Lesson From US Experience: Success Requires Collaboration and Networking
02 March 2016
In 1992, Dr. Richard B. Johnston, Jr. became Medical Director for the March of Dimes Foundation, a highly respected US group focused on preventing birth defects and prematurity and reducing infant mortality. This was one year after a 1991 study provided unmistakable evidence that folic acid could prevent most neural tube defects (NTDs) such as spina bifida. Consequently increasing daily folic acid intake among women of childbearing age became one of the Foundation’s and Johnston’s priorities.
In this role, Johnston’s first visit to the U.S. Food and Drug Administration (FDA) was a polite advocacy meeting. His second appointment called for connecting with his entire professional network while his Foundation colleagues considered more drastic measures – maybe even a public protest.
The March of Dimes joined forces with the US Centers for Disease Control and Prevention (CDC) Division of Birth Defects and Developmental Disabilities. Together they urged the FDA leaders to amend the US grain fortification standard for wheat flour, some maize products, and rice. The standard had included iron and several B vitamins since the 1940s but did not include folic acid, also called vitamin B9.
When the FDA’s proposal to add folic acid became public, “the debate started, and the debate went on for a long time,” Johnston recalled. Fortification opponents argued that people should increase their vitamin B9 intake by eating more fruits and vegetables. Others argued that adding folic acid to the food supply for everyone might cause unexpected health problems.
Though no country was fortifying grains with significant amounts of folic acid at the time, Johnston and Dr. Godfrey Oakley, then the Director of the CDC birth defects program, thought the US should be the first to do so. They believed that too few women would remember to take daily supplements or change their eating habits to include more foods naturally high in folic acid. The amount of folic acid being proposed was not high enough to cause harm; in fact, they believed the folic acid level should be even higher.
By 1995 Johnston and Oakley saw that arguing for higher levels of folic acid was creating a roadblock. They decided it would be more pragmatic to settle for the FDA-proposed level of 140 micrograms of folic acid per 100 grams of enriched cereal grain product. They could try to increase the level later if needed.
Johnston and Dr. Jennifer L. Howse, March of Dimes President, scheduled another appointment with FDA leaders to support the original proposal. The Foundation had earlier discussed the possibility of a protest with people in wheelchairs if the FDA took no action. Severe cases of spina bifida lead to permanent paralysis, and people in wheelchairs would have represented the possible results of not fortifying with folic acid.
Ultimately the protest was not necessary because a collection of letters served the purpose. As a pediatrician, Johnston had been involved in medical professional organizations throughout his career. For his second meeting with FDA leaders, he used his connections to gather letters from the leaders of organizations representing practicing and academic pediatricians, obstetricians, and medical geneticists, as well as a letter from the March of Dimes. Each letter urged the FDA to act as soon as possible to amend the fortification standard to include folic acid.
After asking a few questions of his staff, the FDA commissioner promised Johnston that the change would be made. A few months later, on March 5, 1996, the US Federal Registry published the requirement that folic acid be included in all enriched grain products.
|Dr. Johnston, left, during the March of Dimes Prize in Developmental Biology Award presentation, May 2000. Photo from March of Dimes Foundation.|
“That was one of the very top events of my professional career; it’s still thrilling to me to have been part of that,” Johnston recalled. “I was just lucky to have been in the right position with the March of Dimes, and having been educated and inspired by Godfrey. Basically I represented the private community and Godfrey represented the public health services.”
CDC researchers estimate that 600 to 700 babies are born without spina bifida every year as a result of the US decision to include folic acid in enriched grains. They also estimate that between US$ 400 million and US$ 600 million is saved annually in health care costs, special education and development services for children who would have been affected by spina bifida. The figures do not include the two other NTDs – anencephaly, which is always fatal, and encephalocele, which is rare.
Currently in the US, Hispanic women are about 20% more likely than non-Hispanic women to have a pregnancy affected by an NTD. This is likely because corn masa flour, which is used to make foods commonly consumed in the Hispanic community, was not included in the 1996 fortification regulation. The March of Dimes and five other organizations filed a Citizens Petition with the FDA in 2012 for corn masa flour to be fortified with folic acid, but a final decision has been postponed until April 2016. This is “unfathomable,” Johnston said. “We’re talking about saving money and lives and preventing tragic birth defects and devastating birth outcomes.” (In April 2016, the FDA did allow corn masa flour to be voluntarily fortified with folic acid).
Johnston understands the concerns raised 20 years ago because adding folic acid to grains was new then. No other country example was available, and World Health Organization (WHO) recommendations did not exist. In contrast, now 79 countries fortify wheat flour, maize flour, and/or rice with folic acid, and WHO recommendations guide countries on appropriate levels for fortification.
“We have no evidence to date that folic acid has ever caused harm. Some possibilities have been raised, but no evidence has ever been close to convincing,” Johnston said. “We have solid data, good scientific data, which show it prevents NTDs and folate deficiency anemia and possibly that it reduces cardiovascular disease and stroke. Look at the balance. The risk to benefit ratio is very low.”
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