ARTS & FARCES internet

US Food and Drug Administration (FDA) employees have told a US House of Representatives subcommittee they believe the contaminant found in heparin that has caused 81 deaths was added deliberately. Heparin is a blood thinner used during dialysis treatments for end-stage renal disease patients.

Gardiner Harris, writing for the New York Times reports, “‘F.D.A.‘s working hypothesis is that this was intentional contamination, but this is not yet proven,’ Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday [29 April 2008].”

Woodcock explained to the subcommittee that some of the batches of heparin tested by the FDA contained fully one-third contaminants and suggesting that could have been an accident “strains one’s credulity.”

David Strunce, the chief executive of Scientific Protein Laboratories LLC, the company that supplied the contaminated material to Baxter International which manufactured and distributed the heparin also addressed the subcommittee. Strunce stated that he and his Chinese subsidiary, Changzhou SPL Company Ltd., were “deeply distressed by what appears to have been the intentional introduction of a synthetic contaminant into the crude heparin supply in China.”

Strunce testified that heparin is produced from tissue from the small intestines of pigs. In the US, his company buys raw source material from slaughterhouses and facilities in the US and Canada. The company also uses source material from China. In China, pigs are processed at government-regulated slaughterhouses which provide the intestines to workshops which actually produce the crude heparin. The company then further refines the crude heparin for medical use. Strunce claimed that Chinese crude heparin is used because “the global medical demand for heparin products has increased dramatically over the last decade, and there is an insufficient supply of pigs in North America to satisfy that demand.”

The heparin that Baxter International recalled in January contained crude heparin produced by Changzhou SPL, the Chinese subsidiary of Scientific Protein Laboratories LLC. On 19 March, the FDA identified the suspected contaminant as oversulfated chondroitin sulfate, a substance that standard testing procedures fail to detect.

According to Harris, Strunce testifed that “his company tried to find the original source of the contamination but was stopped by the Chinese authorities.” The Chinese dispute the FDA’s contention that the contaminant is a problem and have demanded the right to inspect US drug factories if the FDA insists on inspecting Chinese factories.

David Nelson, a Congressional investigator, insists that if the FDA had inspected the Chinese heparin plant, the contamination could have been caught before the heparin was distributed. The FDA disagrees, but when the agency finally got around to inspecting the Chinese factory in February, it found so many problems that it blocked exports to the US. Woodcock testified that the FDA currently spends US$11 million per year on foreign drug inspections and would need another US$225 million each year to inspect foreign drug facilities every two years. The Bush administration has proposed increasing the FDA’s entire budget by only three percent next year.

Baxter, the US company that markets and distributes the finished heparin, “bought heparin ingredients from Changzhou SPL from 2004 through 2008 but did not inspect the facility until September 2007.”

In March, Gordon Fairclough, writing for the Wall Street Journal, reported, “Changzhou SPL registered itself in China as a chemical manufacturer rather than a drug company. As such, it doesn’t fall under the jurisdiction of China’s State Food and Drug Agency. The U.S. FDA, in an oversight, also failed to inspect the facility when it began making the active ingredient for the U.S. market.”

Harris reports that “a Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.”

And therein likely lies the motive for the contamination. It’s not a case of international intrigue, merely a case of simple greed. The question is whose; there’s apparently plenty to go around.