BMJ  2008;336:1404 (21 June), doi:10.1136/bmj.39541.702870.59

Head to Head

Should the drug industry work with key opinion leaders? Yes

¹ Complete Medical Group, Macclesfield, Cheshire SK10 1AQ

Feature, doi: 10.1136/bmj.39575.675787.651

Industry commonly works with experts to put across its message. Charlie Buckwell believes that such interaction is essential for medical advancement, but Giovanni Fava (doi: 10.1136/bmj.39541.731493.59) argues that it risks scientific integrity

This question is a microcosm of the broader debate about how the drug industry and clinicians should interact. It leads to two tempting but indefensible end points—either that doctors are immune to marketing and should be free to do as they wish with industry or that industry is inherently corrupting, making all contact with it unethical.¹

Both positions are flawed, and the reality is much more complex: neither medicine nor industry can realise their true value independently of one another.¹ Both have a role in the advancement and delivery of health care. It is not in the interest of the industry to have its products used incorrectly or in the wrong patients, and there are appreciable benefits to healthcare professionals from interactions between industry and opinion leaders.

Current practice

The International Federation of Pharmaceutical Manufacturers and Associations has a clear position on the ethical promotion of prescription medicines. It seeks "to preserve the independence of decisions taken by healthcare professionals in prescribing medicines to patients—nothing may be offered or provided in a manner or on conditions that would have an inappropriate influence on a healthcare professional’s prescribing practice."²

Other industry bodies, such as the Pharmaceutical Research and Manufacturers of America and the Association of British Pharmaceutical Industry, have similar codes of practice with specific rules on how the industry should work with healthcare professionals. There is always the question of whether these codes of conduct are meaningful (or enforced), but in my experience companies and individuals are acutely aware of their obligations.

Opinion leaders, who range from experts with educational influence across many countries to local experts on a given topic in an individual hospital or clinic, can act as educators. They provide analysis, critique, and guidance to other doctors regarding the appropriate placement of a drug in clinical practice.

What is wrong with that? In the era of the internet, with the explosion of social networking and open access, expert opinion is increasingly diluted by opinions from any and all who wish to express a view. In this environment it becomes even more important for companies developing new treatments to work with the leading experts in clinical science and clinical practice, so those experts are supported in having the loudest voice possible.

Responsible cooperation

Even some of the strongest critics of industry working with clinical experts understand why doctors engage with industry in joint research or consulting on scientific issues.³ However, concerns remain that these interactions will bias opinion and compromise patient care. The worry is that invisible influence and subconscious reciprocity have an insidious effect on clinical practice³ or simply that entitlements and obligations created through these interactions conflict with the primary obligations to patients.⁴

However, the fact that drug industry interactions can affect doctors’ clinical practice is not necessarily a bad thing, since it could be through these interactions that doctors become more aware of the legitimate benefits of some drugs.⁵

Furthermore, opinion leaders in my experience are extremely capable of expressing their views, focusing on the right decision for patients, and maintaining their independence. This is what makes them opinion leaders. As long as any engagement with industry is transparent, clinicians can make up their own minds about what they believe and test any conclusions with other experts, colleagues, treatment guidelines, or whatever source they wish. The key is for all parties to have the courage to be transparent about these interactions.

Opinion leaders ought to have more guidance on how and when to work with industry, so as to remove as much ambiguity as possible. Interestingly though, while industry has its codes of practice, there has been a gap in guidelines for opinion leaders on how to work with industry. Those provided by the Association of American Medical Colleges contain useful recommendations, even if the supporting arguments for those recommendations are based on perception of industry motives rather than the reality.⁶ Similarly, some of the recommendations in a recent JAMA article are already well accepted by industry.⁷ However, both of these articles contain more extreme recommendations that are impractical. For example, recommendations to actively discourage doctors from participating in speaker programmes⁶ or to require a statistician from a not for profit organisation to review all publications⁷ are either not helpful or not viable in practice.

The drug industry has an ethical obligation to work with the most influential healthcare professionals to ensure they understand the leading edge thinking of these experts and that the experts have the most up-to-date and accurate perspectives from the companies. There is really no viable option other than to work with opinion leaders. The big question is how this should be done to ensure a fair balance and to reassure all parties that nothing underhand is happening.

If all the stakeholders can operate within rigorous transparency frameworks and be open about what they want to achieve and what they are not willing to do, then there is much benefit to be gained on both sides. However, even with perfect transparency, problems will remain until the industry is widely accepted as a stakeholder in healthcare provision. The solution is not to exclude the industry but to accept that it has a role and to more precisely define that role to minimise suspicion and misunderstanding. Fundamentally, the drug industry is populated with people of high integrity who are passionate about making a positive difference to patient care. Hopefully a more adult relationship can emerge which recognises that fact.

Feature, doi: 10.1136/bmj.39575.675787.651

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Competing interests: Complete Medical Group provides services to the drug industry.

References

1. Jibson MD. Medical education and the pharmaceutical industry: managing an uneasy alliance. Acad Psychiatry 2006;30:36-9.[Free Full Text]
2. International Federation of Pharmaceutical Manufacturers and Associations. Code of pharmaceutical marketing practices. 2007. www.ifpma.org/EthicalPromotion/index.aspx?3_html.
3. Kassirer JP. Extent and implications of the academia-industry connection. Mens Sana Monographs 2007;5:1-6.
4. Moynihan R. Who pays for the pizza? Redefining the relationship between doctors and drug companies. BMJ 2003;326:1189-92.[Free Full Text]
5. Gelb DJ. The role of the pharmaceutical industry in neurological education. Neurology 2005;64:E7-10.[Free Full Text]
6. Association of American Medical Colleges. Report of the AAMC taskforce on industry funding of medical education to the AAMC executive council, for consideration June 18-19 2008. www.aamc.org/research/coi/industryfunding.pdf
7. DeAngelis CD, Fontanarosa FB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA 2008;299:1833-5.[Free Full Text]

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