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 a larger version of this nightmare unfold -- 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.
Then, as now, federal officials flagged the risks posed by compounding pharmacies, which typically are 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 writes in an essay subtitled "Tragedy Repeated," published Thursday in Annals of Internal Medicine.
The primary lesson: that compounding steroid injections, given mainly for back pain, require "meticulous sterility," says 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 latest outbreak, patients have shown symptoms in one to four weeks, the Centers for Disease Control and Prevention says.
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 cited in the report: 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 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 warning letter from the FDA in 2006 to the pharmacy linked to the current meningitis outbreak, the New England Compounding Center.
"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, she says, the companies themselves have a responsibility to ensure safety.
Perfect says it's clear that the country needs to resolve such safety concerns. "Otherwise," he writes, "this will surely happen again."
To see more of USAToday.com, or to subscribe, go to http://www.usatoday.com
Copyright 2012 USA TODAY, a division of Gannett Co. Inc.