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Thu October 11, 2012
Meningitis Outbreak Linked To Compounding Pharmacies
Originally published on Thu October 11, 2012 3:23 am
STEVE INSKEEP, HOST:
We've been watching a deadly medical scandal unfold over the past week. A steroid commonly injected into people's spines to relieve back pain was apparently contaminated by an ordinary fungus.
RENEE MONTAGNE, HOST:
As a result so far, 137 people in 10 states have contracted a rare brain infection of fungal meningitis. Twelve people have died. The tainted drug apparently came from a pharmacy in Massachusetts that shipped nearly 18,000 doses to 23 states.
INSKEEP: NPR's Richard Knox is following this story from Boston. He's on the line. Hi, Richard.
RICHARD KNOX, BYLINE: Good morning.
INSKEEP: This is linked to something called a compounding pharmacy, which I'd never heard of before. What is it?
KNOX: It's a pharmacy that makes drugs and sends them off directly to doctors and hospitals. In this case, in 23 different states around the country. We should probably talk what compounding is. It's basically what pharmacy used to be all about - it's custom mixing a drug. Pharmacists mix a drug up for a particular patient. So for instance a cancer patient may need to have a different dose unless than the off-the-shelf dose, or a child may need to have a liquid preparation of something that only comes in pills. So a compounding pharmacist will mix it up and maybe add some cherry flavoring. The thing is that it's - we've gotten away from that. These companies have sort of morphed into little drug companies. And that's not really what they were supposed to be.
INSKEEP: OK. So this is the kind of work that you could imagine in some previous generation a pharmacist doing by crushing a drug in a mortar and pestle or whatever, and now it's being done on an industrial scale, which means if there's a problem, as there apparently was in one facility, it spreads across the country. How closely regulated are these facilities?
KNOX: Not very closely. And that's one of the big issues that this is shining a spotlight on. They used to be. Back in the 1990s, the FDA had a set of regulations that I'm told was pretty good and thorough and sufficient. But in 2002, the U.S. Supreme Court struck down the law that authorized those regulations. Specifically, they objected to the part of the law that prohibited these companies from advertising their wares across the country. And so the FDA has backed away and now regulation is left to the 50 individual states, which each have their own boards of pharmacy.
INSKEEP: OK. So they're effectively unregulated, at least by the federal government. States may be doing things. Is that possibly the reason there was a meningitis outbreak at this one pharmacy?
KNOX: The investigations on about how it actually occurred are ongoing and we'll learn a lot more about the details. But I think most people agree at this point that the states just don't have the capacity to regulate these sort of industrial-sized national shippers of drugs. I mean, for instance, how is Tennessee - which has had the most cases and deaths of this so far, of the fungal meningitis - how is Tennessee supposed to regulate a compounding pharmacy in Framingham, Massachusetts? And so - and you know, and there's so new evidence, actually, that one of the executives of this compounding pharmacy in Massachusetts and another one in Massachusetts sits on the regulatory board that oversees this.
INSKEEP: On the state level in Massachusetts.
KNOX: On the state level in Massachusetts. She supposedly has recused herself from voting on these companies. But it just shows you how these large-scale pharmacies, compounding pharmacies, have gotten integrated into the regulatory process.
INSKEEP: OK. So granting that we don't know all the answers, we know that there was a fungus which contaminated a steroid that was spread out from this one pharmacy. We don't know exactly why that happened or what relationship regulation might play. But it's shining a spotlight on these pharmacies. What has caused them to grow so dramatically?
KNOX: Well, they can make money doing it. They can make money undercutting the prices of traditional drugs from traditional drug companies. So I guess that's the simple answer. Some people have felt that shortages of drugs, severe shortages that we've been reporting on over the last year or so, may also give them a role to play, and they have. But many people think that that's not the major factor. It's basically - it's a profitable business.
INSKEEP: NPR's Richard Knox following this story from Boston. Richard, thanks very much.
KNOX: Sure. Transcript provided by NPR, Copyright NPR.