OCALA — In the nationwide outbreak of a rare fungal meningitis, this city of 56,315 people has been the epicenter of pain in Florida.
Two more cases of the illness linked to a tainted steroid for back pain were reported in Florida on Friday. The patients, women ages 52 and 79, had been receiving treatment at the Marion County Pain Management Center in Ocala.
Pain clinics in other Florida counties also received shipments of the suspect drug from a compounder in Massachusetts. None of the clinics are in the Tampa Bay area.
But all nine confirmed meningitis cases, including two deaths, are tied to Marion County clinics. That's driving plenty of questions — and anxiety — in a county best known for its picturesque horse farms.
"We just don't know why Marion County," said Craig Ackerman, public information officer for Marion County Health Department. "We don't know."
"Obviously, it's a concern," said Ocala Mayor Kent Guinn, who has been watching one of the nation's biggest medical stories unfold in his local newspaper. "People are anxious."
The outbreak is tied to contaminated lots of methylprednisolone acetate, which have since been recalled, from the New England Compounding Center. Three Ocala facilities — Florida Pain Clinic, Surgery Center of Ocala and Marion Pain Management Center — received contaminated vials, state health officials have said.
Over a five-month period, more than 400 people in Marion County received injections from the lots that were recalled. Health officials and staffers from the clinics have spoken to all but a dozen of those patients, said Ackerman.
The patients are told to call their doctors if they are having any symptoms of meningitis, which range from severe headaches to slurred speech. Depending on the severity of their symptoms, patients may have to endure a painful spinal tap for further testing. Unlike more common forms of the illness, fungal meningitis does not spread from person to person. But it can lead to strokes and death.
Forty-eight worried patients went to Ocala Regional Medical Center or West Marion Community Hospital to be examined. Five remained for observation at the hospitals Friday evening, a spokeswoman said. Another 60 people went to Munroe Regional Medical Center; 11 are still at the hospital.
The outbreak has cast a spotlight on compounding pharmacies, which mix up custom batches of drugs, often for much lower prices than major manufacturers charge. The pharmacies operate with little of the federal oversight required of major drug companies. The New York Times called the meningitis cases "a calamity waiting to happen."
Health providers who use the drugs say they thought the compounder's steroids were safe, since they are legal.
Mike Guarino, administrator at the Surgery Center of Ocala, a free-standing ambulatory center located in a manicured medical office park, said he was "livid" to learn that his staff had unknowingly put patients at risk by giving them a routine injection.
"They're approved to sell in the state of Florida. We've got this piece of paper saying it was safe," said Guarino. "So your questions are, 'Well, what else do we have? Who's regulating?' "
Guarino said patients, some of whom now face the prospect of a spinal tap, were understandably upset, and so is he. "I'm just praying for them," he said.
Guarino said his group turned to New England Compounding a couple of years ago not due to cost but because it was having a difficult time finding a preservative-free version of the steroid. "There was a shortage," he said. Thirty of his patients received injections from the recalled lots, he said; so far none has been diagnosed with meningitis.
Dr. Stephen Pyles owns Florida Pain Clinic, which gave shots from the contaminated batch to about 200 patients, one of whom died. He has raised questions about the health department's science in investigating the outbreak. He said that fungal cultures were never taken from his 70-year-old patient, a man who died of a stroke in July, one month after his back injection.
Still, Pyles said he was horrified to learn that the compounder wasn't subject to standard federal drug manufacturing regulations.
"How can you distribute a drug across the U.S. and not be regulated by the FDA?" he said. "I'm using what I assume they regulate."
Florida Surgeon General John Armstrong said Friday that health officials are following national investigations into the compounder "so that we can ensure that those lessons are rapidly applied in our state."
Meanwhile, one Ocala pain clinic is using the outbreak to its advantage.
The Florida Pain and Rehabilitation Center this week ran an ad in the Star-Banner, boasting: "We NEVER use any kind of cheap, low quality compounding steroids."
Times staff writer Letitia Stein contributed to this report. Jodie Tillman can be reached at [email protected] or (813) 226-3374.