* Death toll rises to 14; total sickened jumps to 169
* Officials say compounder may have violated state license
* U.S. senator calls for federal probe
WASHINGTON, Oct 11 (Reuters) - As many as 14,000 people -
more than previously thought - received possibly tainted steroid
injections tied to a deadly U.S. meningitis outbreak and
patients should watch for symptoms for several months, health
officials said on Thursday.
The officials said the company at the center of the
outbreak, the Massachusetts New England Compounding Center,
appeared to have violated its license by producing large
quantities of drugs rather than prescriptions for individual
patients, as calls grew for a criminal probe.
"This organization chose to apparently violate the licensing
requirements under which they were allowed to operate," said Dr.
Madeleine Biondolillo, director of the Massachusetts Department
of Public Health's Bureau of Health Care Safety and Quality.
NECC officials were not immediately available for comment.
Biondolillo was joined by officials from the U.S. Centers
for Disease Control and Prevention and the Food and Drug
Administration in a briefing on the outbreak. The CDC said the
number of people at risk, which is 1,000 higher than earlier
estimated, was revised after consulting with health authorities.
Fourteen patients have died from the rare form of fungal
meningitis and 169 people have been infected, a rise of 32 cases
since Wednesday, the CDC said. One more patient had an infection
after an injection in the ankle, but meningitis has not yet been
confirmed.
Infections have been detected within two weeks of a patient
receiving the medication, on average, and up to 42 days
afterward.
But anyone exposed to the NECC-supplied vials of the steroid
methylprednisolone acetate - used to treat back pain and other
conditions - should be vigilant for health problems for several
months, CDC officials said. Local health authorities have
contacted over 90 percent of patients who may have been exposed.
Florida reported a second death from meningitis and Indiana
reported its first death from the outbreak, with cases confirmed
in 11 states.
Richard Blumenthal, who sits on the Senate's Health
Oversight Committee, said on Thursday he requested a federal
criminal probe in a letter to U.S. Attorney General Eric Holder.
"I've reached no conclusions, but there are at least
sufficient facts to warrant an investigation," Blumenthal, a
former Connecticut state attorney general and federal
prosecutor, told Reuters in a telephone interview.
"The company, its officers, employees and maybe others may
have violated state and federal criminal laws in their potential
misrepresentations to government agencies regarding their
products," he said.
MAJOR HEALTH SCANDAL
Meningitis is an infection of the membranes covering the
brain and spinal cord. Symptoms include headache, fever and
nausea. Fungal meningitis, unlike viral and bacterial
meningitis, is not contagious.
The outbreak has developed into a major health scandal, with
authorities scrambling to determine how the steroid treatments
were contaminated, track down those affected and treat them. It
has also raised questions about how the pharmaceuticals industry
operates and is regulated.
"We're continuing to investigate the facts and make sure we
have a thorough understanding of exactly what is happening and
exactly what we were or were not told," said Deborah Autor, FDA
deputy commissioner for global regulatory operations and policy.
"The world has changed a lot from the days of mortar and
pestle," Autor said. "This is the time for pharmacists, for
lawmakers, for regulators, for doctors, to grapple with this new
model of pharmacy compounding and come up with a regulatory
scheme that appropriately controls risk."
The FDA regulates drug manufacturers but not the practice of
compounding, in which pharmacies prepare specific doses of
approved medications, based on guidance from a doctor, to meet
an individual patients' need.
The agency can investigate a pharmacy once a risk to public
health arises, and is now part of a probe of NECC, which
operated out of a brick complex next to a waste and recycling
operation in a western suburb of Boston. The company has
suspended operations and recalled all of its products.
The FDA said on Thursday that more than 50 vials of steroid
treatments from NECC t ested positive for a fungus that causes
meningitis.
The pharmacies are owned by Gregory Conigliaro, an engineer,
and his brother-in-law Barry Cadden, a pharmacist who was in
charge of pharmacy operations at NECC. The waste and recycling
facility is another of Conigliaro's business interests.
"It does seem like the agencies, both at the state and the
federal level, may have been misled by some of the information
we were given," Massachusetts Governor Deval Patrick told
reporters on Wednesday.
In six states - Tennessee, Michigan, Maryland, Virginia,
Florida and now Indiana - the outbreak has claimed lives.
Five new cases were reported in Tennessee, which remained
the hardest-hit state with 49 cases, the CDC said. Michigan
added 11 cases and was at 39 on Thursday, with Virginia adding
three to reach 30 and Indiana six to reach 21, the CDC said.
The other states reporting cases are Maryland (13), Florida
(7), Ohio (3), Minnesota (3), New Jersey (2), North Carolina (2)
and Idaho (1), the CDC said.
