As she desperately worked to follow the trail of what would turn into a nationwide fungal meningitis outbreak, Dr. Marion Kainer, an epidemiologist at the Tennessee Department of Health, found there was simply no time to sleep. So she camped out at her Nashville office, grabbing a few hours' rest whenever she could.
"I brought in an exercise mat, with a pillow and a blanket and a change of clothes," Kainer told ABC News.
Her efforts and those of Dr. April Pettit at Vanderbilt University were central to uncovering the cause behind the meningitis outbreak, which has been linked to tainted steroids from a compounding pharmacy in Framingham, Mass. The outbreak has killed 32 people and sickened 438 others in 19 states, according to the Centers for Disease Control and Prevention.
Today on Capitol Hill, Congress holds its first hearing into the deadly outbreak. A host of witnesses are expected to testify, including Food and Drug Administration Commissioner Dr. Margaret Hamburg, and Joyce Lovelace, whose 78-year-old husband, Eddie, died in September after he received one of the tainted steroid injections.
The first hint that something was wrong came in mid-September. Pettit, an infectious disease specialist, was puzzled when a patient she had treated for what doctors believed was bacterial meningitis was readmitted to Vanderbilt University Hospital. The patient was agitated, could barely speak, and complained of a headache and low back pain.
As the patient's condition worsened, Pettit went "the extra mile," according to Dr. William Schaffner, head of preventive medicine at Vanderbilt, and ordered another test of the patient's spinal fluid. But this time "she says to the lab, don't just do your routine, also culture for tuberculosis and fungi," Schaffner said.
Those instructions proved critical. The next day, the lab reported an astonishing result: It had found aspergillus, a type of fungus, in the man's spinal fluid.
Aspergillus meningitis is extremely rare, so Pettit sat down with the patient's family to try to figure out how he might have contracted it. She learned that four weeks before he first became sick, he had received an epidural steroid injection to relieve back pain. Worried about a possible connection, Pettit alerted the state health department. It was Tuesday, Sept. 18.
The email from Pettit ultimately ended up in Kainer's inbox. Kainer, who is in charge of health-care related infections for the state of Tennessee, said she became "quite concerned."
Kainer had two years as a CDC epidemic intelligence officer, a so-called disease detective, under her belt before she joined the Tennessee Department of Health. So she wasted no time in launching an investigation.
By Thursday morning, Sept. 20, Kainer confirmed that Pettit's patient had received a steroid epidural at the Saint Thomas Outpatient Clinic in Nashville. She contacted the CDC to see if it knew of other cases. It did not. But they began to turn up. That afternoon, Kainer learned of two more Nashville patients with suspected meningitis who had also had epidural injections.
"So now my interest really peaked up," Krainer told ABC News.
Still, the cause of the meningitis was not known. Was there mold at the clinic where the injections had been given? Were the drugs or the anesthetic tainted? What about the needles? Kainer was like a detective with a host of suspects but no clear guilty party.
Meningitis Outbreak: Unraveling a Medical Mystery
That same afternoon, Kainer received a tantalizing clue. She found out that one of the epidural steroids had come from a compounding pharmacy in Massachusetts.
"We have concerns about compounding pharmacies," said Kainer. "There have been several outbreaks involving [products] from compounding pharmacies."
It was just two days since the first email alert. The New England Compounding Center, which made the steroid, assured the Saint Thomas clinic it knew of no safety problems with the drug. With the cause of the meningitis still a mystery, the clinic voluntarily shut its doors as a precaution. It has still not reopened.
By Friday, Sept. 21, Kainer had heard of two additional possible cases of meningitis. She and the Tennessee Department of Health sent out an urgent alert asking public health officials and hospitals in the state to report any similar cases of possible meningitis that might be associated with an epidural injection. She suspected the steroid was at the root of the outbreak, but had no proof. Still, she told her boss, "I have a really uneasy feeling about this."
By Monday, there was another suspect case, and Tennessee health officials held a conference call with the CDC to brainstorm. They then called heath officials in Massachusetts to find out more about the New England Compounding Center.
The next day, Tuesday Sept. 25, marked one week since Pettit's email, and that's when the FDA got involved. In the meantime, Tennessee health officials were still trying to narrow down the suspects, working until midnight to create a data base of more than 150 patients who had been treated at the Saint Thomas clinic, looking for any threads of proof. For Kainer and her team, "this is still a diagnostic mystery."
It was still just a hunch that the steroid was at the center of this growing meningitis outbreak, but on Wednesday, Sept. 26, the New England Compounding Center recalled three lots of the drug, some 17,000 vials. The steroid had already been injected into some 1,400 patients.
The CDC put out an emergency health alert to public health departments nationwide, looking for any cases outside Tennessee. The next evening, Sept. 27, a breakthrough came: North Carolina reported a probable case, a patient who had also received a steroid injection from one of the recalled lots.
At the same time, Tennessee's data crunching revealed that patients who'd received more of the steroid were more likely to have gotten sick. For Kainer, it was the first solid evidence that a tainted drug was likely the cause of the meningitis outbreak.
Tennessee's health commissioner wanted every single patient in the state who may have been exposed to the contaminated steroid tracked down, all 1,009 of them. Kainer called the outreach "unprecedented."
Public health nurses knocked on doors around the country, contacted neighbors, tracked down patients in Yellowstone National Park and used Facebook as well as law enforcement to find people. They knew it was critical to locate anyone who may have symptoms and immediately begin anti-fungal medication.
On Oct. 4, the FDA reported it had found what appeared to be fungus in an unopened vial of the steroid. Two weeks later, the agency matched the fungus to the one believed to have triggered the outbreak. Kainer's hunch had been right.
It turned out there had been other cases and at least one death in another state before Dr. April Pettit's patient had became sick. But Vanderbilt's Schaffner said "public health was not notified. It was April who put that all together."
And then, said Schaffner, Dr. Marion Kainer jumped in.
"In a shift car with four gears, Marion is always in fifth," he said.
Kainer said it took a herculean effort not only by her but by nearly 200 staff members at the Tennessee Department of Health. They're not done yet, and are still tracking and monitoring those who received the steroid injections.
As for the floor mat, "it is still in my office," Kainer said. But, she added, with hope, "I have not slept on it for a few days now."
- Public Health