Meningitis Outbreak, 2012
Emily Crocker
In 2012, the
United States witnessed, as Scott Pelley puts it, “the worst pharmaceutical
disaster in decades.” New England Compounding Center (NECC), had begun mass
production of methylprednisolone acetate, a steroid used to treat chronic joint
pain, when recipients of the treatment were diagnosed with fungal meningitis.
NECC
is a compounding pharmacy, meaning that it is authorized to produce medications
for the individual without oversight of the Food and Drug Administration (FDA).
The theory behind this is that producing one prescription at a time should
allow the technicians to put special care into each of the medications, which
would render FDA funds not well spent.
Compounding
pharmacies are bound by one rule, and that is to have a prescription that
matches each of the medications produced. Clearly, prescribers are able to find
loopholes around this rule for their own profit. They write prescriptions for
their imaginary patient under a pseudonym, receive the medication, and sell it
at a price that matches the brand name.
The
influx of prescriptions was too much for the small compounding pharmacy to
handle without oversight of the FDA. “…[T]he
company got greedy and overextended and we got sloppy…” says Joe Connolly, a
technician in NECC’s Clean Room 1. He reports that in a span of three years,
approximately 12 cases of mold were noticed in the clean room, to which the
technicians would respond by cleaning the mold and continuing with their work.
Connolly expressed his concern of patient safety to his supervisor, who simply
shrugged.
 |
| Corrosion of Clean Room 1 storage unit Obtained from 60 Minutes |
Methylprednisolone
acetate was one of the drugs contaminated at NECC. The drug, which is meant to
be injected into joints to relieve pain, was injected into the spine of many
patients experiencing lower back pain. As a result, the fungus entered the
patients’ nerves and caused them to contract fungal meningitis. Meningitis is a
disease marked by inflammation of the membranes surrounding the brain and spinal
cord, where symptoms include headache, nausea, dizziness, and vomiting. It can be caused by viral, bacterial, or fungal infection and is fatal in
some cases.
 |
| Fungus cultured from spinal fluid of an infected patient Obtained from 60 Minutes |
“I’m
on 60mg of morphine every day with no cure in sight…” says Willard Mazure, one
of the many patients affected by the contamination. “The medicine is just unbearable. You know, they talk about
cancer treatments, and I'm sure they're unbearable too. But this is some
unbearable stuff.”
48
people have been killed from the contamination of methylprednisolone acetate
and 720 people are being treated for recurring infection of the fungus. These
statistics are due in part to NECC’s greed. It is because of this greed that
patients speak ill of NECC’s president, Barry Cadden. When multiple patients
were asked what they would say to Barry Cadden, one said, “Whatever I said to him I hope it'd be through bars.”
“I'm sad to say that if we do not put in place the
comprehensive legislation that really defines roles and responsibilities, we will
have other similar problems,” States FDA Commissioner, Margaret Hamburg. Without
proper oversight of compounding pharmacies, instances like this are bound to
happen again.
In
terms of social justice, this situation raises a red flag. Putting the health
of hundreds of Americans was put on the line for financial gain is inexcusable.
Former Commissioner of the FDA, David Kessler, states, “This should not happen
in 2013…There is no reason why people had to die.”
No comments:
Post a Comment