In order to win a licence, a drug has to prove its efficacy and its safety. If a drug trial is relatively short, a drug company can afford to ramp up the potency of the drug in order to prove its efficacy. Safety problems may arise only after the study has finished.
But is this common approach ethical? Dr Koos Stiekema, a research manager with Dutch pharmaceutical Organon, thought not – and he lost his job when he took his concerns to a medical ethics committee. Subsequently, the company also claimed £600,000 of damages against him for the delay in the drug trial.
But an appeal court has found in his favour, and agreed that his actions were responsible, and were not intended to damage the company.
The case revolved around trials into the anticoagulant pentasaccharide, designed to prevent heart attacks in people with unstable angina.
* To discover the inner workings of the pharmaceutical companies, you must read our Secrets of the Drugs Industry. To order your copy of this essential guide, available for £13.75 if delivered in the UK, follow this link: http://www.wddty.co.uk/shop/details.asp?product=341