Concerns increasingly have been raised about the influence of pharmaceutical companies on doctors and their practice of medicine. The pharmaceutical industry has grown in profitability and influence over the past twenty years and is now second only to armaments in the U.S. economy (Public Citizen, 2002). Guidance is available from most Royal Colleges on the appropriateness of using finances/gifts and other benefits from pharmaceutical companies. A declaration of conflict of interest is required for most journals, and evidence shows that there are signs of a small but increasing proportion of articles declaring competing interests in some journals (Hussein and Smith, 2001). Concerns are probably greater in psychiatry, as psychiatric research is particularly susceptible to the influence of vested interests because of the subjective nature of diagnosis and outcome, the variable course of most psychiatric disorders, and the importance of placebo effects, including the context of participating in a research project (Moncrieff et al., 2005).
Psychiatrists increasingly are aware of these issues and are taking appropriate steps to distance themselves from the industry and to regain their independence. While the U.K. Royal College of Psychiatrists has published relevant guidelines (Katona and Cameron 2003), there are some who argue they are not strong enough.
We believe that the influence of the pharmaceutical industry on prescribing, research and publication in the field of psychogeriatrics is not excessive – it is essential for further advancement of knowledge and research. Our argument is based on a number of factors.
Peer support and education
With major cuts in all U.K. National Health Service (NHS) budgets for trainees, sponsored attendance at meetings and seminars is one way of furthering knowledge. In Manchester, we have a study leave budget of £800 (€1,215; US$1,576) for U.K. psychiatric trainees, for a year. There are deaneries where it is tighter. Of course, there needs to be a balance between what is and is not acceptable. For example, one can rarely justify an expensive trip somewhere exotic unless there is a unique meeting not available elsewhere. However, with a £800 annual budget, there are not many conferences a trainee could afford to attend. In the U.K. there are guidelines from The Royal College of Psychiatrists on what is/is not acceptable, and most doctors follow these recommendations. However, speaking for trainees in this country, the small study leave budget is not enough to attend conferences/talks for updating knowledge. Conferences are important not just for educational purposes but also for peer support to discuss what is happening in different areas of the country and what research work is being done elsewhere. Surely in those circumstances it is completely justifiable for doctors to be sponsored by pharmaceutical companies for the advancement of knowledge, and if within accepted guidelines it cannot be excessive. As John Kelly, Senior Vice President for Scientific and Regulatory Affairs of the Pharmaceutical Research and Manufacturers America argues, sponsoring medical education is in the interests of the patients because it facilitates doctors' access to the “best available information” (Moynihan, 2003).
Prescribing
Most meetings are industry-sponsored, and therefore there is a provision that they will advertise their products. In prescribing and advice related to medicines, drug companies are always depicted as the key distorter (Collier, 2006). There is no doubt that drug companies work hard to promote their products and will introduce a certain bias when speaking to doctors. However, this does not imply that doctors will start prescribing that particular product merely on those grounds. Collier argues there are other distorters in the equation too, and these include views of peers, colleagues, opinion leaders and even managers, who control budgets and therefore might bestow or deny privileges. This is especially true with Alzheimer's drugs as, although their efficacy is known in patients with mild to moderate Alzheimer's disease, recent NICE guidelines (2006) advise us to prescribe them only for those with moderate disease. Somehow it is assumed that NICE is independent. However, it is difficult to find any reference to the independence of NICE in official papers or speeches. Therefore, complete independence does not ensure unbiased advice, and nor is partisan advice necessarily incorrect
Ultimately, as Shooter (2005) points out, “drugs do help,” and therefore whatever their ultimate aim, the pharmaceutical companies have poured in millions to alleviate patient distress. The relationship between a doctor and patient ultimately boils down to trust. We, as doctors, guided by the Hippocratic oath, are bound to act in the best interests of the patient on the principles of beneficence and non maleficence. We are also reasonable and rational human beings, and even if a drug company assures us of the quality of their product, this does not mean we will prescribe this without considering its implications.
There is no doubt that being independent improves clarity. However, it is difficult to achieve complete independence and total impartiality when giving advice. Collier (2006) quotes the European Medicines Evaluation Agency's concept of proportionality in determining whether one's advice is biased or not. Once again, this is not absolute and, therefore, only personal adherence to professional codes of conduct on the basis of selflessness, honesty, integrity and objectivity and openness are essential. If these are present, then there is no harm in prescribing, notwithstanding the presence of a little bias.
Research
In psychogeriatrics, the prediction is that the numbers of people in the U.K. over the age of 65 will increase by 15% and those over 85 by 27% over the next ten years (U.K. Government Actuary Department, 2003). Cost illness studies predict that the direct costs of Alzheimer's disease alone exceeds the total cost of stroke, cancer and heart disease (Lowin et al., 2001). It is therefore imperative that research is done to further our knowledge of treatments.
Research is extremely important for the advancement of psychiatry, or any other specialty for that matter. This is an era of reduced government expenditure towards the National Health Service, more so in the research sector. Therefore the pharmaceutical industry has a significant role to play in this area. On the other hand, interactions between doctors and drug companies can lead to ethical dilemmas.
One must also remember that pharmaceutical companies have codes, too; for example, the Association of British Pharmaceutical Industry code stipulates that gifts from companies must cost less than £6 and be relevant to the doctor's work (ABPI, 2001). Yet any trial sponsored by drug companies raises various ethical issues. Doctors argue that the scientific justification behind conducting such a trial lies in the concept of collective equipoise, which means that the medical community as a whole is genuinely uncertain over which treatment is best. Thus, when a physician becomes a researcher, this primary duty is often in conflict when he recruits subjects and randomizes them to one arm of the trial, more so when such a trial is for a pharmaceutical company. However, one must remember, a clinician's primary duty is to promote welfare of the patient.
It is rare that a clinician is totally indifferent to preference between two treatment options used in a trial, because if a new treatment is worth testing either against a standard treatment or against a placebo, there must have been reason to hope that this new treatment is better than the standard treatment or placebo. This hunch/instinct is the basis of many scientific experiments which have led to great discoveries. Pharmaceutical companies have the money to sponsor clinical trials based on such instincts for the betterment of medicine. If the clinician taking part in the trial is aware of his duties to a patient (i.e. he or she can justify that this research will improve knowledge with minimal risk to the patient), then there is no harm for such sponsorship. If true results from such trials are then published with declaration of conflict of interest, even if the results show negative correlations, there is no reason to claim such sponsorship is excessive.
Shooter (2005) argues that the problem lies in the fact that medication is readily available rather than other “talking therapies” which are patchily available and therapists are poorly trained (U.K. Department of Health, 2001). He goes on to argue about the tightened guidelines that The Royal College of Psychiatrists has issued about drug company sponsorship, claiming that the level of industrial sponsorship for College sponsored events has gradually decreased and now forms less than 5% of college income. He emphasizes what we have already argued, namely that drug sponsorship used for entirely worthy causes, such as decreasing attendance fees for trainees, support for psychiatrists from developing countries, or users or carers (who otherwise would not have been able to attend at all), is acceptable. Here again, sponsorship that is for the betterment of medicine cannot be deemed to be excessive.
Publication
An increasing number of clinical trials at all stages in a product's life cycle are funded by drug companies (Dornan et al., 1999). Lexchin et al. (2003) conducted a systematic review and concluded that research funded by drug companies was less likely to be published than research funded by other sources. In spite of the limitations of this review, they found that none of the thirteen industry-funded studies had poorer methodological quality. Journals now have more stringent rules than before on declaration of conflict of interest. In the area of psychogeriatrics, the Alzheimer's Research Trust (ART, 2006) welcomes research by pharmaceutical companies into dementia. From a commercial standpoint, as the population ages, dementia represents an increasingly important market for pharmaceutical companies worthy of research and development investment. ART states that the pharmaceutical industry is fundamental for research because only it can afford the massive clinical trials needed for new drug treatments to be designed, tested and then made available to the public. Within the area of drug development, ART also sees its own role as vital for identifying potential targets for the development of useful drugs which can be taken up by the pharmaceutical companies. All this therefore supports our view that pharmaceutical company sponsored research is essential and not excessive for psychogeriatrics.
In conclusion, there seems to be a growing trend that sees links between pharmaceutical companies and doctors to be wrong or immoral. Drug companies work in relationship with doctors to develop promising and profitable new therapies. An ideal relationship between pharmaceutical industry and medical professionals would be one where “freebies” do not affect/distort the care given to the patient. Doctors are guided by acceptable policies and guidelines which are ultimately aimed at the patient. A doctor's primary obligation is the patient, and there can be no conflict if research or education sponsored by drug companies is ultimately for the benefit of the patient.
