Tuesday, Oct 28, 2008
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.
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Metal particles, door paint found in medication pills
Among 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.
The FDA has been criticized for failing to monitor the drug industry well enough to make sure that such errors do not occur, or that they are corrected more quickly. Critics point out that the FDA often fails to act until several incidents have occurred.
The agency says that it dislikes challenging companies after only one incident, because it is hard to prove that the problem is systemic, as seen in the incident of the paint-flecked pills, which Biovail claimed was a fluke. (Quiz time: How many flukes does it take to make a pattern? FDA answer: There are no patterns. They’re ALL flukes!)
The FDA inspects each factory in Puerto Rico approximately once every two years, by the way. That’s one day out of 730 days.
By the way, wasn’t it the FDA that urged Americans to not buy pharmaceuticals from Canada or Mexico because they might not be safe? Apparently swallowing ground-up machine parts from a pill factory in Puerto Rico is safer than buying quality-controlled pharmaceuticals from Canada, if you ask the FDA. Then again, maybe they’re just trying to protect the U.S. pharmaceutical monopoly.
The pills are dangerous even if they’re manufactured correctly
What these outrageous quality control problems bring to light is the fact that pharmaceuticals are dangerous to your health on two levels: First, there’s the risk of harm or death caused by the drugs themselves, even when they are properly manufactured and consumed. Around 100,000 Americans are killed each year by FDA-approved prescription drugs, according to research conducted by the American Medical Association.
But now, there’s a whole new level of risk: Contamination at the factory. With medication pills possibly containing machine parts, pieces of metal, paint and other contaminants – and the utter lack of proper FDA oversight of these factories – it presents yet another good reason for consumers to find natural alternatives to dangerous prescription medications.
These pharmaceutical pills that are contaminated with metal parts and other chemicals do serve one purpose, however: They make patients sick, bringing them back to the hospital where they are almost certain to be prescribed yet more prescription drugs sold by the very same companies the manufactured the contaminated pills in the first place. Repeat business, anyone?
This article was posted: Tuesday, October 28, 2008 at 5:18 am