Experts respond to the recent clinical drug trial in France
Prof Sir Munir Pirmohamed, Director of the Centre for Drug Safety Science, David Weatherall Chair of Medicine, University of Liverpool, and Vice President Clinical, British Pharmacological Society, said:
“Pain medicine is an important area of research and clinicians have a limited number of options for treatment of pain, many of which are associated with their own adverse reactions (as evidenced by withdrawal of COX-2 inhibitors such as rofecoxib (Vioxx) which was associated with heart attacks) and problems with addiction (for example opiates). There is therefore a need for new analgesics.
“Fatty acid amide hydrolase (FAAH) inhibitors are being developed by a number of pharmaceutical companies as novel drugs for the treatment of pain and inflammation. This is therefore an important area of research which could have major benefits for patients.
“From the information available on websites since the reported incident, BIA 10-2474 has undergone the conventional and regulated process of drug development (including testing in chimpanzees as has been reported by some), and the number of volunteers exposed would be consistent with phase I studies, initially starting at low dose and progressing to higher multiple doses. There are suggestions that this might have been a contaminated batch, but this would be surprising given the stringent quality control procedures which are utilised in drug manufacturing. Nevertheless it is an important potential reason which needs to be excluded through careful analysis of the batch given to the volunteers.
“It is possible that the serious adverse reactions suffered by the volunteers were an off-target effect of the drug (i.e. it was interacting with another receptor, enzyme or target in the body), but without further information on the drug and its pharmacology, it is difficult to be sure. It is therefore vitally important that as much information as possible is made available to the scientific community as soon as possible by the manufacturer. The independent enquiry announced by the French Government is also extremely important – it is vital to identify the reasons behind this tragedy so that lessons are learned for future drug development in this vital area, but also more generally.
“Finally, it is important to state, as many commentators have already done so, that the safety record for drug development is good. The 2012 ABPI report stated that the overall incidence of serious adverse events in phase I trials is 0.02%. Phase I trials remain a vital part of the drug development process and without such trials, we would not have any new drugs, which are still very much needed to treat the many diseases and symptoms for which we currently have few choices.”
The Director of the Medical Research Council’s Centre for Drug Safety Science Professor Munir Pirmohamed has been recognised with a knighthood for his services to medicine. The University of Liverpool’s David Weatherall Chair in Medicine has received a Knights Bachelor in the Queen’s Birthday Honours List 2015.
Professor Pirmohamed is also Consultant Physician at the Royal Liverpool University Hospital and holds the only NHS Chair in Pharmacogenetics in the UK. Professor Pirmohamed said: “I am tremendously surprised, but hugely delighted to have received this honour.
“It is a privilege for me to have worked with so many wonderful people and organisations in the UK and beyond, who strive to make a difference to people’s lives by improving how we develop and use medicines.
“This honour not only recognises my work, but also the efforts of the whole team at the University of Liverpool and the Royal Liverpool University Hospital, who work tirelessly to advance the practice of medicine for patient benefit.”
Personalised health
Professor Pirmohamed’s research, which spans the whole spectrum from discovery to implementation, focuses on individual variability in drug response, including anti-cancer drugs, with a view to evaluating the mechanisms and identifying strategies to personalise healthcare.
As Director of the Wolfson Centre for Personalised Medicines at Liverpool, Professor Pirmohamed has pioneered major new initiatives to establish a clinical evidence base for safe and effective medication based on a patient’s unique genetic make-up, age, weight and diet.
Vice-Chancellor, Professor Janet Beer, said: “Munir Pirmohamed is a key contributor to clinical research at the University of Liverpool, but he has also excelled in a national and an international context, both as an individual researcher and in his inspirational leadership roles. This is a truly deserved recognition of his major contributions to medicine.”