Tainted pills hit U.S. mainland

An investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S. An AP review of 100 pages of Food and Drug Administration reports shows even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills. "People would be shocked to find this whole variety of contamination," said Dr. Sidney Wolfe of the Washington watchdog group Public Citizen. "The common denominator of all these is there's really poor quality control."

The FDA issued a warning letter to Wyeth in May 2006, after consumers reported finding machinery pins inside bottles of Effexor, a leading depression treatment, and the heartburn drug Protonix. The letter expressed concern that the plant was not "able to detect that the affected equipment was missing some of its parts."

In another case cited in a June 2006 FDA inspection report, a plant owned by Teva Pharmaceutical Industries exported drugs — including the diabetes treatment metformin — even though they were known to contain small amounts of metal particles. The company had also received at least six consumer complaints of dark residue inside bottles or foreign material embedded in tablets, according to the report. Teva's quality-control unit said the presence of some metallic material was to be expected because the manufacturing equipment is made of metal, according to the report. Teva recalled 21 different drugs as a result of the inspection, according to FDA officials, and the Israeli drugmaker announced two months later it was closing the plant, citing a restructuring. Denise Bradley, a Teva spokeswoman, insisted the medicine from the now-closed plant was safe and effective despite the contamination.

The reports obtained by AP were produced by FDA inspections from 2003 to 2007 of 13 pharmaceutical plants — roughly half the total in this U.S. territory, a Caribbean island with one of the world's highest concentrations of drug makers. Several are closing or downsizing as the expense of updating decades-old plants to meet regulations adds to struggles with rising energy costs and tightening tax breaks.

Four of the plants described in the reports closed or announced plans to do so after the discovery of significant quality-control problems, but none of them cited the discoveries as a reason for closing. One of those four, GlaxoSmithKline PLC, produced tablets of the popular antidepressant Paxil CR that split apart, potentially causing patients to take incorrect dosages. When the company would not recall all the affected pills, U.S. marshals raided the plant in March 2005 in the largest drug seizure in FDA history and also collected tablets of the diabetes treatment Avandamet after some were found not to have accurate doses of the active ingredient.

Bonnie - while very unusual, I am at a loss for words.