Disney World is known for Mickey Mouse and Space Mountain. But what Kristen Townsley remembers from her childhood visit is a doorknob.
“I reach out for a doorknob,” remembered Townsley. “And I sunk to the ground in hysterical tears because it hurt so bad. To just turn a doorknob.”
The pain continued, and Townsley went from doctor to doctor seeking help. After several years she got a diagnosis: juvenile rheumatoid arthritis.
There is no cure. So, she embarked on a life of frequent treatments and medications, including injections into her spine and pelvis.
At age 28, things were going well, and her pain was under control. But in October 2012, she got a call from her doctor: three injections she’d received were contaminated.
Townsley spent her 29th birthday, not at home in Alabama, but in Minnesota getting treatment at the renowned Mayo Clinic.
“My face was flaking off,” says Townsley.
The tainted injections had given her fungal meningitis, triggering a cascade of medical problems that, she says, continue to today.
Townsley was not alone. Those tainted vials had made their way to 20 states, affecting more than 750 people and killing at least 64 of them.
The FDA, the CDC and state health officials managed the crisis response.
"We basically had to run it as a public health emergency,” says Joshua Sharfstein, who ran Maryland’s health department during the 2012 meningitis outbreak. “We just couldn't expect that people would go to the emergency department and get correctly diagnosed because it was so unusual."
An investigation traced the bad injections to the New England Compounding Center in Framingham, MA. It found that NECC had been using expired ingredients in unsanitary conditions and making large batches.
Barry Cadden, the co-owner and head pharmacists of NECC, is now in the early stages of his trial. He’s accused of second-degree murder and racketeering. If found guilty, he faces up to life in prison.
Although it has taken years to litigate the charges against Cadden, lawmakers and regulators didn’t wait.
The outbreak and the ensuing investigation “led Congress to pass a law significantly expanding the regulatory oversight of compounding pharmacies," says Sharfstein.
These pharmacies are much smaller than big drug manufacturers. But there are two broad types.
Some produce on a tiny scale – often making drugs for just one patient at a time. These are used for patients who have a special need: perhaps for individuals with rare allergies or children who need a smaller-than-standard dose. Others compounding pharmacies make medications in larger batches.
Congress mandated that the FDA oversee the bigger compounding pharmacies. But states remain the primary regulators of the small-dose pharmacies.
Massachusetts—where the outbreak originated—stepped up its regulations following the outbreak.
As the rules changed, Stephen Bernardi changed his compounding pharmacy—Johnson Compounding and Wellness Center outside of Boston—to keep pace.
Bernardi says he’s invested over a million dollars building his pharmacy’s labs, where pharmacists and technicians are subject to new procedures following the outbreak.
"Prior to that, you might have gotten inspected twice in 12 years. Now you’re getting inspected 12 times in one year," says Brenardi.
The state has revamped regulations related to drug testing, cleanliness standards, and expiration dates. And this is not just the case in Massachusetts.
In the years since the outbreak, 18 states have enacted laws related to compounding pharmacies, and other states are following suit. But experts say there’s still a lot of variation state by state.