Patsy Bivins can't stop worrying about the warning letter she got from the hospital.
It came seven weeks after she received two steroid injections in her back to treat chronic pain. The steroid had been made at the New England Compounding Center and was from one of the three lots later discovered to be contaminated with a fungus. The notice informed Bivins, 68, that although she had tested negative for fungal meningitis, she was still at risk of developing the disease, which has so far sickened more than 300 people and killed 24 across the nation.
"It said, 'Go to the doctor if you have headaches,'" said Bivins, a retired waitress in Sturgis, Ky. "Well, I've had headaches for a few days now and I don't know if it's because of the shot or all the stress I'm feeling."
As state and federal health officials struggle to treat an extremely rare and little-understood form of meningitis, about 14,000 patients who were injected with the tainted painkiller face an uncertain — and often angst-filled — future.
Though medical authorities say patients are most vulnerable to stroke and death within the first 42 days of injection, it can still take up to three months for symptoms to become apparent.
Patients like Bivins say the wait has been excruciating.
"I don't really eat a whole lot and I don't sleep now because I'm worried sick," she said. "They say three months, but what if it's not? What if it goes on and on? I don't think they honestly know."
In the hardest-hit states east of the Mississippi River, officials acknowledge that the stress felt by patients and their families has been intense. Just this week, the Tennessee health commissioner started a mental health hotline to help patients cope with the anxiety and uncertainty.
"We're in this in-between state," said Carol Scott, a Los Angeles lawyer whose 89-year-old mother, Ruth, received a tainted shot in August. "I don't want to upset her, but I'm freaked out about this."
Reports of patients who received clean bills of health only to be diagnosed with meningitis weeks later have deepened anxieties.
On Wednesday, a Michigan man whose wife died from the disease last month announced that he too had been diagnosed with fungal meningitis after getting a shot to alleviate neck and back pain. Just a week earlier, George Cary told reporters that a spinal tap showed no indications of meningitis. Now the 65-year-old engineer is receiving powerful intravenous antifungal medicines in a hospital, more than five weeks after his injection.
"I was truly shocked," Cary's daughter, Jill Bloser, told the Detroit Free Press. "I really didn't think he was going to have it because of how much time has passed. ... I really thought he was in the clear."
Investigators from the Food and Drug Administration have traced the outbreak to three lots of methylprednisolone acetate packaged by the now-shuttered New England Compounding Center of Framingham, Mass. The company distributed the tainted drugs to medical facilities in 23 states, including California. All of the center's products have been recalled and are being examined by investigators.
A report this week by Massachusetts health authorities said investigators discovered numerous violations and unsanitary conditions at the compounding center. Black particles could be seen floating in some vials of recalled methylprednisolone, and autoclaves had not been properly tested. Mats designed to trap dirt, dust and other contaminants were visibly soiled, and a pool of water was observed near a leaking boiler.
The steroid medication is often used to ease back pain in older patients and is injected directly into a patient's spinal canal or in tissue alongside the spine. The doses from the compounding center somehow became contaminated with the fungus Exserohilum, a black mold that usually infects grass, and not people. A second type of fungus, Aspergillus, has been detected in one fatal case so far.
"This is a very unusual fungus, so unusual that its name doesn't even appear in any medical school texts," said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine in Nashville.
Unlike bacteria, which can reproduce every 20 minutes, the fungus involved in the outbreak takes days to reproduce. That slow reproduction is partly why the interval between exposure and the onset of symptoms can be so long.
In all but a few cases, the medication containing the fungus was injected in the back. While the steroid was intended to soothe inflammation of a pinched nerve, it also suppressed the body's immune response. As a result, instead of being destroyed by the body, the fungus began to multiply.
Schaffner said the growing fungus uses surrounding tissue as nourishment, destroying it in the process. Eventually, the fungus makes contact with the dura — the tough, protective sheath that surrounds the spinal cord — and "eats" through it. If the injection isn't done properly, the needle can pierce the dura and deposit the fungus directly.
Once the fungus breaches the dura, it invades the spinal fluid and causes inflammation in the thin membranes surrounding the spine and brain.
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