are less biased by commercial interests.
> Download the text of the presentation (pdf in French, 127 Ko).
- A presentation submitted by Martine Ruggli of the Swiss pharmacists association (Société suisse des pharmaciens) demonstrated that clinical research independent of pharmaceutical companies already exists. Based on 3 examples, she showed that independent comparative trials are particularly useful for the quality of care because they are long-term, taking into account large samples of the population, and use the right comparators and outcome measures that are relevant to daily practice.
> Download the text of the presentation (pdf in French, 111 Ko).
- Germán Velásquez, former director of the World Health Organization (WHO) and currently an advisor to the South Centre, described plans for a binding convention for R&D for pharmaceutical products, which would aim to better meet the health needs of the world's population by depending on publicly funded research and unlinking the price of drugs from the costs of research, so as to permit the greatest number of people to useful new medicines.
> Download the text of the presentation (pdf in French, 109 Ko).
Learn about the 2011 Prescrire Awards
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©Prescrire 1 March 2012
"Research financed independently of drug companies: a timely debate" Prescrire Int 2012; 21 (125): iv. (Pdf, free).
