Trial Begins In Meningitis Case That Reshaped Compounding Pharmacies
STEVE INSKEEP, HOST:
Opening statements begin today in the murder trial of a former Massachusetts pharmacist who is accused of causing a nationwide meningitis outbreak that killed 64 people. As Gabrielle Emanuel of member station WGBH reports, this 2012 tragedy has changed lives and reshaped an industry.
GABRIELLE EMANUEL, BYLINE: Disney World is known for Mickey Mouse and Space Mountain. But what Kristen Townsley remembers from her childhood visit is a doorknob.
KRISTEN TOWNSLEY: And I reached out for a doorknob. And I sank to the ground in, like, hysterical tears because it hurt so bad to just turn a door knob.
EMANUEL: 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 in 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 a home in Alabama but in Minnesota, getting treatment at the renowned Mayo Clinic.
TOWNSLEY: My face was, like, flaking off - like, literally.
EMANUEL: The tainted injections had given her fungal meningitis, triggering a cascade of medical problems that she says continue to today. Kristen Townsley was not alone. Those tainted vials made their way to 20 states. Seven hundred fifty people were affected, and 64 of them died. Many of the victims and their families have received compensation. The FDA, the CDC and state health officials managed the crisis response. Joshua Sharfstein was in charge of Maryland's health department.
JOSHUA SHARFSTEIN: We basically had to run this as a public health emergency. We just couldn't expect that people would go to the emergency department and get correctly diagnosed 'cause it was so unusual.
EMANUEL: An investigation traced the bad injections to the New England Compounding Center in Massachusetts. They'd been using expired ingredients in unsanitary conditions and making large batches.
SHARFSTEIN: And that led Congress to pass a law significantly expanding the regulatory oversight of compounding pharmacies.
EMANUEL: These pharmacies are much smaller than the big drug manufacturers. Some produce on a tiny scale, often making drugs for just one patient at a time, say, someone with an allergy or a kid who needs a small dose. Others make medications in large batches. Congress mandated that the FDA oversee the bigger compounding pharmacies. But the small-dose pharmacies are still primarily overseen by states. In Massachusetts, where the outbreak originated, the state stepped up its regulations. As the rules changed, Stephen Bernardi changed his compounding pharmacy just outside Boston to keep pace.
STEPHEN BERNARDI: The part we're in is the anteroom, with our dishwasher and all the stuff. So everything gets prepped out here.
EMANUEL: In this room with a sophisticated ventilation system, pharmacists clean their beakers and other tools. They're subject to new procedures following the outbreak.
BERNARDI: Prior to that, you might've gotten inspected twice in 12 years. Now you're getting inspected 12 times in one year.
EMANUEL: Following the outbreak, 18 states enacted laws related to compounding pharmacies. And other states are following suit. But there's still a lot of variation state by state. So now, as courts litigate the past outbreak, regulators are in the process of reforming a complex industry with the hope of preventing future outbreaks. For NPR News, I'm Gabrielle Emanuel. Transcript provided by NPR, Copyright NPR.