Heparin Contamination A Worst Case Scenario for Some Patients

Los Angeles, CAIt is what some people might call a worst case scenario: A drug given to people already at risk of complications—either because of a major surgery or medical procedure such as dialysis—is contaminated. This is what patients who were given a Heparin injection via Heparin syringes faced. Many were already at risk of difficulties because of their medical condition when they were exposed to the Heparin contamination. They had no idea that the drug given to help them might actually cause serious complications.

As the US Food and Drug Administration (FDA) faces criticism that it did not see warning signs about the potential disaster looming, critics ask how the FDA and pharmaceutical companies did not see that the increase in the price of pigs could result in cost-cutting measures in China.

As Angie Drakulich writes in PharmTechTalk, Heparin is made from pig intestines and those pigs came from China. Before the contamination, the price of pigs in China increased, possibly resulting in some people deciding to cut costs by using a replacement ingredient—one that was cheaper than the price of pig.

"The fact that the price of a key 'ingredient,' if you will, for a major drug was going up, should have raised a red flag to industry that the supply chain for this drug product may be affected negatively," Drakulich writes.

The people who were exposed to contaminated Heparin do not know about the price of the drug's ingredients. They have no idea what environmental factors might cause them to experience complications. All they can do is believe that the drugs and syringes they are exposed to are of the highest possible quality—that the cost of ingredients has not had any effect on the quality of the medication they are receiving.

It is not just Heparin from China that gave patients cause for concern. Some patients were exposed to Heparin that was contaminated with Serratia bacteria, allegedly due to faulty manufacturing procedures at the AM2PAT Inc. facility in the US. As early as 2005, the company reportedly received a letter from the FDA, warning that there were multiple violations "symptomatic of serious underlying problems" in the facility's quality control system. These included inadequate documentation of sterility tests, untrained workers and 7 other breaches of FDA regulations.

AM2PAT moved from that facility to another in June 2007, but complaints about the company's products began to come in, including complaints about sediment and particles in saline solutions from the plant. Patients who were receiving chemotherapy, kidney dialysis and other intravenous medical treatments were exposed to these contaminated pre-filled Heparin syringes and saline syringes. Five deaths were linked to the products and at least 100 others became ill.

Some of the company's officials were charged with falsifying documents so that it would appear that the syringes went through sterility testing. The president of the company fled the country and is the subject of an international manhunt. Two employees were sentenced to 4.5 years in prison for fraud and for allowing the tainted syringes onto the marketplace.

A story in ProPublica, an online news source, highlights how dangerous the tainted Heparin syringes can be. Kyle Pacheco, 19 years old, had been cancer-free for 20 months thanks to a bone-marrow transplant. However, in 2007, he was given intravenous medication via a line that was reportedly flushed with an AM2PAT syringe. Pacheco was diagnosed with a bloodstream infection of Serratia marcescens. He contracted meningitis and fell into a coma that lasted a month.

Although Pacheco has survived the ordeal, his father says he can barely get a spoon to his mouth now and cannot carry on a conversation. Even just moving from his bedroom to the living room is a trial involving slings and lifts. Pacheco's father says Kyle, who survived leukemia, will never be the same.

So, while the FDA faces criticism it should have seen what was coming, and the makers of Heparin syringes face allegations about the lack of quality control at their plants, patients who were exposed to contaminated Heparin continue to fight to get their quality of life back—and ask how this could have happened at all.