Kids must be retested for lead

7 mil­lion poi­son-de­tect­ing pro­ce­dures may have been faulty

The Signal - - USA TODAY - Car­rie Black­more Smith and Han­nah Spar­ling

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.”

Ni­cholas New­man

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.

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