The Fear Factor vs. Open Communications

The "don't ask, don't tell" mentality is still alive and well, a pharmaceutical manufacturing whistleblower suggests.

By Agnes Shanley, Editor in Chief

A mantra of manufacturing today is the breaking down of functional silos that inhibit productivity and process improvements. Communicate better, share information and develop cross-functional approaches to operations, quality, safety and tech transfer, the thinking goes, and good things will happen.

A growing number of pharmaceutical manufacturers are engaging operators and technicians, quality and training staffers in a dialogue concerning how operations might be improved. In the process, these companies gain enthusiastic quality advocates, and invaluable front-line insights.

Not one pharmaceutical company would dispute the importance of employee empowerment and open communication. In practice, however, not all companies may be practicing what they preach. A corporation may have the best policies, ethics and intentions, but if they are not respected or followed at the plant level, they're hollow words.

The Wall Street Journal recently noted a potential connection between supply disruptions of Wyeth's pneumococcal vaccine, Prevnar, recent quality improvement projects at the vaccine's production and vial-filling sites, and a lawsuit filed last October by Mark Livingston, former associate director of training and continuous improvement at Wyeth's Sanford, N.C., manufacturing plant.

Livingston, a training professional with 20 years of manufacturing experience, says he lost his job at Wyeth after repeatedly calling for changes in the Sanford facility's policies regarding training, standard operating procedures (SOPs) and batch recordkeeping systems. Now he is suing Wyeth for violating the employee protection provisions of the 2002 Sarbanes-Oxley Act. Wyeth dismisses Livingston's legal complaints as without merit, but whether they're ultimately found to be fact or fiction, his story is a must read for any pharmaceutical manufacturing professional.

Livingston paints the picture of a growing disconnect between management and operations as pressure intensified to increase output of an important new biologic product. "A small manufacturing operation crunching out a few hundred million in sales was now producing billions of dollars worth of product," he says. Intimidation was used, he alleges, to prevent employees from pointing out problems. In fact, Livingston says, five months before he was dismissed, he was warned to report only on training system design issues, rather than compliance violations.

Livingston brought the site's training program up to basic compliance, he says, but other problems persisted. He had first pointed out issues in September 2000, and, formally, nine other times with various officers between 2000 and 2002. By December, 11 months after receiving a solid performance review and raise, Livingston says he received a pink slip with no formal reason given for dismissal.

Wyeth refused to comment on any specific allegations. The company has been focusing quality improvement efforts on its Pearl River, N.Y., site, is working with a third-party contractor to help with vial filling, and expects to get Prevnar production back to original levels by the middle of the year. "We will defend vigorously," says company spokesman Doug Petkus.

It will be interesting to see how the case unfolds, if it even reaches the courtroom. No matter the outcome, however, the story underscores the challenges that companies — and individual employees — face as they try to improve quality even as resources are stretched thin.

Is empowerment a fundamental practice at your facility, or just the latest management buzzword?

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