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(NaturalNews) An investigation by the Associated Press (AP) has uncovered evidence of widespread quality control problems in pills produced in Puerto Rico, a region that manufactures many of the prescription medications sold in America. Puerto Rico has one of the highest concentrations of pharmaceutical factories in the world, producing $35 billion worth of drugs each year. The United States, with its $300-billion annual drug market, is the island's primary customer, and 13 of the country's top 20 selling drugs are produced in Puerto Rico.
But an AP review of FDA documents finds widespread contamination problems at Puerto Rican pill factories, which have led to the export and sale of tainted and potentially unsafe medications. The documents reviewed concerned FDA inspections of 13 Puerto Rican factories between 2003 and 2007, accounting for approximately half of the pill factories on the island.
"People would be shocked to find this whole variety of contamination," said Sidney Wolfe of Public Citizen. "The common denominator of all these is there's really poor quality control."
This is especially interesting given that the FDA has acted to protect Big Pharma's monopoly drug pricing scheme in the United States by claiming that pills imported from Canada, Mexico or other countries might be unsafe due to contamination or poor quality control. Therefore, the FDA claims, American consumers should be forced to pay the highest prices in the world for drugs sold at monopoly prices in the United States. And yet we're now finding that even those drugs sold in U.S. pharmacies aren't manufactured here, and they may be even more dangerous than the same medications purchased from Canada.
Metal particles, door paint found in medication pillsAmong the incidents identified in the AP review was a case where a worker sorting blood pressure pills for Biovail Corp. noticed blue flecks on the pills that matched the paint on the factory's doors. Eventually, the employee's reports led to the factory covering the drug carts, but no investigation was launched into whether contaminated shipments had gone out, and the incident was written off as a fluke.
"[The] incident was considered an isolated event ... even when the employee reported having observed the same particles before," the FDA report on the incident reads.
In another case, a plant owned by Teva Pharmaceutical Industries continued exporting drugs that it knew to contain small metal particles inside pill bottles or even embedded in the pills themselves. In addition to being aware of conditions inside the factory, the company had received at least six consumer complaints about the pills.
When challenged by the FDA, the company's quality control unit said that the presence of metal in the pills was normal, because the plant's machinery was made out of metal!
The plant closed two months later. As in most similar cases, the company denied any connection between the defective pills and the factory shutdown.
Machine parts ground into medication pills?In May 2006, after patients complained of finding machinery pins inside pill bottles of Wyeth's depression drug Effexor and heartburn drug Protonix, the FDA sent a warning letter to the factory in question, asking why the plant was not "able to detect that the affected equipment was missing some of its parts."
Not all cases involved foreign materials. In March 2005, the FDA raided a Puerto Rican GlaxoSmithKline plant after receiving reports that pills of the antidepressant drug Paxil CR had split apart, making it hard for patients to calculate proper dosages. In that raid, agents found tablets of the diabetes drug Avandemet that contained improper dosages.
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Monday, October 27, 2008
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