Nearly a year after a nationwide outbreak of fungal meningitis erupted, new cases of the disease are still emerging, and efforts to tighten regulation of the type of pharmacy behind the outbreak are moving slowly.
The Food and Drug Administration has reported 14 multistate or
national voluntary recalls so far this year of products made by
so-called compounding pharmacies, which custom-mix large batches of
medications not available from pharmaceutical companies. The FDA
reported only two recalls of products from such pharmacies in 2012,
including the recall of the injection behind the fungal-meningitis
cases. There were none in the four years before that.
The medicines recalled this year by their makers include cataract
drops, testosterone pellets and an injection like the one behind the
doctors say they are struggling to cure patients because very little is
known about a condition that normally affects plants, not people. More
than 700 out of 14,000 people who received tainted injections have
fallen ill since the outbreak began in September 2012, according to data
released this month from the Centers for Disease Control and
Prevention. That includes 86 cases diagnosed since the beginning of this
year. Hundreds are still in treatment. Of those who have gotten sick,
63 have died, including 24 this year, the CDC said.
And while the total number of cases hasn't risen in the past two
months, more could still fall ill. "There's no way this is over for
several years," said Tom Chiller, deputy chief of the CDC's
mycotic-diseases branch, one of the divisions that oversaw the federal
government's response to the fungal-meningitis outbreak last year.
Fungal diseases affecting bones or soft tissue can take months to
develop, he said. The CDC has launched a two-year study of approximately
500 fungal-meningitis patients to learn more about the long-term health
effects of their infections and to monitor the effectiveness of their
The slow pace of moves to tighten oversight and mounting case count
underscores how long the effects of a deadly outbreak are lingering. The
delayed response also illustrates how difficult it is to create a
system meant to mitigate widespread compounding errors.
A Senate bill that would give the FDA
oversight of many large compounding pharmacies—which operate like
manufacturers and sell drugs all over the country—is one of only a few
pieces of legislation that may make it to the Senate floor this fall,
according to Senate Democratic aides. Even if successful, it would be
months, if not years, before enforcement took effect.
The fungal-meningitis illnesses thus far have all been traced to a
single source: the New England Compounding Center, of Framingham, Mass.
NECC, through its court-appointed bankruptcy trustee, declined to
Bob Pinkstaff, of Elberfeld, Ind., thought he had
escaped harm last October when he showed no symptoms of fungal
meningitis despite having received one of the tainted NECC steroid
injections at an Evansville, Ind., pain clinic to relieve back pain from
injuries in a car accident.
But about five months after a spinal tap showed he was okay, a series
of symptoms were unrelenting. Headaches wouldn't go away; his eyes were
ultrasensitive to light. On March 7, a test confirmed the 59-year-old's
worst fears: his blood sample had the mold found in the contaminated
The medications he is on make him sweat profusely, requiring him to
change T-shirts several times a day. His eyes are so sensitive to light
that he has to watch TV with sunglasses. He said his doctors tell him
they don't know when he will be cured.
A spokeswoman for St. Mary's Health,
the multifacility health system in Evansville, Ind., where Mr. Pinkstaff
received his steroid injections and was initially treated, declined to
comment, citing privacy concerns.
"I wish I could just go back and have
my old pain, deal just with the back issues," said Mr. Pinkstaff, who
has been on disability since the car accident.
Doctors have had little experience to go on, as the type of fungus
that contaminated most of the injections—exserohilum rostratum—is
typically found on plants rather than in humans.
"We're unable to say whether a patient who is doing well is really in
the clear or not," said Lakshmi Halasyamani, chief medical officer for
St. Joseph Mercy Hospital in Ann Arbor, Mich., which has treated 195
people for fungal meningitis since October.
Traci Maccoux has spent 40 nights in the hospital since
she was diagnosed with fungal meningitis last October. Her medical bills
alone total more than $430,000, which her insurer has so far covered.
After halting treatment in April, she immediately began having searing
headaches, so she went back on treatment. Side effects from the drugs
have blurred her vision, leaving her unable to drive for long distances
and house-bound. The 23-year-old from Brooklyn Park, Minn., could enroll
in only one class for her junior year of college this fall, said her
mother, Cathy Maccoux. "Her biggest fear is if she'll ever be able to
get her life going again—and nobody knows," she said.
The proposed Senate legislation would give the FDA oversight of big
compounding pharmacies and subject them to regulations like those
required of pharmaceutical manufacturers. Now they are regulated by
state pharmacy boards, but regulation differs from state to state.
Under the bill, which Senate Democratic aides say could come up for a
vote this month, large compounding pharmacies that make sterile
products, such as steroid injections, would be reclassified as
"compounding manufacturers." Those with more than $1 million in annual
revenue would pay a $15,000 fee every year and be placed on a national
registry. Inspections would occur every three years.
The Senate bill "provides the agency with the authorities needed for
more effective and appropriate oversight of the pharmacy compounding
industry," said Erica Jefferson, an FDA spokeswoman. "If we don't, we
will continue to see tragedies that may have been prevented in the
The International Academy of Compounding Pharmacists, an industry
group, opposes the Senate bill. It "will not assure Americans of safety
and will limit the ability of pharmacists to provide vitally needed
medication to patients," an IACP spokesman said. The Senate bill too
aggressively limits the types of compounding allowed at an individual
pharmacy, the spokesman added.
Meanwhile, the number of recalls of productsat compounding pharmacies
has mushroomed. Most recently, on Aug. 11, Specialty Compounding LLC of
Cedar Park, Texas, voluntarily recalled all of its sterilized products
after 15 people developed bloodstream infections caused by Rhodococcus
equi, a bacteria, following injection with a mineral supplement used to
treat conditions associated with low-calcium levels or for cardiac
Specialty Compounding's independent laboratory testing "has not yet
proven an association between the medication compounded by Specialty
Compounding and the infected patients," said a spokesman.
Some patients like Angel Farthing of Abingdon, Md., a Baltimore
suburb, say that due to broader skepticism about prescribing opioid
painkillers, they are having trouble getting physicians to treat their
ongoing pain—intensified by meningitis-related issues like abscesses
near the injection or arachnidits, a clumping up of the nerves.She
finally found someone willing to treat her pain: the same doctor at the
clinic that gave her the NECC injection.
It isn't clear how many more people will develop fungal meningitis,
health officials say. Thousands of those who received injections have
never been tested for the disease. "There remains a currently impossible
to quantify risk for a currently impossible to specify number of
exposed patients," said John Dreyzehner, commissioner of the Tennessee
Department of Health. Tennessee was an epicenter of last fall's