A fungal meningitis outbreak has killed 32 people and sickened 461 in 19
states, according to the U.S. Centers for Disease Control and Prevention’s
latest report. In Florida alone, there have been 23 cases, including three
deaths. A compounding pharmacy in Massachusetts, which distributed pain
steroids that later tested positive for contamination, is at the center
of an investigation into the deadly outbreak.
“Health officials say as many as 14,000 people received the steroid
injections, mostly for back pain,” the Associated Press reports.
The fungal infection causes inflammation of the meninges – protective
membranes that cover the brain and spinal cord. Anti-fungal medication
is used for treatment. But even patients who receive treatment are still
at risk of death, brain damage, hearing loss, learning disabilities, speech
complications, seizures, and paralysis, according to theMeningitis Foundation
On Nov. 14, a hearing of the U.S. House Energy and Commerce Committee convened
to examine the outbreak from the New England Compounding Center’s
facility in Framingham, Massachusetts. According to the NECC website,
the company has recalled all products shipped in 2012.
The AP article published Nov. 14 showed how the congressional committee
charged with investigating the outbreak hammered regulators. “After
a tragedy like this, the first question we all ask is: could this have
been prevented?” asked Rep. Cliff Stearns, R-Florida’s 6th
District, Republican chairman of the oversight and investigations panel.
“After an examination of documents produced by the Massachusetts
Board of Pharmacy and the U.S. Food and Drug Administration, the answer
here appears to be yes.”
A Reuters Newswire article said that in response to these types of questions,
Margaret Hamburg, commissioner of the U.S. Food and Drug Administration,
“insisted that the FDA lacks clear authority to regulate compounding
pharmacies due to conflicting court rulings and other regulatory ambiguities.”
Barry Cadden, co-owner of the NECC, is already exercising his Fifth Amendment
rights. In an AP article, he said: “Under advice of counsel, I respectfully
decline to answer under basis of my constitutional rights and privileges,
including the Fifth Amendment,” he said.