Why Medical Affairs is the Cornerstone for Building Trust in our Industry

This article delivers a clarion call to the pharmaceutical industry to recognize, support and champion the medical affairs professional as the cornerstone for reigniting trust in our industry.

  • Medical affairs professionals are the face of our industry to healthcare professionals (HCPs) globally; rebuilding and maintaining trust among HCPs is vital
  • The primary domains of the medical affairs function – data, quality and safety – are foundations for trust building, according to 2016 data on trust in the pharmaceutical industry
  • The three elements for building trust – reliability, competence, sincerity – are integral to/ingrained in how Medical Affairs professionals operate
  • HCPs must better understand the role medical affairs professionals play in helping to improve patient outcomes

Current Situation:  Declining Trust

According to the 2016 Edelman Trust Barometer – Healthcare Sector Results, which surveyed members of the general public (click here for survey results), trust in the pharmaceutical industry is declining.
Source:  2016 Edelman Trust Barometer

At the same time, the study spotlights three trust building behaviors as opportunities for the industry to address this current dilemma/situation/perception:  data, quality and safety.
Source:  2016 Edelman Trust Barometer

Quality data about the safety and efficacy of pharmaceutical products inform decision-making among healthcare professionals who focus on reducing morbidity and mortality for patients under their care.  HCPs who have access to scientifically balanced, medically accurate, current and transparent data from medical affairs professionals can make more informed decisions.

Medical affairs professionals play a pivotal role as a change agent in light of these findings:  this function is an ambassador and purveyor of quality data with a focus on drug safety.

How We Got Here

As we review what we must do today to rebuild trust, it’s useful to look back at how we communicated with HCPs in the past.

In the 1980’s, many companies employed pharmacists as sales representatives who focused on scientific data.  In the 1990s, in the era of blockbuster drugs, we were focused on selling more drugs; reps were intent on delivering on their forecasts and targets.   The model of pharmacists as sales reps disappeared.

As “promotional” sales reps became the primary face of the pharmaceutical industry, HCPs were inevitably exposed to promotional claims rather than evidenced-based discussions.  In the 2000’s, the industry began returning to an evidence-based orientation focused on patient outcomes.  This was influenced by payers demanding more data; and a boom of trained Medical Scientific Liaisons (2003) who were able to answer questions that fell outside of the product label.

This laid a foundation for the industry when the first Corporate Integrity Agreements (2007) were signed; there was even more scrutiny on the industry’s practices relating to the discussion of investigational data.

“A 2012 Lilly study uncovered a key indicator of trust:  whether claims made by a company’s sales reps were consistent with the HCP’s experience. When marketing claims were aligned with their clinical practice, trust increased.  Conversely, claims that did not support the HCP’s experience diminished the HCP’s trust in that pharmaceutical company,” according to Jennifer Riggins, Advisor, Global Medical Channels and eCapabilities, Eli Lilly and Company.

A return to evidence-based communications with HCPs will reignite trust.

Trust Embodies the Functional Goals of Medical Affairs Professionals

There are a number of trust building models, including a three-pronged approach that combines reliabiity, competence and sincerity. (Gasten, Jean (2014), Building and Restoring Trust, Virginia Commonwealth University School of Business, Center for Corporate Education.)  Medical affairs fits the bill on all three.

  • Reliability – Medical affairs can be relied upon by healthcare professionals and patients to assess and deliver unbiased, scientifically balanced medical information.

Call to Action:   Increase HCP awareness of how industry adheres to rules/regulations and maintains high quality standards when disseminating data

  • Proof Points
  • Value-based medical planning
    • Drives data generation and dissemination with a prioritization on improving patient outcomes
      • Facilitates cross-functional collaboration to create a plan that delivers efficacy and safety data
      • Addresses needs of payers, providers, patients, healthcare professionals (including pharmacists and nurses), policy makers and patient advocacy groups
  • Industry’s rigorous review processes and systems
    • The Medical-Regulatory-Legal review (MRL) process ensures that all pharmaceutical product promotions are medically accurate and comply with FDA regulations and other applicable laws. This process is carried out within pharma companies by the regulatory affairs and legal departments in conjunction with medical affairs (medical staff). All materials used by sales representatives are reviewed.

“Over the past two decades, the pharmaceutical Industry has increasingly prioritized building teams of Medical Affairs professionals uniquely positioned to listen to, interpret, and respond to the needs of HCPs, payers, and patients. They meet these needs by generating and communicating data through many channels, including publications, educational events, and scientific exchange, both spoken and in writing.  Their MSL and Medical Information professionals play a critical role in this work,” says Thérèse McCall, Ph.D., MBA, who specializes in helping companies define and implement a value-based Medical Affairs Strategies.  Thérèse was formally Vice President, Global Medical Communications and Professional Strategies, AbbVie.

  • Competence – Medical affairs professionals are trained to adhere to consistent, high quality standards.

Call to Action:  Increase HCP awareness of the caliber of talent in dedicated medical departments

  • Proof points
  • Credentialed medical affairs professionals, who work in-house for drug manufacturers, help HCPs by providing timely access to extensive, scientifically balanced, and rigorously researched data upon their request.
  • For example, the Medical Information (MI) function possesses a current and comprehensive knowledge base and have clinical experience or training.
  • According to Tiziana Fox, Senior Director Medical Information at Janssen Scientific Affairs, “Most HCP’s don’t realize that Medical Information departments exist within the companies and that this function is not promotional in nature. They are a team of pharmacists – many with advanced degrees and specialized fellowships – who are available to help HCPs address unique product-related patient care needs.  We must to do a better job of making HCPs aware of this service.”
  • Medical affairs professionals have access to a wealth of information about their respective products not available elsewhere: clinical study details, case reports, formulation information, temperature stability data, ingredient sources and other unpublished information. As a result, they are able to create value-based medical plans and provide feedback that is customized to help HCPs make better informed medical decisions.
  • “As highly-trained health care providers and scientists, medical affairs professionals are well-positioned to learn from patients and their health care providers, then use those learnings to provide true “customer-centric” insights back to the organization,” said Diana Morgenstern, MD, Senior Director, Global Medical Affairs, at Pfizer. “Insights converted into “in touch” communications are the proof points of our competence.”
  • Sincerity – Medical affairs leaders come to work every morning with the same sincere goal – to help stakeholders make informed decisions which benefits patients.

Call to Action: Increase awareness of dedicated MI department credentials and the return to evidence-based communications

  • Proof Points
  • Value stories demonstrate how medical affairs professionals focus on providing HCPs with the right data for the right patient at the right time. These actual accounts of the interactions between medical affairs and HCPs show how med affairs professionals focus on gathering and sharing the best data versus promoting a specific drug.
  • Amit Rakhit, Chief Medical and Portfolio Management Officer for Ovid Therapeutics states that, “My team strives to be a credible scientific partner with the health care community.  Providing accurate data in a transparent fashion is of utmost importance, and in the end, if our product is not the right medicine for a particular patient, then that’s ok.  I want the provider to have the full information set readily available so that he or she can make the appropriate treatment decision for each patient.”
  • Organizations like phactMI™ are another example of how the industry builds trust in the pharmaceutical industry. PhactMITM is a collaboration of Medical Information departments across the pharmaceutical industry. The members of phactMITM began their collaboration in 2014 to provide healthcare professionals (HCPs) access to medical information across their organizations through a single point of access to address HCPs’ growing needs for transparent medical information. Their website enables access to the most current product information provided by phactMITM member companies that HCPs need to help make medical care decisions to improve patient outcomes.

A Circular Effect

According to Dominick Albano, Vice President of Global Medical Information at Pfizer, pharmaceutical company MI departments, by virtue of their technical capabilities, product expertise, and access to relevant data, are uniquely positioned to provide valuable scientific information on their products to HCPs, and ignite greater trust in the industry.

“The MI function is a cornerstone of trust because we embody and demonstrate trust building behaviors,” says Albano.  He and his colleagues published a paper on the “MI Theory of Relativity to Model MI Utilization” which posits that utilization of MI services from the industry is multifactorial with trust being one of the key ingredients.  Other factors include ease of access and awareness of the service.

According to Albano: “If we want HCPs to consider medical information from the industry as one of their top choices for obtaining product information, then we must think holistically about what drives utilization.  We can execute well thought out tactics to increase awareness and provide easier access to medical information, but we must also work to establish trust.  And while trust will take more time, the MI function is well positioned to help achieve this goal.  Then, as HCPs utilize medical information more often, we will continue to cement their trust.”

The pharmaceutical industry will always be forced to fight the trust battle in light of the obvious challenges:  politicization of medicine, the cost of drugs, misunderstanding of direct-to-consumer (DTC) advertising objectives, and a general lack of understanding regarding how pharma companies operate, among other considerations.

“Trust is a lot easier to lose than it is to gain,” says Riggins.  “We need to invest in this critical component.”  Medical Affairs professionals are doing just that.

Concludes McCall: “There should be no doubt that the Industry is committed to meeting the needs of the patient and does this in partnership with HCPs, Health Authorities, and patients themselves.  However, there is an on-going opportunity for Medical Affairs teams to communicate this commitment through important organizations such as PhRMA, phactMI and other cross industry initiatives.  The accountability of Medical Affairs professionals to tell this story is critical, and will play a key role in restoring trust in our industry.”