Kids must be retested for lead
7 million poison-detecting procedures may have been faulty
Tests given to millions of kids since 2014 to detect lead poisoning may not have worked properly, delivering false low results to an unknown number of American families.
As many as 7 million tests performed on children over three years could have been wrong, according to the Centers for Disease Control and Prevention. The tests’ manufacturer is confident the number is millions lower.
Parents may not realize that routine doctor visits should include a blood test to screen children for lead. In the barrage of questions about a baby’s development, physical exams, shots and other tests, it can get glossed over — partic-
“Any kid coming in for anything — a snotty nose — we retest them.”
Environmental Health and Lead Clinic
ularly if the test comes back negative.
Although lead has been banned from products such as gasoline and paint for decades, a child can ingest lead easily, so the CDC recommends early testing.
The Food and Drug Administration recalled the faulty tests in May, and eight months later, what went wrong remains uncertain.
Some children thought to be healthy should be rescreened for lead, the CDC advised. No level of lead is considered safe in children.
Nicholas Newman, head of the Environmental Health and Lead Clinic at Cincinnati Children’s Hospital Medical Center, urges anyone younger than 6 to be rescreened.
“Any kid coming in for anything — a snotty nose — we retest them,” said Newman, whose clinic is one of 11 units in a national network specializing in environmental health.
The testing systems in question are manufactured by Magellan Diagnostics.
Officials at Magellan Diagnostics in North Billerica, Mass., work with federal regulators and are committed to fixing the problem, said Amy Winslow, president and chief executive.
“The evidence uncovered during the inspection (of Magellan’s plant) shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue,” Donald St. Pierre, an FDA deputy director, said in a news release in October.
The number of children tested for lead nationwide is dropping, and Jennifer Lowry, chairwoman of environmental health for the American Academy of Pediatrics, fears this recall will exacerbate the problem. “If the physician’s office thinks it is not accurate, then they might not do the screening there,” she said. “They might refer the family elsewhere, and many people won’t go.”
When children ingest lead, the chemical gets into their bloodstreams. Then, it travels to the brain and can cause stunted growth, slurred or delayed speech, violent behavior and even death in rare cases.
For parents, lead poisoning and its unknowns are terrifying, Cincinnati mom Shar Allen Hardy said.
Her nearly 2-year-old son, Wilson, is in the third percentile for height and weight in his age group and just recently began fitting into clothes for children half his age. He started walking late.
His parents moved out of their house into a recreational vehicle to get him away from lead paint chips and dust. Still his blood-lead levels continued to climb. Ultimately, he and his parents had to move from the city to a rural location.
Lead can come from so many places — old paint, plastic toys, blinds, purse handles, jewelry, car keys, tools, dirt — that it can be overwhelming for parents trying to pinpoint a cause.
“You go home and you Google, and you have a heart attack,” Hardy said. “You’re looking around going, ‘This is killing my kid.’ ”
An investigation continues into why Magellan’s lead tests failed.
Magellan said it may have narrowed the cause to a chemical in some blood sample tubes. Winslow, who has led the company for six years, said workers are exploring possibilities.
The accuracy of Magellan’s fingerstick tests is not in question. The company said nine of 10 of its lead tests are finger sticks, also known as capillary tests.
About 2 million would have been venous tests, Winslow said, and only a fraction of those would have been wrong.
In 2006, Magellan’s LeadCare became the first device capable of providing immediate results to families and doctors. Previously, the wait for results took weeks, said Kim Dietrich, professor of environmental health and epidemiology at the University of Cincinnati College of Medicine.
That put treatment on hold and made it harder for doctors to keep track of patients and families.
“These Magellan instruments are still very important and very useful,” said Dietrich, a member of the CDC’s Board of Scientific Counselors.
Magellan started getting complaints about false test results in 2014. In 2015, the company filed a report with the FDA, acknowledging problems but saying it had mitigated them.
The FDA disagreed and issued a Class 1 recall, the most serious type, in May. In October, the FDA sent the company a warning letter, chastising it for how it handled the situation.
“We messed up, and we did not file the proper paperwork with the FDA,” Winslow said.
Doctors suspect lead poisoning stunted the growth of Shar Allen Hardy’s son Wilson, who will be 2 in February. After the family moved out of Cincinnati, they say his condition improved.
Cincinnati health inspector Marilyn Goldfeder conducts home visits for children with lead poisoning Friday.