Feb 21 2006
Doctors employed by pharmaceutical companies must always put the best interests of patients before their medical research, even if it brings them into conflict with their employers, according to new practical advice from the Faculty of Pharmaceutical Medicine published in the February issue of International Journal of Clinical Practice (IJCP).
The Ethical Issues Committee of the Faculty - part of the UK's Royal Colleges of Physicians - has also endorsed the move towards registering all clinical trials before studies are initiated and called for all results to be reported.
"Sometimes doctors working in clinical research find themselves facing difficult ethical dilemmas, especially if the company they work for decides not to publish negative research findings" says Committee Member Dr Ken Paterson from the Department of Clinical Pharmacology at Glasgow's Royal Infirmary in Scotland.
"These situations place a heavy burden on individuals and our practical advice aims to give them external backing when they need to take a stand."
The Faculty's paper provides practical day-to-day advice for doctors working in pharmaceutical research, based on the organisation's recently developed guiding ethical principles, which appear in the same issue of IJCP.
This advice stresses that publication of any results should be agreed between the sponsor and the researcher before the clinical trial starts.
"Sponsors have an ethical responsibility to publish or make available negative research findings which may affect prescribing practices, especially if the medication is already on the market" says co-author and Committee Chair Dr Roger Bickerstaffe, Global Vice President for Solvay Pharmaceuticals, Luxembourg.
"The advent of the Internet means that pharmaceutical companies now have a vehicle for publicising their own results to a mass audience, so there is no excuse for withholding negative results.
"Medical practitioners working in pharmaceutical medicine are bound by the same ethical standards which apply to all doctors, regardless of whether they are working for a company, regulatory body or academic institution" he adds.
"Our guidance clearly places the doctor's responsibility to patients and society ahead of their allegiance to an individual employer."
The aim of the Faculty of Pharmaceutical Medicine, which was established in 1989, is: "To advance the science and practice of pharmaceutical medicine by working to develop and maintain competence, ethics and integrity and the highest professional standards in the specialty for the benefit of the public."
"Both we and the Faculty hope that the material published in IJCP will provide support and advice for physicians and other professionals working in pharmaceutical medicine and that it will stimulate wider discussion and debate on the key issues" says Chris Graf, Publisher of IJCP, the International Journal of Clinical Practice.