A pediatric infectious diseases specialist, Elward recalled in a telephone interview this week the events leading to her alert. Hospital staff immediately called on Elward after tongues and eyelids swelled, heartbeats quickened and blood pressure dropped in two children minutes after they were hooked up to dialysis machines for regular treatment.
The doctor had seen the shock-like reactions in one of the sickened patients, as well as a third child, last November. At the time, she assumed it was a problem with the sterilization of the dialysis equipment. But switching the sterilizing chemical apparently didn't work.
In January, Elward, along with 20 physicians and nurses from the hospital, secured the equipment, took samples of medicines that had been given to the sick children and reviewed patient records for clues. Elward also quickly alerted fellow pediatricians through an online physician list, notified the local health department and warned authorities at the FDA and Centers for Disease Control and Prevention.
"My initial reaction was: It sounds like a chemical exposure," said Elward, who is also an assistant professor at Washington University School of Medicine. "The next thought was: We really need to report this."
It was the kind of reaction that public health scientists in the federal government hope for. Their ability to trace serious side effects depends to a large extent on problems reported by physicians. But busy practitioners don't always report what they should, especially if the side effects don't involve communicable diseases like hepatitis A, HIV and syphilis, which they are required to report.
Elward was not the first doctor to notice problems. A Baxter spokeswoman said the company had begun investigating after other physicians notified it of problems in late December. Some dialysis centers had notified equipment makers, thinking it was a problem with contaminated dialysis machines. Yet Elward was the first to tell federal authorities.
That warning launched CDC scientists on a hasty search to see if the side effects were widespread. The government scientists posted a notice on relevant Internet sites and issued public health advisories. Within two days, physicians, dialysis centers and dialysis supply companies had flooded the CDC with reports of 50 similar reactions among adult dialysis patients in six states.
