Md. native's expertise led to drug recall

The Baltimore Sun

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.

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.

"We were already very concerned about it, but that made us more concerned," said Dr. Priti Patel of the CDC, which is trying to determine if there's still a problem after the Baxter products have been withdrawn.

Elward's high school teacher recalled that she took every biology and chemistry class available, but Elward said she settled on a career in medicine while attending Loyola College in Baltimore. Her interest was stoked, she recalled, by working weekends at Maryland Shock Trauma Center's intensive care unit.

She didn't gravitate to the field's sleuthing side, she said, until she interned from 1988 to 1990 at a laboratory at the Johns Hopkins University studying the origins of HIV infections. In 1994, she graduated from the University of Maryland School of Medicine.

"It was apparent very early on that Alexis was headed for bigger things. She is clearly very bright and showed the kind of attention to experimental detail that is the mark of a good scientist," Dr. Richard Markham, the Hopkins lab director, wrote in an e-mail.

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