If you make your living in the pharmaceutical industry, you have probably read or heard about issues related to data integrity either from FDA Warning Letters or reports in the news and pharmaceutical industry publications.

Data integrity issues are not unique to Pharma and recent history offers no shortage of decision based data integrity breaches across business platforms. From the collapse of Texas based energy company Enron in 2001, to the 2008 melamine adulteration of infant formula in China, to the German Volkswagen emissions software scandal in 2015, we are reminded of the frailty of humans and their impact on business and society when data integrity is compromised.

In the pharmaceutical industry the potential risk of data integrity breaches can be severe: collapse of the company, serious harm to patients, government fines and a damaged reputation.

The spotlight shines bright immediately following the discovery of an intentional data integrity breach. Internally, corrections are made, controls are created or reinforced. Externally companies are fined, executives are jailed, and in the case of the Chinese melamine scandal, sentenced to death. The above examples are extreme to be sure, but in the pharmaceutical industry the potential risk of data integrity breaches can be equally severe: collapse of the company, serious harm to patients, government fines and a damaged reputation.

Quality Culture

In December 2018, former FDA Commissioner Scott Gottlieb stated that while most data integrity issues are the result of inadequate process, “[S]ometimes, data integrity concerns are a result of deceptive practices.” Commissioner Gottlieb went on to say that “Companies need to create a quality culture where employees understand the seriousness of data integrity and promote data integrity as a core value.” [1]

Deceptive practices are dependent on people making a choice. 

If we want a different outcome, we have to introduce a different response to what feels like pervasive and repeated data integrity issues.

Deceptive practices can occur when the elements of Cressey’s Fraud Triangle are present. That is, the ability to manipulate data (Opportunity), an interest in a particular outcome (Motivation), and an internal belief in actions (Rationalization).  

But deceptive practices are dependent on people making a choice.  

The Human Aspect

In Pharma, intentional data integrity breaches often revolve around testing and manufacturing data. The decision to be deceptive may not always be driven by a malicious intent, but can be so intensely personal, based on fear or an internal sense of shame, to an extent that the individual is able to rationalize their deceptive practice:  

If I don’t finish this assay now I will miss the pick-up time at my child’s daycare center…”

 “I’m still on probation, if I admit to the excipient addition calculation error, I’ll be fired…”

“I can’t tell my boss that the data I gave her was inaccurate because she already presented it to her superiors and we will both be embarrassed…”

If we consider the human aspect of Data Integrity and decision making, there is a connection between ethical and compliant decision making and the pillars of mindful leadership. Leaders have to ask themselves if they are modeling the right behavior and if they are providing frontline staff the “space” (i.e. time, trust, motivation) to make good decisions with their data. How do we build this behavior when we are constantly faced with time-based pressures such as shareholder expectations, first to market, or simply the release of a drug product batch?  

Mindfulness Practice

There is ample scientific data to support the health benefits of meditation including the ability to increase focus and clarity. Mindfulness practice provides an avenue for self-awareness and brings an understanding that strong leadership cannot ignore the human side of the business, of which compassion is key.

Mindful leadership practices help us to cultivate mental and physical resilience, skillfully access intuition, recognize unproductive patterns, and learn how to respond more effectively.

Mindfulness meditation has been introduced as a staple of employee development in several Fortune 500 organizations including General Mills, Goldman Sachs, Google, Apple, Nike, and the practice has consistently been shown to serve as a method of relieving employee stress and encouraging increased productivity. [2]

In fact, Janice Marturano, former Vice President, Public Responsibility and Deputy General Counsel at General Mills Inc., opens her book Finding the Space to Lead: A Practical Guide to Mindful Leadership with a story about three senior executives at a multinational food company faced with an international product recall decision. Ultimately the executives decide to initiate the recall. But their decision was reached by combining traditional business skills and “Mindful leadership practices and exercises [that] had taught them to notice the strong pull to react, the mind’s propensity to narrow focus when under stress…” [3] Janice describes that a practice of mindful leadership allows space for creative solutions and understanding the value of ambiguity. Mindful leadership practices help us to cultivate mental and physical resilience, skillfully access intuition, recognize unproductive patterns, and learn how to respond more effectively.  

There are a lot of emotions involved in decisions like a product recall: Fear, anxiety, avoidance.

Meditation expands your ability to “see” (CLARITY), helps you be present in the moment (FOCUS), and supports critical thinking (PROBLEM SOLVING). Do we give staff the “space” to make the best decisions? Decisions that are good not just for the corporation, but community and the employees, as well.

Data Integrity is a core value of Quality Culture and Quality Culture is about the people.  

I recently spoke with Monica Cahilly, a Pharma industry expert who specializes in Data Integrity Assurance & Data Governance. Monica has worked with domestic and international Health Authorities as a consultant and educator and has seen and investigated data integrity breaches in the Pharma industry. Monica had shared with me that she started a regular meditation practice and I asked for her thoughts on the interconnectedness between mindfulness and data integrity. Monica discussed how meditation and mindfulness can help one see issues without emotional attachment. That the stillness or space that the meditative mind creates can lead to an ability to see difficult issues more clearly, diffuse tension, and remove the fear (of job loss, of change, of failure) and that “from that space – all things are possible”.

In her Data Integrity workshops, Monica describes that moving from an Industrial Economy to a Knowledge Economy necessitates innovation, initiative, and critical thinking. With stillness there is a sense of safety and when individuals feel safe this permits risk taking in the sense of innovative thinking (vs status quo). Monica discussed that new Inspection protocols at the FDA include asking about Quality Culture. Data Integrity is a core value of Quality Culture and Quality Culture is about the people.  

Driving Positive Performance

In his article The Happiness Effect, Brooks Carder writes that positive psychology has powerful implications for effective leadership and that employee well-being is in fact a driver of performance. This concept is in contrast to traditional models where the pursuit of Quality was about the discovery and correction of weakness and employee well-being was considered a side effect of quality improvement.  [4]

Mindful leadership has powerful implications for effective leadership and there is clear evidence that well-being is, in fact, a driver of performance.

How do these ideas of employee well-being lead to better performance? To a higher level of Quality Culture? A holistically healthy employee base, one that combines not just mental and physical well-being but emotional well-being fuels creativity, courage, responsibility, and perseverance. Creativity fuels the critical thinking necessary to uncover possibility, courage supports a speak-up mentality, responsibility drives accountability, and perseverance is necessary for root cause analysis and problem solving.

Mindful leadership has powerful implications for effective leadership and there is clear evidence that well-being is, in fact, a driver of performance. Can we approach a solution to intentional data integrity breaches, deceptive practices, through mindful leadership?

Intentional data integrity issues will never disappear completely. People are complex and driven by many motivations. However, the industry can respond differently to understand when deceptive practices are rooted in fear. If we want a different outcome, we have to introduce a different response. Maybe mindful meditation can be a 21st Century tool on the road towards enhanced Quality Culture in Pharma.

 References:

  1. U.S. Food & Drug Administration, Press Announcements. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-efforts-improve-drug-quality-through-vigilant
  2. How to be More Mindful at Work. https://www.nytimes.com/guides/well/be-more-mindful-at-work
  3. Marturano, Janice; Finding the Space to Lead; Bloomsbury Press, 2014
  4. Carder, Brooks; Quality Progress. 2019, Vol. 52 No. 1, 24-30

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