18 Burst results for "Diana Zuckerman"

"diana zuckerman" Discussed on WNYC 93.9 FM

WNYC 93.9 FM

10:24 min | 2 months ago

"diana zuckerman" Discussed on WNYC 93.9 FM

"Within our power to do it. But experts say the fight against cancer is unwinnable. If there isn't also a focus on preventing the disease by regulating carcinogens, the Environmental Protection Agency has historically been slow to act on known carcinogens. And much more research is needed to find out exactly which toxins are making a sick So what would it actually take to win the war on cancer here to explain is Diana Zuckerman, president of the National Center of Health Research, Diana, Welcome to the takeaway. Thanks so much for having me. Okay. First. What kinds of carcinogens? Are we talking about here? Carcinogens in products sold in stores and in food. Are we talking about environmental exposures? Well, Unfortunately, it's it's all of the above. There are so many chemicals and other substances that we know can cause cancer or know that it does cause cancer and some of them are in our environment. And some of them are in her home environment. Some of them are in our backyards s o that we really need to have that comprehensive you. Of what is causing cancers and doing something about it. And what do you make of President Biden's plan? He said he wants to eradicate cancer. What does that realistically look like? Clearly he's very heartfelt on this issue, but his focus has really been on treatments, and that's why he Wants to do a new agency within the National Institutes of Health that would focus on cancer but focus on it as a treatment. That's what NIH Does. I mean, they do look at causes, but they're not looking so much at prevention, and that's what's been missing always, and that's rather Typical of political leaders. Okay, so there's more of a focus on treating cancer versus preventing cancer. Can you tell us? What what has this so called war on cancer looked like in the past. So far, the war on cancer has looked at what is called prevention but is actually early diagnosis. So you hear a lot about screening. There's a lot of interest in screening. For all kinds of cancers, where where that's possible, and that is effective at diagnosing early, But it isn't really prevention usually but most kinds of screening, whether it's mammograms or other kinds of screening that people are most Knowledgeable about really is about finding an early cancer, but the cancer is already there. And so that's why the war on cancer has always been very limited because it's focused on Cancer once it started rather than looking at. How can we prevent it to begin with? Biden did mention prevention in his speech. He talked. I think more specifically about screening for cancer. What are your thoughts on on that approach? It's a good approach as far as it goes, but it is not the way to really and cancer if we want to, and cancer. We've got thousands and thousands of chemicals that were being exposed to many of us every day. Thies Chemicals air in our bodies. The various federal agencies have studied them, and they know that we have them in our bodies. And what we don't know usually is. How? How high those levels have to be. To cause cancer, and that's always going to be different for different people. So if you want to end cancer, as we know it, you would want to have much more information about what are these levels. Which are the chemicals. What are the combination of chemicals and who are the people who are most vulnerable? Most likely to develop cancer if they are exposed to particular. Chemicals and other substances. All right, we have to take a quick break. But stick with us. We'll be back with more on the regulation of carcinogens in just a moment. Mm hmm. On the next. All of its Broadway performances will return on September 14th. We'll get a preview of shows, ticket sales and more from vulture theater critic Helen Shaw and we'll take your calls, plus a look at Anthony Bourdain's final book called World Travel and Irreverent Guide. We'll speak with writer Laurie Wool over four days, friend and co author. I'm Alison Stewart joined me for all of it. We think that new W N Y C Welcome back to the takeaway. I'm Sarah Gonzalez in pretending to Vega. We continue our conversation with Diana Zuckerman, the president of the National Center for Health Research, and we're discussing President Biden's fight against cancer. In a public health experts who have spent their careers examining environmental causes of cancer say it may not be possible to truly stop cancer without the EPA stepping in what is President Biden strategy. You haven't heard about a strategy pertaining to EPA, although his administration has already started to make some corrections of We're, uh EPA has been going in the last couple of years. I should just say that at the end of the Obama administration, an amendment to what's called the Toxic Substances Control Act or Tosca. Amendment was made. That was a bipartisan effort. It was a very big deal at the time of Ah, compromise between What new chemicals and what old chemicals would finally be studied and perhaps, in some cases, taken off the market in exchange for giving states less control over what they did. So, for example, states like California tended to have Much higher standards than other states. So the purpose of this compromise legislation was to put everybody on a more similar level playing field. But what happened in the last four years was that These new regulations that were supposed to take place these new reviews and these new efforts to get carcinogenic chemicals off the market just stopped and they stopped because they stopped doing the right kind of research. They stopped. Looking at the right kind of research. And so hundreds of new chemicals went on the market that we're potentially dangerous but weren't being studied. So the Biden administration has started reversing that, and that's great. But there are thousands of chemicals out there that we still know very little about. What we do know they have that In many cases, they have the possibility of causing cancer. And what is the role of regulation here? How is the EPA falling short in terms of the regulation of carcinogens? Pia is supposed to look at the new chemicals as they are ready to go on the market and not allow them on the market if they show signs of being carcinogenic. And instead requiring that they be studied, But there's still thousands of old chemicals that have already been on the market. And so there's this huge backlog and EPA needs to look at those as well. So EPA was supposed to find the chemicals that were most likely. To cause cancer. And by that, I mean ones that probably we already know cause cancer, but we just don't know under what conditions they cause cancer. So that was what the EPA was supposed to be doing the last few years. And stopped doing and under the Biden administration. Some of these old policies have been reversed back to what the law is supposed to require, which is reviewing and then taking action, so they just stopped reviewing whether certain products sold in stores are carcinogenic. Potentially Cressida genic. It's interesting every time I see Ah, warning on a product that says, you know, this is potentially Crescent agenda come like, Why do we even allow this to be sold in stores? Then, if it's possibly carcinogenic, That's such a good question. And by the way, just in the last couple of days there have been new reports about New evidence and I'll just very briefly mention what they are. The inspector general of EPA came up out saying That EPA you need to do a better job, So that's a good step in the right direction where they're saying, Oops, you know, there are certain chemicals that we should be looking at more carefully that we haven't looked at yet. Um, And in addition to that A new study came out showing that He foster, which are these chemicals known as forever chemicals. They've been in the news a lot lately do cause kidney cancer, and that was in a journal called The Journal of the National Cancer Institute. It was already assumed or thought that pee fast could cause kidney cancer or testicular cancer. But now we have a new study showing That people who have more P fuss in their bodies in their blood are much more likely to be diagnosed with kidney cancer. And where do we find this chemical PIF us Everywhere You know, it's in our homes. Definitely. It's in stain proof carpeting. It can be in our nonstick cookware, and it's also outside as well is something that has been in the news a bit lately, but I think a lot of people are still not aware of people do get confused..

Sarah Gonzalez Laurie Wool Anthony Bourdain Alison Stewart Diana Zuckerman Helen Shaw Toxic Substances Control Act National Institutes of Health EPA September 14th Environmental Protection Agenc NIH Diana thousands President Tosca National Center for Health Res World Travel and Irreverent Gu First thousands of chemicals
"diana zuckerman" Discussed on News Radio 1190 KEX

News Radio 1190 KEX

01:59 min | 8 months ago

"diana zuckerman" Discussed on News Radio 1190 KEX

"Michelle Franzen, an FDA panel reviewing fighters covert 19 vaccine data on safety and effectiveness, set a public mayor meeting ahead of a vote. The vaccine is said to be highly effective regardless of demographics. But during the public comments session, a doctor who is not on the panel pointed out gaps in the clinical trial. There's a lack of diversity. Dr Diana Zuckerman of the National Center for Health Research said black patients were underrepresented. So where patients over 75 How can we ensure informed consent to nursing home patients from We have no data to provide pregnant women were excluded, and it's unclear how well the vaccine works in people with HIV, so Fizer study will have to keep going for many months, even after the vaccine is authorized. Aaron Carter SKI ABC NEWS New YORK Latest on vaccines will be the focus of prime time specials from ABC News this coming Monday on radio and TV President Trump continues to back legal challenges to the election. He's hosting a meeting today, with a group of state Republicans joining in a Texas lawsuit. Seeking to overturn Joe Biden certified wins and four states, one of them in Georgia, where key Senate runoff races are also taking place in less than a month. Vice President Mike Pence is getting out the vote there today next week. President elect Joe Biden heads their president elect Joe Biden will travel to Georgia next Tuesday to campaign for the Democratic Senate candidates in the January 5th run off elections. Item will hit the trail in Atlanta on behalf of John Aasif in Reverend Raphael Warnock. The balance of power in the Senate is at stake in these elections, Also from war knocker, challenging incumbent senators David Perdue and Kelly Leffler, vice president. Pence is in Augusta, Georgia, today to campaign for the Republican Senators. President Trump was in the state last Saturday for a rally. Karen Travers, ABC NEWS Washington, Biden, also announcing former Obama, national security advisor and former ambassador Susan Rice, named director of the White House Domestic Policy Council. You're listening to ABC News. There's a great thing to considered our top story. Washington State is enforcing health regulations.

President Trump Joe Biden ABC News president Senate Vice President Mike Pence Georgia Michelle Franzen Dr Diana Zuckerman ABC FDA Aaron Carter National Center for Health Res Washington Karen Travers Susan Rice New YORK Latest White House Domestic Policy Co Augusta
"diana zuckerman" Discussed on KOMO

KOMO

01:56 min | 8 months ago

"diana zuckerman" Discussed on KOMO

"ABC News. I'm Michelle Franzen, an FDA panel reviewing fighters covert 19 vaccine data on safety and effectiveness at a public mayor meeting ahead of a vote. The vaccine is said to be highly effective, regardless of demographics. But during the public comments session, a doctor who is not on the panel pointed out gaps in the clinical trial. There's a lack of diversity. Dr Diana Zuckerman of the National Center for Health Research, said black patients were underrepresented. So where patients over 75 How can we ensure Informed consent and nursing home patients when we have no data to provide pregnant women were excluded, and it's unclear how well the vaccine works in people with HIV, so Fizer study will have to keep going for many months, even after the vaccine is authorized. Aaron Carter SKI ABC NEWS New YORK Latest on vaccines will be the focus of prime time specials from ABC News this coming Monday on radio and TV. President Trump continues to back legal challenges to the election. He's hosting a meeting today, with a group of state Republicans joining in a Texas lawsuit seeking to overturn Joe Biden certified wins and four states, one of them in Georgia, where key Senate runoff races are also taking place in less than a month. Vice President Mike Pence is getting out the vote there today next week. President elect Joe Biden heads their president elect Joe Biden will travel to Georgia next Tuesday to campaign for the Democratic Senate candidates in the January 5th run off elections. Bite him will hit the trail in Atlanta on behalf of John Aasif in Reverend Raphael Warnock. The balance of power in the Senate is at stake in these elections. Aasif and War knocker challenging incumbent senators David Perdue and Kelly Leffler, vice president. Pence is in Augusta, Georgia, today to campaign for the Republican Senators. President Trump was in the state last Saturday for a rally. Karen Travers, ABC NEWS Washington, Biden, also announcing former Obama, national security advisor and former ambassador Susan Rice, named director of the White House Domestic Policy Council. You're listening to ABC News. Stay.

Joe Biden ABC News President Trump Senate Vice President Mike Pence president Georgia ABC Michelle Franzen Dr Diana Zuckerman FDA Aaron Carter Karen Travers Susan Rice White House Domestic Policy Co National Center for Health Res Obama David Perdue New YORK Latest
"diana zuckerman" Discussed on KGO 810

KGO 810

02:12 min | 8 months ago

"diana zuckerman" Discussed on KGO 810

"Opera for a red wine, actually. Tracking right with you on that. All right. We continue KGO a tip. If you're talking about it, we're talking about KGO San Francisco San Jose, Oakland, a cumulus stations. From ABC News. I'm Michelle Franzen, an FDA panel reviewing fighters covert 19 vaccine data on safety and effectiveness at a public mayor meeting ahead of a vote. The vaccine is said to be highly effective, regardless of demographics. But during the public comments session, a doctor who is not on the panel pointed out gaps in the clinical trial. Lack of diversity. Dr. Diana Zuckerman of the National Center for Health Research said black patients were underrepresented. So where patients over 75 Were informed consent to nursing home patients. When we have no data to provide pregnant women were excluded, and it's unclear how well the vaccine works in people with HIV, so Fizer study will have to keep going for many months, even after the vaccine is authorized. Aaron Carter SKI ABC NEWS New YORK Latest on vaccines will be the focus of prime time specials from ABC News is coming Monday on radio and TV President Trump continues to back legal challenges to the election. He's hosting a meeting today, with a group of state Republicans joining in a Texas lawsuit. Seeking to overturn Joe Biden certified wins and four states, one of them in Georgia, where key Senate runoff races are also taking place in less than a month. Vice President Mike Pence is getting out the vote there today next week. President elect Joe Biden heads their president elect Joe Biden will travel to Georgia next Tuesday to campaign for the Democratic Senate candidates in the January 5th run off elections. Item will hit the trail in Atlanta on behalf of John Aasif in Reverend Raphael Warnock. The balance of power in the Senate is at stake in these elections. Aasif and War knocker challenging incumbent senators David Perdue and Kelly Leffler, vice president. Pence is in Augusta, Georgia today to campaign for the Republican Senators. President Trump was in the state last Saturday for a rally. Karen Travers, ABC NEWS Washington, Biden, also announcing former Obama, national security advisor and former ambassador Susan Rice, named director of the White House Domestic Policy Council. You're listening to ABC News. Hiring can be challenging, but zip.

Joe Biden ABC News President Trump Senate Vice President president Mike Pence Georgia ABC Michelle Franzen Dr. Diana Zuckerman San Francisco San Jose Aaron Carter FDA Karen Travers Susan Rice White House Domestic Policy Co Obama National Center for Health Res David Perdue
"diana zuckerman" Discussed on News Radio WGOW

News Radio WGOW

01:55 min | 8 months ago

"diana zuckerman" Discussed on News Radio WGOW

"I'm Michelle Franzen, an FDA panel reviewing fighters covert 19 vaccine data on safety and effectiveness at a public mayor meeting ahead of a vote. The vaccine is said to be highly effective regardless of demographics. But during the public comments session, a doctor who is not on the panel pointed out Gaps in the clinical trial. There's a lack of diversity. Dr. Diana Zuckerman of the National Center for Health Research said black patients were underrepresented. So where patients over 75 How can we ensure informed consent to nursing home patients? When we have no data to provide pregnant women were excluded, and it's unclear how well the vaccine works in people with HIV, so Fizer study will have to keep going for many months, even after the vaccine is authorized. Aaron Carter. SKI ABC NEWS New YORK Latest on vaccines will be the focus of prime time specials from ABC News is coming Monday on radio and TV President Trump continues to back legal challenges to the election. He's hosting a meeting today, with a group of state Republicans joining in a Texas lawsuit. Seeking to overturn Joe Biden certified wins and four states, one of them in Georgia, where key Senate runoff races are also taking place in less than a month. Vice President Mike Pence is getting out the vote there today next week. President elect Joe Biden heads their president elect Joe Biden will travel to Georgia next Tuesday to campaign for the Democratic Senate candidates in the January 5th run off elections. Fighting will hit the trail in Atlanta on behalf of John Aasif in Reverend Raphael Warnock. The balance of power in the Senate is at stake in these elections. Aasif and War knocker challenging incumbent senators David Perdue and Kelly Leffler, vice president. Pence is in Augusta, Georgia, today to campaign for the Republican Senators. President Trump was in the state last Saturday for a rally. Karen Travers, ABC NEWS Washington, Biden, also announcing former Obama, national security advisor and former ambassador Susan Rice, named director of the White House Domestic Policy Council. You're listening to ABC News. Celebrate home.

Joe Biden President Trump ABC News Vice President Senate president Mike Pence Georgia Michelle Franzen ABC Dr. Diana Zuckerman FDA Aaron Carter Karen Travers Susan Rice White House Domestic Policy Co National Center for Health Res Obama David Perdue New YORK Latest
"diana zuckerman" Discussed on NewsRadio KFBK

NewsRadio KFBK

01:40 min | 8 months ago

"diana zuckerman" Discussed on NewsRadio KFBK

"The vaccine is said to be highly effective regardless of demographics. But during the public comments session, a doctor who is not on the panel pointed out gaps in the clinical trial. There's a lack of diversity. Dr Diana Zuckerman of the National Center for Health Research said black patients were underrepresented. So where patients over 75 How can we ensure informed consent to nursing home patients when we have no data? To provide pregnant women were excluded, and it's unclear how well the vaccine works in people with HIV, so Fizer study will have to keep going for many months, even after the vaccine is authorized. Aaron Carter SKI ABC NEWS New YORK Latest on vaccines will be the focus of prime time specials from ABC News this coming Monday on radio and TV President Trump continues to back legal challenges to the election. He's hosting a meeting today, with a group of state Republicans joining in a Texas lawsuit. Seeking to overturn Joe Biden certified wins and four states, one of them in Georgia, where key Senate runoff races are also taking place in less than a month. Vice President Mike Pence is getting out the vote there today next week. President elect Joe Biden heads their president elect Joe Biden will travel to Georgia next Tuesday to campaign for the Democratic Senate candidates in the January 5th run off elections. Bite him will hit the trail in Atlanta on behalf of John Aasif and Reverend Raphael Warnock. The balance of power in the Senate is at stake in these elections. Aasif and War knocker challenging incumbent senators David Perdue and Kelly Leffler, vice president. Pence is in Augusta, Georgia. Today to campaign for the Republican Senators. President Trump was in the state last Saturday for a rally. Karen Travers, ABC NEWS Washington, Biden, also announcing former Obama, national security advisor and former ambassador Susan Rice, named director of the White House too messed. Policy Council..

Joe Biden President Trump president Vice President Senate Georgia Mike Pence Dr Diana Zuckerman ABC News ABC Aaron Carter Karen Travers Susan Rice National Center for Health Res White House Obama Policy Council David Perdue New YORK Latest
"diana zuckerman" Discussed on KQED Radio

KQED Radio

04:18 min | 10 months ago

"diana zuckerman" Discussed on KQED Radio

"I'm Dave Frieman. Good morning. It's 8 35. It's morning edition from NPR News. I'm Steve Inskeep, and I'm no well, King. Good morning. There are several covert 19 vaccines in development. But before they are approved, they have to be safe. It's the FDA is job to ensure that today an FDA advisory panel is meeting for the first time about the Corona virus vaccine, It'll be making recommendations based not on politically motivated timetables, but on data Sidney Lumpkin covers the pharmaceutical industry for NPR. Good Morning City. Good morning. So what is the deal with this FDA panel? Who's on it? What are they going to be doing well, the regularly turns to committees of outside advisers for guidance. Most often these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today's meeting of the committee that looks at vaccines is going to be a little different. Like everything else in this pandemic. It's a bit unusual. The big difference is that the committee isn't going to be sifting through data for a specific Corona virus vaccine like it normally would The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children's Hospital of Philadelphia. How robust Safety day to be how long For example, after the first notice for Secondo, should patients be followed participants be followed for for any possible safety issue they'll be discussing FDA is existing guidance to companies, which include some of that information, will also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA. Usually he's the advice of these committees, but it doesn't have to. So since there is no vaccine to review, I would think that in ordinary times we would not know about this meeting. It would not be news at all. It's very clear that the FDA wants to make public that this is happening. Why do they want to do that? Well, I mean, it gives the American public a window into the process. There's been so much discussion around whether the FDA will put politics ahead of science, so it's important to see what's going on. And the FDA has questions that it wants. Answers to Here's Dr Miles brought Ah, former FDA epidemiologist There is a level of humility than is coming to his advisers were and I think that's a good thing and they find out they missed some important things. So I'm addressed Those Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in Diana Zuckerman is the president of the National Center for Health Research and Advocacy Group slated to speak. We've seen the guidance of what they're telling cos they're supposed to be studying. Frankly, they're not very stringent. So we are concerned about Hm. She hopes the meeting will delve into making sure the clinical trials are diverse. For example, she also questions whether the study approached. The FDA suggested to manufacturers is long enough to assess vaccine safety. So then how does this meeting set up for next steps in the process of reviewing a vaccine? This is the first of several advisory committee meeting's expected through the fall and winter, the same committee will meet again to evaluate individual vaccines. Instead of full approval. However, vaccine makers will be seeking a truncated version called Emergency Use Authorization. Here's Dr Off it again. The rules here are a little looser in terms of what you would demand in terms of safety or demand in terms of effectiveness of the vaccine. Remember, these vaccines will be given to millions and millions of otherwise healthy people, so making sure they're safe is really important. And so when do we find out more about the leading vaccines? Pfizer in Moderna, the front runners are expected to have their data ready as soon as November. So once they submitted to the FDA, the public meetings could happen really quickly. Sidney Lumpkin, NPR's pharmaceuticals correspondent. Thanks, City. Thank you. In this fall's election, Republicans were trying to fend off further losses in the House. Ben Pay via reports on a Virginia district that could flip little town of Fork.

FDA Sidney Lumpkin NPR News Diana Zuckerman NPR Steve Inskeep Morning City Dave Frieman Secondo Dr. Paul Offit National Center for Health Res Moderna Children's Hospital of Philade Dr Miles Biomedical Advanced Research a Virginia Centers for Disease Control an Ben Pay president
"diana zuckerman" Discussed on KCRW

KCRW

08:40 min | 10 months ago

"diana zuckerman" Discussed on KCRW

"NPR news. I'm Laxmi, saying President Trump's nominee, Judge Amy Cockney, Barrett, is one historic step closer to joining the U. S. Supreme Court in another tumultuous Senate confirmation process overshadowed by a fast approaching general election. In which trumps future in the White House is far from certain. Today. Senate Judiciary Chairman Lindsey Graham, a Trump loyalists help advance barrettes nomination to the full Senate. On the motion to report the nomination of Amy Cockney Barrett. To be an associate justice of the Supreme Court of the United States. The clerk will call the roll. The Democrats boycotted. Here's NPR's cozy snow. This is controversial among Democrats, and they say that they don't support this process. They say the winner of the presidential election should choose the next Supreme Court justice on DH. They do say that they will participate on the Senate floor, which is expected to happen on Monday, but they did not want to participate. And what they say was an invalid process. Kelsey Snell reporting a Minnesota court is dropping a third degree murder charge against a former Minneapolis police officer accused of killing George Floyd. But Derek shot and still faces second degree murder and manslaughter charges. On Memorial Day, The white officer was videotaped heading down Floyd impressing his knee into the back of the black victim's neck. Is Floyd gas that he could not breathe? Three other officers were on the scene like shop and they were fired. Now they're facing aiding and abetting charges. This is NPR. From K C. R W I'm Cherry Glaser With this local news update and alarming trend in Orange County. This case here W's Kaylie Wells, reports hate crimes in O. C have spiked to their highest level in five years. A report released this week by the Orange County Human Relations Commission says hate crimes in the region jumped 24% from 2018 to 2019. Last year, 83 hate crimes were reported to various agencies and organizations. California law defines a hate crime as a criminal act motivated by gender, disability, nationality, race, religion or sexual orientation. Those final three. We're the leading cause of hate crimes in Orange County. While less than 2% of the county's population is black, they were the most targeted race reporting 16 incidents or about 20% of all the counties hate crimes. In cases where religion was the motivating factor. Jews were the focus nearly half the time and I gave biases drove the vast majority of crimes based on sexual orientation. The commission found vandalism, assault or theft to be the most common forms of hate crime. Many of the reported transgressions weren't done behind closed doors. 37% happened in public places and out of 30 cases brought to the O. C District attorney's office in 2019. 18 led to charges being filed for K C R w I'm Kaylee Wells. Santa Barbara County is adding some teeth to its Coben 19 health orders. The Board of Supervisors approved in ordnance this week that allows for enforcement of pandemic rules in unincorporated parts of the county, and that includes penalties for violations is case here, W's Matt Dillon explains. The director of the county's Office of Emergency Management, Kelly Hubbard says the enforcement measures are meant to prevent a possible uptick in the virus as cooler weather settles in Santa Barbara strategy will continue to be based on education. But flagrant and repeat offenders could face a range of civil, administrative and even criminal penalties. Businesses out of compliance could face season desist letters or fines. Another option, suspending or revoking licenses for certain establishments like tattoo parlors or bars if they're found to be out of compliance with health orders. Some violators could even face misdemeanor charges that would carry a fine of up to $1000 or 90 days in jail. A similar proposal came before the supervisors in August, but with covert case is on the decline, then they rejected the ordinance. What was called a crackdown in August is now being hailed as a nuanced tool that will add to enforcement efforts for Casey or W. I'm Matt Dillon. Support for NPR comes from the U. S. Department of Health and Human Services. Medicare Open enrollment is now through December. 7th 2021 plans and information at Medicare dot gov or 1, 800 Medicare and from progressive insurance with the name your Price tool, offering a range of coverage and price options to choose from Now that's progressive. More progressive dot com or at 1 800. PROGRESSIVE. It's 8 34 on K C R w It's Morning edition from NPR News. I'm Steve Inskeep, and I'm No well, King. Good morning. There are several covert 19 vaccines in development, but before they are approved, they have to be safe. It's the FDA is job to ensure that today an FDA advisory panel is meeting for the first time about the Rotavirus vaccine. It'll be making recommendations based not on politically motivated timetables. But on data Sidney Lumpkin covers the pharmaceutical industry for NPR. Good Morning City. Good morning. So what is the deal with this FDA panel? Who's on it? What are they going to be doing? Well, the FDA regularly turns to committees of outside advisers for guidance. Most often these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today's meeting of the committee that looks at vaccines is going to be a little different. How like everything else In this pandemic? It's a bit unusual. The big difference is that the committee isn't going to be sifting through data for a specific Corona virus vaccine like it normally would The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children's Hospital of Philadelphia. How robust safety day to be. How long for example, after the first dose her second, though, should patients be followed participants be followed for for any possible safety issue will be discussing FDA is existing guidance to companies which include some of that information. They also discussed how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA. Usually he's the advice of these committees, but it doesn't have to. So since there is no vaccine to review I would think that in ordinary times we would not know about this meeting. It would not be news at all. It's very clear that the FDA wants to make public that this is happening. Why do they want to do that? Well, I mean, it gives the American public a window into the process. There's been so much discussion around whether the FDA will put politics ahead of science, so it's important to see what's going on. And the FDA has questions that it wants. Answers to Here's Dr Miles brought Ah, former FDA epidemiologist There is a level of humility that is coming to his advisers were and I think that's a good thing. And if they find out they missed some important things. So I'm addressed Those Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in Diana Zuckerman is the president of the National Center for Health Research and Advocacy Group slated to speak. We've seen the guidance of what they're telling cos they're supposed to be studying. Frankly, they're not very stringent. So we are concerned about Hm. She hopes the meeting will delve into making sure the clinical trials are diverse. For example, she also questions whether the study approached. The FDA suggested to manufacturers is long enough to assess vaccine safety. So then how does this meeting set up for next steps in the process of reviewing a vaccine. This is the first of several advisory committee meeting's expected through the fall and winter, the same committee will meet again to evaluate individual vaccines. Instead of full approval. However, vaccine makers will be seeking a truncated version called Emergency Use Authorization. Here's Dr Offit again. The rules here are a little looser in terms of what you would demand in terms of safety or demand in terms of effectiveness of actually remember, these vaccines will be given to millions and millions of otherwise healthy people, so making sure they're safe is really important. And so when do we find out more about the leading vaccines? Pfizer in Moderna. The front runners are expected to have their data ready as soon as November. So once they submitted to the FDA, the public meetings could happen really quickly. Sidney Lumpkin, NPR's pharmaceuticals correspondent. Thanks, city. Thank you. In this fall's election..

FDA NPR NPR News U. S. Supreme Court Senate Sidney Lumpkin Dr. Paul Offit Orange County Amy Cockney Barrett Matt Dillon Santa Barbara County Senate Judiciary United States Orange County Human Relations White House Lindsey Graham George Floyd Steve Inskeep California
"diana zuckerman" Discussed on KQED Radio

KQED Radio

04:11 min | 10 months ago

"diana zuckerman" Discussed on KQED Radio

"It's morning edition from NPR News. I'm Steve Inskeep, and I'm no well, King. Good morning. There are several covert 19 vaccines in development. But before they are approved, they have to be safe. It's the FDA is job to ensure that today an FDA advisory panel is meeting for the first time about the Corona virus vaccine, It'll be making recommendations based not on politically motivated timetables, but on data Sidney Lumpkin covers the pharmaceutical industry for NPR. Good Morning City. Good morning. So what is the deal with this FDA panel? Who's on it? What are they going to be doing well, the regularly turns to committees of outside advisers for guidance. Most often these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today's meeting of the committee that looks at vaccines is going to be a little different. Like everything else In this pandemic. It's a bit unusual. The big difference is that the committee isn't going to be sifting through data for a specific Corona virus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children's Hospital of Philadelphia. How robust safety day to be. How long for example, after the first dose For second, though, should patients be Fowler participants be followed for for any possible safety issue they'll be discussing FDA is existing guidance to companies, which include some of that information, will also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA. Usually he's the advice of these committees, but it doesn't have to. So since there's no vaccine to review, I would think that in ordinary times we would not know about this meeting. It would not be news at all. It's very clear that the FDA wants to make public that this is happening. Why do they want to do that? Well, I mean, it gives the American public a window into the process. There's been so much discussion around whether the FDA will put politics ahead of science, so it's important to see what's going on. And the FDA has questions that it wants. Answers to Here's Dr Miles brought Ah, former FDA epidemiologist There is a level of humility that is coming to his advisers were and then I think that's a good thing and they find out they missed some important things. So I'm addressed Those Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in Diana Zuckerman is the president of the National Center for Health Research and Advocacy Group slated to speak. We've seen the guidance of what they're telling cos they're supposed to be studying. Frankly, they're not very stringent. So we are concerned about Hm. She hopes the meeting will delve into making sure the clinical trials are diverse. For example, she also questions whether the study approached. The FDA suggested to manufacturers is long enough to assess vaccine safety. So then how does this meeting set up for next steps in the process of reviewing a vaccine. This is the first of several advisory committee meeting's expected through the fall and winter, the same committee will meet again to evaluate individual vaccines. Instead of full approval. However, vaccine makers will be seeking a truncated version called Emergency Use Authorization. Here's Dr Offit again. The rules here are a little looser in terms of what you would demand in terms of safety or demand in terms of effectiveness of actually remember, these vaccines will be given to millions and millions of otherwise healthy people, so making sure they're safe is really important. And so when do we find out more about the leading vaccines? Pfizer in Moderna, the front runners are expected to have their data ready as soon as November. So once they submitted to the FDA, the public meetings could happen really quickly. Sidney Lumpkin, NPR's pharmaceuticals correspondent. Thanks, city. Thank you. In this fall's election, Republicans were trying to fend off further losses in the House. Ben Pay via reports on a Virginia district that.

FDA Dr. Paul Offit Sidney Lumpkin NPR NPR News Diana Zuckerman Steve Inskeep Morning City National Center for Health Res Moderna Children's Hospital of Philade Virginia Dr Miles Biomedical Advanced Research a Centers for Disease Control an Fowler Ben Pay president
"diana zuckerman" Discussed on WNYC 93.9 FM

WNYC 93.9 FM

04:26 min | 10 months ago

"diana zuckerman" Discussed on WNYC 93.9 FM

"I'm Steve Inskeep, and I'm no well, King. Good morning. There are several covert 19 vaccines in development. But before they are approved, they have to be safe. It's the FDA is job to ensure that today an FDA advisory panel is meeting for the first time about the Corona virus vaccine, It'll be making recommendations based not on politically motivated timetables, but on data Sidney Lumpkin covers the pharmaceutical industry for NPR. Good Morning City. Good morning. So what is it? What is the deal with this FDA panel? Who's on it? What are they going to be doing? Well, the FDA regularly turns to committees of outside advisers for guidance. Most often these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today's meeting of the committee that looks at vaccines is going to be a little different. How Like everything else In this pandemic. It's a bit unusual. The big difference is that the committee isn't going to be sifting through data for a specific Corona virus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children's Hospital of Philadelphia. How robust should the safety day to be how long For example, after the first dose, or Secondo should patients be followed? Participants be followed for For any possible safety issue they'll be discussing FDA is existing guidance to companies, which include some of that information, will also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo? Once a vaccine is widely available, of course, the FDA usually he's the advice of these committees, but it doesn't have to. So since there is no vaccine to review I would think that in ordinary times we would not know about this meeting. It would not be news at all. It's very clear that the FDA wants to make public that this is happening. Why do they want to do that? Well, I mean, it gives the American public a window into the process. There's been so much discussion around whether the FDA will put politics ahead of science, so it's important to see what's going on. And the FDA has questions that it wants. Answers to Here's Dr Miles brought Ah, former FDA epidemiologist There is a level of humility that is coming to his its advisers were and then I think that's a good thing. And if they find out they missed some important things. Oh, I'm addressed those Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in Diana Zuckerman is the president of the National Center for Health Research and Advocacy Group slated to speak. We've seen the guidance of what they're telling cos they're supposed to be studying. Frankly, they're not very stringent. So we are concerned about, Hm. She hopes the meeting will delve into making sure the clinical trials are diverse. For example, she also questions whether the study approached. The FDA suggested to manufacturers is long enough to assess vaccine safety. So then how does this meeting set up for next steps in the process of reviewing a vaccine? This is the first of several advisory committee meeting's expected through the fall and winter, The same committee will meet again to evaluate individual vaccines. Instead of full approval. However, vaccine makers will be seeking a truncated version called Emergency Use Authorization. Here's Dr Off it again. The rules here are a little looser in terms of what you would demand in terms of safety or demand in terms of effectiveness of the vaccine. Remember, these vaccines will be given to millions and millions of otherwise healthy people, so making sure they're safe is really important. And so when do we find out more about the leading vaccines? Pfizer in Moderna. The front runners are expected to have their data ready as soon as November. So once they submitted to the FDA, the public meetings could happen really quickly. Sidney Lumpkin, NPR's pharmaceuticals correspondent. Thanks city. Thank you in this fall's election. Republicans air trying to fend off further losses in the House, Ben pay via reports on a Virginia district that could flip The little town of Fork Union. Virginia, voted for President Trump by three points.

FDA Sidney Lumpkin NPR Diana Zuckerman Steve Inskeep Morning City Secondo president National Center for Health Res Virginia Centers for Disease Control an Biomedical Advanced Research a Dr. Paul Offit Dr Miles Children's Hospital of Philade Fork Union Moderna Trump Ben
"diana zuckerman" Discussed on The Healthcare Policy Podcast

The Healthcare Policy Podcast

05:54 min | 1 year ago

"diana zuckerman" Discussed on The Healthcare Policy Podcast

"Welcome to the healthcare policy podcast on the host David Intra. . Kosovo. . With me today Dr Rachel Dolan the US House of Representatives ways and Means Committee majority staffer to discuss the majority staffs recently released report titled Under enforced and over prescribed. . ANTIPSYCHOTIC drug epidemic ravaging America's nursing homes. . Dr Dole and welcome to the program. . I David thanks so much for having me. . Please call me Rachel. . While this'll be the last time Dr Dolan's bio is posted on, , of course, , the podcast website. . In testimony before the House Energy and Commerce Committee two, , thousand seven, , the FDA's Dr David Graham stated quote. . Unquote. . Fifteen thousand adults elderly people in nursing homes are dying each year from the off label use of antipsychotic medications. . For an indication that the FDA knows the drug doesn't work the problem has been only FDA for years and years close quote. . Legal the FDA does provide a black box warning label. . Regarding off label use of these drugs, , eleven years later, , Human Rights Watch published a report titled They Want Docile. . How. . Nursing homes in the US overmedicated people with dementia. . The report found in two thousand, sixteen, , , seventeen quote unquote massive use or abuse of Anti Psychotics, , for example, , Sarah. . Quel. . Doll and Rispler doll that have serious side effects including sudden cardiac death. . The human rights report estimated in an average week over one hundred, , seventy, , nine, , thousand, , long-stay Nursing Home Facility patients who administered antipsychotic drugs. . Without a diagnosis which the drugs are indicated or approved rover, , polar disorder and schizophrenia in testimony the ways and means. . Committee. Heard . this past November Richard Mollet Executive Director of the Long Term Care Community coalition concluded quote the use of San Anti psychotics in skilled nursing facilities is so extensive that puts the US in violation of internal conventions and covenants on torture and cruel inhumane and degrading treatment or punishment. . Close quote. . This is my third related interview. . In December twenty twelve I discussed the topic with Diana Zuckerman. . And in February, , eighteen high interviewed Hannah Lamb who authored the above mentioned human rights report. . With me again to discuss the ways and means report just released titled Under enforced and over prescribed is Rachel Dolan the reports lead author. . So that Rachel as background let's get right into this or immediate <hes> neatly into the specifics of the report. . What did the report find regarding <hes> the extent to which? ? They're persists overuse or misuse of anti psychotics in skilled nursing. . David. . So the report showed what what you what we would expect from your introduction, , which is the use of antipsychotic does persist in nursing homes across the country and it remains quite high and not of course, , has implications for patient safety and and health <hes>. . We found in the fourth quarter of Twenty nineteen approximately twenty percent of all skilled nursing facility residents in the US. . So that's about two, , hundred, , Ninety, , eight, , thousand, , six, , hundred, , fifty people every week received some form of antipsychotic medication <hes>, , and most of that was without any psychosis diagnosis for which these drugs are indicated <hes>. . So specifically, , we actually looked at trends and surveyor citations for unnecessary medication use in nursing home. . So that's kind of the. . Part of this study and what we found was a clear change in citation rates for these facilities between the change in administrations from the Obama Administration to trump administration <hes>. . So we found citations for antipsychotic misuse in sniffs increased by two hundred percent between twenty, , fifteen, , twenty seventeen but then declined by twenty two percent from two thousand, , seventeen to twenty eighteen, , and importantly a ten percent of citations associated with actual harm or immediate jeopardy to a residence health or safety. . So those are some of the most severe citation surveyors ever capture resulted in no fine from twenty seventeen to twenty eighteen under the trump administration. . So you know. . I. . Would say even though this study in particular couldn't determine causation <hes> we we did see a clear association between the Trump Administration's regulatory rollback campaign twenty, , seventeen, , twenty eighteen and a reduction in citations for these particular drugs. . Okay thank you and we'll get into the trump administration's <hes> regulatory decisions in this regard in a minute let me just ask as a follow up or an aside question and I don't think I saw this new report. . So you may not have these numbers top of mind but worth asking, , can you give an approximation of the cost? ? To the Medicare program at least relative to the overuse I, , mean, , this is a massive amount of money in reimbursement for these medications. . I don't remember offhand. . Let's see I think in the in the actually in the report we got <hes>. . About one third of older adult Medicare part d enrolling with dementia who spent more than one hundred days in a nursing humber prescribed antipsychotic in two, , thousand, , twelve constituting roughly three, , hundred, , sixty, three, , , million part D plan payments that year <hes>, , and of course, , there's also cost associated with hospitalizations for inappropriate use of these drugs <hes>. . So I would expect you know that that that is obviously very under an understatement <hes> understated estimate that does not capture the full realm of payments. . So it's it's fairly substantial. .

FDA Dr David Graham Rachel Dolan Dr Dole US Human Rights Watch Nursing Home Facility House Energy and Commerce Comm Diana Zuckerman Hannah Lamb Rispler Richard Mollet Sarah Executive Director Long Term Care Community
Dr. Rachel Dolan Discusses The Antipsychotic Drug Epidemic

The Healthcare Policy Podcast

05:54 min | 1 year ago

Dr. Rachel Dolan Discusses The Antipsychotic Drug Epidemic

"Welcome to the healthcare policy podcast on the host David Intra. Kosovo. With me today Dr Rachel Dolan the US House of Representatives ways and Means Committee majority staffer to discuss the majority staffs recently released report titled Under enforced and over prescribed. ANTIPSYCHOTIC drug epidemic ravaging America's nursing homes. Dr Dole and welcome to the program. I David thanks so much for having me. Please call me Rachel. While this'll be the last time Dr Dolan's bio is posted on, of course, the podcast website. In testimony before the House Energy and Commerce Committee two, thousand seven, the FDA's Dr David Graham stated quote. Unquote. Fifteen thousand adults elderly people in nursing homes are dying each year from the off label use of antipsychotic medications. For an indication that the FDA knows the drug doesn't work the problem has been only FDA for years and years close quote. Legal the FDA does provide a black box warning label. Regarding off label use of these drugs, eleven years later, Human Rights Watch published a report titled They Want Docile. How. Nursing homes in the US overmedicated people with dementia. The report found in two thousand, sixteen, seventeen quote unquote massive use or abuse of Anti Psychotics, for example, Sarah. Quel. Doll and Rispler doll that have serious side effects including sudden cardiac death. The human rights report estimated in an average week over one hundred, seventy, nine, thousand, long-stay Nursing Home Facility patients who administered antipsychotic drugs. Without a diagnosis which the drugs are indicated or approved rover, polar disorder and schizophrenia in testimony the ways and means. Committee. Heard this past November Richard Mollet Executive Director of the Long Term Care Community coalition concluded quote the use of San Anti psychotics in skilled nursing facilities is so extensive that puts the US in violation of internal conventions and covenants on torture and cruel inhumane and degrading treatment or punishment. Close quote. This is my third related interview. In December twenty twelve I discussed the topic with Diana Zuckerman. And in February, eighteen high interviewed Hannah Lamb who authored the above mentioned human rights report. With me again to discuss the ways and means report just released titled Under enforced and over prescribed is Rachel Dolan the reports lead author. So that Rachel as background let's get right into this or immediate neatly into the specifics of the report. What did the report find regarding the extent to which? They're persists overuse or misuse of anti psychotics in skilled nursing. David. So the report showed what what you what we would expect from your introduction, which is the use of antipsychotic does persist in nursing homes across the country and it remains quite high and not of course, has implications for patient safety and and health We found in the fourth quarter of Twenty nineteen approximately twenty percent of all skilled nursing facility residents in the US. So that's about two, hundred, Ninety, eight, thousand, six, hundred, fifty people every week received some form of antipsychotic medication and most of that was without any psychosis diagnosis for which these drugs are indicated So specifically, we actually looked at trends and surveyor citations for unnecessary medication use in nursing home. So that's kind of the. Part of this study and what we found was a clear change in citation rates for these facilities between the change in administrations from the Obama Administration to trump administration So we found citations for antipsychotic misuse in sniffs increased by two hundred percent between twenty, fifteen, twenty seventeen but then declined by twenty two percent from two thousand, seventeen to twenty eighteen, and importantly a ten percent of citations associated with actual harm or immediate jeopardy to a residence health or safety. So those are some of the most severe citation surveyors ever capture resulted in no fine from twenty seventeen to twenty eighteen under the trump administration. So you know. I. Would say even though this study in particular couldn't determine causation we we did see a clear association between the Trump Administration's regulatory rollback campaign twenty, seventeen, twenty eighteen and a reduction in citations for these particular drugs. Okay thank you and we'll get into the trump administration's regulatory decisions in this regard in a minute let me just ask as a follow up or an aside question and I don't think I saw this new report. So you may not have these numbers top of mind but worth asking, can you give an approximation of the cost? To the Medicare program at least relative to the overuse I, mean, this is a massive amount of money in reimbursement for these medications. I don't remember offhand. Let's see I think in the in the actually in the report we got About one third of older adult Medicare part d enrolling with dementia who spent more than one hundred days in a nursing humber prescribed antipsychotic in two, thousand, twelve constituting roughly three, hundred, sixty, three, million part D plan payments that year and of course, there's also cost associated with hospitalizations for inappropriate use of these drugs So I would expect you know that that that is obviously very under an understatement understated estimate that does not capture the full realm of payments. So it's it's fairly substantial.

Dr Rachel Dolan FDA David Intra United States Antipsychotic Trump Administration Nursing Home Facility Dr Dole Us House Of Representatives Dr David Graham Human Rights Watch Kosovo House Energy And Commerce Comm Means Committee Diana Zuckerman America Obama Administration Psychosis Rispler
"diana zuckerman" Discussed on The Healthcare Policy Podcast

The Healthcare Policy Podcast

02:52 min | 1 year ago

"diana zuckerman" Discussed on The Healthcare Policy Podcast

"Dr Dole and welcome to the program. I David thanks so much for having me. Please call me Rachel. While this'll be the last time Dr Dolan's bio is posted on, of course, the podcast website. In testimony before the House Energy and Commerce Committee two, thousand seven, the FDA's Dr David Graham stated quote. Unquote. Fifteen thousand adults elderly people in nursing homes are dying each year from the off label use of antipsychotic medications. For an indication that the FDA knows the drug doesn't work the problem has been only FDA for years and years close quote. Legal the FDA does provide a black box warning label. Regarding off label use of these drugs, eleven years later, Human Rights Watch published a report titled They Want Docile. How. Nursing homes in the US overmedicated people with dementia. The report found in two thousand, sixteen, seventeen quote unquote massive use or abuse of Anti Psychotics, for example, Sarah. Quel. Doll and Rispler doll that have serious side effects including sudden cardiac death. The human rights report estimated in an average week over one hundred, seventy, nine, thousand, long-stay Nursing Home Facility patients who administered antipsychotic drugs. Without a diagnosis which the drugs are indicated or approved rover, polar disorder and schizophrenia in testimony the ways and means. Committee. Heard this past November Richard Mollet Executive Director of the Long Term Care Community coalition concluded quote the use of San Anti psychotics in skilled nursing facilities is so extensive that puts the US in violation of internal conventions and covenants on torture and cruel inhumane and degrading treatment or punishment. Close quote. This is my third related interview. In December twenty twelve I discussed the topic with Diana Zuckerman. And in February, eighteen high interviewed Hannah Lamb who authored the above mentioned human rights report. With me again to discuss the ways and means report just released titled Under enforced and over prescribed is Rachel Dolan the reports lead author. So that Rachel as background let's get right into this or immediate neatly into the specifics of the report. What did the report find regarding the extent to which? They're persists overuse or misuse of anti psychotics in skilled nursing. David. So the report showed what what you what we would expect from your introduction, which is the use of antipsychotic does persist in nursing homes across the country and it remains quite high and not of course, has implications for patient safety and and health We found in the fourth quarter of Twenty nineteen approximately twenty percent.

FDA Dr David Graham Rachel Dolan Dr Dole US Human Rights Watch Nursing Home Facility House Energy and Commerce Comm Diana Zuckerman Hannah Lamb Rispler Richard Mollet Sarah Executive Director Long Term Care Community
"diana zuckerman" Discussed on Bodies

Bodies

07:37 min | 1 year ago

"diana zuckerman" Discussed on Bodies

"And then one day in two thousand thirteen seven years after. She got the mashed in her body. Melinda got a call from a friend she said. Hey Melinda have you seen any of those commercials on TV about the Mesh Litigation? No she said Melinda hadn't seen the commercials but I went online and I found that there were thousands and thousands and thousands and thousands of women around the globe that had experienced this exact same thing that I was going through. A river of anger and rage in me was unleashed. I couldn't deal with this anger by making myself busy by achieving things by building scale replicas of the homes or living out of a gingerbread you know that I took that anger and focused it on the research because by this point you know I had a PhD. I know how to research shit. Melinda discovered that the Johnson Johnson Gyn Care Mesh have been brought to market without ever being tested on humans and it wasn't just mesh the majority of the tens of thousands of implanted devices that are on the market today like hip implants breast implants and dental implants were never safety tested in clinical trials on humans. That does seem crazy. You know you need a little history here. The FDA's mandate was to look at the safety of Food and drugs. That's Diana Zuckerman. She's the president of the National Center for Health Research. It wasn't until the nineteen seventies after an IUD device injured thousands of women that Congress finally started drafting a law that would require the FDA to regulate medical devices in the same way that it regulated drugs to make sure they were safe by running human trials but by then there were already thousands of medical devices on the market and the medical device industry was pretty good at lobbying and the companies that made them were like. What are we supposed to do? Take all these devices off the market and test them at this time. Doctors were already using Mesh for surgery. Hernia repair and so in nineteen seventy six in Congress passed the law requiring clinical trials medical devices. They first grandfathered in any device currently on the market and they added a section to the law. That said that you can put a new device on the market without testing on humans. As long as it's similar enough to something else that already exists overtime partially under pressure from device companies the FDA kept loosening. Its definition of similar enough over the years. More and more devices were allowed to be sold. That weren't even that similar. They would be a product made out of a different kind of material used in different parts of the body perhaps a different shape a different size and yet they were still being allowed on the market the first transactional. Mesh was created in nineteen ninety six and since it was similar enough to Mesh used for other parts of the body the FDA cleared it but it was recalled only a few years later because of thousands of injuries the most common complication was erosion. This is when the Mesh pushes through tissue or into organs and yet device manufacturers like Boston scientific and Johnson and Johnson kept putting new trans vaginal meshes onto the market and the FDA kept clearing them because they were similar enough to this. First Trans Vaginal Mesh. It didn't matter that had been recalled in two thousand five Johnson and Johnson's started selling new version of trans-national Mesh. Gyn Care Pro. Left for Pelvic Organ prolapse the Mesh that the doctor implanted into Melinda and again the FDA cleared it without requiring human trials from Johnson and Johnson. It was similar enough. Melinda was reading about thousands of women who've been injured or even killed by Gyn Care Mesh. So why wasn't the FDA doing anything about it? The FDA keeps track of device injuries and deaths in a database which is accessible to the public. If you're a patient or a doctor and there's any injury from a device you can submit it directly into the database yourself and if you're a manufacturer and you receive a complaint from a doctor patient you are required to submit a report the FDA but there's a major flaws in this database for starters. It's clunky and nearly impossible to search even the FDA doesn't know everything that's in there which is why someone they majors. Tomes built her own system. Which pulls data from the FDA website and makes it user friendly and truly searchable? So let's say your doctor and you're trying to figure out how common erosion is with Pelvic Prolapse Mesh if you go onto the FDA website you'll only find about two thousand cases of erosion but if you use major system with the more advanced search capabilities you see the true number which is about seventeen thousand cases of erosion which is a big difference but even major says numbers are not the full picture. There's another flaw in the database. Just last year in two thousand nineteen journalists reported that there was another database that was hidden from public. What was happening was that manufacturers were allowed to submit reports that bypassed the public database. Here's address so even concerned. Physicians weren't getting the data. They needed to make choices for their patients so it wasn't just about patients not knowing it was about physicians in the medical community knowing about the true number of risks with the devices in the months that followed under pressure the FDA released five million previously hidden reports to the public. For the first time may dress ran the numbers suddenly the reports for some of the riskiest implanted devices doubled or tripled like for example when she looked at breast implants. Reports of complications rose to nearly half a million about five times. The amount that was available before the FDA released the data majors thought that she and the public finally had all the injury reports but then a few months later she got a call from a patient harmed by Mesh instead. Oh how many ever came out in that big data dump and I looked it up and went. Oh my gosh. They'd never released those. The FDA did not release the data from rush as of this recording the FDA still hasn't released them when we reached out to the FDA spokesperson told us an email that the FDA never received these reports in question the alternative summary reports about Mesh for manufacturers however based on our reporting. We found evidence that they did. I can see manufacturer summary reports for Gyn Care Mesh and I can see that. The data from these reports has been redacted this information that we need in order to have the full picture on mash. It's same.

FDA Johnson Johnson Gyn Care Mesh Gyn Care Mesh Melinda Johnson Congress Diana Zuckerman Boston scientific president National Center for Health Res Tomes
"diana zuckerman" Discussed on People's Pharmacy

People's Pharmacy

05:53 min | 3 years ago

"diana zuckerman" Discussed on People's Pharmacy

"You know, they aren't doing all that much better in some ways. In some ways they do, like I said, the mandatory registries are certainly better, and I think there's less of a drive to over treat and implant devices unnecessarily because that's a big problem in this country is not necessarily that devices are bad and don't work, but that some of them that do work in certain very specific circumstances are put in way too many people. So that drive is reduced in countries where we take away the dramatic profit motive that we have in this country where some doctors receiving literally tens of millions of dollars to implant and promote the plantation of some of these devices. So in that sense, they're better off in the sense that they're CE Mark, which is the equivalent of our FDA's clearance in approval process. When. May get a c e Mark on their devices. It's already been shown to be as ridiculous czars. Some researchers in Europe did a very smart thing. They cut out a piece of the aren't Nash that you, you know, literally aren't colored mesh that you used to carry arches. We've all seen that bags of oranges. They cut out a piece of that mesh and they submitted it for a CE Mark as surgical mash, and it one see Mark. So on of the Marcus, what like a stamp of approval? Yep, yes. It's the equivalent of DA's clearance or approval of device. So obviously there wasn't any evaluation done on this. No, but the same thing's true in this country. You know there was a case with interviews, which is a combination device that uses both a biological drug and a metal device or plastic device. And what they do is they put this what they call our ex-pm p to. And that. That's a stimulator in that bone stimulator is put into little sponges that are stuck into a little tube. And that tube goes into the spine of patients that have a destroyed spine, either from trauma or a compressed Iska ruptured discs. And what they did was the manufacturer submitted a new little device, a little tube that was sized only for the neck, but had been previously approved only for the lumbar spine of lumbar spine is the lower spine. Those big huge bones. The spines in the neck are very tiny, and this was a trick that's very much like the surgical mesh trick would they did is they told the FDA that this too was based on a predicate device from the lumbar spine. But it was clearly size. It couldn't be used in lumbar spine. It was really intended for the next which is where surgeon started implanting. It will the problem with putting it in the neck is that the bone stimulator over stimulates bony growth, then impinged on patient's Airways and spine and actually caused deadly responses in a number of patients. And in fact, one surgeon went ahead and did a study because she was so alarmed by the number of patients who they had to intubate to put on on life support after having the surgery in the neck. And they found that there were quite a large number of excess deaths when this was implanted in the neck. So yeah, the same thing goes on here and that's why I think we need much better oversight, much better regulation. And unfortunately, money has been winning the day industry has really spread. It's love very liberally on doctors on journal. Editors on patient groups, giving their money to everyone in sight, and everybody seems to have their handout and the people who are losing our patients. Jeannie Lancer. Thank you so much for talking with us on the people's pharmacy today. Thank you so much. You've been listening to genie Linzer an award-winning medical investigative journalist and former nightside's journalism fellow. She spoke with us on Skype. She's a former physician assistant and a long term contributor to the b. m. j. her new book is the danger within us America's untested unregulated medical device industry and one man's battle to survive it. After the break, we'll talk more about medical devices will be speaking with Dr. Diana Zuckerman president at the National Center for health research. Her expertise is in epidemiology and public health doctors. Zakar men will help us understand how the food and Drug administration regulates devices and how that differs from the way the agency regulates medications can. Inductors learn about safety and affected nece data for the devices they are recommending or implanting doctors Kerman will give us advice on how we can become better informed. So as to protect ourselves better. You're

food and Drug administration FDA Kerman b. m. Europe Dr. Diana Zuckerman Mark Nash Marcus Jeannie Lancer nightside president National Center for health res America
"diana zuckerman" Discussed on WNYC 93.9 FM

WNYC 93.9 FM

01:32 min | 3 years ago

"diana zuckerman" Discussed on WNYC 93.9 FM

"But they are still making determinations of how safe they think a product is and whether they think the benefits outweigh the risks and what right to try legislation would do is get rid of even that layer of protection well what's likely to happen here with new placid will it be pulled back entirely carry new warnings that patients who are desperate may still try it but they should be aware of the risk of severe injury or death where's this going it's hard to know what's going to happen next my understanding is that this drug does come with what's called the black box warning that's the strongest warning that the fda does provide similar to the black box around cigarettes where they warn you not to smoke but the black box warning for niclas said actually is apparently identical to the warning for many other drugs it's not really specific to this one drug so at the very least it needs to have a warning that makes it much clearer that parkinson's patients who take this drug could die could die suddenly could die sooner but i think from a practical point of view once it becomes known that an expensive drug is not working very well that there is no good evidence that it's helpful and that it can be deadly gets harder and harder to sell it and they're get to be a lot more lawsuits dr diana zuckerman is president of the national center for health research doctors.

fda niclas parkinson president dr diana zuckerman
"diana zuckerman" Discussed on KQED Radio

KQED Radio

02:35 min | 3 years ago

"diana zuckerman" Discussed on KQED Radio

"Support for k q e d comes from comcast time is valuable which is why comcast is working to improve its customer service with two hour appointment windows including nights and weekends learn more at comcast dot com slash service and by eric and wendy schmidt whose fun for a strategic innovation supports transformative ideas that benefit humanity law protecting the natural world recognizing through science the editor dependence of all living systems welcome back to the takeaway on todd's about one million americans are living with parkinson's disease it's a neuro degenerative disorder that can cause tremors balance issues even hallucinations and delusions along with a lot of other symptoms two years ago a new drug was approved to help with hallucinations and delusions that afflict people with parkinson's where there are often few treatment options new pima venturing is the first and only fda approved treatment for hallucinations and delusions associated with parkinson's disease or pd psychosis new placid was fast tracked to the market by the food and drug administration manufacturer acadia pharmaceuticals got approval after just six weeks trials and only two hundred patients in most drugs undergo years of study before gaining approval well since then more than eighteen hundred adverse events reports have been filed with the fda and at least five hundred people have died while taking that drug diana zuckerman is president of the national center for health research there and fda and pharmaceutical industry watchdog group and she says these breakthrough drugs can be appealing for patients in dire need despite the risks but the fast track labeling can be misleading it has to be a breakthrough in terms of potential treatment but it doesn't actually have to be proven to work so in order to get these drugs on the market more quickly the fda allows a lot of different shortcuts one of them is studying a drug for only six weeks when the patients are gonna take for months or perhaps years another is having fewer patients so that if a few of them die you don't know if they've died because of the drug or they would have died anyway you know all of those issues of safety and effectiveness really require longer term studies with thousands of patients and that's not what happens with a breakthrough drug those are not the standards they're used.

wendy schmidt todd hallucinations parkinson acadia pharmaceuticals diana zuckerman president comcast eric editor parkinson's disease six weeks two years two hour
"diana zuckerman" Discussed on KQED Radio

KQED Radio

02:19 min | 5 years ago

"diana zuckerman" Discussed on KQED Radio

"A kidney transplant when she was ten here's some items a my post transplant wishlist how about a chance that a kidney in our less of rest and i wanted fear toxic medications and it would be great if manage can be taken just want servais he wishes the drug she must take didn't pose a lifetime cancer risk and she wonders what will happen when years from now her transported kidney fails and she will need a new one allow lose my job doesn't mean thoughts concerns thank you for listening you have to be a historically hasn't considered it's worked strictly from the patients point of view the generally starts with a company pitching a new drug or device and is supposed to answer the more narrow question is the product safe and effective kevin long geno who heads the national kidney foundation is optimistic that the fd will broadened its horizons as a considers things from the patients part of year defected third a holding the events indicates it they're taking your very seriously how much leveraged you feel patience haven't dealing directly with a drug companies in saying hey these are are problems we need solutions i think patients have very little him dirk companies to hope looking forward is that when drug companies bring new product to the fd a for evaluation the agency can ask whether the tests of these products will measure outcomes that patients care about if gate history demonstrated that it's paying more attention to what patient want earlier this year after hearing impassioned please from parents and they're scientific allies the agent to temporarily approved a drug for duchenne muscular dystrophy even though the science in hand didn't provide proof positive that the drug was effective patients considered the had a victory but that makes consumer watched of diana zuckerman nervous the badness about what's happening is that so much of patient employed is involving patience who are working with or recruited by drug companies these companies por millions of dollars into advocacy organization and provide information to patience so the patient forces are sometimes also channeling commercial impressed zuckerman who heads the national center for health research worries that desperate patient hear more about the potential benefits then the risks clearly.

kevin diana zuckerman