By Jonathan D. Rockoff , Sun Reporter|March 13, 2008
WASHINGTON — WASHINGTON -- On Jan. 4, Dr. Alexis M. Elward, a troubleshooter at St. Louis Children's Hospital, was summoned to investigate severe allergic reactions in two children undergoing dialysis there. Elward -- an Annapolis native trained in Maryland -- quickly mobilized a team of investigators and alerted authorities, the start of an international probe into contamination of the blood thinner Heparin.
The government's publication of her alert triggered an outpouring of similar reports, which resulted in a major recall of the popular drug last month.
"We immediately wanted to know, is this a problem just we are having or are other hospitals having it as well?" recalled Elward, who specializes in infectious diseases in children.
The government now counts more than 700 reports of serious side effects among Heparin users, and perhaps as many as 21 deaths. A leading American maker, Baxter International Inc., has recalled virtually all of its Heparin products in the United States, and companies in Germany and Japan have recalled their Heparin products.
A major focus of Heparin investigators is why the recalled products contained a contaminant that mimicked the drug's key ingredient. Investigators are also exploring whether the possible counterfeit was responsible for the bad reactions.
Since the key ingredient came from China, the scare has rekindled fears about the integrity of exports from China and the adequacy of inspections by the U.S. Food and Drug Administration, prompting congressional hearings.
"I don't think the pharmaceutical industry knows what it's doing in China, and I don't think the U.S. 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. He said the Baxter recalls show the need for serious restrictions on Chinese drug imports.
Elward's role in the international health scare -- from providing one of the first warnings to the government to now calling for tighter monitoring of drugs from overseas -- comes as no surprise to mentors in her home state, where she distinguished herself as a high school valedictorian and quick-learning research assistant.
"One, she's smart enough to recognize something is wrong here. Two, she's got the drive and ambition to get to the bottom of things," said Bert Kiessling, one of her teachers at what was then called Martin Spalding High School, in Severn.
