Critics of the research in complementary medicines need to take heed of the scepticism that is increasingly present regarding ‘evidence’ for orthodox treatments.
Of course we all want ‘evidence’, but evidence is only as good as the quality of the research, it’s transparency and the absence of bias. 85% of trials are sponsored by the pharmaceutical companies; when comparing drugs, the vast majority show that the sponsoring company’s drugs are more effective than the comparison drug. For example, we have all been lead to believe that the new neuroleptics are safer and more efficacious than the old.
'The story of the atypical antipsychotics is a tale of the triumph of profit over patient benefit, of marketing over ethics', says Prof Tim Kendall, director of the National Collaborating Centre for Mental Health. Doubts about the veracity of the superiority of second-generation atypicals started to emerge about 10 years ago and it is now thought that there is no difference in clinical efficacy between the two classes of drugs.
If you haven’t already done so, I would urge anybody who puts ‘evidence’ on a pedestal to read ‘Reality Check’ in the BMJ. Ray Moynihan refers to the mounting corroboration that there is a massive positive bias in the publication of trials.
In the past 15 years there have been quite a number of articles in eminent journals that raise this problem. For example, we find that in the New England Journal of Medicine among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Access to the unpublished evidence was obtained under the Freedom to Information Act.
In the UK, NICE does not have a legal right of access to unpublished trial results which the industry submits to the regulator and the MHRA is unable to prosecute companies for witholding information, so how can NICE ensure that their recommendations are evidence based?
The problems of selective publication are further explored in the subsequent two articles of the same BMJ, urging greater access and transparency of data, disclosure of unpublished evidence and better quality reporting by the European Medicines Agency, in order to provide more useful information to all.
Much research now exists that demonstrates that company funded research is most likely to lead to positive results. Non-publication of inconvenient findings is only one of the mechanisms that may explain this finding. Others mechanisms might include multiple publication of positive results, incongruous interpretation of results, choice of comparator agents, aswell as ‘seeding trials’, or marketing trials, that are not trials at all but are marketing attempts to introduce an intervention to clinicians. No doubt there are other mechansims, too.
The UK Biobank has recruited half a million citizens and will follow them up, monitoring lifestyle, environment, health and disease. It is, to some extent, funded by the pharmaceutical industry. The data may in part be used to develop new drugs. An editorial in the Lancet discusses selective reporting, refers to John Bell, chair of its science committee, and states that he is also a director at Roche. I looked at the UK Biobank website’s page of its supporters and although John Bell is named, I cannot find a declaration of interests.
It seems blatantly obvious that commercial interests have a massive influence in the pharmaceutical world. Bilions of pounds of profit are at stake. Until we have an effective mechanism to ensure quality of information that addresses these factors and moreover as we move towards a medical service that is increasingly ruled by market forces, we should be mindful of the power of Big Pharma and stay wary, critical and questioning of ALL evidence.
