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Entries in Aspergillus Meningitis (4)

Wednesday
Nov142012

Meningitis Outbreak: How Two Docs Helped Unravel a Medical Mystery

Jared Wickerham/Getty Images(NEW YORK) -- As she desperately worked to follow the trail of what would turn into a nationwide fungal meningitis outbreak, Dr. Marion Kainer, an epidemiologist at the Tennessee Department of Health, found there was simply no time to sleep. So she camped out at her Nashville office, grabbing a few hours' rest whenever she could.

"I brought in an exercise mat, with a pillow and a blanket and a change of clothes," Kainer told ABC News.

Her efforts and those of Dr. April Pettit at Vanderbilt University were central to uncovering the cause behind the meningitis outbreak, which has been linked to tainted steroids from a compounding pharmacy in Framingham, Mass. The outbreak has killed 32 people and sickened 438 others in 19 states, according to the Centers for Disease Control and Prevention.

The first hint that something was wrong came in mid-September. Pettit, an infectious disease specialist, was puzzled when a patient she had treated for what doctors believed was bacterial meningitis was readmitted to Vanderbilt University Hospital. The patient was agitated, could barely speak, and complained of a headache and low back pain.

As the patient's condition worsened, Pettit went "the extra mile," according to Dr. William Schaffner, head of preventive medicine at Vanderbilt, and ordered another test of the patient's spinal fluid. But this time "she says to the lab, don't just do your routine, also culture for tuberculosis and fungi," Schaffner said.

Those instructions proved critical. The next day, the lab reported an astonishing result: It had found aspergillus, a type of fungus, in the man's spinal fluid.

Aspergillus meningitis is extremely rare, so Pettit sat down with the patient's family to try to figure out how he might have contracted it. She learned that four weeks before he first became sick, he had received an epidural steroid injection to relieve back pain. Worried about a possible connection, Pettit alerted the state health department. It was Tuesday, Sept. 18.

The email from Pettit ultimately ended up in Kainer's inbox. Kainer, who is in charge of health-care related infections for the state of Tennessee, said she became "quite concerned."

Kainer had two years as a CDC epidemic intelligence officer, a so-called disease detective, under her belt before she joined the Tennessee Department of Health. So she wasted no time in launching an investigation.

By Thursday morning, Sept. 20, Kainer confirmed that Pettit's patient had received a steroid epidural at the Saint Thomas Outpatient Clinic in Nashville. She contacted the CDC to see if it knew of other cases. It did not. But they began to turn up. That afternoon, Kainer learned of two more Nashville patients with suspected meningitis who had also had epidural injections.

"So now my interest really peaked up," Krainer told ABC News.

Still, the cause of the meningitis was not known. Was there mold at the clinic where the injections had been given? Were the drugs or the anesthetic tainted? What about the needles? Kainer was like a detective with a host of suspects but no clear guilty party.

 That same afternoon, Kainer received a tantalizing clue. She found out that one of the epidural steroids had come from a compounding pharmacy in Massachusetts.

"We have concerns about compounding pharmacies," said Kainer. "There have been several outbreaks involving [products] from compounding pharmacies."

It was just two days since the first email alert. The New England Compounding Center, which made the steroid, assured the Saint Thomas clinic it knew of no safety problems with the drug. With the cause of the meningitis still a mystery, the clinic voluntarily shut its doors as a precaution. It has still not reopened.

By Friday, Sept. 21, Kainer had heard of two additional possible cases of meningitis. She and the Tennessee Department of Health sent out an urgent alert asking public health officials and hospitals in the state to report any similar cases of possible meningitis that might be associated with an epidural injection. She suspected the steroid was at the root of the outbreak, but had no proof. Still, she told her boss, "I have a really uneasy feeling about this."

By Monday, there was another suspect case, and Tennessee health officials held a conference call with the CDC to brainstorm. They then called heath officials in Massachusetts to find out more about the New England Compounding Center.

The next day, Tuesday Sept. 25, marked one week since Pettit's email, and that's when the FDA got involved. In the meantime, Tennessee health officials were still trying to narrow down the suspects, working until midnight to create a data base of more than 150 patients who had been treated at the Saint Thomas clinic, looking for any threads of proof. For Kainer and her team, "this is still a diagnostic mystery."

 It was still just a hunch that the steroid was at the center of this growing meningitis outbreak, but on Wednesday, Sept. 26, the New England Compounding Center recalled three lots of the drug, some 17,000 vials. The steroid had already been injected into some 1,400 patients.

The CDC put out an emergency health alert to public health departments nationwide, looking for any cases outside Tennessee. The next evening, Sept. 27, a breakthrough came: North Carolina reported a probable case, a patient who had also received a steroid injection from one of the recalled lots.

At the same time, Tennessee's data crunching revealed that patients who'd received more of the steroid were more likely to have gotten sick. For Kainer, it was the first solid evidence that a tainted drug was likely the cause of the meningitis outbreak.

Tennessee's health commissioner wanted every single patient in the state who may have been exposed to the contaminated steroid tracked down, all 1,009 of them. Kainer called the outreach "unprecedented."

Public health nurses knocked on doors around the country, contacted neighbors, tracked down patients in Yellowstone National Park and used Facebook as well as law enforcement to find people. They knew it was critical to locate anyone who may have symptoms and immediately begin anti-fungal medication.

On Oct. 4, the FDA reported it had found what appeared to be fungus in an unopened vial of the steroid. Two weeks later, the agency matched the fungus to the one believed to have triggered the outbreak. Kainer's hunch had been right.

It turned out there had been other cases and at least one death in another state before Dr. April Pettit's patient had became sick. But Vanderbilt's Schaffner said "public health was not notified. It was April who put that all together."And then, said Schaffner, Dr. Marion Kainer jumped in.

"In a shift car with four gears, Marion is always in fifth," he said.

Kainer said it took a herculean effort not only by her but by nearly 200 staff members at the Tennessee Department of Health. They're not done yet, and are still tracking and monitoring those who received the steroid injections.

As for the floor mat, "it is still in my office," Kainer said. But, she added, with hope, "I have not slept on it for a few days now."

Copyright 2012 ABC News Radio

Thursday
Oct112012

Fungal Meningitis Outbreak: 170 Cases, 14 Deaths

Hemera/Thinkstock(ATLANTA) -- The U.S. Centers for Disease Control and Prevention reported two more deaths linked to the outbreak of fungal meningitis from steroid shots for back pain, bringing the total number of people who have died to 14.

The CDC also reported that 170 cases of the rare form of fungal meningitis have now been reported in 11 states.

The outbreak of aspergillus meningitis has been linked to an injectable steroid, called methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass. A sealed vial of the drug, obtained by the U.S. Food and Drug Administration, contained levels of fungus that were visible to the naked eye.

The New England Compounding Center has recalled all of its products and shut down operations, but health officials estimate that 13,000 people may have been exposed to the suspect steroid since May.

Forty-nine of the fungal meningitis cases -- six of them lethal -- have been reported in Tennessee. Cases have also been reported in Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Virginia and, most recently, Idaho.

[For a map of cases by state, click here.]

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the U.S. Centers for Disease Control and Prevention.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said CDC's Dr. Benjamin Park, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville. "There's no such thing as mild aspergillus meningitis."

Fungal meningitis is diagnosed through a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Tuesday
Oct092012

Fungal Meningitis Death Toll Continues to Rise

iiStockphoto/Thinkstock(NEW YORK) -- An eleventh person has died and 108 more have been sickened by a rare form of fungal meningitis, health officials said Tuesday.

The outbreak of aspergillus meningitis has been linked to an injectable steroid, called methylprednisolone acetate, made by a Massachusetts pharmaceutical company. A sealed vial of the drug, obtained by the U.S. Food and Drug Administration contained levels of fungus that were visible to the naked eye.

The New England Compounding Center, based in Framingham, Mass. has recalled all of its products and shut down operations, but health officials estimate that 13,000 people may have been exposed to the suspect steroid since May.

Thirty-nine of the fungal meningitis cases -- six of them lethal -- have been in Tennessee. Cases have also been reported in Michigan, Virginia, Indiana, Maryland, Florida, Minnesota, North Carolina, Ohio and, most recently, New Jersey.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the U.S. Centers for Disease Control and Prevention.

The CDC's Dr. Benjamin Park says most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, redness or swelling at the injection site can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville. "There's no such thing as mild aspergillus meningitis."

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Monday
Oct082012

CDC Reports Eighth Fungal Meningitis Death

Jared Wickerham/Getty Images(ATLANTA) -- Health officials estimate that 13,000 people may have been exposed to contaminated lots of an epidural steroid that has been linked to a rare fungal meningitis that has infected 105 people across nine states, killing eight of them. Fourteen new cases and one new death have been reported since Sunday.

Although the number of cases has increased, the outbreak does not include any new states. The number of people with fungal meningitis, which is not spread person-to-person, has grown by 64 percent since Friday.

The outbreak of aspergillus meningitis has been linked to spinal steroid injections, a common treatment for back pain. A sealed vial of the steroid, called methylprednisolone acetate, was found to contain fungus, according to the U.S. Food and Drug Administration.

The states with reported cases include Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia. Tennessee has the most cases, with 35, including four deaths.

"FDA is in the process of further identifying the fungal contaminate," said Dr. Ilisa Bernstein, acting director of the FDA's Center for Drug Evaluation and Research Office of Compliance. "Our investigation into the source of this outbreak is still ongoing."

The steroid came from the New England Compounding Center in Framingham, Mass., a specialty pharmacy that has recalled three lots of the drug and shut down operations. Calls to the pharmacy were not immediately returned and its website is down.

Roughly 75 clinics in 23 states that received the recalled lots have been instructed to notify all affected patients.

"If patients are concerned, they should contact their physician to find out if they received a medicine from one of these lots," said Dr. Benjamin Park of the U.S. Centers for Disease Control and Prevention, adding that most of the cases occurred in older adults who were healthy aside from back pain.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis, such as headache, fever, dizziness, nausea and slurred speech, are subtler than those of bacterial meningitis and can take nearly a month to appear. Left untreated, the inflammatory disease can cause permanent neurological damage and death.

"Fungal meningitis in general is rare. But aspergillus meningitis -- the kind we're talking about here -- is super rare and very serious," said Dr. William Schaffner, president of the National Foundation for Infectious Diseases and chairman of preventive medicine at Vanderbilt University Medical Center in Nashville. "There's no such thing as mild aspergillus meningitis."

The disease is diagnosed with a lumbar puncture, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

"Treatment could be prolonged, possibly on the order of months," said Park, adding that the IV treatment would require a hospital stay.

Unlike bacterial and viral meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

The FDA has, however, advised health providers to stop using any product made by the New England Compounding Center during the investigation.

Copyright 2012 ABC News Radio







ABC News Radio