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CDC Telebriefing Transcript

Advancing HIV Prevention and
Severe Acute Respiratory Syndrome (SARS)

April 17, 2003

DR. GERBERDING: We have information to provide about the new HIV prevention initiative here, which I think is going to be another great step forward in terms of our capacity to prevent HIV in the United States. But before I talk about that, I also wanted to give an update on some of the--on information that we have reported today relative to SARS, another global epidemic which I think is of interest to all of us.

As of yesterday, WHO is reporting over 3,200 cases of SARS and 159 deaths globally, with cases now in 22 countries. In the United States, we are including 208 suspect patients in our list. Most of these patients are still under active investigation. But what we're reporting in the MMWR today is that we're making some changes in how we're categorizing patients. We are now going to include information about probable patients with SARS, which are those patients who have pneumonia and would be consistent with the case definition that the WHO is using internationally.

So when we use that definition, we end up out of the 208 suspected cases, 35 of them meet the case definition for probable SARS. So, as predicted, a much smaller proportion of the total than one might think if we looked at the broader net.

We use the broader case definition. We will continue to use the broad case definition for epidemiologic purposes in this country because we want to cast the widest possible net and make sure that we are providing the best medical care and also the best isolation for people who are suspected of having this condition.

In the United States, a total of 19 people who are contacts of travelers have been identified with suspected or probably SARS so far. Of these, five are health care workers, and the other 14 are host household contacts. Today in the MMWR we report two pairs of SARS cases where we have a probably SARS infection and spread, in one to a child, in another case to another household member. The testing for these individuals is incomplete, although one of the index cases does have evidence of the coronavirus infection.

From the laboratory front, we were very delighted to hear that WHO had agreed that we had sufficient evidence to indicate that coronavirus is the cause of SARS. We have based that not only on the work done here, but the work done in 11 other laboratories around the world. And we are, of course, still interested to know if there's a co-factor or other factors that influence either the transmission or the clinical presentation of the disease. So we're still open-minded about all of these factors, and we'll continue to work hard to understand the pathogenesis or the cause of the severe pneumonia as well as the other maybe less severe manifestations of the illness.

We have issued now almost 500,000 traveler alerts to travelers in over 2,100 flights. We're using a similar approach to people who are arriving at U.S. ports of entry on ships or cruise lines. And this mechanism continues to be one of the major factors that helps us to identify potentially infected people early enough to get into isolation and to prevent spread to others. So we really appreciate the support that the public health system and the travelers are giving us in making the system successful. But, again, it's important that we remain vigilant because we are watching with great concern the events in other parts of the world, particularly in China and Hong Kong and Singapore where there is ongoing transmission of this virus at a very accelerated pace in certain communities. And we don't think that there's anything unique about the United States from that perspective, and we're talking about a virus here, not an environment or a class of people. And so the first line of defense for us is early detection and appropriate isolation and infection control precautions.

Now, let me move on to talk about the HIV prevention initiative that was also in the MMWR, and we do have copies of the MMWR for you people here, and it is also available on the CDC website so you can refer to it if you haven't had a chance to preview it already.

We have a very, very sad situation in the United States. Each year we continue to see about 40,000 new HIV infections domestically. We have well over 800,000 people living with HIV in our country, but an estimated 200,000 of these people do not know they are infected and, tragically, are not getting appropriate treatment for their HIV infection. This is an intolerable situation in the minds of the public health officials and certainly in the minds of clinicians who are seeing these patients when they're diagnosed late in their course of illness and, again, tragically, have not had the opportunity to benefit from the potentially life-saving treatments that we now have available.

CDC has been involved with HIV since the initial cases were recognized way back in 1981. In fact, Dr. Jaffe, who's now the director of the National Center for HIV, STD, and TB, was present at the very beginning of the AIDS epidemic in this country, and I think Harold would agree with me that we've made enormous progress in that global epidemic. But our prevention efforts have stalled. We are not making the kinds of ongoing progress in reducing new cases that we would expect to be able to achieve given some of the recent advances in testing technology and so forth.

So I really look at this initiative from wearing my hat as a clinician. I worked for a long time at San Francisco General Hospital, and I have, I think, firsthand experience about how sad it is when people acquire this infection and don't get the appropriate medical care that they deserve and need. And there are a lot of barriers to getting the services people need, but one of the barriers is access to diagnostic HIV testing. So one of the main themes of this new initiative is to open up the door to testing so that people can learn their status and get the appropriate treatment and prevention services that they deserve and need.

There are four aspects to the initiative. The first aspect is to work with clinicians in medical settings and make HIV testing a routine component of medical care. This means that if people live in an area where HIV is highly prevalent or are a member of a risk group or have a behavior that increases their chance of exposure, they should be asked simple questions: Do you have unsafe sex? Do you use an injection drug? And if the answer to those questions is either yes or maybe or perhaps I don't want to tell you, then that person should be offered the HIV test. And this makes it a routine component of care.

And one of the barriers that we're removing to that is taking the requirement out of the CDC guidance that we have extensive prevention counseling as a prerequisite to getting the HIV test. In the past, we have conditioned getting tested on acceptance and participation in a fairly comprehensive behavioral counseling intervention. That intervention is still critically important. We have evidence from research studies that it does help people change their behavior and reduce their risk. But in the medical environment, it's a barrier to getting the test done because many clinicians either don't know how to do that kind of counseling or simply don't have the time to squeeze it into a very brief office encounter.

So we're removing that requirement as a condition for testing, but we are also ensuring that access to prevention counseling is still available to all people, whether they're infected or at risk for infection.

I want to make very clear, as I talk about HIV testing in this initiative, that in none of the initiative components are we talking about mandatory HIV testing. CDC is not recommending mandatory testing of any group of people under any circumstances. I know that when we talk about voluntary or routine, sometimes the vocabulary gets confusing, but we are talking here about simply treating an HIV test like any other medical test that would be a normal part of standard and good-quality and humane medical care.

The second component of the initiative really takes advantage of the new technology that we have. The FDA has licensed a rapid test for HIV that can easily be done in non-medical settings, and the test has also been waived, meaning that it does not have to be done in a certified laboratory. It can be done in a variety of other settings that would not necessarily be linked to the kind of laboratory that you think of when you go in for your regular blood testing.

So the initiative targets access to rapid testing in community settings where people who need to be tested are finding trusting relationships within individuals or where they are gathering for other kinds of community services or care, and examples of that would be things like sexually transmitted disease clinics, perhaps shelters, drug treatment centers, and correctional facilities, and so on and so forth.

So we want to eliminate the access to the medical system per se as the barrier to testing, and the advantage of the rapid test is that people can get their results in 20 minutes from the time that the test is done, and they don't have to make an appointment and come back for a follow-up. They'll learn accurate information about their HIV status while they are in that medical setting. So it is a way to speed up access to the test, but more importantly, speed up access to the information.

Of course, that will only be useful if then the infected people in those circumstances are referred or linked to appropriate medical treatment and prevention services, and those prevention services need to be available also for the people who are not HIV infected but who are at risk for exposure. So we are continuing to emphasize prevention services, prevention case management, but we're just trying to make these services available to people in other settings.

Now, let me talk about the third component of the initiative, which is an expansion of our HIV prevention focus. Most of our efforts from a CDC perspective and, really, I think, from a state and local health agency perspective have been on addressing the behaviors among uninfected people that put them at risk for exposure and subsequent HIV infection. That needs to continue. HIV is a disease that is spread through risky behaviors, and to the extent that we can support people's motivation to prevent those behaviors, we're all for it.

But we haven't put as much emphasis on HIV-infected people as a component of the prevention paradigm as perhaps we should. When a person with HIV infection is diagnosed, it's very important to know who their partners are and to make sure that the partners have access to testing and the same treatment services if they're infected, and, of course, the same prevention counseling and other prevention management services.

This emphasis on HIV prevention in the already infected people is something that needs to be brought into the mainstream of medical care, and we have great support from HRSA and CMS and other components of Health and Human Services. Secretary Thompson is very much in favor of taking this collaborative and integrative approach to ensuring that people have the whole spectrum of services. And we're going to work hard within HHS to remove any of the barriers to these services that may exist now.

We also at CDC have identified about $35 million through some increases in our congressional appropriation and through some other programs that are ending so that we will be able to support demonstration projects and other innovations with state and local health agencies and community organizations to see how can we do this in a way that really enhances identification of the infected people but also ensures that this is done in a humanistic way and emphasizes the importance of the spectrum of services that people need, not just an HIV test or not just an assessment of partners.

The final component of this initiative is addressing the concerns we all have about transmission of HIV in the perinatal setting. CDC believes very strongly that each case of perinatal transmission really represents a failure of our public health system, and we want all mothers to be screened for HIV infection. We are recommending what is known as the opt-out approach, which basically means that mothers who are not already tested for HIV be asked to have the test in the same way that we would do other perinatal screening tests. So we are, again, making the testing a routine part of perinatal care. Mothers can decide not to have the test. That's a perfectly reasonable choice on their part. But if they choose not to have the test, then we want to make sure that their children are tested after birth so that they can benefit from the life-saving treatments that we have available.

CDC is not prescribing to the states how this perinatal testing should be done. If states choose to use an opt-out approach for the children, that's fine. Some states are using a mandatory testing for the children born to untested mothers. We are not going to prescribe to them what is the appropriate way, but we are going to insist that we do everything we can to ensure that children who are born to infected mothers have access to antiretroviral treatment so that they can get the best possible chance of remaining infection-free and going on to have a healthy life.

So those are really the four components of the initiative. They're described in a lot more detail in the MMWR, and I'm sure we'll be able to provide more specificity as we develop the programs and work with our partners in the state and local governments, and I think importantly our partners in the clinician community--you know, again, I look at this in the same way that I would look at it if I was still a clinician at San Francisco General Hospital, and that is that this is the correct thing to do from a medical practice standpoint. Doctors need to be able to contribute to the identification and diagnosis of HIV, and we all want people who are infected to benefit from the life-saving therapies that we have. It's tragic and really unacceptable that 200,000 people in this country don't know their HIV status, and that is what this initiative is really designed to address.

I think we're taking advantage of the strengths of our public health model and our public health approaches to HIV and disease transmission, but we're also engaging the medical community in a much broader way to really assist in doing everything we can to stop the spread of this tragic illness.

Now, I would like to end with just a small reflection on the fact that I was talking about HIV, which we know is a global epidemic, and started by talking about SARS, which also is a global epidemic right now. And these two diseases are both caused by viruses, but obviously the modes of transmission and the patterns of transmission are very different. But every time there's an epidemic of a new infection, infectious diseases, it's also followed by an epidemic of fear. We're seeing increasing reports about the stigma in the Asian community associated with SARS, and we've all experienced for the past 22 years some of the fear and stigma that have been associated in the past with HIV infections.

I think all of us need to take the high road here and appreciate that these are diseases caused by viruses. There are sensible and important things that we can do in the public health system, in the medical system, and in the community at large to focus on supporting and expressing empathy for the people who are affected, supporting the kinds of services and prevention modalities that will help protect the exposed individuals, and certainly thinking about what we as citizens can do to be part of the global community in the most constructive way possible, because we are all in this together and the illnesses that are over there one day or in that people one day could very easily be over here or in our families in the future.

Thank you.

I can take some questions from the reporters here in the room, and also there are reporters on the telephone. So I'll start with a question from a reporter on the phone. Please use the microphone so that we pick up your question.

QUESTION: The reports today out of Hong Kong suggest that the sewer system might be a method of transmission for the SARS virus there. It raises the question of concern: Could that be a problem here in terms of transmission as well?

DR. GERBERDING: The reports from Hong Kong are just coming out now and there have been reports of identifying the coronavirus in still specimens, and presumably they're examining the environment in the apartment building where people were infected.

Finding virus in the stool or in an environmental object, and attributing that as the cause of exposure are two very different things, and so what needs to happen is a great deal of epidemiologic work to determine whether or not it's true and related, and that work is ongoing and we look forward to receiving that information and learning more about it.

Let me take a telephone question, please.

MODERATOR: That will come from the line of Adam Marcus with HealthSouth. Please go ahead.

QUESTION: Hi; thanks for holding the briefing. I'd like for you to please clarify the last component of the HIV piece. Is CDC making mandatory screening of any infant whose mother did not have HIV testing, or at least that's what you would like and it's up to the states to implement that?

DR. GERBERDING: Let me very clear. CDC is not recommending any mandatory testing of any group of people including newborns. We are not recommending mandatory testing. We are recommending routine screening of mothers and we are recommending that states figure out how to make sure that any infant that slips through the cracks has access to testing.

QUESTION: Are there some states that currently--hello?

QUESTION: Hi, Dr. Gerberding, Betsy McKay [ph] from The Wall Street Journal. Could you tell us how much you're spending on this, you know, HIV prevention initiative, its components and overall.

DR. GERBERDING: We'll be able to give you the details of how we create new programs as we go through it. We have $35 million of new money for demonstration projects that are designed to help us, you know, learn how to do this in the best possible way. This is a new model and it's going to take some, you know, trial and error, to make sure that we achieve the goals that we intend to achieve.

We're also going to be spending about $5 million to evaluate the overall effectiveness and accountability of our programs.

But in addition, we have close to a billion dollars of money for a whole spectrum of HIV programs and services at CDC and a lot of other money through other sectors of Health and Human Services, and so as we initiate this program with our state and local partners, we will be revising our grant guidance, and resources that are currently being used for prevention services can be utilized to support the components of the new initiative.

This is not a drastic change in direction. It's a focusing and an emphasis on the specific program components that I had mentioned, because we are not achieving the progress that we intended to achieve with overall HIV prevention program. So i think we had input from the community, many communities and many constituents over the last several months, and we are trying to be responsive to the interests in each of those communities as we go forward.

We are very interested in assuring that our focus for HIV prevention continues to address the populations and communities that are the most heavily affected by HIV, and that would include minority communities, inner city communities, and various other constituents.

So we are not abandoning any of our activities. Rather, we are trying to achieve a better result.

Let me take a question from the phone, please.

MODERATOR: First a reminder to those on the phone lines. If you'd like to ask a question please press one now.

And we'll now go to the line of Maggie Fox with Reuters. Please go ahead.

QUESTION: Hi, Dr. Gerberding. I'd like to ask if you can give any kind of idea of what might have happened in the United States, had you not cast such a wide net as you've done.

I know you're talking in theoreticals, but it'd be nice to be able to have an idea of that, and also, can you speak to the idea of the Hong Kong authorities believing that the virus has somehow become more virulent there because it's affecting younger people.

DR. GERBERDING: Let me speak about the approach to containment of this SARS illness in the United States and I think we did cast a very wide net, early on, and we know that we have many more people in that net than likely truly have SARS. We'll be able to say that more definitively as we have more testing of the samples from those patients.

I really can't predict what the shape of the epidemic would have looked like if we hadn't focused in on the people with the pneumonia, because there is some evidence that those people are the most likely to serve as sources of transmission, and hopefully we'll never know, because we really want to make sure that we are doing everything we can to recognize and isolate people, up front.

We are not seeing transmission here beyond individuals tightly linked to SARS cases, and those cases in travelers, and it may very well be that our isolation system is contributing to that, but it might also just be luck, that we just haven't had very many people who are highly infectious, and the people we've had in that group have been isolated and our infection control programs in hospitals are geared up for this kind of isolation because of our recent experience over the last few years with tuberculosis and other pathogens.

So I'd like to say it was the decisions that we made but I think it would be premature to hazard that guess.

I'll take a question here.

QUESTION: Dr. Gerberding, can you elaborate on the research going on in The Netherlands and testing on monkeys and possible treatment for SARS, and any association you may have with the research going on there.

DR. GERBERDING: Thank you. Last week, when we said that we had sequenced the coronavirus genome, we also indicated that there were two things that needed to happen before we could confidently say that the coronavirus was the cause of SARS.

One was that we needed to show that we could cause infection in an animal model and then recover virus from diseased tissue in that animal, and that the virus was the same as the coronavirus we're talking about, and the other is that we would show evidence of the coronavirus in lung tissue from a human being with SARS.

Both of those criteria have been met to the satisfaction of the scientists in the collaborating laboratories around the world and The Netherlands laboratory is the laboratory that was he first to inoculate an animal, create a SARS-like respiratory illness and then recover the virus from that tissue.

So that really was the important work that needed to happen over the last week and we will be hearing more about the details of that science later. The WHO hosted a meeting of the various scientists from the laboratories and the data were presented there but we haven't yet seen it in print.

So we look forward to being able to review that and will have more comments at that point in time.

I'll take a question from the telephone.

MODERATOR: Thank you. That will come from Joanne Silberner with NPR. Please go ahead.

QUESTION: Hi, Dr. Gerberding. Why at this point, particular point in time, did you decide to break out the probably causes?

DR. GERBERDING: I think we have a testing available now and that's going to help us sort out the cases that are truly related to the coronavirus and the cases where we can't find any evidence of coronavirus. So we also recognize that we're creating some confusion and inconsistency with the WHO approach to this, so we've been working back and forth with WHO to try to make sure that the way we're reporting suspected cases is understood by everyone.

We don't want to exaggerate the scope of the problem here by including individuals that wouldn't be included in the case list from other countries.

So I think it was just a natural evolution of our precision of reporting and we're confident that the distinction between a probable and a suspected case is sufficient, so that we can have some confidence that the probably cases really are more likely to actually have the condition.

Let me take a question over here.

QUESTION: Thank you. Jennifer Smith for Southern Voice [?]. I understand that both of these issues are completely separate, but I'm curious if there's any crossover, if you've noticed any of the 208 suspected cases might be among HIV-positive people or if there's been any alert by CDC to any HIV or AIDS primary care physicians about special precautions for HIV patients regarding SARS?

DR. GERBERDING: I do not have information about the HIV infection status of the individuals who are suspected of SARS in the United States and I don't think we have that information globally. Do we, Dr. Hughes? So I don't know at this point in time. We will be looking at various risk factors for severe disease, including immunodeficiency states and some of the epidemiologic cohort studies that are going on, or case controlled studies that are in progress in various parts of the world.

So if there is enhancement of disease or a risk associated with immunodeficiency, that will be the way we find it. It'll just take us time to get those data together and really look at that.

A question from the telephone, please.

MODERATOR: Thank you. That will come from John Lowerman with Bloomberg News. Please go ahead.

QUESTION: Hi; thanks for taking my question, Dr. Gerberding. Can you tell us more about the role of testing and how soon those tests will be implemented. Have they been implemented already? Do the states have them? What's happening with those genetic tests for coronavirus?

DR. GERBERDING: Thank you for clarifying. I wasn't sure if you were talking about rapid HIV testing or--

QUESTION: Oh, sorry about that. Yeah. Yeah. Coronavirus.

DR. GERBERDING: Maybe I could ask Dr. Hughes to just give us an update on the status of the deployment of the coronavirus virus to the states. It's an ongoing process and we've made a lot of progress, but we're still working on it.

DR. HUGHES: Hello. I'm Dr. Jim Hughes. I'm director of the National Center for Infectious Diseases here at CDC. That's an excellent question. We're working very hard right now to ready the recently-developed polymerase chain reaction test for detection of the SARS-associated coronavirus, so that we can deploy that in laboratories participating in the Laboratory Response Network, which includes all state public health laboratories and a number of other collaborating federal agency laboratories.

We're doing this as rapidly as possible but recognize the fact that there's a need to further validate this recently developed test and then to develop reagents and provide direction to the collaborating laboratories in how this might be used.

We're on a fast-track here and we're hoping that within two weeks we'll the PCR test out, and then we'll be working to develop antibody tests for distribution as well.

DR. GERBERDING: I'll take another question from the telephone, please.

MODERATOR: Thank you. We'll move on to the line of Jennifer Warner with WebMD. Please go ahead.

QUESTION: My question was somewhat related to the PCR test. Do you have plans to adopt that as part of the clinical diagnosis of SARS and how might that affect some of the probable versus suspected cases that you'll be including in your reports to WHO, and also, does WHO have plans to include that in its definition as well?

DR. GERBERDING: I know this is sometimes difficult to understand, why we take this approach, but when we're developing laboratory tests for epidemiologic purposes, for example, using it in a case definition so that we can take appropriate public health action, we can put tests out for that purpose from CDC to the labs, just as Dr. Hughes described, very quickly.

But in order to use a new test to diagnose and make treatment decisions in individual patients, we must have the FDA approval process involved.

FDA is working very closely with us on something called an NDE, which is a protocol for getting experimental tests out into the clinical domain, and we expect that process to move as fast as it possibly can, and FDA has been marvelous about working on it with us.

But until we have that particular protocol established, technically, we can't say to a patient your coronavirus test is positive, that means you have coronavirus infection or SARS, and we need to provide the following medical decisions on this basis.

So it's a subtle distinction. One is sort of public health purposes and the other is individual patient decisions.

But as Dr. Hughes said, these are just new tests and nobody knows how sensitive or how specific or how accurate they are, and we don't want to be in a position where we make a mistake, medically, on the basis of a test that may not prove to be reliable enough for that purpose.

So we do have an intention of releasing a case definition that incorporates what we know now about the reliability of the tests we have, but we need to still continue testing more samples in more patients before we can really provide interpretive criteria around that for patients.

I'll take a question here.

QUESTION: Is there any concern about the shipping ports? We get a lot of goods from China. Transmission of SARS there?

DR. GERBERDING: We are utilizing the same strategy for passengers on shipping vehicles, vessels and/or cruise liners that we're using for airliners. Most of the shipping industry does not come directly to the United States, or most of the vessels don't arrive straight here from the ports of departure in Asia. So there are intermediary steps and the industry has been extremely cooperative in taking a great deal of responsibility for ensuring that the crew and passengers on those vessels have the same health alert information that the arriving airline passengers have.

A question from the phone, please.

MODERATOR: Thank you. That will come from Marian Falco with CNN. Go ahead, please.

QUESTION: Hi, Dr. Gerberding. As always, thanks for much for doing this. Just a few questions. Number one. So basically with the tests that you do have, would it be proper to say it's the type of test that you could use to determine if someone doesn't have to be in quarantine anymore, because they don't have it, but not the type of test that say you have and we have to treat you this way? That's question number one.

Number two, because I couldn't get on the call at the very beginning, could you just repeat the numbers and clarify the definition probable, suspected. And third, do you have any information about some reports that were coming out of Singapore that a few mothers who were expecting children, after the children were born there were some respiratory problems? And these were children born to suspected, definite SARS cases.

DR. GERBERDING: Let me take the first question. Can we use the coronavirus test as the criterion for initiating quarantine or deciding quarantine isn't necessary, and the answer to the question simply right now is no.

The information about the accuracy and reliability of the test is not sufficient to use that as the only criteria for a decision about who needs to be isolated or evaluated or quarantined.

We'll be using the clinical definition, first and foremost, and as we learn more about the accuracy of the test, then perhaps that could be added on as a helpful piece of information or included in the decision note. But we're not there yet.

With respect to the probable and suspected cases, very quickly, we have a total of 208 suspected cases in the United States right now, and thirty-five of them we would consider to be probably cases.

You can find the MMWR on the CDC Web site and that'll give you a lot more information about those individuals.

With respect to the last question about mothers in Singapore, I think I would have to ask, again, Dr. Hughes, if he can give us an update on what we know about that. I don't think we have enough information to really say anything definitely but of course we're concerned.

DR. HUGHES: Yes. We're learning as we go here and I've not actually heard specifics about the reports of illness in newborns born to mothers affected by SARS. That is something that needs to be looked into, but so far, there's no indication of anything suggesting that's happening in the United States.

QUESTION: And the probable ones are the ones that are definitely more likely to have it; right?

[Simultaneous conversation.]

QUESTION: [inaudible] reports that they think the SARS virus comes from animals, and an earlier report that [inaudible] mentioned to Dr. Hughes at a press conference earlier, that some of the first people who were suspected of having SARS had eaten wild game.

I wanted to know if you had heard anything more about that?

DR. GERBERDING: Well, the true other [?] epidemiology, which means we have to get out in the field where the first cases occurred and really do that hard work of tracking down potential exposures, and again it's casting a wide net. Now finding the first cases is challenging because they probably occurred many months ago now, and then getting the kind of exposure history, in retrospect, is really a challenge.

We have teams, the WHO team is certainly prioritizing this as one of their major points of investigation. The reason we think about animals with coronavirus is because we know that coronaviruses do cause illness in both mammals as well as birds, and so there is always the possibility of a species jump or a recombination that could have transferred to humans.

But it's really speculative at this point and, we, unfortunately, didn't get any clues by looking at the genome of the virus, that are really telling us, oh, you know, this is almost like the bird coronavirus because it didn't look like much of any of the viruses we already had in our reference strain collection.

So there's a lot of work to be done and we'll get there.

I'll take a question from the telephone, please.

MODERATOR: That will come from Larry Altman with the New York Times. Please go ahead.

QUESTION: Yes, Dr. Gerberding, can you talk about whether there have been any efforts in the United States to replicate trying to fulfill Cox postulates as Dr. Esterhaus has done in the Netherlands? And, secondly, some of the clinicians have complained that there has been not enough information about the possible transmission of the secondary cases in the health care setting of the formerly 208 or the 35 cases now, and can you speak to the information that clinicians and epidemiologists, hospital control epidemiologists wanted?

DR. GERBERDING: Let me ask Dr. Anderson to answer your first question about where we are right now with the animal models for coronavirus for purposes of causality as opposed to viral testing. But I'll take your second question, which is the specificity of the information about transmission to health care personnel is first and foremost something that the state health departments are investigating and have access to, and so we do rely on the support that we get from them and the information we get from them and turn that around.

The guidance that we've created for the infection control community we think is exactly the right guidance to prevent spread in hospitals, and the fact that we've had so few cases of transmission to health care workers tells us that we're probably on target.

We do recommend that health care personnel where N-95 respirators and that patients be put in airborne precautions, even though we haven't proven airborne transmission. And that really is the highest level of infection control that we have in health care settings, so I think we have erred on the side of caution and really are doing everything we can.

As you know, it's also difficult to tell sometimes exactly how transmission occurred. Health care workers have so many different kinds of contacts with patients that saying, oh, it was touching this or breathing that or this particular moment in time is just about impossible. So, unfortunately, without more experience we're not going to be able to indicate a priori what the hazardous circumstances really are.

Let me ask Dr. Anderson here, who is the head of the division responsible for the coronavirus at CDC, to address the initial question.

DR. ANDERSON: Thank you. Things are moving along very quickly, but it does take time to do the studies, and I think the group in the Netherlands really did an excellent job of very quickly looking at the monkey animal model and the pathogenesis of SARS.

We provided virus to the group at the National Institutes of Health that is also looking at these types of models with the idea of looking at vaccine development, and those studies are in progress.

QUESTION: Does that mean that the virus has been injected into primates and other animals in the United States?

QUESTION: I wonder if we could get a bit more detail about the testing that's been done on the probable and suspected cases here in the U.S. The MMWR says that five of the 33 probables are positive for showing evidence of recent infection with coronavirus, and I'm wondering does that mean that 28 are negative? And if not, can you tell us how many have been tested [inaudible]--

DR. GERBERDING: The testing of those samples is ongoing, and part of the problem is that, you know, the convalescent specimen has to be taken after 21 days, and so many of the individuals are not past the 21-day point. So the testing is no--we can't say it's positive, we can't say it's negative. We can say it's pending, because we need the final sample to draw conclusions. So we're only reporting now what we can say definitively has either happened as a positive, happened as a negative, or in the case of the two clusters that we described, that we have negative acute specimens but we're waiting for the convalescent specimen to call. So stay tuned. We'll be able to tell you more information about that soon.

QUESTION: Just to clarify, does that mean that you have not yet been able to rule out any patients as having been definitively not infected because you don't have [inaudible]--

DR. GERBERDING: Again, with the test that we have right now, until we do more tests and we know what the sensitivity of the test is, we're going to be very loath to say someone doesn't have SARS on the basis of a test until we know that if--that the majority--the vast majority of people who have SARS truly will have a positive test. So it's just a state of the unfolding progress that we're making in the test validation. And, remember, we have two tests here. We have a PCR test. Usually the problem with the PCR test, because it can take up very tiny amounts of the virus gene, is that it's not specific, and by that I mean that sometimes it's positive when the person doesn't have the disease. And we have concerns about that, particularly in laboratories that don't have gold-standard protocols for processing the sample because you can get crossover and very easy to get a false positive.

So these are laboratory issues, and they're just part of the unfolding of the science of the testing process. And we'll get there, but we're not quite there yet.

Another telephone question, please?

OPERATOR: Thank you. We'll now move on to the line of Steve Sturnberg (ph) with USA Today. Please go ahead.

QUESTION: Hi, Dr. Gerberding. If I could move to HIV for a little bit, two questions. One is I'm wondering what barriers you--whether there were any barriers to overcome in order to change these recommendations for--and to make HIV testing more routine in the medical setting.

And my second question has to do with perinatal testing and your willingness for obvious reasons to allow mothers to opt out. And I guess I'm wondering if states decide to mandatorily test infants, doesn't that conflict with the mother's opportunity to opt out? If you find the child is positive, then you can assume the mother is positive. Could you talk about that?

DR. GERBERDING: Yes, let me address the first question about barriers to initiating this new emphasis on HIV prevention and testing.

This is a situation where I think CDC is picking up where a lot of people in the medical community have already been, and by that I mean that many clinicians have felt for a long time like that they would like to have more capacity to use HIV testing as a diagnostic tool in the medical environment. And, in fact, the CDC has already in its guidance suggested that we utilize more slimmed down versions of the counseling process in medical settings so that we could promote HIV testing. So this is a progressive change in how we are looking at diagnostic HIV testing.

I think the real precipitant here for taking a big step forward is the fact that the rapid test became available, and that allows us to utilize the test in other settings and to apply the same approach at the community level. So it's a huge technological advance that has profound implications, we hope, for the undiagnosed people.

With respect to the issue of perinatal testing, again, we do not recommend mandatory testing of anyone, and I agree with you that if a child is tested automatically by a state when the mother has refused testing, there are issues there, and that's exactly why we are relying on the states to make the local decision about how they want to handle that or address that in their own environments.

The evidence suggests that an opt-out approach will achieve the same degree of perinatal testing as a mandatory approach, and so we've put that information out to clinicians who will be distributing additional information to colleagues in the medical and public health environment to help them think through whether or not individual states need to change any of their statutes or policies for this.

But from a CDC perspective, what we're interested in--we are not very interested in how people accomplish this as long as it's done in a fair and humanitarian way. We are interested that we don't miss any kids, and so the emphasis I'm making is to the extent possible, available, and routine, is where we are putting our energy.

I'll take a telephone question, please.

OPERATOR: Thank you. Our next question comes from Nancy McVicker with the Florida Sun Sentinel. Go ahead, please.

QUESTION: Thanks, Dr. Gerberding. Down here in Florida, we had a couple of cases where there was some fear that this had gotten out into the community, one coworker possibly infected and a child who went to school.

Do you have the results back yet on those two cases? I guess they were kind of moved to the head of the line.

DR. GERBERDING: If I do, I wouldn't tell you in a press conference.



DR. GERBERDING: That's really information that first and foremost needs to be managed by the state health department and the clinicians who are involved in the care and treatment of the patient. So we agree that those were priority specimens, but I can't comment on their status right now.

QUESTION: And those are not--

DR. GERBERDING: We'll take one more question from the phone, please.

OPERATOR: Thank you. That will come from the line of Garrett Condon which the Hartford Courant. Please go ahead.

QUESTION: Yes, Dr. Gerberding, some otherwise healthy people have died of SARS around the world. I wonder if we have uncovered any unusual risk factors that might lead to a particularly serious case of SARS?

DR. GERBERDING: We have not yet identified factors that are associated with severity. While there are certainly cases in all age groups, there is a tendency for the elderly people to sometimes have a more several clinical course or to have a worse outcome. But we are not at a point where we have the right numerators and denominators to be able to say that for sure.

So, again, this is epidemiology in progress, and we have to do the kinds of comparisons between various groups of patients to really narrow down the list of, you know, is this an exposure issue, is it a factor of the immune status of the individual who's exposed, are there any other co-factors that come into play here that predict severity. You know, again, we're just learning as we go, and so as quickly as we can figure this out, we'll be reporting it either in this format or in the MMWR.

Harold? Dr. Jaffe?

DR. JAFFE: [inaudible].

DR. GERBERDING: Thank you. Dr. Jaffe would like to make a clarifying statement about the rapid HIV test.

DR. JAFFE: Since, as Julie pointed out, this is really an important advance, I think it's important that you're completely clear on the use of the test. This is a screening test. It's very accurate, but it has to be confirmed if it's positive. So basically if you do a rapid test on an individual and it's negative, you can tell them, "You're not infected." If it's positive, you have to tell them, "This is a preliminary result. You may be infected. We're going to send your blood to a laboratory to confirm the results, and you will need to come back probably in a week or two to get that result.

When this has been used, almost everybody does come back to get the confirmed result. So the person would not be told on their first visit, yes, you are definitely infected.

DR. GERBERDING: Thank you. That is very important because we don't want to leave people--the problem that leads to this two-step process is that the test is very sensitive and you can rule out infection, but it's not entirely specific and sometimes there are false positives. And you certainly wouldn't want somebody thinking they had HIV infection on the basis of an inaccurate test result. So thank you, that was a very important clarification.

I appreciate your interest in both these issues, the SARS issue and the HIV initiative, and we again really recognize that both of these conditions are global epidemics, and both of them have caused our scientific, our public health, and our whole community to come together to really recognize that we live in a global village.

Thank you.

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