‘Concealed’ drug trial results put lives in danger
01/12
Patients’ lives are being put at risk and public money wasted on ineffective medicines because researchers are concealing clinical trials amid a “culture of haphazard publication and incomplete data disclosure”.
According to papers published by the British Medical Journal (BMJ), researchers who conceal trial results are accused of failing patients who agreed to participate in clinical in order to benefit science.
One BMJ paper, by researchers at the University of California and Copenhagen, re-examined conclusions from reviews for nine drugs including antipsychotics, an antibiotic, and treatments for dementia and migraine, after adding the unpublished reports provided by the US Food and Drug Administration.
They found 46 per cent of the positive outcomes had been overestimated, 46 per cent had been underestimated and only 7 per cent were identical when the missing data was considered. The psychiatric drugs fared worst: all were less effective and more harmful when published data was included. An earlier study found that by concealing negative results, the benefits of 12 commonly prescribed antidepressants had been over-egged by an average of 32 per cent.
The BMJ also highlights how researchers conducting systematic reviews often fail to mention missing data in their conclusions, which could further mislead clinicians.
Dr Kate Law, director of population and clinical research at Cancer Research UK, said some companies deliberately “parked” results they considered to be a “commercial disaster” in that hope that the drug would later prove effective for a different tumour or different disease stage.
Source: Nina Lakhani, i Newspaper 4th January 2012