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Secretary Thompson Testifies Before House Subcommittee

Aired October 23, 2001 - 10:29   ET


BILL HEMMER, CNN ANCHOR: Straight to Washington. Health and Human Services Secretary Tommy Thompson now talking about vaccine development and the response of recent outbreak the scare of anthrax in Washington and New York and extending down into Florida, Tommy Thompson.


TOMMY THOMPSON, HEALTH AND HUMAN SERVICES SECRETARY: ... on September 11, and more recently with the current anthrax investigations.

Let me emphasize that we have worked together with our partners across all levels of government, from the Federal Bureau of Investigation to the United States Postal Service, from local hospitals to county governments to address these more recent terrorist events. And soon after the first case of anthrax exposure in Florida, the Department of Health and Human Services through the CDC alerted all public health departments in the country to be on the lookout for anthrax-like symptoms, including those associated with inhalation and cutaneous.

As you know, anthrax is not contagious. Contracting inhalation anthrax, for example, is fundamentally different from exposure to the agent. You would have to inhale 8,000 to 10,000 spores of anthrax into your lungs before actually coming down with the disease. So simply having anthrax spores in one's nose does not mean that you are infected with anthrax.

The drug Ciproflaxin, commonly known by it's brand name Cipro, is effective in the treatment of inhalation anthrax, even after infection.

And Representative Sanders, I want you to know that I made that crystal clear to Bayer that we will not accept the price that they offered; and we will be negotiating this afternoon. And I'm sure you'll be -- I hope you will be satisfied with the outcome.

We have taken and continued to take every precaution, and we have made Cipro available to the widest number of people suspected of being exposed to inhalation anthrax. But other drugs such as doxycycline and penicillin have been approved by FDA as treatments for anthrax, and they're generic. The FDA's approval will include instructions on what dose to use and how long to treat the inhalation form of anthrax. The CDC has asked that local hospitals in and around the nation's capital pay particular attention to any suspicious respiratory or skin infections.

We at the department have been monitoring hospitals in the area and are closely monitoring the cases of two postal workers who are infected with inhalation anthrax in the District of Columbia.

And we're all deeply saddened by the deaths of two local postal employees, whose death have been linked to anthrax. Our thoughts and prayers are with their families.

And throughout the past month, the CDC and local public health departments have been working hard to trace back the source of the anthrax-tainted letters that have been received in this country. They've used the best science to follow the trail of these letters and they've used the best science to assess the risk of anthrax exposure to employees, both at the work places where the letters were received and at the postal facilities where the letters passed through.

Public health officials are relying heavily on science as they track these letters; identified those who may have been exposed and determine a course of treatment. These efforts were evident in the Florida and New York cases, where the letters were identified and those who may have been exposed were tested and treated. The CDC has done a good job of finding the letters in question and getting treatment to those at risk. The work of the CDC has likely saved many from serious illness and death.

We have good science, but it is also, ladies and gentlemen, an evolving science. Remember we have never had cases of anthrax attacks in this manner before. It is a new challenge that we are all facing as a country. We also need to get ahead of the science. We will be even more, gentlemen, aggressive in securing the safety of our postal workers who may have been exposed to a tainted letter.

CDC, the union and the postal authorities are meeting this afternoon in order to find ways to better secure the safety of all employees.

And therefore, I am making it clear today to this committee and to the American public, the Centers for Disease Control, that when a case of anthrax does emerge, we will immediately move in at any and all postal facilities that might have handled that piece of mail. We will build the scientific link between the post office of the postmark and the recipient of the letter.

In other words, we'll not only immediately begin testing and treatment at the site where the letter was received, but simultaneously begin testing and treatment at all postal facilities through which that letter may have passed. And we will make medicine immediately available to those employees who may have been at risk of exposure. We have plenty of antibiotics to treat anthrax. And we're going to err on the side of caution in making sure people are protected.

I ask for the cooperation and partnership of local public health departments in this endeavor.

We're also going to lend the United States Postal Service our scientific expertise in developing ways to protect postal workers as they sort and deliver the mail, as well as what technology might help in making mailrooms more safe. We've been assisting the postal service from the onset and we're going to continue to make our resources and expertise available to them, and we're having a meeting this afternoon to finalize and to be able to improve those terms.

Postal workers have a tough job and it's a job that becomes even tougher in some parts of the country, but we're going to ease their burden by going to the greatest lengths to make sure that their health is protected. If we even remotely suspect that an anthrax-tainted letter may have passed through a facility, we're going to get there, test the facility and make the appropriate treatment available to those who may have been exposed. We're going to act quickly and, if need be, let the science catch up to our actions. If it turns out postal workers did not come in contact with anthrax spores, we can always take them off the antibiotics.

Never has our nation's public health surveillance been more important. And the dedicated public servants in the Department of Health and Human Services as well as the public health officials in all of our local communities are committed to being even more thoroughly prepared to respond tomorrow than we are today.

And I know -- I know some critics are charging that our public health system is not prepared to respond to a major bioterrorism attack and I know that some state and local labs are feeling overwhelmed right now as they respond to people's natural fears about what might be waiting in their mail, and I understand that our local first-responders are also feeling overburdened. But the response from state and local authorities to each and every threat is continuing and will continue. And we should be proud of how well everybody has responded to events that have broken our hearts even as they have steeled our resolve. But we must continue our efforts to be better prepared for future events.

So an effort to ensure the department is fully prepared and better coordinated, I recently announced the creation of a bioterrorism advisory committee in my office. And Dr. D.A. Henderson, who certainly is renowned for his role in eradicating smallpox, heads that committee. Dr. Henderson and his staff will provide seasoned advice to the department on all bioterrorism activities, including efforts to improve state and local preparedness.

And just this last week President Bush requested an additional $1.5 billion to strengthen our ability to prevent and respond to a bioterrorism attack. Of the total funds requested, two-thirds are being designated for the production of vaccines and antibiotics. In addition, the president has requested $300 million for improving state and local readiness which specifically includes $122 million for training communities in distribution of the medicines during an emergency, Representative Sanders. We must accelerate the production of vaccines and antibiotics and we must invest in essential programs to assure the speedy and orderly distribution of antibiotics and other supplies in the event of a major bioterrorism event.

The president request includes $643 million to expand the national pharmaceutical stockpile and $509 million to speed the purchase of 300 million doses of smallpox. And with these resources, HHS will expand its program capabilities to respond to an all- hazardous event.

As you all know, there are currently eight push-packs each consisting of 50 tons of medical supplies available as part of the stockpile. Each one includes no less than 84 separate types of supplies; things like antibiotics, needles and IVs, a tablet counting machine and oxygen masks, and each push-pack provides a full course of antibiotics and other medical supplies and is able to be shipped to an area within 12 hours to help state and local response efforts. We were able to deliver one push-pack into New York City on September 11 within seven hours.

These push-packs have enough drugs to treat two million individuals for inhalation anthrax following an exposure.

I have directed that the stockpile development should be increased for inhalation anthrax so that 12 million persons could be treated. CDC will reach that level of response within the next 12 months.

I also want to point out, the president signed an executive order yesterday, urging us to go ahead quickly on this program.

With the additional resources, we also add for more push-packs to a total of 600 tons of medical supplies from the current eight and have them strategically located across the country, making more emergency supplies available and augmenting our existing supplies.

The president and my department are also committed to the development and the approval of new vaccines and therapies. The CDC, the Food and Drug Administration and the National Institute of Health, all agencies within HHS, are collaborating with the Defense Department and other agencies to support and encourage research to address the scientific issues related to bioterrorism.

The capability to detect and counter bioterrorism depends, to a significant degree, on the state of relevant medical science. Our continuing research agenda, in collaboration with CDC, FDA, NIH and DOD, is critical to our overall preparedness.

So let me outline several other areas that our budget requests. The president is calling for $88 million to expand our capacity to respond to bioterrorism incidents, including $20 million for the CDC's rapid response and advanced technology and specialty labs which provide quick identification of the suspected agents and the tactical assistance to state labs.

Also included in this amount is $20 million to support additional expert epidemiology teams that can be sent to states and cities to help them respond quickly to infectious disease outbreaks and other public health risks. And let me reiterate my conviction, personally, that every state should have at least one federally funded epidemiologist who has graduated from the epidemic intelligence service training program like Scott Lillibridge program has. Every state health department, I believe, should have one.

The president is also asking for $50 million to strengthen the metropolitan medical response system to increase the number of large cities that are able to fully develop their MMRS units. It is imperative that we work closely with cities to ensure that their MMRS unites have the proper equipment and training, increasing that from 97 to 122.

We're also providing $50 million to assist hospitals and emergency departments in preparing for and responding to incidents requiring mass immunizations and treatment. And we're providing $10 million to augment state and local preparedness by providing training to state health departments on bioterrorism as well as emergency response.

The president is also requesting $40 million to support early detection surveillance to identify potential bioterrorism agents, which includes web-based disease notification to the health community nationwide. This amount will provide for the expansion of our health alert network, more commonly referred to as HAN, which helps early detection of disease to 75 percent of the nation's 3,000 counties.

I wish and hope to have all counties connected in the coming years. We're providing $15 million to support the increased capacity in no less than 78 laboratories in 45 states. This funding will enhance our ability to identify and detect all critical biological agents, and we're implementing a new hospital preparedness effort to ensure that our health facilities have the equipment and training they need to respond to mass casualty incidents.

Finally, as to food safety, the president is also requesting $61 million to enhance the frequency and the quality of imported food inspections and to modernize the import data system to enable us to detect tainted food.

This funding will also provide for 410 new FDA inspectors to help ensure that our food is better protected. The administration has sent to Congress legislation to strengthen our ability to protect the nation's food supply. This measure will require prior notice of imported food shipments, enhancing our ability to inspect food, allowing for detention of food suspected of being tainted and providing flexibility for the FDA to approve drugs and other treatments for dealing with illness resulting from biological attacks.

Mr. Chairman, let me conclude by noting that, despite the events of recent days, every American must and should continue to live their lives, working, spending time with family, having a meal out or shopping at the local mall, and they should be able to do that with confidence.

American citizens can be sure that their government agencies, local, state and federal, are ready to respond to biological warfare and bioterrorism quickly and effectively throughout the country. None of us enjoys contemplating bioterrorism, but as responsibile public servants doing so is a matter of fulfilling the public's trust in us. Under the leadership of President Bush, we're taking all the steps necessary to keep America safe in an era when biological and chemical attacks are as possible as they are unthinkable.

I want to thank you, Mr. Chairman for letting me speak about this matter of critical importance, and now I am glad to answer your questions.

REP. CHRISTOPHER SHAYS (R), CONNECTICUT: Thank you, Mr. Secretary, for your thorough statement. I again want to thank you for allowing us to use your facility and also to thank you again for your presence here before the committee. It is the intention of the chairman to have five-minute questions for each member, and then we'll do a second round where we will go 10 minutes if any member wants to.

I just want to set up the stage for my question. We've had three commissions that have come before our committee, that Gilmore commission, the Bremer Commission, the Hart-Rudman commission. And of all of them have basically said to this committee and in their reports that we haven't had a proper assessment of the terrorist threat, that we don't have a strategy to deal with it, and we aren't organized effectively to implement a strategy.

Now that's what they said last year. And obviously things have changed. You have the president who has put Tom Ridge in charge of reorganizing to maximize our effort.

We recognize that the best thing that could happen is we could detect and prevent an attack, whether catastrophic or sand in the gears, which is what we have right now. We have in that process a crisis if an attack is under way, and how does the government deal with it.

Then we have -- if an event occurs, we have the criminal Justice System trying to discover, you know, where this attack happened, who is responsible, and so on, who do we hold accountable?

I would parenthetically say I view all of this not as criminal action; I view as act of war. I think we are at war.

And then we come to what we call the crisis management, where FEMA comes into play and so on. I put you pretty much in that category of the crisis has occurred. And this hearing is to look at the role vaccines play in civilian preparedness. You're free to speak on anything. Members are free to ask anything they want. I know you will respond as you choose.

But one of the things we want to know what are what are the near and long-term of roles of vaccine against biological warfare and terrorism? How adaptable is the current regulatory process to development and approval of biowarfare defense vaccines. That's kind of the thrust of the hearing.

And so with that as the thrust,I'm interested to know, do you plan or recommending that we vaccinate the entire U.S. population for say a smallpox outbreak.

THOMPSON: No. We do not. If I could just set my response a little bit longer than just that, quick response of -- if I might Mr. Chairman. I want everybody to know that right now, as soon as a consequence happens, we would immediately put an order and put on notice our 7,000 individuals that belong to our 90 DMAT teams throughout the United States. As soon as the crisis happens, they contact the state health department, who contacts CDC. We would send immediately some epidemiologist from Atlanta to that local. And they would work in cooperation with the local hospital to local emergency workers, and the state health to develop a plan. They would, then call us with that plan. In the Humphrey building, we have a huge room downstairs set aside, in which we have people like Scott Lillibridge other professionals around. That's on the sixth floor.

I hope go down and look at it before you leave today, members of the committee.

And then they would send out whatever they need as far as extra personnel as well as medical supplies. In regards of your specific question on vaccination. We have, as you know, 15.4 million dosage of smallpox vaccine right now. And Dr. Tony Falici is doing research on right now, to determine if we could dilute that down 5-1 or 10-1; 10- 1, you would only have infected rate of about 70 percent; 5-1 we think is going to be around 90 percent, and that would be very effective, 90-95 percent, and we would then have 77 million dosages, and that has been analyzed by Tony Falici and the people out at NIH, and they say it's very potent, very effective. We have enough dilulent (ph) and needles to handle the 15.4 million dosages of smallpox. We are in the process. We sent out what's called a request for information. I met with the pharmaceutical companies, several of them last week, and seven companies now indicated they would like to get involved in issuing some sort of bid to produce smallpox vaccine.

QUESTION: Could I just ask you in this regard...


QUESTION: After you've done your experimentation with animals, you have to go through one phase where you do, you know, a handful of...

THOMPSON: Protocol.

QUESTION: Human protocol.

For initial safety and to see how well it immunizes. And then you go to phase two, which could take two years to much longer, with self hundred patients, to determine its safety and efficacy, and then you go to phase three, where you're dealing with even more, and it's hard for me to know how we can reach a timetable of, you know...

DR. ANTHONY FALICI, NIH: In two years.

THOMPSON: That's why the Dr. Falici is here because we have already worked that out. FALICI: Let me just say after your answer, and then I'll go to Mr. Kanicich (ph), we are talking about trying to expand the availability and dosage of an already-approved vaccine, so it's a different story from having to go. We are talking about the dilutional studies on smallpox.

QUESTION: Let's be clear, is this the vaccine that the...

FALICI: Absolutely. This is highly effective vaccine that we used to vaccinate routinely for until 1972, and in 1972, it was discontinued. We have 15.4 million doses in the U.S. government reserve. That is already an approved vaccine. The studies that were done preliminarily on 60 individuals compared a broad range of dilutions. We took the undiluted, which we know works. Decades of history tells us it works.

Their safety, obviously there are some issues that we could discuss about the risk benefit of that, because there are uncommon, but nonetheless potentially serious toxicities.

QUESTION: Let me just interrupt you a second. This is an older vaccine, which is truly not as pure. It's there, and it is approved.

FALICI: Right.

QUESTION: But aren't we ultimately looking to produce a new vaccine? And that's really what I was saying.

FALICI: We are. Exactly, we have immediate plan to answer the question what happened if something happens a month or three weeks now, what happens if something happens six months to a year. And the department's leadership has asked us to put together a plan which addresses the immediate, the intermediate and the long range. The question you asked about the initial doses of the diluted one. That's the immediate plan. So you have 15.4 million doses. We did a preliminary study last spring, where we compared the undiluted with 1- 10 with 1-100. We found 1-100 dilution didn't work well, not very significant take.

Let me explain, because I know the question you asked is very relevant. This is something that's tested for safety and take rate, and by take rate, we mean to get the characteristic skin reaction, which traditionally historically has been highly correlated with protection against smallpox infection.

We'll never be able to do a challenge study, because it would be unethical and unthinkable to challenge someone with smallpox. So we're asking what is the safety in the component, and what is the take rate? In the preliminary study, we found that it was about 70 percent take rate. Since that, we felt was not adequate enough, we redesigned a larger study, which is a 650-patient study. The screening has started. The vaccinations will start within a few weeks. In that study, we compare 1-10 with 1-5 with undiluted. Since we know in previous study that we got 70 percent take rate on the...

QUESTION: Is this with animal we're that we're doing this? FALICI: No, this is humans, sir. And this is not a phase-one study. This is called a phase-four study, because it's done with an already-approved product.

UNIDENTIFIED MALE: Let me just say this to you. I'm a little uneasy, given the chairman here going over my five minutes. I do want this issue, so I will allow the other members the same amount of time.

I just want to separate the old method that's in storage. You haven't yet addressed the new one, and I don't want you to, because that's a longer issue, and we will take up later. If you don't have smallpox outbreak, how are you able to really determine its efficacy, because you can't inflict people with smallpox to try to see if it works.

FALICI: Let me try to explain that. As I mentioned just a moment ago, we have a lot of historical experience that when you get a take, namely you have the characteristic reaction...

QUESTION: Define take again.

FALICI: A take, if I get a vaccination and I put the drop on my shoulder, many of us who were born before 1972, if you look on your shoulder, you see a very faint little scare, and what it is a little prickly type scar, and what happens is you put a drop on your shoulder, and you take a typical classical needle, a bifurcated needle, and you put about 15 jabs, until there is a little bit of blood, in an area about five millimeters. After, it's a primary, you haven't been vaccinated before, or if it's someone like you or I who have been vaccinated before, we would have a secondary take.

My daughters would have a primary take, and what that would mean is that after a period of time, you would have the gradual evolution of what looks like a postule, inflamed and then a scab, and then ultimately the scab falls off. We know that that is correlated with protection. So even though we can't and should not challenge someone, we have extraordinary historical information that that take is associated with protection.

So the studies that we're doing -- and let me just finish briefly what I was saying, that the ones that have just recently started, that will be finished by the beginning of the year, the end of January, the beginning of February, will determine if you compare the undiluted, which we know works, with a 1-5 and 1-10, and we -- for example, the 1-5 let's say gives you a 90 percent take. It's not unreasonable assumption, but we have to do the experiment first before we can give you that information. If the 1-5 gives you a very good take rate and is safe, then you have the potential for over 75 million doses available to you. That's the immediate plan, and as you mentioned, we can go later on into what the intermediate and the long range plan is.

QUESTION: Let me just summarize what I think you basically have said and is the answer, there is no intention to have a universal vaccination program.

FALICI: That's correct. QUESTION: That could only happen obviously if we had new production with a new vaccine, which we are -- my understanding, we're moving forward with that. Our other members may get to that question, but in terms of the existing stock, you're basically saying the 12 million that is in...

FALICI: 15.4.

QUESTION: Well, 12 are in great shape, and three million is questionable.


QUESTION: If we use the 15, that you think ultimately -- that you will see a 1 -- a 5-1, and this will be FDA approved.

FALICI: It is not unreasonable to assume that the 1-5, but we have to do the study, and that's the reason we have to do that.

QUESTION: And that will be FDA approved.

FALICI: Yes, yes.

QUESTION: So in other words you saying, not that you are ordering them to, but that you won't move forward unless it's FDA approved.

FALICI: Right. The FDA will be involved...

QUESTION: I just want to make sure.

FALICI: Right, the FDA will be involved in looking at the safety and the take rates. So the idea about were there any unusual reactions when you diluted it? Was there something that was not predictable. So there certainly FDA involvement. This is not something that do and just give it.

THOMPSON: Let me just say something really quickly. We have increased the purchase from a canvas from 40 million doses to 54. That's the one that has the exclusive contract. And they have indicated that they will have that delivered to us by next July.

QUESTION: Right. But I don't want to get on the new one yet, Mr. Secretary, just because it raises the question about, you know, I'd be here another 20 minutes with you. I used at least 10 minutes, and Mr. Kasinich (ph), you have 10 minutes.

QUESTION: Thank you very much, Mr. Chairman.

Mr. Secretary, I want to put things in perspective here. Does the incidents have any information that the incidents of reports of anthrax are more widespread than the incidents that we've seen reported at the various media outlets and in the Capitol here?

THOMPSON: And, Congressman, some of that stuff is classified. And I don't think we should discuss in this... QUESTION: Well, we need to know. It would be comforting for the American people to know. Is this a widespread problem, or is it fairly localized?

THOMPSON: To the best of my knowledge, it is what we've seen so far. We have no intel to say this is going to be a wider-spread thing, but we have to be prepared for it, Congressman.

QUESTION: I understand, but when we're speaking of threat assessment, we're speaking of something that, at this point, is localized.

THOMPSON: That is to the best of our information at this point in time, but we are preparing for something much more dramatic.

QUESTION: And your in contact with, obviously, the FBI concerning threat assessments and being able to analyze so that you can prepare accordingly.

THOMPSON: That is correct. There are two paths currently going on, the criminal path and public health path. We are responding to the public health path. The FBI is doing the criminal investigations in Florida, and New York and in Trenton.

QUESTION: But you don't see anything, or do you see anything which would favor a mass stockpiling, or prophylactic consumption of Cipro, or any other drug that is related?

THOMPSON: We feel that to be on the prudent side, it imperative for us to increase the amount of purchase from antibiotics that would treat two million for 60 days up to 12 million. And we feel that it is also advisable, even though we have no knowledge or basis at this point in time for any kind of smallpox, to have 300 million doses of smallpox vaccine, just in case it ever did break out, because it's so contagious.

QUESTION: There's no connection, though, between that...


QUESTION: And a threat assessment, there is not.

This is you saying, what if this happens...

THOMPSON: We have to be prepared.

QUESTION: Let's be prepared, but you don't have any information that suggest they're any kind of a reason for the American people to be concerned that suddenly smallpox is going to be reality in their community.

THOMPSON: That's correct. That is correct.

QUESTION: A few weeks ago when the first discussion began to surface about anthrax, I remember a report -- at least I'm pretty sure this is what I heard, that there was a theft of some anthrax from a government lab? Did you hear of that at all?

THOMPSON: We have heard of it. But we have also found out that there's a lot of rumors that are going on. A lot of the rumors that are going on, we don't know about that.

QUESTION: Let's go back to threat assessment and the role of health and human services. Are you aware of where any biological agents that could be used against people anywhere are in the control right now of various government laboratories?

THOMPSON: We are absolutely certain there's biological agents in government laboratories, because they're doing research on them, congressman.

QUESTION: Right. OK, do you ever talk to the people who are doing research on these -- on anthrax, on smallpox, on botulism, any of the others about the security of that, and the connection between that security and public health concerns?

THOMPSON: I certainly have, in fact. I went down to CDC and went through the laboratories down there and be spending a couple of day next week in CDC, Congressman, doing just that. We also looked at the IG report, which I had done, to take a look at laboratories security. And we have been increased the laboratory security in all of CDC and all of NIH labs, and we're asking for some more money at this appropriation to improve it even more so.

I am not satisfied if that's what you are asking on the laboratory security presently. It's much better than it was three months ago. And it will much better if we get this necessary money to do so.

QUESTION: Could we have that report submitted for the record?


QUESTION: Thank you.

QUESTION: Since we talk about threat assessment here, we should be aware of the what the government may posses that could create some problems.

So I would also like to ask you, Mr. Secretary, you articulated a number of agencies that you have been in touch with. Have you been in touch with, for example, the Department of Defense relative in search going on in the Department of Defense and security of those defense- related matters where they might be looking into different types of warfare?

THOMPSON: We have -- let me answer in two ways. First off, we have the most virulent viruses in the world in our laboratories.

QUESTION: That's what I'm concerned about.

THOMPSON: I mean, we're the only ones that are really -- we and the Russians are the only ones that are supposed to have smallpox virus. I said we are supposed to.

HEMMER: We have been listening to testimony, in Washington, of Health and Human Services Secretary Tommy Thompson -- a lot of talk there.

Two very critical things pointed out. We heard Tommy Thompson, about 30 minutes ago, say quote, "We need to get ahead of the science," and all the question and answer right now is how the federal government has been responding to try and get a handle and ahead, potentially, of the science of the recent outbreaks we have heard about anthrax and also discussion about smallpox.

The other bit of news coming out there was Tommy Thompson indicating that the policy has now changed according to the federal government: At any point if there's detection of anthrax -- in any letter in any postal facility in the United States -- that will be immediately shut down, and those facilities will be examined and tested. He was saying, quote, "We will err on the side of caution." This is in respond to criticism yesterday that some postal workers in Washington and in Baltimore kept working while it was known that a letter with anthrax contained inside of it was opened in the office of Senate Majority Leader Tom Daschle. That was a result of quick action today from Tommy Thompson, very forceful in his statements that we have heard.




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