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Fatal Flaws: What’s causing a cluster of severe birth defects in Washington state?

Fatal Flaws: What’s causing a cluster of severe birth defects in Washington state?

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Efforts to fortify corn masa flour, a staple of Hispanic families, have stalled in the FDA.

In August 2012, a veteran nurse at a rural, 25-bed hospital in central Washington state noticed a disturbing trend. Twice in the past six months, she’d seen babies delivered with the fatal birth defect known as , a gruesome condition in which infants are missing part – or all – of the brain and skull.

When Sara Barron brought the problem to the attention of her colleagues in the three-county region, the news was grim: Fellow health workers had recorded cases of anencephaly and other neural tube defects, too, at a rate far higher than national estimates.

Experts with the Centers for Disease Control and Prevention stepped in; so did epidemiologists and experts with the Washington State Department of Health. But an early analysis that examined only medical records of affected women showed no clear or compelling reason behind the growing cluster of dozens of serious neural tube defects.

I first covered this story as a health reporter for NBCNews.com. When I came to The Seattle Times to take over the health beat last year, I knew the regional story was one of the top issues I wanted to continue to follow, particularly since the problem remains completely unresolved.

There have been 41 pregnancies with anencephaly in the three-county region since 2010, including five with due dates in 2015 alone. The anencephaly rate in the region last year was 9.5 cases per 10,000 births; the national rate is 2.1 per 10,000.

Despite three years of scrutiny, health officials appear no closer to understanding – or solving – the problem. They’ve only recently begun interviewing a fraction of the women in the region with pregnancies affected by anencephaly – and have yet to make the results of those surveys public.

About the only thing health experts have determined for sure is that a lack of folic acid, a B vitamin crucial to neural tube development, is at least partly to blame.

Some health experts say one part of the solution lies in a petition that has languished with the federal Food and Drug Administration since 2012. That’s when a coalition led by the March of Dimes urged the agency to fortify corn masa flour, the staple grain of Hispanic families, with folic acid – the same way rice and wheat flours were fortified in the U.S. nearly 20 years ago. That move reduced the rate of neural tube defects in the population by 40 percent, preventing 10,000 cases in a decade, experts said.

But FDA officials have declined to move forward, requiring additional safety testing and stability documentation before they’ll consider taking the corn masa petition out of abeyance. Meanwhile, critics say the agency’s 1996 decision not to bolster the grain has allowed thousands of neural tube defects to occur in Hispanic women, who are already 20 percent more likely than white women to suffer neural tube defects during pregnancy.

One former head of the CDC’s birth defects division said the FDA’s failure to fortify corn masa flour with folic acid is almost certainly a key cause of the problem in central Washington – and a similar source of concern across the nation and around the world.

My project will focus on two top issues: The first is the ongoing effort by birth defect prevention advocates to persuade the FDA to move forward with folic acid fortification of corn masa. Fortification of wheat and rice flours was considered one of the top 10 public health interventions of the 20th century, and advocates say it has the same potential now, with the rising Hispanic population in the U.S. By 2050, one third of all babies in the country will be born to Hispanic mothers, according to ChildTrends.org.

The second part of the project will focus on the details of the state and federal investigation of the cluster of birth defects and on the efforts of public health officials to prevent additional cases, even as they work to understand those that already have occurred. We’ll look at the data that back the numbers, the few similar clusters that have occurred in the U.S., and what outside experts think should be done next.

And, finally, the project will also detail the impact this cluster has had on both the Anglo and Hispanic communities in the region, and the devastating effects of these birth defects on the doctors, community health workers and, most of all, the individual families who’ve endured them.

[Photo by simenon via .]

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