Striving for better patient care and outcomes with our drugs — pharmaceuticals and “companion” genomic testing

Before entering Pharmaceutical Medicine, I trained as a Chemical Pathologist, which involved the biochemical investigation of body fluids, such as blood, urine, faeces, cerebrospinal fluid, etc. Over the years in Pharmaceutical Medicine, I am one of those rare individuals who has been part of the launch of a drug in the UK (as the UK Medical Adviser at Pfizer), then a practising Consultant Chemical Pathologist who prescribed lipid-lowering agents for my patients, and later a patient prescribed the very same medicines that I supported and launched. As a patient, I am now taking two products that I was involved with from my time in Cardiovascular Medicine at Pfizer. I know the adverse reactions of being on a statin and a calcium channel blocker, and I am fortunate to be at my expected LDL-cholesterol target of <1.8 mmol/L and have well-controlled blood pressure.

One of my patients recently asked me about interactions between statins and her medications. Then, the whole issue of drug-to-drug interactions hit me: I do not have all the appropriate drug–drug reactions at my fingertips. Additionally, whilst conducting an audit on my patients who were prescribed an enzyme inhibitor for PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9), which binds to lipoprotein receptors, only 30% of them achieved the  European Atherosclerosis Society’s standard for LDL-cholesterol targets of <1.8 mmol/L, 10% discontinued treatment and 14% failed to respond to treatment (< 15% LDL reduction). The Chemical Pathologist in me questioned why we in Pharma do so much to promote efficacy but do not put the same effort into understanding and educating the clinicians on drug-to-drug reactions, adverse reactions and non-responders to the medicines we produce and market.

Measuring PCSK9 levels in the blood before and after taking medication provides some initial clues – statins have been known to increase PCSK9 expression in some cases, potentially impacting the effectiveness of inhibitors. Unfortunately, PCSK9 tests are not offered, and the current tests are far from standardised or reproducible, so this option is limited to research purposes only. Should Pharma not undertake research and develop tests as companion diagnostics? In my audit, 32% of the patients on PCSK9 inhibitors had <40% reduction of LDL-cholesterol compared to the 50 – 60%, which was the average reduction; it would have been appreciated if one could identify these patients beforehand.

Dr John Bolodeoku is currently a Consultant Chemical Pathologist and Pharmaceutical Physician working for the Life Sciences Sector (Pharmaceuticals, Diagnostics, Devices and Laboratories).  After completing his specialist training in Chemical Pathology and Human Metabolism, he joined the Pharmaceutical Medicine Industry (1997) as a Clinical Research Physician at BIOS (Consultancy & Research) Organisation in Bagshot with its Phase I unit at Basingstoke Hospital and then went to Medical Affairs in Pfizer UK in Sandwich, Kent as Medical Adviser. He then moved to Europe to work in Medical Affairs for Yamanouchi Pharma Europe in the Netherlands as a European Medical Manager (2000). He was promoted to Director of Medical Affairs & Health Economics at Yamanouchi Pharma Europe (2021).

He went on to become the Senior Medical Director for the merged company of Yamanouchi and Fujisawa, Astellas Europe (2005), and he resigned from Yamanouchi/Astellas as Vice President for Medical Affairs and Health Economics (2009) and was awarded an Honorary Life Member Award by Astellas Europe.  He started his own consulting company, JB Consulting, to broaden his reach into diagnostic pathology. JB Consulting’s pharmaceutical assignments have included Daiichi Sankyo, Lilly Diabetes, Lilly Oncology, Novartis, TEVA, MSD, UCB (Medical Adviser), NAPP (Head of Medical Affairs), Biogen Idec & Celgene (UK & Ireland Country Medical Director), Roche Ireland (Country Medical Director), ICON Solutions (Clinical Research Physician and Principal Investigator).  He is an Associate of the Faculty of Pharmaceutical Medicine and has held several positions: Chairman of the Committee of Affiliates, Associates and Members (CAMM), Executive Member of the Faculty Board and Representative to the British Medical Association Medical Academic and Scientific Committee.  He is a Visiting Senior Lecturer in the Centre for Pharmaceutical Medicine Research (CPMR) at King’s College London.  In addition, he has been an Honorary Consultant Physician (Lipids) at North Hampshire Hospital, Basingstoke, UK, since 1999 and has been a key opinion/thought leader for the following pharmaceutical companies with lipid-lowering medication Pfizer, MSD, Novartis, Daiichi Sankyo and Sanofi.