WEDNESDAY, Nov. 14 (HealthDay News) -- The owner of the
Massachusetts specialty pharmacy implicated in the meningitis
outbreak that has killed 32 people declined to testify Wednesday
before a Congressional committee investigating the matter, the
After a series of questions from members of the House Energy and
Commerce Committee, Barry Cadden, co-founder of the New England
Compounding Center, said: "Under advice of counsel, I respectfully
decline to answer under basis of my constitutional rights and
privileges, including the Fifth Amendment."
The committee hearing is focused on whether the outbreak, which
has also sickened 438 people, could have been prevented.
Also expected to speak Wednesday is U.S. Food and Drug
Administration Commissioner Margaret Hamburg. She is expected to
tell the committee that new laws are needed to give her agency more
legal authority and funding to oversee so-called compounding
pharmacies, like the one in Massachusetts at the center of the
deadly outbreak, the
Compounding pharmacies combine, mix or alter ingredients to
create drugs to meet the specific needs of individual patients.
Such custom-made drugs may include a smaller dose, for example, or
the removal of an ingredient that might trigger an allergy in a
patient, according to the FDA.
Compounding pharmacies aren't subject to the same FDA oversight
as regular drug manufacturers.
The New England Compounding Center in Framingham was the source
of the tainted steroid injections, which are typically used for
back and joint pain. The company has ceased operations since the
meningitis outbreak first surfaced early last month.
Meningitis is inflammation of the lining surrounding the brain
and spinal cord. Infected patients have developed a range of
symptoms approximately one to four weeks following their
On Thursday, Hamburg is scheduled to testify before the Senate
Committee on Health, Education, Labor, and Pensions.
Last month, FDA investigators who toured the Framingham plant
found foreign, "greenish-black" material in some vials of the
injectable steroid suspected as the cause of the illnesses, federal
health officials said. The contaminated product was one of a host
of potential violations discovered during the recent inspection,
the officials said.
"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during an Oct. 26 news conference.
In addition, the company couldn't prove that the equipment used
to sterilize these products was actually able to sterilize them,
The FDA also found that the company wasn't able to keep its
"clean room" clean, Lynn said. "A clean room is a space designed to
maintain a controlled environment with low levels of airborne
particles and surface contamination," he explained.
The U.S. Centers for Disease Control and Prevention on Friday
had the following state-by-state breakdown of cases: Florida: 23
cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case;
Illinois, 2 cases; Indiana: 52 cases, including 4 deaths; Maryland:
23 cases, including 1 death; Michigan: 128 cases, including 7
deaths; Minnesota: 11 cases; New Hampshire: 13 cases; New Jersey:
27 cases; New York: 1 case; North Carolina: 3 cases, including 1
death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 3 cases;
South Carolina: 1 case; Tennessee: 81 cases, including 13 deaths;
Texas: 2 cases; Virginia: 50 cases, including 2 deaths.
Ten of the 438 cases involve what the CDC calls "peripheral
joint infection," meaning an infection in a knee, hip, shoulder or
elbow. These joint infections aren't considered as dangerous as
injections near the spine for back pain that have been linked to
the potentially fatal meningitis infections.
The CDC and state health departments estimate that roughly
14,000 patients may have gotten steroid injections from the New
England Compounding Center. All of the fungal meningitis patients
identified so far were thought to be injected with the steroid
methylprednisolone acetate, according to the CDC.
People who have had a steroid injection since July, and have any
of the following symptoms, should talk to their doctor as soon as
possible: worsening headache, fever, sensitivity to light, stiff
neck, new weakness or numbness in any part of your body or slurred
speech, the CDC said.
The U.S. National Library of Medicine has more about
injections for back pain.