David Gillen is Head of Medical for the Pfizer Primary Care Business Unit covering Europe, Canada, Australia and New Zealand. Until last year, he was UK Medical Director. He is a member of the Editorial Advisory Board of the British Medical Journal and also serves on sub-committees of the ABPI, NICE and UKCRC and was a member of the RCP working party looking at the relationship between Industry, Academic Medicine and the NHS. We’re extremely grateful to him for making time in his busy schedule to speak with us.
Since you first qualified in 1992, you must have seen and adapted to tremendous changes in science, business and best practice. What have been the highlights, both of your own career, and of clinical research in general, over that period?
For me, the highlight came when I was fortunate enough to spend some time in the USA, working in cardiovascular medicine in Pfizer. During that time I led a team that led the development of a combination compound of amlodipine and atorvastatin in a single pill, a drug called Caduet that is now available in the USA and some countries in Europe (although not, unfortunately, in the UK). I was responsible for getting that programme completed and getting that drug through the FDA. In many ways, people may say that was an easy one, but what I learned was that there’s no such thing as an easy development process, and no such thing as an easy regulatory process. That, obviously, was an achievement.
I’ve worked about 20 programmes over my time at Pfizer, and that’s the only one that I can honestly say I’ve been involved with that has made its way to patients. I recall, subsequent to the launch of that medicine in the US, someone actually came to do some gardening at our house and it turned out that this chap was actually a patient taking the drug that I helped to develop. Obviously, that feels good. Having being trained as a clinician, when you move to industry people sometimes look at you quizzically, and say “don’t you miss the patients?”, and I do miss them. I see my job as more of a public health type of model, but it’s obviously nice when you get the immediate feedback from a patient who’s taking something that you’ve managed to play a part in developing. So, that’s probably my personal highlight.
Generally, I’ve noticed a burgeoning increase in the need for health technology appraisal and the importance of economics in decision-making, led by bodies like NICE, certainly throughout Europe. What I’ve noticed most is the paradigm shift in the development of drugs: we used to talk about the probability of technical and regulatory success, now we’re talking more about the probability of technical, regulatory and access success. I think that’s been the fundamental difference that I’ve seen, and you can’t really deny that it’s a good thing. It’s a tough thing to do, but it’s important as a tax-payer that we can justify investments in health that occur when you take a medicine.
I’ve also noticed an increasing distrust between the pharmaceutical industry and our prime stakeholder, the healthcare professional who prescribes a drug. I think that is a danger for innovation and a danger for patients. I think this distrust is two-way: everyone says that prescribers don’t trust industry and the dichotomy between ‘research and development’ and ‘sales and marketing’, but I think some of the “..sense of entitlement culture” that maybe some aspects of the healthcare culture have become used to with industry hasn’t helped them either.
Coming back to what you said about health technology assessment, do you think the earlier engagement we in the UK have had with that discipline is actually going to serve us well in the future? It’s only ever going to become more important…
I think there are two parts to early engagement: the really heartening thing about NICE is that they’re now offering scientific/economic advice on compounds in development. We’ve just had our first experience of that, and it was a good one, and I think that certainly should help decision-makers in big companies make decisions on how they do their clinical studies in order to improve the likelihood of getting the right type of data to achieve regulatory approval and access approval.
I think the general attitude to NICE has been one of increasing acceptance; initially it was one of suspicion from the pharmaceutical industry but increasingly now one of recognition that it’s the way forward and we have to work with it.
I actually do some work at NICE on one of their guidance groups, and I perennially comment that pharmaceutical interventions and, to a degree, device innovations seem to be the focus of health technology appraisal. I do wonder whether sometimes other parts of the health service should be looked at to challenge whether or not they’re economically viable.
When you put the cost of interventions in the context of the overall NHS budget…
Yes, that’s something that we don’t talk about enough: the medicines bill as a proportion of the total NHS spend has been constant at around 10 or 11% for the past 20 years or so, yet NHS spending has gone up. I think that’s not always a message that we get out, as an industry, and I think we should. Medicines improve the quality and quantity of patients’ lives; the reality is, though, that as a company we have a limited time to recoup the investment that we make on that. I don’t think we’ve been terribly honest about saying that; I think we need to be a bit more up-front about the business that we’re in. I think it’s a important business and one that I’m very proud of, and I don’t think we should hide away from the fact that it is a business.
You’ve spent almost all of your industry career with Pfizer; do you feel that being a leader in Big Pharma enables you to make more of a difference to patients than if you’d stayed on the ‘front line’ of healthcare delivery?
I think it’s different: as I said previously you have a public health view rather than an individual health view. I used to love the clinic. I managed to continue doing that when I first started at Pfizer, and I encourage my colleagues who join industry to do that too, although unfortunately I don’t have time to do it any longer. I think that if you’re involved in developing or maintaining a medicine in the marketplace, and if it’s a good medicine, then it’s improving millions of people’s lives and you could never do that as an individual physician. So, it’s balancing that lack of immediate feedback with longer term feedback about the benefits that these medicines bring.
At a conference a few weeks ago, you commented that there are areas of clinical research where the UK should simply not try to compete, and focus on what we do well. Is this message getting through, or are we trying to be all things to all people?
I think it is starting to get through; at that conference the reality was that there’s an awful lot of interest in the UK in life science organisations and in commercial R&D as part of the platform that every significant hospital and Trust should have as part of it’s quality of care agenda. I think that’s right: if you’re doing clinical trials, you’re involved in the research, and if you’re involved in research then you tend to providing better quality of care. So, there’s a lot of interest, but there’s a reality check: historically, the UK has not performed as well as other countries in western Europe and elsewhere. So, for rational reasons, decisions are being made to not necessarily include the UK in some studies.
However, there are certain areas that I think we as a country should and do really excel at, including oncology studies, paediatrics and conditions like Alzheimer’s disease, where we have some real leading lights on the global stage. I think it’s also important to focus on what types of research we do; rather than the big Phase III studies, perhaps the “learning”-type studies in Phase I and early Phase II would be more appropriate for countries like the UK. We are perennially charged, in my company and others, with the expense of medicines and one way to try to reduce this expense is to do the most costly part of R&D, which is late-stage, in areas of the world that are less expensive, with bigger populations where it’s easier to recruit patients.
So, I think we should be focusing on certain phases of the drug development paradigm, in certain therapeutic areas, and perhaps some of the more sophisticated types of study. This also makes sense from a quality of care standpoint, and I think that if we do this then we will regain the reputation that we historically had.
You also mentioned the ‘preferred status’ of high-performing countries in terms of Pfizer resources (as contrasted with outsourced resource elsewhere) and likelihood winning studies. How should countries currently not making the grade avoid a downward spiral?
There’s always going to be ‘good’ sites in ‘bad’ countries, so to speak. I would suggest that those ‘good’ sites should be entrepreneurial, develop a communication strategy and try to partner with the right companies. It seems to me that in clinical research the customer relationship changes: in many ways, the sponsor is the customer, so the people who are hungry and want to interact with companies like mine will be the ones who get a chance. So, I would encourage people to think like that, with leadership that believes that commercial R&D and clinical research is part of the triumvirate of education, research and quality, and who will get out there and talk about it in meetings and at any opportunity with companies. People will take a chance on good, enthusiastic sites even if you’re in a less good country.
You’ve been quoted (on Twitter, of all places) as saying “as an industry we must not be apologists. Stop thinking of ourselves as a cheque book; we are much, much more than that.” What more should industry do to be valued as a collaborator by other healthcare professionals?
One of the things that I’m very proud of over the past couple of years is the work that I was part of at the Royal College of Physicians, looking at the relationship between the industry, academic medicine and the NHS. Many of the ideas in that document are also transferrable outside the UK, and what it talks about is really redrafting the ‘contract’ to make it much more of a partnership and doing the right thing for the patient, which we all agree is the most important thing. Whether we’re healthcare professionals or the industry, what we’re all trying to do is improve the patient’s quality and quantity of life. The best way to do that is clinical trials, in order to get the medicine to the patient and to learn more about that medicine.
My sense is that the relationship is different when you’re doing clinical trials, and it should be more grown up. My view is that, as the sponsor of a study, we have a responsibility to make sure that the study is delivered, for the patients, for the healthcare system but also for Pfizer and its shareholders. Therefore, we have a responsibility to insist that it’s done to the right speed and the right quality, which allows a very different conversation to take place than might happen if you’re doing a sales pitch for a medicine. The conversation on the former is much more collaborative and partnership-based and that’s the model we should be working towards. We should learn from our colleagues throughout clinical research, and the really good monitors are the ones who have that sort of relationships with their sites.
… and the view is longer-term, not to just completing this study, but to every future patient who might benefit from the intervention.
I think that’s right; the wonderful thing about my business unit is that we have responsibility for our medicines all the way from proof of concept in Phase II right through to loss of exclusivity. That’s a real responsibility and the lifecycle of a medicine continues throughout that period and every trial, whether it’s in Phase II or Phase IV, is as important in terms of trying to understand how a drug is used in real practice.
Finally, if you could change one thing about the wider world of medicine, beyond the scope of your current role, what would it be?
Well, it wouldn’t be in medicine: the one thing I’d change in my life would be to have more time with my kids and my family. I love my job, its challenges and its politics, but I do wish I could spend more time with them. I hope they understand why I do my job, and I think they do, but an ideal world would have more hours in a day, so I could do everything I want to in developing medicines and still have more time at home.
