The Food and Drug Administration reported last week that the number of deaths associated with heparin, a brand of blood thinner, has risen. The brand of heparin associated with the problems is made by Baxter International. Baxter produces most of the heparin used in the United States. Heparin is made from pig intestines, which, of course, could be supplied by U.S. farmers. Baxter buys its supplies from a Chinese plant. Federal drug regulators said last Thursday that they found “potential deficiencies” at a Chinese plant, Changzhou SPL, that supplied much of the active ingredient for heparin.
The FDA also said it was investigating two Chinese wholesalers that supplied crude heparin to Changzaou SPL, as well as those that sold raw ingredients to the wholesalers. The New York Times reported last week that at least one of the Chinese wholesalers received supplies from small, unregulated family workshops that scraped the mucous membrane from pig intestines and cooked it, producing crude heparin. Changzaou SPL began shipping the heparin ingredient to Baxter in 2004, but the FDA did not get around to inspecting the Chinese plant until last week! Getting access to this plant could not have been difficult because the majority owner of the plant is Scientific Protein Laboratories, a Wisconsin company. The FDA now admits that it violated its own policy by failing to inspect this plant. The FDA inspection last week found multiple safety violations, including the fact that the plant made some heparin with “material from an unacceptable workshop vendor.’ The image conjured by that description is of a poor, unsanitary Chinese farm.
This alarming news coincides with the federal preemption decision last week by the U.S. Supreme Court in which the Court held that lawsuits against manufacturers of certain medical devices which received from the FDA pre-market approval, were pre-empted by federal law. The decision, authored by Justice Scalia, assumes the FDA pre-market approval is a rigorous process. One hopes that this flawed rationale is not extended to pharmaceutical drugs such as heparin. As the heparin situation illustrates, the FDA is impotent to keep up with even minimal safety inspections. The FDA does not itself test new drugs submitted by manufaturers for FDA approval. Rather, the FDA relies upon pre-market clinical studies submitted to the FDA by the drug manufacturer. The flaw in this system is that history is replete with examples of drug manufacturers submitting only the clinical trial test results that support a conclusion of safety and efficacy, and hiding from the FDA test that show the proposed drug is unsafe and/or not efficacious. Once the drug is approved, the post-marketing safety process is essentially to use as canaries in a coal mine the U.S. consumer. Manufacturers continue to move much of the manufacturing process overseas to countries like China, and the FDA is slow to inspect the overseas plants. There seems to be an epidemic of poisonings of U.S. citizens by food and drug products coming from China. This is exactly the wrong time for the Supreme Court to try to preempt the very lawsuits that may be the last line of defense against these dangerous products.