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Press Briefing Transcript

CDC and FDA Joint Telebriefing on Investigation of Meningitis Outbreak

Thursday, October 4, 2012 at 2 p.m. ET

OPERATOR: Welcome. Thank you all for standing by. At this time I’d like to remind parties that your parties are in a listen only mode until the question and answer session. At which time, press the star to ask a question. Today's call is being recorded. If you have any objections, you may disconnect at this time.

CURTIS ALLEN: Thank you. Thank you for joining this telebriefing with CDC and the FDA on the investigation of the ongoing meningitis outbreak. Today, Benjamin Park, M.D. that’s P-A-R-K, Dr. Benjamin Park, medical officer at the Mycotic Diseases Branch at CDC will be speaking and from FDA, Ilisa Bernstein from the Office of Compliance at FDA will be also speaking. Dr. Park will make a few remarks and then we will turn it over to Ms. Bernstein and they will make a few remarks and then we will open it up for questions. So let's start with Dr. Park. Thank you.

BENJAMIN PARK: Thank you, Curtis. On September 21, 2012, CDC was notified by the Tennessee Department of Health of a patient with the onset of meningitis approximately nineteen days following epidural steroid injection at a Tennessee ambulatory surgical center. All initial cultures of cerebrospinal fluid (CSF) and blood were negative for any potential infection; subsequently the patient had a fungus isolated from CSF by fungal culture. On September 28, 2012, investigators identified a case outside of Tennessee, possibly indicating contamination of a widely-distributed medication. To date, a total of 35 cases in six states have been identified with a clinical picture consistent with fungal infection. Tragically, at least five deaths have been reported. Fungus has been identified in specimens obtained from a total of five patients thus far. While investigation into the exact source of these infections is ongoing, all infected patients received preservative-free methylprednisolone acetate from among the three lots voluntarily recalled by the New England Compounding Center in Framingham, Massachusetts, on September 25th. I would now like to read you the names of the 23 states that have received medication from the New England Compounding Center. These are the 23 States that received preservative free methylprednisolone acetate among the three recalled lots. These states include California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Iowa, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. Infected patients have presented approximately one to four weeks following their injection with a variety of symptoms including fever, new or worsening headache, nausea and our new symptoms consistent with a stroke. Some of these patients symptoms were very mild in nature. Cerebrospinal fluid obtained from these patients has shown findings consistent with meningitis. It is important to note that this type of meningitis is not transmissible from person-to-person. CDC and FDA are working closely with state health departments on this challenging investigation. Out of an abundance of caution, CDC and FDA recommend that all health care personnel cease use and remove from their pharmacy inventories any product produced by the New England Compounding Center. CDC also recommends that clinicians contact all patients who received injections using product from any of the three recalled lots to determine if they are having symptoms. Patients may be experiencing mild symptoms, not typical of meningitis. Such as new or worsening headache without fever or neck stiffness. If patients are having new or worsening symptoms, even mild symptoms, they should be evaluated immediately. While CDC is only aware of infections occurring in patients who have received epidural steroid injections, patients who received other type of injections of methylprednisolone acetate from those three lots should be tested from signs of infection such as swelling, increasing pain, redness and warmth at the injection site and should be encouraged to seek evaluation if such symptoms exist. This is an ongoing investigation. Unfortunately, despite the current recall, we expect to see additional cases as this investigation unfolds. However, it is possible if patients are identified soon and started on appropriate antifungal therapy some of the unfortunate consequences may be averted. CDC will be updating you as more information becomes available. Now I would like to turn it over to my colleague, Dr. Ilisa Bernstein who will discuss the investigation at this facility.

ILISA BERNSTEIN: Thank you. I’m Dr. Ilisa Bernstein, Director of the Office of Compliance in FDA's Center of Drug Evaluation and Research. We would like to update you today on several important developments that have come to light. The product that has been most closely associated with this outbreak of meningitis is preservative-free methylprednisolone acetate, 80 milligrams per ml, an injectable steroid compounded and distributed by New England Compounding Center in Framingham, Massachusetts, also known as NECC. FDA has detected fungal contamination by direct microscopic examination of particulate matter taken from a sealed vial of methylprednisolone acetate collected from NECC.  FDA is in the process of further identifying the fungal contaminant. Foreign material has also been observed in other vials produced by the company they were collected by FDA during an inspection. Additional microbial testing is under way. Last week, three lots of methylprednisolone acetate were recalled. As of yesterday, New England Compounding Center has voluntarily shut down all operations and expanding its recall to include all methylprednisolone acetate prepared by NECC as well as all other drug products for intrathecal administration prepared by NCEE. FDA will post this expanded recall information on our website as soon as it is available. At this time, NECC has voluntarily ceased distribution all of their products. While these are significant steps towards containing the potentially contaminated drug products out of abundance of caution, FDA is taking the additional step of advising all health care practitioners to not to use any product that originated from New England Compounding Center until the investigation into the source of the outbreak is complete and further information is provided. We are urging physicians and other health care practitioners, clinics, and hospitals, to check their drug supply and purchase records to determine if they have purchased products from NECC to immediately discontinue use and isolate those products from their supply. To be clear, investigation into the source of the outbreak is ongoing but given the severity of the illnesses we have seen so far, we believe these precautionary measures are warranted to protect the public health. FDA is continuing to work with CDC and officials from Massachusetts and other states to investigate and control this situation. Thank you.

CURTIS ALLEN: Okay. Before we open it up for questions, Dr. Park will re-read and make a correction to the list of states.

BENJAMIN PARK: Thank you. I’d just like to say that I should have mentioned Ohio and not Iowa. So I’m going to read those states again. States are California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. Again, these are the States that received one of the three lots that were voluntarily recalled by New England Compounding Center on September 25th.

CURTIS ALLEN: Dr. Park, thank you. Rose, we can open it up for questions now.

OPERATOR: Thank you. At this time, if you'd like to ask a question, please press star 1 on your touch tone phone and tell us your name and I will announce when we are ready for your question. One moment please the first question from David Brown from The Washington Post. Your line is open.

DAVID BROWN: Hi, thanks a lot. Can either of you give us some sense of the volume of material, the number of vials that this company has made of methylprednisolone, in particular, I guess this 80 milligram dosage, but also perhaps other products? That is one question. And the other one is was this stuff mixed up on-site in Framingham or was it produced elsewhere and distributed through this company in Massachusetts?

CURTIS ALLEN: FDA?

ILISA BERNSTEIN: Hi. This is Ilisa Bernstein. We don't have that information at this time in terms of the volume of product that they produced with respect to the methylprednisolone acetate. We are working with the firm to get a list of the products that they do manufacture and we do plan on posting that on our website as soon as that is available. We are still looking at -- we don't have any information -- more information at this time about the facility itself.

DAVID BROWN: So you don't know whether it was made there?

ILISA BERNSTEIN: The information -- we are -- our investigation and inspection is ongoing at this time.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: Thank you. The next is from Daniel Denoon. Your line is open from WebMD.

DANIEL DENOON: Thank you very much. Can you give us some sense, please, of how many patients may have been exposed? We’re asking doctors to contact people who may have received this injection. Can you give us some sense, the number of estimates of people who are going to be getting calls?

CURTIS ALLEN: Dr. Bernstein?

ILISA BERNSTEIN: I can't answer that question.

CURTIS ALLEN: Okay. Thank you. Next question, please.

OPERATOR: The next is from Mike Stobbe, Associated Press. Your line is open.

MIKE STOBBE: Hi. Thanks for taking the question. First of all, you said 35 cases in six states. Could you name the six states? How many cases in each of those states and how many deaths in each of the states? Also, could you give a little more information about the inspection, when you were in there, and what -- what you saw in addition to material and some of the vials? Did you see a broken auto clave or unsanitary conditions? What did you see in the plant?

CURTIS ALLEN: Dr. Park will name the states and then we will turn it over to Dr. Bernstein for the second part of the question.

BENJAMIN PARK: Yeah, thank you. As of this morning, our case count, as you mentioned, was 35 cases in six states. Currently, we have 25 cases in Tennessee, we have one case in North Carolina, we have two cases in Florida, we have four cases in Virginia, we have two cases in Maryland, and we have one case in Indiana. Now, of the deaths, of the 25 cases in Tennessee, three of them have been deaths. Of the four in Virginia, one has been a death. Of the two in Maryland, one has been a death.

MIKE STOBBE: Thank you.

BENJAMIN PARK: That is a total of 35 cases and five deaths.

CURTIS ALLEN: Dr. Bernstein?

ILISA BERNSTEIN: For the second part of the question, I’m going to ask the New England District Director to comment.

MUTAHAR SHAMSI: Hi. Good afternoon, everybody. My name is Mutahar Shamsi, the District Director for the New England District Office of FDA Office of Regulatory Affairs. The question, I believe, was -- what have our investigators seen, is that right?

MIKE STOBBE: When did you go there and what did you see?

MUTAHAR SHAMSI: We started the inspection on Monday in connection with our state partners with the Massachusetts board of pharmacy and we started that on October 1st and we observed the -- the investigators observed foreign particulate matter in one unopened vial as Dr. Bernstein has described. The investigation is still ongoing and I can't comment on the rest of the findings now.

CURTIS ALLEN: Could you spell your name for the reporters, please?

MUTAHAR SHAMSI: Sure. Mutahar. Last name is Shamsi.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: The next is from Steve Osunsami from ABC news. Your line is open.

STEVE OSUNSAMI: Yes. One question. The open vials, was it of the same medicine methylprednisolone acetate that you saw contaminants in New England? My other question is can you give me a basic idea of what these epidurals are commonly used for and what settings? You know, what sort of clinical settings that that medicine is commonly used?

CURTIS ALLEN: FDA, please.

ILISA BERNSTEIN: The question was about open vials? I will --

STEVE OSUNSAMI: You said -- you said that -- that you -- that -- when you investigated the New England plant, that you found contaminants in -- I got the sense other things were contaminated. I’m wondering did you find contamination in different compounds, different medicines that were being made in New England?

ILISA BERNSTEIN: I’m going to refer to New England District Director on that.

MUTAHAR SHAMSI: Hi. Not at this point. It was unopened vials that we saw, foreign material that was not consistent with the finished product.

STEVE OSUNSAMI: But what medicine was it?

MUTAHAR SHAMSI: Investigation is still ongoing so, again, I don't have much more than that.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: Thank you. The next is from Liz Kowalczyk from the Boston Globe.

LIZ KOWALCZYK: Thank you very much for taking our questions. Just going back to the estimates on the number of patients. Are you saying you don't know in these three lots, you don't know the approximate number of doses that would be in a lot?

ILISA BERNSTEIN: This is Ilisa Bernstein. Our investigation is ongoing so we don't have that information at this time.

LIZ KOWALCZYK: Secondly, could you expand on? The two things you found. One was the foreign material in unopened vial that was observed by the New England inspectors but you said in your open comments a separate test in one of the sealed vials of this particular drug in question also fungal matter was found in a separate closed vial?

ILISA BERNSTEIN: Yeah. Let me just repeat what I said just to be clear. Because we -- we looked by direct microscopic examination at a sealed vial, material that was from a sealed vial of methylprednisolone acetate. Looking under microscopic examination, it was identified as a fungal contaminant.  For the sake of time, because we -- everything is unraveling and unfolding very quickly, we have not been able to further microbial testing of additional vials and what is necessary. So, right now, we can only say that it is a foreign material. I’m going to -- my colleague is going to Ian Deveau -- may have some other things to comment on.

IAN DEVEAU:  I just wanted to repeat. Materials from an unopened vial was looked at under the microscope by FDA laboratory and what appeared under the microscope indicated a fungal, a fungal matter. The additional material is undergoing testing to identify the fungus in question and those tests have been initiated as of this morning.

CURTIS ALLEN: Dr. Park, do you have something to say?

BENJAMIN PARK: Yeah. I’d just like to go back briefly to the question about the scope of the potential exposure. While we don't yet know exactly the number of vials, I think that is a question for FDA, but what we do know is that -- as I mentioned, there were 23 states involved and we think there were approximately 75 facilities in total that have received product from one of these three recalled lots.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: Thank you. The next is from Denise Grady from the New York Times. Your line is open.

DENISE GRADY: Thank you. You mentioned also that no more products should be used, that this New England center was making. Their website indicated that they had a license to operate in 50 states. Does that mean that there could be injectable drugs or other drugs that they made? Could they be really all over the country, you know, beyond the 23 states where the methylprednisolone was shipped? Thanks.

CURTIS ALLEN: Dr. Bernstein?

ILISA BERNSTEIN: Thank you. You know, at this time, we don't know, but if they are licensed in 50 states, there is a possibility that it could be elsewhere, not just this product, but as well as other products that they have made. That's why, because we don't know the scope of this, we don't know -- but we do know there is a risk, that's why we are asking physicians and other health care practitioners and hospitals and clinics to not use product at this time until we can continue with the investigation.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Yeah. Thanks. I’d just like to, you know, re-emphasize one point, is that CDC is only aware of infections occurring in patients who received epidural steroid injections from one of these three lots.

CURTIS ALLEN: Next question.

OPERATOR: The next is from Richard Knox from National Public Radio. Your line is open.

RICHARD KNOX:  Thanks. Do you know when you're likely to find out how many doses are at question here? And also are there other sources for this drug? I mean, lots of people get these injections every day so a lot of people will be wondering whether they might have gotten injection from another company or are they only two companies in the country that supply this drug?

CURTIS ALLEN: Dr. Bernstein?

ILISA BERNSTEIN: Well, we're -- we're working with a firm right now to get more information about this. I can't tell you at this time when we will find out, but we are continuing to get more information. With respect to how do they know if they got the product, well, they should talk to their doctor or clinic and try and find out if they have any questions or concerns, check with their doctor and see what they received. The doctors or clinics or hospitals should have records on what type of product or where they got it from. But there are other FDA approved versions of methylprednisolone acetate injection on the market with and without preservatives. So the -- only the doctor or the facility will be able to know specifically what product that patient received.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Yeah. I’d just like to add to that. You know, CDC is actively working with our state department health partners to contact the facilities who have received the recalled lot and these facilities that received the recalled lot are actively contacting all patients to let them know they have received medication from one of these lots and to check on these patients' symptoms. However, another point I’d like to make, if patients are concerned about what product was used in their procedure they should contact the physician that performed their procedure.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: The next is from Amy Burn. CBS News

AMY BURN: Can you tell me how far in time you're asking hospitals and health care workers to contact patients, back to what date in a procedure or approximately? Mid summer? You know, early spring? How far back?

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Yeah. Thanks for that question. The lot -- again, we are only asking facilities to contact patients who received the recalled lot at this time and those lots go back to approximately July of this year.

CURTIS ALLEN: Thank you. Next question.

OPERATOR: Thank you. The next is from Jonathan Serrie from Fox news.

JONATHAN SERRIE: Good afternoon. Can you tell us more about the treatment for this type of meningitis? I’m also assuming that time is of the essence, what time frame produces the most ideal results with these treatments and how effective are they?

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Sure. It's important to say that fungal meningitis is quite a rare infection and physicians may not be immediately suspecting it. That being said, it's important for physicians to understand that diagnostic testing should be performed in order to evaluate patients to see if they have this fungal meningitis. Now, the treatment for this infection is with an antifungal medication, either one or two antifungal medications and these medications are given intravenously and so patients need to be admitted to the hospital to receive these medications. The other thing I would like to point out is that hopefully we can identify patients early because we think that early antifungal treatment can improve the outcome of these patients.

CURTIS ALLEN: Ok, thank you, next question, please.

OPERATOR: The next is from Jonathan Rockoff from Wall Street Journal your line is open.

JONATHAN ROCKOFF: Hi. Thanks. Two questions. First, Dr. Bernstein, could you just go over the expanded recall that NECC is undertaking?  I didn't catch all of that. Second, I just wanted to be sure, Dr. Park that you're saying that CDC hasn't seen any adverse events in patients taking NECC products other than from those three specific lots.

CURTIS ALLEN: We will go to Dr. Bernstein first and then to Dr. Park.

Ilisa BERNSTEIN: Thank you. So, as I said, the expanded recall by NECC includes all methylprednisolone acetate prepared by NECC, as well as all other drug products for  intrathecal  administration prepared by NECC. However, as we said today in an abundance of caution as a precautionary measure, we are urging physicians and health care practitioners and clinics and hospitals to check their drug supply for all product that they have purchased from NECC and discontinue use at this time.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Yeah. Just to confirm what I was saying. Based on our investigation to date, we have no evidence of any adverse events any of the other NECC products, of course, the investigation is actively ongoing and we are continuing to investigate all leads.

CURTIS ALLEN: Next question, please.

OPERATOR: The next is from Tim Ghianni from Reuters News Service. Your line is open.

TIM GHIANNI:  Hi. Thanks for taking these calls. You actually answered most of my questions already, but I do have a question. You do say that you are not -- I mean, you're saying that it's not necessarily all from this Framingham facility when you're looking for the absolute source of this stuff, of this disease, or everything that you've seen so far, are you looking beyond the Framingham facility beyond them for this medication? That's all.

CURTIS ALLEN: Dr. Bernstein?

Ilisa BERNSTEIN: Thank you. The investigation into the source of the outbreak is still ongoing.

CURTIS ALLEN: Next question, please.

OPERATOR: The next is from Matt McClain from WFLA, Tampa, Florida. Your line is open.

MATT MCCLAIN: Thank you. You mentioned these steroid injections were used primarily for back pain but could this type of steroid be used for other treatment such as allergy or sinus infections, and then the second question is can you tell me where the cases in Florida took place, what area of Florida?   

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: To answer your second part first. I don't have that information but we can get back to you at that. The first part of your question about the steroid usage, this steroid product and FDA may chime in, if I’m misspeaking, but my understanding is that this steroid product is an injectable medicine that is used in injectable situations, so it would not used for purposes such as allergies or asthma or things like that.

CURTIS ALLEN: FDA, anything further?

Ilisa BERNSTEIN: We don't have the right experts in the room to answer that call -- or answer that question at this time.

CURTIS ALLEN: Next question, please.

OPERATOR: The next is from Phil Williams from WTVF-TV, Nashville. Your line is open.

PHIL WILLIAMS: Thank you. Can you tell me is there any concern or evidence that NECC has shared preparation facilities with any pharmacies potentially operating under different names? And also what can you tell me about sterility testing that may have been done on these lots? Was that done?

CURTIS ALLEN: Dr. Bernstein, please.

Ilisa BERNSTEIN: Thank you. I’m going to defer to Captain Mutahar Shamsi, who is local there and maybe he has some information about that.  I don't know.

MUTAHAR SHAMSI:  I’m sorry. Could you repeat the question again?

PHIL WILLIAMS: Is there any evidence or concern that NECC may have shared preparation facilities with other pharmacies operating under different names?

MUTAHAR SHAMSI: As I’ve said, we are still conducting an active investigation and we just are not sure at this time. And we will have that information shortly, I hope.

PHIL WILLIAMS: And then have you looked at whether they did sterility testing on these lots before they were shipped out?

MUTAHAR SHAMSI: That is all part of our investigation and it's still ongoing.  I cannot comment on that right now.

PHIL WILLIAMS: Just a quick follow-up. When you went to the facility, did it just have NECC's name on it, or was there another pharmacy's name on the door and the paper work?

MUTAHAR SHAMSI:  I believe it was just NECC.

CURTIS ALLEN: Next question, please. Thank you.

OPERATOR: The next is from Joe Neel from NPR. Your line is open.

JOE NEEL: Hi.  I just want to clarify the recommendation for when people should call their doctors. Are you saying anyone who’s gotten a steroid injection since July should check with their doctor, or should they only check if they have symptoms?

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: If patients are concerned, they should contact their physician to find out if they received a medication from one of these lots.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: The next is from Alice Park from Time magazine. Your line is open.

ALICE PARK: Yes. A couple of questions. First, could you clarify how long the antifungal treatment would -- would be required? I've seen everything from months to, you know, up to a year. And, secondly, for the FDA, could you just comment in general?  I know the investigation is ongoing, but could you comment in general on whether there was something about the compounding process or the monitoring of the compounding pharmacies that might have -- that perhaps make such contamination more likely, or can you just -- some general comments about whether compounding pharmacies are more sort of vulnerable to this type of contamination.

CURTIS ALLEN: We will go first to Dr. Park and then to FDA. Dr. Park?

BENJAMIN PARK:  I think the question was how long should antifungal therapy be used, and currently, we think that this type of meningitis is quite severe as we have been describing here. The antifungal treatment for this is intravenous antifungal treatment and requires initial hospitalization. But the duration of antifungal therapy could be prolonged possibly on the order of months.

CURTIS ALLEN: Dr. Bernstein? Your part of the question?

Ilisa BERNSTEIN:  I believe the question was what did we see -- can you please repeat that second question?  I just want to make sure.

ALICE PARK: If you could just address -- my understanding that is compounding pharmacy and could you just address, in general, whether the monitoring of compounding pharmacies makes, you know, contamination like this more possible or is there something more that the FDA could be or should be doing in terms of working with the state pharmacy boards, or just in general whether, you know, these -- these type of facilities are more vulnerable to this type of contamination or episode.

Ilisa BERNSTEIN:  Thank you. I’m actually going to ask my colleague Dr. Anderson to answer that.

KATHY ANDERSON: Hi. This is Kathy Anderson. I’m acting Director of the Office of Unapproved Drugs and Labeling Compliance. And the day-to-day operations of compounding pharmacies are regulated primarily by the state boards of pharmacy which regulate the practice of pharmacy and license individual pharmacies and pharmacists. FDA also has authority over drugs made by compounding pharmacies but that authority is limited -- I’m sorry. But that authority by law is more limited than its authority over drugs made by nonpharmacies. So for example, compounding drugs they are not approved by FDA and they don't undergo that same premarket approval for safety effectiveness that FDA approved drugs do.  

CURTIS ALLEN: The next question, please.

OPERATOR: The next is from Richard Weir from Boston Herald.

RICHARD WEIR: Hi, thank you for taking my question.  I wanted to ask about whether or not there have been any – any NECC has been subject to any previous complaints or review by any of your organizations? Can you also talk about past production problems? And secondly, I wanted to just clarify the unopened vial where the foreign contaminant was found? Is that an additive used in the process of making this particular steroid—injectable steroid or was this the finished product that was going to be shipped out to consumers?

CURTIS ALLEN:  FDA, please.

Ilisa BERNSTEIN: The first question I’m going to defer to, Dr. Anderson and then Dr. Deveau.

KATHY ANDERSON:  With respect to prior -- prior history with New England compounding center, the agency did issue a warning letter to the firm in 2006, but that letter did not address the compounding practices that are at issue today. And we work closely with the Massachusetts Board of Registration and Pharmacy.

IAN DEVEAU: Just to clarify. The vial in which a foreign matter was detected was a finished dosage form, finished dose. And the foreign matter under microscopic examination was a fungus.

CURTIS ALLEN: Next question, please.

OPERATOR: The next is from Scott Couch from WZTV Nashville. Your line is open.

SCOTT COUCH: Thank you. I’m curious. Yesterday there were two deaths from Tennessee. Today, we have had a third. What can you tell me, if anything, about that death?

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: I’m going to have to defer you to the Tennessee Department of Health for that information.

CURTIS ALLEN: Thank you. Next question, please.

OPERATOR: The next is from Tyisha Fernandes from Fox25. Your line is open.

TYISHA FERNANDES: Hi most of my questions have already been answered, but I do have one.  Dr. Park said that there were 23 states that could be affected in that you do expect to see additional cases. Is it just in those 23 states or could other states pop up as well.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Again, we would like to re-emphasize that currently our cases are only in the patients that have received this medication from one of these three lots. There are these 23 states. And these states are actively going -- undergoing outreach to their patients. It's certainly possible that there could be patients that arise in other lots -- excuse me, in other states. However, if they are related to these -- it's likely they got injection in one state and moved to a different state.

CURTIS ALLEN: Thank you. Next question.

OPERATOR: Next is from Michelle Castillo, CBSnews.com. Your line is open.

MICHELLE CASTILLO: Hi, I’m just wondering if you could tell us more about the patients that have been infected? Is there a certain age group that is at risk and out of the people who have died, what age group or gender or demographic are we looking?

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: The patients in our -- the patients we have detected are varying ranges. They tend to be older in nature because these are the patients that have had spinal epidural steroid injections for lower back pain and these patients tend to be a little bit older.  I don't have the exact age group in front of me. As well as the patients who died are also tend to be a little bit older. But, the other thing to emphasize here is that many of our patients are, except for low back pain and -- except for low back pain are otherwise somewhat healthy.

CURTIS ALLEN: Thank you. We only have time for about two more questions so next question, please.

OPERATOR: Next is from Jessica Bliss Tennessean Newspaper. Your line is open.   

JESSICA BLISS: Hi, thanks. You mentioned that fungal meningitis is quite rare.  I wondered if you could quantify that at all if you could give us an idea the past incidents in the United States on year-by-year basis for fungal meningitis.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Fungal meningitis is not a reportable condition so we don't know how often it occurs.  However, I will say that fungal meningitis is extremely rare and -- fungal meningitis is extremely rare and many of these cases are actually due to -- due to -- in people who are profoundly immunocompromised. For example people who have bone marrow transplants who get meningitis as a result of there being -- severely immunosuppressed.

UNKNOWN SPEAKER: We have some clarifying information from FDA.

CURTIS ALLEN:  Ok, thank you thank you.   

ILISA BERNSTEIN: Hi, this is Ilisa again.  I just want to clarify in terms of what the scope of the expanded recall. So, the New England compounding center entered into a voluntary surrender of its pharmacy registration to the Massachusetts Board of Registration and Pharmacy yesterday. As part of that agreement, the pharmacy agreed to immediately commence a recall regarding all methylprednisolone acetate and other drug products prepared for intrathecal  administration because that is not a word that people are readily familiar with.  I wanted to make sure that is clarified that it’s intrathecal. It's the route of administration.  

CURTIS ALLEN: Thank you very much. This will be the final question, please.

OPERATOR: This is from Morgan Gilliam, WNEW All News 991. That line is open.

MORGAN GILLIAM: Hi, thank you. I just want to know a little bit or clarification around the time line of the Maryland deaths, if you knew when they were injected and sort of how long it was and the location of the Maryland deaths.

CURTIS ALLEN: Dr. Park?

BENJAMIN PARK: Thank you for your question.  I will have to refer you to the Maryland Department of Health for that information.

CURTIS ALLEN: Thank you very much. The FDA, have any additional comments before we close?

Ilisa BERNSTEIN: Not at this time. Thank you.

CURTIS ALLEN: Thank you. This will conclude this telebriefing. A transcript of this media availability will be on the CDC website at CDC.gov/media and it will be up shortly. There also be an audio file available it will be on the web. But if you're interested in getting a copy of that before it goes onto the web, call the press office at 404-639-3286. Thank you. Have a good day.

OPERATOR: Thank you. This concludes today's conference. Thank you for joining. You may disconnect at this time.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDC 24/7 – Saving Lives. Protecting People. Saving Money Through Prevention. Learn More About How CDC Works For You…
CDC 24/7 – Saving Lives. Protecting People. Saving Money Through Prevention. Learn More About How CDC Works For You…
Contact Us:
  • Centers for Disease Control and Prevention
    1600 Clifton Rd
    Atlanta, GA 30333
  • 800-CDC-INFO
    (800-232-4636)
    TTY: (888) 232-6348
  • Contact CDC-INFO
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention   1600 Clifton Rd. Atlanta, GA 30329-4027, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348 - Contact CDC–INFO

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