Upjohn’s Shuck and Jive Routine

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Every once in a while an instance of product dumping comes along that is so blatant, you have to rub your eyes and look again. Consider the case of Panalba.

Panalba was an antibiotic made by the large, U.S.-based Upjohn Company. It was launched in 1957 and promoted heavily. By 1968, Panalba sales totaled $18 million, or 12 percent of Upjohn’s domestic gross income. Yet in that same year and the two that followed, strong scientific evidence of Panalba’s harm appeared:

In 1968, 30 experts from the National Academy of Sciences issued a unanimous report on Panalba and 49 other antibiotics of a similar nature. These drugs are harmful, the scientists said; they should be removed from the market.

On May 27, 1969, FDA Commissioner Herbert Ley Jr., himself a specialist in antibiotics, testified before a Senate committee about the effects of novobiocin, one of the two ingredients of Panalba. Roughly one out of every five patients who receives it, Ley said, has an allergic reaction.

Twelve patients receiving Panalba died as a result of its side effects (mostly from blood disorders).

FDA inspector Roy Sanberg, searching Upjohn files, discovered several ten-year-old company-sponsored studies showing that tetracycline, the other of Panalba’s two ingredients, was more effective than Panalba, when used alone.

After much bureaucratic wrangling and resistance by Upjohn, the FDA finally forced Panalba off the market in 1970.

If you think all this evidence against Panalba would make its manufacturer think twice before selling it elsewhere, think again. Under FDA regulations, antibiotics are not legally classified as “drugs.” Were Panalba considered a drug, it would undoubtedly have lost its FDA approval and, thus, been illegal for export. But because of this classic loophole in the law, it is now perfectly legal for Upjohn to export Panalba. (Actually, its two ingredients are exported separately and combined and packaged in Upjohn’s foreign plants.) Today, after being the target of one of the strongest cases against a drug in regulatory history, Panalba is sold in 33 countries under another name — Albamycin-T.