Foreign drug safety problem
Adverse patient reactions in Germany to the blood thinner heparin possibly linked to a Chinese source underscore the growing public health problem posed by the world's increasing reliance on China to supply basic ingredients for many life-saving drugs.
The decision by the German government to recall heparin produced by Rotex Medica GmbH came after 80 patients suffered adverse reactions. The decision follows a recall in the United States of a heparin preparation sold by Baxter Healthcare Corp. The U.S. Food and Drug Administration has linked Baxter's heparin to as many as 19 deaths and hundreds of other adverse reactions since Jan. 1, 2007. In both cases, the reactions are believed to be related to ingredients imported from China.
The FDA reported last week it had found a "contaminant" in many samples of Baxter-manufactured heparin that may cause adverse reactions. The origin of this "heparin-like compound," which is not detected by standard tests, remains a mystery. The Washington Post reported that FDA Chief Medical Officer Janet Woodcock is investigating whether the contaminant is a result of faulty manufacturing or was added intentionally to cut costs. According to the Post, the FDA is leaning toward the theory that the contamination occurred in China, before Baxter received ingredients for manufacture. Meanwhile, the FDA has warned U.S. manufacturers to use a more sophisticated test involving nuclear magnetic resonance spectroscopy to detect the contaminant.
This points to a growing problem. In recent years China has become the major supplier of drug ingredients to U.S. and European manufacturers. But safety inspections by agencies like the FDA have not kept pace. The FDA is required by law to inspect each U.S. drug manufacturing facility at least once every two years. In contrast, the Government Accountability Office reported last fall, foreign inspections are optional, unsystematic and underfunded.
Overall, the FDA inspects only 7 percent of foreign drug plants, and the inspections are skewed toward traditional suppliers to the U.S. market. From 2002 to 2007, the FDA conducted only 88 inspections of the estimated 714 Chinese plants producing drug ingredients for the U.S. market. During the same period, it conducted 133 inspections of the 150 such plants in Italy, the GAO said.
The heparin investigators are trying to track the contaminated ingredients back to the point of origin, either in the village workshops that process the required pig intestines or in subsequent stages of manufacturing. A major embarrassment to the FDA was the disclosure that, because of bureaucratic error, it had never inspected the Chinese plant that supplied Baxter. Neither had the Chinese Food and Drug Agency.
It is going to take new legislative authority, much larger drug safety budgets, and a high degree of international cooperation to repair the holes that the heparin cases have revealed in the drug safety system. We can only hope there are no more tragic surprises in store before this essential work is carried out.
E-mail this story 
Printer-friendly version
Notice about comments:
The Post and Courier is pleased to offer readers the ability to comment on stories. We expect our readers to engage in lively, yet civil discourse. The Post and Courier does not edit user submitted statements and we cannot promise that readers will not occasionally find offensive or inaccurate comments posted in the comments area. Responsibility for the statements posted lies with the person submitting the comment, not postandcourier.com. If you find a comment that is objectionable, please click "suggest removal" and we will review it for possible removal. Please be reminded, however, that in accordance with our Terms of Use and federal law, we are under no obligation to remove any third party comments posted on our Web site.
Full terms and conditions can be read here.
Comments
This article has 0 comment(s)
