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Editor's Choice

What drives recommendations for practice?

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m471 (Published 06 February 2020) Cite this as: BMJ 2020;368:m471

Rapid Response:

Commercial influence and conflicts of interest on research evidence, medical education and patient care: Rekindling the imperative for transparency and independence with medical socioeconosophy (MSE) and multiparameter-based medicine (MBM)

The ‘Recommendation of Practice Guidelines’ ordinarily should be a welcomed ‘Intervention’ to standardize, guarantee and assure the ‘Best Clinical Judgement’ for the desired ‘Best Clinical Practice’ in the ‘Improved Practice of Medicine’. The ‘Yawning Damage’, occasioned by the persisting and pervading ‘Plague and Scourge’ of ‘Commercial Influence’ and ‘Conflicts of Interest’, is impacting negatively and increasingly on the ‘Practice of Medicine’1! It is suggested that ‘Recommended Practice Guidelines’ are causing a ‘Plethora of Possibilities’: ‘Clarity’, ‘Controversy’ and ‘Confusion’! There have been pointers to the ‘POTENTIALITY’ of the ‘Damaging Effects’ of ‘Conflicts of Interest’ and ‘Commercial Influence’ in the ‘Practice of Medicine’ and particularly in ‘Infant and Young Child Feeding Enterprise’[1-11]!

The ‘Challenge to Science and Best Practices’ is signposted by ‘Commercial Influence’ and ‘Conflicts of Interest’ which have become the determinants of the ‘Design’, ‘Conduct’ and ‘Reporting’ of Research [12]. The ‘Commercial Sponsors’, through the contentious ‘Professional-Industry Collaboration’, set the path for ‘Research Conduct’, ‘Research Output’, ‘Research Reporting’ and ‘Research Communication/ Dissemination’ [2,13]! Predictably, ‘Sponsored Clinical Trials’ report more favourable ‘Research Outcomes’ with the ‘Sponsor’s Products’ and may involve ‘Drugs’, ‘Devices’, ‘Diagnoses’ and ‘Data’!! The implication is that ‘Research Outcomes’ are increasingly being treated and regarded with ‘Considered Suspicion’ with the ‘Erosion’ of the ‘Confidence in Science and Medicine’!! The field of ‘Medical Education’ has similarly been targeted by ‘Commercial Influence’ and ‘Conflicts of Interest’ with negative impact on ‘Medical Education Curricular Issues’ [2]! This calls for ‘Medical Reformation’ which comprehensively should involve ‘Medical Education’, ‘Medical Practice’ and ‘Medical Research’!

In the field of ‘Medical Education Reformation’, there is the Proposed Intervention which seeks to strengthen and broaden the robust ‘Formation’ and ‘Production’ of ‘Medical Doctors’ with exposure to ‘Basic Medical Education Improvement (BMEI) Intervention’ with the infusion of ‘Medical Socioeconosophy (MSE)’[14-18]! This guarantees the improved knowledge of ‘Medical Doctors’ in ‘Interdisciplinarity’ and the relevant aspects of the selected relevant ‘Non-Medical Academic Disciplines (NMADs)’ with built-up capacity and heightened index of suspicion to detect, recognize, avoid and, perhaps, manage ‘Conflicts of Interest’ and ‘Commercial Influence’ in the attractively packaged ‘Professional-Industry Funding Relationships’ which are increasingly at the disposal of the Professionals!

For ‘Medical Practice’, the ‘Improvement Thrust’ has been the direction dictated by the ‘Evidence-based Medicine Movement’ which itself has become ‘Work in Progress’ as a result of the ‘Difficult Challenges’ with ‘Evidence-based Practice’ and what constitutes the ‘Current Best Available Evidence’! It is increasingly becoming clear that the ‘Recommended Practice Guidelines’ evolve from ‘Guidelines Formulation Processes’ which are not ‘Transparent’ and not ‘Independent’ of ‘Commercial Influence’ and ‘Conflicts of Interest’ [1-5]! In fact, there are the suggested ‘Difficult Challenges’ of ‘Overdiagnoses’ and ‘Over-Medicalization’ of the Populace with the resultant precipitation of ‘Medication-induced Disorders’ in otherwise ‘Healthy Populations’ due to the pervading ‘Commercial Influence’ and ‘Conflicts of Interest’ [1,2,4]! The ‘Basic Medical Education Curriculum Improvement’ with the infusion of ‘Medical Socioeconosophy’ will also contribute to producing ‘Medical Doctors’ who will be robust, resilient and resistant to the ‘Industry-induced Overdiagnoses’ and ‘Industry-induced Over-Medicalization’! This additionally impacts on ‘Policy Formulation’ for ‘Optimal Patient Care’ in Medical Practice”!

The field of ‘Medical Research’ appears to bear the brunt of the ‘Commercial Influence’ and ‘Conflicts of Interest’ as ‘Funded Research’ is no longer trusted to yield the ‘Current Best Available Research Evidence’! For a harvest of the ‘Current Best Available Research Evidence’, the ‘Funded Research’ is not a ‘Trustworthy Source’ of ‘Transparent Independent Evidence’ [1-3,5]! This ‘Difficult Challenge’ is compounded by the other ‘Publication Bias Challenges’ associated with ‘Research Evidence’ from ‘Systematic Reviews’ and ‘Meta-Analyses’ [19-22]! A further ‘Confounding Issue’ on the ‘Credibility’ of the ‘Current Best Research Evidence’ is the ‘Role of Gender’ in ‘Research Reporting and Publication Bias’ [23,24]! The tendency to regard and treat the ‘Current Best Available Research Evidence’ as the ‘Sine Qua Non’ for the ‘Best Quality Practice of Medicine’ has been criticized with the suggestion of ‘Multiparameter-based Medicine (MBM)’ as a reasoned and conceptualized replacement for ‘Evidence-based Medicine (EBM)’ [25,26]! As ‘Hierarchy of Evidence Pyramid’ is used to facilitate ‘Evidence-based Medicine (EBM)’ so is the ‘Parameter-related Pyramids of Evidence’ now suggested as an imperative for the ‘Multiparameter-based Medicine (MBM)’ [27]!! Since several ‘Parameters’ are to be considered for ‘Optimal Medical Practice’ beyond the ‘Current Best Available Research Evidence’, it is hoped this will minimize the undue ‘Pressure’ from ‘Commercial Influence’ and ‘Conflicts of Interest’ to undermine the ‘Transparency’ and ‘Independence’ of ‘Patient Care Decision-making Processes’!

The 2009 ‘Landmark Report’ of the United States Institute of Medicine (IOM) is instructive in documenting the ‘Difficult Challenges’ with the ‘Issues’ of ‘Commercial Influence’ and ‘Conflicts of Interest’ in ‘Medical Research’, ‘Medical Education’ and ‘Medical Practice’ [2]! It was suggested that ‘Commercial Influence’ and ‘Conflicts of Interest’ could remarkably undermine the ‘Premium’ that can be invested in Science, the ‘Reliability’ and ‘Validity’ that can be assured from Medical Education, the Optimal Patient Care to be hoped for and, indeed, the ‘Public Trust’ that is due to the ‘Medical Profession’! After a decade of the ‘Landmark IOM Report’, it is suggested that some improvement in ‘Transparency’ appears to be the case but ‘Independence’ from ‘Industry Commercial Influence’ persists!! Such persisting practices include ‘Conflicted Authors’ in ‘Guidelines Formulation’ and ‘Industry Influence’ in ‘Medical Education’ among others5! The British Medical Journal (BMJ) has been in the forefront of ‘Systemic and Systematic Institutional Campaign’ to assure ‘Transparency’ and ‘Independence’ in ‘Matters’ related to ‘Medical Research’, ‘Medical Education’ and ‘Medical Practice’ [3,5, 28, 29]! The BMJ has stopped the publication of ‘Works’ from Authors with proven links to the ‘POTENTIALITY’ of ‘Financial Conflicts of Interest’ and has also declined ‘Advertisement of Breastmilk Substitutes’ from the Industry with huge ‘Income Losses’!! The BMJ, in fact, declared its ‘Industry-derived Revenues’ as a ‘Commitment’ to this ‘Campaign’ [28]! The Journal has called for ‘Action’ to propel the ‘Campaign’ to achieve ‘Transparency’ and ‘Independence’ from ‘Commercial Influence’ and ‘Conflicts of Interest’ in ‘Medical Research’, ‘Medical Education’ and ‘Medical Practice’ [30,31]!!

REFERENCES
1. Macdonald H. What drives Recommendations for Practice? BMJ 2020; 368:m471 of 6th February 2020
2. Lo B, Field MJ. Conflicts of interest in medical research, education and practice. National Academies Press 2009
3. Chew M, Brizzell C, Abbasi K, Godlee F. Medical Journals and industry ties. BMJ 2014; 349: g7197 of 28th November 2014
4. 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
5. 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
6. Eregie C.O. ‘Making the Code Work for Optimal Infant and Young Child Feeding: Rekindling the ‘Health Professional Associations-Industry Funding Conversation’ and the ‘INAGOSICI Phenomenon’. https://www.bmj.com/content/364/bmj.1544/rr of 14th February 2019
7. Eregie C.O. ‘‘Health Professional Associations-Industry Funding Conversation’: The RCPCH now truly leading the Way in Children’s Health’. https://www.bmj.com/content/364/bmj.1544/rr-0 of 16th February 2019
8. Shenker NS. The resurgent influence of big formula. BMJ 2018; 362:k3577
9. 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
10. Gillison F. Reflections from a Casualty of the food industry research funding debate. BMJ 2019; 365: l2034 of 7th May 2019
11. Eregie C.O. ‘More Talk on the ‘Health Professional Associations-Industry Funding’; Conflicts of Interest are better avoided: A Proactive Role for ‘Medical Socioeconosophy’. https://www.bmj.com/content/365/bmj.l2093/rr-3 of 22nd May 2019
12. Rochon PA, Stall NM, Savage RD, Chen AW. Transparency in clinical trials reporting. BMJ 2018; 363:k4224
13. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcomes. Cochrane Database Syst Rev 2017; 2:MR000033.pmid:28207928
14. Eregie C.O. ‘More Talk on the ‘Health Professional Associations-Industry Funding’; Conflicts of Interest are better avoided: A Proactive Role for ‘Medical Socioeconosophy’. https://www.bmj.com/content/365/bmj.l2093/rr-3 of 22nd May 2019
15. Eregie C.O. ‘The NHS Health Workforce Crisis and the Modern Firm: Considering an Additional Role for ‘Medical Socioeconosophy’ in Basic Medical Education Curriculum Improvement’. https://www.bmj.com/content/365/bmj.l4173/rr-3 of 26th June 2019
16. Eregie C.O. ‘’Fit-for-Purpose’ Medical Doctors in Today’s Globalized World: Further Imperative for ‘Medical Socioeconosophy’ in Basic Medical Education Improvement’. https://www.bmj.com/content/366/bmj.l4997/rr-1 of 30th August 2019
17. Eregie C.O. ‘Medical Reformation: The imperative for the complementarity of the ‘twin interventions’ of generalism and medical socioeconosophy’. https://www.bmj.com/content/368/bmj.m157/rr-1 of 19th January 2020
18. Eregie C.O. ‘Religion, spirituality and medicine: a further imperative for ‘medical socioeconosophy (MSE)’ in medical education improvement’. https://www.bmj.com/content/368/bmj.m106/rr-5 of 29th January 2020
19. Stewart LA, Clarke MJ. Practical methodologies of meta-analyses (Overviews) using updated individual patients’ data. Cochrane Working Group. Stat Med 1995; 14:2057-2079
20. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence-based Medicine: What it is and what it isn’t. BMJ 1996; 312:71-72
21. Haidich AB. Meta-analysis in medical research. Hippokratia 2010; 14 (Suppl 1):29-37
22. Forsyth S. What is opinion and what is evidence? BMJ 2019; 366:l5395 of 13th September 2019
23. Lerchenmueller MJ, Sorenson O, Frank F, Tanner MC, Jena AB, Ruth L. Gender differences in how scientists present the importance of their research: observational study. BMJ 2019; 367:l6573
24. Jagsi R, Silver JK. Gender differences in research reporting. BMJ 2019; 367:l6692
25. Eregie C.O. ‘Beyond Evidence-based Medicine (EBM) as ‘Work In Progress’: An Innovative Proposal for ‘Multiparameter-based Medicine (MBM)’. https://www.bmj.com/content/366/bmj.l5395/rr of 4th October 2019
26. Eregie C.O. ‘Research Evidence as the Sine Qua Non for Evidence-based Medicine (EBM) as ‘Work In Progress’: How Justified?’ https://www.bmj.com/content/366/bmj.l5395/rr-0 of 6th October 2019
27. Eregie C.O. ‘Prospective Meta-analysis (PMA) in ‘Evidence-based Medicine (EBM) Movement Improvement’ as ‘Work In Progress’: The Imperative of ‘Parameter-related Pyramids of Evidence’ to address the ‘EBM Interventional Inequity’. https://www.bmj.com/content/367/bmj.l5342/rr of 22nd October 2019
28. Godlee F, Abbasi K, Bloom T. BMJ declares its revenues from industry. BMJ 2017; 359:J4930
29. Godlee F. Disentangling ourselves from ‘big formula’. BMJ 2018; 363:k5146
30. Godlee F, Macdonald H, Moynihan R, Bero L. Call to action on commercial influence in health. http://bit.ly/2GVplHm
31. Moynihan R, Macdonald H, Bero L, Godlee F. Commercial influence in health: from transparency to independence. bmj.com/commercial-influence

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria,
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

12 February 2020
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, College of Medical Sciences, University of Benin, Benin City, Nigeria