Dr Ranjana Srivastava writing in the Guardian:
reports that after two doses of an experimental drug in a clinical trial a man she knows has been left with profound nerve damage, chronic pain and the inability to use his dominant hand.
The man, already suffering from a rare multisystem disease, was caught between a rock and a hard place: continue to suffer (when no conventional medicine would help) or participate in a clinical trial that might, ultimately, help him and others. Sadly the side-effects of the trial medication exaggerated his problems and have left him worse off.
In this case the gentleman known to Dr Srivastava alleged that rare but serious toxicities should have been better explained to him and had they been he would not have participated in the trial, there was a lack of good communication, his complaints were not taken seriously and the process of obtaining informed consent was lax.
A perhaps surprising flip-side to researcher misconduct is that participants in clinical trials have also been found to mislead. Some withhold relevant medical information (such as the use of prescription and recreational drugs) and others exaggerate symptoms or even pretend to have them in order to be allowed to participate. Dr Srivastava describes this having had tragic consequences for a participant in a sleep study who died having failed to disclose anorexia and self-induced vomiting which, had they known about it, would have caused the researchers to exclude her.
This interesting article concludes that we must hope for total integrity in researchers and participants involved in clinical trials. We need clinical trials but their outcomes may impact on the medicines prescribed to us by our doctors – and thus our lives.