Understanding The Role Of Compounding Pharmacies After Dozens Of Deaths

Mar 26, 2017
Originally published on March 26, 2017 1:17 pm
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LOURDES GARCIA-NAVARRO, HOST:

In the fall of 2012, officials were scrambling to figure out why people across the country had contracted fungal meningitis and other rare and dangerous infections. They ended up tracing the outbreak back to the New England Compounding Center, or NECC. Its contaminated injections sickened more than 700 people, killing at least 64 of them. It was the largest pharmaceutical-caused health crisis in U.S. history.

This past week, Barry Cadden, the co-owner and head pharmacist at NECC, was convicted of racketeering and fraud. However, he was acquitted on murder charges for the patients who died. We're joined now by Gabrielle Emanuel of member station WGBH in Boston. She's been following Cadden's trial and the compounding pharmacy industry more broadly. So Gabrielle, help us understand what exactly is a compounding pharmacy. Let's refresh our memories here.

GABRIELLE EMANUEL, BYLINE: So if you go to a local CVS or a Walgreens, that would be a retail pharmacy. You go up to the counter, and you get your medication that was likely made in bulk by a drug manufacturer.

GARCIA-NAVARRO: OK.

EMANUEL: But those medications don't actually work for everyone. Some people are allergic to an ingredient, or they need maybe a specific dose. Compounding pharmacies make those drugs, basically custom-made medications, for an individual patient.

GARCIA-NAVARRO: So let's go back to the subject at hand, which is Barry Cadden's pharmacy. It's now closed. What did they find out during the trial? What was the condition of the place where the drugs were made?

EMANUEL: It was absolutely filthy. So the clean rooms, which are basically where drugs are made - there was mold; there were insects; there were bacteria in there. And when that came out, a lot of people were asking - where were the inspectors? Where were the regulators? And actually, the prosecutors introduced an exhibit during the trial, and it's a video of Cadden doing an employee training, and he's talking about those inspectors.

(SOUNDBITE OF VIDEO)

BARRY CADDEN: They don't even know what they're looking at. They have no clue. They go around. They're, like, oh Barry, this place looks great. OK. Hey, I got to go - cup of coffee. And they go out the door. Really, that's what it is like.

GARCIA-NAVARRO: That's an incredible bit of audio - very incriminating, one would suspect.

EMANUEL: Yeah. And after this all came to light, there was a lot of confusion as people were kind of finger-pointing. They were saying, who's to blame for this? And it wasn't totally clear whether the FDA, the Food and Drug Administration, was supposed to be overseeing them - they oversee drug manufacturers. Or did it fall to state regulators who usually oversee pharmacies?

GARCIA-NAVARRO: So have things changed? Have these compounding pharmacies gotten safer? Is that now clear, who has regulatory oversight?

EMANUEL: So this outbreak was a big wake-up call. It focused attention on this industry. And in 2013, right after the outbreak, Congress passed a law clarifying what outfits are overseen by the FDA and which ones are overseen by state government. Now, a lot of compounding that's done for individuals are still overseen by states.

And many states have stepped up their regulations. However, it's not a perfect system, and there are two big issues here. First, states may have stronger regulations, but they don't necessarily have sufficient resources for oversight and regular inspections. The second problem is that there is a lot of variability from one state to the next.

GARCIA-NAVARRO: Variability, what does that mean?

EMANUEL: Some states have really strong regulations and other states really don't. In the 2012 outbreak, the injections were made in Massachusetts - here where I am - but none of the victims were here in Massachusetts. The drugs had actually been shipped out to more than 20 states.

GARCIA-NAVARRO: That's Gabrielle Emanuel from member station WGBH in Boston.

Thanks so much.

EMANUEL: Thank you.

GARCIA-NAVARRO: And tomorrow on Morning Edition, a story of how families in Puerto Rico are coping with a severe outbreak of the Zika virus. Transcript provided by NPR, Copyright NPR.