JRSM >
Volume 101, Number 4 >
Pp. 159
JRSM kamran.abbasi{at}rsm.ac.uk
March was a bad month for drug companies. An analysis of all trials of antidepressants submitted to the US Food and Drug Administration revealed that these wonder drugs were little better than placebos except in severe depression. GSK was slammed by Kent Woods, head of the UK’s Medicines and Healthcare Products Regulatory Authority, for the company’s failure to disclose all safety data about one of its blockbuster drugs, which also happened to be an antidepressant. And a whistleblower from Reckitt Benckiser claimed that the company had blocked generic versions of Gaviscon, another blockbuster drug, costing the NHS millions of pounds.
The unifying theme of these ethical embarrassments is the conclusion that companies have remained determined to protect their commercial interests at the expense of the public health and the public purse. Business pressures drive an unending demand for growth. A chief executive might deliver a profit of £10 billion, but if that represents static year-on-year growth, or even a reduction, then that gargantuan profit is barely tolerable in the corporate environment. Ultimately, drug companies are not judged by an improvement in patient outcomes but by an increase in sales, although you might hope that the two are related. Risk-share models have come the closest to linking revenue to outcomes but they remain experimental.
While shareholder value remains a company’s main objective, it is hard to imagine that companies will cease to use the skills of clever lawyers and ingenious marketers to game the system. A rich global company can call on greater resources than some of the world’s poorest countries. This ground reality leaves the public sector in a position of considerable weakness, resorting to naming and shaming through journal articles, regulatory authorities and television scoops. For a multinational organization these are minor and transient irritations.
Yet the battle is not futile; indeed, it is an essential one if patient care is the central concern. Companies have already been encouraged to register their clinical trials, and new US legislation will force companies – and other sponsors – to publish trial results within a year of completion of a study if they seek FDA approval.
This is a step that could genuinely change behaviour, but it requires support and sensible implementation. First, the results that are made public must be sufficiently complete to allow a meaningful appraisal of a trial. They must be accompanied by the original trial protocol to identify any important differences between how the study started and how it ended up. These trial results must be freely and publicly available in searchable online databases.
Journals must also play their part. Already, some august publications are becoming concerned about the possibility that research findings might be revealed in a public results database before they are published in a journal. Editors and publishers should put the public interest first and take responsibility for adding sufficient value during the publication process so that journal publication remains an important method of communicating research findings to a relevant audience.
But these policies are meaningless when governments are unwilling to legislate. Once again, as with trial registration, the UK and Europe must follow the US, where Ted Kennedy showed sufficient leadership to change the law. Legislation and leadership is also required here to force companies, and all other sponsors, to publish trial results. The question is how quickly the UK will act to bring this about. Thus March may have been a bad month for drug companies, but it can become a catalyst for a change that will improve patient care and, ironically, help improve the public perception of drug companies.
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