Since he started taking adalimumab for his Crohn’s disease three years ago, he says he has rarely felt better: he is no longer taking steroids, has started to recover from 15 years of side effects and spends less time in care and off work on sick leave.
However, he fears that since the NHS Reforms on 1 April, whether the NHS is getting value for money in continuing this patient’s treatment will be brought “into sharp focus”.
The patient was recently told that “no trials had been done to determine what the minimum effective dose of adalimumab was” and nor would “there likely ever be”.
He says as a patient he needs clinicians to interpret data and reviews so that appropriate decisions can be made but asks how this can happen if experts “don’t get to see the whole picture” and if we don’t even know which trials are being run.
The makers of this drug are now seeking a legal injunction to prevent the European Medicines Agency from disclosing “trial data submitted during the drug’s approval process”. The patient believes it vital that “all data [...] are made available” so that he, his doctors and his local CCG can make decisions about the “efficacy and cost effectiveness of treatments”.
He concludes that the decision by the drug company is a “backward step” and is “offensive” to trial “participants, patients, and the wider public who ultimately pick up the tab”.
Personal view: “I’m a patient: show me the trial data”,
BMJ 2013;346:f2336 doi:10.1136/bmj.f2336