New York Times
POSTED: 01:30 a.m. HST, Dec 22, 2012
YPSILANTI, Mich. — Dr. David Vanderberg admitted three patients to St. Joseph Mercy Ann Arbor hospital Tuesday and called a fourth with news that left her in tears: She had a large abscess deep inside her back, near her spine, and would need surgery as soon as possible.
The patients were part of a second, growing wave of serious infections from the same tainted drug that caused a nationwide meningitis outbreak. The drug, contaminated with a fungus, was injected near the spine to treat chronic back or neck pain.
This public health disaster, in its third month, is far from over. Meningitis seems to have waned, but spinal infections near the injection site are on the rise. They can be dangerous and hard to detect. At least 200 have occurred, and more are expected because nearly 14,000 people had injections from tainted lots of the drug.
On Thursday, the Centers for Disease Control and Prevention urged doctors to look harder for these infections — to consider MRI scans even in patients who did not feel worse after the injection but whose existing back or neck pain simply did not get better. This advice was more aggressive than previous recommendations, which had called for scans only if patients had new or worsening symptoms. The new message could lead to thousands of additional scans and will almost certainly find new cases.
"We know we're not out of the woods," said Dr. Tom M. Chiller, the deputy chief of the mycotic diseases branch of the CDC. "People could still be harboring or developing infections in their spines now."
The disease outbreak, first detected in September, was caused by contaminated batches of a steroid, methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass. The company was shut down and has been under investigation by state and federal authorities, and on Friday night announced that it had filed for Chapter 11 bankruptcy protection. The filing seeks to establish a fund to compensate individuals and families affected by the outbreak.
So far, 620 people in 19 states have fallen ill, most with meningitis or spinal infections, or both; 39 have died. Infections inside joints have also occurred. Nearly all the illnesses have been caused by a black mold called Exserohilum. The treatment is a long course of antifungal drugs, which can have dangerous side effects.
Jona Angst, 45, of Brighton, Mich., did not have meningitis but learned in November from an MRI scan that she had a spinal infection, she said in an interview. She had surgery to clean out the infection and then took two antifungal medicines. The drugs caused liver and kidney problems, and because of potential heart effects she had to be on a cardiac monitor. The medicines also touched off vivid, frightening hallucinations. She saw animals and people who were not there, heard voices and came to believe that the nurses were conspiring to kill her.
She is back at home now, still taking one of the drugs, voriconazole, which she will need for months. It gives her nausea and vision problems, and saps her energy. Sometimes her husband finds her weeping, from illness, exhaustion and fear, he said. They do not know if or when the infection will go away. Her back pain seems to be returning.
"I have no clue what's going to happen," Angst said. "I'm scared to death."
Harold Rye, 73, a retired autoworker in Maybee, Mich., had meningitis and then a spinal infection. He was hospitalized twice, for a total of 43 days, and needed two operations. Before the illness he was strong and active, a gardener and deer hunter. Now, he said in an interview, "I'm so weak I can't walk through the house without stumbling."
Blurred vision, from voriconazole, keeps him from driving, and he thinks the drug is causing mental confusion, too. There seems to be no end in sight.
"They can't give me a clean bill of health," he said.
Both Angst and Rye have hired lawyers to sue New England Compounding.
"I want somebody to go to jail for this, but I don't think it's going to happen," Angst said.
In shaping its new advice on MRI scans, the CDC relied heavily on data from Michigan, which has had 223 people with meningitis or infections in their spines or joints — more than a third of the nation's cases. No state has been hit harder, and no hospital has treated more patients than St. Joseph Mercy, which has had 53 cases of meningitis and more than 100 spinal infections.
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More than 80 have had surgery for the infections. More than 30 patients are still in the hospital. Two- to three-week stays are common, and a few have been there for more than six weeks. Many will still be there next week, and the nurses have prepared Christmas cards to put on their breakfast trays. None of the patients were infected at the hospital; all were among 643 people who received the tainted injections at one nearby private clinic, Michigan Pain Specialists, in Brighton.
At the peak of the outbreak, more than 80 people with fungal infections were in the hospital. A new ward had to be opened to handle the surge. About 30 nurses were brought in from other cities, and a portable MRI scanner was parked outside the hospital in a truck. The emergency room, which usually did a few spinal taps a week, performed more than 60 in one day to test for meningitis in people who had been exposed to the drug. A special Fungal Outbreak Clinic was created to care for patients after they left the hospital and to keep track of the hundreds still at risk.
Doctors at St. Joseph Mercy were the first to recognize that spinal infections were becoming a major problem, first in patients recovering from meningitis, and then in others who had apparently never contracted meningitis. The hospital took a bolder step than the CDC has ever recommended: Its doctors decided that every patient exposed to the contaminated drug should be offered an MRI scan of the injection site to look for abscesses and other signs of infection.
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Although the infections can cause severe pain, they can also lurk in the spinal area and produce few or no symptoms, the scans revealed. They can take months to become apparent. Often an initial MRI is negative, and later ones positive. A significant number of the scans are equivocal, and the doctors generally wait and repeat them, to avoid using the toxic drugs unless they are really needed.
In many cases, patients cannot distinguish pain that might be due to an abscess from the chronic pain that drove them to seek steroid shots in the first place. But whether the infections cause pain or not, they should be treated with drugs and possibly surgery, doctors say. Untreated, the infections can damage nerves and bone, and the fungus might even eat its way through the protective membranes around the spinal column, invade the brain and cause meningitis.
"Everyone would advocate early treatment," Chiller said. "No one would want to just let it sit. It wouldn't go away on its own. You need to do something."