The pounding headaches started a few days before Mark Klaserner boarded a plane for Colorado last fall and got worse after he landed.
“They got so strong, I decided my glasses needed to be replaced. I told my ex-wife I needed new glasses,” the 57-year-old Milford man recalled.
It was late September.
Back home in Michigan, 87-year-old Milda Mattila of South Lyon was among those starting to show up at area hospitals with headaches, fevers and other symptoms of bacterial meningitis. But tests showed no bacteria in their spinal fluid. Doctors were baffled.
Klaserner, the hospital patients and hundreds of other people across the country didn’t know it yet, but they were unwitting victims in an unfolding, unprecedented public health crisis. Their mysterious illnesses eventually would be linked to tainted steroid injections produced by a compounding pharmacy in Massachusetts.
The shots — meant to relieve pain — instead had injected a fungus that was attacking the patients’ bodies.
Michigan has been the hardest-hit state in the fungal meningitis outbreak. Meningitis is an inflammation of the membrane that surrounds the brain and spinal cord.
The shots have sickened at least 259 Michiganders and killed 14, not including three Michigan residents whose deaths are included in Indiana’s case count because they received their shots there. Nationwide, 730 people have fallen ill. Fifty-one have died.
“We’ve never had anything like this,” said Dr. David Vandenberg, medical director of clinical outcomes management at St. Joseph Mercy Ann Arbor, the hospital that became the epicenter for treating outbreak victims in Michigan. “The thing it’s most comparable to would be a slow train wreck, where there’s 200 victims, but they come in over a period of a few months rather than on the same day.”
Weeks-long hospital stays are not uncommon. Mattila has been hospitalized since early October.
Health officials have traced the contamination to the Framingham, Mass.-based New England Compounding Center (NECC), where inspectors found dirty equipment, a leaky boiler and microbial growth in vials of the steroids. Investigations related to the outbreak are ongoing.
“What makes this tragedy worse is the fact that it seems that these deaths and illnesses could have been prevented,” U.S. Rep. Fred Upton, R-Mich., said at a Capitol Hill hearing last fall.
The rate of illness has slowed considerably. But people are still getting sick, developing potentially life-threatening fungal infections. People are still dying.
Continuing fear and anger among patients is magnified by uncertainty. Many patients don’t know how long they’ll need to take powerful anti-fungal drugs — or whether they’ll ever fully recover.
Investigation grows from Tennessee case
Plagued by back pain for most of his adult life, Klaserner chose epidural steroid injections for relief as he waited for his insurance company to approve back surgery. He got a shot before taking an important trip.
“I wasn’t going to miss my first grandson’s birth in Denver,” he said.
Epidural steroid injections are a common procedure. Every year in the U.S., more than 500,000 epidural steroid shots are administered just among people who are on Medicare.
But in Tennessee, one man in his 50s who had gotten an injection was very, very sick. Weeks after receiving an epidural steroid injection, he visited Vanderbilt University Medical Center with a headache, neck pain and chills. He was admitted to the hospital, but his condition improved with antibiotics, so he was sent home.
A week later, he was back. His back pain had gotten worse. A scan showed he had an epidural abscess, a pocket of infection near his spine.
Dr. April Pettit ordered additional tests of fluid drawn during a spinal tap and made a shocking discovery: the fungus Aspergillus fumigatus. She also learned from the man’s family that he had received epidural steroid injections prior to falling ill. On Sept. 18, she sent an email about the case to officials at the Tennessee Department of Health.
“This is something that’s really unusual. Alarm bells were ringing,” said Dr. Marion Kainer, an infectious diseases physician at the Tennessee Department of Health, recalling her reaction to the email.
Kainer launched what would eventually become a nationwide investigation.
Within a few days, she learned that two other people in Tennessee had developed meningitis after receiving steroid injections at the same clinic as the first man, the St. Thomas Hospital Outpatient Neurosurgical Center in Nashville. The injections had all come from the New England Compounding Center. Another patient had an unusual posterior circulation stroke.
Kainer contacted the federal Centers for Disease Control and Prevention. No other cases of fungal meningitis had been reported.
A health department official visited the clinic Sept. 21 and found no water leaks or other possible explanation for the fungal contamination.
After suffering seizures, strokes and bleeding on his brain, the man who sparked the investigation was taken off life support and died. He would become the first documented case of illness stemming from contaminated lots of preservative-free methylprednisolone acetate linked to the NECC.
By Sept. 25, Kainer had identified seven other people in Tennessee who got sick after receiving injections. In a conference call that day with health officials from Tennessee, Massachusetts and the CDC, the compounding pharmacy said no adverse events had been reported with the steroid.
Then, the NECC issued a voluntary recall of three lots of the steroid. A national alert was issued, asking health officials to report meningitis cases in patients who had received steroid injections. North Carolina reported a case the next day, Sept. 27, confirming for the first time that the problem was bigger than Tennessee.
On Sept. 28, the Michigan Department of Community Health was notified by the CDC about a potential multi-state outbreak of meningitis linked to epidural steroid injections, said Jay Fiedler, the section manager of Surveillance and Infectious Disease Epidemiology for the MDCH. He said the alert asked the state to report any such cases back to the CDC, but didn’t provide specific information about how or where patients were exposed.
Fiedler said state health officials learned Oct. 2 the names of the four clinics in Michigan that received the tainted steroids. Staff at the clinics and state officials spent the next few days frantically trying to reach patients who had received injections.
For many, it was too late.
Still believing his headaches were caused by outdated prescription eyeglasses, Klaserner was watching TV in Colorado a few days after his grandson was born. He saw a news program about the fungal meningitis outbreak. Almost simultaneously, his doctor called.
Klaserner cut his trip short and flew home to Michigan on Oct. 10. He went to St. Joseph Mercy Ann Arbor, where a spinal tap confirmed he had fungal meningitis.
“They admitted me right then,” he said.
The first local cases linked to the outbreak had begun trickling into St. Joseph Mercy in September, according to doctors there. A handful of people who had headaches, fevers and other symptoms of meningitis underwent spinal taps. The tests showed an elevated number of white blood cells in the spinal fluid but no sign of the bacteria that would indicate the more common bacterial meningitis.
Some patients were treated with antibiotics and sent home. More people were getting sick.
“We knew that something unusual was happening,” said Varsha Moudgal, an infectious-diseases physician at the hospital.
In early October, around the same time the CDC issued its first public nationwide alert about the outbreak, doctors at St. Joseph Mercy connected their cases to the tainted steroids that NECC had shipped to 23 states.
The tainted injections have led to not only meningitis and spinal and paraspinal infections, but also joint infections and strokes.
St. Joseph Mercy became a sort of ground zero, treating more people connected to the outbreak than any other facility in the country. At one point in November, so many people were hospitalized at one time with confirmed cases of fungal illnesses — about 80 — that the hospital had to send some patients elsewhere.
St. Joseph’s parent company, Trinity Health, brought in 28 nurses from other facilities. The hospital opened beds that had been offline. Doctors created a database containing names of more than 600 people who received bad shots at one nearby facility, Michigan Pain Specialists in Brighton. They also established a fungal outbreak clinic to monitor people after they were discharged from the hospital.
Chaplains organized a support group for anxiety-ridden patients and their families. It was the hospital’s only support group to meet six days a week.
A few weeks into the outbreak, doctors noticed an alarming number of epidural abscesses. They decided to suggest that every patient exposed to the bad steroids have an MRI to screen for the infections. State health officials expedited approvals to expand operating room capacity and bring in a mobile MRI machine.
One reason St. Joseph treated so many cases was its proximity to Michigan Pain Specialists. There was an effort to centralize treatment in one place. Hospital officials say 643 people were injected with the fungus at the clinic — which is not affiliated with the hospital — between Aug. 9 and Oct. 2.
Patients also were exposed at Southeast Michigan Surgical Hospital in Warren, the Michigan Neurosurgical Institute in Grand Blanc and the Neuromuscular and Rehabilitation Associates of Northern Michigan in Traverse City. In all, at least 1,791 people in the state received the toxic shots.
Fungal meningitis is rare and difficult to treat. Because the fungus grows slowly, some people didn’t develop meningitis or other infections for weeks. Spinal taps didn’t always show disease in people later found to be sick.
That was the case for George Cary of Howell. His wife, Lilian Cary, 67, suffered a stroke and died Sept. 30 after receiving a tainted injection, although her death wouldn’t be linked to the outbreak until a few days later.
Cary had also gotten a shot from the same clinic, Michigan Pain Specialists. In October, about two weeks after being told that a spinal tap showed he did not have meningitis, he developed severe headaches, neck pain and light sensitivity. A new test showed he had the disease.
The last case of meningitis in Michigan linked to the outbreak was reported Nov. 17. The last new case nationally was March 22, according to the CDC. Epidural abscesses and other infections in and around the spine continue to pop up.
“You’re always wondering. It’s always uncertainty — is something going to surface?” said Lydia Doyon, a 45-year-old mother of four from Oxford who received a tainted steroid injection.
The fungus most often found in patients, Exserohilum rostratum, is a common environmental mold. Before the outbreak, it was rarely known to cause illness in humans.
“Because this disease never existed before eight weeks ago, we really are using our best judgment and guess, but it is not certain,” Vandenberg said in early December at St. Joseph Mercy. “We’re adjusting our approach to patients as we learn more and more.”
It took a while for doctors to figure out what was wrong with Milda Mattila, the 87-year-old South Lyon woman who has been hospitalized since October.
A relative called 911 on Sept. 18 when Mattila had cognitive problems that suggested a possible stroke. Her daughter, Carol McKee, said she was admitted to St. Joseph for observation. Without a definitive diagnosis needed to admit her under Medicare and because she had lost the ability to walk, the hospital sent her to a rehabilitation facility. McKee said Mattila developed a low-grade fever and went back to the hospital, then back to rehab, then to the hospital again and back to the rehab a third time.
“I’m telling the doctors something is wrong. This is not right, her diminished level of activity. She’s just not the same,” said McKee, a registered nurse.
After Mattila’s son called from out of state on Oct. 4 upon hearing news about the fungal meningitis outbreak, Mattila went back to the hospital and had a spinal tap that confirmed fungal meningitis.
The antifungal drugs used to treat patients are powerful and can have brutal side effects, including mental fogginess, visual problems and hallucinations. Patients on the medicines are monitored for signs of liver or kidney damage.
Laura Blodgett, a spokeswoman for St. Joseph Mercy Ann Arbor, said a rare side effect of prolonged use of voriconazole, one of the two main antifungal drugs used to treat patients, is a temporary, painful inflammation of the lining of the bone.
“My husband put on my socks, and he touched my skin, and I yelled out in pain,” Pam Jusufi, 46, of Brighton said recently.
Many patients don’t know how long they’ll have to keep taking the antifungal medicine.
“It’s not your typical infectious disease with a well-known incubation period,” said JoLynn Montgomery, an assistant research scientist in the department of epidemiology at the University of Michigan Department of Public Health. “At this point, we don’t have an end point.”
Dr. Thomas Chiller, deputy chief of the mycotic diseases branch of the CDC, said he wouldn’t be surprised to see new fungal illnesses develop up to a year from the last tainted shot.
“I think that will be the exception, not the rule. I think, thankfully, most of the cases have already occurred,” he said.
On high doses of antifungal medicine, Klaserner had double vision and hallucinations, seeing his brother or a nurse in his hospital room when he was alone. Sometimes, silver, red, green and blue sparkles danced around people’s faces.
Klaserner said he was on a constant stream of IV fluids and gained 60 pounds of water weight. His swollen legs and abdomen ballooned to twice their normal size, making it impossible for him to tie his shoes.
“I feel like my skin is about to explode,” he said last fall from his hospital room.
Klaserner was hospitalized for fungal meningitis for seven days in October. He was readmitted two weeks later after doctors discovered through an MRI that he had an epidural abscess. They cut a wedge out of one of his vertebrae to clean out the infection.
Klaserner’s second hospital stint lasted 38 days.
“The longer it goes, the madder I get,” he said at the time. “I could die. I could die tomorrow.”
More than three months after leaving the hospital, Klaserner still takes antifungal medicine every day. His back still aches.
The former tool-and-die maker tries to stay positive but worries about finances and finding a job. Feelings of anger bubble up.
“The one thing I do know for a fact that I am most resentful for is that I have aged at least close to 10 years,” he said. “At least 10 years of my life came off like that. I feel older. I’m slower. My reflexes are not as good as they were.”
Klaserner recently got good news: After another MRI and spinal tap, doctors told him he may be able to get off the antifungal medicine in six months.
But a terrifying, nagging uncertainty hangs over his future.
“One or two times, I asked different doctors — I said if I’m 67 years old and I’m on the golf course and start getting symptoms of headaches and nausea, I said what do I do? They said I need to go to the ER and tell them I had fungal meningitis.
“This will continue to impact me the rest of my life,” he said. “I have no doubt.”
By Ann Zaniewski - Detroit Free Press (MCT)
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