The e-mail Dr. Marion A. Kainer received on Sept. 18 suggested an investigation of a case of fungal meningitis and stroke in a man whose immune system was normal and whose only risk for the infection was a spinal injection of a steroid.
?Alarm bells went off? because of its rarity, Dr. Kainer, an epidemiologist at the Tennessee health department, said in an interview.
She immediately began what became a national investigation that has now identified 409 cases, including 30 deaths, from a fungus so unusual that it is not in medical textbooks. The fungus was transmitted through injections of a contaminated steroid drug prepared by the New England Compounding Center in Framingham, Mass.
Dr. Kainer?s investigation led Tennessee to take extraordinary measures to track down 1,009 people at risk of the fungal infection. The state is credited as the driving force in discovering one of the most shocking outbreaks in the annals of American medicine.
The discovery came in large part because of Dr. Kainer?s diligence and expertise in infectious diseases, neurology and public health. It came, too, from the clinical acumen of Dr. April C. Pettit, an infectious disease specialist at Vanderbilt University who sent the e-mail to the health department.
The still-evolving findings also illustrate the strengths of the government?s response to a public health crisis.
Dr. Kainer, like other physicians in hospitals and clinics, often detect the initial cases. But usually only health departments and other government agencies have the ability and authority to track down additional cases to document disease outbreaks and warn those at risk. It is work that private groups seldom can do, in part for lack of funds and the authority to examine patient records.
The national surveillance system for outbreaks of infectious and other communicable diseases relies on reports that physicians are required to send to local and state health departments and that are then relayed to the Centers for Disease Control and Prevention. At the federal agency in Atlanta, epidemiologists identify outbreaks by studying trends.
At the same time, the fungal meningitis cases have exposed weaknesses in government. A dispute surrounds the Food and Drug Administration?s failure to act earlier to prevent the outbreak. The federal agency has been attacked for failing to use its authority to protect the public from the dangerous practice of large-scale drug compounding that led to the outbreak. But the agency, whose top officials have remained relatively silent, says Congress has not given it the clear authority needed to have taken action.
Dr. Kainer?s investigation progressed in steps similar to peeling the layers of an onion.
Within two days of receiving Dr. Pettit?s e-mail, Dr. Kainer learned that the steroid had come from the New England Compounding Center.
?That got me very concerned,? Dr. Kainer said, because she had taken part in epidemiologic investigations involving different infections linked to compounding centers. Inquiries determined that the New England center had received no reports of infections linked to its steroid, and the C.D.C. knew of no additional recent cases of fungal meningitis and stroke.
An inspection by Dr. Kainer?s staff and from the clinic that administered the injection showed no obvious source of local fungal contamination, like recent construction or water leaks.
Then Dr. Kainer learned of three additional suspect cases of meningitis and stroke linked to the clinic. But fungi had not yet been identified in those patients? spinal fluid. Also, her team could find no correlations in factors like time of day or week when the patients received the injections. One patient had a particular kind of stroke known as posterior circulation, which attracted Dr. Kainer?s attention because she had learned in neurology that fungal infections can cause such strokes.
?What didn?t make sense was that two patients appeared to be improving without antifungal treatment, and that didn?t fit the clinical picture,? Dr. Kainer said.
So she and her team took additional steps. One was to issue a statewide alert to identify similar cases; none were reported.
?We tell doctors and health workers we would rather have 15 false alarms than miss one case,? Dr. Kainer said.
Then she learned that the two patients who had been improving had taken a turn for the worse.
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