On Pepcid

Unsurprisingly, I have indigestion. My Dad had indigestion, I have indigestion, lots of out-of-shape American males have indigestion. Now, just as antibiotics are one of the things that make modern life better than antiquity, I can point to the presence of drugs like Pepcid Complete as proof positive that civilization is making progress. My Dad would belch for hours, I take a Pepcid and belch for minutes. Progress.

That is, until Fall of last year, when Pepcid Complete unaccountably disappeared. I put it on the shopping list, my wife came back with nada. I went to the drugstore, all the shelves were barren. This phenomenon, the complete and utter disappearance of this product within a relatively short period of time, has been chronicled on many other Blogs (i.e., http://www.totalsuckage.com/2010/11/mysterious-disappearance-of-pepcid.html). What’s sort of weird is that the reasons behind its disappearance have been very sparsely reported. By January, the quality control problems within the McNeil unit of J&J had been brought to light (http://www.nytimes.com/2011/01/16/business/16johnson-and-johnson.html?pagewanted=1&partner=rss&emc=rss), and shortly thereafter the Lancaster, PA plant that made the beloved Pepcid was shut down via a FDA Form 483, a notice of non-compliance. This plant and several others have recently been re-opened essentially under government control (http://www.nytimes.com/2011/03/11/business/11drug.html?src=busln). Whether this results in a return of Pepcid Complete to the shelves remains to be seen.

But here’s the weird thing: why didn’t / don’t we know more about this? You have a recall of E. coli-tainted peanuts or beef, folks go through the roof. But Pepcid disappearing almost overnight? Mostly silence, and ominous murmurs on Blogs. And it must be admitted it doesn’t help that similar quality control problems were dealt with in part by carrying out ‘phantom’ recalls of Tylenol that involved Smurf-like buyers raiding stores and denuding the shelves (http://money.cnn.com/2010/09/16/news/companies/johnson_johnson_recall_hearing/index.htm). Surely such corporate behavior would not carry over into skewing the results of Internet searches. Naw. It’s almost enough to make me want to get out my tinfoil hat and join with Alex Jones’ minions to decry our exploitation by the command-and-control structure created by the Bohemian Grove crowd. Or something like that. It’s actually hard to keep up with the latest in conspiracy theories unless you really work at it.

But back to the point: we have essentially ceded the quality control of our products to watchdog agencies, like the FDA, and cross our fingers and hope that all is well. Now, such an enormous responsibility must overwhelm the FDA even in the best of times, much less these austere times when its budget is being whacked. And the FDA doesn’t regulate all products, anyway, as we saw when we imported melanine-laden pet food from China.

From a biodefense point of view, I find it surprising that we don’t have more independent confirmations of food and drug quality. As commenter ‘j’ on Total Suckage said, you can gain deeper insights into the McNeil quality control problems by reading through FDA reports (http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM233908.pdf), but really these say very little about what the actual problems are, or how the products may have ultimately been adulterated (or not).

The fact is that there is no profit in monitoring the things we put in our bodies. J&J to this day has been remiss in stepping up to explain to consumers what the heck is going on. The government has been tight-lipped, potentially because hearings, including criminal complaints, continue to waft through the system, but also because what good does it do to destroy J&J? The business of America is business. Thus, we are left with a system that feels unsettlingly non-transparent, even though transparency is a HPLC trace or so away. I suspect that a band of undergraduates with some medium grade lab equipment could probably identify major impurities and perhaps even lot-to-lot variations in many beloved consumer products. But then what? The undergraduates sound the alarm and get sued? Or, worse, the undergraduates get it wrong and the counterculture picks it up and runs with it (we all know about those Satanists at Procter and Gamble, right; http://www.snopes.com/business/alliance/procter.asp?).

Our defense against toxins, whether accidental, intentional, or some corporate combination of both, should be more distributed, less centralized. But this will be damnably hard: while it is likely that biologicals can largely be typed by sequence, accurately determining chemical composition is still non-trivial. There have been calls for developing simple melamine sensors, and such would be useful … for melamine. For the other gazillion compounds of concern, not so much. This is one of those puzzlers where I think I’ve identified an important problem, but right now don’t have much in terms of a solution. Actually, the best solution is J&J’s own Credo (http://www.jnj.com/connect/about-jnj/jnj-credo/), which I really wish they (and many other companies) would live up to. Even though it’s the fox watching the henhouse, confidence in the analytical abilities of our corporate masters is our first, best line of defense against product adulteration. Just consider it an invisible tariff protecting American industry. Oh, wait, in these globalized times there’s no such thing as American industry anymore. Oh well. I can pine for the military-industrial complex along with my pining for just one more bottle of Pepcid Complete. Burp.


- originally posted on Monday, March 28th, 2011