Epi in Action

by Valerie Gregg


Eighteen days after conception, the neural tube closes like a zipper around the embryonic spinal cord and brain. If folic acid levels are low, the tube may not close completely. If a hole is left arou nd the spinal cord, the result is paralyzing spina bifida. If the hole is near the top of the tube, the result is fatal anencephaly. In the United States, about 4,000 pregnancies a year are affected by neural tube defects. Rates are highest in northern Ch ina and in the southeastern United States. The reason why, says Godfrey Oakley, is folic acid deficiency.

Godfrey Oakley is the folic acid ambassador 24 hours a day.

At restaurants, on airplanes, at weddings, and on the street -- wherever he meets a woman of child-bearing age, he inevitably asks: "What do you know about folic acid?"

The only way to conduct a public health campaign with limited funding is to live the message, day in and day out, says Oakley, former director of CDC's Division of Birth Defects and Developmental Disabilities. It took five years of dogged persistence f or Oakley to see the data on folic acid's preventive effects against spina bifida and anencephaly translate into good policy.

"Opportunities for primary prevention that are as simple as this are rare," says Oakley, now visiting professor of epidemiology at RSPH. "It was a no-brainer. The science was the best kind there is -- randomized, controlled trials showing hands-down th at giving women folic acid supplements before they become pregnant drastically reduces the risk of neural tube birth defects. The solution was so easy, so inexpensive, and so proven to work. Just get folic acid added to all grains labeled 'enriched' and a ll women are covered. But it took the FDA five years to do it."

In 1991, after years of smaller, observational studies, a randomized, controlled trial showed that synthetic folic acid supplements prevent one-half to three-fourths of neural tube birth defects. The federal Food Additive Law had not been changed since 1943. In 1996, the FDA gave the nod to add synthetic folic acid to all grain products.

The nutrition and medical communities spent the time in between debating whether women should receive extra folic acid from natural food sources or synthetic vitamins added to grains. Some also feared that too much folic acid would mask pernicious anem ia among the elderly.

Oakley spent much of that time speaking and writing on the benefits of folic acid supplements. He published editorials about folic acid in major medical journals like JAMA, the NEJM, and Pediatrics. He also recrui ted the March of Dimes to the cause.

"I felt like I was repeatedly ramming my head into a wall for five years," says Oakley. "Meanwhile babies were continuing to be born with preventable defects that put them in wheelchairs for life. But we kept our eyes on the prize of healthy kids, and it's finally paying off."

Although he retired from the CDC in 1998, Oakley's work is not done. With Emory colleagues at Grady Memorial Hospital, he is seeking ways to get the word out to lower-income women. A recent study showed that only 4% of pregnant patients at Grady were t aking multivitamins with folic acid before they became pregnant. He continues to write editorials in major journals calling for more public education on the benefits of folic acid. He's also carrying on an international e-mail campaign to add it to the fo od supply around the globe.

Here's his advice to public health professionals who want to see research become public health policy. "Find someone on the outside to lobby for your cause. You have to work the system. You have to be a policy entrepreneur. It can be very hard to get t he politics and the logic heading in the same direction. The greatest frustration is to see that people could be saved at the stroke of pen, and to have others drag their feet."

Although Oakley won't be content until neural tube defects are a thing of the past, he has made tremendous progress. Last fall the CDC's Morbidity and Mortality Weekly Report reported that median blood folate levels had tripled among women in the United States.

For his efforts, Oakley was named "Man of the Week" by Peter Jennings on NBC News in 1996. This year, he received the Extra Mile Award in New Zealand, and the Governor of Oklahoma named Sept 13 and 14 Godfrey Oakley Days.



Godfrey Oakley



 'The science was the best kind there is -- randomized, controlled trials showing hands-down that giving women folic acid supplements before they become pregnant drastically reduces the risk of neural tube birth defects
.' -- Godfrey Oakley



Timeline for Prevention


June 1991: A British randomized, controlled trial shows that folic acid supplements protect women with a prior pregnancy affected by spina bifida or anencephaly from recurrence. The study is halted so all subjects can receive folic acid supplements.

July 1991: Study results are published in the British journal Lancet.

August 2, 1991: The CDC recommends that women with previous pregnancies affected by neural tube defects consume 4,000 micrograms of supplemental folic acid daily.

Fall 1991: The FDA declares that folic acid does not prevent birth defects among high-risk women.

September 1991: At a meeting held at CDC, officials decide to propose 400 micrograms of supplemental folic acid for all women of child-bearing age.

November 1991: The FDA asks CDC officials to sign off on a statement in the Federal Register to read "Folic acid does not prevent spina bifida." They decline.

May 1992: A Hungarian randomized, controlled trial of folic acid supplementation for all women in a general population shows that folic acid supplements prevent neural tube defects, cutting their numbers in half. Oakley: "Any straggler s inside the CDC changed their minds."

June 1992: The head of the Public Health Service Nutrition Board receives conflicting notices from the CDC and FDA on whether folic acid supplements prevent neural tube defects.

September 1992: The Public Health Service recommends that all women of child-bearing age receive 400 micrograms of folic acid daily via food fortification, supplements, or diet. Oakley: "This action actually changed the recommended dai ly allowance six years before the FDA did it formally. It was a landmark moment."

Fall 1992: An FDA advisory committee meets to discuss adding synthetic folic acid to all grains labeled with the word "enriched." The consensus was in favor of fortification.

Summer 1993: Oakley meets with the medical director of the March of Dimes. Oakley: "I put the data in his hands -- reprints of the articles on the randomized, controlled trials -- and he was convinced."

1992-1995: Professional organizations, including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics, officially endorse the CDC recommendations on folic acid supplementation.

December 1995-January 1996: The March of Dimes urges the commissioner of the FDA to put folic acid enrichment back on its agenda before January 30, the birthday of Franklin Delano Roosevelt.

January 28, 1996: The FDA puts folic acid enrichment back on its active agenda.

March 6, 1996: The FDA publishes new fortification regulations requiring that folic acid be added to enriched grains at a concentration estimated to increase synthetic folic acid consumption by only 100 micrograms.

January 1, 1998: All enriched grains have folic acid included. It was the first time that a new vitamin had been added to enriched grains since 1943.

1998: Oakley retires from CDC, leaving the birth defects division with a $25 million budget increase. He credits March of Dimes' lobbying efforts for the budget support.


Blood folate levels among American women have tripled since synthetic folic acid was added to all grain products labeled 'enriched' in 1996, according to a CDC study published in October 2000.


Spring 2001 Issue | Dean's Message | Taming Urban Sprawl | Rites of Passage
Resistance Fighter | Epi in Action | The Big Picture
WHSC | RSPH

Copyright © Emory University, 2001. All Rights Reserved.
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Web version by Jaime Henriquez.