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)
To physician John Perfect, the nationwide outbreak of fungal
meningitis linked to contaminated steroid injections made by a
compounding pharmacy feels painfully familiar.
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.
MORE: As drug making goes global, oversight found lacking
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.
MORE: Fungal Meningitis outbreak worsens in Florida
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.
that sort of cleanliness, "fungi grow aggressively," Perfect says,
perhaps because of the way that they interact with steroids, which
suppress the immune system.
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.
MORE: Inside CDC's meningitis 'war room'
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.
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."