UPDATE 3-US meningitis outbreak widens as demands rise for criminal probe


* 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

(Updates throughout with briefing from U.S. health officials)

By David Morgan

WASHINGTON, Oct 11 (Reuters) - As many as 14,000 people -more than previously thought - received possibly tainted steroidinjections tied to a deadly U.S. meningitis outbreak andpatients should watch for symptoms for several months, healthofficials said on Thursday.

The officials said the company at the center of theoutbreak, the Massachusetts New England Compounding Center,appeared to have violated its license by producing largequantities of drugs rather than prescriptions for individualpatients, as calls grew for a criminal probe.

"This organization chose to apparently violate the licensingrequirements under which they were allowed to operate," said Dr.Madeleine Biondolillo, director of the Massachusetts Departmentof 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. Centersfor Disease Control and Prevention and the Food and DrugAdministration in a briefing on the outbreak. The CDC said thenumber of people at risk, which is 1,000 higher than earlierestimated, was revised after consulting with health authorities.

Fourteen patients have died from the rare form of fungalmeningitis and 169 people have been infected, a rise of 32 casessince Wednesday, the CDC said. One more patient had an infectionafter an injection in the ankle, but meningitis has not yet beenconfirmed.

Infections have been detected within two weeks of a patientreceiving the medication, on average, and up to 42 daysafterward.

But anyone exposed to the NECC-supplied vials of the steroidmethylprednisolone acetate - used to treat back pain and otherconditions - should be vigilant for health problems for severalmonths, CDC officials said. Local health authorities havecontacted over 90 percent of patients who may have been exposed.

Florida reported a second death from meningitis and Indianareported its first death from the outbreak, with cases confirmedin 11 states.

Richard Blumenthal, who sits on the Senate's HealthOversight Committee, said on Thursday he requested a federalcriminal probe in a letter to U.S. Attorney General Eric Holder.

"I've reached no conclusions, but there are at leastsufficient facts to warrant an investigation," Blumenthal, aformer Connecticut state attorney general and federalprosecutor, told Reuters in a telephone interview.

"The company, its officers, employees and maybe others mayhave violated state and federal criminal laws in their potentialmisrepresentations to government agencies regarding theirproducts," he said.


Meningitis is an infection of the membranes covering thebrain and spinal cord. Symptoms include headache, fever andnausea. Fungal meningitis, unlike viral and bacterialmeningitis, is not contagious.

The outbreak has developed into a major health scandal, withauthorities scrambling to determine how the steroid treatmentswere contaminated, track down those affected and treat them. Ithas also raised questions about how the pharmaceuticals industryoperates and is regulated.

"We're continuing to investigate the facts and make sure wehave a thorough understanding of exactly what is happening andexactly what we were or were not told," said Deborah Autor, FDAdeputy commissioner for global regulatory operations and policy.

"The world has changed a lot from the days of mortar andpestle," Autor said. "This is the time for pharmacists, forlawmakers, for regulators, for doctors, to grapple with this newmodel of pharmacy compounding and come up with a regulatoryscheme that appropriately controls risk."

The FDA regulates drug manufacturers but not the practice ofcompounding, in which pharmacies prepare specific doses ofapproved medications, based on guidance from a doctor, to meetan individual patients' need.

The agency can investigate a pharmacy once a risk to publichealth arises, and is now part of a probe of NECC, whichoperated out of a brick complex next to a waste and recyclingoperation in a western suburb of Boston. The company hassuspended operations and recalled all of its products.

The FDA said on Thursday that more than 50 vials of steroidtreatments from NECC t ested positive for a fungus that causesmeningitis.

The pharmacies are owned by Gregory Conigliaro, an engineer,and his brother-in-law Barry Cadden, a pharmacist who was incharge of pharmacy operations at NECC. The waste and recyclingfacility is another of Conigliaro's business interests.

"It does seem like the agencies, both at the state and thefederal level, may have been misled by some of the informationwe were given," Massachusetts Governor Deval Patrick toldreporters 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 remainedthe hardest-hit state with 49 cases, the CDC said. Michiganadded 11 cases and was at 39 on Thursday, with Virginia addingthree 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 inNashville; Writing by Michele Gershberg; Editing By Greg McCuneand Peter Cooney)