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                                                    Metro
        Fungal infection poses challenges to
        patients, officials
        By Liz Kowalczyk | GL O BE ST AF F   O CT OB E R 17 , 20 12




                                                                        CHERYL SENTER FOR THE BOSTON GLOBE

        Matthew Spencer still suffers from occasional headaches.


        Two weeks after Matthew Spencer received a steroid injection for back pain, he was feeling
        even worse, suffering from an aching head, stiff neck, nausea, and stabbing back pain. Finally,
        he drove himself to the emergency room.

        Doctors suspected fungal meningitis. Test results were not definitive, but the steroid had been
        made by the Framingham pharmacy linked to an expanding national outbreak of the rare and
        dangerous disease.




http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
Page 2 of 4
        After seven days in the hospital, the part-time mayor of Somersworth, N.H., was back home
        Tuesday, where a machine pumps a powerful antifungal medication into his veins five hours a
        day. The drug causes liver inflammation, and for the first 30 minutes of each treatment,
        images flicker across his eyes.

        Spencer’s situation illustrates many of the challenges public health officials, physicians, and
        patients are grappling with in the outbreak: Fungal meningitis is usually exceedingly difficult
        to diagnose, and the treatment is risky and arduous.

        “It’s like going to a supermarket and buying a bottle of water and finding out it’s Windex,’’ said
        Spencer, 42, about receiving a steroid potentially contaminated with fungus. “It’s
        unfortunate.’’

        Spencer waited more than two weeks after his epidural injection on Sept. 19 to seek medical
        care. In part, that was because he and his doctors attributed his initial symptoms to the
        injection itself, which he received to ease pain from spinal stenosis caused by an old Coast
        Guard injury.

        “I know people who have been called” by health officials “and still haven’t gone to get tested,’’
        Spencer said in a telephone interview. “I want to encourage them to do that.’’

        Doctors often have to make the diagnosis without laboratory test results positively identifying
        fungus in the spinal fluid, as they did with Spencer.

        Dr. Paul Sax, an infectious disease specialist at Brigham and Women’s Hospital in Boston, said
        spinal fluid often is negative for fungal contamination, because fungus grows very slowly and
        common tests are not always sensitive enough to detect it. Repeated testing is often required,
        and even then, spinal fluid sometimes never shows up positive.

        As a result, the Centers for Disease Control and Prevention is advising doctors on conference
        calls and its website to start treatment when patients exhibit meningitis symptoms, have a
        high white blood cell count, and have been exposed to sterile injectable steroids made by New
        England Compounding Center.

        On Monday, the Food and Drug Administration expanded its advice to health care providers,
        saying they should evaluate patients who have received any injectable drug made by the
        company and who have symptoms of meningitis or infection at the site of a joint injection.

        “Fungal meningitis is a very serious problem,’’ Sax said. Treatment should be started before
        “definitive evidence if you have a suspected case, because the longer you wait, the longer the
        infection has to become severe.’’


http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
Page 3 of 4
        The CDC, however, has stopped short of recommending that patients without symptoms
        receive intravenous therapy, at least for now, because the risks include liver and kidney
        damage. In the case of liver inflammation caused by the antifungal voriconazole, it is usually
        reversible if the drug is stopped before the symptoms are too severe, Sax said.

        Some patients with severe cases will be on intravenous drugs for months. No one knows the
        optimal length of therapy because fungal meningitis is so rare, doctors said.

        “The burden of treatment is unclear; therapy could go on for years,’’ said Dr. James P. -
        Rathmell, chief of pain medicine at Massachusetts General Hospital, who earlier this week was
        on a panel in Washington, D.C., discussing the outbreak. Doctors “just don’t know, because
        this is a new phenomenon,’’ he said.

        The CDC said the number of infected patients grew to 233 Tuesday; 15 patients have died. The
        FDA has expanded the potentially contaminated drugs to include two injectable steroids made
        by New England Compounding, though most patients infected received injections of
        methylprednisolone acetate, and a solution used during heart surgery. On Tuesday, the agency
        sent criminal investigators to the offices of the company, suggesting the growing seriousness
        of the situation.

        The outbreak has focused attention on a little-known corner of drug-making called
        compounding that some critics argue has fallen through the regulatory cracks.

        Jeffrey Montpetit, a lawyer in Minneapolis, filed a class action lawsuit last week on behalf of
        Minnesota residents injected with potentially tainted steroids.

        Lead plaintiff Barbe Puro developed a headache, stiff neck, and nausea, classic signs of
        meningitis, soon after her Sept. 17 spinal injection. But she first thought her symptoms were
        due to her back condition, Montpetit said. It was not until the state health department -
        informed her a week later that she had been exposed to a tainted steroid that she went to her
        doctor to be evaluated for fungal meningitis.

        “I don’t know that anybody has a solid handle on what to tell people and when to tell them
        ‘you are all clear,’ ” said Montpetit. “There are no definitive answers. The most difficult issue
        for people is the uncertainty, wondering whether or not I am going to get fungal meningitis —
        and die.”

        Spencer said he has had recurring back pain dating to his 20 years in the Coast Guard. He
        retired in 2009. “That’s the nature of being on a small patrol boat’’ he said. “It rocks and rolls
        and pitches. Your body gets really tortured.”



http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
Page 4 of 4
        Kay Lazar of the Globe staff contributed to this report. Liz Kowalczyk can be reached at
        kowalczyk@globe.com.



                                         © 2012 THE NEW YORK TIMES COMPANY




http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012

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Boston globe 10 17 12 fungal infection treatment

  • 1. Page 1 of 4 Metro Fungal infection poses challenges to patients, officials By Liz Kowalczyk | GL O BE ST AF F O CT OB E R 17 , 20 12 CHERYL SENTER FOR THE BOSTON GLOBE Matthew Spencer still suffers from occasional headaches. Two weeks after Matthew Spencer received a steroid injection for back pain, he was feeling even worse, suffering from an aching head, stiff neck, nausea, and stabbing back pain. Finally, he drove himself to the emergency room. Doctors suspected fungal meningitis. Test results were not definitive, but the steroid had been made by the Framingham pharmacy linked to an expanding national outbreak of the rare and dangerous disease. http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
  • 2. Page 2 of 4 After seven days in the hospital, the part-time mayor of Somersworth, N.H., was back home Tuesday, where a machine pumps a powerful antifungal medication into his veins five hours a day. The drug causes liver inflammation, and for the first 30 minutes of each treatment, images flicker across his eyes. Spencer’s situation illustrates many of the challenges public health officials, physicians, and patients are grappling with in the outbreak: Fungal meningitis is usually exceedingly difficult to diagnose, and the treatment is risky and arduous. “It’s like going to a supermarket and buying a bottle of water and finding out it’s Windex,’’ said Spencer, 42, about receiving a steroid potentially contaminated with fungus. “It’s unfortunate.’’ Spencer waited more than two weeks after his epidural injection on Sept. 19 to seek medical care. In part, that was because he and his doctors attributed his initial symptoms to the injection itself, which he received to ease pain from spinal stenosis caused by an old Coast Guard injury. “I know people who have been called” by health officials “and still haven’t gone to get tested,’’ Spencer said in a telephone interview. “I want to encourage them to do that.’’ Doctors often have to make the diagnosis without laboratory test results positively identifying fungus in the spinal fluid, as they did with Spencer. Dr. Paul Sax, an infectious disease specialist at Brigham and Women’s Hospital in Boston, said spinal fluid often is negative for fungal contamination, because fungus grows very slowly and common tests are not always sensitive enough to detect it. Repeated testing is often required, and even then, spinal fluid sometimes never shows up positive. As a result, the Centers for Disease Control and Prevention is advising doctors on conference calls and its website to start treatment when patients exhibit meningitis symptoms, have a high white blood cell count, and have been exposed to sterile injectable steroids made by New England Compounding Center. On Monday, the Food and Drug Administration expanded its advice to health care providers, saying they should evaluate patients who have received any injectable drug made by the company and who have symptoms of meningitis or infection at the site of a joint injection. “Fungal meningitis is a very serious problem,’’ Sax said. Treatment should be started before “definitive evidence if you have a suspected case, because the longer you wait, the longer the infection has to become severe.’’ http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
  • 3. Page 3 of 4 The CDC, however, has stopped short of recommending that patients without symptoms receive intravenous therapy, at least for now, because the risks include liver and kidney damage. In the case of liver inflammation caused by the antifungal voriconazole, it is usually reversible if the drug is stopped before the symptoms are too severe, Sax said. Some patients with severe cases will be on intravenous drugs for months. No one knows the optimal length of therapy because fungal meningitis is so rare, doctors said. “The burden of treatment is unclear; therapy could go on for years,’’ said Dr. James P. - Rathmell, chief of pain medicine at Massachusetts General Hospital, who earlier this week was on a panel in Washington, D.C., discussing the outbreak. Doctors “just don’t know, because this is a new phenomenon,’’ he said. The CDC said the number of infected patients grew to 233 Tuesday; 15 patients have died. The FDA has expanded the potentially contaminated drugs to include two injectable steroids made by New England Compounding, though most patients infected received injections of methylprednisolone acetate, and a solution used during heart surgery. On Tuesday, the agency sent criminal investigators to the offices of the company, suggesting the growing seriousness of the situation. The outbreak has focused attention on a little-known corner of drug-making called compounding that some critics argue has fallen through the regulatory cracks. Jeffrey Montpetit, a lawyer in Minneapolis, filed a class action lawsuit last week on behalf of Minnesota residents injected with potentially tainted steroids. Lead plaintiff Barbe Puro developed a headache, stiff neck, and nausea, classic signs of meningitis, soon after her Sept. 17 spinal injection. But she first thought her symptoms were due to her back condition, Montpetit said. It was not until the state health department - informed her a week later that she had been exposed to a tainted steroid that she went to her doctor to be evaluated for fungal meningitis. “I don’t know that anybody has a solid handle on what to tell people and when to tell them ‘you are all clear,’ ” said Montpetit. “There are no definitive answers. The most difficult issue for people is the uncertainty, wondering whether or not I am going to get fungal meningitis — and die.” Spencer said he has had recurring back pain dating to his 20 years in the Coast Guard. He retired in 2009. “That’s the nature of being on a small patrol boat’’ he said. “It rocks and rolls and pitches. Your body gets really tortured.” http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012
  • 4. Page 4 of 4 Kay Lazar of the Globe staff contributed to this report. Liz Kowalczyk can be reached at kowalczyk@globe.com. © 2012 THE NEW YORK TIMES COMPANY http://www.bostonglobe.com/lifestyle/health-wellness/2012/10/16/mayor-matthew-spencer-antifungal-dru... 10/17/2012