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USA failed to learn from earlier meningitis outbreaks

7:10 AM, Oct 22, 2012   |    comments
A laboratory technician packages cerebrospinal fluid of a confirmed meningitis case Oct. 9 at the Minnesota Department of Health in St. Paul. It was to be sent to the CDC for further testing.(Photo: Hannah Foslien, AP)
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To physician John Perfect, the nationwide outbreak of fungal meningitis linked to contaminated steroid injections made by a compounding pharmacy feels painfully familiar.

That's because Perfect treated patients sickened in a nearly identical outbreak 10 years ago, when five people in North Carolina became ill and one died. Watching the unfolding of a larger, nationwide version of this nightmare -- with 285 people sickened and 23 dead -- feels like living through the movie Groundhog Day, in which a man is forced to relive the same horrible day over and over, he said in an interview Sunday.

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Then, as now, federal officials flagged the risks posed by compounding pharmacies, which are typically regulated by state pharmacy boards rather than the Food and Drug Administration.

"We learned, or thought we learned, several important lessons from the outbreak," Perfect wrote in an essay subtitled "Tragedy Repeated," published Thursday in Annals of Internal Medicine.

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The primary lesson: that compounding steroid injections, given mainly for back pain, require "meticulous sterility," wrote Perfect, chief of infectious disease at Duke University Medical Center in Durham, N.C.

Without that sort of cleanliness, "fungi grow aggressively," Perfect says, perhaps because of the way that they interact with steroids, which suppress the immune system.

The September 2002 outbreak involved the same steroid, methylprednisolone acetate, as the current outbreak, although the shots were contaminated with a different fungus. Back then, patients took up to six months to develop symptoms, Perfect says.

In the current outbreak, patients have shown symptoms in one to four weeks, the Centers for Disease Control and Prevention say.

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The CDC sounded an alert on the risks of compounding after the September 2002 meningitis outbreak.

One danger: health-system pharmacists might not even realize they're buying compounded medications, according to the CDC's Morbidity and Mortality Weekly Report.

Another danger: Unlike big drug companies, "in most states, compounding pharmacies are not required to report adverse events associated with their products to state or federal agencies," the CDC report said.

The law hasn't changed since the 2002 outbreak, says Michael Carome, deputy director of the advocacy group Public Citizen's health research group. And there have been a "series of alarm bells" since then, Carome says, including a 2006 warning letter from the FDA to the pharmacy linked to the current meningitis outbreak, the New England Compounding Center. In that letter, the FDA cited potential health risks with an anesthetic cram and warned the pharmacy that it was acting like a drug manufacturer.

"This tragedy could have been prevented," Carome says.

FDA spokeswoman Sarah Clark-Lynn says the agency has limited authority to regulate compounding pharmacies. And while the agency can inspect facilities when there is a problem, the companies themselves have a responsibility to ensure safety, she says.

Carome says the FDA already has such authority, however, which the agency cited in its 2006 warning letter.

Although the current meningitis outbreak is still unfolding, Perfect said it's clear that the country needs to resolve the safety issues raised by compounding pharmacies. "Otherwise," he writes, "this will surely happen again."

USA Today

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