Monday, July 03, 2006

"From Optimism to Disillusion about Commitment to Transparency in the Medico-Industrial Complex"

Iain Chalmers has just published an important commentary. Its content is evident from the title above. (Full citation: Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. J Royal Soc Med 2006; 99: 337-341.)

Chalmers began by explaining why he was optimistic during the 1990s that the pharmaceutical industry was beginning to show willingness to increase the transparency of the clinical research they sponsored. However, towards the end of the decade, disillusionment set in, as he found that promises were not being kept. Although there was some apparent progress after Eliot Spitzer, the Attorney General for the state of New York in the US, sued GlaxoSmithKline "for witholding information about important possible adverse effects of drugs taken by children for depression," this again appeared illusory. Chalmers wrote,
Only then did the drug industry start to try to limit the damage caused by its failure to follow the lead given by Schering Healthcare and Glaxo Wellcome nearly a decade earlier. In a press release issued in June 2004, GlaxoSmithKline announced that it would make the results of all its clinical trials publicly available. The company did not explain how, given that its trials register had been allowed to fall into disrepair, the public would know whether all results were being made available.

If GlaxoSmithKline really is committed to the kind of openness the public has come to realise is needed, one might have expected it to have endorsed the Good Publication Practice for Pharmaceutical Companies Guidelines developed by its dismissed former employees and colleagues in other companies. It has not. Indeed, at the time of writing, only six pharmaceutical companies have endorsed the guidelines—Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals.

On 6 January 2005, the industry announced a global commitment to clinical trial registration and publication. Whether this commitment amounts to the‘big changes' that Richard Sykes judges are needed is an open question. First, the commitment applies to only a tiny proportion of the clinical trials which should be informing prescribing practices because it is not being applied to trials conducted in the past. Second, there is a continuing flow of empirical evidence of biased reporting and interpretation of industry trials. My judgement is, therefore, that industry's actions are simply too little and too late to deal with its current reputation for being less than honest with its research....
Chalmers' conclusions were striking.
Biased under-reporting of research harms and sometimes kills patients, quite apart from the waste of resources that results from this form of scientific and ethical misconduct.

As I have made clear, biased reporting and lack of transparency is not limited to commercially-sponsored research; but the empirical evidence makes clear that it is a particularly noticeable problem in that sphere. Those who collaborate with industry need to be clear that their acquiescence in these forms of scientific misconduct inevitably casts doubt on their integrity....

The responsibilities of doctors should be unambiguously to their patients. Yet some clinician researchers (with plenty of encouragement from government and the institutions with which they are associated) appear to have become so seduced by the financial rewards resulting from collusion with industry's agenda and practices that they have forgotten this most fundamental of their professional duties. Indeed, that is the most depressing cause of my optimism of a decade ago becoming disillusionment today.
Chalmers ended with some practical suggestions:
1. All pharmaceutical companies should join Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals in publicly endorsing the Good Publication Practice Guidelines for Pharmaceutical Companies
2. Industry as a whole should put in place mechanisms for promoting and monitoring adherence to these guidelines, thus making clear to the public that it regards under-reporting of research as just as serious a form of scientific misconduct as fabrication of data
3. Industry should voluntarily take steps that go beyond the minimum currently being required for clinical trial registration,30 for example, by publishing full protocols at the inception of all randomized trials.
Good ideas. Is anyone listening, especially the institutions that have been encouraging researchers into sometimes dubious industry collaborations, and the researchers themselves who have entered into these collaborations without protest?

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