 Good afternoon. Thank you for joining us today. My name is Eva Brandstetter and I'm a senior editor from Publica. We're going to get started in a few minutes, minute or two after a few more folks join us. So just to sort of set the stage here during this event our reporters are going to review their investigation into the 2021 Phillips recall. Millions of Phillips Respironics machines were recalled as part of this and breathing machines and other devices we'll be talking about today. We're going to be joined by expert panelists who's going to they're going to share their experiences and answer questions answer your questions about the recall, you know the impact on patients, trying to get replacement machines, and the potential short and long term health risks that are exposed by the recalled devices. So we're covering a lot today. At the end of the program will take some time to answer audience questions as well. Just a quick note that the event is being recorded and a link to the video will be emailed to everyone who's registered today. And just want to note that closed captioning of the program is also available and can be enabled by clicking on the closed caption option on the bar at the bottom of your screen. So it looks like we have enough folks to get started and I just wanted to welcome you again if you're just joining us. My name is Ziva brand stutter and I'm a senior editor at Republica. And, you know, I'm, we're happy to welcome you to our session this afternoon that the chat is open. And I encourage you to let us know where you're tuning in from. And before I turn it over to our publishing partner on this important project, I just want to take a moment to say how proud I am of this journalism. You know, we often produce journalism here at Republica in partnership with news organizations all over the country and this is one such example. We're very proud of the results so far of this and the fact that we're providing you actionable information about a clear health risk that you may be concerned about. The reporters working on this project spent more than a year. They come through thousands of documents. They interviewed hundreds of people all over the world. They worked very hard to develop a deep understanding of complex science that was involved in this project. And they also worked hard to press reluctant officials to provide some answers and to get to the bottom of what happened. You know what they uncovered is a story of massive failure to warn the public of a clear danger to the health of millions of people. That's just a short summary of what they found and we're going to be providing links to the to the story that we published so far. That story we published in late September is just the first among a series of stories that that we're working on that examine how and why that failure occurred. So as a reminder, this meeting is being recorded to be shared on ProPublica's YouTube channel and the discussions will have during this panel conversation are for educational purposes only. So information shared during this session by our speakers is not intended to be professional medical advice or diagnosis or treatment. As I'm sure you can understand that although they're the top medical professionals in their fields, they can't diagnose and treat you over over zoom. Your doctor can though in your in person or in zoom. So you should always obviously seek the advice of a qualified medical professional with any questions you have regarding your care. And today we're really focusing on answering your questions about what we know, according to the data and research that's available. I'm happy to introduce Teresa Lindemann. Teresa is an editor at the Pittsburgh Post Gazette and our publishing partner on this project. Teresa, welcome. Thank you, Ziva. It's been a long road hasn't it. I really appreciate the opportunity to participate in this important discussion about built recall, and about the information that Debbie sense for sense of her I'm going to talk properly with ProPublica and Mike Salah with the Post Gazette, along with their reporting teams were able to share with readers. It's clear from everything that we're seeing that this recalls had a direct impact on the lives of many of those who've joined us here today. The Post Gazette has had a tradition of public service journalism of devoting time and resources to stories that are relevant to our readers, and that shine a light on issues that might otherwise be overlooked. It is in fact one of the core missions of local journalism organization like ours. And especially important responsibility as regional media outlets across America look for ways to serve their communities with journalism that truly matters. I remember one Mike who leads the Post Gazette three year old I team started investigating this more than a year ago. It was clear. This was more than a Pittsburgh story. It is grounded here, but it is a bigger story than that. After he and Deb, a longtime investigative journalist began discussing what appeared to have happened and the global impact of these devices. It became clear that this was the kind of investigation that ProPublica is uniquely prepared to really dig into with excellent reporting, and then to share with the millions who might need to learn more about just what happened here. The Post Gazette has been honored partner with ProPublica about this essential coverage. Before bringing on Debbie and Mike to talk about the reporting, we wanted to share with you some of the voices of those who have been impacted by this recall. So this video is an excerpt based on an upcoming short documentary by both news organizations that tells the stories of people impacted by this recall. At that company, at the time, you figure, well, I got a good company, it's going to be fine. But the fact of the matter is, most of the key people were gone. It's not an easy death you're talking about. It's not like a quick death. It's an arduous death. I either use the machine and take a chance, it's going to hurt me. Or I don't use the machine, I could die tonight. So I thought I have a better chance with the machine. What we did every wedding anniversary was look at our wedding album pictures. We did that every year. So I did that by myself. When he was using his first machine, they had already known for three years that they were defective and yet they were still issuing defective machines causing health issues. Thank you for that, Teresa. And now I think that Debbie and Mike are going to join us on screen and they're going to talk about their investigation for a little bit and then you're going to hear from the experts and I promise we'll get to some of your questions. Thank you. Mike. Yeah, thanks for introducing us. My name is Mike and Teresa and clip. My name is Michael Salah. I'm a deputy managing editor of the post Gazette and Debbie would you like to introduce yourself. Thanks. Thanks Mike, my name is Debbie sense of her and I'm a pro-publica reporter. I think we'd like to take a few minutes now to share a recap of this investigation for those who may not have had time to read our findings. Mike and I started working, talking about this project early last year. And we really saw it as, as, as a public health emergency we truly believed that there were people that needed to understand what was happening and and what to do about it and what this company Phillips Respironics knew and when. And I don't, I can't speak for Mike but in all my years as an investigator for Porter, and Mike and I have partnered on stories before. Can't remember another story where it wasn't just the number of people, millions of people who were impacted but it was the range of people who were impacted from veterans to people with chronic illnesses to otherwise healthy people who struggle with sleep apnea and had to be counted on these machines to breathe at night I remember walking into a sleep apnea or sleep disorder center, renowned sleep disorder center at the University of Michigan, and learning about a recalled machine that they needed to use on newborns who had breathing problems and so as Mike and I started looking at this, we realized that there were a tremendous number of people that needed to understand what had gone wrong and why, particularly because Phillips Respironics, actually said that these machines were dangerous and could potentially have toxic and carcinogenic effects, but then the company started to walk back those statements and basically said I think we kind of kind of got it wrong here and Mike and I really wanted to drill down and understand what those health risks are and what they could be both now and in the future and in the future for these patients. And that really nailed it when she said the challenge, we had worked on projects going back to 2005, starting at the Miami Herald, but this was a project where the sense of people needing answers. It was never more acute that I could tell they were desperate, they were looking for someone to tell them about the science about the potential impact about what the company knew and when and the fact that they were so dependent on these devices that you know these devices change their lives and now all of a sudden, a machine that was supposed to allow them to live longer was actually in a could cause destruction in their lives and I think that's really hit us. And then just talking to the, some of the people that were on these devices some that develop cancer. Still, they're in a quandary knowing did this cause my cancer, could it have given all the scientific evidence there. And our interview with the former Attorney General in Louisiana Debbie and I interviewed in his kitchen one day. And this was a gentleman who fought big tobacco in the 1990s on behalf of his state, and one major a major judgment against the company for dollars. And here he was in the in a position, the irony of ironies now. He was somebody who had developed cancer as a result of a product liability in the position he was in. And so anyway, these were some of the people also that inspired us to keep to keep digging and to keep looking at records and to keep finding the answers. Yeah, and one of our core findings of this investigation is that over an 11 year period. The company kept secret several thousand reports warnings about about this defect which just put simply in many of their ventilators and their CPAP and CPAP machines. The company had inserted and inserted an industrial phone because the machines were really noisy and we're keeping people up at night and this phone was supposed to reduce the vibrations and the noise. And what this company found years before they announced the recall was that the phone could degrade, could degrade, often in heat and humidity and send fumes and black particles through the machine and into the masks worn by people, potentially into their noses and mouths and lungs. And so what we found is a core finding was that the company held back, more than 3000 complaints or reports about degrading foam and they held it back from the FDA from people who were supposed to help keep the public safe they're supposed to track trends like this and then do something about it and instead, more than 11 years past, before the company announced a recall and the company has said we took action as soon as we thought that there was a serious problem and we quickly announced a recall and the company has since said that they regret the pain and suffering caused by the recall. But the key questions that Mike and I wanted to ask is, if you knew about this for years, why didn't you do something sooner. And then the other element that really challenged us was the science. The company at first during the recall said these, these devices and because of the emissions from this phone that was breaking down could cause life threatening injuries permanent impairment, and it doubled back and it, and it, and it started to say after lawsuits were filed and everything else on further review we don't believe it has long term effect. So we started delving into the science, interviewing toxicologists, epidemiologists, every public health doctor that had been following this issue. We ultimately found something very disturbing that while the company was disputing many of the compounds saying that these didn't meet certain thresholds they weren't saying the one thing that kept kept us up at night, I would say, was that there was a genotoxic positive responses which means that the, the, some total of the chemicals have the ability to change cells, and that can that can cause cancer. And so while that we're still years away from making those links. That's what really struck us in the science that you can't undo that it's almost a game over with those with that genotoxic results cytotoxic results. We're very disturbing to us and it allowed us to again keep digging and trying to find answers. And clearly, all of the medical experts, nobody knows why people, you know, we're getting sick I mean it's impossible to say why someone got sick developed cancer. You know, there were as Mike said, thousands of people who have reported everything from respiratory infections to kidney and lung problems and liver problems to cancer and we've interviewed a number of families and I think that's really why we wanted to invest the time in this because there's just a lot of fear there's a lot of fear Mike and I interviewed a young woman 23 years old who said, I'm not sick now but I'll spend the rest of my life worrying about it. And so I think that's why we really devoted the time to do this work and why we partnered up to do it we honestly saw it as a, in some ways an unprecedented public health emergency at least in the field of respiratory care. Now I think with this recap, we'd like to now invite our external panelists to join us on the screen. Let's, let's swap on and off I feel like I know them already. Dr Rita F. Redberg is a cardiologist who practices general and preventative cardiology and a professor of medicine, the University of California San Francisco. Dr. Redberg studies how the assessment of medical technology for safety and effectiveness influences and is influenced by public health policy. Thank you Dr. Redberg we're honored to have you here. Dr. Rojika Breeden is a board certified sleep medicine physician who's practiced medicine for over 20 years. She treats sleep medicine patients in the Pacific Northwest, and she was invaluable to us as well, and explaining to us, the chaos of the recall, the challenges she faced with her patients and why our reporting was so important to shed light on this story. And Dr. Muhammad Adil Rishi is a pulmonary critical care and sleep medicine physician. He is the chair of the Public Safety Committee of the American Academy of Sleep Medicine and associate professor of medicine at Indiana University School of Medicine. I'm grateful to have you here because we know that the American Academy of Sleep Medicine was has been heavily involved in in helping patients way through this recall so thank you Dr for being here with us. I think we wanted to start with some questions for our panelists and I'd love to start with Dr. Braden. Did you as someone who was treats thousands of patients with sleep disorders, was there any sense prior to June 14, 2021, the day Phillips announced this recall that there was a problem with these machines, particularly their celebrated dream machine, right, which is often used for the treatment of sleep apnea. Any sense of what was to come? Absolutely not. We had no idea at all. We believe the devices were safe. In our practice, over 99% of our patients were on dream stations at the time. And we were absolutely blindsided when this happened. On the day of the recall announcement, we were seeing patients, we had no knowledge that this was going to happen. And we had had patients report various symptoms, but had never associated that with the use of the machine. So, in retrospect, we may have had patients reporting cough or sinus issues or other issues had no associations that that could have been from the machine. So, once it happened, we were in the same boat as all of the patients with very little information, and it was just an just overwhelming chaos. So, Dr. Rishi, I think you were taken completely. Go ahead, Mike, you go next. No, I was going to say Dr. Brayden. So you were taken completely by surprise. Did the call start right away into your sleep clinic? Absolutely. So, we were seeing patients, the clinic was absolutely flooded with calls right away because the announcements went out on the news channels, the announcements went out, you know, on the internet. And we were notified by Respironics by a routine email that the recall had occurred. And so our phones were flooded, patients started coming into our office, holding their machines, saying, what do I do with this machine? Is it safe? What's going on? How do I get a replacement? There was no process in place at that time. We had no knowledge of how concerning the recall was, what machines were affected. At that time, we were told it was just the dream station. And we were incorrectly told that the 50 series, 60 series and previous machines might be safe for the patients to use. So patients were digging out old machines and using them in those first days. We were getting conflicting information that maybe if patients bought filters, they could use them and that could be helpful and that could be helpful. We got information that maybe if they had not used ozone cleaners, then maybe that was something that was a saving grace for them. And so the amount of misinformation that was flying around was just chaotic. It was changing from day to day. And patients did not know what to do. And there was no process yet in place when the recall announcement was made on how to get that, you know, remediated or how to get any kind of replacement. And Dr. Rishi, I would imagine all three of you would probably agree. I mean, adherence to CPAP therapy is so important, right, for people with obstructive sleep apnea and sleep apnea. How did you counsel patients and how do you continue to counsel patients who were worried that, you know, what do I do, you know, I can't get a replacement machine, do I stay on on a machine that we know has been recalled. And, and we know that some people have stopped using machines altogether they're just they don't, they've lost a little bit of faith here. How do you counsel patients with those kinds of questions. Thank you for that question. I think part of the issue was that early on, and my colleagues on the panel would would remember this. Phillips had toward patients to discontinue using their machines and then contact their providers. That was the initial recommendation from Phillips as they announced a recall. And that caused a lot of patients to stop using their machine. And that can be very dangerous. You know, for some patients, the risk is prohibitive to stop using a respiratory device. Some patients depend on the machine, especially the home ventilators to stay alive. And they just can't. And I have to underline this, they can't and should not stop using that device. You know, the risk is different from different patients. You know, somebody who has milder disease, there might be alternative treatments available that can mitigate some of their symptoms. There are patients who have comorbid conditions like heart disease or lung disease. The risk profile obviously would be different patient who's pregnant. You know their risk profile would be different. And so this is a very personal decision that patient has to make in consultation with their doctor or their provider. And that's what I have recommended to my patients. And in accordance to the recommendations from American Academy of Sleep Medicine in the early days. There was a webinar done by the Academy within a month of the recall, where we came up with the initial guidelines based on expert opinion on how the physicians were involved and on the front lines of this recall should triage patients as they come in with these recall devices. And so, and we've continued to use those recommendations to it's out because, you know, we're still in the recall we're still seeing patients with these recall devices. Dr. Redberg you've, you have researched and been a scholar of public health and these issues for a long time, and watching recalls roll out sometimes very, very deadly ones. What comes to mind when this thing was playing out. What, what did you ask yourself or the things that you wanted to know as a scholar as well. Well, I think Dr Breeden and Dr Rishi have highlighted a lot of issues that this was a terrible process because there were so many people impacted but it highlights a lot of the issues. I mean, you always want to know how could we avoided this and how could patients, fewer patients have been harmed. And it points to problems that I see, I'm a cardiologist and I've seen this. Unfortunately, it's not an isolated occurrence I see it frequently in medical device cardiology recalls pacemakers defibrillators and other devices. The pattern is similar the company has known about these problems for many years before anything gets reported to the FDA and then even more years until it gets reported to the public so obviously that's a lot of avoidable serious problems. And then to have not informed providers, you know have someone like Dr Breeden, find out the same day as her patients and is just a terrible failure and communication by the company, and the FDA to inform, you know providers and patients so that we can be ready for this is a huge burden, not just for patients but for providers because we don't have systems in place in the best you know, we're so advanced in this country we have no systems for notifying people of recall this was actually lucky, because it had so much media coverage. There are a lot of recalls where I have patients who come into see me and they have no idea that they are. They have in their body and device that has been recalled because nobody was able to contact them and nobody let them know. It just highlights all of the avoidable problems that is really hard to keep seeing occurring over and over again because people are getting hurt, some people are dying and these are avoidable because. And the last thing I'll say on this topic is that the, you know, part of the problem is that people are reporting to the company and then it's the company's discretion on when to report to the FDA and whether to report to the FDA at all and that results in very long delays so I think having patients and doctors report directly to FDA which is not the current process would be so much better because it wouldn't allow the company. It's essentially the Fox guarding the henhouse when the company is the one who's getting the reports of problems with their, you know, big profitable equipment. I wonder if Dr Braden or Dr Rishi perhaps might answer this question I'm thinking of a young woman named Connie Thompson is 24 or 23 who I mentioned earlier who is now worried about what happens in the future and really nobody really knows how long term health impact might be right there's been no significant studies the FDA just a few weeks ago announced that Phillips will be doing more studies. How do you counsel someone who's just fearful that there'll be long term health effects here and should should they continue to use your machine like what what would you say to a young woman who thinks that something could happen, you know down the line. I mean that's a very legitimate question that's coming up every single day with all of our patients. And you know the first thing of course we always say is we have to get them off a recalled machine immediately. So they cannot be on anything that is recalled. And people have said well how do I trust the new machine how do I trust a phone that was kind of rushed in and you know put in and you know that has its own concerns, you know in terms of safety and long term study and all of those things. So patients have to monitor themselves for any symptoms. We are, I am counseling patients to report any symptoms that they have of any sort to the FDA meta watch and making sure that the that we're being very vigilant, and patients are really appreciating that. We did not realize the possible correlation between the use of the CPAP devices and some of these symptoms that could seem very common such as cough or sinus infections, or other respiratory type illnesses or even other systemic issues such as kidney issues, liver issues, or other things in the past, not understanding the possible systemic exposures of these, you know, VOCs and other contaminants. But now I am strongly encouraging every patient if they do have symptoms, or anything to make sure that they report it and to be vigilant to those symptoms, but in any one person, we can't predict that risk without more data. And, you know, I think as Dr. Redberg was saying, you know, we really need, you know, studies on this, but you know is the fact starting the hen house in terms of who's doing those studies, and who's really going to be doing that on a population basis. You know, we really need large studies to detect the kind of things that we are looking for, you know, in any one small practice or in any one, you know, hospital based practice, we're not going to be able to see the kind of effects. You know, that we might need to see to really understand what the scope of the exposure may show over time. But I think, I think data is lacking. I would say that there have been some studies done. So, I wish, you know, I shouldn't say that there are no studies. Two of the studies were actually highlighted on the Philips website. I think, early on, I think one is a Canadian study. And then the other one is a friend study. The others are retrospective. I think one has about 7000 patients, other one has about 4500 patients. Both of them did not demonstrate increased cancer risk, although others should be said that the second study, the friend study, I think some of the authors had, you know, had financial support from Philips. There has been another study done in Sweden. That's an interesting study. I think over 18,000 patients in that one. They demonstrated that in counties where there were more use of Philips machines, those patients tended to use more medications for respiratory symptoms like albuterol. And the risk was higher in patients who had pre-existing respiratory conditions. They also demonstrated that maybe there was a slight increased risk of lung cancer. Although once you took out the county where the use of tobacco was highest, you know, that difference went away. But certainly I think some were concerned. I think the latest one is actually from here in the U.S. I think published in the range of scope last year by a group from KS-Western. And they demonstrated that there's been a tremendous increase in the reports of cancer in patients with CPAP use, although over 95% of those reports have come after 2021. So there's some concern that maybe there's a bandwagon effect here. But I think the data, you know, we definitely need stronger studies. I mean, most of this data is retrospective. And I agree that, you know, when you're looking at, you know, any type of treatment, you know, there's always risk. You know, we all physicians know this. The real question is what's the magnitude of the risk. You know, if the risk is 0.0001% and the benefit is great, then, you know, you do the treatment. If the risk is 20%, then maybe it's not, you know, it's not a good deal. But this magnitude of the risk is what we don't know. And that's the problem right now. So counseling patients about the risk is difficult because we don't know the magnitude of the risk. I have a question for Dr. Redbird. The FDA, as Debbie pointed out, in the wake of our first story, said that Phillips is testing so far of the phone has not been adequate. And they essentially said Phillips is going to continue to do these studies. And the question is, should there be a third party doing these. I mean, we're relying on a company that it's flip flopped several times first saying these are serious. This is a serious health risk. Then it says it's not a health risk. And, and I mean, at what point does the FDA play a stronger role in helping the public understand the complexities of these health issues. Well, that's a great question. And obviously, Phillips is probably not the best, it would be much better to have independent, you know, academic, even Phillips could give a grant independent researchers that are not part of the company. You know, and that's generally true. You don't want people doing the study that have a vested financial interest in the outcome of the study that is not the way to do good science. And so that would certainly be true here, besides the history with Phillips and the flip flopping and the long many years of delay in announcing any problems that they knew about. So that's absolutely true. And the other point I just wanted to make to pick up on Dr. Rishi's comment is that it's a big problem in adverse event recording that we don't know the magnitude of the risk because a lot of this data stays secret. So we don't, we don't know how many adverse events were reported we only know how many got got put on the FDA website and again that's up to the company. And then we don't know how many machines are out there because that's all proprietary information. So you obviously want to have some data your chances one in 10 or one in 100. And you can't get that data in our current system because so much of that data is kept secret by the company and that's what we allow. So we would need a change in regulations for the FDA. Thank you Dr. Redberg. One of the things that Mike and I were struggling to figure out early on was how many machines were still out there because the company kept announcing five, about five million machines had to be replaced but the FDA said that as many as 15 million had been built with this crumbling foam and we couldn't quite figure out what the actual number was from from anywhere and and and so Dr. Braden I actually had a question for you. One of the questions that we're getting from our readers is they can still sometimes can't get a replacement machine or they get a refurbished machine like you and you said that they don't quite trust, you know, it was the motor actually replaced was the and some people are just as still waiting. Do you have any tips because I know you're still really pushing to help patients get recalled machines replaced. Absolutely. So we're seeing this every day. The recall is not over. Some patients have received refurbished machines, which are dirty or not functioning well or, you know, I just had a patient today who said they got a refurbished machine that was letting off a horrible smell. And so they didn't feel that it was safe to use and inhale that, you know, let alone, you know, you know, you know, use it on a daily basis. So, so we're still having this problem with the replacement machines. If a person has not yet received their replacement. The first thing you need to do is go to the respironics recall website and make sure you have registered it correctly. And so make sure that you have entered your serial number, ensure that your serial number is part of the recall and get a confirmation number that says that you have registered for the recall. Once that has been done, if you still have done so and have not received your recall replacement, you need to check into their patient portal and see if they say that they are waiting for some information. This has been a bottleneck that has been a huge problem. Patients have been told that they've been quote unquote waiting for prescriptions from their doctor when we were never, you know, no information was requested of us. If we had a same token, we would sometimes our phones would be flooded with a thousand phone calls one day saying we need a prescription for Mr. Smith, we need a prescription for Mr. Jones, we need a prescription for this person. And so we would be sending out thousands of prescriptions that day. So the way that the recall replacements have been administered has had no particular rhyme or reason that we can see it had nothing to do with when you registered your machine. It had nothing to do as at least in the early year and a half of how severe your sleep apnea was or anything of that sort. So you have to go to the patient portal and see what the process was. Another issue was the advanced machines. So people were on ASVs or a that's machines. The process for that replacement has been different and has been even more confusing for our patients. So many of those were not shipped directly to patients. They were shipped directly to their durable medical equipment company where they received the machine. And many of those durable medical equipment companies have not reached out directly to the patients to say that we have a repair kit for you or we have a replacement for you. And so it's just kind of sitting gathering dust. And then when I talked to the patients, I said, Have you gotten your recall replacement? And they say, No, I registered two years ago. I still haven't. And I say, Oh, you have an advanced machine, please call your DME company. And then they've called the DME company and gotten it taken care of. So, so I definitely recommend going to the patient portal if you've already registered. But if you haven't make sure you have registered and that your machine is part of the recall. Another issue, which has been really problematic is patients whose devices were greater than five years old. And this is a huge loophole that has been very problematic because patients who had devices that were greater than five years old have sometimes been told by restaurants that that was aged out and that they were not going to get a replacement machine. And yet the patients are being told by their insurance companies that because the machine is technically functional, but only the only thing wrong with it is that it's recalled that it's really restaurant. The patient may not be able to get this job to replace it and not the insurance companies, or the patient may be able to get a replacement through insurance, but they have a large copay or a large deductible. And they can't really afford to replace it. And so their only option is to stay on a recalled machine. I love seeing a lot of these kind of loopholes. And, you know, I really recommend if you're in these situations to work with your doctor to see if they can advocate for you in any way and see if they can fight to help you help you try to get your machine. And this is what we're doing all day we're trying to do our best to try to get patients off recalled machines and get them to stay for machines so that they can sleep at night and breathe. Just just really quickly one quick follow up. A lot of patients as you know we're getting offers from Phillips of $25 or $50. What is that and should people accept those offers. I cannot tell a patient whether they should accept those offers or not. I will be honest that I had previously thought that perhaps there was some analysis going on once a person's machine was mailed in, as to which machines were having this defective foam issue. This would help with the epidemiology and analysis of finding out what was going on. I now realize that that might have been a bit idealistic in retrospect. And so whether a person feels that they want to get rid of the device and send it as one patient said send the evidence back to Phillips or not is up to them. So I cannot recommend whether a patient should do that or not. That is completely up to them. Dr Rishi, do you have any thoughts on that at all with what you've been counseling your patients. Yeah, I think one thing that probably important to mention at this stage two years out from the recall is the patients who are having the recall devices right now. Let's not forget who those patients are. One of our members was at the patient advisory committees, FDA's patient advisory committees, open house last month and kind of express these concerns that the American Academy of Sleep Medicine has about this issue, which is that these are the patients who are the most at rest. These are the poor patients. These are the indigent. These are the uninsured or the underinsured. These are the patients who are in jail. These are our elderly who can't get on the internet or don't know how to get on the internet. The people who have the means are no longer on recall devices. Let's be honest about that. They bought a brand new machine two years ago and they are using a brand new machine or they bought them some other treatment. So the folks who are left behind are the folks who are always left behind. And I think it's high time that we will learn that unless our regulators make sure that we have a process where, you know, these high risk patients are not left behind, you know, they are the ones who suffer in that. And just to wrap up this part of our discussion, Dr. Redberg to Dr. Rishi's point, the FDA stepped in, as you know, after the recall and urged Phillips in a letter to move this process forward, this replacement process forward more quickly. Does the FDA have any ability to really mandate that, to really push hard for companies to send out replacement machines in a timely way, or is it basically up to the company how they handle that? That's a good question. I don't know if the FDA, if the FDA can do something stronger than sending them a letter, which is a questionable effect if it doesn't have consequences to not following what the letter spells out. And that is a problem we see with a lot of the FDA actions is if there are not consequences, they're often ignored. But I don't know the specifics of how much more authority the FDA could exercise. Dr. Redberg raises a good point, because these companies can get warning letters and warning letters and more. And at the end of the day, they just keep doing what they're doing sometimes. So, yeah, a little more enforcement action. Thank you everyone. Thank you. Thank you so much, Devin Mike, and wanted to thank our panelists. We're going to move to the Q&A portion where we've selected some of your questions that, especially those that are repeated that are coming through, but I wanted to thank Dr. Redberg, Dr. Brayden and Dr. Rishi so much for sharing your insights and ask you to hang on. You guys to hang on for the questions from the audience and Teresa is joining me as well. For this part of the discussion. Before that, we would like to share a link to our event survey in the chat box and we really appreciate your feedback. It's important to us here at ProPublica we do many of these live events and we'd love to see what we can do better. We have received nearly, I think over 500 submitted questions for this event that helped inform this conversation and the content. So thank you. Many of the questions we received were about how to help report your health concerns. So if you suspect that you do have health issues that may have been caused by your breathing machine. You can submit a report using the MedWatch Online Voluntary Reporting Form and we're sharing a link to that in the chat. None of us have the magic answers to whether anyone health condition is caused by these machines. This is something that will play out over many years. But there are commonalities that are turning up in our interviews and with the doctors, the patients that they're seeing. So, you know, we can talk in general, but again, we can't the panel can't give specific medical advice or diagnose conditions. You know, you need do need to check with your doctor if you have any concerns for sure. Please be aware that you're electing to ask questions in a public forum. And so, you know, this platform is not HIPAA compliant. And accordingly any information you provide about yourself during the meeting either in the chat function or the meeting of course is recorded and not private anymore. But we really want to focus on your questions to the and the themes that keep coming through about what to expect what we know what the latest information is. So if you'd like to ask a question, please click the Q&A icon at the bottom of your screen to submit it to us. And now to our first question. And I'll ask the first question then Teresa you can choose one to follow up with lots of questions about how do we know that CPAP machines made by other companies don't have a similar defect. And then also questions about how can we trust the replacement dream machine or the replacement Phillips machine. So any of our medical professionals want to talk about what we know about whether other machines that have not been recalled whether Phillips or not are safe. No one wants to take that. Go ahead, Dr. Brayden, you don't want to take that one on. I don't think I think the reason nobody's, you know, raising their hand to take that one is we don't have an answer to that. This is, you know, we trusted that the dream station and that the other machine was safe and we had no understanding or inkling that it wasn't. The question is if we had had, you know, in any one practice and a cruel of issues that we said wow this particular model is really bad or anything like that. And so, you know, in, we don't know if that could happen tomorrow. So Monday morning the way it happened with a restaurant with another machine. What we can say for what it's worth is that we are not aware of the competing brands having adopted a new phone. And that we have been that has been told to us. So, so for what that's worth. We are not aware of that, but, but we cannot, you know, we cannot say for sure. I am not aware of that and we have not been told that so, but, but we do know that these recalls can happen. So, so we don't, we're not able to say that and we would if I had a patient on the competing brand who had symptoms that could be referable to using their machine. I would tell them to go to the med watch and FDA and record the same thing. All of these things need to be tracked. We have to make sure that we, you know, are very vigilant to anything that could come from these medical devices. Yeah, I think for what's worth resmet, which is the main competition in the market for a restaurant X has come out and said that they don't use the same material form as a restaurant X does and that they have not seen the same problems that the risk baron X machines have. Similarly, you know, you may remember the risk baron X masks, the CPAP masks were also recalled, because of these magnets that were there in these masks. The competition which is again resmet has come out and said that their magnets are less strong and so they don't cause the same sort of interference as is, you know, present with the risk baron X mask. Again, I agree with my colleague, you know, on the panel that that doesn't mean that we are not vigilant. We especially with this type of recall that all of us have gone through I've told my colleague that it was like a second pandemic during the pandemic. You know, I think we are all, you know, burnt once and so we are all, you know, we all have to be super vigilant about any anything that we see and observe. I think we have to remember that, you know, they're like 15 million machines, recall 15, and you know, maybe when millions of them had seen problems, you know, a single practice may have seen only a few of those over several years. So it's, you know, you're only seeing a piece of the puzzle and you will not solve the puzzle, you know, and so only the person who's seeing the whole puzzle, you know, they were to see the whole picture and then solve what's actually going on and then obviously, you know, the individual practice will never be able to see the whole picture. And that's why you would not be able to tell what's actually going on. And that's why this reporting system is so important. And who sees the reporting is very important as well. I think Mike and I learned everything we ever want to know about foam in the reporting of this project and what we learned was that the foam in the Phillips machine was a polyester based foam it actually looks like a ring of spongy black foam and Phillips and his main competitors Dr. Rishi pointed out as resmet and they used a foam made of silicone. So it was a different material as you know, and and so there is that fact. One of the other issues was that resmet I believe said from the beginning that if you used an ozone cleaner it would invalidate your warranty. So my understanding is that patients were warned not to use an ozone cleaner. Why that was the case. I don't know maybe they knew that their phone would break down more with ozone or they just said it wasn't tested with that. I know that the ozone is only a part of why the phone may have broken down in some cases in the restaurant machines as well. But it could break down without that ozone exposure. But just, you know, some of those factors may also not have, you know, been in play for as well. And they did the company did initially say in almost the same breath we're going to have a recall, and don't use the ozone they kept saying that but interestingly enough, the FDA to its credit came out later to say, look, yes, it can accelerate the breakdown of the phone, but let's let's face it. It's still the phone itself is breaking down. Let's not blame the cleaner even though it can accelerate the process. And secondly, the ventilators that were made by Phillips that also had the phone that was breaking down. They used that ozone cleaner in the ventilators and those were still breaking down so it kind of took the bat out of their hands but I see they continue to to try to advance that. Hey, I'm was really glad you guys are just in the ozone issue because we are seeing a lot of questions in the chat, people asking about oh doesn't this only apply to those that that people use the ozone cleaner. But another question that we're seeing a lot is people who did not see black particles who did not see degradation. And if it's something that they need to worry about if maybe it was only the machines that you could see, you know, what was going on there. Phillips. We actually obtained as part of our reporting an internal report done by people in Phillips experts inside of Phillips that said that you can often see you don't have to you can't necessarily see with the naked eye degrading foam I mean. So, the absence of black particles doesn't necessarily mean that there wasn't a problem. Is that what you were going to say Dr Braden. Exactly. They could be microscopic, you may not have been able to see it, it may have also been fumes that you may have inhaled. So the absence of actually being able to see the black particles does not mean that that your machine is safe or that you should continue to use a recall device or that your previous use of a recall device was not associated with risk. There have been many questions about the recall itself and how people know whether their machine has been recalled or which machines have been recalled so we dropped a link in the chat. That is the most up to date list of recall machines. The FDA has. There are also lots of questions to the medical professionals on this panel. The general questions about should they go and have a check up. If they have a minor health problem that they think might be related or a major health problem or no health problem. Should people go and schedule like a special check up if they've been using one of these recall machines with their doctor to just to see if they have a health related impact. If you are concerned about your health or have any question about your health you should talk to your doctor or your provider. I think that that's a recall or no recall I think I think if you have a question. We should always encourage and I always encourage our patients to just ask just just ask the question but what's on your mind. And you know your provider or your physician, you know, knowing the knowledge about your medical history can then guide you as to what needs to be done next. And so that's what I would recommend if there's anything on your mind talk to your provider. And also questions about how whether people should report concerns whether people should report illnesses to you know as part of this recall if they've been using one of the recall machines. And that's completely up to you know the patient and whether you sometimes doctors report these. The factory, most normally the company does but patients are certainly welcome to report any concerns they have to the FDA, which tracks these illnesses and adverse events as we call we put that chat in the, that link in the chat earlier, and that's that voluntary report form and we might be able to read up that if you can't find it. You know what's interesting about that we could not have done this story, even as journalists. Forget about regular even as journalists without that that that data that Medwatch data those adverse events reports that go to the FDA and one of the things we found out is only about 10% right Dr. In fact, in Medberg about only about 10% of adverse events are actually even reported to the FDA. So, who knows what else is going on out there that the FDA does know about. Absolutely, so I would certainly encourage anyone who has a concern to report it because to report doesn't mean that it was definitely associated with the device but there's no way to do an investigation or find a safety signal, unless you report. Reporting to FDA as Debbie said shared the information you can report directly to FDA. Everyone does tend to report to the sponsorments. One of the things I'm seeing repeated in the questions as well is if they people have received a new machine and new Phillips machine. You know, do they can we feel comfortable using that and I'm not sure you guys have the experts and, and all that King, but I mean obviously there's no recalls on the more recent machines. Any thoughts on that Mike. I'm sorry, I, Debbie can you answer that because I don't know your first. Internet connection. You repeat Teresa I also froze up. Basically, I'm not people are wondering if they've received quite some machine if they bought a newer machine from Phillips, you know if that's something that they should, they're comfortable using it's not involved in the recall from my understanding. That's, that's a really good question. I hope I'm sure everybody knows this but just in case so, so Phillips recalled the dream station one, which is this how I remember it. Dr brain and don't laugh but I remember it like, oh, it's the, it's the white machine right that's the dream station one. Right but the dream station to their newer model, which they launched just really weeks before they announced the recall in 2021 was made with a different industrial foam, a silicone phone that's that's the black machine and so, at least according to Phillips, that that is there are no no issues with that machine. I'm sorry I mean interrupt you Dr. That's my understanding is that correct, but also just just as a reminder, it is not just the dream station one that was affected. There are many other devices that were out there. The 50 series the 60 series the m series. The other restaurant models that many people were using that were also affected by the recall, but the newer dream station to have the silicon based foam that is considered safe. There were 20 models in all, starting for it with their ventilators in 2009, and it's just going to be those devices that have what they call the peeper foam the polyester polyurethane foam. And that's in there but yeah you're right Dr brain. It's the devices are in the millions initially they said, it would affect 15 million. I believe now dub what are they saying in terms of replacements is it well in the FDA has reported that 15 million machines built since 2009 by Phillips had this problem foam Phillips has reported that only about 5 million 5.5 million are being replaced I'm guessing I don't know that that's just the number of people who've registered for new machines I don't know how Phillips came up with that number how they know that only 5.5 million are still in circulation, as opposed to the larger number of 15 million or were somewhere in between. We're receiving a lot of questions about like what kinds of health outcomes are being seen again not people asking for individual, you know, diagnosis but could the doctors on the panel talk briefly about outcomes that you've seen that might be related. And then the specific question about any have we noticed any increase in lymphoma among dream station users. So I think, in general, there are two situations that supposedly can happen by exposure to to this breakdown of foam so one is that there's larger particles that break down and get into this the respiratory circuit of the device. And then the second issue is that as the breakdown happened there's off casting of fumes that also get into the circuit. The particulate matter the larger particulate matter has been associated with airway inflammation or more like asthma like symptoms. Whereas these gaseous materials have been as you've heard, potentially, potentially increasing the risk of cancer. As far as I'm aware, I don't know if there's any specific increased risk of lymphoma. But those are the concern. We don't know for sure that if that really does increase the risk of cancer or if it really does increase the risk of airway airway disease. So what are the concerns and again, we don't know for sure but if you're having those symptoms and if you're one on one of those one of these devices. Now I would definitely talk to your provider and as we said, report to the FDA. We could point out that Phillips has said that they're more recent testing on the dream station and similar devices has found. No, I think their words were appreciable harm to patients. But, but the FDA, as Mike pointed out earlier has said the tests were not adequate and has asked Phillips to run more tests. Even toxicologists that were involved in the testing have told Debbie and I that they they have serious concerns about Phillips's representations of some of these tests so I think all that needs to be played out and that goes to the question that I when I asked Dr. Redbird, shouldn't there be a referee and all this somewhere. The FDA somebody to step forward and offer some clarity to this, you know, when the time is right. Absolutely. I mean, clearly, you know in terms of communication to physicians to patients back to the company there needs to be a neutral party to assure answers to these questions and assure safety. That's, um, it's, there's a question from one of our people saying, which gets sort of the process going on. Why did the FDA permit this to be handled as a quote, voluntary recall. And that kind of gets us to how this system works. Can you sign that a little bit. And that's often the case is that the FDA, you know, when adverse events safety warnings accumulate the FDA has discussions with the company and they offer them the opportunity for a voluntary recall which they everyone, the FDA the company feel is preferable to the FDA forcing a recall and, and generally they negotiate the terms the, I think the timing and then the company will announce the recall but you'll notice almost all recalls are voluntary recalls. That's what the FDA has. Because they think it moves quickly, right, the idea is to more quickly get it to the market. Because we need the FDA to comment on why they do that. But it is important to note that the FDA shortly after the recall and to this day has classified the Phillips recall as a class one which is the most serious recall it's it's reserved for devices that that according to the FDA have the potential to cause serious injury or or death, and throughout, you know, all the Phillips reporting on the test results and, and now saying it's not as potentially not dangerous and we might have gotten it wrong the first time. The FDA has not changed that classification it's still considered a class one recall. I will comment that the company when they get the adverse event reports they classify how they're going to, if, if they're going to enter them in the FDA database and how they're going to classify them. So in work I did with some colleagues at UCSF that was published in Gem internal medicine in 2021 we discovered that a significant number of deaths that that occur in people that have devices and we're not just talking about any medical devices where a death occurred, and it was reported to the FDA the company reported it in a category other than death. So if you were just searching the FDA database, it would not reflect all the deaths that occurred and could delay reporting of safety signals and also the FDA is severely understaffed in their post market surveillance and monitoring of the adverse event database. We probably have heard from all the news coverage the emphasis that the FDA is on getting things onto the market and getting them onto the market quickly which often means settling for less than high quality science and not having randomized trials and using surrogate endpoints instead of actual clinical endpoints that are meaningful to patients. But it means that's where the FDA resources are going and they're not going into monitoring the adverse event database and looking carefully for serious adverse events so all of those things are going to delay recognition of serious problems with devices that are out on the market and delay warnings to patients and physicians and the recall actions. And the last thing on that, there is, if it is a serious adverse event or the companies are supposed to report within 30 days of their notification of the event, but we have observed and again published in the medicine cases where that wasn't done and the FDA does have the authority I know that for for consequences to the for the company for failing to report in a timely fashion serious adverse events but they do not exercise their regulatory authority in that regard. Mike and I were surprised surprised maybe we shouldn't have been surprised but we reported in the story that they held back this company held back several thousand complaints and only submitted them to the FDA after the recall and some of the complaints were 910 or 11 years old and we were surprised that that that was allowed to play out. We have a few more questions here and we're, you know, about six minutes from wrapping this up so I'm going to hit try to hit as many of these as we can to get people answers. One question involves our plans for further investigation. And so, you know, while we can't disclose like everything we're working on and exactly the nature of the stories because we're still doing our work, I will say that some obvious questions about today are the FDA and regulatory failure and the recall process and sort of getting information about, you know, about the recall and whether it's been handled appropriately. Deb and Mike anything you want to add on that. And the W raised a really good point is, is the FDA monitoring does it hit the power to monitor these recalls, and it does. There is a law it's codified that when they do read when they do launch a recall, they give all of their information to the FDA, how they're going to carry it out. And so it's really up to the FDA to monitor it and hold their feet to the fire, when it comes to getting them the devices. They put out the FDA has put out some warnings, or you know public statements to say it's not meeting these obligations, but it hasn't gone beyond just putting out press releases. So the FDA does have the power to impose the law on this. We'll see, we'll see what happens. Yeah, we have, we have please keep reading we have more stories coming out we know there's a lot of questions I. Again, I cannot remember the last time I published something where I got so many responses and questions from from readers and so we see themes and those questions and our teams are really really hard to produce some more stories quickly. Yeah, I'll just say if you ask questions today that weren't addressed. Don't worry that effort has not been wasted we are reading these we are letting inform our reporting. And we wanted, you know, this is a public service so we want to make sure we we get to those urgent questions. And also questions about where patients can go for updates on this topic from trustworthy medical websites or journals, obviously for public and Pittsburgh Post because that are not we're not a medical journal. You know, we may not track this on a granular basis in the way that some sites might but did that medical experts on the panel have any suggestions, and it's okay if you don't for attendees. I mean, I would say the FDA's website has had frequent updates regarding the recall Philips website has had updates periodically regarding the the the the recall ESM American Academy of Sleep Medicine has a Philips recall page, which actually condenses the research from both FDA as well as from from Philips in addition to instruction from, you know, and advice from the American Academy of Sleep Medicine, medical medicine to providers. And those are the resources that I have, you know, kind of falling back on doing this these trying times as the Academy and all the sleep physicians have worked with this, this difficult time to provide our patients the best care we can under these circumstances. And I will just a reminder that we have time for a few more questions but we will follow up with an email that has more resources and links so we'll try to reiterate some of these resources that we've been dropping in the chat for you all. Teresa any burning question that you want to get to. And I'm not sure how much can go into depth on this but someone said do you know how the process unfolded in countries that have national database of patient records. They would they go specifically but we obviously had a partner in Amsterdam that worked with us on this reporting as well in terms of the, which is where well Philips is based. We touched on how things were different in different countries. If nothing else I think that's worth looking into more in terms of how the recalls kind of played out but I don't know if you guys want to. Next the question for Dr. Redberg is do other countries have stronger regulatory systems, then then we have here or we consider the gold standard in medical device regulation. I think that a big question I know. It's a great way it's, it's kind of in flux, I would say that other countries do have much stronger post market surveillance so that they have national registries and they can identify problems. You may remember the middle on middle hip recall but that was, we were made aware in the United States of the very high revision rate with those middle on middle hips that had been FDA approved because of registries from Great Britain and Australia where they tracked every device. They are, you're able to do much better tracking than we do and they get more information are able to let patients know much sooner. I think that is our last question and we want to make sure we get everyone out of here on time I just want to say how deeply grateful I am for hundreds of you spending your time. Listening about to the results of our investigation asking your questions, I really want to thank the panelists. These are busy medical professionals busy reporters and editors that took their time out to do this so I thank you so much for joining us and for your thoughtful questions. This event has been recorded. So you'll receive an email with the full video of today's event will also post this recording on the ProPublica YouTube channel. A link to our event survey is going to be added to that email and we really appreciate your feedback it helps us inform future panels like this from all of us at ProPublica. Thank you so much for joining us and good night.