Monday, May 3, 2010

Tylenol Recalls Give Drugs a Bad Name

The recalls of Tylenol products announced in January are still going on, and three more rounds of recalls have been announced, the latest on Friday. The vagueness of the latest recall announcements is hardly reassuring: McNeil found unknown particles, unidentified or unauthorized ingredients (apparently in powder form), and inaccurate doses in tests of dozens of Tylenol products. There is little reason to imagine that this round of recalls is the end of it, so at this point, sick people take Tylenol and related products at their own risk.

So much has gone wrong with Tylenol, it’s hard to list it all. An FDA panel last summer ruled that the liver toxicity of its active ingredient is a serious problem requiring changes in dosage and labeling. A mold-related chemical found its way into the product, and then the required recall was delayed for months because of confusion at McNeil. Since the recalls have been issued, there have been data errors and web server failures, making it hard for people to tell whether the drugs they were taking have been recalled. And to top it all off, McNeil has made up an unbelievable story about a moldy pallet somehow getting into the product, causing the original problems. The FDA, which doesn’t have much of a track record in identifying manufacturing problems in drugs in the first place, is just now conducting its review of the problem. It could be a comedy of errors if it weren’t such a serious matter. But aside from the stories of customers sickened by bad drugs, the entire story is bad news for McNeil and the drug industry. The problems with Tylenol, even little problems like dead links on the web site, tarnish the commercial image of drugs. To sell drugs, pharmaceutical companies have to present them as problem-solvers. Yet drugs can cause problems just as easily as they can solve them, and McNeil seems to keep reminding us of this. This also affects the image of people who use drugs — for everyone who says, “I’m glad there’s a drug for that,” there is someone else who says, “I’m glad I don’t have to be bothered with that.”