19 Burst results for "Food Drug Administration"
FoundMyFitness
"food drug administration" Discussed on FoundMyFitness
"People are wrong and cell phones all day and they don't even use my own lines anymore. And you could even say, so anyway, the. Response is one of caution. And the appropriate response is we're going to cautiously take this to the food Drug Administration. But that requires that the government allows us to take the food and the Drug Administration, which right now we can't do because 2016 rider says we can't even allow the FDA to accept these nominations for clinical trials. So this is a very head in the sand kind of approach to science. It usually that the careful and most FDA trials are very carefully vetted before they go in. Preventing of that careful accumulation of data could cause lives. I don't think it's urgent with the case in the case of germline, no one has articulated a particular thing other than HIV resistance, which is what I think was actually a pretty good choice of CCR 5 and HIV resistance in JK House case. I think some people maybe don't appreciate how stigmatizing HIV can be in certain communities in China. So anyway, it's a complicated issue that I think we need to be respectful of both the potential future and the path safe path towards it. How do you think we can equip people with the right knowledge in order to come to well recent conclusions? Surrounding germline editing, understandings of complexities. So we've got background rotational rate and offspring impact. I mean, if you compare it to, again, a background mutational rate or a paternal chemo, right? If a man goes and he gets cancer and he gets treatment and then after the treatment goes off and has a child, you know, we kind of accept that mutational rate. So things that are known about germline mutagens, I guess. Right. I mean, the chemotherapy is a perfect example. Or the radiation you get living at high altitude.
WNYC 93.9 FM
"food drug administration" Discussed on WNYC 93.9 FM
"It's a scene repeated every day at thousands of Thor's and flea markets across the United States. 37 year old Jennifer Pope found a vintage military style trunk at a Michigan flea market in the 1990s. Then a teenager, she used it to store her records. She didn't know the green paint coating the trunk contained lead. Pop art held onto the trunk for years, around 2014, her child Wallace started pulling up on the trunk. That's when Pope Hart noticed Wallace's motor skills were delayed. And had eating and feeding issues at 18, 19 months old was finally pulling the stand and would pull the sand at that trunk and turn around and run to me and that is around when I noticed the numbers going on. The numbers were Wallace's blood lead levels, Wallace got tested regularly for lead. In 2014, the numbers came back at 5.3 micrograms per deciliter, putting Wallace's levels in the top two and a half percent of children, according to the Centers for Disease Control. Pop art used the home lead test to swab items in our home and identify the culprit. And I tested the trunk and that was positive. Like immediately, bright red on the swab and I was like, oh, okay. We found the forest. We found a source. Patti Davis is what the consumer product safety commission, which regulates lead in goods and recalls products when levels are too high. The current standards in place for protecting kids from lead didn't go into effect until 2008. You want to keep vintage products vintage toys away from children. You want to keep, even the toys that you played with as a child, if they were made prior to 2008, you want to keep those away from children. Antique items aren't the only lead hazards consumers face. New products can also contain the toxin, especially if they aren't specifically intended for children. While items for kids must meet rigorous standards limiting lead content to 100 parts per million for general use items, there remain voluntary standards for lead content and items like jewelry. Kids are more vulnerable to lead poisoning because they are more likely to accidentally ingest it by putting their hands in their mouths and because their bodies and brains are still developing. Jose bravo is what the campaign for healthier solutions, a group lobbying stores to demand manufacturers produce items without lead. Bravo says there's not enough coordinated federal protection. Most often than not, people would say, well yeah, you know, the EPA or the food Drug Administration or somebody is safeguarding our health when it comes to that. That's not the reality. The group's recent product screening report found that more than half of the 100 items purchased at discount stores contain toxic chemicals, including lead. These days, mom Jennifer peppard avoids vintage items and feels safer using products made after lead based paint was banned in 1978
Bloomberg Radio New York
"food drug administration" Discussed on Bloomberg Radio New York
"With David Weston on Bloomberg radio Facebook was a blower Francis hall gun a former product manager in the civic integrity unit testified this week before Congress about some of the dangers that Facebook poses Facebook knows that it's amplification algorithms things like engagement based ranking on Instagram can lead children from very innocuous topics like healthy recipes I think all of us could eat a little more healthy All the way from just something innocent like healthy recipes to anorexia promoting content over a very short period of time For his takeaways from the testimony I talked to early Facebook investor roger mcnamee cofounder of elevation partners and author of zucked waking up to the Facebook catastrophe Roger told me that Francis haugen had an extraordinary amount of access in her role at Facebook She was absolutely at the center civic integrity was responsible for addressing harms to users So she was in exactly the right place She's just utterly convincing in everything she does I thought her testimony was exceptional I can not tell you how much of a relief it is to me that she has come forward because we have known about these issues but what her work has done in bringing out tens of thousands of pages of documents is to eliminate Facebook's argument that they didn't know It is incredibly clear from these documents that Facebook crafted a business model based on attention It was designed to maximize profits at any cost which is an understandable thing in capitalism So it's completely understandable that it would work that way But at the same time in this case the harm that was done to public health to democracy to teenage girls has been incalculable and the core point is they knew it was there They knew it was going to happen It was they were warned about it and they chose to just continue to optimize profits And again in capitalism that's understandable but it really does cry out for regulation the same way that when the food industry was unsafe in 1906 we created the food Drug Administration when chemicals were unsafe in the 50s we created the environmental laws This came to our attention in part because of The Wall Street Journal reporting based on the documents that miss Hogan and it had to do with children and with the Facebook new or believed about the possible risks to children What do we know about that And what does Facebook know So Facebook has known this since the day it brought Instagram The goal of Instagram from the beginning was to make young girls look better than they really are And through that process to by making the look better the effectively create a whole culture of envy And that is the business model And there's nothing you can do to change that It's been there from the David and scream was created and it is a threat to the psychological well-being of an entire generation of young women and the key thing to understand is this is not a business model that exists only at Facebook It exists in various forms at Google that Amazon and Microsoft and it's now being adopted throughout the economy How much of this is because of the algorithms and the way they're designed Well a 100% of it is The way to think about this is that this is we're dealing with a business model based on attention and the best way to get people's attention is either the scare the more outrage So roger it really raises in my mind the question is is this a bug or a fix I mean could they fix this without really substantially undermining their business model No No no you can't You can still have Facebook and Instagram But you can't have them at their current profit levels because profit maximization is what essentially leads to all the harms What can be done by Congress or by creation of an agency you mentioned before perhaps an agency I think we already have enough information to design And we need three classes of things We need to think about safety and there I think something that looks like the FDA that simply looks at every technology product On a regular basis not just once but continuously to make sure that they are safe And it effectively creates a way for consumers to go to the government and say I'm sorry this is not working out for me here are the reasons why.
WCPT 820
"food drug administration" Discussed on WCPT 820
"As you said oh it's a private matter It's private It's not private Is it doctor It's not a private matter 675,000 Americans are dead Yeah we used to say you know people would say oh this is my choice to take a risk or not Except it isn't your choice Because it isn't your choice You must deal with the reality that we have to stop these spread of COVID I just put an article that said eventually first of all that COVID is going to be chronic This is it We're not going to eradicate it in anything resembling a tight timeline This is going to be many many years Because we have pockets of unfettered growth of coronavirus all over the world That's that So we're going to have to live with it And the way you're going to protect yourself yourself is to get vaccinated And the way we're going to protect everybody is for everybody to get vaccinated and we're so far from that stuff I don't like thinking about it but that's the fact that I know I know doctor Corbett who invented Moderna vaccine said it's too late We're going to live with this now I mean the fact that it didn't have to be this way is so infuriating I'll need to talk to you about blood pressure medication or something else But anyway we have laboratories out here in California We have the lowest rate in the country right What we did works vaccination rates masking all of that The latest example LA on vaccinated people will be banned from visiting popular amusement parks including 6 flags magic mountain Universal Studios when new regulations go into effect next month There is part of a health order announced on September 15th that will require proof of vaccination to enter bars lounges nightclubs breweries wineries and distilleries here in LA county Interestingly Chris you're in charge of this Being a Disney homo Yeah They will not apply to Disneyland It's not in LA county In Orange County Right but they inserted an indoor mask mandate and they recommend vaccination while not requiring proof I feel like we just have to have mandates everywhere Doc don't you and I don't know how you're recommending how we get there You can't get into a restaurant in New York without showing proof of vaccination And you probably read the story that was very popular restaurant called carmine I think what side of me and we're visitors from Texas physically attacked the restaurant staff who was asking for their proof of vaccination Yeah I know this is a family show so I'm going to temper my language here But the fact that people attacked a restaurant worker doing their job and protecting the public self is you know just a particular small but an outrage nonetheless just hearing it Let's talk about boosters the FDA obviously just authorized Pfizer for American 65 and older those with high risk conditions those in workplaces with high exposure risks but stop short of a similar push for the broader population Data released by Pfizer last week shows the two dose vaccine regimen remains highly effective against severe cases of disease even as its protection against symptomatic cases has waned falling from 96% to 84% after 6 months Pfizer said a third shot would restore its effectiveness to 95% So there's been confusion obviously about this but am I one of those people that I'm happy to file follow the science and the data you and Travis and I are Moderna we'll hear probably in a couple of weeks right What their recommendations are I mean I'm fine with that Following the science and going okay people 65 and over an immune compromise people should go first What's your take on the whole booster thing Yeah so let's break this down It is a little confusing So two big federal agencies have to approve anything like this First is the FDA The FDA food Drug Administration says this product the case this vaccine is safe The data shows it safe and its effective And they are advised by an outside adviser group to reset conclusion And this is what just happened The FDA got all the input they like what they see And there's a formal approval of the safety and effectiveness of the third dose The next part of the process is the CDC The Center for Disease Control and Prevention And then they have to say okay we hear what the FDA is saying And now we are going to approve as a matter of policy that people in certain categories are going to get the booster The categories as you say over 65 and severe immunocompromised but also there's another category that's going to warrant this booster shot And that's for people who work around a lot of other people In grocery stores and especially healthcare workers So all that will be approved If you are less than 65 with no you're not working that kind of environment And you don't have other compromising health factors you may or may not at some point in the future be eligible for the luster shop But right now you're not going to be anytime soon Which is fine And I agree with all of that We had one doctor said I don't think a booster dose is going to significantly contribute to controlling the pandemic I think it's important the main message we transmitted is that we've got to get everyone two doses That obviously is the big factor right now And as we just played the president I mean obviously the World Health Organization has condemned plans about boosters They said that obviously the shots would yield a far greater return if they were administered as first and second doses in developing nations where new variants are likely to emerge because the variants are circulating so wildly He said as we've seen the emergence of variant after variant we can not get out of it until the whole world gets out of it together You've said that over and over here with the huge disparity in vaccination coverage we're simply not going to be able to achieve that So yeah so yeah I mean so it would modern our J&J and a couple of weeks would that be different the recommendation for some reason or no No I think we're going to have the same set of recommendations for all the available and approved vaccines In other words those are the categories that we just eliminated this whole entirely entirely and will rec be recommending that you get a booster shot But I just want to underscore again the World Health Organization's position here because it's critical It's not only critical to those countries where the vaccination rates which is all over Africa Less than 2% of the population have even gotten a first dose that we can not turn away from that Fact stuff because that's where the festering the growing the development of mutations will occur and it all come back to haunt the entire world So the problem in sub Saharan Africa for example is our problem You live in a fancy suburb and somewhere in California and New York or wherever you're going to be potentially a victim of our failure to recommend to understand art Well and quickly before you go I know you have a hard break here but data released by J&J indicates the protection afforded by J&J doesn't wane like Pfizer and Moderna though a second shot would booth booth its efficacy against mild to severe COVID from 74% up to 94% And then I don't even want it because Chris is here and he's a Pfizer snob I don't want to get into New York Times Story Moderna versus Pfizer both knockouts but one seems to have the edge a series of studies found the Moderna vaccines seem to be more protective as the months pass than the Pfizer Oh where is the hang.
Bloomberg Radio New York
"food drug administration" Discussed on Bloomberg Radio New York
"Takeaways from the testimony I talked to early Facebook investor roger mcnamee cofounder of elevation partners and author of zucked waking up to the Facebook catastrophe Roger told me that Francis haugen had an extraordinary amount of access in her role at Facebook She was absolutely at the center of civic integrity was responsible for addressing harms to users So she was in exactly the right place She's just utterly convincing in everything she does I thought her testimony was exceptional I can not tell you how much of a relief it is to me that she has come forward because we have known about these issues But what her work has done in bringing out tens of thousands of pages of documents is to eliminate Facebook's argument that they didn't know It is incredibly clear from these documents that Facebook crafted a business model based on attention that was designed to maximize profits at any cost which is an understandable thing in capitalism So it's completely understandable that it would work that way But at the same time in this case the harm that was done to public health to democracy to teenage girls has been incalculable and the core point is they knew it was there They knew it was going to happen It was they were warned about it and they chose to just continue to optimize profits And again in capitalism that's understandable but it really does cry out for regulation the same way that when the food industry was unsafe in 1906 we created the food Drug Administration when chemicals were unsafe in the 50s we created the environmental laws This came to our attention in part because of The Wall Street Journal reporting based on the documents that miss hug and it had to do with children and what the Facebook knew or believed about the possible risks to children What do we know about that and what does Facebook know So Facebook has known this since the day it bought Instagram The goal of Instagram from the beginning was to make young girls look better than they really are And through that process to by making the look better the effectively create a whole culture of envy And that is the business model And there's nothing you can do to change that It's been there from the David and scream was created and it is a threat to the psychological well-being of an entire generation of young women and the key thing to understand is this is not a business model that exists only at Facebook It exists in various forms at Google that Amazon and Microsoft and it's now being adopted throughout the economy How much of this is because of the algorithms and the way they're designed Well a 100% of it is The way to think about this is that this is we're dealing with a business model based on attention and the best way to get people's attention is either the scare the more outrage So roger it really raises in my mind the question is is this a bug or a fix Could they fix this without really substantially undermining their business model No No no you can't You can still have Facebook and Instagram But you can't have them at their current profit levels because profit maximization is what essentially leads to all the harms What can be done by Congress or by creation of an agency you mentioned before perhaps an agency I think we already have enough information to design We need three classes of things We need to think about safety and there I think something that looks like the FDA that simply looks at every technology product On a regular basis not just once but continuously to make sure that they are safe And it effectively creates a way for consumers to go to the government and say I'm sorry this is not working out for me Here are.
Bloomberg Radio New York
"food drug administration" Discussed on Bloomberg Radio New York
"A blower Francis haugen a former product manager in the civic integrity unit testified this week before Congress about some of the dangers that Facebook poses Facebook knows that it's amplification algorithms things like engagement based ranking on Instagram can lead children from very innocuous topics like healthy recipes I think all of us can eat a little more healthy All the way from just something innocent like healthy recipes to anorexia promoting content over a very short period of time For his takeaways from the testimony I talked to early Facebook investor roger mcnamee Cofounder of elevation partners and author of zucked waking up to the Facebook catastrophe Roger told me that Francis haugen had an extraordinary amount of access in her role at Facebook She was absolutely at the center civic integrity was responsible for addressing harms to users So she was in exactly the right place She's just utterly convincing in everything she does I thought her testimony was exceptional I can not tell you how much of a relief it is to me that she has come forward because we have known about these issues but what her work has done in bringing out tens of thousands of pages of documents is to eliminate Facebook's argument that they didn't know It is incredibly clear from these documents that Facebook crafted a business model based on attention It was designed to maximize profits at any cost which is an understandable thing in capitalism So it's completely understandable that it would work that way But at the same time in this case the harm that was done to public health to democracy to teenage girls has been incalculable and the core point is they knew it was there They knew it was going to happen It was they were warned about it and they chose to just continue to optimize profits And again in capitalism that's understandable but it really does cry out for regulation the same way that when the food industry was unsafe in 1906 we created the food Drug Administration when chemicals were unsafe in the 50s we created the environmental laws This came to our attention in part because of The Wall Street Journal reporting based on the documents that miss hug and had you with children and what the Facebook knew or believed about the possible risks to children What do we know about that And what does Facebook know So Facebook has known this since the day it bought Instagram The goal of Instagram from the beginning was to make young girls look better than they really are And through that process to by making the look better the effectively create a whole culture of envy And that is the business model And there's nothing you can do to change that It's been there from the David and scream was created and it is a threat to the psychological well-being of an entire generation of young women and the key thing to understand is this is not a business model that exists only at Facebook It exists in various forms at Google at Amazon at Microsoft And it's now being adopted throughout the economy How much of this is because of the algorithms and the way they're designed A 100% of it is The way to think about this is that this is we're dealing with a business model based on attention and the best way to get people's attention is either the scare the more outrage So roger it really raises in my mind the question is is this a bugger effect I mean could they fix this without really substantially undermining their business model No No no you can't You can still have Facebook and Instagram But you can't have them at their current profit levels because profit maximization is what essentially leads to all the harms What can be done by Congress or by creation of an agency you mentioned before perhaps an agency I think we already have enough information to design We need three classes of things We need to think about safety and there I think something that looks like the FDA that simply looks at every technology product On a regular basis not just once but continuously to make sure that they are safe And it effectively creates a way for consumers to go to the government and say I'm sorry this is not working out for me here are.
WCPT 820
"food drug administration" Discussed on WCPT 820
"Orange County Right but they inserted an indoor mask mandate and they recommend vaccination while not requiring proof I just I feel like we just have to have mandates everywhere Doc don't you And I don't know how you're going to how we get there You can't get into a restaurant in New York without showing proof of vaccination And you probably read the story that was very popular restaurant called carmine I think it was sediment Visitors from Texas physically attacked the restaurant staff who was asking for their proof of vaccination I know this is a family show so I'm gonna temper my language here but the fact that people attacked a restaurant worker doing their job Yeah And protecting the public self is you know just a particular small but an outraged nonetheless If you're right Let's talk about boosters the FDA obviously just authorized Pfizer for American 65 and older those with high risk conditions those in workplaces with high exposure risks but stop short of a similar push for the broader population Data released by Pfizer last week shows the two dose vaccine regimen remains highly effective against severe cases of disease even as its protection against symptomatic cases has waned falling from 96% to 84% after 6 months Pfizer said a third shot would restore its effectiveness to 95% So there's been confusion obviously about this but am I one of those people that I'm happy to file follow the science and the data You and Travis and I are Moderna We'll hear probably in a couple of weeks right What their recommendations are I mean I'm fine with that Following the science and going okay people 65 and over and immune compromised people should go first What's your take on the whole booster Yeah so let's break this down It is a little confusing So two big federal agencies have to approve anything like this First is the FDA The FDA food Drug Administration says this product this case this vaccine is safe The data shows it safe and its effective And they are advised by an outside adviser group to reset conclusion And this is what just happened The FDA got all the input They like what they see And there's a formal approval of the safety and effectiveness of the third dose The next part of the process is the CDC The Centers for Disease Control and Prevention And then they have to say okay we hear what the FDA is saying And now we are going to approve as a matter of policy that people in certain categories are going to get the booster The categories as you say over 65 and severe immunocompromised but also there's another category that's going to warrant this booster shot And that's for people who work around a lot of other people in grocery stores and so on And especially healthcare workers Yeah So all that will be approved If you are less than 65 with no you're not working that kind of environment And you don't have other compromising health factors you may or may not at some point in the future be eligible for right now you're not going to be anytime soon Which is fine And I agree with all of that Yeah one doctor said I don't think a booster dose is gonna significantly contribute controlling the pandemic I think it's important the main message we transmit is that we've got to get everyone two doses That obviously is the big factor right now And as we just played the president I mean obviously the World Health Organization has condemned plans about boosters They said that obviously the shots would yield a far greater return if they were administered as first and second doses in developing nations where new variants are likely to emerge because the variants are circulating so wildly He said as we've seen the emergence of variant after variant we can not get out of it until the whole world gets out of it together You've said that over and over here with the huge disparity and variation vaccination coverage we're simply not going to be able to achieve that So yeah so yeah I mean so Moderna J&J in a couple of weeks would that be different to recommendation for some reason or no No I think we're going to have the same set of recommendations for all the available and approved vaccines In other words those are the categories that we just eliminated this whole entirely entirely and will rugby recommending that you get a booster shot But I just want to underscore again the World Health Organization's position here because it's critical It's not only critical to those countries where the vaccination rates which is all over Africa Less than 2% of the population have even gotten the first dose that we can not turn away from that fact stuff because that's where the festering the growing the development of mutations will occur and it all come back to haunt the entire world So the problem in sub Saharan Africa for example is our problem You live in a fancy suburb and somewhere in California New York or wherever you're going to be potentially a victim of our failure to recommend to understand art Well and quickly before you go I know you have a hard break here but data released by J&J indicates the protection afforded by J&J doesn't wane like Pfizer and Moderna though a second shot would booth its efficacy against mild to severe COVID from 74% up to 94% And then I don't even want it because Chris is here and he's a Pfizer snub I don't want to get into New York Times Story Moderna versus Pfizer both knockouts but one seems to have the edge a series of studies found the Moderna vaccine seemed to be more protective as the months pass than the Pfizer Oh where is he hanging on a second Kris I'll find it Pfizer is a big hammer said doctor Wilson Moderna is a sledgehammer Just saying it's okay I'll tell you what anything you conclude about the studies to date in that realm of efficacy and long-term protection you should write in pencil because you're going to have to erase it the next couple of studies that come out It's been a well but if I have a second to gloat with Chris I'll do it So yes Yeah yeah Anyway so it's all it's all dependent on the most recent studies And I don't think the end of the story is here yet Yep everybody Just get the shot whichever one it is They're all great Okay Team vaccine All right I love you doctor doom See oh not next week It's my big birthday but I'll see you the week after Okay Okay Bye bye All right okay Oh I'm sorry I didn't want to You know what I didn't want to do it in front of doctor doom but it is our vaccine is a sledgehammer It's better.
The Editors
"food drug administration" Discussed on The Editors
"Made us part of your feed at industry and services out there from spotify to i tunes and if you like what you hear here please consider giving us a glowing five star review on itunes. If you don't like what you hear here please forget. I said anything. So m mb. Joe biden has gone there. He wants to impose a vaccine mandate not on the military not on federal workers. Not on contractors are not just on those people but on employers that have more than one hundred people working for them. There is an instance reaction to this on the right a firestorm of opposition. People saying that they're not gonna comply urging people not to comply would do you make well. It's a betrayal of what biden said. Which is that. He was against mandates and didn't think they would could work From the federal government it will send people who are Paranoid about the government's agglomeration of emergency powers and it's continued broken promises. Through shifting goalposts vaccine it will send them into a tizzy Saying i see. I told you so You know this is just going to get worse and worse Biden struck every room. Note in his speech he He failed to describe an in state to the pandemic and the emergency measures. He's introducing have introduced at a time. When i think a huge amount of the public is exhausted of this he made it personal. Instead of you know The appropriate rhetorical posed to strike for president of the entire country is to urge people to do what they can for the common. Good right for the the Vaccine's will help us end this pandemic instead. He expressed exasperation and A lack of patience with scores of millions of americans like directly he. He vented his anger and frustration and the frustration of keno. Two hundred million americans at another eighty million americans. He he said things that make no sense. You know that in in one breath he said if you get the vaccine your chance of being hospitalized for kobe. Nineteen is one hundred sixty thousand and he immediately shifted to saying. I now have to take these extraordinary steps to protect you. The vaccinated from the unvaccinated and of course you know it involves this move through osha and your employer so the hr department. That already tells you what to think. And what pronouns do you use and how to sign off on your emails. They will now tell you what to do with your doctor or what you have to do in lieu of it. This is many baleful trends of cova era governance and progressive era governance all compacted into one mandate and also. It's not clear that they believe this is going to pass muster the osha regulations. Don't really work like this. They're supposed to be kind of exclusively for workplace issues. And this is an attempt to achieve a broader public health goal. In ron clean is a even said like this was a re tweeted claims that this was a brilliant way to get around limitations of federal authority. Well that could be wrong. Client has the the worst re tweets of any white house chief staff ever. I think. I think we can favorite saying that mean that could be cited in that re tweet could be cited in case the in a hearing that that puts this thing down in circuit court could be evidenced itself. The the white house knows what it's doing is not above board. It's just it's it's also it seems to me is desperate. Sign of panic that we seem to be if you look just by case numbers and even by death numbers. We're now in a worst spot currently than we were twelve months ago when we had no vaccines and the white house's panicking they promise to shut down the virus and they don't know how to do it at this point and so the only idea that is satisfying cathartic to launch. Is this attempt to use sticks to beat the recalcitrant into compliance. I think this is carried out further. I think we could start seeing Resistance to this the way you saw resistance in paris or in rome or other european capitals where you have major street protests and demonstrations against these mandates and. it's also just kind of set on fire. This mood on the left. That sort of like well healthcare is a right exactly if you don't do the right things if you don't get the vaccine. Maybe shouldn't go get icu treatment. Maybe you should be triage away. Maybe your health insurance premiums should go up if you're not behaving right in all that stuff It's the sort of stuff that makes you reach for the safety on your weapon is it. It's it's a threat So yeah i think this was a disaster and I think it would be better for biden if the courts somehow saved him from this. You know i mean maybe maybe the ideas that the courts won't let us through but a bunch of major companies will Respond to this by imposing mandates of their own volition. Jim we're gonna talk about the divan. On the politics a second segment on on the mandate here but just on the policies so that last point that. Mvp was making del. Devil's advocate take here. So this is an epidemic now a pandemic really of the unvaccinated. Yeah we're having breakthrough cases but thank god. They're not particularly serious. Most of the time and the vaccine protects you from Hospitalization and death. Where we we've seeing these. Michael also alluded to these astonishing number. Some of the worst of the pandemic of not the the worst of the pandemic right now among those tens of millions of unvaccinated people. So just as a public health matter. Maybe this thing isn't gonna stand but maybe you tell yourself well. This is yet another way and a more rigorous way to send the message that you really should get vaccinated and maybe you know. Get struck down places. Maybe some employers don't do it but some employer is will do it or even if they're not complying with the mandate might say well you know what we're just gonna have our own own policy mandating vaccination on our own power which know various private companies have already done anything to be said for that way of looking at it. Well i want to rehash what michael had said about the contradiction. The speech the idea that if you're vaccinated you're really protected. You really don't have anything to worry about the odds of you. Having a bad reaction are extraordinarily small. And also we're gonna protect you from the unvaccinated. Co workers are unvaccinated people in society. There's a lean out in the morning jolt today. This is like a couple other kind of ramifications of this thinking that if you're vaccinated some other unvaccinated first of living down the street is a threat to you and biden. Emphasizing that there are eighty million americans could get vaccinated. Have not gotten back sedated yet. They're also fifty million americans who are not vaccinated who cannot get vaccinated because they are children aged eleven or younger and according to the us food drug administration bat vaccine is not going to be ready for them earlier than midwinter. Apparently they're hoping for before the end of the year but in all likelihood it's looking at january and one of the points that was kinda contradictory to everything else biden mustang about the need to get everybody vaccinated splits possible is by no means. We're going to rush it. They were not gonna have any particular they would not unveil or you know promote or allow vaccinations for kids until they were one hundred percent certain that there were safe in in alaska but even bigger than the issue of oh by the way. We've got this big mass of americans who are leather younger who can't get vaccinated. We'll get back in it for awhile. We've also got the matter of several billion people around the world who can't get back at the heart of this by really specifically say this. But you hear this from folks on the left and the people who are really pro vaccination all the time this idea that every unvaccinated person is basically a ticking time bomb The idea that the virus could get into them and it could mutate and god forbid someday we can up with a variant. that cannot be stopped by vaccinations. And then we're right back to january twenty twenty..
South Florida's First News with Jimmy Cefalo
Krispy Kreme Doubles Free-Doughnut Offer as First Vaccine Wins FDA Approval
"Christie Cream is doubling its free donuts offer for people who are vaccinated against Covid 19, now offering them to free donuts a day through from August 30th until September, 5th. The promotion comes after the Food Drug Administration gave full approval to the Pfizer vaccine. Starting in March. Crispy cream had been offering a free donut a day for the rest of the year. Two people who are vaccinated as a way to encourage getting the shots. The chain has given away more than 2.5 million doughnuts. Though the real through the deal so far, customers need to show their vaccination card. Or your tattoo to get $3.
The 11th Hour with Brian Williams
"food drug administration" Discussed on The 11th Hour with Brian Williams
"Meanwhile speaking of the active duty. Us military the white house is speeding. Up the evacuations. Out of afghanistan now with eight days left officially until the august thirty one troop withdrawal deadline. Ministration says in the past twenty four hours. Nearly eleven thousand people have been evacuated from kabul about forty eight thousand have been airlifted out since august. The fourteenth crowds desperate to leave afghanistan. Remain outside the airport gates where it's bedlam. Pentagon says u. s. military. Commanders are in contact with the taliban. Today we learned about another mission to rescue stranded americans outside the airport. The commanders on the ground certainly had the authorities they need to pursue opportunities to bring people in and one of the means that their disposal is of course rotary aircraft helicopters. And and we have done that on a couple of occasions. I certainly wouldn't rule out that we would do it again if it if it was the best way. So for the record a couple of extractions thus far. Meanwhile there's increasing pressure on biden to extend that august thirty one deadline for troop withdrawal while he's left the door open for that possibility leaders in the taliban have declared that a red line of their own today. The white house was asked about the taliban resistance. And the president's plans we are in talks with the taliban on a daily basis through both political and security channels decided whether he is going to need more time yawn august thirty first taking this day by day. And we'll make determinations as we go. We believe that we have time between now and the thirty first to get out any american who wants to get out and just tonight members of the house. Intelligence committee received a classified briefing on afghanistan. There chairman adam schiff democrat. California expressed his doubts that the evacuation mission will indeed be accomplished by the end of august.
The 11th Hour with Brian Williams
"food drug administration" Discussed on The 11th Hour with Brian Williams
"Good evening once again day. Two hundred sixteen of the biden administration. Which now has vaccine that has received full. Fda approval in its arsenal. This comes as the biden. White house is ramping up the effort to get tens of millions of unvaccinated americans. Their first shots pfizer's to dose vaccine is the first of the three available in this country to win this. Fda permanent approval so far they've all been used under this emergency authorization maderna's up next then j. and j. this afternoon president biden had a blunt message for the unvaccinated. If you're one of the millions of americans who said that they will not get the shot when it's until has four and final approval of fda is now happened. The moment you've been waiting for is here. It's time for you to go. Get your vaccination today. If you're a business leader a nonprofit leader the state or local liver who has been waiting for full. Fda approval to require. Vaccinations i call you now to do that requiring medical experts are also weighing in as you might imagine saying this is a critical vote of confidence that points to the vaccine safety. The full approval process means that this vaccine now has checked every box and dot every i and cross every t that any other fully approved vaccine has done in. The fda is gold standard food drug administration's the gold standard for the world in terms of Regulatory body there's no other nash national regulatory authority that that matches the fda now according to our nbc news count. Total cova cases in the united states have now passed thirty. Eight million one million new cases have been added over just these last six days. Cdc data showing over fifty one percent of us are now fully vaccinated. Nearly sixty one percent had at least one dose and as the president recommended more vaccine. Mandates are going into effect earlier today. The country's largest school system announced its own roles. All teachers and staff in the new york city public school system must have at least one dose in them by september twenty seventh pentagon also preparing to send specific vaccination guidelines to over a million active duty servicemembers. Meanwhile speaking of the active duty. Us military the white house is speeding. Up the evacuations. Out of afghanistan now with eight days left officially until the august thirty one troop withdrawal deadline. Ministration says in the past twenty four hours. Nearly eleven thousand people have been evacuated from kabul about forty eight thousand have been airlifted out since august. The fourteenth crowds desperate to leave afghanistan. Remain outside the airport gates where it's bedlam. Pentagon says u. s. military. Commanders are in contact with the taliban. Today we learned about another mission to rescue stranded americans outside the airport. The commanders on the ground certainly had the authorities they need to pursue opportunities to bring people in and one of the means that their disposal is of course rotary aircraft helicopters. And and we have done that on a couple of occasions. I certainly wouldn't rule out that we would do it again if it if it was the best way. So for the record a couple of extractions thus far. Meanwhile there's increasing pressure on biden to extend that august thirty one deadline for troop withdrawal while he's left the door open for that possibility leaders in the taliban have declared that a red line of their own today. The white house was asked about the taliban resistance. And the president's plans we are in talks with the taliban on a daily basis through both political and security channels.
Zero Blog Thirty
"food drug administration" Discussed on Zero Blog Thirty
"Can't get the vaccination to minimize some of those risks. That they have just fucking take it so we could be done with this ship right. Yeah just will say oh. What about the complications. You look at. The numbers. Accomplish vaccine are such a fraction of a fractured fractured. Compared to if you get cove it's just crazy. Yes same proudly like auto want that because we don't know what future you drink four cans of monsters. You ribbon heaters all day long and you drink like a fish. You're not concerned with your body. You treat your body like a dumpster. The president news now the president could issue a waiver requiring troops to get back stagnated prior to formal vaccine approval by the us food drug administration. That's what the lawmakers saying. This should be obvious. Fear once the the fda approves it financially maybe people's minds will be at ease a little bit. But that's another part of the controversy. Hasn't been prepared. Jay which i understand. Yeah i get that too. But the science behind the corona virus and that has been around for a long time and every major scientists in the world that does vaccination does medicine focused on that for about a year. And that's the and there are so much money that was poured into it. If we had the same amount of effort for cancer we would cure cancer to like if the entire world population of the smartest biologist and all that really focusing on one thing they. I'm sure they could solve anything. They want to with unlimited money and unlimited like resources Defense secretary lloyd austin. He is seems to be tipping towards mandatory vaccines. He said quite frankly. I'm inclined to move towards making sure that everyone is protected. He said this kind of candidates celtics last week. So i have a feeling that it's come into for the military argument that it's for national security. Because i yeah. I just think people just don't want told what to do. Ever join the military. Got one talking. I'm not saying the military specifically. I'm talking about general but yes especially the military. Don't don't join the adverse to being told what to do what i really. That's it comes down to his the choice for themselves. And they don't want to be put in a position where they feel forced to do it one way or another because a lot of people will just dig their heels in principle rains very much so like if you give them marina choice to do something or not. Do something it's going to be. Don't do it i. That's going to be the go-to because there's not very many as as a young junior enlisted troops and combat arms. That you have control over so if you're given like i can control this for myself. You're going to keep that long as you possibly can. A one officials said we're not going to do it for not order is our soldiers mindset. I guess is what they said again. It they understand that too. That's exactly that's the way they'll fucking cookie crumbles. Let's let's move onto round number. Four was is going to be our interview with randy. The natural tour serious now zero block thirty to have backed randy. The natural quarteur. Who have said is my favorite fighter of all time. I used to love like being marine being a staff sergeant. He really came in and was when you started smacking all tito ortiz on the button and give them a little hooker snapper treatment. This is my guy. This is the guy that arrived with forever. And it's great to have you back on the show. Great to be back on..
Life is Short with Justin Long
"food drug administration" Discussed on Life is Short with Justin Long
"There now so much more research being done about three events that happened in two thousand six is their way to unpack that quickly for people just so they know a little bit. About the history of wine our why this comes the forefront so after nixon launches the drug war. The funding dries up for psychedelic research. It was never actually prohibited but I it became stigmatized scientists. In wanna go near it. There was no money to do it. There was a group of people who never lost faith in the potential of psychedelics. It was heavily researched in the fifties by psychiatry and and and was regarded as a very promising treatment for mental disorders and for addiction And this small group of people clung to this passion for for psychedelics. And they waited for the moment when they could bring it back and they started And there was a change in management at the fda also the food drug administration and someone came in Who's in charge of drug approval. Who who announced basically. I mean quietly to researchers that they would henceforth treat psychedelics. Like any other drug. There would be no special problem with studying. If you had a good study. They would allow you to do it and beginning in the early nineties. They let a couple of people. Do some studies wanted the i was with. Emt by a psychiatrist named rick stras men and then a little later in the decade A group got a formed out in california. And bob jesse. Who's who's a hero in my book. who is a former tech exec..
KDWN 720AM
"food drug administration" Discussed on KDWN 720AM
"Old former New York City mayor once celebrated for his leadership after 9 11 has been under federal scrutiny for several years over his ties to Ukraine. The dual searches sent the strongest signal yet he could eventually face Federal charges. An FBI operation gave law enforcement remote access to hundreds of computers to kill her. A massive hack of Microsoft Exchange email server software and now the Justice Department's top national security official says that tool is likely to be deployed judiciously in the future. As the government develops a framework for its use of the department announced earlier this month that had obtained a warrant from a federal judge in an operation involving the removal of malicious coating that gives hackers a foothold in the networks. The government removed the Web shells from hundreds of vulnerable computers affected by the hack that Microsoft's blamed on a group operating out of China. Going posted Another loss as the pandemic continues, undercutting demand for new planes and the company deals with more problems around it's 7 37 Max Boeing announced Wednesday lost $537 million in the first quarter. It's less than it lost a year ago, but still more than analysts thought. Still, the quarter ended, Boeing suffered a new setback with its 7 37 max jetliners, more than 100 of which are now parked again because of issues around electrical grounding. CEO David Calhoun, says 2020 ones that inflection point for Boeing with distribution of vaccines against covert 19 picking up and helping the airline industry. And the Biden administration is expected to propose a ban on mental cigarettes, a move back by a civil rights groups that say black Americans air hurt by the industry's aggressive marketing of the products. The Food Drug Administration is slated at briefing with lawmakers today as it faces a court deadline to respond to a 2013 citizen's petition seeking the van. It wouldn't require congressional approval. However, the FDA would have to submit proposed rules and seek public input. Ah final band could take years and would likely be challenged in court by the tobacco industry, which has repeatedly sued the FDA to block Regulation. Take us with you. Wherever you go. Download the TAC. Streamline free mobile app Reach out to yours Truly any time across the board on social media, I met Matt Ray talk. Use the hashtag A FN What will the show on Twitter at America's First news used the hashtag af en It's Thursday morning, April 29th. We are just getting started as still to come on. A FN in North Carolina law that gives this court's authority over the release of Body Cam video is Coming under harsh of scrutiny will explain And with interesting Corona virus vaccines lagging some states are getting creative offering incentives. All of that more on the way you've got a FN Yeah. First America's first news will be right back. I tried other friends that.
The Shawn Harvey Morning Show Podcast
"food drug administration" Discussed on The Shawn Harvey Morning Show Podcast
"Be careful out there and the assassin down up saying this in this country. Black folks brown folks latinos minorities. Be careful street right now in a sack on understand why me saying this. But it's the facts in his factual. Be careful we all need to pray for children and everybody out there. You have a have a twenty two twenty three year old. Jose got a twenty-three myself. I've got a thirty seven year. Old son in coach has a son on the way and he has these kids and we all have loved ones. Even if you don't have children in that chat room you do have nephews nieces or kids that you and teenagers that you look we just need to pray for these folks and pray for us today in this country only thing that right now we could only do right now out. Paris tells the police. Paul push hands on both steering wheel. Don't say and let them know that everything's in the glove compartment and we still get killed. We're actually twenty yards the lighting. And you get maced did beat up right. You reach the documents and they sent you. Because i can't wait acapa. I've got i've run. What the hell is going on and not by sight getting killed right right right i tell you i feel as though having a black sun in america and i say something because they are more targeted than the females but we are still talking about. What a big black sun. It's like a soldier walking on of a battlefield land mines. It's dangerous very dangerous. Dangerous so crazy on a turkey to let us pray for us. Spray for all of us yes does barbie said it was forty three million black votes. We don't play pray for off now all we have to do right now. And the sad to say that in in this country with the social unrest and this woman needs to be. You can't commit this type across right right coach that racism supersede everything that was going on around you. You should be in jail just with a clear simple fact that you committed this murder right down the block from epicenter of racial injustice in this country she saw the number one in that need and as melanin and when she saw that weapon was the scene. New shiites eliminate that threat. That melanin is that melanin is a one weapon that they all fear right. Exactly one on the switch right. We got in this class code. Cold cold kicks ass. What's the next story. we'll talk about. Kobe boca called on live with this real quick. Let's clap coach. He always wrong. Yes johnson and johnson is in hot water again guys. The cdc and fda recommends us to pause use of johnson and johnson colbert nineteen vaccine over. Blood clot concerns the us senate for disease control prevention then. Us food drug administration has recommended that the us paused the use of johnson. Johnson copay nineteen vaccine over six reported. Us case a rare and severe blood clot issue The six report cases were among more than six point. Eight million doses of johnson johnson. The vaccine administered in the us office cases occur among women between the ages of eighteen. Forty eight as occurred between six to thirteen days after vaccination according to a joint statement on tuesday dr and schnaut chat principal. Deputy director of the c. d. c. and Dr peter marks director of fda centers for biologics evaluation and research. The cdc will convene a meeting of the Rivalry committees or station practices on wednesday to further review these cases and assess their potential significant significance. Thank you bobby. Look well there. You go coach whole cindy you could start your parade city and all the other conspiracy theories that are out there. Running around would heavy resentment. They go oh happy day. You have six confirmed cases of blood clots and more calm and probably more to come more right right right and you've been notified for it. Yeah this is not a conspiracy. I applaud this inflammation. I welcome it. Because it's factual and the people we got the blood clots. God bless you probably recover from that to more about this very rare some some conditions of very rare rare fair having i got johnson johnson. They probably wouldn't have those back. Blood clots i. I've i've i've i've had this johnson and johnson. You got lucky okay. And there's no blood clots yet. But at least i'm notified with the information in the facts. Hold you people have been vaccinated barbie. We got six blood clots. Well guess that six dangerous six six and coach who share. I say this respectively to the six. Let's call them the funky six out of a hundred million party. Mathematically doesn't even register on board still something because -cerned abou- chanoine sex people if it wasn't cost because sars have never made a statement therefore is caused for nine and you're right the people especially for women right and you're absolutely right. Guess what you just said. That was factual you said that the cdc had caused concern to notify people to do certain things with this vaccine. That's great no because facts but it yet. It's facts and it's causing concern. So six people little blood clot had hangovers. That was worse than blood. Clots logo on a three-day crat. Run now that then this blood clot coach. You think about all this now. I think i'm a numbers guy. Percentages mean a lot so overall i think. Hey that's pretty affecting. If i evaluate plan with somebody they shot six billion shots and miss six of them pretty good. You're you're you're you're pretty pretty short. But now and i'm not against those six. That he missed a that he'd been six though that he six billion you know so on on overall. I'm happy with the numbers. I'm glad to see the seasons being very transparent in the sense. Speaking of the sixty days that happened with the blood. Kat blood clots something that you definitely want to look for. But he said what the timeframe it with like within seven days seven days it and it was happening. So hopefully you know. Sean you on the other side of that. I'm on the other side of that seven to ten days. So if your past that you should be good you know you got you. Got a hundred million johnson in the arm. Six five six black glass vile six blit klotz.
WNYC 93.9 FM
"food drug administration" Discussed on WNYC 93.9 FM
"If the pathway through this pandemic is vaccines. It's a dark and twisted one. For all the issues with distribution, and there are issues there is equally an issue with supply. President Biden announced this week that his administration is working to buy an additional 200 million doses of the vaccines. But as Dean Baker, senior economist at the Center for Economic and Policy Research, explains, where still constrained by the matter of who can actually manufacture them? Maturino Fizer own a patent and what that means is that no one else could produce them without getting a license from those two companies. So while in principle we might think that there are other companies that either have the manufacturing capacity or could develop it. You don't have that option unless Majorino Fizer are prepared to give that to them. Patents are former monopoly Unless we change the policy. There's not much we could do about that. And both. These companies had access to hundreds of millions of dollars in public money and billions of dollars in advance purchase commitments. Yeah. This is really striking. In the case of Madonna. We literally paid for their development to this vaccine. We gave them somewhere in the order of form that 3440 million to do the original development And then the phase one phase two testing, And then the government put up another roughly 440 million to pay the cost of phase three. Testing where Determined that it's safe and effective. And of course, the Food and Drug Administration proved that drug companies often say, Well, they need a pen and they have to charge high prices because they took a big risk. And sometimes their drugs fail. Which is true, of course. This case. Suppose the FDA looked and goes. It's a no go. It's not effective. It's not safe. Well, they were paid. Rush, Marama Chandran and Zoe Phil wrote in the Nation this week that we shouldn't be calling these Fizer vaccines or Moderna vaccines at all. They're the people's vaccine. We paid for them, and one of the things we really would've liked was full transparency on all of the research results, so they're giving it to the FDA, The Food Drug Administration and I'm not saying they don't do a good job, but still things will get through. They can't analyze everything. They're rushed. And inevitably there will make some mistakes if we're fully transparent if you had the dad and they're so that You could look what happened to younger people to older people, people we had heart issues. People might have had other conditions. Then researchers all over the country all over the world would be able to go through it, and maybe they would catch something that the FDA missed. I don't entirely understand what the data has to do with monopoly ownership of the drug because the data refers to how it's worked out in the trial's not how it was made or what its components are or any of that. Well, to my view. There's not a good argument for keeping the data secret. But most of the drug companies insist on that, and there's a very pernicious reason as to why they might want to keep it secret, and that's they may look to misrepresent. Safety or effectiveness of their drugs. That's a big part of the story. The opioid crisis, you know, produce farmer, which was one. Of course the big opioid manufactures it from the first day this was selling is a generic, anyone could produce it. They won't have a big incentive to go out and market and tell doctors. Oh, don't worry. It's not addictive. They wouldn't be doing that. My view is why don't we just pay for the research upfront? Then you don't have that issue, And that's exactly what we did with Madonna. We paid for the research of front. We still give them a pant monopoly, which makes zero sense. But if you pay for the research out front Then they don't have cost to cover. Currently, the government spends roughly 45 year on biomedical research. If you look at what the industry spends its roughly 90 billion, so more less twice that amount. Suppose we look to replace what the industry spends. We were spending say, somewhere around 130 140 year on prescription drug research and development. Well, then we would have paid for the company's in advance to do the research. Once it was approved, it could be sold to generic from the first day. What these manufacturers become essentially our research companies they stand to make far less money from the actual cell of the drug that they were paid to create. And to my view, that's exactly what we want. I'm not looking to put in these companies out of business. Fizer Merc all the big companies presumably would want to stay in business. They've had years of experience doing research. So they would put in bids on these contracts. They're going to research cancer drugs. You know my view. If they're asking me, I designed the system. Everything's open source. So as soon as you get a lab result, you put it up on the Web. So every everyone could see it your scenario, which I really I love it. So socialist. It's just a different type of capitalism. I'm not concerned that they could make us much prophetess they do under the current system. I mean, maybe they will. I frankly hope they don't talk about serving the public. Yes, that that's our goal in designing the system, and we always have to remember pent. Monopolies are government policy because again I don't know how many times have argued with people that go. You want your share of the market, and I'm sorry. Pent monopoly is from the government. So we're already interfering with the markets were deciding how best to do it. The situation that we're in now wasn't inevitable. Back at the beginning of the pandemic, the W H O set up. A covert 19 technology access pool to promote the sharing of knowledge, and there were early reports about how the pandemic is going to change. How the world does science make it more collaborative. There was a lot of cooperation early on that many scientists talked about. There were a lot of developments that were posted on the Web. You had international cooperation scientist in Europe in China in the United States. But then we quickly huddled down. You had the company saying, OK, we're gonna work on this. We're gonna work on that They wanted to get pat monopolies and have vaccines treatments that Would allow them to make lots of money and what in principle we would want to see was collective sharing of knowledge and also open access to technology so that when these vaccines were being developed Anyone with the means to produce the vaccines would have been able to. We would have liked to have hundreds of millions of each of these vaccines available, maybe even billions at the point where they were approved. Maybe we would have made 800 billion doses of the five sir vaccine and it gets the December and turns out FDA looks at it and they say it's a no go well. That's unfortunate, but you go. Okay, so the vaccines cost roughly $2 each toe produce again not exact figure about ballpark number, so we threw $2 billion in the garbage. We've spent the US loan somewhere in the order of $5 trillion now, in in covert relief this past October, there was a proposal put forward by India and South Africa. Asking the W T O to exempt member countries from some forms of intellectual property enforcement. Which would allow them to produce generic versions of coded vaccines and treatments. And that was an immediate No go but aren't there Global provisions for emergencies just like this. Yeah, This is a fascinating question. So the trips accords trade related aspect of the national property, part of the W T O as of 1995. Those require all countries to doubt us down patent laws. But they have special permission during emergencies to override those pent laws, then special permission has very, very rarely been invoked. And the reason for that is the United States and I suspect European countries as well have basically threatened retaliation. What kind of retaliation denying the drugs? They're not giving them anyway. Various forms of trade were retaliation. This came up with South Africa in the 19 nineties. We threatened to put up terrorists because they were gonna do that on a drug that was used to treat AIDS patients, and this was, I think 99 Bill Clinton's still president, then the U. S. Threatened them with retaliation where we would make it more difficult for them to export items to the U. S. Al Gore, of course, is running for president in in 2000, number of AIDS activist It went to his speeches and they protest that And Clinton back down on it because it was hurting Gore. Gore didn't want to be associated with the I Forget whether they actually issued the compulsory license because again you get this this dance we're Countries threatened to issue compulsory licenses and then often to prevent that from actually happening. The company agrees to radically reduce the price that that's happened several times. I don't know if Fizer or Madonna or Johnson Johnson, If that one comes out, could even do the little jig of saying Oh, no, we'll drop the prices because they can't make enough. We're talking about hundreds of thousands of potential lost lives. The pharmaceutical industry, saying, Oh, well, they it's complicated technology that couldn't possibly produce it..
WNYC 93.9 FM
"food drug administration" Discussed on WNYC 93.9 FM
"Fizer own a patent and what that means is that no one else could produce them without getting a license from those two companies. So while in principle we might think that there are other companies that either have the manufacturing capacity or could develop it. You don't have that option unless maternal Fizer are prepared to give that to them. Patents are former monopoly Unless we change the policy. There's not much we could do about that. And both these companies Had access to hundreds of millions of dollars in public money and billions of dollars in advance. Purchase commitments. Yeah, this is really striking. In the case of Madonna. We literally paid for their development to this vaccine. We gave them somewhere in the order of 434 140 million to do the original development and then the phase one phase two testing. And then the government put up another roughly 440 million to pay the cost of phase three testing where they determined that it's safe and effective. And of course, the Food and Drug Administration proved that Drug companies often say Well, they need a pen, and they have to charge high prices because they took a big risk, and sometimes their drugs fail. Which is true. Of course, this case, suppose the FDA looked and goes. It's a no go. It's not effective. It's not safe. Well, they were paid. Rush, Marama Chandran and Zoe Phil wrote in the Nation this week that we shouldn't be calling these Fizer vaccines or Madonna vaccines at all. They're the people's vaccine. We paid for them, and one of the things we really would have liked was full transparency on all of the research results, so they're giving it to the FDA, The Food Drug Administration and I'm not saying they don't do a good job, but still things will get through. They can't analyze everything. They're rushed. And inevitably there will make some mistakes. If we're fully transparent if you had the dad and they're so that you could look what happened to younger people to older people, people we had heart issues. People might have had other conditions, then researchers all over the country all over the world. Would be able to go through it and maybe they would catch something that the FDA missed. I don't entirely understand what the data has to do with monopoly ownership of the drug because The data refers to how it's worked out in the trial's not how it was made or what its components are or any of that. Well, to my view, there's not a good argument for keeping the data secret. But most of the drug companies insist on that and There's a very pernicious reason as to why they might want to keep it secret, And that's they may look to misrepresent the safety or effectiveness of their drugs. That's a big part of the story. The opioid crisis, you know, produce farmer, which was one. Of course the big opioid manufactures it from the first day this was selling is a generic, anyone could produce it. They won't have a big incentive to go on market and tell doctors. Oh, don't worry. It's not addictive. They wouldn't be doing that. My view is why don't we just pay for the research upfront? Then you don't have that issue, And that's exactly what we did with Madonna. We paid for the research out front. We still give them a pant monopoly, which Makes zero sense. But if you pay for the research out front, then they don't have cost to cover. Currently, the government spends roughly 45 year on biomedical research. If you look at what the industry spends its roughly 90 billion, so more less twice that amount. Suppose we look to replace what the industry spends. We were spending say, somewhere around 130 140 billion year prescription drug research and development. Well, then we would have paid for the company's in advance to do the research. Once it was approved, it could be sold as a generic from the first day. What these manufacturers become essentially our research companies they stand to make far less money from the actual cell of the drug that they were paid to create. And to my view, that's exactly what we want. I'm not looking to put any of these companies out of business. Fizer Merc all the big companies presumably would want to stay in business. They've had years of experience doing research so they would put in bids on these contracts. They're gonna research cancer drugs, you know, In my view, if they're asking me, I designed the system, Everything's open source. So as soon as you get a lab result, you put it up on the Web so every everyone could see it your scenario, which I really I love it. So socialist. It's just a different type of capitalism. I'm not concerned that they could make us much prophetess they do under the current system. I mean, maybe they will. I frankly hope they don't talk about serving the public. Yes, that that's our goal in designing the system, And we always have to remember pent. Monopolies are government policy because again I don't how many times I've argued with people they go. You want your share of the market, and I'm sorry. Pent monopoly is from the government. So we're already interfering with the markets were deciding how best to do it. The situation that we're in now wasn't inevitable. Back at the beginning of the pandemic, the W H O set up. A covert 19 technology access pool to promote the sharing of knowledge, and there were early reports about how the pandemic is going to change. How the world does science make it more collaborative. There was a lot of cooperation early on that many scientists talked about. There were a lot of developments that were posted on the Web. You had international cooperation scientist in Europe in China in the United States. But then we quickly huddled down. You had the company saying, OK, we're gonna work on this. We're gonna work on that They wanted to get pat monopolies and have vaccines treatments that Would allow them to make lots of money and what in principle we will want to see was collective sharing of knowledge and also open access to technology so that when these vaccines were being developed Anyone with the means to produce the vaccines would have been able to We would have liked to have hundreds of millions of each of these vaccines available, maybe even billions at the point where they were approved. Maybe we would have made 800 billion doses of the five sir vaccine and it gets the December and turns out FDA looks at it and they say it's a no go well. That's unfortunate, but you go. Okay, so the vaccines cost roughly $2 each toe produce again not exact figure about ballpark number, so we threw $2 billion in the garbage. We've spent the US loan somewhere in the order of $5 trillion now, in in covert relief this past October, there was a proposal put forward by India and South Africa. Asking the W T O to exempt member countries from some forms of intellectual property enforcement. Which would allow them to produce generic versions of covert vaccines and treatments. And that was an immediate No go but aren't there Global provisions for emergencies just like this. Yeah, This is a fascinating question. So the trips accords trade related aspect of the national property, part of the W T O as of 1995. Those require all countries to doubt us down patent laws, but they have special permission during emergencies to override those pet laws. Then special permission has very, very rarely been invoked. And the reason for that is the United States and I suspect European countries as well have basically threatened retaliation. What kind of retaliation denying the drugs? They're not giving them anyway. Various forms of trade were retaliation. This came up with South Africa in the 19 nineties. We threatened to put up terrorists because they were gonna do that on a drug that was used to treat AIDS patients, and this was, I think 99 Bill Clinton's still president, then the U. S. Threatened them with retaliation where we would make it more difficult for them to export items to the U. S. Al Gore, of course, is running for president in in 2000, number of AIDS activist It went to his speeches and they protest that And Clinton back down on it because it was hurting Gore. Gore didn't want to be associated with the I Forget whether they actually issued the compulsory license because again you get this this dance we're Countries threatened to issue compulsory licenses and then often to prevent that from actually happening. The company agrees to radically reduce the price that that's happened several times. I don't know if Fizer or Madonna or Johnson Johnson, If that one comes out, could even do the little jig of saying Oh, no, we'll drop the prices because they can't make enough. We're talking about hundreds of thousands of potential lost lives. The pharmaceutical industry, saying, Oh, well, they it's complicated technology that couldn't possibly produce it..
NewsRadio KFBK
"food drug administration" Discussed on NewsRadio KFBK
"For breaking news. Thank you now on use the local news producer tried tactic on the tens, every 10 minute mornings and afternoon and weather travel is gonna be tricky out there with Storm Sacramento's news 93.1 kfbk. So one asked about the vaccine. This is the group that did the recommendation to the F Food Drug Administration, FDA. They called the A C I P. There. These all these experts that weigh in on things, and they are recommending that vaccination should be Deford. If you've had the virus. They say, deferred until you've recovered from the acute illness. In other words, if you're experiencing symptoms, and you've completely completed the isolation period For most people as 10 days after the onset of symptoms, so Um, they're not saying Don't get it. They're just saying, Don't get it right away. I Every every vaccine is different when I was a Child in grade school. They lined up all the kids. Who go get their polio vaccine. And they told me you're not allowed. Yeah, they booted me out of the lines and you're not allowed because I actually had polio. So they said. You can't get the vaccine. Well, I never got the polio vaccine, but I got polio before then before it came out. I know idea and well, let's play, um Dr William Hazel time. Um, big immunology, immunologist guy and He Played cut. Nine. This is where he talked. They were talking asking about Moderna earlier today, and he said the antibodies in the modern a vaccine May not be permanent. Well, you know, First of all, I'd like to congratulate with Jennifer publishing their data of their phase 12 trials, and in that publication, you can see how long the neutralizing antibodies those of the ones that are important. That's just the advice the virus. Does that actually doing the work to protect last and what that data shows is that Half life. That is the time at which half of the original antibodies were still active is about three months. That's not a surprise because when they develop vaccines for Zika or Ebola's arrested choice, official virus, That's what they found that the real question is how many have lives. Can you go down? Six months? Nine months, 12 months before you run out of gas and can't stop the virus anymore? I think that's what we're going to learn. It's not necessarily true of all the vaccines, but it might be. Let's take something like the flu. The flu vaccine has a similar half life, maybe even little shorter yet we use it. It's effective, so it's not necessarily a limitation, but it is a caution. There's something we have to watch over time. Yeah. Hadn't heard that from anybody else. Dr Hazel time. Says Moderna as and he presumes it's the same with everybody else. That's the half life on this thing. Maybe they don't know what it is. So everybody's rushing around trying to get the vaccine and it may be where you're gonna have to rush around again. Next year, do the same thing. 855295 66 100 George in Florida. Hello, George. Yeah. Time. Average question about the phone where? I'm sorry. Time, like, Excuse me. I appreciate you The answer in the school, you know, Like the phone where people say why I was still I was in this store that sir This'll Ugo. If you're gonna do something You leave the phone on your couch. You put the TV on especially sporting game, which is about three hours. And you do what? You gotta do this to me. Or you could learn. Sign language and use Morse code. The feds will never know what you're doing. Yeah. Don't know They're listening, but I know they know where you are. I don't Well, that you know. No. Somewhere some well, Mrs Grubach, right? You're right. I mean this fall. Right. You need the phone there was was sent for you expecting The bank robber isn't that smart? The bank robber walks into the bank with the phone in his pocket. Oh, not only works in the phone his pocket when he pulls out, the teller says, Can I have idea gives in the vices number twice is good to know that before I liked I liked Like the stupid crook stories. They're great, I'll tell you Surveil quick. I was I was driving the road down the road and stay with 64. There's a warm art and I seen a big TV on a truck. I said, Wow, I wish I had that TV. That's really look nice. Don't you know when I went home? I looked at my phone and she said, Well, mark televisions on it. I was like, Oh, yeah. Oh, yeah way, Tom. It was a wake up call like it. All right. Just keep your mouth shot. Yeah. Oh, I mean, I mean, There are some some of those big department stores the targets or some of those. I don't know if it's target doesn't but you could be in the store and up will pop a little coupon for something that you happen to be standing in front of. Yeah. I was shouldn't Wal Mart the other day, and I like that by a lot of eggs, and I buy a lot of cheese, And those sudden came up. Said this Krupa for eggs? Yep. I was, like, sure. My bike. I'm sure I mean, I mean, do you? You know you believe that you have privacy? I don't Don't No, no, no, no, I'm grabbing. Really, You know? Yeah. I mean, it's scary. Like I can stuff in the mill. I'm like I never order it by my sort of it. Diverse emits. I'm like this is weird. I says I one day I was watching and commercial about life. We shorts. Thanks. Says I don't need life insurance. And it's about a 34 days later. I guess I think in the middle of life for church exact coincidence? Yeah, but I don't know, but no, I don't agree with you. There is no private shape. You know, it's gone. Gotta learn. Sign language. I look it. Don't get me. Don't get me started on sign language. I Have gotten in more trouble over sign language because You'll see. Some government official standing there at a news conference and they've got all the reporters and their cameras and microphones and everything else and standing next to the politician is somebody Doing sign language and I've I've often Well, I've said it out loud a couple of times. Why do they have they have closed captioning? You know, so why would they need sunlight? Well, I got a very nice lady who sent me a Brother firm email about her daughter could not here and how important this Woz and it does make a lot of sense when she explained it to me from the view of viewpoint of somebody that is death, but they also Um It's I said, Well, this is sign language. I I know nothing about it. Is it the same around the world? And she said no. Every language has its own sign language. Would think it would be university. Yes, Yes, I learned is not. So I get in trouble with the people that are part of hearing or death Find or family.
The Afternoon News with Kitty O'Neal
Millions of Pills Flood Ohio CVS Pharmacy
"That at knuckle heads bar and grill in Parma Ohio perfect name they disclose the CVS across the street had received more pain pills over a seven year period than any other drug store in Cuyahoga county over six million pills in a seven year period so less than a hundred thousand pills now six doesn't know no nothing less than a million pills per year we put it out just slightly less that's all I don't know if that's allotted to CVS go to a CVS their business what they're off they're everywhere they're busy so there was a homeless encampment just beyond the CVS is a popular place for her when users and this one guy who got caught up in all of this is I don't blame CVS he condemned the drug companies may large profits and encourage doctors to prescribe opioids if I'm a drug company I I of course I'm going to try and sell my product there's been approved by the food drug administration of course I am that's what you do that's what they're in business to do that's why I mean I I you got to hang it on that's why the doctors make a lot of money had been given a lot of responsibility they're the ones who have to oversee this in the pharmacies have to be careful about making sure that there's no fraud involved and they do have these programs now to make sure that you're not out doctor shopping so who's to blame this trial is underway they're gonna try and sued the drug makers I I don't know it sounds like these opioids been around a long enough time to to were doctors you're the doctor the colleagues he was he was very cautious I presume most doctors are specially with something new and I'm not going to take the word of a pharmaceutical sales person I'm gonna do my research what is what do the studies say and does the FDA did the FDA say anything in their literature that were proving this but caution caution caution this has it's highly