It took only two days for the institutional review board at Hurley Medical Center, a city-owned hospital in Flint, Mich., to approve the research plan presented by Dr. Mona Hanna-Attisha, a Hurley pediatrician, to test children she thought might be exposed to lead poisoning through Flint's water supply.
"What we did in that short period of time could only have happened at an institution like Hurley," said Hanna-Attisha, who is also an associate professor at College of Human Medicine at Michigan State University. "We are very lean."
An IRB is a committee established by a healthcare institution to review and approve research involving human subjects. The IRB ensures research complies with all federal, institutional and ethical guidelines.
While Hanna-Attisha already was thinking about whether children in Flint were exposed to lead in their public drinking water supply, she decided to analyze children's blood-lead levels after she read an explosive study in early September conducted by Virginia Tech University's Marc Edwards, the nation's leading lead exposure expert, that refuted state tests and pronouncements.
Edwards' Flint Water Study showed that 90% of the 277 collected samples from Flint homes showed lead levels that were above 25 parts per billion, far above the 15 ppb danger level.
In his report, Edwards said Flint has “a very serious lead in water problem.” Data from his testing show Flint water was 19 times more corrosive than Detroit water. He warned residents not to trust state officials that the water going into their homes was fine.
“Everybody in Flint who drank the water was exposed to lead,” Hanna-Attisha said. “There are 8,000 to 9,000 children in Flint of a population of 100,000. I wanted to know if kids were getting lead and how much."
Lead mostly affects unborn children and those ages 6 or younger whose brains are still being formed. Research shows lead causes irreversible brain damage, developmental delays, speech problems, rashes, a boosted risk for behavioral issues and other serious chronic conditions.
“Within two hours after contacting (Hurley's) chief medical officer, we got the data we needed,” she said.
Crucial to the data collection, Hanna-Attisha said, was Hurley's electronic medical record system. The EMR had data on blood samples of dozens of children in Flint.
“IRB approval normally takes a month. But our institution is a public hospital with a mission to serve people. Everybody acted quickly. The whole research project was completed in two weeks. At other institutions, nobody would have funded it. This was pure altruism out of our duty to protect the community,” she said.
At a Sept. 24 news conference, Hanna-Attisha and other doctors presented the findings.
Her study showed the percentage of children 6 years old and younger with more than 5 micrograms per deciliter of lead in their blood increased from 2.1% when Flint purchased Lake Huron water from the Detroit water system to 4% after the switch to Flint River water.
Some children in certain ZIP codes were being exposed to triple the average lead levels from the water, jumping from 2.5% of the children tested to 6.3%.
Hanna-Attisha, who is also lead with the MSU/Hurley Pediatric Public Health Initiative, said her study was immediately criticized by state officials, with references that it was creating hysteria and that it was part of a political witch hunt to blame the Snyder administration. But Hanna-Attisha got key backing from key supporters including Melany Gavulic, Hurley's CEO; Dr. Lawrence Reynolds, CEO of Mott Children's Health Center in Flint; the Genesee County Medical Society, and state Sen. Jim Ananich of Flint.
Within a week, however, several state employees, led by Dr. Eden Wells, the chief medical executive with the Michigan Department of Health and Human Services, and several state epidemiologists were agreeing with Hanna-Attisha.
“We were able to show our data was consistent with hers,” said Wells, who is also a clinical associate professor of epidemiology at the University of Michigan School of Public Health.
Wells said Hanna-Attisha and the Flint physician network helped galvanize support within the medical community to get the message out about how lead in Flint's water supply was affecting children.
“I am proud of what Mona and our organization did,” said Kirk Smith, CEO of the Flint Area Health Coalition, who also supported the study from day one. Hurley, the health coalition and the medical society "demanded action from the city and the county. It was a public health threat.”