* 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
(Recasts, adds details throughout)
By David Morgan and Tim McLaughlin
WASHINGTON/BOSTON Oct 11 (Reuters) - The pharmacy at the
center of a deadly U.S. meningitis outbreak possibly linked to
tainted steroid injections faced mounting federal and state
scrutiny on Thursday, including a potential criminal probe, as
the national death toll climbed to 14.
As many as 14,000 people - 1,000 more than previously
thought - received injections from suspect shipments of steroid
treatments produced by the Framingham, Massachusetts-based New
England Compounding Center (NECC).
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.
The scare 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.
Massachusetts State Attorney General Martha Coakley
announced an investigation of NECC's operations after state
health officials said the company appeared to have violated
licensing requirements that limited compounding activities to
In compounding, pharmacies prepare specific doses of
approved medications, based on guidance from a doctor, to meet
an individual patient's need.
A U.S. House of Representatives committee with oversight of
health issues including drug safety called on NECC's co-owner
and chief pharmacist to document its role in the crisis, while a
Senate Democrat asked the U.S. Justice Department to conduct a
criminal probe of possible fraud violations.
As the pressure grew, NECC and two sister companies
-Ameridose LLC and Alaunus Pharmaceutical LLC - disclosed they
hired attorney Paul Cirel from the Boston law firm Collora LLC,
which is known for its high-level criminal defense work.
"We are absolutely engaged with federal and state
authorities to determine what led to the distribution of these
unsafe drugs," said Coakley spokesman Brad Puffer. "Once we have
identified the conduct and circumstances that led to this
tragedy, we will identify any potential legal action."
NECC officials were not immediately available for comment.
'NOT OUT OF THE WOODS'
The Centers for Disease Control and Prevention said 169
people who received epidural steroid injections for back and
neck pain have now been infected with rare fungal meningitis, a
rise of 32 cases since Wednesday. One more patient had an
infection after an injection in the ankle.
Meningitis has not yet been confirmed in that case, but it
underscored official concern that infections could begin rising
among those who received treatments for joint pain.
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.
Infections have been detected on average within two weeks of
a patient receiving the medication and as long as 42 days
afterward. Health authorities said more than 50 vials of the
steroid had so far been confirmed as contaminated with more
tests under way.
Anyone exposed to the NECC-supplied vials of the steroid
methylprednisolone acetate should be vigilant for health
problems for several months, CDC officials said. Local, state
and federal health authorities have contacted over 90 percent of
the 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.
"We are not out of the woods yet," said Dr. Todd Weber,
manager of the CDC's response to the outbreak.
The House Energy and Commerce Committee asked NECC to brief
its staff on the outbreak sometime before Oct. 18 and preserve
"all documents and communications that may be relevant to
understanding how the product was contaminated and distributed,
as well as business practices of the NECC in general."
Richard Blumenthal, who sits on the Senate's Health,
Education, Labor and Pensions 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.
The FDA can investigate a pharmacy once a risk to public
health arises and it 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.
"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 related pharmacies are owned by Gregory Conigliaro, an
engineer, and his brother-in-law Barry Cadden, the pharmacist in
charge of pharmacy operations at NECC and the recipient of the
House briefing request. The waste and recycling facility is
another of Conigliaro's business interests.
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 10 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.
(Additional reporting by Ros Krasny in Boston, Tim Ghianni in
Nashville; Writing by Michele Gershberg; Editing By Greg McCune
and Cynthia Osterman)
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