Ocala clinic disputes link between death and meningitis outbreak
Published: Wednesday, October 10, 2012 at 9:13 a.m.
Last Modified: Wednesday, October 10, 2012 at 9:13 a.m.
An Ocala pain clinic disputes the state's decision to link a local patient's death to a multi-state fungal meningitis outbreak.
Dr. Stephen Pyles acknowledges the patient — a 70-year-old Marion County man whose name officials have not released — died in July about two weeks after receiving an injection at his Florida Pain Clinic.
But Pyles doubts the patient contracted that rare form of meningitis, which has been linked to tainted vials of methylprednisolone acetate, a steroid administered to relieve back pain.
The Florida Department of Heath says there's enough evidence to link the man's death to the tainted medicine, which Pyles' facility unknowingly used until a recent nationwide recall.
The death came months before the discovery that a Massachusetts compounding pharmacy had distributed as many as 17,000 vials of the medicine to facilities in 23 states, including three clinics in Ocala.
The state says the deceased man is the sixth confirmed fungal meningitis case in Florida — and the only fatality — linked to the outbreak. All Florida cases are in Marion County.
There have been 12 deaths in five states, including six in Tennessee alone. Officials say 137 patients, including the six in Marion County, have fallen ill in 10 states.
Florida Department of Health epidemiologist Dr. Carina Blackmore said the kind of "basilar stroke" the Florida man suffered was the same kind suffered by patients whose deaths have been linked to tainted injections and the resulting fungal meningitis.
"We feel very confident that the (man's) clinical presentation … is very similar to the clinical presentation seen in other cases associated with this outbreak," Blackmore said.
Blackmore is a veterinarian specializing in environmental epidemiology. She is not a medical doctor.
Pyles said the link between the patient and the meningitis outbreak is weak.
For one, the doctor said no definitive fungal culture test was ever performed after the man's death.
He also said about 20 percent of all strokes are characterized as "basilar."
Medical literature reviewed by the Star-Banner for this story was consistent with Pyles' stroke claims when it involved bursting blood vessels in the brain.
"And I saw this patient two weeks after the injection and he was doing fine," Pyles said.
Pyles said it's unlikely he injected the man with a vial from one of the three recalled lots.
Pyles said the suspect vials of steroid arrived at his business the day before he injected the now-deceased patient. Based on his practice — existing supplies are used first — it's unlikely the patient would have received medicine from a newly arrived batch.
In addition to all that, the patient also had high blood pressure and other medical issues, Pyles said.
The local facilities that received tainted vials, as identified by the Florida Department of Health, are:
• Florida Pain Clinic
• Surgery Center of Ocala
• Marion Pain Management Center
The three clinics and local hospitals continue to get telephone calls and visits from people who were notified that they were injected with the potentially contaminated medicine.
Lena Jedlicka, of the Marion Pain Management Center, said her business advises patients who show any of the symptoms linked to the disease to report to the emergency room.
Jedlicka would not say how many of the business' patients received suspect injections, but did say the facility made about 300 telephone calls notifying people of the recall. She said some patients could have received more than one injection.
Asked if patients were canceling future injections out of fear of more contamination, Jedlicka said she hasn't seen significant cancellations.
Pyles said he treated about 65 patients with the suspect lots. Surgery Center of Ocala said it treated about 20 patients.
Ocala Health System Chief Medical Officer Dr. Arthur Osberg said 37 people who had been injected with the suspect steroid have gone to one of OHS' two facilities: Ocala Regional Medical Center and West Marion Community Hospital.
Of the 37, 25 were tested for the disease. Although test results can take several days, 22 were admitted based on their symptoms. Of those 22, 15 were still in hospitals Wednesday.
Osberg said none of the tests have been positive for fungal meningitis, but that could change.
Munroe Regional Medical Center officials said more than 60 people have come in complaining of symptoms. Several were held for additional observation.
Even facilities not involved in the outbreak are taking action. The Florida Pain and Rehabilitation Center in Ocala took out an ad in Wednesday's Star-Banner noting that it has never used the contaminated product.
"If you have been treated in our facility, you should be safe and fine," the ad copy reads.
The type of fungal meningitis involved in this outbreak is not contagious, like other, more common forms of the disease. This kind is caused by a fungus often found in leaf mold.
Symptoms included worsening, severe headache; nausea; dizziness; fever; sensitivity to light; and new weakness or numbness in any part of the body. Health officials said some patients were experiencing stroke-like symptoms, including slurred speech.
They warned that some of the symptoms could be mild, making it more difficult for patients with the disease to suspect what is wrong.
Contact Fred Hiers at 397-5914 or email@example.com.