Baxter Heparin Problems First Reported by St. Louis DoctorMar 13, 2008 | Parker Waichman LLP
The Baxter Heparin recall had its origins in a report filed by one St. Louis doctor. In early January, Dr. Alexis M. Elward—a pediatric infectious disease specialist, an assistant professor at Washington University School of Medicine, and troubleshooter at St. Louis Children's Hospital—was called on to investigate severe allergic reactions in two children undergoing dialysis. Elward assembled a team of investigators and alerted authorities, initiating the international probe into contamination of the blood thinner Heparin. Following the government's publication of Elward’s report, similar reports started pouring in, resulting in a major recall of Baxter Heparin last month.
"We immediately wanted to know, is this a problem just we are having or are other hospitals having it as well?" said Elward.
Government reports of serious reactions linked to Heparin now number over 700 with an estimated 21 deaths. Baxter International, Inc., has recalled virtually all of its Heparin products in the US; companies in Germany and Japan have recalled their Heparin products, as well.
Hospital staff immediately contacted Elward who saw two children with swollen tongues and eyelids, quickening heartbeats, and dropping blood pressure minutes after being hooked up to dialysis machines for treatment. The doctor saw the reactions in one of the patients, as well as a third child, last November. Elward assumed the problem was with sterilization of the dialysis equipment; however, switching the sterilizing chemical didn't eliminate the symptoms.
In January, Elward and 20 physicians and nurses secured equipment, took samples of medicines given to the sick children, and reviewed patient records. Elward contacted other pediatricians through an online physician list, notified the local health department, and warned the Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). "My initial reaction was: It sounds like a chemical exposure. The next thought was: We really need to report this," said Elward.
Elward was not the first doctor to notice problems. A Baxter spokeswoman said the company began investigating when other physicians notified it of problems late December. Some dialysis centers notified equipment makers, believing there were problems with contaminated dialysis machines; however, Elward was the first to advise federal authorities, which launched the CDC search for side effects. Government scientists posted a notice on relevant Internet sites and issued public health advisories.
Within two days, physicians, dialysis centers, and dialysis supply companies flooded the CDC with reports of 50 similar reactions among adult dialysis patients in six states. "We were already very concerned, but that made us more concerned," said Dr. Priti Patel of the CDC, which is trying to determine if there's still a problem now that most Baxter products have been withdrawn.
Heparin investigators are focusing on why recalled products contained a contaminant that mimicked the drug's key ingredient and are investigating whether the possible counterfeit was responsible. Since the key ingredient came from China, fears about the integrity of exports from China and the adequacy of inspections by the FDA were heightened, prompting congressional hearings. "I don't think the pharmaceutical industry knows what it's doing in China and I don't think the US government knows what it's doing in China," said Michael Santoro, a Rutgers University business professor who has written about the drug industry's business in China. Santoro said the Baxter recalls show the need for serious restrictions on Chinese drug imports.