Meningitis Outbreak Toll Now 33 Dead, 480 Sickened, CDC Says
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FRIDAY, Nov. 16 (HealthDay News) — The ongoing meningitis outbreak
tied to tainted steroid injections has now reached 480 cases, and
another person has died, bringing the total fatalities to 33, the U.S.
Centers for Disease Control and Prevention announced Friday.
The latest death from a rare, fungal form of meningitis occurred in
Indiana, the agency said.
The political and legal fallout from the steroid-linked outbreak also
continues to mount. On Thursday, the head of the lobby that represents
compounding pharmacies told a U.S. Senate committee that tighter
federal regulations were not needed to oversee his industry, despite
the rising death toll from the outbreak that’s been linked to products
from these types of pharmacies.
According to the Associated Press, the head of the International
Academy of Compounding Pharmacists testified that existing
regulations, which primarily put oversight responsibility on
individual states, are enough to monitor compounding pharmacies.
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 U.S. Food and Drug Administration.
These specialty pharmacies aren’t subject to the same FDA oversight as
regular drug manufacturers. So, some members of Congress are calling
for greater FDA regulation of these businesses.
But David Miller, chief executive officer of the compounding
pharmacies’ lobbyist group, told the senators that current state laws,
if enforced, would have prevented the meningitis outbreak. And the
Massachusetts company in question, the New England Compounding Center
in Framingham, was shipping medication without first receiving
prescriptions from doctors, a violation of its state-issued pharmacy
license, Miller said in prepared testimony, the AP reported.
“The operations of NECC were clearly outside of the scope of the
state’s licensure requirements and their license should have been
pulled long ago,” Miller said, according to the AP.
The International Academy of Compounding Pharmacists has spent more
than $1 million lobbying Congress in the last 10 years and has
successfully defeated laws and regulations opposed by the compounding
industry, the AP reported.
On Wednesday, the owner of the New England Compounding Center refused
to testify before a House of Representatives committee that’s also
investigating the steroid/meningitis outbreak.
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 AP reported.
But FDA Commissioner Margaret Hamburg told the House committee
Wednesday that new laws are needed to give her agency more legal
authority and funding to oversee compounding pharmacies.
“The challenge we have today is that there is a patchwork of legal
authorities that oversee the action we can take,” Hamburg, who was
nominated to head the FDA by President Obama in 2009, said in prepared
testimony, the AP reported.
She said Congress should draft new laws and provide more funding to
police large specialty pharmacies, such as the New England Compounding
Center, which aren’t subject to the same FDA scrutiny as big drug
manufacturers.
“In light of growing evidence of threats to the public health, the
administration urges Congress to strengthen standards for non-
traditional compounding,” Hamburg said.
Republican lawmakers, who constitute the majority party in the House
of Representatives, spent considerable time focusing on the New
England Compounding Center’s checkered past, asking Hamburg why
regulators at the FDA and the Massachusetts board of pharmacy did not
take action against the company several years ago, the AP reported.
Hamburg said problems uncovered in past inspections were “very
serious,” but that the FDA, under current law, was obligated to defer
to Massachusetts authorities, who have more direct oversight over
pharmacies in the state, the AP reported.
Last month, FDA investigators who toured the New England Compounding
Center’s 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 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: 55 cases, including 5 deaths; Maryland: 23 cases, including 1
death; Michigan: 158 cases, including 8 deaths; Minnesota: 13 cases;
New Hampshire: 13 cases; New Jersey: 31 cases; New York: 1 case; North
Carolina: 3 cases, including 1 death; Ohio: 17 cases; Pennsylvania: 1
case; Rhode Island: 3 cases; South Carolina: 1 case; Tennessee: 82
cases, including 13 deaths; Texas: 2 cases; Virginia: 50 cases,
including 2 deaths.
Eleven of the 480 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.
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