By Tom Wilemon and Walter F. Roche Jr. | The Tennessean
Fungal infections soared 27 percent in Tennessee since Thanksgiving after state health officials redoubled efforts to identify new illnesses in the national outbreak, Health Commissioner Dr. John Dreyzehner said Thursday.
The surge is due to a new wave of localized infections at the injection site among people who got spinal epidurals with moldy medicine produced by New England Compounding Center.
Massachusetts, where the company is located, continued actions Thursday to revamp and improve oversight of pharmacy labs, while a judge in that state issued an important ruling for people suing the company.
Illnesses in Tennessee now total 107, with 23 new ones since the holiday, Dreyzehner said. Eighty-one of the illnesses since the outbreak began are cases of meningitis, but almost all the new cases are localized infections.
One new case was meningitis alone, while two other people were diagnosed with both meningitis and localized infections. The state's death toll remained unchanged at 13.
Although these localized infections -- boils along the spinal column that may not be visible -- are not considered as life threatening as meningitis, they could progress into causing that disease, Dreyzehner said.
"If we are not vigilant with the localized infections, we could indeed have a second wave of meningitis for some people," he said.
Risk period is unknown
At this point, known infections are linked to only the recalled steroid methylprednisolone acetate, but the state is urging doctors to be on the lookout for illnesses stemming from other New England Compounding products. Contaminants also have been detected in unopened vials of triamcinolone, a steroid that is injected into the eye as a treatment for a type of vision loss called age-related macular degeneration.
Dreyzehner could not say when the risk window will end for people exposed to the moldy medicine. The longest period for an infection to occur after the last injection of methylprednisolone acetate has been 82 days in Tennessee, he said, while nationwide the longest reported incubation period has been 120 days.
"Those numbers could lengthen," Dreyzehner said. "We really don't know. ... That's why, frankly, this is such a difficult infection for people involved. Imagine yourself having to live with this where this has happened. You weren't expecting it and the medical community can't really tell you with precision when your period of risk ends. That's something we feel very sad about for the people who are affected."
Almost all the people at risk for the localized infections from procedures in Tennessee have been contacted.
"There's a few that we have not been able to reach," Dreyzehner said. "We have sent those folks letters and will be doing home visits as we did before. Our efforts earlier have paid off in that we know where most of these folks are now."
The antifungal drug Voriconazole can be prescribed for the localized infections, but the boils also have to be drained and cleaned out, he said. In a few cases, another antifungal, Amphotericin B, has been prescribed.
Dr. John Jernigan, who leads the nationwide response to the outbreak for the U.S. Centers for Disease Control and Prevention, said this week that the time is unknown for how long people will have to take Voriconazole.
The later wave of illnesses includes spinal abscesses and bone infections.
"This was something we expected to see early on but we didn't," Jernigan said. "We were puzzled by that. Now, they are emerging as a later manifestation of the disease. That's representing some treatment challenges. Some of these patients have required surgical interventions."
Jernigan noted that the steroid medicine hampered people's natural immune response.
"It's a bad combination," he said. "Some people have referred to it as kind of a perfect storm because you got this bad pathogen in this very vulnerable part of the body and you're basically blunting the immune response because of the medication you are getting."
At one point, state health officials thought the outbreak in Tennessee would ebb by Nov. 8 -- about six weeks after the last epidurals with the moldy medicine were administered at the three clinics in Tennessee linked to the outbreak. This window was for meningitis and cases of stroke stemming from meningitis.
Although the type of fungal meningitis diagnosed in the most cases -- Exserohilum -- is a new form of the disease spawned by the contaminant being injected into the spinal area, a smaller cluster of another type of fungal meningitis also caused by spinal injections more than a decade ago had an incubation period as long as 160 days.
"We won't be surprised if we continue to see some cases that might present months out -- and that was with meningitis," Jernigan said. "Soft-tissue manifestation might have a longer incubation period. We don't know yet about that.
"With the number of cases coming in, we expect we have seen the vast majority, but it wouldn't surprise us if we continue to see some cases trickle down as we get further out on the tail of this evidence curve."
New faces on licensing board
In Massachusetts, where the tainted steroids originated, state health officials announced the appointment of three new members to the 11-member board that licensed New England Compounding. One of the new appointees, Patrick Gannon, replaces Sophia Pasedis, a pharmacist who worked for a related company, Ameridose.
State officials had asked her to resign when questions were raised about whether she properly recused herself from board matters relating to the two companies, which have common ownership. Pasedis refused the request, but her term officially expired last month.
The new appointees include two who work for health care firms and one who works for BlueCross BlueShield of Massachusetts.
In another development, interim Massachusetts Health Commissioner Dr. Lauren Smith announced that additional compounding firms were cited as part of a new crackdown on drug compounders.
Partial cease-and-desist orders were issued against Pallimed Solutions in Boston and The Whittier Pharmacist in Bradford. Pallimed was cited for using improper ingredients in preparing a compounded drug, and Whittier was cited for sterility violations.
A third Massachusetts drug compounder, Oncomed Pharmaceuticals of Waltham, was issued a cease-and-desist order Nov. 21 because of problems with chemotherapy drugs it was preparing.
Also in Boston on Thursday, U.S. Magistrate Judge Jennifer C. Boal said she will allow lawyers and experts representing plaintiffs in a dozen pending cases against New England Compounding to inspect the NECC facility.
Attorneys for the compounding firm had argued that any evidence collected would be meaningless because of the long time lapse and damage from Hurricane Sandy.
Attorneys for the plaintiffs, including the families of victims who died from fungal meningitis, argued that inspection of the facilities was "critically important and indeed will in all probability reap scientifically valid evidence needed to establish the plaintiff's claims."
Contact Tom Wilemon at 615-726-5961 or email@example.com or follow him on Twitter @TomWilemon. Contact Walter F. Roche Jr. at 615-259-8086 or firstname.lastname@example.org.