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"When the wind is southerly I know a hawk from a handsaw"
- Hamlet in Hamlet, Shakespeare (1600)

Media pundits, such as The Financial Times' Stefan Stern  [link], are quick to draw an analogy between the 1982 and 2010 Tylenol crises:  same company, same brand, same trust perception.   Right?  Wrong!

The 1982 Tylenol crisis featured a sinister external plot to contaminate products on retail shelves to harm or kill consumers.  It was a criminal act by an individual external to the manufacturer at a time when the product was well beyond the control of the manufacturer.  The modus was the intentional tampering with product in free sale by injecting them with lethal cyanide.

The 2010 Tylenol crisis features the systemic failure and partial collapse of overarching quality systems within J&J, the product manufacturer.  The failure is widespread, in theory involving all plants, brands, forms, sku's, etc. until otherwise proven.  Why?  Drug quality systems underwrite all products manufactured under cGMP whether Rx or OTC.  There is no way now to judge the full extent of the system failure, for example, whether it extends to Rx products.  The 2010 failure is internal to the company, self-inflicted, and always within its sphere of control.  The resultant damage is the unsympathetic loss of trust in the company and all its brands.  Unlike the 1982 tampering incident restricted to one brand the company itself is the perpetrator not the victim.  It must now exculpate itself.  A more fitting analogy may be as a criminal defendant who waives their right to legal counsel choosing instead to muster their own compelling case.

This time around J&J must do much more than simply remove product from the market.  It must move to convince consumers that its internal neglect, sloth, and sloppiness are not a throwback to Upton Sinclair and the early days of the 1900's.  J&J sinned on both ends---in manufacturing and marketing defective products (Tylenol and others) and once having released them into the trade failing to heed consumer feedback that something was very wrong (Benadryl poisonings).  In a similar recent case the FDA moved on defective Icy Hot Heat Therapy patches (Chattem/Sanofi) that remained in the market for a period of about one year before any action was taken.

In 1982 J&J was the victim of a deranged criminal act.  In 2010 the victims are the many consumers of J&J products, not J&J.  Big difference, no analogy.

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[Dr. Riker, President & Founder, On Point Advisors, LLC, is a former Associate Director, Personal Healthcare at Procter & Gamble, and the last Vice President of R&D/QA & Chief Scientific Officer at Chattem]

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