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Martin Rourke1

Author affiliations
1RCSI medical student

Royal College of Surgeons in Ireland Student Medical Journal 2012;5: 93-95.

Martin Rourke asks if the relationship between doctors and drug company representatives is in the best interests of all concerned.


Scenario
The following scenario was observed while on rotation in general practice:
A female representative from a leading pharmaceutical firm made an appointment to meet with a general practitioner (GP) to discuss an antiviral drug that was new to market. She was professional and confident in her presentation and established an excellent rapport with the GP.
She advised the GP of the specific patient type that would benefit most from her company’s antiviral drug, and mentioned some of the common side effects. However, she presented the benefits in terms of relative rather than absolute risk reductions. She stated that her new product showed a 50% relative risk reduction in gastrointestinal symptoms, when in fact the absolute risk reduction was just 1%. On departure, she left two sample packs for the GP.

Introduction
The drug representative-GP interaction has been studied extensively from a marketing and sales perspective. More recently, ethical issues surrounding the relationship between the medical profession and the pharmaceutical industry are being considered.1,2 Meeting with representatives from the pharmaceutical industry is purely optional; however, over 90% of GPs agree to meet drug representatives.3 In Ireland, a GP can expect to receive, on average, 2.2 visits per week that last 6.2 minutes, with a mean of 3.3 products promoted by representatives during each visit.4 For recently launched brands, cost analysis demonstrates that the return on investment for every dollar spent on direct detailing can be as high as US$10.29.5

As a medical student who was once both a drug representative and marketing manager for a large pharmaceutical company, the commonly encountered scenario above drew my attention from an ethical perspective.

Reflection on the ethical implications of the GP-drug representative relationship can be divided along the lines of the four ethical principles of justice, autonomy, beneficence and non-maleficence.

Justice
In daily practice, GPs must consider whether their actions treat all persons equally and if healthcare resources are being allocated to patients fairly. If uneven distribution of resources occurs, they must decide if such inequities are justified.
Sample dropping is an established practice aimed at increasing brand awareness. The drug representative provides free samples to a GP, who then passes these samples on to the patient as a starter pack with a prescription for continuing the medication. In this particular scenario, it is worth contemplating to whom the doctor will allocate the expensive sample antiviral medications. Given that the samples are not sufficient to cover all his patients, the doctor may subconsciously create a preferential system of healthcare within his own practice.

Light-hearted corner

Are you drug company-dependent? The following modified CAGE questionnaire may be of help:
C Do you drink your Coffee from a drug branded cup?
A Do you Autograph with a drug branded pen?
G Do you write the branded rather than Generic name in the drug Kardex?
E Have you Eaten a drug company-sponsored lunch in the last week?
If you answered yes to two or more of the above questions, you may indeed be drug company-dependent.

My own adaptation of Jamsey’s11 original parody of the CAGE questionnaire for alcohol dependence.

Autonomy
When consenting to medical intervention, patients are doing so in the belief that the treatment options detailed by the GP are the most appropriate for their condition. This is the basis of informed consent. The practitioner must objectively assess, distil and deliver information to the patient that is free from bias. Any dampening of objectivity may negatively impact the doctor-patient relationship as the patient may lose trust in the physician.

While 70% of practitioners believe they can benefit from the prescribing information gained from medical representatives, difficulty arises if this is the only source of information consulted for a particular treatment.6 Of note, a survey of 200 GPs and 230 hospital doctors revealed that in 42% of cases, prescribing information on the last ‘new drug’ the physician prescribed was provided solely by pharmaceutical representatives.7 As such, the potential for providing the patient with imperfect information is a real possibility, as pharmaceutical companies and their representatives are not unbiased.2 An example of this is highlighted in the above scenario, where the representative provides relative rather than absolute risk reductions to exaggerate the benefits of the company’s new drug.

Beneficence
Medical advances pioneered by the pharmaceutical industry have delivered many benefits to patients on a global scale, from the development of injectable insulin for the treatment of diabetes to proton pump inhibitors for the treatment of gastro-oesophageal reflux disease.1

The development and delivery of medicinal products saves lives, enhances quality of life and is estimated to be responsible for approximately half of the 26-year increase in life expectancy encountered over the last century.8

The benefits of the pharmaceutical industry reach beyond that of the clinical encounter alone. For example, according to a 2006 Pharmachemical Ireland report, 14 of the top 15 global pharmaceutical companies now have operations in Ireland and directly employ in excess of 24,000 people.9 Shares in these companies are linked to private pension funds, and pharmaceutical exports generate 44% of the nation’s total exports, making Ireland one of the largest net exporters of medicines worldwide.9

Non-maleficence
Above all else, the GP must do no harm – primum non nocere. Therefore, treatment options must benefit the patient. However, no drug is without its side effects, and the physician must be aware of the potential harms before prescribing a medication. Herein lies an ethical challenge. Pharmaceutical representatives are in the business of selling benefits rather than potential harms or side effects – that is, their objectives are not necessarily patient centred. Ultimately, the representatives’ performance is assessed based on sales. Thus, drug promotion is guided by the interests of the shareholder rather than those of the patient. That said, doctors, patients and representatives alike hope that the next new drug will be of great benefit in combating illness.

Furthermore, it is unlikely that all side effects are known at the time of product launch. Stage IV post-marketing surveillance studies often reveal side effects that were not detected at or before licensing. Doctors must be cognisant of ‘the law of the new drug’ and the oft-unpredictable life cycle many new drugs can follow.10

In 1982, Jeste and Wyatt proposed ‘the law of the new drug’. The authors described the pendulum-like swing of a product’s patented life, first in the direction of overvaluing the new drug as a risk-free panacea, next to the extreme of overemphasising the drug’s toxicity and thus limiting clinical usefulness, only later to reach a midpoint on the arc at which drugs are appraised realistically as beneficial in particular patient groups, albeit with genuine and well-documented side effects.10

It is clear that effective medical practice requires the appropriate use of pharmaceutical products.1 The key issue is how to use interactions between the pharmaceutical industry and prescribers to best benefit patients. Having witnessed this scenario time and again as a drug representative, I believe that a simple ‘1:1 minute rule’ can serve as a guide to how one might ethically approach such encounters to maximise patient benefit.

A ‘1:1 minute rule’ means that for every minute a doctor spends with a medical representative who is detailing a drug for the treatment of a certain disease, the healthcare professional should spend an equal amount of time studying the relevant evidence-based medicine, with a particular emphasis on areas not always communicated by drug representatives, such as side effects of the drug or current independent protocols and guidelines for treating the given disease.

Conclusion
While the debate regarding the pharmaceutical representative-practitioner relationship is often an emotive one, it is clear that practitioners need the pharmaceutical industry to deliver new and better treatments. The doctor must acknowledge the potential of being subtly influenced by interaction with drug representatives and embrace ways to counterbalance it. Application of a simple ‘1:1 minute rule’ is one possible method to counteract potential for bias and enhance the relationship between the drug representative and the prescriber to the benefit of the patient.

Acknowledgements
Special thanks to Maeve Royston (Department of General Practice, RCSI) for her patience and valuable input – míle buíochas.

References

  1. Fischer MA, Keough ME, Baril JL et al. Prescribers and pharmaceutical representatives: why are we still meeting? J Gen Intern Med. 2009;24(7):795-801.
  2. Somerset M, Weiss M, Fahey T. Dramaturgical study of meetings between general practitioners and representatives of pharmaceutical companies. BMJ. 2001;323:1481-4.
  3. Lexchin J. Doctors and detailers: therapeutic education or pharmaceutical promotion? Int J Health Serv. 1989;19:663-79.
  4. O’Mahony B. Interaction between a general practitioner and representatives of drug companies. BMJ. 1993;306:1649.
  5. Neslin S. Return on investment analysis of pharmaceutical promotion (RAPP): an independent study 2001. Accessed December 12, 2011. Available from: http://www.docstoc.com/docs/69287888/ROI-Analysis-of-Pharmaceutica l-Promotion-(RAPP)-An-Independent.
  6. Lichstein PR, Turner RC, O’Brien K. Impact of pharmaceutical company representatives on internal medicine residency programmes. A survey of residency programme directors. Arch Intern Med. 1992;152(5):1009-13.
  7. McGettigan P, Golden J, Freyer J, Chan R, Feely J. Prescribers prefer people: the sources of information used by doctors for prescribing suggest that the medium is more important than the message. Br J Clin Pharmacol. 2001;51:184-9.
  8. Ableson PH. Improvements in health care. Science. 1993;260:11.
  9. Pharmachemical Ireland. The pharmaceutical industry c2006. Accessed December 12, 2011. Available from: http://www.pharmachemical ireland.ie /Sectors/PCI/PCI.nsf/vPages/News_and_events~Publications~the-pharmaceuti cal-industry-22-03-2010/$file/The%20Pharmaceutical%20Industry.pdft.
  10. Munetz MR, Schulz SC. Minimisation and overreaction to tardive dyskinesia. Schizophr Bull. 1986;12(2):168-72.
  11. Yamey G. Pen “Amnesty” for doctors who shun drug companies. BMJ. 2001;322(7278):69.

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