Editor’s Note: Mark Livingston, plaintiff in an ongoing federal whistleblower case against his former employer, Wyeth Pharmaceuticals, recently received the Joseph A. Calloway Award for Civic Courage, given by the Nafeek Nader Trust for the Community Interest. (Also given an award was FDA’s Dr. David Graham.) In accepting the award in a December ceremony in Washington, D.C., Livingston delivered the following candid speech.These comments do not necessarily represent the views of PharmaManufacturing.com or Putman Media. We welcome your responses or rebuttals; please send e-mails to [email protected] .Ladies and gentlemen, thank you for being here tonight. I believe we are here to recognize not only Dr. Graham and myself, but all individuals who summon the faith and courage to challenge unethical and unlawful practices.I want to share with you the story regarding my attempt to change the dysfunctional regulatory compliance culture of a pharmaceutical manufacturing plant in the years 2000-2002.I was hired in 2000 by Wyeth Pharmaceuticals to help in the introduction of Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and meningitis in babies. The North Carolina facility where I worked is the sole production site for this pediatric vaccine which is taken in a four-dose regimen by every infant in the United States at 2, 4, 6, and 12 months. One of my key responsibilities was to assure compliant manufacturing through quality training and continuous improvement systems.Within weeks of hire, I was approached by numerous employees with regulatory compliance and safety concerns. My own investigation revealed chronic under-staffing at this 24x7 operation as well as shortcuts within basic quality control and training processes.As Wyeth attempted to meet the rapidly growing demand for Prevnar and to meet mandates of a FDA consent decree for quality control violations, large numbers of new employees with limited backgrounds in vaccine production were being hired. Because of the complex nature of biological vaccine manufacturing, basic training for front-line employees took 12 months.At the same time, repeated quality audits in 2000, 2001, and 2002 revealed noncompliance with corporate and FDA regulatory standards.In mid-2002, I wrote a letter to Wyeth management refusing to misrepresent the compliance status of the site in an upcoming consent-decree audit whose results were to be forwarded to the FDA.After being directed by management to not discuss or provide information regarding noncompliance, I filed complaints with ethics and compliance officers of the company, alleging gross noncompliance and release of product in violation of FDA regulations.Two months after my internal whistleblowing, I faced disciplinary action with a threat of termination for 10 alleged performance deficiencies, one of which included a “gag order” to not discuss compliance deficiencies with internal or external contacts (which I interpreted to mean the FDA).Two months after this retaliation, I was terminated for alleged “professional misconduct” by the same two company officials who delivered the gag order.In reality, I was terminated for my efforts to address and rectify quality compliance failures leading to the adulterated release of vaccine in violation of both FDA consent decree mandates and SEC regulations regarding disclosure. With help from the Government Accountability Project, I brought suit against Wyeth in federal district court for retaliatory discharge in violation of whistleblower protection provisions of the 2002 Sarbanes-Oxley Act.Throughout my 21-year career as an organizational development, human resource, training, and quality improvement professional, I have helped talented and progressive leaders learn how to change their organizational cultures to continuously improve workplace performance. I have spent a considerable amount of time and effort teaching and coaching people to use diagnostic tools to discover the root causes of problems and take action to prevent recurrence of systemic failures and breakdowns. As a result, I’ve developed expertise in redesigning and implementing operating and quality systems that engage workforces to deliver intended compliance and financial outcomes.Organization or workplace culture is defined as the shared attitudes and perceptions within an organization. It is made up of the values and behaviors that formally and informally influence how employees think about themselves, their colleagues, their leadership, and their work. The “way we do things around here” gives people a common identity, builds commitment to achieve important objectives, and shapes human performance. Considerable research in the last ten years has verified the relationship between an organization’s culture and its operating results and financial performance.The valuable lessons I’ve learned from successful as well as failed efforts to change culture and improve performance include these:
- Successful leaders proactively become aware of what’s really taking place on the front-line of their organization.
- Successful leaders quickly move through the typical responses of denial and resistance.
- Successful leaders move past personal fear and confront unacceptable situations, including intimidating forces of resistance assembled against them.
- In fighting the battle between greed, financial security, and personal integrity, successful and ethical leaders absolutely know the “right choice” to make and the “right thing” to do.
- What is the real purpose and mission for our work?
- How do I make a decision when it comes to safety vs. profit?