By Hien Nguyen, MD, Judy Walker, MD
Pharma is at a crossroads. 2018 has been a seminal year with multiple events coming to a head and leading many of us to reconsider how we operate. Establishing a professional benchmark of excellence for Medical Science Liaisons (MSLs) as we will see needs to be the future for the industry to maintain the highest standards of excellence for professional development and training of MSLs.
In this paper we examine some of these critical trends in 2018 and offer a way forward.
Industry payments to Journal Editors
If the opioid crisis of 2018 wasn’t enough to raise concerns about pharmaceutical industry practices and that some major change was needed, then consider the amount of money given to peer reviewed journals which report the results of some of the most important clinical trials in medicine. Medical guidelines and physician decisions on how to treat patients are often based on data that is presented in these journals. The notion of ‘evidence based medicine’ has become the buzz word in recent years. However, a recent study by Liu et. al, (2018) cites the amount of money paid by pharma companies to some major medical journals is highly suspect and may possibly taint the ‘evidence’ (see Table 1).
(Liu et al., BMJ, 2017)
Insufficient data supporting Institutional Review Board submissions
What’s more shocking are the results from bioethicists at Hannover Medical School and McGill University in Montreal which analyzed 109 applications from three institutional review board chairpersons. As McRae (2018) points out,
“These documents were used to approve trials between 2010 and 2016. The applications – called investigator brochures – provide the review board with all of the evidence that they should require to make a sound judgment on whether a clinical trial can safely proceed. Such pre-clinical data tends to include the results of animal trials that demonstrate the potential efficacy and risks of a potential medical treatment. Among the 109 investigator brochures there were 708 efficacy studies that used animal models. Surprisingly, nearly 9 out of 10 studies had no reference to a published report, making it hard to know whether the study would even pass peer review. What was particularly alarming was the relative absence of details on methodology – 95 percent of the studies contained no mention of processes used to avoid the pitfalls of bias.”
The Opioid Crisis and Purdue Pharma’s response
Earlier this year, Purdue Pharma, the OxyContin maker, eliminated its sales force and claimed it was going to use medical science liaisons (MSLs) to educate healthcare providers (HCPs). The role of medical affairs (the function under which MSLs sit) is supposed to be (1) Data Generation and (2) Data Dissemination. That is, to objectively, ethically and properly educate HCPs on the latest information and data within a particular therapeutic area.
These are just 3 examples of events in the last year that shape our views and highlight the growing importance of standards in medical affairs.
Who are medical affairs professionals?
If we look at who actually makes up medical affairs professionals, they are an interdisciplinary group of professionals (MD, PharmD, & PhD professionals). Most medical, pharmacy and PhD programs do not train graduates to work in the pharmaceutical industry. Rather, they are prepared to work in traditional roles such as clinical practice, retail pharmacy or a bench scientist (R&D) for PhDs. This leaves a significant gap where most have to learn on the job-through experience. Therein lies the issue. The Accreditation Council for Medical Affairs (ACMA), in conjunction with St. John’s University College of Pharmacy and Philadelphia College of Pharmacy, recently presented data at the American Association of Colleges of Pharmacy (AACP) which surveyed pharmacists in the pharmaceutical industry about whether or not their training prepared them to work in the pharma. Unfortunately, the overwhelming majority (72%) indicated they did not receive adequate training and preparation for their roles in medical affairs.
Standardization & Board Certification for MSLs- the Future in Pharma
The role that medical affairs plays is critical to the education of HCPs. Moreover, pharma uses a collaborative model for the development of new products, data and technologies. Oftentimes, medical affairs is involved in facilitating these discussions and identifying the opportunities via key thought leaders (KTLs) in the medical world. Pharmaceutical industry medical affairs professionals need to be trained on the core competencies necessary to be a competent and well-rounded medical affairs professional. This is critical given the evolving role of stakeholders that they interact with as well as the rapidly changing healthcare landscape.
Indeed, it is the ethical responsibility of every pharmaceutical industry CEO to ensure that there is (1) a minimum standard of competencies that all medical affairs professionals demonstrate and (2) that they are consistent across the industry. This will help to raise standards around the world and ultimately improve patient care. Moreover, this training or credentialing should in fact come from a third party accrediting body to ensure that there is no bias. But most importantly to ensure a common standard across the field.
Liu et. al., (2017). Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study. British Medical Journal BMJ; 359:j4619.
Yasinski, E. (2018) Study questions animal efficacy data behind trials. Science, Vol 360, 6385. 142.
Piller, C., You J., [July 5, 2018] Hidden Conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns. [Internet]. [cited 2018 Dec 10]. Available: https://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
McRae, M (April 6, 2018) An Alarming Number of Clinical Trials Are Greenlit Based on Shockingly Poor Data [Internet]. [cited 2018 Dec 10]. Available: https://www.sciencealert.com/limited-data-included-pre-clinical-investigator-brochures-german-review-boards
Paavola, A., June 20, 2018]. Purdue Pharma Cuts Remaining Sales Force [Internet]. [cited 2018 Dec 10]. Available: https://www.beckershospitalreview.com/pharmacy/purdue-pharma-lays-off-remaining-sales-force.html
Kanmaz et. al, (2018). Are Pharmacy Schools Adequately Preparing Graduates for Roles in Industry? Poster #90 American Association of Colleges of Pharmacy Annual Meeting, Boston, MA.