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Let’s talk about sex, and relations with industry

BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l2093 (Published 09 May 2019) Cite this as: BMJ 2019;365:l2093

MORE TALK ON THE ‘HEALTH PROFESSIONAL ASSOCIATIONS-INDUSTRY FUNDING CONVERSATION’; CONFLICTS OF INTEREST ARE BETTER AVOIDED: A PROACTIVE ROLE FOR ‘MEDICAL SOCIOECONOSOPHY’

Formally launching an ‘Anti-Infection Drug’ formalizes ‘Potential New Drug Resistance’ and emergence of ‘Actual Resistance’ is only a matter of time and its usage. Similarly, the 1981 Formal Adoption of the International Code of Marketing of Breastmilk Substitutes formalized ‘Potential Code Violations’ and documentation of ‘Actual Violations’ was also only a matter of time and its ‘Implementation and Enforcement’! Considering the ‘Principal Groups’ at the 1979 United Nations Meeting on Infant and Young Child Feeding, ‘Conflicts of Interest (COIs)’ in ‘Code Violations Arrowhead’ was foreseen. The COIs in focus in this Presentation concern ‘Health Professional Associations-Industry Funding’ and was envisioned and addressed in Code Article 7.3 (WHA 34.22/ 1981). Subsequent Relevant World Health Assembly Resolutions have consistently addressed perceived Code ‘Ambiguities’, ‘Uncertainties’, ‘Doubts’, ‘Definitions’, ‘Inclusions/ Exclusions’ etc for better Implementation! Technically, ‘The Code’ is the ‘1981 Adopted Code’ read/ implemented in conjunction with ALL ‘Subsequent Relevant WHA Resolutions’ equal in ‘Status’ with the original ‘Code Provisions’!

Allowing for ‘Fundamental Human Rights and Discretion’, ‘Health Professionals’ were permitted to engage with ‘Industry/ Industry Funding’ provided that ‘COIs’ were eliminated/ appropriately managed as reflected in several WHA Resolutions (49.15/ 1996, 58.32/ 2005, 61.20/ 2008, 65.60/ 2012, 67.9/ 2014)! Obviously, ‘Health Professionals’ could not strictly avoid being ‘Conflicted’ and relevant WHA Resolutions then proposed the ‘Framework for Engagement of Non-State Actors (FENSA)’ and developed ‘Risks of Engagement Assessment Tools’ in 2012-2015 to objectively prevent, diagnose and manage COIs but to no avail. The WHA 69.9/ 2016 was thus a ‘Strategic Inevitable Intervention’ which subsumed the ‘2016 WHO Guidance’ on ‘Ending the Inappropriate Promotion of Foods for Infants and Young Children’1. Several ‘Health Professionals/ Health Professional Associations’ continue to resist strict implementation and compliance with the ‘Recommendations’ of the ‘2016 WHO Guidance’ particularly the prohibition of the ‘Sponsorship of Health Professionals, their Associations and their Scientific Meetings’!

The courageous and salutary decision of the Council of the Royal College of Paediatrics and Child Health (RCPCH) on the 13th February 2019 to decline future ‘Industry Funding’ is worthy of emulation by other ‘National Paediatrics Associations/ Societies’2. It is, indeed, more gratifying that the Annual General Meeting (AGM) of the RCPCH, in May 2019, overwhelmingly voted to uphold the Council’s earlier decision! It is conjectured that the ‘RCPCH Stance’ will imprint on the planned 2020 ‘Joint Meeting’ of the RCPCH with the International Paediatrics Association (IPA) with possible desired impact on ‘World Paediatrics Associations/ Societies’ and, indeed, members of the ‘Union of National African Paediatrics Societies and Associations (UNAPSA)’ including the ‘Paediatrics Association of Nigeria (PAN)’ of which I am a ‘Life Member’! PAN is well-advised to follow the path of productive progress to ‘Make the Code Work’ for Optimal Infant and Young Child Health3! The envisioned desired ‘PAN Posture’ will most likely influence other UNAPSA Members!!

To avoid the very difficult to manage COIs, a more ‘Primordial, Proactive and Preventive Approach’ is imperative! It is increasingly clearer that ‘Health Professionals’ will benefit from robust formative ‘Mentorship/ Mentoring Exposure and Experience’ to be able to decide on the ‘Health Professional Associations-Industry Funding Relationships/ Conversation’4,5. The mantra that ‘Free lunches aren’t really free’ should alert young ‘Health Professionals’ early in their career. ‘Industry Funding’ is laced with the ‘Potentiality’ for COIs which do not require ‘Actuality’ for diagnosis of their existence! The ‘Communication’ by Godlee5 (‘Let’s talk about ……and relations with industry’) necessitates this ‘Presentation’! While the experience communicated by Booth and Detsky4 is from the ‘Pharmaceutical Enterprise’, the gleaned ‘’Formative Avoidance of Industry Funding’ is apt and applicable to the ‘Infant and Young Child Feeding Enterprise’. ‘Industry Influence’ is pervading with impactful possibilities re: Patient Care (‘Overdiagnosis’ and ‘Overmedicalization’), Medical Education, Clinical Research, Journal Publications Interpretation of Medical Evidence, Guidelines Formulation and Certification Examinations6,7! Links with ‘Industry and Industry Funding’, no matter how seemingly inconsequential, are tinged with the ‘Potentiality’ of ‘Bias’ which begets ‘Clouding of Judgements and COIs’. Some have, in fact, suggested that accepting ‘Industry Funding’ is ‘Crossing the Red Line’ with obvious ‘Moral and Ethical Problems’8! The US Institute of Medicine (IOM) ‘Landmark Report’ on COIs in Research, Medical Education and Practice is quite instructive9! While ‘Industry Collaboration’ offers some possible benefits, there is the ‘Potentiality’ of a plethora of ‘Monstrous Difficulties’: Influenced Professional Judgement, Compromised Integrity of Research Governance, Compromised Integrity of Clinical Governance, Tainted Principles of Education and Compromised Public Trust in Medicine among others! The proactive thrust, thus far, has been a ‘Clarion Call’ for ‘Senior Colleagues’ to deliberately embark on ‘Mentoring/ Mentorship’ of ‘Junior Colleagues’ so that, with ‘Appropriate Desired Formation’, COIs can be Prevented, Diagnosed and Managed; preferably Prevented: COIs are better avoided!

Another ‘Purposeful Intervention’ is the conscious scrutiny and exclusion of ‘Conflicted Authors’ from the ‘Call for Manuscript Submission’ to Biomedical Journals. The BMJ has been in the ‘Arrowhead’ of this approach to rid ‘Medical Education’ and ‘Biomedical Literature’ of ‘Industry Funding-influenced Publications’ and subsequent ‘Biased Development of Evidence and Evidence-based Guidelines’10. A word of caution for ‘Meta Analyses and Systematic Reviews’ and ‘Evidence-based Medicine (EBM)’: A ‘Clarion Call’ for more critical use of the ‘Forest Plots’ and ‘Funnel Plots’!! There must be sustained ‘Zero Tolerance for Conflicted Authors’ suspected most readily from the link with ‘Industry/ Industry Funding’!

This Presentation is also a response to ‘Help move towards independence from commercial interests’11! There should be proactive ‘Medical Education Improvement Intervention’. My 2013 Oxford Round Table Presentation on ‘Medical Socioeconosophy: The ‘PRICE Plus’ of Medicine’ is instructive! A structured improvement in the ‘Basic Medical Education Curriculum (BMEC)’ with the infusion of relevant ‘Non-Medical Academic Disciplines (NMAD)’ is it. These NMAD are harvested guided by the ‘Backronym ‘PRICE Plus’’. The ‘PRICE’ encompasses several NMAD captured by the ‘Backronym Letters’ and ‘COIs’ is taught pedagogically under the ‘Letter C’. This very ‘Primordial Proactive and Preventive Intervention’ assures that every ‘Graduating First Degree Medical Doctor’ is armed with matters relating to COIs; To be ‘Forewarned’ is to be ‘Forearmed’! Future Presentations will dilate further on ‘Medical Socioeconosophy’ to address the Triad: COIs, Transparency and Independence for ‘Health Professionals’!

REFERENCES
1. WHO Sixty-ninth WHA. Ending inappropriate promotion of foods for infants and young children. WHA 69.9. http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R9-en.pdf; May 28th 2016. Accessed 24th February 2017.
2. https://www.rcpch.ac.uk/news-events/news/rcpch-statement-relationship-fo...
3. Eregie C.O. Making the Code Work for Optimal Infant and Young Child Feeding: Rekindling ‘Health Professional Associations-Industry Funding Conversation’ and the ‘INAGOSICI Phenomenon’. https://www.bmj.com/content/364/bmj.1544/rr of 14th February 2019
4. Booth CM, Detsky AS. From the $80 hamburger to managing conflicts of interest within the pharmaceutical industry. BMJ 2019; 365:L1939 of 3rd May 2019
5. Godlee F. Let’s talk about sex and relations with industry. BMJ 2019; 365:L2093 of 9th May 2019
6. Wang AT, McCoy CP, Murad MH, Montori VM. Association between Industry Affiliation and position on Cardiovascular risk with rosiglitazone: Cross-sectional Systematic Review. BMJ 2010; 340: c1344
7. Van Tulleken C. Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers. BMJ 2018; 363: k5056
8. Gillison F. Reflections from a Casualty of the food industry research funding debate. BMJ 2019; 365: l2034 of 7th May 2019
9. Lo B, Field MJ. Conflicts of interest in medical research, education and practice. National Academies Press 2009
10. Chew M, Brizzell C, Abbasi K, Godlee F. Medical Journals and industry ties. BMJ 2014; 349: g7197 of 28th November 2014
11. Moynihan R, Macdonald H, Henaghan C, Bero L, Godlee F. Commercial interests, transparency and independence: a Call for Submissions. BMJ 2019; 365: l1706 of 16th April 2019

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria
UNICEF-Trained BFHI Master Trainer
ICDC-Trained in Code Implementation
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria
*No Competing Interests.

Competing interests: No competing interests

22 May 2019
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology, University of Benin and Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria. Also, UNICEF-Trained BFHI Master Trainer and ICDC-Trained in Code Implementaion. Also a Technical Expert/ Consultant on FMOH-UNICEF-NAFDAC Project on Code Implementation in Nigeria
Institute of Child Health, University of Benin, PMB 1154, Benin City, Nigeria