Unlike its response to the 1982 product tampering crisis, Tylenol is writing a textbook case with its reaction to the FDA's concerns about dosage...a case history of what not to do.

Last week, an advisory panel of doctors and consumer representatives (whoever they are) announced that:

  • The recommended maximum adult single and daily dosages of nonprescription acetaminophen for adults should be lowered
  • The 1,000-mg OTC version should be upgraded to prescription-only status
  • Every prescription version of the drug should carry a serious safety warning, and
  • Products that combine acetaminophen with other drugs (like decongestants) should be banned entirely

Why the draconian recommendations? 

It seems that it's pretty easy to inadvertently get too much acetaminophen into your system, and that doing so is a major cause of liver damage. More than half of such cases involve prescription use, but I sense that the advisory panel is concerned that consumers just don't grasp how potentially dangerous an overdose can be (or easy to do). I know I sure didn't. I've popped an extra Tylenol or two on more than one occasion. Turns out that the FDA has been worried about this very danger since 1977.

Who knows what the agency will finally issue as a ruling, but it's interesting to watch the response to the crisis coming out of Tylenol:

There is no crisis.

The company has declared via newspaper ads and PR that Tylenol is safe when taken in the recommended doses. It "shares the FDA's goal" of helping to ensure that products are used safely, etc. Nothing has changed, and consumers have nothing to worry about. 

This is a far cry from its much-celebrated response to the product tampering issues in the early 1980s. Then, it yanked all its products from store shelves, invented a new safety wrap for bottle-tops, and forced much of the CPG industry to follow in its footsteps. It was a different crisis, for sure, and perhaps it had little choice regarding its response. And while we mostly credit it as a PR case history, it was really an operational reality event. Tylenol did real things, and PR simply communicated it. 

Now, we're only getting words that are disconnected from reality. The language it uses is disingenuous, at best. Its newspaper ad:

  • Declares "nearly 50 million adults and children in the U.S. rely on acetaminophen, the active ingredient in Tylenol," without clarifying that a lot of that reliance is on products other than Tylenol
  • Claims that, when taken as directed, "doctors know" that Tylenol "...is the safest brand of pain reliever you can use," without explaining how they know what doctors know, or that generic pain relievers aren't more or less safe than one another, by definition
  • Advises that the product's safety has been "...well established through more than 50 years of clinical use and scientific investigation," when that research and investigation (and the numbers of people sick with liver problems in hospitals) are what prompted the latest recommendations from the FDA's advisory panel

Some really smart writer penned this blather, thinking that all the crisis needed was a witty retort. Yet the strategy leaves one fundamental question unanswered, and it's in the center of the newspaper ad:

"However, as with any medicine, it’s important for you to know that misusing Tylenol can be harmful. If you take more than the recommended dose (overdose), you can cause serious liver injury."

One time? One pill over the limit? What does liver damage feel like? How will I know? Is the stuff that powerful

The fact that those two sentences go unanswered renders everything else moot. What a missed opportunity to follow its own lead, and respond to a challenge to its brand with some substantive action. Here's what it could have done:

  • Where are the third-parties? Corporate reputations are at all-time lows, and nobody believes declarations on web pages or ads, so why didn't Tylenol enlist some credible third-parties to talk with/for it? Maybe some of those "consumer representatives" who participated in the advisory group? Where is the outsider affirmation that Tylenol gets the context of what's going on, and isn't just trying to make us get what it wants us to believe?
  • Where's the detailed, proactive help? How many permutations of Tylenol are there? 100? Do they all contain the same amount of acetaminophen? What are the most likely conflicts, whether within the Tylenol brand family, or with other leading brand names? Publishing a help line isn't enough; ultimately, Tylenol isn't a product (it’s a generic drug), but rather a service, so the branding needs to deliver ongoing information and help...from which would emerge reassurance
  • What happened to real action? Maybe smaller dosages, or less active ingredients/pill make sense? How about dispensers that meter dosage? What about developing a truly integrated wellness product offering, so Tylenol could all but guarantee that its pain killer and nasal decongestant wouldn't fry consumer livers?

This crisis isn't over. But I fear that Tylenol has already written the textbook entry on its response.

Original Post: http://dimbulb.typepad.com/my_weblog/2009/07/a-textbook-case.html

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