By Tom Wilemon and Walter F. Roche Jr.
| The Tennessean
of a rare form of fungal meningitis has evolved into a national health
crisis that has sickened at least 26 people in five states, killing four
of them -- and officials say the count is certain to rise.
Massachusetts specialty pharmacy that already had a record of regulatory
violations was linked Wednesday to the disease outbreak and voluntarily
surrendered its license. Doctors and health officials in Tennessee had
alerted federal officials that the company's medicine might be the cause
of the infections -- an action that mobilized the nation's health-care
system to identify illnesses in other states and keep more people from
Tennessee's quick response -- starting with a young
doctor who first realized that the injections could be the culprit --
was "a textbook example of how to do things right," said Dr. William
Shaffner, a Vanderbilt professor who is president of the National
Foundation of Infectious Diseases.
However, more than 1,000 state
residents who had already received the steroid epidural injections will
still have to wait and wonder whether the pathogen that causes the
disease -- a common mold called Aspergillus -- is incubating in their
Tennessee residents at risk are those who received
epidural steroid injections as a pain treatment at Saint Thomas
Outpatient Neurosurgery Center in Nashville, Specialty Surgery Center in
Crossville and PCA Pain Care Center of Oak Ridge between July 1 and
The state expanded the window of concern by 30 days back to July 1 on Tuesday.
on our mission to protect people in Tennessee, we feel it is important
to be appropriately cautious in expanding the time window to identify
others who may have been potentially infected," Tennessee Health
Commissioner Dr. John Dreyzehner said.
The Tennessee Department of
Health reported 18 suspected cases as of 1 p.m. Wednesday, but the
official count, which will be updated again today, is certain to rise,
The FDA is still
investigating the scope and cause of the outbreak, said spokesman Erica
V. Jefferson, who revealed Wednesday that New England Compounding Center
had voluntarily recalled three lots of the steroid methylprednisolone
-- the drug used in the epidural injections -- on Sept. 26.
compounding center was cited by the FDA in 2006 for multiple violations
of federal laws and regulations based on a 2004 inspection at its
Framingham, Mass., office.
The firm was charged with misbranding
drugs prescribed for eye treatment, misbranding an anesthetic drug and
failing to provide adequate directions for its use and promoting the use
of a cancer drug for an unapproved purpose.
"Your company is distributing an unapproved drug in violation" of federal regulations, the FDA warning letter states.
from the Tennessee State Pharmacy Board show that the president of New
England Compounding, Barry J. Cadden, has a currently valid pharmacist
license. Cadden could not be reached for comment either at home numbers
in Massachusetts and Rhode Island or at the company offices.
Conigliaro, the company vice president, also was unavailable either at
his home in Framingham, Mass., or at the company offices. The company
has been in operation since 1998.
Although its website was offline
Wednesday, an archived version of the company website lists the drug
methylprednisolone acetate as one of its available products. It also
states that the firm is licensed to distribute drugs in all 50 states.
company described itself on the archived website as "dedicated to
providing the highest quality compounded medications and services to
patients and prescribers."
Federal court records show the company
was sued in 2010 by an Illinois firm which charged that New England
Compounding had illegally hacked a database and violated the federal
computer fraud and abuse act. New England denied the charges and the
case was eventually settled.
Doc connects dots
physician April Pettit, who first made the connection between the
injections and the illnesses, knew nothing about this company when she
sent an email to the state Health Department. After a patient with
symptoms of meningitis did not respond to antibacterials and a spinal
tap showed no evidence of the usual infectious agents, she ordered a
second spinal tap with instructions to test for fungal pathogens.
knew something was wrong when it tested positive for Aspergillus -- a
type of fungal infection that usually affects only people with
compromised immune systems. She also learned that her patient had had an
epidural injection and wondered if this was how he caught the
"I thought the health department should investigate that possibility," Dr. Pettit said in an interview Wednesday.
So she sent an email and officials with the state Department of Health called her "pretty immediately."
two days, a couple of patients with meningitis-like symptoms who also
had received the injections were admitted to Saint Thomas Hospital. They
had no proof of an unusual pathogen, such as a fungal agent, but they
were looking at the connection when Dr. Marion Kainer, director of
healthcare-associated infections for the state, called. They reported
their two cases.
Tennessee alerted the CDC that there could be a
potential problem with contaminated products associated with epidural steroid injections used for pain management.
The FDA Wednesday
released the lot numbers for the medicines that New England Compounding
Center had voluntarily recalled on Sept. 28. The numbers are tools that
health care professionals use to inventory and ensure the safety of
products. The numbers, for 80 mg/ml injections of methylprednisolone
acetate, were Lot #05212012@68, Beyond Use Date (BUD) 11/17/2012; Lot
#06292012@26, BUD 12/26/2012; and Lot #08102012@51, BUD 2/6/2013.
Numbers are in flux
official count of sick patients may not have included some new
admissions to Saint Thomas Hospital, the epicenter of the outbreak in
Tennessee. Dreyzehner said Saint Thomas had 2,000 vials of the recalled
Dr. Robert Latham, an infectious disease specialist at
Saint Thomas, said Wednesday afternoon it had 16 patients believed to
have the fungal meningitis, including two in critical condition
Wednesday night. Nine of those patients were admitted from 7 a.m.
Tuesday to 7 a.m. Wednesday, he said.
Vanderbilt has two patients. Two other patients, who were among the first to become sick, died.
However, the condition of the patients currently hospitalized ranges from stable to critical at the hospitals.
"Most of our patients are walking the halls when they want to," Latham said.
who seek treatment early have better chances, he said, but that does
not mean doctors are prescribing antifungal drugs as a preventive
medicine. The drugs would do more harm than good if given to people
without symptoms or evidence of the fungal meningitis because of toxic
side effects, he said.
Saint Thomas has begun keeping a website tally that also includes information for patients who received the spinal injections in a clinic on its ninth floor.
Jenkins, 81, of Hermitage, a retired juvenile court judge, who received
epidural injections at Saint Thomas for back pain on Aug. 7, Aug. 21
and Sept. 11, is one of the people waiting to see if has symptoms.
just going to do my same routine and wait and see what happens and go
from there," Jenkins said. "I think my wife is more worried than I am."