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CDC Telebriefing Transcript
West Nile Virus Update
September 3, 2002
MS. SWENARSKI: Thank you very much, everyone, for joining us. I apologize
for this late notice, but I'm glad you were able to get the advisory and to
join us.
We're here to give you an update on CDC's investigation of a West Nile virus
case and possible transmission through organ transplantation. Dr. James
Hughes will be our main spokesperson, and will make some brief remarks. He's
the director of CDC's National Center for Infectious Diseases.
Afterwards, we'll have a Q&A opportunity, and we have several people on the
line available to answer questions. Those are Dr. Jesse Goodman of the FDA;
William Hobson, from the Health Resources and Services Administration, also
part of HHS; Dr. Steven Wiersma, of the Florida Department of Health; and
Dr. Susan Lance-Parker, from the Georgia Department of Human Resources.
Dr. Hughes.
DR. HUGHES: Thank you very much, Lisa, and thank all of you for joining us
here for this update this evening.
The Centers for Disease Control and Prevention, the Food and Drug
Administration, the Health Resources and Services Administration, the
Georgia State Department of Health, and the Florida Department of Health
continue to investigate possible West Nile virus transmission through organ
transplantation. CDC and the Florida Department of Health laboratory have
confirmed that three of four persons who received organs from a single donor
were infected with the West Nile virus. Those three had encephalitis. One
has died, and the other two are recovering in the hospital.
The Florida Department of Health is obtaining samples from the fourth organ
recipient
for West Nile virus testing. This person developed a febrile illness after
transplantation, and is now recovering at home.
Testing of the organ donor demonstrated evidence of West Nile virus
infection from samples taken shortly before death. The means of the donor's
infection remains under investigation. It is most likely that the donor
became infected with the West Nile virus either through a mosquito bite or
via a blood transfusion shortly before organ donation.
As a precaution, remaining blood products from donors of blood given to the
organ donor as well as to the organ recipients are being recalled. Donors of
blood given to the organ donor are being contacted so testing for West Nile
virus can be done. Recipients of blood products from these donors are also
being contacted and tested for the West Nile virus.
The CDC, Food and Drug Administration, Georgia and Florida state health
departments, Health Resources and Services Administration, and blood
collection agencies are working together to identify the source of the organ
donor's infection.
Thank you very much. That completes my update. My colleagues and I will be
happy to respond to your questions.
MS. SWENARSKI: Okay we're ready for the first question.
AT&T FACILITATOR: First we go to Miriam Falco of CNN.
QUESTION: Hi. Thanks for doing this again. I just want to clarify if I heard
it right. Three out of the four people who received organs were indeed
infected with West Nile; we've confirmed that?
DR. HUGHES: That's correct.
QUESTION: Okay, one has died, the other two are recovering in the hospital?
DR. HUGHES: That's correct.
QUESTION: And the patient with the fever after transplantation is at home.
Did you say that you were sending the stuff to the Florida Department of
Health, or where is that patient? That patient is in Florida, right?
DR. HUGHES: That patient is in Florida, and we may want Dr. Wiersma to
comment on the specifics of what's being done to further investigate that
patient.
QUESTION: Okay, and before we get to that, just one other point of
clarification. You have also confirmed that the donor had West Nile?
DR. HUGHES: There is evidence, yes, today that the donor had evidence of
West Nile infection that was apparent at the time of organ donation. The
question is, of course, how did the donor acquire that infection.
QUESTION: Right. So if the gentleman from the Florida Health Department
could answer the question, that would be great. Thank you.
DR. WIERSMA: Sure. The 71-year-old female patient in Florida is being tested
by the Florida Department of Health laboratories, and those results are not
yet available.
AT&T FACILITATOR: Next we go to Seth Ornstein [sp] with Knight-Ridder.
Please go ahead.
QUESTION: Yes, and once again, thank you for doing this. On the how the
organ donor got infected, you say it's either a mosquito bite, which is
normal, or blood transfusion. I'm wondering how many--when did the donor
receive blood, and how many units have you been able to track from there,
where the West Nile might have been?
DR. HUGHES: Yes, that's the focus of the active, ongoing investigation. The
organ donor was injured in an automobile accident on July 30th, and received
a number of blood products over the next two days.
QUESTION: And so I guess the idea is--and then the person died, so do you
think--what you're saying is that perhaps the person received donated blood
early and then within two days after the person died, the donation was there
so it would have been a very quick transmission? And why do you think that
it's not--I guess, and why is it not the normal mosquito thing?
DR. HUGHES: Well, I'm not speculating this evening. I'm just giving you the
facts as we currently know them. And again, I'll emphasize that this is an
ongoing investigation, so the information will continue to accumulate over
the next one to two weeks.
You know, again, in terms of how did the donor acquire this West Nile virus
infection, the two possibilities are a mosquito bite before the time that
the person was injured in the automobile accident, or receipt of a blood
product immediately after the injury.
QUESTION: And I guess--okay, I was just trying to figure out why you would
go to the blood product instead of the normal mosquito bite.
DR. HUGHES: Well, I think we have to aggressively pursue the possibility
that a blood product is responsible for this. I mean, that's the focus of
the investigation, to determine whether or not a blood product is involved.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: That is from the line of Dierdre Henderson with the Denver
Post.
QUESTION: I'm wondering why there's no quick test available for West Nile to
screen it out of blood that goes into the blood system. Right now there's a
test that, within 24 hours, can alert the blood centers for hepatitis or HIV
in a sample, and then that sample isn't used. How long does it take to test
for West Nile? Is it close to 24 hours, and how long will it take to get a
test close to 24 hours for West Nile?
DR. HUGHES: Okay, let me make several comments on that. First of all, West
Nile virus infection is an excellent example of an emerging infectious
disease. It was just identified for the first time in the Western Hemisphere
there years ago. To date, all confirmed cases of West Nile have been as a
result of being bitten by a mosquito. Yes, today we do have tests to screen
blood for HIV and for HCD and for a number of other blood-borne pathogens,
but it took several years to develop those tests.
There are tests available for diagnosis of West Nile virus infection. They
have been evaluated and used for the diagnosis of infection of people with
symptoms. So we won't be starting from scratch in looking at tests that
could be used to screen the blood supply. But the available tests have
really not been evaluated in that context.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: That is from the line of Rick Weiss with the Washington
Post.
QUESTION: Hi. Two questions. One, is West Nile virus clonally diverse enough
so that genotyping could tell you with some assuredness whether the strains
in the recipients are, you know, probably came from this donor as opposed to
themselves having been bitten by mosquitos; and are you doing those tests?
And secondly, how many people are in this dragnet that you've now described
with all the recipients of various blood products from all the various--I've
heard as many as 37 units were put into this woman, so there's a lot of
people potentially that you're looking for right now.
DR. HUGHES: Rick, this is Jim Hughes. Excellent question. First, in terms of
the diversity of this virus, it's not diverse at all, unfortunately, so that
the molecular typing that we will do, and will do that through sequencing of
nucleic acid that we're able to amplify from specimens that we have, we will
do that. But we do not anticipate that it will be very helpful in the
context of the investigation, because to date all the strains of West Nile
that have been looked at in the United States are virtually identical.
In terms of the number of people, that is the focus of the ongoing
investigation. And I hesitate to give specific numbers because the other day
we did say 37, and now further investigation has actually identified that
blood the donor received actually came from as many as slightly over 60
people. So we're--I'm going to stay away from the numbers because they will
change.
QUESTION: But each of those 60 people, on average, blood from one person
goes to X number of people. Can you give me that average number?
DR. HUGHES: I can't off the top of my head give you that average number, but
what I can do is tell that we're working with our partners to identify those
blood components and to hold them so that no additional components are
administered to patients.
MS. SWENARSKI: Next question, please?
AT&T FACILITATOR: That is from the line of Marilyn Marccion [sp] with the
Milwaukee Journal-Sentinel.
QUESTION: Hi. Thank you for doing this. Dr. Hughes, is anything known about
how long the virus circulates in blood, and can you say anything about the
risk of transmitting through organs versus blood, or any precautions you
could take for testing organs right away?
DR. HUGHES: In terms of duration of the virus circulating in blood, what we
know is that by the time people who become symptomatic as a result of West
Nile virus infection, by the time they're symptomatic, the virus is very,
very, very difficult to demonstrate in their blood. So the virus presumably
circulates during the incubation period, which is recorded to range anywhere
from two to three days on the low end, up to 14 days on this high end.
QUESTION: Okay, a follow-up, then. Does that give you any optimism about a
narrow window that you might be able to test for in terms of someone's being
able to be a blood donor?
DR. HUGHES: Well, it's important to recognize this in contrast to some of
the other viruses that we've talked about earlier--HIV and hepatitis C
virus. This is not a chronic infection. This is an acute infection, so that
the period of viremia, as we say, would be expected to be relatively brief.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: We'll go to A.J. Hostetler with the Richmond Times
Dispatch.
QUESTION: Hi, good evening. I understand that a couple of weeks ago the FDA
alerted the country's blood banks to the issue of transmission. I also
understand that the organ procurement organizations, however, have not heard
anything from the FDA or the CDC. Do you have any plans to alert them? And
also, if you're telling blood banks to be on the alert for people who are
sick with West Nile, doesn't that then allow all those people who are
infected but asymptomatic to still get through?
DR. HUGHES: Well, first, let me invite my colleagues from both the FDA and
HRSA, who are on the line, the answer your questions. First, maybe, FDA, Dr.
Goodman.
DR. GOODMAN: Yeah, I think your question is a very important one, which is
can asymptomatic blood donors, during that brief period Dr. Hughes
described, potentially transmit virus through the blood supply. And that is
a lot of what the intensive investigation of this case is about, and we do
have a concern. If that occurs and occurs to a significant degree, then
disqualifying donors who are sick or have early signs of infection would not
remove those patients from the blood supply. And applying screening, at
least to people at potential risk of having --donors at potential risk of
being exposed to West Nile would be the logical strategy.
So this is an evolving situation. If blood transmission is confirmed--and,
in fact, irregardless--you know, we do want to move toward having the
availability of screening if needed. So we can move in that direction if
needed.
QUESTION: And my question about the organ procurement organizations, are
they going to be alerted?
DR. HUGHES: Sure. Mr. Hobson is on the line. He may wish to speak to that.
MR. HOBSON: Yes, we're preparing a notification to go out to the organ
procurement organizations basically asking them to maintain awareness of all
of the CDC information, clinical information alerts, all of the FDA clinical
information alerts, and what we will be doing is trying to focus their
awareness on this problem. At this point in time, it's been outlined. There
are no specific changes in procedures that we're ready at this point in time
to really recommend with regard to the organ procurement organizations.
DR. GOODMAN: You know, Jim, just to amplify a little there on the testing
issue. Again, Jim's point that this is a brief time window, I think does
help keep some perspective on the risk; and also the point that in the
United States each year there are approximately 4.5 million recipients of
blood. And if this turns out to be indeed a case that was transmitted by
blood--and we are very concerned about it--but if it turns out, it has to be
kept in that perspective of the large number of transfusions that occur.
That doesn't mean it's acceptable, but we need to keep the risk in that
perspective.
The other point I think Jim partly got at that's important is that some of
the technologies that could be brought to bear are technologies now in use
in research and public health laboratories, including CDC, that share some
elements with what the blood banks and the blood industry have been able to
implement for other viruses where there has been a need to detect them in
blood screening, so that we would anticipate at least that we have a head
start, if needed, in transferring that kind of technology from the research
or public health lab to the much larger, potentially more challenging
clinical blood banking arena.
QUESTION: Dr. Goodman, are you talking about the nucleic acid testing?
DR. GOODMAN: That would be one example. That would be one example,
absolutely.
QUESTION: Okay, thank you. I apologize for the excessive follow-ups.
DR. GOODMAN: No, that's fine.
MS. SWENARSKI: Thank you. Next question, please.
AT&T FACILITATOR: We'll go to Dr. Sean Kenniff with CBS-Miami.
Okay, we're not getting a response. We'll move on to Bob Serkin [sp] with
CBS Radio.
QUESTION: Yes, thank you very much. Dr. Hughes, yesterday you said that no
one should not seek blood if they need it, from various blood banks. Do you
make the same statement today, and can you once again, perhaps in simpler
terms, explain how much do you think at this point the nation's blood supply
has been contaminated by this problem?
DR. HUGHES: Well, first of all, thank you for the question, but at the
moment there's no evidence right now that the nation's blood supply has been
contaminated at all. This is the focus of an ongoing investigation, and one
of the possibilities is that the donor acquired infection as a result of
receipt of a blood product; the other possibility is the donor acquired
infection as a result of a mosquito bite, which is the common way, and so
far the only way, that people in this country have acquired West Nile virus
infection.
QUESTION: So, again, you're saying to people who need blood not to, in any
case, hesitate to get it?
DR. HUGHES: Yes. I will say today what I said recently, which was that if I
personally needed a blood transfusion, the last thing I'd be worried about
is West Nile virus infection. If I needed an organ transplant because I was
chronically ill, the last thing I would be worried about, I think, is West
Nile virus infection. And finally, I think it's very important that we not,
in translating this message, that we not do anything to discourage people
from donating blood, because we experience blood shortages frequently and we
must not discourage blood donors from donating.
QUESTION: And if I could just clarify one more point. You said earlier that
some blood was being recalled. Am I right in saying that, and if so, what is
it exactly being recalled?
DR. HUGHES: Yes, you are correct. Some of the blood is being recalled. The
blood that I mentioned, that there are over 60 donors that provided blood
components that the organ donor received, so all of the blood from those
60-plus donors that has not yet been administered is being recalled.
MS. SWENARSKI: Thank you. Next question, please.
AT&T FACILITATOR: We'll go to Tina Heffman with St. Louis Dispatch.
QUESTION: Hi. It's the Post-Dispatch.
I wanted to know if you are advising blood banks to take any other screening
measures of their blood donors, if you're advising them to ask people about
recent mosquito bites, given that people could be asymptomatic but still
have virus circulating in their blood.
MS. SWENARSKI: Dr. Goodman, would you like to answer that?
DR. GOODMAN: Sure. I think that, again, just to reiterate, it's important to
keep in perspective that this is under investigation, but we don't know at
this point whether the transfusion, one of these multiple transfusions might
have transmitted the virus.
Your question is a good one, which is short of having--if that is the case,
and if there is a need for better screening for this disease, could a
question such as mosquito bites improve that screening. I think most of the
medical evidence would suggest that that wouldn't be very effective. Of
course, the--you know, many, many people in the United States will report
mosquito exposures in the summer months and we would then automatically
create a humongous shortage of blood based on a risk that at present would
appear extremely low.
So that's one point. The other point is that there will be other individuals
who may not report or have noticed mosquito exposure who may themselves--in
fact could be infected if that indeed was the source of the infection.
So unfortunately, I don't think that would be an efficient or effective way
of screening at this time.
QUESTION: So you're reporting that they should do business as usual, their
usual screening practices?
DR. GOODMAN: At the present time, what--first of all, I would say that for
the Public Health Service and the agencies on this phone call, it's hardly
business as usual. Everybody is working around the clock to try to figure
out what the source of this is and in fact whether blood could have been the
source. For the blood banks there are no new recommendations at this time.
As stated before this even occurred, we did work to alert the blood
community to this possibility and to do what we can with current screening
to exclude people who might at least have early symptoms of West Nile
disease. If the evidence warrants and we need to go beyond that, we will try
to adapt whatever would be an effective strategy to deal with this, whether
it's trying to rapidly implement new screening tests, as described, or
whether we can come up with other identification of donors who might be at
risk to transmit the disease.
AT&T FACILITATOR: Next we go to Ann Carrns with the Wall Street Journal.
QUESTION: Hi. Thank you. I have a couple of points to clarify. I'm still a
little confused as to, of these 60-plus blood donors, how many have been
tracked and identified, and if there is any estimate of the number of
patients who may have received transfusions with that blood before this
recall was implemented.
And if I could also ask Dr. Goodman to give his title, please.
DR. HUGHES: Okay, in terms of the number of people that may have received
blood from these 63 people, it's a relatively low number. It's roughly--it
appears to be roughly a dozen.
DR. GOODMAN: And my title is deputy director of the Center for Biologics,
Evaluation, and Research at FDA.
QUESTION: Okay, thank you. And a quick follow-up. Of these dozen that appear
to have received the blood, has any of them been contacted, any of them have
symptoms of West Nile?
DR. HUGHES: That investigation is in progress. And remember now, I didn't
say a dozen, I said roughly a dozen.
AT&T FACILITATOR: Next we go to Lynn Adreen [sp] with ABC News.
QUESTION: Is it possible--thank you for doing this conference call. I was
just wondering, is it possible, in a way that the general public can
understand--what will you do to determine how the donor--what methodology do
you use to determine how the donor contracted West Nile, or is it just a
shot in the dark?
DR. HUGHES: Well, it's not a shot in the dark. What we're doing is, as we do
every day when we're dealing with infectious disease issues, is we work very
closely with partners at the state and local level. And you will recall that
I pointed out that the people in Georgia and people in Florida have been
working very hard on this through the weekend. We work with our federal
partners, FDA and HRSA, and the blood banking community to aggressively
investigate this. We work in the field doing epidemiologic investigations
assessing the clinical picture. And then we work very hard in the laboratory
to apply modern laboratory techniques to identification of infected
patients.
So that is what is going on. And it's going to continue to go on for at
least a couple of more weeks.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: That will be from the line of Bill Scanlon [sp] with Rocky
Mountain News.
QUESTION: Yes, most people who get infected are asymptomatic. Is that also
true, or somewhat less true, of people who might get infected by blood
transfusions, given their sicknesses and diseases? If 10 people get infected
with blood, should we expect maybe one or two or three, or all 10 of them,
to because symptomatic with West Nile?
DR. HUGHES: Okay, well, we--I can't answer that question precisely, but let
me tell you what we do know. What we know is that, as you said, the majority
of people who are infected with West Nile virus remain totally asymptomatic.
Of those who develop an illness, the vast majority develop a very mild
illness, and only one of approximately 150 will develop the severe form of
West Nile virus that we're discussing in these patients.
We know that risk factors for severe disease are primarily age. And so
people over the age of 50 are at increased risk for having the severe
manifestations of the disease. With many infections, people who are immuno-suppressed
or immuno-compromised, such as these organ transplant patients are, are at
increased risk for severe--more severe disease on average.
So that's what we do know.
MS. SWENARSKI: Thank you. Next question, please.
AT&T FACILITATOR: Next we go to Ben O. Schmidt [sp] with WTVJ-Miami.
QUESTION: I just wanted to simplify something. It's a little redundant, but
I wanted to simplify again two points. Number one, are you able to find--I
think you answered this, and this is to any of the doctors, are you able to
find out when someone should not--in other words, when someone may be a
hazard to a blood supply? Is there that test out there now which can
determine at what stage of the virus they shouldn't give blood? And number
two is, if you could simplify again the numbers of potential donors and the
number of people being tested.
DR. HUGHES: Dr. Goodman, can you take that first question?
DR. GOODMAN: Yeah. I think that, in fairness, right now there is not a test
refined to the point that it could be employed in blood banks all over the
United States tomorrow to test everybody's blood and determine whether there
is any risk of that individual transmitting the virus. You know, on the
other hand, to reiterate, there is technology that's been applied to
viruses, like the AIDS virus and hepatitis, where the risk is considerably
higher because they are chronic infections, but some of those
technologies--similar technologies have been used in research and public
health labs and could be adapted and tested for use and probably scaled up
and into use fairly rapidly.
We don't have enough information right now to know exactly, you know, what
proportion of individuals might have what amount of virus, and what risk, if
any, that might pose at all to people who receive the transfusion.
So it's an area where we're investigating, gaining new information rapidly,
but if needed, do have tools to bring to bear on this and will work, all of
us together, to do that.
And I guess--Jim, you've been handling the question on the numbers of blood
donors, et cetera.
DR. HUGHES: Okay, yes, thank you, Jesse. Yes, I guess--one other point
before we go to the numbers is simply to remind people that we have said
that FDA has reminded the blood banking community of the need to exclude
people with acute febrile illness from donation. That doesn't get at the
asymptomatic infections, but it certainly would get at people with mild
symptomatic West Nile virus infection.
Now, in terms of the quantitative aspects with respect to this organ donor,
the person received blood from approximately 60 different people. What is
being done there is several things. There is--as I've mentioned, we've put a
hold on transfusion of any of those blood components that remain. We're
working with our state and local partners and the blood banks to obtain
remaining samples that they have held from those units so that those can be
tested for evidence of West Nile infection.
But we're not stopping there. In addition, we're working with the blood
banks and the transfusion services to notify those donors, and we'll be
asking them some questions and be offering them the opportunity to be tested
for evidence of recent West Nile virus infection.
So it's a multi-faceted investigation.
MS. SWENARSKI: Thank you, next question, please.
AT&T FACILITATOR: Next we go to Kristin Wyatt [sp], with the Associated
Press.
QUESTION: All my questions have been answered, thank you.
AT&T FACILITATOR: Thank you, Ms. Wyatt. And next we'll go to Emilio Morero
with WLTV.
QUESTION: I've already had mine answered as well. Thank you.
AT&T FACILITATOR: Next we'll go to Sharon Butterworth with WPLG-Miami.
QUESTION: Thank you. My question's for Dr. Wiersma. Is there any new
information you can give me on the 71-year-old woman who you said you had
taken samples of. Is she still hospitalized, and can you elaborate at all on
the illness you said she had after the transplant?
DR. WIERSMA: Well, I think, as Dr. Hughes has already pointed out, we're
limiting how much information we put out on all these patients while the
investigation's ongoing. We can say that she is at home recuperating at this
time. That's about as much detail as we can give.
MS. SWENARSKI: Is there a follow-up?
QUESTION: Nope, that's it.
MS. SWENARSKI: All right, thank you. Next question?
AT&T FACILITATOR: We will go to Larry Altman with the New York Times.
QUESTION: Yes, three questions here, quickly. One, has there been question
of any new case or new cluster that has arisen as a result of the publicity
over the one you're working on? Second, how much of the blood remaining the
Georgia has not been recalled? And thirdly, have any of the blood banks
begun testing blindly just on donors to see if they're picking up stray West
Nile virus? Have they done that in the past?
DR. HUGHES: Okay, Larry, this is Jim Hughes. First of all, we're not aware
of any additional clusters needing investigation at this time, but we have
continued to urge people to heighten their surveillance efforts and to
report promptly any cases of suspected West Nile virus infection occurring
in a person who's received a recent transplant or a blood transfusion.
In terms of the recall in Georgia, all the blood that I mentioned has had a
hold put on it.
QUESTION: Yes, but how much has been used and how much remains?
DR. HUGHES: I can't be quantitative there, but again, the approximately
dozen people that have received, that we know have received this blood, that
we're following up on.
Now, in terms of what blood banks are doing, maybe Jesse could comment on
that better than I.
DR. GOODMAN: No, I'm not aware of the kind of testing that you're talking
about. But we have been discussing the kind of public health and research
agenda sections that would be helpful in further defining whether there's
risk and the quantity of that risk.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: We will go to Chuck Raven with the Miami Herald.
QUESTION: Hi, there. I just wanted to check on a date. The accident victim
who was the organ donor, what day did that person pass on?
DR. HUGHES: For confidentiality reasons, we're trying to not be real
specific when it comes to dates. But it was right at the end of July.
QUESTION: I believe earlier you guys said July 30th. But that's okay.
I also--how long typically, the organs that were donated, is it within a
day, within two days, within a week that these organs have to be received by
the receiver?
DR. HUGHES: They need to be transplanted quickly. Maybe Mr. Hobson could
comment on the specifics. They wouldn't be held for a week.
QUESTION: Do you know what date the 63-year-old man in Miami had his heart
transplant?
DR. HUGHES: That's for Dr. Wiersma.
DR. WIERSMA: I don't know that we've released that information in the past,
but--
DR. HUGHES: Right, that gets to confidentiality concerns and we're reluctant
to be that specific.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: We'll go to Rick Weiss with the Washington Post. Please go
ahead.
QUESTION: Hi. Thanks for the chance for one more follow-up. You've been very
careful about making the point that you don't know how the organ donor may
have become infected and that it may have been a mosquito bite. But can you
be a little more up front with regard to the implications of your findings
that at least three out of the four recipients of organs now have been found
to have this same infection? I mean, if you get this by organ transplant, I
take it it's by means of blood.
DR. HUGHES: The organ donor, again, if this resulted from organ
transplantation--and it appears to have--then the organ donor was the
source. So the question then, again, becomes did the organ donor get the
infection as a result of a mosquito bite or as the result of the
transfusions that were used to treat the acute severe injury that led to the
person becoming the organ donor.
QUESTION: Right, but--
DR. HUGHES: And this person obviously received a lot of blood products
following the injury before donation.
QUESTION: But even if it's uncertain how she became infected, isn't the
evidence quite strong now that this disease can be transmitted by blood,
either via an organ transplant or perhaps other means?
DR. HUGHES: Or, you know, the organ itself. You know, blood or the organ.
The patients received the organ, which presumably had--may have had some
blood components in it.
QUESTION: So is that a yes?
DR. HUGHES: I'm telling you what I know.
QUESTION: That the evidence is now fairly strong that this disease can be
transmitted by blood or organs directly from person to person?
DR. HUGHES: Again, what I'm saying is that in this cluster of three
confirmed cases of West Nile infection, with the possibility that there will
be a fourth, that there's clear evidence that organ transplantation appears
to have been the source.
Now, having said that, though, let me, you know, throw in one bit of
additional information. These patients all lived in areas where
mosquito-borne transmission of West Nile virus is occurring and is
continuing to occur. So it--this is complicated. It's important that we not
jump to conclusions and that we continue to follow this aggressive ongoing
investigation. And we will share new results with you as they become
available.
MS. SWENARSKI: Thank you, next question, please.
AT&T FACILITATOR: That is from the line of Paul Monise [sp] with WCBS-TV.
QUESTION: Thank you for taking my question. There's a lot of concern here at
the New York blood center about shortages. The president and CEO said to me
today that he is concerned that if the mosquito question made it on the
list, it would dissuade many people from donating and cause even more of a
shortage. So you mentioned that the risk is very low, perhaps 1 and 2 in
10,000. If 4.5 million transfusions are done every year, you're still
talking about the potential for 900 people to become infected with West
Nile. Would it be prudent to halt blood donations for a period of time until
an accurate and quick test could be developed?
DR. HUGHES: Well, maybe--Dr. Goodman, would you like to take a first crack
at that?
DR. GOODMAN: Well, I think that to halt blood donations, you know, in all
areas where there is a possibility that a person could get West Nile, based
on the current circumstance of a single incident where the possibility of
transfusion transmission is being considered would probably hurt a lot more
people than it would conceivably protect. I think we do need to proceed to
have a test that can be used if this problem is such that there's that need.
And I think we do need to take the measures that we're talking about. But I
think that that would be premature and would probably hurt more individuals
than it would conceivably help.
DR. HUGHES: Let me make one other comment. You know, West Nile virus is a
member of a group of viruses called flavy viruses, and that includes dengue
virus and St. Louis encephalitis virus and yellow fever virus, and others.
In terms of what's known about blood-borne transmission of these agents or
organ transplantation-associated transmission of these agents that are very
common in many parts of the world, is that there is very little
documentation of transmission.
With dengue, for example, there is one instance of transmission of dengue
virus infection in a bone marrow transplant that was done between siblings.
In addition, there is one case of dengue virus infection documented to have
occurred as a result of a needle stick injury. And that's it.
DR. GOODMAN: I could add that to our knowledge, in countries where this has
been around for a long time, including Israel, we are not aware of any
transmission. You know, I think this is new. It's an emerging infection. We
need to monitor it. But, you know, even your question, if this was--you
know, first of all, it's important to realize that risk estimate that you
cited was based on some of the best available data, but the data is very
limited and that estimate was also based on the assumption that it would
transmit to any individual exposed to the blood, which may not be correct
either. But we certainly haven't seen 900 cases of West Nile virus from
transfusion. We may possibly [inaudible] in the case of an organ transplant
donor infected; we don't know yet.
So I think that, again, the current situation makes us concerned about a
risk but does not suggest that that risk is widespread at this time. And to
reiterate, that for people who need blood or an organ transplant, the
benefit is going to far outweigh that risk. We need to continue to work on
this and, if there is a need for additional intervention, to do that in a
very timely manner.
QUESTION: A follow-up, if I could. Is there any better estimate today, and
how long would it take to develop a quick test to detect West Nile either
right before someone were to give blood or after the blood enters the
system?
DR. HUGHES: Well, it's not going to happen tomorrow or next week. I mean,
these things take time. It's months, at least.
MS. SWENARSKI: Thank you. Next question, please.
AT&T FACILITATOR: We'll go to Ira Dreyfus with AP Radio.
QUESTION: Hi, just two quick questions. One of them is exactly how much
blood are we talking about from these 60-some-odd folks? And exactly when do
you expect to get results back?
DR. HUGHES: Well, in terms of results, they're becoming available daily.
But, you know, the testing that's involved in documenting West Nile virus
infection is done in a sequential manner. So that's why we've been saying
that this investigation is going to be continuing for at least a couple of
weeks.
QUESTION: So then you don't expect final results for at least a couple of
weeks? And exactly how much blood are we talking about?
DR. HUGHES: Well, how much total blood we're talking about is one of the
subjects that we're focusing on in the investigation.
QUESTION: Can you give me a ballpark?
DR. HUGHES: No, I gave you the ballpark in terms of there being about a
dozen--roughly a dozen people who have appeared to have received blood from
these approximately 60 donors. But beyond that, in terms of how many units,
I don't have that information. But it's being collected.
QUESTION: Okay. And do you have yet a date by which you expect to have
enough results to make a determination?
DR. HUGHES: You can't predict in these ongoing investigations. We know more
today than we knew yesterday; we'll know a little more tomorrow than we know
today. But stay tuned.
MS. SWENARSKI: Thank you. Next question, please.
AT&T FACILITATOR: We will go to Miriam Falco with CNN.
QUESTION: Thank you. I have a couple of more questions. Number one, did the
donor--I don't know if your investigation has gone this far, but did your
donor show any symptoms of West Nile virus? Of course, that person, if they
would have been bitten by a mosquito, could have been asymptomatic.
And then number two, what was the time between the organs being donated and
received and the illness appearing in the four patients?
And then also, if the gentleman from the FDA could tell me exactly what it
was that led to the alert two weeks ago. What specifically made the FDA say
we've got to check the blood?
DR. HUGHES: Let me answer the first two, and then let Jesse speak to the
third.
As far as we can tell, and this is--we're not finished with the information
gathering, but as far as we know today, the donor was not ill prior to the
injury that she received.
The incubation period, the time from receipt of organ to onset of symptoms
was in the range of two to two and a half weeks.
DR. GOODMAN: On your question about the alert and why we issued it, I think
there are several reasons that I can share with you. One is that it has been
clear from the epidemiologic data being collected by CDC that the incidents
and number of cases of West Nile virus and its geographic distribution in
the United States was spreading. It was also clear from knowledge about this
disease that--and the anecdotal information Dr. Hughes mentioned about rare
cases where some of the other flavy viruses were transmitted through bone
marrow or other mechanisms--but not, to our knowledge, blood
transfusion--but it was clear that this biologically was plausible and can
make sense.
In addition, our colleagues at the CDC did some mathematical modeling based
on a New York epidemic of three years ago to try to determine, based on this
short period in which virus could be in the blood, what would be the risk
that that could be going on with a blood donor at the time they were
donating blood.
And putting all this together with, really, the desire to be ahead of the
curve, to always keep blood as safe as possible, to increase awareness so
that if there were a problem we would hear about it, and to reduce the risk
to the extent that we felt we easily could and appropriately could by being
sure that these donor exclusion criteria were followed--thinking through all
those things and working together with all our partners, we decided to issue
the alert at that time.
QUESTION: If I may follow up, though, since the high incidence of cases
started much earlier this summer, why didn't this happen, like, in July,
instead of two weeks ago? Did it have something to do with the knowledge of
these four cases, and--
DR. GOODMAN: Absolutely not. We were not, certainly, aware of that at all at
FDA. You know, I can't speak for CDC, but certainly we were in intimate
discussions with CDC and this didn't come up. In fact, we were discussing
this at that point as a theoretical possibility and, you know, debated
whether we should do this, and felt that, on balance, we should.
A proximate event occurring about that time was a publication of the
modeling information, and we sort of felt that we needed to keep that in
perspective but also address that. So in terms of the timing, that was a big
part of that, to my knowledge.
MS. SWENARSKI: Next question, please.
AT&T FACILITATOR: We'll go to John Lauerman with Bloomberg News.
QUESTION: Hi. Thanks for taking my call. Just a little housekeeping. So
there are three patients with confirmed West Nile virus who received
transplants. Could you just go through them and tell me which state and what
is the medical condition of each of the patients? I understand that two have
died and one is still sick, but I want to make sure who is where and who is
in what kind of condition.
DR. HUGHES: Well, let me offer Dr. Lance-Parker the opportunity to speak
about the two in Georgia and then Dr. Wiersma to speak about the two in
Florida.
DR. LANCE-PARKER: Hi. There were two patients who received organs in
Georgia. One patient died; the other patient is hospitalized but improving.
QUESTION: That patient has encephalitis, is that right?
DR. LANCE-PARKER: That patient has encephalitis.
MS. SWENARSKI: Dr. Wiersma?
DR. WIERSMA: Yes. There were two patients in Florida that received organ
transplants. One patient, who was a 62-year-old male who had encephalitis
and is a confirmed case, and is recuperating in hospital. The second person
received a transplant, we do not have any lab tests back on. That is a
71-year-old female. That patient is recuperating at home.
QUESTION: Okay. So one patient has died.
DR. HUGHES: Correct.
QUESTION: One patient has died, okay. All right, thanks very much.
MS. SWENARSKI: Thank you. Next question.
AT&T FACILITATOR: We'll go to Tom Maugh with the Los Angeles Times.
QUESTION: The number of 60 for donors, is that because you use pooled
products? Is that why there are so many potential donors here?
DR. HUGHES: And it's approximately 60.
QUESTION: Well--yeah, approximately, okay.
DR. HUGHES: This individual was severely injured in a motor vehicle crash.
In an effort to save the individual, multiple transfusions were provided.
QUESTION: Now, if you don't find West Nile in any of the people who donated
to her, then is that presumptive evidence that she was infected by a
mosquito?
DR. HUGHES: Well, that--if we're able to get specimens from everybody who
was involved in donation of blood or blood products that the donor received,
it may. If those specimens were all handled correctly and tested carefully,
as they will be in our lab and other public health labs, then the evidence
would, if that were to happen, then that probably would suggest the
possibility of community-acquired infection.
But it's the reason that we need to move as rapidly as we can to collect
those specimens that are available, identify and talk with the donors, and
obtain additional specimens. That is how we will try in the end to determine
the most likely route of transmission.
QUESTION: One thing I haven't heard here is anybody talk about the role of
immuno-suppression in this. These are all transplant patients, so their
immune systems are being battered down pretty strongly. Could that have
played a major role in this?
DR. HUGHES: Well, I did mention it briefly in terms of what we know about
risk of developing severe manifestations in West Nile infection. We know
that the principal determinant of that is age, and that in general it's
people over 50 who are at increased risk for severe disease. But for most
infectious diseases, being immuno-suppressed puts you at risk for developing
more severe disease, so we would think that that's probably true here as
well.
MS. SWENARSKI: Thank you. We have time for one more question.
AT&T FACILITATOR: And that question will be from the line of Dierdre
Henderson with the Denver Post.
QUESTION: I was curious if the testing that you have available right now
will give you an indication of when the donors were infected. If I were a
donor and I gave a month ago, would you be able to tell if I was infected a
month ago, versus bitten by a mosquito a week ago?
DR. HUGHES: Well, in terms of the tests that we have available, there
are--it's not going to be possible to precisely determine that. We look for
different types of antibody, we look for evidence of viral nucleic acid, and
we can look for evidence of virus. And when you get those results from any
individual patient, you can make an informed judgment about--within a range
of roughly when infection might have occurred. But it's not going to be very
precise.
DR. GOODMAN: Jim, just to add--one of the things that CDC and the blood
organizations are working on is obtaining samples from the actual donor
material at the time of blood donation. And at least for a substantial
number, or maybe Jim can comment, in the majority of these cases that
material is available and will be tested by CDC. So that should really help
if we find the virus itself or its nucleic acids at that time. If a patient
just subsequently developed--a donor, excuse me--on follow-up was just found
to have antibody, as Dr. Hughes said, it could be, you know, hard to known
exactly when they acquired that infection, or where.
MS. SWENARSKI: Thank you. That concludes our telebriefing for this evening.
We would like to add that we will continue to update you all as the
investigation progresses and that this evening we will post a transcript of
the telebriefing. Thank you very much.