JEFFREY BROWN: A rare but deadly outbreak of meningitis is raising concerns for thousands of patients nationwide, and sparking questions about the way certain pharmacies are regulated.
The outbreak has been linked to tainted steroid injections used to help fight back pain. The medication was distributed by a pharmacy located just outside of Boston.
The New EnglandCompoundingCenter had already recalled the steroid. And on Saturday, it issued a voluntary recall for all of its products from the Framingham, Mass., site.
But it came too late for 105 people who contracted a rare form of fungal meningitis, including eight who died. Family members say the victims were stricken with little warning.
SHARON WINGATE, wife of victim: Have a shot. Six days later, you’re fighting for your life.
JEFFREY RUSSELL, son of victim: I mean, everybody is going through the same thing. It’s just hard to see your mother.
JEFFREY BROWN: In all, nine states, mostly in the Midwest and South, have reported cases in the outbreak, according to the Centers for Disease Control. Health officials say that, unlike other types of meningitis, this form is not contagious.
Still, the CDC says 13,000 patients have had injections in recent months. People who received the shots are being urged to get tested.
And for more about the outbreak itself, we turn to the federal Centers for Disease Control. Dr. John Jernigan is an epidemiologist working on the investigation.
So, Doctor, where are we now in this outbreak? Are you expecting more cases to appear?
DR. JOHN JERNIGAN, Centers for Disease Control and Prevention: Well, Jeffrey, to date, we have had 105 cases reported to us from nine states. And of those 105 cases, there have been eight deaths.
You might have noticed that the number of cases reported has increased in the last several days. And this is mainly because we’re doing a better job at finding these cases.
We don’t think the outbreak is spreading any more rapidly. It’s just that we’re reaching out to patients who might have been exposed and we’re identifying more cases.
JEFFREY BROWN: So, the rise is not unexpected, you’re saying?
DR. JOHN JERNIGAN: That is correct.
We’re working — CDC is working carefully with state health departments to reach out to every patient who might have received an injection with one of the potentially contaminated medications to find out if they’re having symptoms.
And in some cases, we are identifying patients who have become ill and are presenting for care and we’re — they’re being added to our case list.
JEFFREY BROWN: Now, what is known at this point about how this happened, how this could have happened?
DR. JOHN JERNIGAN: Well, every case that we have identified so far has received an injection, an epidural injection, with one of these contaminated lots of a medication that’s commonly used to treat low back pain.
We think that these lots may have been contaminated somewhere during the production process.
And so when the patient is exposed to this medication, the germs that are in the contaminated medication incubate and have found their way into the central nervous system and caused a syndrome known as meningitis, which is basically an inflammation, infection of the lining that surrounds the brain and spinal cord.
JEFFREY BROWN: Now, how unusual is this? You’re describing a fairly routine procedure, this injection, but to impact so many people across so many states, how unusual?
DR. JOHN JERNIGAN: This is a very unusual type of meningitis. Most meningitis is caused by bacteria.
Fungal meningitis is very rare. Usually, if we see fungal meningitis at all, it’s in patients whose — whose immune systems are severely compromised, such as patients who are undergoing treatment for cancer. It’s unusual to see fungal meningitis in patients with normal immune systems.
JEFFREY BROWN: And tracing it to this one facility, a so-called compounding pharmacy, is that going to — is this going to provoke a new look at these kinds of facilities?
DR. JOHN JERNIGAN: I think whenever we do investigations of outbreaks, we do as much as we can to learn what’s going on, not only to protect the people currently involved, and to make sure that no other infections happen and to make sure that people who might have been exposed or ill receive the proper treatment.
I’m sure we will look at changes that can be made at the level of the facility that’s making the injections, changes that can be made by the physicians themselves, and also obviously looking at the procedures in these compounding pharmacies to see if there are changes that can be made in the future again to prevent this type of thing from happening again.
JEFFREY BROWN: And, briefly, those thousands of people who may have been exposed, what do they look for? What should they do?
DR. JOHN JERNIGAN: I think anyone who has been exposed to one of these potentially contaminated lots, and if they’re concerned, to contact the physician who did the injection or contact the clinic where the injection has taken place. And they will have information on them for how to respond and whether or not to seek care.
JEFFREY BROWN: Do you think these people are at great risk, low risk? How do you define it?
DR. JOHN JERNIGAN: Well, again, the investigation is ongoing.
So far, we think that the vast majority of patients who might have received an injection by one of the contaminated lots have not developed signs of meningitis.
And it’s possible that they won’t. We’re continuing to follow them closely. We’re continuing to learn more about this outbreak.
I think it’s important that people who have been exposed to be vigilant for the onset of symptoms, such as headache, fever, stiff neck, sudden onset of slurred speech or weakness or difficulty walking. Should any of those things occur, again, they should contact their physician.
JEFFREY BROWN: All right, Dr. John Jernigan of the CDC, thanks so much.
DR. JOHN JERNIGAN: Thank you very much, Jeffrey.
JEFFREY BROWN: And now to more on those questions about so-called compounding pharmacies that have arisen in the wake of this outbreak.
For that, we’re joined by Kevin Outterson, director of the health law program at BostonUniversity.
Well, first question is the most basic one. What exactly is a compounding pharmacy?
KEVIN OUTTERSON, Boston University: Well, Jeff, historically, pharmacists could compound in their small offices, do something that worked well for a patient that maybe was allergic to an ingredient in the normal drug or perhaps do something for children, you know, take an adult drug and put it into a — you know, a flavored syrup for children.
But these pharmacies we’re talking about here are really almost industrial-scale, large commercial compounding, shipping, as we know from this outbreak, all across the country. So it’s a very different thing from the classic historic practice of compounding.
JEFFREY BROWN: Well, so, what we’re seeing is not unusual in that sense just in terms of the reach around the country. How unusual though is a problem like this emanating from one of these pharmacies?
KEVIN OUTTERSON: It is unusual. But, there have been examples in the past decade of smaller problems, not quite so dramatic as this fungal meningitis.
But the difficulty is that John at the CDC and the folks at the FDA, they are able to respond after the fact, after people are sick or dying from these conditions.
The FDA today really doesn’t have the right sort of authority from Congress to regulate this type of compounding, this industrial compounding before the fact, before there’s a problem.
JEFFREY BROWN: Well, that, of course, is the big question being raised now is, who is guarding? Who is watching against something like this happening? What is the regulatory regime? It begins with the states, rather than at the federal level?
KEVIN OUTTERSON: Well, it’s a pharmacy. So, just like the CVS or Walgreens on your corner, it’s regulated first by the state, by whatever state it happens to be in. And the FDA is in charge of regulating drugs and drug manufacturing.
So, if Pfizer or Glaxo wants to produce a drug in China or Ireland or anywhere else in the world and sell it in the United States, that factory is under FDA regulation, very strict rules on how the — how sanitary it is, how careful they are preventing contamination.
But a compounding pharmacy, especially one that is industrial in scale, just doesn’t have that type of FDA regulation.
JEFFREY BROWN: Well, that’s a hard one for people to understand, isn’t it? It’s a pharmacy like the one on the corner, but you’re saying it’s more of an industrial pharmacy with quite a long reach.
So, what kind of discussion is there in your world about who could do more, who might be better to oversee it, what could the FDA do, even under current law?
KEVIN OUTTERSON: Well, there’s a little history here.
In 2002, the Supreme Court actually struck down a law that gave the FDA some authority in this area. It’s the Thompson vs. WesternStatesMedicalCenter case. And the Supreme Court said on First Amendment grounds that compounding pharmacies have the right to advertise their services.
And the FDA had taken the opposite position based on legislation from Congress in the 1990s. Congress held some hearings in 2003, but really nothing ever came of those hearings.
So we have a situation in which the FDA used to have more clear authority, but it was taken away by the Supreme Court.
JEFFREY BROWN: So, briefly, you’re expecting this case to have some kind of impact on all of that?
KEVIN OUTTERSON: I would think that people in Congress would be taking a careful look at whether or not these types of industrial-scale compounding pharmacies should be regulated more like a drug manufacturing facility.
JEFFREY BROWN: All right.
Kevin Outterson at BostonUniversity, thanks so much.
KEVIN OUTTERSON: Thank you.