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Dec 24, 2009
12/09
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i will continue to work with my colleagues in congress and the fda to provide more resources to the fda for dietary supplement oversight. and before i conclude, i want to stress an extremely important point -- since enactment of dshea, almost every commissioner is on record stating that the agency has enough enforcement authority to regulate dietary supplements. and the current commissioner, in a recent speech, mentioned that "reports have noted that there has been a steep decline in the fda's enforcement activities." some serious violations have gone unaddressed for far too long produce include violations including product quality, adulteration, and false branding. misleading advertising. furthermore, in providing an example of the fda stepping up its enforcement activities, dr. ann burke cited enforcement actions against people selling over the county -- over-the- counter body building substances that include steroids. she said, these are unproven and she said, these are unproven and unapproved drugs, not simply put, under current law, the products are not allowed to be marketed. i ap
i will continue to work with my colleagues in congress and the fda to provide more resources to the fda for dietary supplement oversight. and before i conclude, i want to stress an extremely important point -- since enactment of dshea, almost every commissioner is on record stating that the agency has enough enforcement authority to regulate dietary supplements. and the current commissioner, in a recent speech, mentioned that "reports have noted that there has been a steep decline in the...
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Dec 24, 2009
12/09
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i will continue to work with my colleagues in congress and the fda to provide more resources to the fda for dietary supplement oversight. and before i conclude, i want to stress an extremely important point -- since enactment of dshea, almost every commissioner is on record stating that the agency has enough enforcement authority to regulate dietary supplements. and the current commissioner, in a recent speech, mentioned that "reports have noted that there has been a steep decline in the fda's enforcement activities." some serious violations have gone unaddressed for far too long produce include violations including product quality, adulteration, and false branding. misleading advertising. furthermore, in providing an example of the fda stepping up its enforcement activities, dr. ann burke cited enforcement actions against people selling over the county -- over-the- counter body building substances that include steroids. she said, these are unproven and unapproved drugs, not dietary supplements. in other words, they are considered adulterated and misbranded under the food and drug cosme
i will continue to work with my colleagues in congress and the fda to provide more resources to the fda for dietary supplement oversight. and before i conclude, i want to stress an extremely important point -- since enactment of dshea, almost every commissioner is on record stating that the agency has enough enforcement authority to regulate dietary supplements. and the current commissioner, in a recent speech, mentioned that "reports have noted that there has been a steep decline in the...
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Dec 9, 2009
12/09
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eye 162
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only fda approved drugs from fda inspected plants in canada, the european countries, japan, new zealand or australian. that's all. why? because they have an identical chain of custody to us. and that's the basis on which we determine how reimportation could work and could work safely. but i want to describe a recent scandal that illustrates the double standard that some want to apply to this question. and the scandal was about a drug called heparin. a blood thinner commonly used by dialysis patients. it was a link to last year to more than 62 deaths. heparin was ultimately pulled from the market, and according to baxter health care, which markets have been in the u.s., the allergic reaction to heparin that caused those deaths appear to be cause by a contaminant that was added in the place of the active and greet and heparin somewhere during the manufacturing process, most likely in china. "the wall street journal" did a really important story on the heparin contamination. they reported that more than half of the world's heparin gets it start in china's poorly regulated supply chain. thi
only fda approved drugs from fda inspected plants in canada, the european countries, japan, new zealand or australian. that's all. why? because they have an identical chain of custody to us. and that's the basis on which we determine how reimportation could work and could work safely. but i want to describe a recent scandal that illustrates the double standard that some want to apply to this question. and the scandal was about a drug called heparin. a blood thinner commonly used by dialysis...
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Dec 24, 2009
12/09
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we just met -- dea and fda are working together. we just met regarding products and pharmaceutical train. it is not a question of us not working together. it is the scheduling process. we work together fine. >> let us know if you need changes in the law. we are always going to have bad actors. we'll always have criminals. it seems to me there is enough legal authority there to get these bad substances off the marketplace, but i understand that there's some evil people out there. it does fda tell you when they deny new ingredient notification that it could involve an anabolic steroid? >> if i may, may i talk to one of my scientists? >> yes. >> we do not receive a warning, a scientist to scientists, no. >> do you do with your own chemists? the chemical analysis we do, but the studies, the cellular studies and animal studies all have to be outsourced. >> do you check with fda to make sure they have received the dietary ingredient notice for our compound you are looking at investing in? >> not in regard to anabolic steroids. >> on page
we just met -- dea and fda are working together. we just met regarding products and pharmaceutical train. it is not a question of us not working together. it is the scheduling process. we work together fine. >> let us know if you need changes in the law. we are always going to have bad actors. we'll always have criminals. it seems to me there is enough legal authority there to get these bad substances off the marketplace, but i understand that there's some evil people out there. it does...
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Dec 16, 2009
12/09
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eye 265
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specifically, the fda stated importing mullen fda approved prescription drugs posed for potential risk to patients. let me go over those four risks. the first, the drug may not be safe and effective because it did not undergo the rigorous fda regulatory review process. number two, the drug may not be consistently made a high-quality product because the facility in which it was manufactured was not reviewed by the fda. third, the drug may not be a substitute double with the fda approved product because of differences and composition or manufacturing and forth the drug could be contaminated or counterfeit as a result of inadequate safeguards in the supply chain. if the agency that oversees drug safety is saying it would have difficulty guaranteeing the safety of the nation's drug supply with free importation i have grave concerns particularly since the fda is already underfunded and understaffed. but let's take a moment to examine how europe, which does allow free importation, has shared in terms of safety. british authorities say counterfeit drugs often exchanged hands between middlemen
specifically, the fda stated importing mullen fda approved prescription drugs posed for potential risk to patients. let me go over those four risks. the first, the drug may not be safe and effective because it did not undergo the rigorous fda regulatory review process. number two, the drug may not be consistently made a high-quality product because the facility in which it was manufactured was not reviewed by the fda. third, the drug may not be a substitute double with the fda approved product...
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Dec 10, 2009
12/09
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eye 189
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only fda approved drugs from fda inspected plants in canada, the european countries japan, new zealand, or australia. that's all. why? because they have an identical chain of custody to us. and that's the basis on which we determine how reimportation could work and could work safely. but i want to describe a recent scandal that illustrates the double standard that some want to apply to this question. in the scandal was about a drug called heparin, a blood thinner commonly used by dialysis patients was linked laster to more than 62.. heparin was pulled from the market and according to baxter health care which market separate than the u.s. the allergic reactions to heparin that caused those deaths appear to be caused by a contaminant that was added in the place of the active ingredient in pepper and somewhere during the manufacturing process, most likely in china. "the wall street journal" did a really important story on the heparin contamination. they reported that more than half of the world's heparin gets its start in china's poorly regulated supply chain. this is what "the wall stree
only fda approved drugs from fda inspected plants in canada, the european countries japan, new zealand, or australia. that's all. why? because they have an identical chain of custody to us. and that's the basis on which we determine how reimportation could work and could work safely. but i want to describe a recent scandal that illustrates the double standard that some want to apply to this question. in the scandal was about a drug called heparin, a blood thinner commonly used by dialysis...
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Dec 17, 2009
12/09
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fda is going to want to get a good look. we're going to want to get a good look at how effective they are, how safe they are. and i would say even in the best case scenario, if we had a candidate to go forward in the next five years, i think there's going to be some interim period where we still use the seasonal vaccine at the same time that we move in some of the universal vaccines. so i think there will be plenty of opportunity for the companies to adjust to the new knowledge-based, to the new products. and then do the kind of things that tony just described. >> another question from online. >> we have a question from the university of minnesota. the question is for dr. robinson, dr. gellin that has been local opposition to the rollout. named because it is untested and new. given that, how are you planning to be able to persuade the public to truly accept a new vaccine with new technology? >> well, i think there's nothing special about the flu and new technology. i think what we've indicated is there's research, a number o
fda is going to want to get a good look. we're going to want to get a good look at how effective they are, how safe they are. and i would say even in the best case scenario, if we had a candidate to go forward in the next five years, i think there's going to be some interim period where we still use the seasonal vaccine at the same time that we move in some of the universal vaccines. so i think there will be plenty of opportunity for the companies to adjust to the new knowledge-based, to the...
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Dec 12, 2009
12/09
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fda wants to get a good look.ective and safe they are i would say that even in the best case scenario if we had a candidate to go forward in the next five years there will be some interim where we still use the seasonal vaccine at the same time we move in some of the universals into play. plenty of opportunity for the companies to adjust to the>> ledge base to the new products and to again do the things that tony described. >> question from on-line? >> yeah, we have a question from marion from yuan rersty of minnesota for doctor robinson. there's been vocal opposition to the h1n1 saying it's untested and now. when it was based obstacle along established vaccine. given that how are you planning to persuade the public to truly accept a new flue vaccine with new technology? >> well i'll start. i think there's nothing special about flu and new technologies. i think what we've indicated is there's a number of new technologies coming that trajectory and each time-line you've seen are quite long. there's a lot of ideas t
fda wants to get a good look.ective and safe they are i would say that even in the best case scenario if we had a candidate to go forward in the next five years there will be some interim where we still use the seasonal vaccine at the same time we move in some of the universals into play. plenty of opportunity for the companies to adjust to the>> ledge base to the new products and to again do the things that tony described. >> question from on-line? >> yeah, we have a question...
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Dec 24, 2009
12/09
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the efforts to give the fda more resources have not been successful. i think there are some things that need to be done here, some real questions. i think the drug enforcement administration needs to answer a question which is not been answered today about why superdrol is not placed on its schedule 3 list after it was identified as being an anabolic steroid. if he needs some revision on your listing, let us know. did not wait for our to come to you. -- do not wait for us to come to you. the business about waiting for us to ban a substance 10 years after the fda issued its first advisory and only after they received thousands of reports of adverse effects, including debts, that is not satisfactory. -- including deaths, that is not satisfactory. when the senator talks about the legitimate part of the industry, i think that most are bested legitimate. if you have 15 million people who are taking the supplements and steroids. although some of that is legitimate. exposing millions of people to problems. from my view, i think we need to look of some pre-cle
the efforts to give the fda more resources have not been successful. i think there are some things that need to be done here, some real questions. i think the drug enforcement administration needs to answer a question which is not been answered today about why superdrol is not placed on its schedule 3 list after it was identified as being an anabolic steroid. if he needs some revision on your listing, let us know. did not wait for our to come to you. -- do not wait for us to come to you. the...
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Dec 22, 2009
12/09
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. >> [inaudible] the white house pressure the fda to send this letter to help kill the -- the fda isncerns by the fda about reinterpretation are not something that came with the obama administration. if one can do this safely, it was the concern of the fda to the prior administration, so this is about 810-year concern by the fda in terms of safety. -- this is about a 10-year concern. if you look back at the history of concerns that have been had about safety, they have been there for quite some time. happy holidays. >> [inaudible] >> no, enjoy your holidays. >> [inaudible] >> i have not seen that information. thanks. >> a question for robert gibbs about parker griffith. news that parker griffith, a freshman democrat will announce he is switching parties to become a republican. that will take place this afternoon in his district in northern alabama. the senate is in day 19 of debate on health care legislation. democrats passed the bill through procedural votes this morning, paving the way for more debate, although there were also hints from the majority and minority leaders that negot
. >> [inaudible] the white house pressure the fda to send this letter to help kill the -- the fda isncerns by the fda about reinterpretation are not something that came with the obama administration. if one can do this safely, it was the concern of the fda to the prior administration, so this is about 810-year concern by the fda in terms of safety. -- this is about a 10-year concern. if you look back at the history of concerns that have been had about safety, they have been there for...
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Dec 15, 2009
12/09
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none of that exists under the safety drug -- host: the fda sent a letter to you and others saying youraises safety concerns. it says the white house is attempting to strike balance, expressing aprofessional 06 these ideas to allow the imports while bowing to safety concerns. what if they -- i spoke to -- guest: i said it could have come from a copying machine several years ago. think i the letter was prompted by somebody else to send to capitol hill because they were worried that in my amendment passes it's the lead the on a cheap suit that the arm falls off. they are worried that whatever deal someone made with the pharmaceutical company will not stick if $100 billion is taken out of pharmaceutical rev neuse. we're talking about over $3 trillion takeover next three years by overcharging the american people with being tauppingd about? guest: no. not at all. the letter, and by the way, this same type of letter was sent when tomi thompson was head of hhs, and he said with that letter i can't possibly certify the safety of the drug supply, but after tomi thompson left office, he walked ou
none of that exists under the safety drug -- host: the fda sent a letter to you and others saying youraises safety concerns. it says the white house is attempting to strike balance, expressing aprofessional 06 these ideas to allow the imports while bowing to safety concerns. what if they -- i spoke to -- guest: i said it could have come from a copying machine several years ago. think i the letter was prompted by somebody else to send to capitol hill because they were worried that in my...
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Dec 17, 2009
12/09
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the fda has oversight and defense fabulous board.and many of the decisions we have going forward, the public health emergency countermeasure enterprise which is a governing body within the department and u.s. government for countermeasure development. as has been pointed out earlier this is a long continuum for development. this pipeline has seen many products that have to be invented and go through so that you have one or two at the end. where we work with our partners in the department of defense is once products move out of the phase i there is a hand off. as a dotted line, it does work past the this and we go earlier. we have a fine transition of these parts. in order to have something at the end we have to have many products going forward. i bring that to you because as dr. fauci pointed out earlier, the re-emergence of the avian flu, the katrina hurricane response actually lead to a real need for national strategy for influenza announced in november of 2005. the implementation plan came out in 2006. the ability to have in our c
the fda has oversight and defense fabulous board.and many of the decisions we have going forward, the public health emergency countermeasure enterprise which is a governing body within the department and u.s. government for countermeasure development. as has been pointed out earlier this is a long continuum for development. this pipeline has seen many products that have to be invented and go through so that you have one or two at the end. where we work with our partners in the department of...
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Dec 10, 2009
12/09
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there is a letter from the fda. you know, the practice we have seen it this over the years that they say, well, we don't have the resources or it will impose more risk. the fact is this amendment provides the resources for them. because of those that are going to register to be able to ship fda-approved drugs into this country and a better price are going to have to pay a fee. the people that are selling will pay a fee and those pharmacies and others in our country who will be receiving will also pay a fee. this actually funds -- >> require no additional funding from the taxpayer? >> no additional funding from the taxpayer at all, those that decide they will offer these lower-priced prescription drugs will be paying a fee for the purpose of being able to do that but this is not a taxpayer funded issue at all and it will provide the additional resources and pay for those without asking the taxpayers to come up with the money. >> two these countries that are included in the senator's amendment, do we have absolute ass
there is a letter from the fda. you know, the practice we have seen it this over the years that they say, well, we don't have the resources or it will impose more risk. the fact is this amendment provides the resources for them. because of those that are going to register to be able to ship fda-approved drugs into this country and a better price are going to have to pay a fee. the people that are selling will pay a fee and those pharmacies and others in our country who will be receiving will...
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Dec 15, 2009
12/09
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what about the opportunity to reimport the fda approved drugs that comes from the identical chain of custody that we have. >> host: all right. let's let our viewers weigh in. you're on the air. >> caller: yes. what i'm calling to say is i wanted to ask how he feels the rates of the jobs that the senate has been doing on the health care bill. i think it's terrible. you finally broke my back. i'm telling you. i can't believe it. you are staking everything on everybody's paying into the insurance companies. that's the only thing that everybody needs to be done. this is terrible. >> host: all right. how would you rate the debate? >> i don't think you give a grade until it's over. it's not done. we're at the -- inspect final hours here. but there's a lot yet to do. then let's make a judgment when it done, is this something that advances the country's interest or not. one the important questions is if we do nothing, is the system working? it works in some ways and other way it is doesn't work at all. we have 100,000 deaths, 45 million people that don't have health insurance. health insuran
what about the opportunity to reimport the fda approved drugs that comes from the identical chain of custody that we have. >> host: all right. let's let our viewers weigh in. you're on the air. >> caller: yes. what i'm calling to say is i wanted to ask how he feels the rates of the jobs that the senate has been doing on the health care bill. i think it's terrible. you finally broke my back. i'm telling you. i can't believe it. you are staking everything on everybody's paying into...
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Dec 21, 2009
12/09
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CNN
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it's important that the reimportation of drugs, they have to be fda approved and there has to be safety issues to be dealt with. and we see what the deals are and one of the problems s. this is a very complex and very big bill and a lot that we really don't know we're just getting started. stay with us. this is a very big night with a very big vote. when we come back, we'll talk about the high political stakes for the president and his party. >>> the idea of taking health care reform and getting some legislation that would make a big difference, a democrat from iowa there. beyond the particulars in the health care bill, for the white house and the president's party, we have the best team here to help us sort through all of that. a tremendous number of good folks there. dana bash, david gergen, april ryan, and also joins us, let me start with a quick question here. the democrats truly seem to be putting an awful lot of chips into this kitty and saying, we believe this will really work and for all of the republican anger that we saw from john mccain here, we also see republicans saying to
it's important that the reimportation of drugs, they have to be fda approved and there has to be safety issues to be dealt with. and we see what the deals are and one of the problems s. this is a very complex and very big bill and a lot that we really don't know we're just getting started. stay with us. this is a very big night with a very big vote. when we come back, we'll talk about the high political stakes for the president and his party. >>> the idea of taking health care reform...
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Dec 11, 2009
12/09
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>> the fda, senator carper was downstairs singing the fda has sent a letter blocking this amendment, the fda sent a letter we've seen in the past about safety and soundness -- >> and we require a lot of resources. i found out there's only 11,000 people that work over there and i assure every day they are filled with responsibilities. we all know what this is about. we all know it is the deal forma cut. that is what bill we brag about that was on the front page of newspapers all over america. c'mon, and let's not kid each other. it's all about the way to deal with pharma and they won the deal to hold and that means no drug free importation, no competition amongst medicare patients outside of part v i'm not revealing secrets. it's been on the front pages every paper of america. >> i would ask you to reflect a little bit. it wasn't long ago you had a different relationship with a man to your right, senator mccain, you were not on the same side. [laughter] you were not on the side with dick row to read the list goes on to read you endorsed him in 08. how do you feel now -- [inaudible] >>
>> the fda, senator carper was downstairs singing the fda has sent a letter blocking this amendment, the fda sent a letter we've seen in the past about safety and soundness -- >> and we require a lot of resources. i found out there's only 11,000 people that work over there and i assure every day they are filled with responsibilities. we all know what this is about. we all know it is the deal forma cut. that is what bill we brag about that was on the front page of newspapers all over...
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Dec 16, 2009
12/09
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the food a drug administtion said the poncy of the shots had dropped since th were ipped out but fda officials said children who ceived the shs are still protected. that mea they won't have to be vaccinated ain. re than 50 million roman-sty window shades and ll-up blinds are also bei recalled. the consumer productafety commission saitoday they might rangle young children who ge entangled in theords. eight sucheaths have been reported since 2001. the ndow coverings were sold at major retaile including walmart, potte barn, and j.c. penney. the washingtond.c., city council voted overwhelming today toegalize gay marriage, starting in march. the bi now goes to mayor adrian fenty, who's expectedo sign it. from therethe measure goes to congss, which has the final say over the disict's laws. levision evangelist oral robertdied today at a hospital in nport beach, california. he sufred complications from eumonia. starting in e 1950s, roberts eated a multimillion-dollar ith healing ministry. he also founded a private christian unersity bearing his name in tulsa, oklahoma. oral rerts was 91 year
the food a drug administtion said the poncy of the shots had dropped since th were ipped out but fda officials said children who ceived the shs are still protected. that mea they won't have to be vaccinated ain. re than 50 million roman-sty window shades and ll-up blinds are also bei recalled. the consumer productafety commission saitoday they might rangle young children who ge entangled in theords. eight sucheaths have been reported since 2001. the ndow coverings were sold at major retaile...
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3.1K
Dec 19, 2009
12/09
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and within prialt was approved for use by the fda in 2004.it is the most effective painkill since discovery of the opiates in the early 1800s. it's a thousd time its more pott than morphine but doesn'lead to tolerae. it's huge breakthrough. >> and it y not be the on venom of value. >> oths are in clinical trls to protect cells in the brain from dying when they don't get eugh circulation like aft a stke or after a head inry or during open-heart surgery. and we haven even begun to idtify the thousands and tens of thousands compounds at these cone snails make. >> here we have some emples of con i ferrs. >> finally he ys there's the story of taxal. thousand it comes from free, the pas civic ewe threated by logging, not climate chge t is an object lessoin the value of seemingly dissable ecies. >> this tree w routinely burnednd discarded in old growth forests bause its wi small, irregularly shaped. it had no commcial value. t the national cancer institute -- instute did this massive screeni of plants in the ited states in the '60to find medicines t
and within prialt was approved for use by the fda in 2004.it is the most effective painkill since discovery of the opiates in the early 1800s. it's a thousd time its more pott than morphine but doesn'lead to tolerae. it's huge breakthrough. >> and it y not be the on venom of value. >> oths are in clinical trls to protect cells in the brain from dying when they don't get eugh circulation like aft a stke or after a head inry or during open-heart surgery. and we haven even begun to...
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190
Dec 6, 2009
12/09
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eye 190
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is not, it doesn't leave the bench because i sign my name to every veldt and if it is detective the fda can come back and say what happened on that particular one. if one of those bells is defective someone is going to die. this is a life-and-death procedure. and she said i could never live with that. 99% met trulock is good enough but she said i could never live with that but she said when i go home at night you know what i'm thinking about? i am thinking about this 5,000 people in the world today who were alive because of the heart valves that i made. now does anyone in this room doubt that this woman is a leader? at the time she was making $18 an hour and now she's probably making figures 60% more than that but she will never be wealthy. she is wealth the inside because she knows she is making a difference in life. budde think everyone in that facility comes to to say, this is one good enough? who does the training for all the workers in the plan? she does not have to be a director. who is she is making a difference and i think each of us has that opportunity and the way that we solv
is not, it doesn't leave the bench because i sign my name to every veldt and if it is detective the fda can come back and say what happened on that particular one. if one of those bells is defective someone is going to die. this is a life-and-death procedure. and she said i could never live with that. 99% met trulock is good enough but she said i could never live with that but she said when i go home at night you know what i'm thinking about? i am thinking about this 5,000 people in the world...
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Dec 22, 2009
12/09
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the fda is not denying it. the senator stands by his charge. . this is a 10-year concern. the notion that this crop up in the last couple of weeks, those notions about safety have been there for quite some time. happy holidays, guys. >> [unintelligible] >> enjoy your holidays. thank you. i cannot even tell you -- no. >> [unintelligible] any comment? >> i have not seen that information. thanks. >> also at the white house today, president obama met with several small community bank ceo's. his remarks to reporters after that confirmed that he would stay at the white house until the senate completes its work on health care legislation. >> all right, everybody. it is good to see all of you. i just completed a meeting with 12 regional community banks to have the same conversation i had with some of the larger banks last week and i have been having with ceo's from companies across the country over the last year. that is, how do we continue to sell a baby gains we have made during the course of this -- continue to consolidate the gains we've made during the course of this year? so
the fda is not denying it. the senator stands by his charge. . this is a 10-year concern. the notion that this crop up in the last couple of weeks, those notions about safety have been there for quite some time. happy holidays, guys. >> [unintelligible] >> enjoy your holidays. thank you. i cannot even tell you -- no. >> [unintelligible] any comment? >> i have not seen that information. thanks. >> also at the white house today, president obama met with several small...
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Dec 13, 2009
12/09
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eye 181
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we decide whether the fda should approve a particular drug. we see what the drug works, and a double blinded experiment relative to placebo and able to compare people who are treated and those who weren't. tells us whether not that works or as an economist, as much as i would love to carry a randomized experiment it's not always possible. we talking about how i would love to know one of the questions i wanted to know, do prisons reduce crime. it's not like they have allowed me to go out and run an experiment where i lock up a bunch of people and i randomly release some people in another state and see what happens. in that kind of a world economies have had is what i call accidental experience to figure out the gains. nor do i i look for quirks where something a law change or if you want to talk about abortion and crime, i have a controversy theory about how abortion, legalization of abortion in the 1970s reduced crimes in the 1990s. truly not a random experiment, but after abortion became legal in some states, in some states it was easy and su
we decide whether the fda should approve a particular drug. we see what the drug works, and a double blinded experiment relative to placebo and able to compare people who are treated and those who weren't. tells us whether not that works or as an economist, as much as i would love to carry a randomized experiment it's not always possible. we talking about how i would love to know one of the questions i wanted to know, do prisons reduce crime. it's not like they have allowed me to go out and run...
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Dec 6, 2009
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this health care bill, the fda is not watching out for us and it's simply a big bailout for the health industry for all these doctors and all this, and the last thing that i want to say is with these illegal aliens here, you can look at this housing crisis, you can look at this health care crisis, and you can look at this school crisis with these kids -- you say you don't want to leave any kids behind, but these schools are so filled up with illegal aliens, look at the grades that the fourth and eighth graders are getting. >> host: larry klayman, a couple of things there. why don't you focus on one of them, and we'll hour your response. >> guest: well, the thing i focused on is that dick is a patriot, he's someone who represents the way the american people feel today. american people are turned off by both political parties. american people feel betrayed, the american people can't put food on the table, they can barely afford to go to mcdonald's or fast food restaurants, they can't get mortgages. none of this trillion dollars that has been spent by the government that's going to put us
this health care bill, the fda is not watching out for us and it's simply a big bailout for the health industry for all these doctors and all this, and the last thing that i want to say is with these illegal aliens here, you can look at this housing crisis, you can look at this health care crisis, and you can look at this school crisis with these kids -- you say you don't want to leave any kids behind, but these schools are so filled up with illegal aliens, look at the grades that the fourth...
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Dec 7, 2009
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when we decide what to the fda should approve a particular drug we do randomized experiments to see whether the drug works in a double blind experiment relative to a placebo and we are able to compare the people treated to the people who weren't. they were in the price of the different between now comes tells whether or not the drug works. as an economist as much as i would love to try randomized experiments it isn't always possible so we talk in the book about how i would love to know, one of the questions i wanted to know was to prisons reduce crime but it's not like the nsf is going to allow me to go out and run a randomized experiment where i look up a bunch of people in one state at random and randomly release a bunch of people from another state and see what happens. so in that kind of the world, complex world we live in, economists had to use like occidental experiment to to give the answers. in other words, i look for works, something like a law change or if you want to talk about abortion a crime. i have the controversy of theory about how abortion, legalization of abortion in the
when we decide what to the fda should approve a particular drug we do randomized experiments to see whether the drug works in a double blind experiment relative to a placebo and we are able to compare the people treated to the people who weren't. they were in the price of the different between now comes tells whether or not the drug works. as an economist as much as i would love to try randomized experiments it isn't always possible so we talk in the book about how i would love to know, one of...
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Dec 6, 2009
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when we decide whether the fda should approve a particular drug we go do randomized experiments, whether the drug works in a double blind experiment relative to a placebo and we are able to compare people treated to the people who were not. they were in the eyes of a different outcome still is whether or not the drug works. as an economist have much as i would love to carry out randomized experiences it isn't always possible. we talk in the book how i would love to know -- one of the questions i wanted to know is to prisons reduce crime. but it's not like the nsf allowed me to do a randomized experiment where i lock up people in one state and random and randomly three release from another state and see what happens. in that kind of world, complex world we live and we have to use what i call accidental experiment to figure out the answer. in other words, i look where quirks where something like a wall we change or, like, so if you want to talk about abortion and crime have a controversy of theory about how abortion, legalization of abortion in the 1970's reduced crime in the 1990's. so it
when we decide whether the fda should approve a particular drug we go do randomized experiments, whether the drug works in a double blind experiment relative to a placebo and we are able to compare people treated to the people who were not. they were in the eyes of a different outcome still is whether or not the drug works. as an economist have much as i would love to carry out randomized experiences it isn't always possible. we talk in the book how i would love to know -- one of the questions...
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Dec 11, 2009
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it is up to state government not the fda to determine the extent of regulatory oversight and enforcement granted to each transit system. this results and a patchwork of 27 separate state oversight programs guided by regulatory framework of inconsistent practices come unlimited standards and marginal effectiveness property
it is up to state government not the fda to determine the extent of regulatory oversight and enforcement granted to each transit system. this results and a patchwork of 27 separate state oversight programs guided by regulatory framework of inconsistent practices come unlimited standards and marginal effectiveness property
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Dec 30, 2009
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the fda which is the organization that involved for the regulation of the drugs, vaccines it's a rock plays a very important role of which complement each other. so what you have also programs within the federal government to get drugs available to people who cannot have otherwise access to drugs. so it's very synergen to the customer just get complementary then the department of human services from the research to the surveillance to the prevention to getting safe and effective drugs to the people who need them. >> host: let's get to the phones. with a lot of callers eager to talk with dr. anthony fauci. linda is on the democrats' line in cells vary massachusetts. >> caller: good morning, seize and and dr. fauci. i'm excited. i think this is the third time i've been able to get in and talk to you on a different subject because i am a health educator myself. one of the concerns i have about the whole influenza epidemic in terms of someone who is trying to educate patients and encourage them to get the vaccine is the we anecdotally the vaccine is distorted it. my experience it didn't g
the fda which is the organization that involved for the regulation of the drugs, vaccines it's a rock plays a very important role of which complement each other. so what you have also programs within the federal government to get drugs available to people who cannot have otherwise access to drugs. so it's very synergen to the customer just get complementary then the department of human services from the research to the surveillance to the prevention to getting safe and effective drugs to the...
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Dec 12, 2009
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they said the fda has not taken any action -- fta any action on their recommendations. they said that if they have the authority, they do not have money. we need to act. as you can see, i am really hot about this. what i would like you to do is to pass legislation that fixes mentor and deals with the largest issues. my legislation is complementary to what the president is advocating and secretary lahood is discussing. my legislation is focused on the implementation of the national trends safety board's recommendations. we would implement the prior recommendations, particularly in emergency evacuation standards, crashworthiness data requirements. these are ntsb's most urgent requires rigid requirements. we have federal safety requirements for buses and airplanes but not for subways. one would be on crashworthiness standards. i think you would find it interesting that there is no standard for the safety of these cards. we need to be able to prevent the cars from telescoping upon crashing. people died because they telescoped. the ntsb offered a recommendation in 2006 and n
they said the fda has not taken any action -- fta any action on their recommendations. they said that if they have the authority, they do not have money. we need to act. as you can see, i am really hot about this. what i would like you to do is to pass legislation that fixes mentor and deals with the largest issues. my legislation is complementary to what the president is advocating and secretary lahood is discussing. my legislation is focused on the implementation of the national trends safety...
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Dec 28, 2009
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we built standards around by a medical interventions that are essentially overseen by the fda. in the broad intervention arena of whichab aba would be part of that, there's not a licensing body that oversees this in quite the same way. it is a gap. the question is, even in this health care reform discussion, when you're talking about treatments that may not be given in a doctor's office or in one of the 15 hospitals that in falls families to the minister care, 10, 15 hours a week, how does that get reimbursed and how do we set standards for the degree of care and the level of care that is needed to be reimbursed? >> was that rhetorical? [laughter] i cannot answer that question now. >> i am a psychiatrist. [laughter] >> asking probing -- [laughter] >> that is true. well, again, obviously we have a whole range of interest here and everything from their research into the causes. obviously, there is a lot of talking about vaccines. we had some questions about it. about the number of vaccines and how we set up that kind of a study that ms. boyd -- i think it was misspellms. halverso
we built standards around by a medical interventions that are essentially overseen by the fda. in the broad intervention arena of whichab aba would be part of that, there's not a licensing body that oversees this in quite the same way. it is a gap. the question is, even in this health care reform discussion, when you're talking about treatments that may not be given in a doctor's office or in one of the 15 hospitals that in falls families to the minister care, 10, 15 hours a week, how does that...
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Dec 25, 2009
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. >> from the standpoint of any financial help to you, what is the fda establishing? family with a quadriplegic who is on the event. because of having power source through a ventilator and his bed has to have a special type of bed that is sent up to power, their power bill is over $1,000 a month. because of that, the special care that scott will have to receive because of his injuries even though the money will come in per month, but we would have to pay for bills will be large. the net will be small. >> dimension one other comment. -- you mentioned one other comment. once he became a veteran, it was not funded. >> that is correct. >> is the currently giving that? >> he is currently receiving cognitive therapy which is absolutely fabulous. try care one not pulled from the supplemental fund. they're asking soldiers to pay for cognitive rehabed. right now, they're not covering the elective we have. >> we should do something about that. >> i hope that you can. >> we are not talking about to be concurrent pay issues as well. we need to meet moving forward. >> thank you, m
. >> from the standpoint of any financial help to you, what is the fda establishing? family with a quadriplegic who is on the event. because of having power source through a ventilator and his bed has to have a special type of bed that is sent up to power, their power bill is over $1,000 a month. because of that, the special care that scott will have to receive because of his injuries even though the money will come in per month, but we would have to pay for bills will be large. the net...
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Dec 29, 2009
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the fda the organization involved for the regulation of the drugs the vaccines plays an important rolene of the concerns i had about the whole flu epidemic in terms of someone trying encourage the vaccine is the way anecdotally the vaccine was distributed. it really didn't go to the groups. lawyers in boston got they're vaccine prior to healthcare. workers, where i work we didn't get the seasonal flu until mid-september. which was a private sector screw up because the private supplier decides to get them clients with more business which was kind of disconcerting to me. secondly, we have residents that illness during the height of the h1n1 but the doctors would not culture them. when i hook at thecbc they only count the cases lab confirmed and i'm concerned there's distortion about that. lastly, when were we expecting this virus to mutate? i'm having trouble convincing people to get the vaccine for both influenzas. >> you asked several questions. let me try to answer them quickly. first of all, with regard to the seasonal flu vaccine. absolutely correct. people should get it, the priori
the fda the organization involved for the regulation of the drugs the vaccines plays an important rolene of the concerns i had about the whole flu epidemic in terms of someone trying encourage the vaccine is the way anecdotally the vaccine was distributed. it really didn't go to the groups. lawyers in boston got they're vaccine prior to healthcare. workers, where i work we didn't get the seasonal flu until mid-september. which was a private sector screw up because the private supplier decides...
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Dec 14, 2009
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according to an fda report, it would cost $50 billion just to get the nation's seven largest transit systems to good repair. i am hopeful that robust real modernization funds will be part of the bill. rail modernization funds spend quickly. they create jobs and they are an investment in infrastructure that is critical to our economic health. these funds must be part of any effort to make transit safer. i want to think the administration for a well thought out proposal. i look forward to working with them. this issue is of the upmost importance and cannot be held hostage by the reauthorization process. despite the full committee schedule, i certainly hope and expect that we will market safety legislation next year. let me recognize the distinguished ranking member for his comments. >> thank you. i am eager to hear the testimony so i will thank you and the committee for this hearing and welcome secretary will hood and i have had the pleasure of serving with him in the house. thanks for your continuing service. >> i want to echo the chairman's comments on the importance of transit safet
according to an fda report, it would cost $50 billion just to get the nation's seven largest transit systems to good repair. i am hopeful that robust real modernization funds will be part of the bill. rail modernization funds spend quickly. they create jobs and they are an investment in infrastructure that is critical to our economic health. these funds must be part of any effort to make transit safer. i want to think the administration for a well thought out proposal. i look forward to working...
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Dec 30, 2009
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mentioned a natural foods and legislation that would take that out of the free market and put it under the fda supposedly or whatever. happen point do we draw the line. this person is going to be on the personal liberties. they are abusing their health. and somebody needs to turn, you know, that person around. you said 50%. that would be a compromise. where does personal liberty go? >> the question is how far do we go? your end point might be different than somebody elses. it's about 30 years ago. and i think what i did in my own mind was i choice to speak out. i didn't really expect a political career. and i wasn't looking forward to it. but i wanted to speak out with the assumption that somebody was going to listen. and nothing much would happen. and i always wanted to say. at least i made the effort. so we all here, i believe, want to continue making the effort. but we also know that when do we do something else? and that to me is since i am not an endorser of violence, i don't like anticipate in it. i believe there is an certain time when individuals just flat out say no. so i have respect
mentioned a natural foods and legislation that would take that out of the free market and put it under the fda supposedly or whatever. happen point do we draw the line. this person is going to be on the personal liberties. they are abusing their health. and somebody needs to turn, you know, that person around. you said 50%. that would be a compromise. where does personal liberty go? >> the question is how far do we go? your end point might be different than somebody elses. it's about 30...
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Dec 2, 2009
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i mean, if they become so oppressive dan afghanistan that the people, the fda still want them there.out the way we use the cia to get the russians out of afghanistan. and i mean we have to many problems here at home. the way to strengthen this nation is, you know, to take care of some of the problems we have here, i mean, with health care, with the economy and, if you know, we can't be trying to build nations and trying to establish government in the nation that's never had a successful central government. >> okay, thank you for the call. earlier today senior administration officials on a conference call with reporters outlining a dance of the president's speech had one of the points they made is the effort to try to stabilize the economy in afghanistan in particular for the farmers. in a couple of minutes were listening to another conference call from senator mitch mcconnell who is the republican leader in the senate. we've also get his reaction to the president's speech. the next will go to david from long island. go ahead please. >> hello, i'm going to say that i am opposed to the
i mean, if they become so oppressive dan afghanistan that the people, the fda still want them there.out the way we use the cia to get the russians out of afghanistan. and i mean we have to many problems here at home. the way to strengthen this nation is, you know, to take care of some of the problems we have here, i mean, with health care, with the economy and, if you know, we can't be trying to build nations and trying to establish government in the nation that's never had a successful central...
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Dec 9, 2009
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the fda supports hamp as part of the solution.n addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance to the guys that values. the ftse's experience has provided a number of lessons learned that we would like to share with the community. i would like to emphasize one key points. laws that make good business sense and help consumers maximize recovery on troubled mortgages. first, and foremost early communication and modification efforts give the best chance of success. success is much for likely if you contact the borrower earlier, give a mod offer and give them on for an experienced delinquency. effective communication with borrowers acquires a
the fda supports hamp as part of the solution.n addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance to...
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Dec 12, 2009
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the presenters you are about to hear from are the leading experts from hhs, nih and the fda and the importance of the tawfiq couldn't be more timely. the flu vaccine we use today is extraordinarily safe. is extremely effective. is the same flu vaccine we have used to immunize 100 million americans annually for decades. the process we used to make it is cumbersome and outdated. we could have had a better indication of the need for new flu vaccine technology and our experience with the 2009 h1n1 fires this fall. the flu vaccine's active agreement is grown in chicken eggs and like the influence of virus itself it can be temperamental and unpredictable. this year, when we needed manufacturers to ramp up production quickly, the antigen decided it would take its time, but even before the first outbreak of h1n1 we have known we needed to develop new technologies that will provide maxene with the same level of protection but with the 21st century ability to meet the demand. it will be several more years before we are able to wean ourselves away from egg-based vaccine but we are committed to moving ahe
the presenters you are about to hear from are the leading experts from hhs, nih and the fda and the importance of the tawfiq couldn't be more timely. the flu vaccine we use today is extraordinarily safe. is extremely effective. is the same flu vaccine we have used to immunize 100 million americans annually for decades. the process we used to make it is cumbersome and outdated. we could have had a better indication of the need for new flu vaccine technology and our experience with the 2009 h1n1...
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Dec 1, 2009
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the fda -- f a a will release an of this year or early next year a note of proposed rulemaking. committee and they are writing the rules but we have not seen it yet. we have advocated for certainly more time, more recuperative rest time at home than just 24 hours every seven days. but again, more of the complex matrix. but we believe those rest periods have to be protected and certainly expanded in this case. host: is the stronger regulations regarding the number of hours pilots work and fast turnaround? is there concern about reduction in pay? they are paid by air time. guest: it is something we will probably have to address. but we expect the pay hours will be roughly the same as they are today. i think certain operations may reduce some of their monthly flying. one of the things we're asking for is there are a lot of different types of flying. while we were talking mostly about airline passenger flying -- major's and regionals -- there is a huge section of the industry flying cargo, scheduled cargo, on schedule, flying through the department of defense. right now i guarantee
the fda -- f a a will release an of this year or early next year a note of proposed rulemaking. committee and they are writing the rules but we have not seen it yet. we have advocated for certainly more time, more recuperative rest time at home than just 24 hours every seven days. but again, more of the complex matrix. but we believe those rest periods have to be protected and certainly expanded in this case. host: is the stronger regulations regarding the number of hours pilots work and fast...
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Dec 9, 2009
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the fda supports hamp as part of the solution. in addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance to the guys that values. the ftse's experience has provided a number of lessons learned that we would like to share with the community. i would like to emphasize one key points. laws that make good business sense and help consumers maximize recovery on troubled mortgages. first, and foremost early communication and modification efforts give the best chance of success. success is much for likely if you contact the borrower earlier, give a mod offer and give them on for an experienced delinquency. effective communication with borrowers acquires
the fda supports hamp as part of the solution. in addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance...
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Dec 15, 2009
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i call it the fda bone structure. the backbone is our sba employees. we have over 100 field offices all across the country. we are a small agency with a big mission. our most valuable asset in achieving that mission is our people. we also have 14000, 14000 affiliated counselors. these include 900 small business development centers. mostly located at community colleges, local universities. we have more than 100 women's business centers. we say that we have a counselor within 45 minutes to an hour of most small business that are out there. and we have 370 chapters of our mentoring program, which is called score. altogether, these folks serve more than a million clients a year. this past year we have been working particularly hard because small business owners have had to shift gears in order to survive. many of them have come in to redo their business plan. and these people are helping new entrepreneurs start up businesses. i want to point out who runs scored. he has an entire volunteer army. of retired executives. and he has challenged them over the nex
i call it the fda bone structure. the backbone is our sba employees. we have over 100 field offices all across the country. we are a small agency with a big mission. our most valuable asset in achieving that mission is our people. we also have 14000, 14000 affiliated counselors. these include 900 small business development centers. mostly located at community colleges, local universities. we have more than 100 women's business centers. we say that we have a counselor within 45 minutes to an...
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Dec 29, 2009
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we built standards around biomedical interventions that are essentially overseen by the fda. >> uh-huh >> but in the broad psychosocial intervention arena of which aba or behavioral interventions would be part of that, there is not an agency and there's not a sort of licensing body that oversee he -- oversees this in quite the same way. and in this healthcare reform discussion, when you're talking about treatments that may not be given in a doctor's office or may not be at one of the 15 hospitals but it involves training families to administer care, 10, 15 hours a week, how does that get reimbursed? how do we look at quality measures for outcomes and how do we set standards for the degree of care and the level of care that's needed to be reimbursed? >> you asked me that question or was that just rhetorical? [laughter] >> i am a psychiatrist so i -- >> asking probing questions. >> how do i feel, doctor? [laughter] >> well, again, obviously, we have a whole range of interest here. and everything from the research into the causes. i mean, obviously dr. insel, there's a lot of talk about v
we built standards around biomedical interventions that are essentially overseen by the fda. >> uh-huh >> but in the broad psychosocial intervention arena of which aba or behavioral interventions would be part of that, there is not an agency and there's not a sort of licensing body that oversee he -- oversees this in quite the same way. and in this healthcare reform discussion, when you're talking about treatments that may not be given in a doctor's office or may not be at one of...
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Dec 19, 2009
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the fda supports hamp as part of the solution.n addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance to the guys that values. the ftse's experience has provided a number of lessons learned that we would like to share with the community. i would like to emphasize one key points. laws that make good business sense and help consumers maximize recovery on troubled mortgages. first, and foremost early communication and modification efforts give the best chance of success. success is much for likely if you contact the borrower earlier, give a mod offer and give them on for an experienced delinquency. effective communication with borrowers acquires a
the fda supports hamp as part of the solution.n addition, we continue to remain open to new approaches that may be necessary to respond to the scope and changing character of the mortgage problem. our loss share and agreements for failed banks require either the fdic model program or we have to continue to push for responses. for example, we burst temporary forbearance for borrowers that lose their jobs in recession. we also will provide gloucester in finance to support principle breakdance to...
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Dec 29, 2009
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the fda, which is, the organization that's involved for the regulation of the drugs, the vaccines, eta pays a very important -- place a very important role all which compliment each other. you have programs within the federal government to get drugs available to people who can not have otherwise access to drugs. so it's really very synergistic and complimentary within the department of health and human services anywhere to the research, to surveillance to prevention to getting safe and effective drugs to people who need them. >> host: let's get to the phones. we have a lot of callers eager to talk to dr. anthony fauci. linda on democrat line in massachusetts. >> caller: good morning, c-span and good morning, dr. fauci. >>. >> guest: good "morning call" this is third time i've been able to talk to you. each time on a different subject because i'm a. concerns about influenza epidemic and trying to educate patients and encourage them to get the vaccine is the way that, anecdotally at least the vaccine was distributed. from my experience really didn't go to priority groups. there were he
the fda, which is, the organization that's involved for the regulation of the drugs, the vaccines, eta pays a very important -- place a very important role all which compliment each other. you have programs within the federal government to get drugs available to people who can not have otherwise access to drugs. so it's really very synergistic and complimentary within the department of health and human services anywhere to the research, to surveillance to prevention to getting safe and...