TOPICS > Health

More Drugs May Have Been Tainted, Linked to Meningitis Outbreak

October 16, 2012 at 12:00 AM EST
More sick patients raise concerns of the spreading effect of a New England compounding company's tainted medicine, which has caused meningitis in several people. Judy Woodruff talks to USA Today's Dan Vergano about the public health effort to warn doctors, as well as the regulatory authority of the FDA.
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TRANSCRIPT

JUDY WOODRUFF: And we turn to the latest on the meningitis outbreak and tainted medications.

The Centers for Disease Control reported today that another 19 people have been diagnosed with fungal meningitis. That brings the total number of cases so far to more than 231 people in 15 states. Fifteen have died. The overwhelming number of cases have been linked to a steroid injection used for back or joint pain.

But the Food and Drug Administration is concerned about how many people may have been exposed to the fungus found in that medication and others made by the New England Compounding Center. It said yesterday that at least two additional drugs, one a cooling solution used in heart surgery, the other used in the eye, may also be linked with meningitis. The widening number of cases and the investigation are triggering more questions.

And we ask some of them of Dan Vergano. He’s been reporting on all this for USA Today.

And welcome.

DAN VERGANO, USA Today: Thanks for letting me be here.

JUDY WOODRUFF: So, how did authorities know that other drugs might be involved in all this?  

DAN VERGANO: Well, they have two sick patients. One is a case of potential meningitis in a heart transplant patient. The other is a person who has a fungal infection that’s linked to meningitis.

It’s not a full-blown case of meningitis in that case, but it’s enough that you have two new patients who may have been infected by these medications made by this pharmacy. And that’s enough to trigger the warning from FDA.

JUDY WOODRUFF: And the concern is other types of infections as well as meningitis, as I understand it; is that right?  

DAN VERGANO: Meningitis is the chief concern, but, yes, it can cause infections in the joints and things like that, that — not a good idea.

JUDY WOODRUFF: But the connection, as I also understand it, is not completely confirmed yet. They have the patients. They’re concerned that there may be a link, but they haven’t been able to nail it down yet.

DAN VERGANO: Right.

FDA is careful to say they’re only saying it’s out of an abundance of caution. That’s their language. Here, we have a potential meningitis case in patients — in a patient who had a drug from this pharmacy, but it’s not enough. You know, you have to basically have the fungus in the patient or the meningitis in the patient and see the link directly to the medication they received. And they haven’t been able to do that yet. So, this is at this point a caution.

JUDY WOODRUFF: And, again, at this point, we’re just talking about two cases, two people. Is that right?

DAN VERGANO: Today two people. That’s aside from the, you know, 231 or so patients that we’re talking about with the original drug.

JUDY WOODRUFF: So, how is the FDA going about looking for more people?  Is it — I mean, have they just put the word out to doctors offices and hospitals around the country?  

DAN VERGANO: Well, our public health enterprise is going into operation here.

State health folks are taking a look for patients. They’re talking to hospitals. Everybody is reporting it and keeping an eye out for it. So, typically, it’s the state that will note a case, send it out, lab samples. And if it comes back positive, then CDC adds it to the list. And here we have suspect cases where FDA is worried about them.

JUDY WOODRUFF: And so it’s a matter of just putting the word out and hoping people respond?  

DAN VERGANO: No.

I mean, we have an active public health enterprise in this country and state boards are tackling it. But, yes, they’re trying to get out the word out to doctors, so they notice and report these things, take that first step and worry about these cases. Don’t give these drugs. Doctors aren’t supposed to give these drugs to people anymore and to alert these patients. The FDA is saying to patients — to doctors, rather, tell your patients who may have been treated with ophthalmic drugs, heart transplant patients who may have gotten this company’s drug, tell them they may be at risk and have them come in and check them out.

JUDY WOODRUFF: And are they saying what symptoms people should be looking for?  

DAN VERGANO: Yes.

Meningitis’ symptoms are fever, but especially stiff back, headaches, soreness. And that sounds like a lot of things , but if you have the combination of having been treated with this company’s drugs and those sort of things, it typically takes about two weeks to develop they said after — one to three weeks — but two weeks is sort of the medium after you receive one of these injections for the symptoms to appear.

JUDY WOODRUFF: And so again, Dan, what is the FDA — I know the CDC is obviously involved in this, state agencies, public health agencies. What are they doing to try to get to the bottom of this, especially when it comes to the New England Compounding Center where all of this started?  

DAN VERGANO: Well, each one of the players you named has different responsibilities. That’s how we do it in this country.

The primary responsibility is with the company to deliver safe drugs. But when that doesn’t happen, then the state has responsibilities to oversee compounding centers like this one. FDA has jurisdiction over the drugs they deliver out from the facility. And CDC is just keeping an eye on cases. They have sort of the public health side, so they see the sick people.

So, here we see the different parts of the enterprise in action. And in fact, you have state boards essentially finding cases. You know, Virginia found an interesting case with an injection that caused just an infection, not a meningitis case, and Michigan and Tennessee very active states reporting these cases and CDC sort of picking them up.

And so all these pieces are kind of working together.

JUDY WOODRUFF: And is there — from your reporting on this — and you have focused on public health issues a lot. Is it your sense that the agencies feel they have the staffing and the resources to get to the bottom of this?  

DAN VERGANO: Well, they won’t come out and say that often to us. But clearly FDA wanted more oversight over these facilities.

There’s this failed history of regulatory — you know, regulations that didn’t get passed that they pulled for, lost court case a decade ago where FDA was trying to exert more authority. And the agency, you know, can always — well, the agency probably would have wanted to inspect this place sooner than they ended up doing it. So, it seems like they could have used a little more muscle.

JUDY WOODRUFF: Is there a very — is there a real concern though that other drugs could be — I mean, these two additional cases obviously raise a red flag. But is there a concern that still other drugs could be somehow contaminated from this center?  

DAN VERGANO: Sure.

All 1,200 or so drugs this company makes aren’t being used anymore. FDA recommended they be recalled, and the company said we’re pulling them back and stopped. So, that by itself tells you that here’s a concern. FDA doesn’t put out these kinds of warnings. This is going to disrupt a whole bunch of patients’ lives, just out of an abundance of caution.

It’s not clear that there’s a link between these two new cases that the FDA is talking about and this company. But they’re just being very careful here. And they don’t even know how many people may have gotten them the ophthalmic or the heart drug at this point. They’re still figuring that out.

But it’s going to cause a lot of worry and a lot of trouble for people.

JUDY WOODRUFF: Sounds like we’re still on the early side of all this.

DAN VERGANO: That’s right.

There’s a pattern to outbreaks. And here we’re still seeing more cases, 19 new cases announced today, eight the day before. It was 163 last Thursday. So we’re still on the growing side of the outbreak. You know, they stopped delivery of this company’s drugs October 3. They’re saying one to three weeks for symptoms to develop, and talking about ones back to May.

You know, we could be — it looks like we’re going to be seeing more cases. There was a telling thing today in the map CDC released. Before, they had been noting states where there were five or more cases. But, today, they bumped it up — 10 or more cases, they noted. So, that’s kind of a sign that they’re expecting to see more.

JUDY WOODRUFF: Dan Vergano, USA Today, we thank you very much for talking with us.

DAN VERGANO: You bet.