Heparin, a blood thinning medication administered to hundreds of thousands of people every day, was at the center of a tainted drug scandal earlier this year. The raw ingredient used to make heparin, which is sourced from manufacturers in China, was found to be contaminated with a counterfeit ingredient. In many patients, tainted heparin caused anaphylaxis – a severe and sudden allergic reaction – which in some cases proved fatal.
Eventually, tainted heparin would be implicated in dozens of deaths and hundreds of illnesses in the U.S. Heparin would be recalled in many countries that, like the U.S., relied on Chinese suppliers for heparin ingredients. And serious questions would be raised about the ability of U.S. regulators to insure the safety of drugs and drug ingredients made by overseas manufacturers.
In January 2008, Baxter International, responsible for about 50 percent of the U.S heparin supply, recalled 9 lots of its 1000/unit mL multi-dose Heparin vials. The recall was initiated after Baxter received 100 reports of patients who experienced extreme allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products.
A month later, the U.S. Food & Drug Administration (FDA) issued a Public Health Advisory warning doctors and other health practitioners not to use Baxter heparin products. The FDA said at the time that since the beginning of 2008, it had received 350 reports of side effects linked to Baxter heparin. The FDA also said that four patients had died after being administered the drug.
By the end of February, the FDA had received more than 400 reports of severe allergic reactions following the administration of Baxter heparin, including 21 deaths. At that point, Baxter recalled all of its remaining heparin products.
The investigation into tainted Baxter heparin soon focused on the company’s Chinese supply chain. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
Changzhou used two consolidators to supply it with a raw ingredient, which like chondroitin sulfate, was made from pig intestines. Those consolidators obtained the ingredient from unregulated workshops. In April, FDA Commissioner Andrew von Eschenbach said that while the FDA had no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”
There were soon similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin had been identified in 12 countries. In the US, other heparin suppliers issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products
The tainted heparin scandal raised serious questions about the FDA’s ability to police overseas drug makers. Due to a computer error, the FDA never inspected the Changzhou plant as is required by law. When heparin problems finally forced the agency to conduct an inspection, it found a multitude of problems. The FDA issued Changzhou a warning letter, and barred the company from exporting to the U.S. until corrections were made.
Unfortunately, the FDA’s failure to inspect Changzhou was likely not an isolated case. An audit released by the Government Accountability Office (GAO) in November reported that the FDA did not know how many foreign firms are actually subject to inspection. According to the GAO, the agency had a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected. In those rare cases where the FDA actually did visit foreign plants, officials provided advance warning and relied on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections. The report was alarming, considering the fact that about 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, and a growing share come from countries like China, that are still working on implementing a product safety infrastructure.
Since that GAO audit was released, the FDA has made little progress improving its track record of overseas inspections. In a follow-up report released in April, the GAO estimated it would cost between $67 million and $71 million to inspect all foreign manufacturing sites every two years. But The FDA has only proposed spending about $11 million on foreign inspections in fiscal 2008, the GAO said.
In June, the FDA completed its review of 93 deaths related to heparin that occurred from Jan. 1 to March 31, when reports of heparin adverse reactions peaked. Of 10 reports of death from severe anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths, so the FDA could not determine if those patients received tainted heparin.
Of the remaining 83 fatalities, the FDA described 13 as “potential complications of heparin use” such as bleeding; 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure. The FDA said that there was insufficient information available about the remaining 45 fatalities to conclusively cite a cause of death.
While the worries surrounding tainted heparin have died down, concerns that the FDA can insure the safety of drugs and other products coming from overseas suppliers have not. While Congress has recently granted the agency more money to improve oversight, many experts say it still lacks the manpower and funding needed to protect U.S. consumers. Until the situation changes, the threat that other tainted drugs could endanger more patients in the future is very real.
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