How should you prepare yourself for consulting to, or even giving a talk for, a drug company? How sure are you that you can recognise and manage potential conflicts of interest? How can you protect your reputation and good standing? How should you accept payment and how much should it be? In this article we outline some of the pitfalls for doctors considering working with the drug industry and suggest some approaches to minimising the risks.
The drug industry often needs to call on the expertise of NHS clinicians and university academics at all stages in the development and commercialisation of medicinal products. Many NHS clinicians and university research departments find the financial inducements to partnership attractive in a cash constrained public health sector. This creates the potential for considerable conflict of interests.
This relation between leading doctors and drug companies is facing increasing media scrutiny because the same doctors have appreciable influence over local and national healthcare policy. The Health Select Committee in the UK parliament is examining the influence of the drug industry on the wider healthcare sector.
The medical and lay media have been unyielding in their pursuit of scandalous stories about drug companies. “Free pens and pizza lunches, sponsored conferences, and compromised medical education. Courtesy golf and unaffordable holidays. Thought leaders and ghost writers. These are the trappings of doctors and drug companies being entwined in an embrace of avarice and excess, an embrace that distorts medical education and patient care.”1 In the United States the debate is equally fierce. The National Institutes of Health have imposed a one year ban on paid consulting work for its staff because of irreconcilable conflicts of interest.2
Yet it would be wrong to see the drug companies as pure villains. The drug industry has a track record of developing and bringing to market medicines that have contributed substantially to addressing some of the world’s greatest health needs. Drug bench science and medical research are highly regulated. As the cost and risks of developing new drugs continue to grow, it becomes increasingly unlikely that any new drugs can be developed to maturity outside the industry.
The UK health economy requires a successful drug sector and the industry requires NHS and academic partnership. In recognition of the very real public relations challenge facing the drug industry, the NHS Alliance and the Association of the British Pharmaceutical Industry issued a joint document in 2004 entitled Working Together for Patients.3 This called for more high quality, best practice collaboration that benefits patient care. The document concluded that trust, built through greater understanding and reconciliation of these respective agenda, could lead to this goal being achieved.
Box 1: Examples of areas for invited collaboration
Basic science projects
Developing clinical trial protocols with a company
Investigator in company clinical trials
Investigator initiated studies—clinical or preclinical
Authoring papers and textbooks
Presenting to meetings
Consulting to regulatory functions
Consulting to medical functions
Consulting to marketing functions
Shared marketing projects
Consulting to public relations and corporate affairs functions
Media work and advocacy
Can doctors work ethically with the drug industry?
The current situation presenting unmanageable risk to the reputations of both consultants and drug companies is untenable. Lack of clarity, unequal power relationships, and lack of training in transparent best practice all contribute to the media and public perception that the relationship is cosy, entwined, and unregulated. We suggest four key steps for doctors considering working with the industry.
(1) Recognise the nature of the problem
Fundamentally, this is a question of different primary interests. While a public service ethos governs clinical practice and university research, the main “driver” for industry is, unavoidably, the need to protect shareholder interests. Clinicians seek better patient care, academics seek independent research that serves the public good, but industry seeks timely delivery of innovative products that will maximise financial return and shareholder value. While it does not necessarily follow that these interests are conflicting, it is at the very least necessary to recognise how easily such conflicts can arise.
(2) Understand the nature of partnership
There is a need to secure a more equal partnership reliant on pooled expertise rather than on exploitation of ignorance. Interaction between consultants and sales and marketing through drug representatives presents a risk to both sides. Each party must understand the agenda of the other, be clear as to the goals of any partnership, be clear as to the legal implications of the partnership (written or unwritten), and be transparent in their working practice.
Doctors intending to consult to the drug industry need to understand the motives and interests of their industry counterparts. It is equally important that they understand the strict regulatory frameworks that govern the actions of industry employees in order to support companies in preventing any breach of these regulations and to avoid impropriety. These range from the International Conference on Harmonisation of Good Clinical Practice (ICH GCP)4 in research to codes of promotional practice governing sales and marketing.5
(3) Be clear exactly what you’re being asked to do
Drug companies have many functional areas, including research departments, regulatory affairs, marketing, sales, and corporate affairs. How well do you understand what will be done with the work to which you are contributing? More specifically, how will your contribution be used? Do you understand the role of the person in the company who is inviting your collaboration (box 1)?
Box 2: Existing guidance with web links
American Medical Association: www.ama-assn.org/ama/pub/category/11910.html
American College of Physicians: www.acponline.org/journals/news/jul-aug03/drug.htm
Association of the British Pharmaceutical Industry: www.abpi.org.uk/Details.asp?ProductID=244
General Medical Council: www.gmc-uk.org/standards/default.htm
World Medical Association: www.wma.net/e/policy/r2.htm
Royal College of Psychiatrists: www.rcpsych.ac.uk/publications/cr/cr117.htm
There are also a number of organisations which offer specific training in ICH GCP for investigators in clinical trials:
• Institute of Clinical Research: www.instituteofclinicalresearch.org/content/your_career/training/intro_gcp_cr
Finally, there are providers of training in the broader relationship with industry:
• Arbor Vitae Education: www.arborvitae.org.uk/
How will your work be recognised? Will you have authorship? Will you be paid? Are you acting as an individual or on behalf of your employer or other body? Should you receive payment personally or should it go to your employer? Are you trained to negotiate these conditions, and should your employer be involved in the negotiation?
(4) Formalise appropriate training in your personal development plan
The new NHS consultant contracts are time sensitive, with agreed job plans supported by appropriate personal development plans and training within the frameworks of clinical and research governance. Job plans can include specified arrangements for consultancy work and this work should be included in personal development plans. For clinicians and clinical academics who work, or intend to work, with industry the issues outlined above should be considered within the job plan and resultant personal development plan. There may well be a case for study leave and funding to train in support of this agenda. There is a pressing need to establish and regulate this field. Through training, benchmarking, and shared learning, best practice standards will emerge and can be disseminated, protecting the reputation for those who observe the standards set.
While clinicians undertaking research in collaboration with the drug industry are required to undergo ICH GCP training, there is no such requirement for clinicians to be trained with regard to promotional codes of practice before working with marketing or other corporate functions.
Some organisations provide useful guidance (box 2). This is often general in its scope, however, and does not address the real world dilemmas encountered by clinicians and academics offered money by drug companies for various activities.
Working with industry is not without its risks but can be of benefit to individual collaborators and to the health economy as well as to the drug companies. It is important to go into such work with your eyes wide open. Training in the relevant issues is vital in maximising the benefits of such work while minimising the professional risks entailed.
Competing interests: Peter Aitken has previously worked as a research physician in the drug industry and owns shares in Arbor Vitae Education, which provides courses training in consultancy to the drug industry. Cornelius Katona has provided consultancy to, received research funding from, and given talks for several drug companies.
- Abbasi K, Smith R. No more free lunches. BMJ.2003;326: 1155-6.
- News. BMJ2004;329: 758.
- Working together for patients. ABPI and NHS Alliance, 2004.
- ICH GCP Sixth international conference on harmonisation, new horizons and future challenges. 13-15 November 2003, Osaka, Japan.
- Association of the British Pharmaceutical Industry. Code of practice for the pharmaceutical industry. London: ABPI, 2003.