* CDC says more than 200 people infected so far
* Company faces array of investigations
CHICAGO, Oct 15 (Reuters) - A fungal meningitis outbreak
linked to contaminated steroid injections expanded to 15 states
on Monday as Pennsylvania reported its first case of the disease
that has killed 15 people nationwide.
The Pennsylvania patient, who received an epidural steroid
injection in July from medications supplied by New England
Compounding Center (NECC) of Framingham, Massachusetts, is being
treated in a hospital, the Pennsylvania Department of Health
said.
The new case means that all but eight of the 23 states that
received suspect medications from the Massachusetts specialist
pharmacy have reported at least one case of fungal meningitis, a
rare and deadly disease that has proven difficult to treat.
Over the weekend the Centers for Disease Control and
Prevention said its tally of cases, which sometimes lags reports
from state health departments, showed 205 people stricken with
the disease after receiving injections. Illinois and New
Hampshire reported their first cases.
The suspect lots of steroid were shipped to 76 facilities in
23 states, including two locations in Pennsylvania.
"We have been working directly with the clinics to ensure
that patients who received these injections are monitored and
receive any necessary follow-up," said Acting Pennsylvania
Secretary of Health Michael Wolf.
Health authorities believe that nearly 14,000 people
nationwide received injections from the potentially contaminated
medication.
The state worst affected by the outbreak, Tennessee with 53
cases and six deaths, was holding an administrative hearing on
Monday to determine whether to suspend the license of NECC.
At one hospital in Tennessee, St. Thomas in Nashville, more
than 275 patients have undergone spinal tap tests, a painful
procedure to determine if they have meningitis, and 33 people
infected with meningitis have been treated.
The company faces an array of federal and state
investigations. It has recalled the suspect medicines,
surrendered its license to operate in Massachusetts and
suspended operations. A sister company, Ameridose, also has
suspended operations.
Meningitis is an infection of the membranes covering the
brain and spinal cord. Symptoms include headache, fever and
nausea. Fungal meningitis is not contagious.
The outbreak raised questions about how the pharmaceuticals
industry operates. NECC engaged in a little-known practice
called drug compounding that is not regulated by the Food and
Drug Administration, which generally oversees drug makers.
In compounding, pharmacies prepare specific doses of
approved medications, based on guidance from a doctor, to meet
an individual patient's need.
A Reuters investigation found that one NECC customer
received solicitations from the company for bulk orders and
failed to require proof of individual patient prescriptions as
required by state regulations.
The emails support assertions made last week by state
pharmacy regulators that the compounding firm, which was
authorized to deliver products only in response to
patient-specific prescriptions, had violated its license in
Massachusetts.
Several states, including Michigan, Massachusetts, Indiana,
Minnesota and Ohio, are investigating the company.
The 15 states reporting cases of meningitis are Tennessee,
Michigan, Pennsylvania, New Hampshire, Illinois, Indiana,
Minnesota, New Jersey, Texas, Idaho, Maryland, North Carolina,
Virginia, Ohio and Florida.
(Additional reporting by Michele Gershberg; Editing by Vicki
Allen)
