|Home | About | Journals | Submit | Contact Us | Français|
Clinical researchers working on new drugs were “cleared” last week of allowing their ethical standards to sink to an all time low, in a debate held at a conference on clinical research at the Royal College of Physicians in London.
A small majority of the audience worked in the drug industry, and although the debate was not limited to research within the industry the convincing win must have cheered those in the drug business, who feel that they have recently been under attack.
The contestants in the debate, entitled “This house believes that the ethics of clinical research have reached an all time low,” were Richard Smith, former editor of the BMJ and now executive director at UnitedHealth Europe, who argued for the motion, and Trevor Jones, former director general of the Association of the British Pharmaceutical Industry.
Dr Smith's first example of unethical behaviour by researchers inside and outside the drug industry was drawn from studies of inappropriate authorship. He said that it was not uncommon for people who had contributed little to research studies to be named in their reports, while others whose names should have appeared were sometimes left off. Having brandished this evidential weapon he moved on to list instances of inappropriate inducements to participants, non-declaration of competing interests, and various other forms of research misconduct.
Professor Jones's armour plate, burnished over years of defending the drug industry against all comers, survived the hail of what he dismissed as, predominantly, old chestnuts. As far as the drug industry was concerned, he said, to be caught breaking the rules of clinical research would not only be ethically compromising but might also jeopardise an investment worth millions of pounds. Why would a company want to do that? Besides, he added, think of the number of ethics committees and the even greater number of people sitting on them. Are they all fools?
The question was rhetorical—but an indirect reply can be read into the outcome of the debate. The audience rejected the motion, handing victory to Professor Jones by an uncounted but substantial margin.
Earlier in the conference, which was organised by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, Keith Bragman, an independent consultant in pharmaceutical development, bewailed the public image of pharmaceutical medicine. Members of the profession, he said, are seen as secretive, dishonest, and arrogant rule benders who carelessly put people's lives at risk.
The message that standards now are higher than ever has not got through, he claimed.
Ian Rubin, medical director of Ashfield Healthcare and, like Dr Bragman, a member of the faculty's ethical issues committee, discussed the issue of loyalty versus responsibility. He was harsher on the industry than Dr Bragman had been.
He said that although companies' mission statements often put the patient at the centre of their concerns, staff sometimes felt stronger loyalty to their own interests and those of their fellow employees than to the sentiments expressed in these statements. Maybe the commitment to patients should be an explicit and not merely an implicit responsibility of medical directors of companies—more of whom, he added, should serve on company boards.
On the ethics of restricting patients' access to new drugs, Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), clashed with a patients' representative, Mary Baker, president of the European Federation of Neurological Associations.
Professor Rawlins gave a lucid account of NICE's philosophy and way of working. Speaking of anticancer drugs, he mentioned that of the score or so that NICE had reviewed only three had been rejected for reasons of cost effectiveness. And even for these he made no apology. He quoted Archie Cochrane's aphorism that “all effective treatments should be free.” Sorry, Archie, he concluded: those days are gone.
Dr Baker resolutely rejected what she called the “Malthusian” attitude of governments: that our need for health care necessarily outstrips our ability to pay for it. She said that we should consider the size of the pie before arguing over how to divide it.
She took Professor Rawlins to task for NICE's use, in assessing drugs, of the quality adjusted life year (QALY), believed by some to discriminate against elderly people.
Professor Rawlins responded by defending QALYs and then accused patients' groups of refusing to concern themselves with anything but their own disease.
The paediatrician Zulfiqar Bhutta of Karachi's Aga Khan University said that what countries like his most need is not discovery but implementation. Research on new drugs was fine—but not at the expense of learning how to make better use of what we already have.
The final presentations turned the focus to the ethics of using healthy humans in clinical trials. Some commentators believed that the advent of new biotechnological agents will shift more of the burden of testing from animals to humans. The recent debacle at Northwick Park, where the lives of six volunteers were endangered, showed that lessons still needed to be learned (BMJ 2006;332:683 doi: 10.1136/bmj.332.7543.683).