* CDC says 231 people have contracted meningitis
* FDA "can't assure the sterility" of NECC products
* More lawsuits from victims who contracted meningitis
(Updates number of cases, Markey call for probe, FDA comments)
By Bill Berkrot
NEW YORK, Oct 16 A leading U.S. lawmaker called
on Tuesday for an investigation of whether the company at the
center of the deadly meningitis outbreak violated federal laws
covering potentially addictive drugs, a day after the health
scare widened to new medications.
The U.S. meningitis outbreak continues to grow and has so
far killed 15 people and infected 231, according to a tally from
the Centers for Disease Control and Prevention on Tuesday.
"We're nowhere near the end of this problem. And we will see
more patients reporting in ill and we'll have to treat many more
going forward," Dr. William Schaffner, an infectious diseases
expert at the Vanderbilt University Medical Center in Nashville
said on "CBS This Morning."
The Food and Drug Administration's on Monday widened its
investigation of the cause of the fungal meningitis outbreak to
other drugs made by a Massachusetts pharmacy, the New England
Compounding Center (NECC) - a development which Schaffner called
"We'll have to notify many more patients across the country
that they may have been exposed to a fungal infection," said
Schaffner, who has consulted with the worst affected state of
Nearly 14,000 people nationwide are at risk of infection
because they received injections from the suspect steroid
medications shipped to 76 facilities in 23 states. Health
authorities have not yet said how many more people may be
affected by the additional drugs.
Another 19 people were reported stricken with fungal
meningitis on Tuesday, bringing the total nationwide to 231.
That total does not include two people who have a fungal
infection from joint injections, so the total of infections
In Washington, Massachusetts Democratic congressman Edward
Markey called on the Justice Department to investigate whether
NECC violated federal laws designed to stem illegal activity in
NECC already faces multiple investigations by the FDA and
several states, but Markey's request could launch an even more
serious probe involving the Drug Enforcement Agency, which
oversees sales of potentially addictive or "controlled" drugs.
"This is a matter that I believe requires further
investigation by the DEA to ensure that this facility, already
believed to have broken Massachusetts state law, has not also
skirted federal law related to controlled substances," said
Markey, a senior member of the committee that oversees business.
'CAN'T ASSURE THE STERILITY'
The FDA said Monday it was looking into two other drugs made
by NECC, based outside of Boston in Framingham, Massachusetts.
The agency said it had received reports of a patient with
possible meningitis who received an injection of a different
steroid than the one found to have caused the deaths. It said
Tuesday that one transplant patient was infected with a fungus
linked after receiving a drug used in open heart surgery made by
NECC. The FDA had originally said two heart patients were
Another patient identified by the FDA received an injection
of the steroid triamcinolone, also supplied by NECC.
During a conference call on Tuesday with doctors on the
meningitis outbreak, an FDA official stressed that the two
additional products had not been linked to confirmed infections.
"There's a good probability they are not linked," FDA
official Janet Woodcock said. She asked doctors to contact
patients injected since May to make sure they have no signs of
NECC said in a statement that it was reviewing the new
information from the FDA.
The FDA has been inspecting the NECC facilities, and on
Tuesday Woodcock told doctors that based on the condition of the
plant and other factors, "we really can't assure the sterility
of these products."
The legal threat to NECC also mounted as more victims of
meningitis filed lawsuits.
Lyn Laperriere, who remains in hospital with fungal
meningitis, filed a federal lawsuit in Michigan on Tuesday. The
lawsuit says he received an epidural injection of
methylprednisolone acetate manufactured by NECC on Sept. 6 and
shortly afterward showed symptoms of fever, headache, stiff
neck, nausea and vomiting as well as light sensitivity.
Laperriere went to a hospital in Ypsilanti, Michigan where
he was admitted and began treatment first for bacterial
meningitis which proved ineffective, the lawsuit states. He was
later diagnosed with fungal meningitis and is being treated.
Brenda Bansale of Howell, Michigan, who also is hospitalized
for fungal meningitis, filed a federal lawsuit in Detroit on
Monday that contends she was injected on Aug. 28 and developed
severe headaches and nausea on Oct. 4.
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.
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 has raised questions about how the
pharmaceuticals industry operates. NECC engaged in a practice
called drug compounding that is not regulated by the FDA, 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 NECC solicited bulk
orders from physicians and failed to require proof of individual
patient prescriptions as required under state regulations,
e-mails to a customer showed.
State pharmacy regulators have said that NECC violated its
license in Massachusetts by not requiring patient prescriptions
before shipping products.
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.
(Reporting by Susan Heavey in Washington, Michele Gershberg in
New York and David Bailey in Minneapolis; Writing by Greg
McCune; Editing by Vicki Allen and Cynthia Osterman)