The Consequences of Poor Regulations

“Pi (π) Day” is March 14 (3/14, i.e., 3.14), which is a special day in Princeton, NJ, about three miles from where this author lives. The celebration of this date began in 2009 to honor Albert Einstein, whose birthday is March 14, and to celebrate mathematics. It has grown into a weeklong celebration and includes lectures, Einstein look-a-likes, tours of his home, specially priced food and other things—soup for $3.14, and a replica of his bicycle for $314.15—and of course, pie-eating contests. Reflecting on the special events of this particular week, the author considers two other events that occurred at this time: one in the U.S. and one in the EU, both of which exemplify the results of poor regulations. They are detailed here.

Compounding in the U.S.

On March 10, 2013, the CBS television network program 60 Minutes aired a segment on issues concerning the New England Compounding Center (NECC). This facility had shipped contaminated epidural steroid injections that led to a meningitis outbreak beginning in May 2012. Deaths and painful injuries were reported, and the company filed for bankruptcy in December 2012. The television broadcast, led by correspondent Scott Pelley, featured interviews with David Kessler, former U.S. Food and Drug Administration (FDA) commissioner; and Margaret Hamburg, MD, current FDA commissioner, among others. Following are some key points, taken from the show transcript.