(NaturalNews) The FDA has come into conflict with Congressional investigators over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.
Earlier this year, the FDA issued its first alert over tainted supplies of the blood thinner heparin. To date, the contaminated drug has caused allergic reactions that have led to more than 1,000 adverse events in the United States, including 81 confirmed deaths since January 2007. The tainted drugs have also been detected in 10 other countries.
In spite of the original warning, the FDA recently discovered that tainted heparin was still on the shelves in some California hospitals. In response, the alert was widened to include hospitals, physicians groups and pharmaceutical organizations.
"We found it on crash carts, catheter labs, and even on one hospital pharmacist's shelf," said Karen Riley of the FDA.
Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery. In 2007, then-lead heparin manufacturer Baxter International made $30 million in sales of the drug.
Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States. According to Baxter Chairman and Chief Executive Robert Parkinson, China is a favored source for heparin in particular, because "that's where the pig population is."
The active ingredient in heparin is derived from pig intestines, and China has five times the pig population of the United States.
The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.
The FDA has determined that the tainted heparin was adulterated with a heparin-like chemical called oversulfated chondroitin sulfate, derived from shellfish. The presence of this synthetic chemical suggests that the drugs were deliberately tampered with during the manufacturing process, probably to decrease costs for the supplier. But the FDA does not yet know at what stage in the manufacturing process the chemical was added.
This is only the latest source of conflict between the FDA and Congress over the heparin crisis. From the beginning, members of Congress have criticized the FDA's handling of the situation.
"The FDA thinks they have it under control, but they really don't," said Rep. Bart Stupak. "If I was the FDA director, I'd shut down every drug coming in from China" until each one had individually been proven to be safe.
But the FDA retorted that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.
Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.
"It was indistinguishable from the real heparin," Parkinson said.
But Parkinson noted that since then, Baxter has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.
Stupak blasted the Memorandum of Agreement as "useless," saying it does not give the FDA any real access to Chinese factories.
"I can go to the plant there [China] and look at the paint on the walls, but not be allowed to inspect the lab," he said.
The agency inspected a number of Chinese heparin ingredient factories in February, but alleges that it was not allowed access to all the workers, records and workshops. An FDA compliance official has told Congress that another inspection could be attempted, but "I cannot say whether they will admit us or not, or whether they will allow us to do a full inspection."
One of the plants inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world's major supplier of heparin's active ingredient.
Because no evidence has yet emerged that contamination took place at any of the inspected factories, Baxter says it "is seeking access further down the supply chain to the Chinese facilities."
Chinese health officials have objected to claims that their country was the source of the contamination, pointing out that the drug could just as easily have become adulterated at Baxter's processing plant in New Jersey. The Chinese State Food and Drug Administration has accused the U.S. drug company of failing to cooperate with the Chinese government's own investigation into the contamination. According to China, Baxter refused to supply samples of the drug to Chinese inspectors who visited the Cherry Hill, N.J. plant in April.
At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug. However, at the company's recent shareholder meeting, Parkinson said that Baxter has yet to incur any serious legal costs from the crisis. A full quarter of the hourlong meeting was devoted to discussing the heparin situation.
Baxter's sales in 2007 reached a new record at $11 billion.
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