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Infection adds mystery to meningitis outbreak

OCALA — Four months ago, Vilinda York's eyesight went dim, her body dripped sweat and her head throbbed so badly she couldn't hear the paramedics banging on her front door.

Thanksgiving came, then Christmas, then New Year's Day. Today, York remains in the hospital, dealing with the mysterious effects of what should have been routine pain treatments.

York, 64, is one of 678 people sickened in a rare outbreak of fungal meningitis traced to contaminated steroid shots used to treat back and joint pain. The outbreak has killed 44 people, according to the U.S. Centers for Disease Control and Prevention.

Many of those first sickened have left their hospital beds. The story has faded from headlines. But the impact of the outbreak lingers in a new wave of infections, in questions over regulatory gaps and in the lives of patients such as York, a retired clothing saleswoman who has worn nothing but hospital gowns since September.

Day after day, she lies in a bland room at Ocala's Munroe Regional Medical Center. She reads her Bible, watches home improvement shows on television and tries not to think about the mold lurking in her body — or the medications that leave her nauseated and wiped out.

This is an infection so rare, even top experts can't tell York what the future holds. She knew she was sick when she called 911 back in September, but never imagined she'd be in the hospital so long.

"I thought it'd be like the flu," she said, "and in a few weeks you just get up and go."

• • •

On Sept. 18, just days before York landed in the hospital, a Vanderbilt University infectious disease specialist named April C. Pettit notified a longtime associate at the Tennessee Department of Health she had seen something odd: a case of fungal meningitis in a patient whose immune system was normal.

Meningitis is an inflammation of the brain and spinal cord lining, which can range from mild to deadly. Usually, its source is bacterial or viral. To get it from a fungal source is extraordinarily rare, seen only occasionally in patients with immune systems severely weakened by AIDS or cancer, for instance.

At the health department, epidemiologist Marion A. Kainer was intrigued. An interesting detail stood out: The patient recently received a steroid injection at a Nashville clinic.

Kainer's detective work sparked a national investigation into the steroid's manufacturer, the New England Compounding Center.

On Oct. 4, the U.S. Food and Drug Administration verified it had found mold in a sealed vial of the steroids produced at the Massachusetts firm. The business was shuttered and supplies pulled from medical offices around the nation.

But by then, nearly 14,000 people had already received contaminated injections. Most seemed to suffer no ill effects; others were not so lucky.

Rare as fungal meningitis is, these cases were even more unusual, predominantly caused by Exserohilum rostratum, a fungus never before seen in meningitis cases, said Dr. William Schaffner, an infectious disease specialist and chairman of Vanderbilt's Department of Preventive Medicine.

That's why nobody is absolutely certain of how to treat the condition.

The CDC settled on a couple of antifungal drugs that slow the mold's growth until the immune system kicks in. But side effects — which can include hallucinations as well as serious liver and kidney damage — are alarming and unpredictable. Nor is it known when it's safe to stop these powerful drugs.

"We're still in the process of trying to determine exactly how long these patients have to be treated," said Schaffner. In some cases, patients may be on the drugs for a year, he said.

Officials say the highest risk period for developing fungal meningitis from the NECC steroids ended in November — six weeks after the drugs were recalled and injections stopped.

But then came a second wave of problems: infections, including dangerous abscesses, near patients' spines, where the steroids were injected.

More than 400 patients have developed the painful site infections, according to the CDC. Some of those also had meningitis; others thought they had escaped harm until the site infections cropped up.

Eleven new cases were reported in the week ending Jan. 7.

Dr. Tom Chiller, deputy chief of CDC's fungal diseases branch, said the second wave appears to be tapering off. But with such a novel condition, he can't be certain. Patients may dismiss the symptoms of those infections — spinal and joint pain — as recurrences of the complaints that led them to pain clinics in the first place.

"We're just aren't sure if people aren't reporting'' new symptoms, he said.

• • •

York's story begins months before the meningitis outbreak. A January 2012 car accident left her with such back pain that she couldn't make her usual neighborhood walks or water aerobics classes.

After months of misery, her doctor recommended steroid shots to ease the pain. So in August, York got two spinal injections one day at Marion Pain Management Center, then a third 10 days later. After the first round, she noticed her legs were tingling. After the third shot, her vision started blurring.

The back pain hadn't gone away. But York was facing bigger problems.

On Sept. 27, she felt herself beginning to black out and called 911.

Initially, she said, doctors diagnosed her with bacterial meningitis, which is contagious, and had her quarantined. Diagnosis is tricky, said Tennessee epidemiologist Kainer. For one, doctors rarely think to test for fungal meningitis. And when they do, the testing requires a much greater volume of fluid — obtained through a painful spinal tap — to detect the clumps of mold.

Within weeks of York's arrival at the hospital, though, word was out that patients were contracting fungal meningitis from a bad batch of steroid shots. In Florida, Marion County was the epicenter of the outbreak. Of the 25 people sickened in the state, 18 had received their contaminated shots at two Marion County clinics.

York was put on the antifungal medication but had terrible reactions, vomiting so often she couldn't eat solid food or get out of bed.

On a recent morning, York, who has not developed an additional infection near her spine, was able to shuffle slowly around her room, shadowed by the mobile drip unit she has nicknamed "Slim Jim." A petite woman with auburn hair that's grown too shaggy for her taste, she can get food down now but hasn't wanted much. Weeks after the holidays, a tin of cookies sat unopened next to a handful of greeting cards. A small artificial Christmas tree, stuffed into a cardboard box, perched on the dresser.

She was pale and seemed to have trouble understanding questions. Her lawyer, John Piccin, who is representing her in a lawsuit against New England Compounding and Marion Pain Management Center, said her condition has improved in recent weeks.

At first, he said, "I'd come in here, and she'd be sweating and lying in bed."

York's doctors did not respond to interview requests. But she said a test late last month showed the fungus remained in her body. She said doctors aren't satisfied she's healthy enough to go home. The discharge date on the dry erase board in her room remains blank.

It's unclear how many of the outbreak's victims remain in hospitals. The CDC's Chiller said he hears that most of them are at home, taking their drugs by mouth instead of intravenously. Piccin has three other clients who got sick from the steroid shots, and all are back home.

Most of the time, York is alone in her hospital room. A widow, she has two grown children who live out of state. Church friends try to visit weekly. She celebrated Christmas with a nurse who stopped by with a CD player and holiday music.

She misses simple pleasures like sunshine, hair appointments and the flowers in her garden. "They're probably dead now," she said.

Asked about home — she's a Midwestern transplant, in Ocala for the last 10 years — York began to cry.

"Some days it's real happy. Some days it's not. It was especially hard Christmas Eve. Where I come from, there were lots and lots of lights. We'd drive for 50 miles to look at them. The more lights the better."

Sitting in a dimly lit hospital room more than 1,000 miles away, she said she wants to go back.

Times researcher John Martin contributed to this report. Jodie Tillman can be reached at [email protected] or (813) 226-3374.

By the numbers

678 Total fungal infections, including meningitis, due to contaminated steroids from New England Compounding Center

414 Patients with injection site infections

Deaths in the U.S.: 44

Cases in Florida: 25

Deaths in Florida: 3

Florida patients with injection site infections: 2

The fungal meningitis outbreak revived a controversy that has cropped up several times in recent years without being resolved: Should compounding pharmacies escape the kind of regulation that governs major drug manufacturers ?

The now-bankrupt New England Compounding Center, which produced the tainted steroid medications, was shut down and is being investigated by state and federal authorities.

Traditional compounding involves reformulating a drug to meet patients' individual needs. For instance, a compounder might produce a drug without the usual dye or preservative for somebody with an allergy. But in recent years, some so-called compounding pharmacies had begun producing drugs on a mass scale.

The U.S. Food and Drug Administration regulates major drug manufacturers, but compounders fall under a mix of state regulations. The FDA has tried to expand its authority, but the industry has fought its efforts.

"The FDA had to wake up and learn about compounding pharmacies again," said William Schaffner, chairman of Vanderbilt University's Department of Preventive Medicine. "The compounding industry has had to encounter in a severe fashion how it is they comport themselves. They have resisted in the past. I think now they've rethought that."

He said he hopes Congress will pass legislation this year to prevent such a contamination from occurring again through new inspections and regulations.

Dr. John Armstrong, Florida's surgeon general, said he's waiting for the results of a Massachusetts review of New England Compounding before recommending whether Florida needs to make changes. But apparently to get ready for change, the Florida Board of Pharmacy recently collected information from the nearly 7,880 pharmacies in the state authorized to compound.

Armstrong said state officials believe the federal government should already be regulating the larger compounders, though he declined to say whether any of the 7,880 fall under that category.

NECC, meanwhile, faces lawsuits from patients hurt in the outbreak such as Vilinda York of Ocala. Her attorney, John Piccin, has also sued Marion Pain Management Center in Ocala, where York received the medications. He said the clinic should have done a better job researching the source of its medication, especially since NECC had faced state action in the past.

Jodie Tillman, Times staff writer

Infection adds mystery to meningitis outbreak 01/19/13 [Last modified: Saturday, January 19, 2013 8:07pm]
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