Devena Moore breaks out in rashes and her blood vessels sometimes swell until they’re bulging out of her skin. Dizziness, headaches, and fatigue are frequent companions, forcing her to give up competitive walking.
Moore keeps a thick, color-coded binder — yellow tab to record her medications, blue for hospitalizations, orange for medical test results — on her kitchen table. With the same precision she uses to track nutrition education for the West Virginia health department, the 39-year-old nurse charts the destruction wreaked on her body by a contaminated steroid shot she received a year ago to relieve back and hip pain.
“It gets to the point that it just wipes me out,” she said.
Across the United States, people like Moore are grappling with a cascade of baffling and often debilitating illnesses, the legacy of tainted pain injections made at a Framingham specialty pharmacy. Long after New England Compounding Center shut down last October and headlines faded, many of the patients report they are still suffering unexplained blistering and rashes, blurred vision, headaches, trouble thinking , and strokes. They wonder when — or if — they will ever feel better.
Nearly 14,000 people in 20 states received the bad shots last summer and early fall, and federal regulators say 750 came down with fungal meningitis and other infections. Sixty-four of the patients have died — 19 since January — though it’s not known how many of the deaths were directly attributable to the fungal infections.
Some physicians are treating patients who weren’t diagnosed with fungal infections until five, six — even eight — months after they received the tainted steroids. The US Centers for Disease Control and Prevention is trying to sort out whether the infections in these cases took months to incubate, or whether the patients were unable to get a proper diagnosis before then.
The lingering illnesses come against a backdrop of partisan battles in Congress that have blocked passage of legislation to tighten federal oversight of speciality pharmacies like New England Compounding, leaving patients vulnerable to more outbreaks tied to contaminated drugs from such pharmacies, which mix their own medications and are mostly regulated by states. In August, the Food and Drug Administration announced a nationwide recall of products from a Texas specialty pharmacy, similar to New England Compounding, because of bacterial bloodstream infections in 17 patients linked to one of the company’s products.
Patient advocates say they are frustrated the CDC has not taken more of a leadership role and sent out disease trackers to investigate the ongoing misery. The agency is instead relying on case reports forwarded to it from often-overwhelmed state health departments, and calls from individual physicians.
“We don’t have a coordinated response across the health system to track these folks and to collect information periodically that describes what’s happening,” said Terri Lewis, a rehabilitation specialist at Southern Illinois University Carbondale who administers a Facebook page for patients affected by the outbreak.
Much remains unknown about the fungal infections. Caused by a black mold known as Exserohilum, they are so rare that specialists do not know how long the fungus, which can evade screening tests, can lurk in patients’ bodies. They can’t say whether the continued problems patients are reporting are smoldering infections, lingering side effects from the toxic antifungal treatments many took for months, residual tissue and nerve damage from their initial infections, or not related to the infections at all.
The chief fungal disease authority at the CDC, Dr. Benjamin Park, said his agency is also frustrated with the many unknowns, but is doing its best with limited money.
Last month, the CDC said it would fund a two-year study by researchers from the University of Alabama School of Medicine to track 500 patients from the states hardest hit in the outbreak — Indiana, Michigan, Tennessee, and Virginia.
“There are all kinds of anxieties about this infection. Unfortunately, I don’t think there are a lot of answers,” Park said.
“We do hear about patients doing quite well, who are off treatment and have fully recovered, leading completely normal lives, and others who don’t do well and are needing to go back on therapy,” he said.
Devena Moore is on her third round of antifungal drugs after struggling for months to get proper treatment.
Moore received two steroid shots in her spine in July and August last year, then a third in her right hip in September — from a batch that would later be deemed contaminated. Within days, she developed flu-like symptoms. By the time she went back for a fourth shot at a Parkersburg, W.Va., pain clinic, on Oct. 2, she felt dizzy and as if “someone had poured lead into my leg.”
She was hospitalized Oct. 7 with a fever, a blinding headache, and nausea.
Moore said her primary care physician haggled with an infectious disease specialist for months after that, with one putting her on antifungal medication and the other taking her off, until both agreed in January that she had a fungal infection in her right hip.
Battling searing hip pain, tunnel vision, dizziness, and rashes, Moore said she struggled to find doctors in West Virginia who knew how to treat her escalating health problems.
“By my second hospitalization in February, the doctors decided it best to see someone who had more experience,” she said. “They didn’t know how to help me here.”
Moore, who lives across the line in Belpre, Ohio, headed to specialists at the Cleveland Clinic, where she was given a drug typically used to treat autoimmune diseases such as lupus and arthritis, in hopes it would ease inflamed lymph nodes in her neck that periodically closed off her throat.
A few states away in New Jersey, 48-year-old Dee Morell, an X-ray technician, received a contaminated shot in her left hip for arthritis the same September day Moore was injected.
What followed were months of screening tests showing fluid buildup in her hip, but tests of the fluid kept coming back negative for infection. She was put on antifungals in January, after one test showed what appeared to be damage caused by an infection in the hip area.
One hip surgery and months of tests later, Morell said her hip pain is still so acute, she needs constant pain medications to make it through the day, and has been unable to work since last November. She, too, battles rashes and fatigue.
“Financially we are not going to make it,” said Morell, who worries about losing her home as she waits for disability insurance benefits to kick in.
Dr. Thomas Walsh, an infectious disease specialist at Weill Cornell Medical College, believes many more of the people who received contaminated injections may be suffering unrecognized side effects. He said the CDC did a good job controlling the outbreak in its early days but needs to issue continuing guidance to physicians on how to diagnose patients still battling unexplained illnesses.
“When patients are complaining of pain, and we know our diagnostic [tools] are poor, we have to take a step back and say maybe there is more going on here,” he said. “We are still left with more than 13,000 people, US citizens, who need help.”
Walsh has advised both the CDC and Terri Lewis’s Facebook advocacy group.
One nagging problem for many patients is the pain that drove them to seek injections. Until doctors can say for sure the fungus has been knocked out of their bodies, patients remain vulnerable to a fungal flare-up if they receive more of this kind of pain treatment, because steroids weaken the immune system, Walsh said.
But specialists disagree over the best way to pinpoint lingering Exserohilum infections. One blood test that some are using, Fungitell, does not have FDA approval because, the agency said, the manufacturer has not demonstrated it can detect Exserohilum.
The CDC recommends MRI scans, detailed three-dimensional images of the body’s soft tissues, to spot the fungus. Yet arthritic and inflamed joints can mimic infections on the images, making it tough for specialists to distinguish fungal infection from the original joint pain. The agency has also recommended testing spinal fluid for elevated levels of white blood cells.
Walsh is among a consortium of scientists who recently developed a test to detect the DNA of Exserohilum fungus in patients’ blood, but it has also not been approved by the FDA.
Many of the insights on how to treat this fungal mystery have been gleaned from doctors in Michigan. Shortly after the outbreak last fall, doctors at St. Joseph Mercy Ann Arbor opened a clinic to screen 629 patients who received the contaminated steroids at a nearby pain clinic. They found that roughly one-third of them developed infections.
“I think that our proactive approach caused us to find patients before they developed dramatic symptoms,” said medical director Dr. David Vandenberg.
The team’s approach and findings of strange spinal abscesses in many patients helped shape the diagnostic advice CDC issued for physicians.
Most of the hospital’s patients were treated with antifungals for six months, but a third are expected to be on the drugs for at least a year because their infections have not responded, Vandenberg said.
Many who have completed treatment have done well, but a few are still reporting rashes, headaches, blurry vision, and mental slowing, which are known potential side effects from the medications, Vandenberg said, adding that it can be difficult to distinguish complications caused by the drugs from symptoms of infection.
The hospital intends to track patients it treated for fungal infections indefinitely, he said.
The road ahead for Moore is uncertain. Doctors put her back on antifungals last month because lymph nodes in her groin, near where she received her steroid shot, started swelling. The inflammation traveled up her spine to her neck, closing off her throat again.
“I am off the medicine for three or four months and my throat starts to get thick again,” she said. “It won’t go away.”Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.