Chesapeake, Va. — Ginny Rauch thought she was
going to die. The pain in her legs and back was so excruciating that she could
hardly breathe at times. A steroid shot that was supposed to ease her back pain
had instead left her with a
near-fatal case
of fungal meningitis.
That was 2002. Now, 10 years later, Rauch has flashbacks to her ordeal and
says she is angry that a
new
meningitis outbreak has killed 29 people and sickened 377 across the U.S.,
including in North Carolina.
“When I heard what happened to all these people, I could just not believe
that this had happened, because it’s cleanliness,” Rauch said. “If they had done
what they said they were going to do, this would’ve never happened.”
Rauch was one of the lucky ones 10 years ago. She survived, while two other
North Carolinians died. The 71-year-old former Raeford music teacher, who now
lives in Virginia, says she is on a mission to hold the Food and Drug
Administration accountable for the tainted medicine, even if that means speaking
before Congress.
“I just don’t feel that we should ever have to have this conversation again.
To me, it’s ridiculous. It’s absolutely ridiculous,” Rauch said. “We’re killing
our own people in the United States from filth.”
A Spartanburg, S.C., pharmacy manufactured the tainted medicine that sickened
Rauch and killed two others. The current meningitis cases stem from a specialty
pharmacy in Framingham, Mass.
In both cases, the shots came from compounding pharmacies. Compounding, which
involves making a special order for an existing drug, is something all
pharmacies do. Pharmacy experts say special orders aren’t the problem. The
problem is when pharmacies start mass producing those special orders for the
public, instead of just for one patient.
“It’s hard not to attribute this to greed, simple greed,” said Jay Campbell,
executive director of the North Carolina Board of Pharmacy, which inspects
pharmacies. “The issue is where is the line between legitimate compounding
pharmacies and full-blown manufacturing?”
Campbell says big compounding companies can sell drugs for less. They need
FDA inspection but often operate in a gray area and avoid the type of oversight
Campbell thinks they need.
The FDA released a statement to WRAL Investigates, saying that its
"regulatory authority over compounding pharmacies is more limited by statute
than it is for typical drug manufacturers."
"Compounding pharmacies and pharmacists are responsible for the quality and
safety of the drugs they produce for patients. The FDA will continue to act
within its existing authorities to protect public health and help ensure the
safety of medical products," the FDA's statement continued.
"Once the immediate crisis is contained, the FDA is committed to working with
Congress, compounders, the states, and all other stakeholders to strengthen the
system to prevent tragedies like this from happening again."
Inspectors struggle to visit clinics regularly
In North Carolina, eight state inspectors cover 1,600 pharmacies across the
state, 40 to 50 of which specialize in compounding. At that rate, it takes two
to three years to do routine visits for each.
Compounding pharmacies are regulated by state boards of pharmacy and are
exempt from FDA regulations. The FDA regulates only the ingredients.
No meningitis outbreaks have been tied to North Carolina pharmacies, but in
2005, large drug orders from Triangle Compounding Pharmacy were called into
question after a
woman died using the
company's numbing gel for hair removal. The company was issued an Order of
Reprimand, which is a form of public discipline that goes to the National
Practitioner Data Bank. No problems have been reported since.
The WRAL Investigates team examined two years of state inspections for all
North Carolina pharmacies and found no major problems. However, inspectors noted
several times that compounding areas needed to be cleaned better to avoid cross
contamination of drugs. Inspectors also found a lot of expired drugs still on
shelves.
FDA inspectors struggle with resources for routine inspections as well.
In 2008, pre-filled syringes of saline from an Angier company – under FDA
inspection – were linked to a
bacterial
infection outbreak that killed five people and infected at least 288. Two
managers of the company, AM2PAT, pleaded guilty to fraud and allowing tainted
drugs into the marketplace and were serving four-year sentences in federal
prison.
Federal authorities are still searching for Dushyant Patel, the company’s
former president and chief executive, who was indicted on 10 federal charges,
including fraud and selling adulterated medical devices. Authorities said in
2010 that he might have fled to his native India.
After a
2005 warning letter to
AM2PAT, inspectors found no major safety violations in annual visits.
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