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‘Munchausen by Internet’ crises a warning for all HCPs
A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown.
The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.
Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.
“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.
Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.
“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.
He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.
The study was published in the May issue of the Annals of Clinical Psychiatry.
A warning for others
In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.
“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.
In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.
Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.
For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.
In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
Elaborate scenarios
The first two cases were ultimately determined to involve one person who had created elaborate scenarios.
In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.
The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.
Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.
Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.
Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.
After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
Child deaths
After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.
In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.
Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.
In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.
Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.
Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.
She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
Multiple COVID crises?
In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.
Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.
Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.
In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.
However, at least three other doulas said they had supported the same “family.”
Online training program
In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.
Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.
DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.
Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”
However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”
In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:
- Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in submitting detailed posts.
- Near-fatal exacerbations of illness alternating with miraculous recoveries.
- Personal claims that are fantastic, are contradicted by later posts, or are disproved.
- Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
- Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.
A version of this article first appeared on Medscape.com.
A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown.
The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.
Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.
“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.
Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.
“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.
He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.
The study was published in the May issue of the Annals of Clinical Psychiatry.
A warning for others
In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.
“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.
In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.
Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.
For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.
In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
Elaborate scenarios
The first two cases were ultimately determined to involve one person who had created elaborate scenarios.
In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.
The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.
Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.
Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.
Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.
After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
Child deaths
After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.
In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.
Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.
In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.
Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.
Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.
She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
Multiple COVID crises?
In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.
Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.
Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.
In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.
However, at least three other doulas said they had supported the same “family.”
Online training program
In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.
Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.
DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.
Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”
However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”
In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:
- Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in submitting detailed posts.
- Near-fatal exacerbations of illness alternating with miraculous recoveries.
- Personal claims that are fantastic, are contradicted by later posts, or are disproved.
- Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
- Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.
A version of this article first appeared on Medscape.com.
A new study documents a handful of cases of women with Munchausen syndrome by Internet who targeted doulas in the United Kingdom during the COVID-19 lockdown.
The five cases were investigated by Kathryn Newns, MSc, DClinPsy, a clinical psychologist in Cambridge, England, who said the cases were brought to her attention by a doula she herself had used for the birth of her own child a decade earlier.
Dr. Newns said she believes these are not isolated cases – either geographically or in terms of the specialty involved.
“I don’t think it is likely that this is only happening in the United Kingdom. And I’m sure it’s not just happening in the doula world,” Dr. Newns told this news organization.
Coinvestigator Marc Feldman, MD, a clinical professor of psychiatry at the University of Alabama, Tuscaloosa, coined the term “Munchausen by Internet” in a 2000 article. The expression refers to use of electronic media to perpetrate hoaxes that reward posers with sympathy, control, or emotional gratification. The hoaxers do not seek financial gain.
“The ease of carrying out Munchausen behaviors makes me think that it must be much more common than it ever was,” Dr. Feldman said in an interview.
He noted that the new DSM-5 will eliminate the terms “Munchausen” and “Munchausen by Internet” and will clarify that “factitious disorder” can be partly or wholly carried out online.
The study was published in the May issue of the Annals of Clinical Psychiatry.
A warning for others
In the past, those with factitious disorder had to go to medical libraries to study up on the ailment they wanted to feign. They would then present to an emergency department or a doctor’s office and act convincingly, Dr. Feldman said.
“Now all you have to do is go to Wikipedia and you can become an expert on a medical ailment within a few minutes,” he added.
In the five cases described in the study, the hoaxers created rich stories, especially in cases 1 and 2. In those cases, the perpetrator turned out to be the same person. Subterfuge “obviously made it much harder to know she wasn’t who she purported to be,” said Dr. Newns.
Dr. Feldman noted that in Munchausen by Internet, there may be some element of truth within the stories.
For health care professionals, “it takes a considerable leap to assume that somebody who’s talking about some dreaded ailment is in fact exaggerating or outright lying,” he said.
In the five cases described in the study, persons contacted doulas, then related traumatic stories and described dramatic, immediate needs. All of the doulas were working remotely because of the COVID-19 pandemic. This likely made it easier for the perpetrators to pull off the hoaxes. The health care professionals agreed to share their experiences in the hopes of warning others.
Elaborate scenarios
The first two cases were ultimately determined to involve one person who had created elaborate scenarios.
In case 1, the hoaxer, who called herself “Jessica,” texted the doula “Charlotte” when she was allegedly 39 weeks’ pregnant. She said she was unable to go to the hospital because of the COVID-19 risks to her husband, who had cystic fibrosis and had recently undergone a heart and lung transplant.
The husband “Jordan” took over communications, using the same WhatsApp number as Jessica, as Jessica went into labor.
Ostensibly, a midwife team had come to Jessica’s and Jordan’s house. When the doula was on the phone with Jordan, she heard Jessica crying, grunting, and screaming, and then, at 2:00 a.m., she heard the sound of a baby crying. A photo of the baby was texted to Charlotte.
Soon, there were many problems. Jessica allegedly had a postpartum hemorrhage, and mother and baby were taken to separate hospitals. The baby was then diagnosed with congenital heart disease.
Over the next week, “midwives” started texting back and forth with Charlotte. The doula began to have doubts and asked a midwife to share a visual communication.
After receiving no response, Charlotte used a video call, got Jessica on screen, and told her she thought there was no baby. Jessica said the baby was real and showed a “growth chart” as proof of the 5-day-old baby’s existence. The birth and baby noises were later determined to be recordings.
Child deaths
After sharing information among themselves on a private Facebook group, the doulas determined that the person in case 2, “Dakota,” was the same woman who was involved in case 1.
In case 2, a doula had spent 2 years supporting Dakota through the deaths of a parent and her baby, who had a congenital defect. A baby-loss charity had also worked with Dakota but could not confirm the baby’s existence.
Dakota had gone so far as to make a video for the doula that showed a hospital room. In a voice-over, Dakota thanks everyone for the support she received as the baby died.
In case 3, “Hannah” texted a doula seeking emotional but not birth support. The doula, Nikki Barrow, has recounted the case on her own blog.
Hannah became desperate when she went into labor. Ms. Barrow remained close via texts, phone, and video calls, even as the baby supposedly died after 3 days. The doula lit a candle for the baby and cried with Hannah.
Ms. Barrow was eventually able to break away from Hannah, saying she was not a bereavement specialist. However, days later, Hannah tracked her down and claimed she had an infection in her heart and did not have much time to live. At that point, Ms. Barrow stopped all contact.
She determined from other doulas that Hannah had been hoaxing doulas for 4 or 5 years. Some had offered to get her help, but she refused and ended all contact.
Multiple COVID crises?
In case 4, a woman sought support on a doula-centered Facebook page and said her partner “Jack” would be in touch. Jack sent the doula hundreds of emails, texts, and WhatsApp messages and then said he was hospitalized with COVID. The woman, “Hayley,” was also soon diagnosed with COVID.
Hayley refused video contact and did not share photos. Drama continued to unfold. She reported that her baby was breach, that she had a second uterus with a second pregnancy simultaneously, and that the baby had COVID.
Hayley also claimed that her partner had come to the hospital, had raped her, and had brandished a gun. When the doula called the police, they did not find Hayley at the hospital or elsewhere.
In case 5, a “grandmother” contacted “Lisa” to find a doula for her daughter-in-law, “Anna.” Hours later, Anna was giving birth, and the baby had to be taken to the hospital because of cardiac and breathing problems. The doula heard nothing more after a few weeks.
However, at least three other doulas said they had supported the same “family.”
Online training program
In all cases, the doulas were not paid for their time. Reports to the police prompted no action because no money had changed hands. Some doulas said they felt bereaved, angry, or “silly” that they had been hoodwinked. All noted how difficult it was to disengage from clients who seemed to be in peril.
Ms. Barrow decided to create an online training program in which doulas are advised on how to stay safe while working online.
DoulaMatch, which matches birth support specialists with women in the United States and Canada, offers tips to help protect doulas from hoaxes.
Kim James, BDT(DONA), ICCE, LCCE, CLE, the owner and operator of DoulaMatch, said the organization is aware of “scammers who waste everyone’s time and have found doulas to be the latest easy targets.”
However, she noted, “I’ve only very occasionally and anecdotally heard about people fabricating a pregnancy for emotional gratification.”
In his 2000 article, Dr. Feldman offers clues to help detect hoaxers. He advises clinicians to be wary of the following:
- Cases in which the length, frequency, and duration of posts are incongruous with the severity of the illness the person is claiming to have; for example, someone who claims to be in submitting detailed posts.
- Near-fatal exacerbations of illness alternating with miraculous recoveries.
- Personal claims that are fantastic, are contradicted by later posts, or are disproved.
- Continual dramatic events occurring in the person’s life, especially when others in a group become the focus of attention.
- Others ostensibly posting on behalf of the individual who have identical patterns of writing, such as making grammatical errors, misspellings, and using stylistic idiosyncrasies.
A version of this article first appeared on Medscape.com.
Digital therapeutics extends its reach in neurology
In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.
“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.
Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.
“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
The digital dolphin treating stroke
Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.
“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”
In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.
Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
Reaching young patients through virtual play
Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.
“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.
Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
A first for therapeutic video games
In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.
Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.
EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.
“This therapeutic game gives repeated stimulation of the cognitive processes and networks that support multitasking and attention. And in doing that, my hypothesis is that there will be a restoration of function to that cognitive control network,” said Dr. Gunning. Gamified interventions, she added, are more fun and engaging for patients compared with more conventional therapies.
The fully remote trial will randomize approximately 100 participants to digital cognitive intervention and control groups. Over 6 weeks, the experimental group will be asked to play EndeavorRx at least 5 days per week, for about 25 minutes per day. Pre- and postintervention cognitive assessments will be compared between the groups.
“As far as digital interventions for mental health and cognitive disorders, the pandemic has just really accelerated the work ... that means that in the future more people can actually access what we’re doing in our labs and clinical research,” said Dr. Gunning. “I hope this is going to lead to more scalable approaches that will have a farther reach in the community.”
Dr. Krakauer said he envisions a future where neurologists prescribe medications, devices, and “immersive, plasticity-enhancing digital interventions.”
Hopefully, the synergy of these treatments will be a game changer for our patients.
Dr. Croll is a fellow in the department of neurology at New York University Langone Health in New York City and has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.
“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.
Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.
“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
The digital dolphin treating stroke
Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.
“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”
In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.
Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
Reaching young patients through virtual play
Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.
“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.
Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
A first for therapeutic video games
In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.
Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.
EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.
“This therapeutic game gives repeated stimulation of the cognitive processes and networks that support multitasking and attention. And in doing that, my hypothesis is that there will be a restoration of function to that cognitive control network,” said Dr. Gunning. Gamified interventions, she added, are more fun and engaging for patients compared with more conventional therapies.
The fully remote trial will randomize approximately 100 participants to digital cognitive intervention and control groups. Over 6 weeks, the experimental group will be asked to play EndeavorRx at least 5 days per week, for about 25 minutes per day. Pre- and postintervention cognitive assessments will be compared between the groups.
“As far as digital interventions for mental health and cognitive disorders, the pandemic has just really accelerated the work ... that means that in the future more people can actually access what we’re doing in our labs and clinical research,” said Dr. Gunning. “I hope this is going to lead to more scalable approaches that will have a farther reach in the community.”
Dr. Krakauer said he envisions a future where neurologists prescribe medications, devices, and “immersive, plasticity-enhancing digital interventions.”
Hopefully, the synergy of these treatments will be a game changer for our patients.
Dr. Croll is a fellow in the department of neurology at New York University Langone Health in New York City and has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.
“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.
Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.
“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
The digital dolphin treating stroke
Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.
“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”
In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.
Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
Reaching young patients through virtual play
Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.
“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.
Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
A first for therapeutic video games
In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.
Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.
EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.
“This therapeutic game gives repeated stimulation of the cognitive processes and networks that support multitasking and attention. And in doing that, my hypothesis is that there will be a restoration of function to that cognitive control network,” said Dr. Gunning. Gamified interventions, she added, are more fun and engaging for patients compared with more conventional therapies.
The fully remote trial will randomize approximately 100 participants to digital cognitive intervention and control groups. Over 6 weeks, the experimental group will be asked to play EndeavorRx at least 5 days per week, for about 25 minutes per day. Pre- and postintervention cognitive assessments will be compared between the groups.
“As far as digital interventions for mental health and cognitive disorders, the pandemic has just really accelerated the work ... that means that in the future more people can actually access what we’re doing in our labs and clinical research,” said Dr. Gunning. “I hope this is going to lead to more scalable approaches that will have a farther reach in the community.”
Dr. Krakauer said he envisions a future where neurologists prescribe medications, devices, and “immersive, plasticity-enhancing digital interventions.”
Hopefully, the synergy of these treatments will be a game changer for our patients.
Dr. Croll is a fellow in the department of neurology at New York University Langone Health in New York City and has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New guideline for replacement ART: CAB/RPV LA not for everyone
“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”
Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
Gaining consensus
Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.
With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.
CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
Other considerations
Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m2, the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.
CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.
And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
Clinical, institutional considerations
Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.
“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.
Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.
A version of this article first appeared on Medscape.com.
“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”
Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
Gaining consensus
Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.
With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.
CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
Other considerations
Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m2, the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.
CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.
And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
Clinical, institutional considerations
Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.
“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.
Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.
A version of this article first appeared on Medscape.com.
“One of the most important considerations before switching HIV patients to injectable long-acting cabotegravir/rilpivirine [CAB/RPV LA; Cabenuva, ViiV Healthcare] is for the patient and the clinician to arrive at this decision together,” Elliot DeHaan, MD, told this news organization. “This therapy is not necessarily for everyone.”
Dr. DeHaan is lead author of the newly released clinical guideline from the New York State Department of Health AIDS Institute for use of CAB/RPV LA as replacement antiretroviral therapy (ART) in virally suppressed adults with HIV. He explained that the guidance expands upon Health & Human Services’ Feb. 24 CAB/RPV LA recommendations, highlighting some of the most important clinical and patient considerations necessary to implement injectable ART. “There are a lot of things that need to be laid out beforehand,” he said.
Gaining consensus
Approved by the FDA in late January 2021, CAB/RPV LA is considered an optimization strategy for individuals with HIV whose virus is suppressed by oral ART and who might prefer monthly injections to daily oral therapy. While there are various reasons why patients might wish to switch to a long-acting injectable, one of the primary concerns is adherence. Of note, the guidance points to phase 3 clinical study findings that suggest high levels (86%-91%) of patient satisfaction with CAB/RPV LA, which portends a promising future for this therapeutic approach.
With regard to patient preference, recommendations focus on the need to thoroughly discuss several critical requisites with potential candidates, including a 4-week lead-in daily oral ART course (CAB [Vocabria] 30 mg, RPV [Edurant] 25 mg) before initiating a loading dose. Patients should be advised of the potential for development of resistance should dosing be interrupted for any reason (CAB and RPV have extended half-lives ranging from mean 5.6 to 11.5 weeks for CAB and 13 to 28 weeks for RPV), as well as the need to return to oral bridging therapy if subsequent injections are not administered within the 7-day window period. If the maintenance dose is delayed beyond 2 months, a loading dose and restart is necessary.
CAB/RPV LA therapy is administered into opposing gluteal muscles (CAB into one gluteus medius and RPV into the contralateral gluteus medius), and injection-site pain beginning 1 day post-injection and lasting 3-4 days is common. In phase 3 clinical trials, as many as 83% of patients experienced adverse effects (AEs), which also include nodules, induration, and swelling at the injection sites. Fortunately, 99% of AEs were of mild to moderate severity. While pain tends to decline over several injections, Dr. DeHaan said that it’s an important part of the initial discussion about switching therapies.
Other considerations
Prior resistance testing, ART treatment history, and/or baseline genotypic resistance testing that includes both reverse transcriptase and integrase genes should be reviewed or conducted before initiating treatment. K103 mutations alone are not considered exclusionary. Virologic failures (defined as two consecutive plasma HIV-1 RNA measurements greater than 200 copies/mL), while rare, were reported in 13 clinical trial participants. Recent data suggest that patients who developed resistance despite adherence had at least two of three factors: a body mass index greater than 30 kg/m2, the HIV-1 subtype A6/A1, and the presence of proviral RPV RAMS.
CAB/RPV LA does not treat hepatitis B (HBV) coinfections, reinforcing the need for concurrent oral HBV therapy.
And there’s a paucity of data on the safety and efficacy of CAB/RPV in children and adolescents, or during pregnancy/lactation, precluding its use in those patient populations.
Clinical, institutional considerations
Adaptation of CAB/RPV LA as ART requires specific clinical institutional planning, especially in light of current pandemic-related resource and staffing limitations. Monthly dosing must be done within a 7-day window and requires preparations akin to initial loading doses. In addition to pharmacy resources and onsite storage requirements, the guidance points to patient scheduling and reminder systems, access (patient transportation, work constraints, parking), and most importantly, contingency plans for care (including oral bridging therapy) should a clinic be forced to shut down for any reason. Additional factors include billing protocols, insurance or third party authorizations, and provision of counseling and education training.
“Given that this is a completely new way of thinking among providers, we’re all learning together,” said David Koren, PharmD, MPH, a clinical pharmacy specialist in infectious diseases at Temple University, Philadelphia. “The guidelines provide a nice framework for taking the next step to operationalize these processes into practice, taking into account that barriers to implementation are still unknown.” Dr. Koren was not involved in the development of the guidelines.
Dr. DeHaan has disclosed no relevant financial relationships. Dr. Koren disclosed serving on a prior Advisory Panel for ViiV Healthcare US.
A version of this article first appeared on Medscape.com.
Treating bioterrorism-related plague: CDC issues new guidelines
The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.
Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.
The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
Key changes
Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”
On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.
The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.
There are additional oral options to conserve IV medications and supplies in a mass casualty event.
For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
Bubonic plague
Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.
Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.
Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.
Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
Pneumonic and septicemic plague
The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.
Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
Meningitis
About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.
Infection control
Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.
Bioterrorism
A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”
Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.
Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.
Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”
Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”
Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.
Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.
The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
Key changes
Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”
On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.
The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.
There are additional oral options to conserve IV medications and supplies in a mass casualty event.
For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
Bubonic plague
Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.
Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.
Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.
Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
Pneumonic and septicemic plague
The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.
Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
Meningitis
About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.
Infection control
Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.
Bioterrorism
A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”
Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.
Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.
Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”
Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”
Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.
Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.
The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
Key changes
Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”
On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.
The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.
There are additional oral options to conserve IV medications and supplies in a mass casualty event.
For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
Bubonic plague
Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.
Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.
Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.
Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
Pneumonic and septicemic plague
The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.
Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
Meningitis
About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.
Infection control
Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.
Bioterrorism
A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”
Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.
Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.
Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”
Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”
Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Thousands of patients were implanted with heart pumps that the FDA knew could be dangerous
John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
Warning signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A no-brainer”
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-led oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, not penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run its course”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
This article first appeared on Propublica.
John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
Warning signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A no-brainer”
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-led oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, not penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run its course”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
This article first appeared on Propublica.
John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball–sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas of 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died 2 days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they rely mostly on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient focused,” said Dr. William Maisel, director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make Geoffrey Martha, CEO, or Nnamdi Njoku, president of mechanical heart support, available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued: “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will provide technical support and troubleshooting for patients and medical staff. Medtronic said it will offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
Warning signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A no-brainer”
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-led oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, not penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run its course”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
This article first appeared on Propublica.
U.S. health system ranks last among 11 high-income countries
The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.
The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.
Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.
Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.
“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.
In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.
In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”
Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.
“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.
“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
High infant mortality, low life expectancy in U.S.
Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.
Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”
The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
U.S. excelled in only one category
The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.
The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.
The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.
New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
‘Too little, too late’: Key recommendations for U.S. to improve
Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.
“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.
He then summarized the team’s recommendations on how the United States can change course.
First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.
Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.
The United States must also improve access to care, he said.
“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.
Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”
Reducing income-related barriers is important as well, he said.
The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.
That could have implications for the COVID-19 response.
Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.
“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.
Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”
Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund.
A version of this article first appeared on Medscape.com.
The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.
The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.
Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.
Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.
“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.
In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.
In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”
Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.
“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.
“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
High infant mortality, low life expectancy in U.S.
Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.
Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”
The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
U.S. excelled in only one category
The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.
The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.
The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.
New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
‘Too little, too late’: Key recommendations for U.S. to improve
Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.
“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.
He then summarized the team’s recommendations on how the United States can change course.
First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.
Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.
The United States must also improve access to care, he said.
“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.
Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”
Reducing income-related barriers is important as well, he said.
The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.
That could have implications for the COVID-19 response.
Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.
“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.
Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”
Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund.
A version of this article first appeared on Medscape.com.
The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.
The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.
Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.
Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.
“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.
In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.
In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”
Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.
“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.
“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
High infant mortality, low life expectancy in U.S.
Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.
Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”
The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
U.S. excelled in only one category
The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.
The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.
The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.
New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
‘Too little, too late’: Key recommendations for U.S. to improve
Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.
“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.
He then summarized the team’s recommendations on how the United States can change course.
First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.
Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.
The United States must also improve access to care, he said.
“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.
Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”
Reducing income-related barriers is important as well, he said.
The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.
That could have implications for the COVID-19 response.
Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.
“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.
Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”
Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund.
A version of this article first appeared on Medscape.com.
Oncologists face nightmares every day with prior authorization
Editor’s note: Prior authorization has been flagged as the biggest payer-related cause of stress for U.S. oncologists. In one survey, 75% said prior authorization was their biggest burden, followed by coverage denials and appeals (62%). Another survey found that practices spent on average 16.4 hours a week dealing with prior authorizations.
Around 5% of my emails every day are from insurance companies denying my patients the treatments I have recommended. A part of every day is spent worrying about how I’m going to cover my patients’ therapy and what I need to order to make sure it doesn’t get delayed.
Many doctors are retiring because they don’t want to deal with this anymore. There are many times that I have thought about quitting for this reason. A partner of mine had a heart attack last year. He’s a few years older than I am – in his mid-50s – and that scared me. I actually had a CT angiogram just to make sure. They told me my heart is fine, but I worry because of all these frustrations every day. And I’m not alone. For every doctor I work with, it’s the same story, and it’s just ridiculous.
For example, I had a patient with a huge breast mass. My nurse got me the prior authorization for an emergency biopsy. I got back the results for estrogen and progesterone receptor status, but not the HER2-neu results because that test required another authorization.
Authorization shouldn’t be required for every single step. I understand if maybe you need to get an authorization to do something outside the standard of care or something that is unique or unheard of, but HER2-neu biopsy is standard of care and should not require additional authorization.
And the sad part is, that patient turned out to be HER2-neu positive. She lost 4 weeks just waiting for an authorization of a test that should be a no-brainer.
We cannot even do a blood count in our office before getting authorization from some insurances. This is a very important test when we give chemotherapy, and it’s very cheap.
And then another nightmare is if you want to give a patient growth factors when you see their blood count is going down. Sometimes the insurance company will say, “When they get neutropenic fever, we’ll allow it with the next cycle.” Why do I have to wait until the patient develops such a problem to start with a treatment that could avoid it? They may end up in the hospital.
I think I’m one of the more conservative doctors; I try to do everything scientifically and only order a test or a treatment if it’s indicated. But sometimes this guidance costs more money. For example, an insurance company may say to order a CT scan first and if you don’t find your answer, then get a PET scan.
So I order a CT scan, knowing it’s not going to help, and then I tell them, “Now I need a PET scan.” That’s another week delay and an extra cost that I don’t want the system to incur.
I’ve even had some issues with lung screening scans for smokers. This screening has reduced mortality by 20%; it should be a no-brainer to encourage smokers to do it because many of them may not even need chemotherapy if you find early-stage lung cancer. And the screening is not expensive, you can do it for $90 to $100. So why do we have to get authorization for that?
Sometimes I push back and request a “peer-to-peer,” where you challenge the decision of the insurance company and speak to one of their doctors. Out of 10 doctors, maybe three or four will do the peer-to-peer. The rest will give up because it’s so frustrating.
In one case, I wanted to modify a standard regimen and give only two out of three drugs because I thought the third would be too toxic. But the insurance company wouldn’t approve the regimen because the guidelines say you have to give three drugs.
Guidelines are guidance, they should not dictate how you treat an individual patient – there should be some allowance in there for a doctor’s discretion. If not, why do we even need doctors? We could just follow treatment regimens dictated by computers. They have to allow me to personalize the care that my patient deserves and make changes so that the treatment can be tolerated.
But then, I get that one patient whom I feel I really helped and I realize, “Okay, I can help more people.”
I had this one patient, a young, 40-year-old nurse with breast cancer – also HER2-neu positive. She’d had her surgery and finished her adjuvant chemotherapy. One of the things that you do as standard of care, after a year of trastuzumab, is you start them on neratinib. There are studies that show it improves progression-free survival if you give them an extra year of this drug as an adjuvant.
I prescribed the neratinib, but the insurance company denied it because the patient “did not have positive lymph nodes and was not considered high risk.” I told them, “That’s BS, that’s not what the indication is for.” I asked for a peer-to-peer and they said the policy did not allow for peer-to-peer. So, I made a big fuss about it. We appealed, and I finally spoke to a pharmacist who worked for the insurance company. I told him, “Why did you guys deny this? It’s standard of care.” He said, “Oh, I agree with you, this will be approved. And actually, we’re going to change the policy now.”
When that pharmacist told me they were going to change the policy, it was like someone gave me 1 million dollars. Because, you know what? I didn’t just help my patient; now other patients will also get it. The hope is that if you keep fighting for something, they will change it.
I think every doctor wants to do the best for their patients. It’s not like they don’t want to, but really, I am fortunate that I have the means to do it. We’re a big practice and we have dedicated staff who can help.
If you’re a small practice, it’s almost impossible to deal with this. I have two nurse practitioners, and a lot of their work is filling out paperwork for insurance companies.
We had a colleague, a solo practitioner, who would send us his patients with complicated therapies, because he couldn’t afford the time or the effort or the risk of not getting reimbursed. His practice could have paid out $100,000 for drugs and not get a reimbursement for a few months.
Even when an insurance company does give the preauthorization, there’s always this disclaimer that it doesn’t guarantee payment. If they find in the future that your patient didn’t meet the criteria, they can still deny payment.
If the insurers refuse coverage, we really work hard at getting patients free drugs, and most of the time, we manage to do that. We either look to charitable organizations, like the Leukemia and Lymphoma Society, or we look for rare disease societies or we go to the pharmaceutical company.
For really expensive drugs, pharmaceutical companies have a program where you can enroll the patient and they can help copay or even cover the drug. For less expensive drugs, it might not be a big problem, but for a drug that can cost $18,000 to $20,000 a month, that’s a big risk to take.
It’s confusing for patients, too. They get angry and frustrated, and that’s not good for their treatment, because attitude and psychology are very important. Sometimes they yell at us because they think it’s our fault. I encourage them to call their insurance companies themselves, and some of them do.
I don’t do it with every patient, but there are some more educated patients who are advocates, and if their condition is stable, I do encourage them to call their senators or congressmen or congresswomen to complain.
I don’t mind treating complicated patients. I don’t want to say I enjoy it, but I like challenges. That’s my field, that’s medicine, that’s what I’m supposed to do. But it’s really sad and frustrating that, when you want to treat a patient, you first have to look at their insurance to see how much care you can actually give them.
Maen Hussein, MD, is physician director of finance at Florida Cancer Specialists and Research Institute, Fort Myers. He is a board member of the Florida Cancer Specialists Foundation and sits on the board of directors for the Florida Society of Clinical Oncology.
A version of this article first appeared on Medscape.com.
Editor’s note: Prior authorization has been flagged as the biggest payer-related cause of stress for U.S. oncologists. In one survey, 75% said prior authorization was their biggest burden, followed by coverage denials and appeals (62%). Another survey found that practices spent on average 16.4 hours a week dealing with prior authorizations.
Around 5% of my emails every day are from insurance companies denying my patients the treatments I have recommended. A part of every day is spent worrying about how I’m going to cover my patients’ therapy and what I need to order to make sure it doesn’t get delayed.
Many doctors are retiring because they don’t want to deal with this anymore. There are many times that I have thought about quitting for this reason. A partner of mine had a heart attack last year. He’s a few years older than I am – in his mid-50s – and that scared me. I actually had a CT angiogram just to make sure. They told me my heart is fine, but I worry because of all these frustrations every day. And I’m not alone. For every doctor I work with, it’s the same story, and it’s just ridiculous.
For example, I had a patient with a huge breast mass. My nurse got me the prior authorization for an emergency biopsy. I got back the results for estrogen and progesterone receptor status, but not the HER2-neu results because that test required another authorization.
Authorization shouldn’t be required for every single step. I understand if maybe you need to get an authorization to do something outside the standard of care or something that is unique or unheard of, but HER2-neu biopsy is standard of care and should not require additional authorization.
And the sad part is, that patient turned out to be HER2-neu positive. She lost 4 weeks just waiting for an authorization of a test that should be a no-brainer.
We cannot even do a blood count in our office before getting authorization from some insurances. This is a very important test when we give chemotherapy, and it’s very cheap.
And then another nightmare is if you want to give a patient growth factors when you see their blood count is going down. Sometimes the insurance company will say, “When they get neutropenic fever, we’ll allow it with the next cycle.” Why do I have to wait until the patient develops such a problem to start with a treatment that could avoid it? They may end up in the hospital.
I think I’m one of the more conservative doctors; I try to do everything scientifically and only order a test or a treatment if it’s indicated. But sometimes this guidance costs more money. For example, an insurance company may say to order a CT scan first and if you don’t find your answer, then get a PET scan.
So I order a CT scan, knowing it’s not going to help, and then I tell them, “Now I need a PET scan.” That’s another week delay and an extra cost that I don’t want the system to incur.
I’ve even had some issues with lung screening scans for smokers. This screening has reduced mortality by 20%; it should be a no-brainer to encourage smokers to do it because many of them may not even need chemotherapy if you find early-stage lung cancer. And the screening is not expensive, you can do it for $90 to $100. So why do we have to get authorization for that?
Sometimes I push back and request a “peer-to-peer,” where you challenge the decision of the insurance company and speak to one of their doctors. Out of 10 doctors, maybe three or four will do the peer-to-peer. The rest will give up because it’s so frustrating.
In one case, I wanted to modify a standard regimen and give only two out of three drugs because I thought the third would be too toxic. But the insurance company wouldn’t approve the regimen because the guidelines say you have to give three drugs.
Guidelines are guidance, they should not dictate how you treat an individual patient – there should be some allowance in there for a doctor’s discretion. If not, why do we even need doctors? We could just follow treatment regimens dictated by computers. They have to allow me to personalize the care that my patient deserves and make changes so that the treatment can be tolerated.
But then, I get that one patient whom I feel I really helped and I realize, “Okay, I can help more people.”
I had this one patient, a young, 40-year-old nurse with breast cancer – also HER2-neu positive. She’d had her surgery and finished her adjuvant chemotherapy. One of the things that you do as standard of care, after a year of trastuzumab, is you start them on neratinib. There are studies that show it improves progression-free survival if you give them an extra year of this drug as an adjuvant.
I prescribed the neratinib, but the insurance company denied it because the patient “did not have positive lymph nodes and was not considered high risk.” I told them, “That’s BS, that’s not what the indication is for.” I asked for a peer-to-peer and they said the policy did not allow for peer-to-peer. So, I made a big fuss about it. We appealed, and I finally spoke to a pharmacist who worked for the insurance company. I told him, “Why did you guys deny this? It’s standard of care.” He said, “Oh, I agree with you, this will be approved. And actually, we’re going to change the policy now.”
When that pharmacist told me they were going to change the policy, it was like someone gave me 1 million dollars. Because, you know what? I didn’t just help my patient; now other patients will also get it. The hope is that if you keep fighting for something, they will change it.
I think every doctor wants to do the best for their patients. It’s not like they don’t want to, but really, I am fortunate that I have the means to do it. We’re a big practice and we have dedicated staff who can help.
If you’re a small practice, it’s almost impossible to deal with this. I have two nurse practitioners, and a lot of their work is filling out paperwork for insurance companies.
We had a colleague, a solo practitioner, who would send us his patients with complicated therapies, because he couldn’t afford the time or the effort or the risk of not getting reimbursed. His practice could have paid out $100,000 for drugs and not get a reimbursement for a few months.
Even when an insurance company does give the preauthorization, there’s always this disclaimer that it doesn’t guarantee payment. If they find in the future that your patient didn’t meet the criteria, they can still deny payment.
If the insurers refuse coverage, we really work hard at getting patients free drugs, and most of the time, we manage to do that. We either look to charitable organizations, like the Leukemia and Lymphoma Society, or we look for rare disease societies or we go to the pharmaceutical company.
For really expensive drugs, pharmaceutical companies have a program where you can enroll the patient and they can help copay or even cover the drug. For less expensive drugs, it might not be a big problem, but for a drug that can cost $18,000 to $20,000 a month, that’s a big risk to take.
It’s confusing for patients, too. They get angry and frustrated, and that’s not good for their treatment, because attitude and psychology are very important. Sometimes they yell at us because they think it’s our fault. I encourage them to call their insurance companies themselves, and some of them do.
I don’t do it with every patient, but there are some more educated patients who are advocates, and if their condition is stable, I do encourage them to call their senators or congressmen or congresswomen to complain.
I don’t mind treating complicated patients. I don’t want to say I enjoy it, but I like challenges. That’s my field, that’s medicine, that’s what I’m supposed to do. But it’s really sad and frustrating that, when you want to treat a patient, you first have to look at their insurance to see how much care you can actually give them.
Maen Hussein, MD, is physician director of finance at Florida Cancer Specialists and Research Institute, Fort Myers. He is a board member of the Florida Cancer Specialists Foundation and sits on the board of directors for the Florida Society of Clinical Oncology.
A version of this article first appeared on Medscape.com.
Editor’s note: Prior authorization has been flagged as the biggest payer-related cause of stress for U.S. oncologists. In one survey, 75% said prior authorization was their biggest burden, followed by coverage denials and appeals (62%). Another survey found that practices spent on average 16.4 hours a week dealing with prior authorizations.
Around 5% of my emails every day are from insurance companies denying my patients the treatments I have recommended. A part of every day is spent worrying about how I’m going to cover my patients’ therapy and what I need to order to make sure it doesn’t get delayed.
Many doctors are retiring because they don’t want to deal with this anymore. There are many times that I have thought about quitting for this reason. A partner of mine had a heart attack last year. He’s a few years older than I am – in his mid-50s – and that scared me. I actually had a CT angiogram just to make sure. They told me my heart is fine, but I worry because of all these frustrations every day. And I’m not alone. For every doctor I work with, it’s the same story, and it’s just ridiculous.
For example, I had a patient with a huge breast mass. My nurse got me the prior authorization for an emergency biopsy. I got back the results for estrogen and progesterone receptor status, but not the HER2-neu results because that test required another authorization.
Authorization shouldn’t be required for every single step. I understand if maybe you need to get an authorization to do something outside the standard of care or something that is unique or unheard of, but HER2-neu biopsy is standard of care and should not require additional authorization.
And the sad part is, that patient turned out to be HER2-neu positive. She lost 4 weeks just waiting for an authorization of a test that should be a no-brainer.
We cannot even do a blood count in our office before getting authorization from some insurances. This is a very important test when we give chemotherapy, and it’s very cheap.
And then another nightmare is if you want to give a patient growth factors when you see their blood count is going down. Sometimes the insurance company will say, “When they get neutropenic fever, we’ll allow it with the next cycle.” Why do I have to wait until the patient develops such a problem to start with a treatment that could avoid it? They may end up in the hospital.
I think I’m one of the more conservative doctors; I try to do everything scientifically and only order a test or a treatment if it’s indicated. But sometimes this guidance costs more money. For example, an insurance company may say to order a CT scan first and if you don’t find your answer, then get a PET scan.
So I order a CT scan, knowing it’s not going to help, and then I tell them, “Now I need a PET scan.” That’s another week delay and an extra cost that I don’t want the system to incur.
I’ve even had some issues with lung screening scans for smokers. This screening has reduced mortality by 20%; it should be a no-brainer to encourage smokers to do it because many of them may not even need chemotherapy if you find early-stage lung cancer. And the screening is not expensive, you can do it for $90 to $100. So why do we have to get authorization for that?
Sometimes I push back and request a “peer-to-peer,” where you challenge the decision of the insurance company and speak to one of their doctors. Out of 10 doctors, maybe three or four will do the peer-to-peer. The rest will give up because it’s so frustrating.
In one case, I wanted to modify a standard regimen and give only two out of three drugs because I thought the third would be too toxic. But the insurance company wouldn’t approve the regimen because the guidelines say you have to give three drugs.
Guidelines are guidance, they should not dictate how you treat an individual patient – there should be some allowance in there for a doctor’s discretion. If not, why do we even need doctors? We could just follow treatment regimens dictated by computers. They have to allow me to personalize the care that my patient deserves and make changes so that the treatment can be tolerated.
But then, I get that one patient whom I feel I really helped and I realize, “Okay, I can help more people.”
I had this one patient, a young, 40-year-old nurse with breast cancer – also HER2-neu positive. She’d had her surgery and finished her adjuvant chemotherapy. One of the things that you do as standard of care, after a year of trastuzumab, is you start them on neratinib. There are studies that show it improves progression-free survival if you give them an extra year of this drug as an adjuvant.
I prescribed the neratinib, but the insurance company denied it because the patient “did not have positive lymph nodes and was not considered high risk.” I told them, “That’s BS, that’s not what the indication is for.” I asked for a peer-to-peer and they said the policy did not allow for peer-to-peer. So, I made a big fuss about it. We appealed, and I finally spoke to a pharmacist who worked for the insurance company. I told him, “Why did you guys deny this? It’s standard of care.” He said, “Oh, I agree with you, this will be approved. And actually, we’re going to change the policy now.”
When that pharmacist told me they were going to change the policy, it was like someone gave me 1 million dollars. Because, you know what? I didn’t just help my patient; now other patients will also get it. The hope is that if you keep fighting for something, they will change it.
I think every doctor wants to do the best for their patients. It’s not like they don’t want to, but really, I am fortunate that I have the means to do it. We’re a big practice and we have dedicated staff who can help.
If you’re a small practice, it’s almost impossible to deal with this. I have two nurse practitioners, and a lot of their work is filling out paperwork for insurance companies.
We had a colleague, a solo practitioner, who would send us his patients with complicated therapies, because he couldn’t afford the time or the effort or the risk of not getting reimbursed. His practice could have paid out $100,000 for drugs and not get a reimbursement for a few months.
Even when an insurance company does give the preauthorization, there’s always this disclaimer that it doesn’t guarantee payment. If they find in the future that your patient didn’t meet the criteria, they can still deny payment.
If the insurers refuse coverage, we really work hard at getting patients free drugs, and most of the time, we manage to do that. We either look to charitable organizations, like the Leukemia and Lymphoma Society, or we look for rare disease societies or we go to the pharmaceutical company.
For really expensive drugs, pharmaceutical companies have a program where you can enroll the patient and they can help copay or even cover the drug. For less expensive drugs, it might not be a big problem, but for a drug that can cost $18,000 to $20,000 a month, that’s a big risk to take.
It’s confusing for patients, too. They get angry and frustrated, and that’s not good for their treatment, because attitude and psychology are very important. Sometimes they yell at us because they think it’s our fault. I encourage them to call their insurance companies themselves, and some of them do.
I don’t do it with every patient, but there are some more educated patients who are advocates, and if their condition is stable, I do encourage them to call their senators or congressmen or congresswomen to complain.
I don’t mind treating complicated patients. I don’t want to say I enjoy it, but I like challenges. That’s my field, that’s medicine, that’s what I’m supposed to do. But it’s really sad and frustrating that, when you want to treat a patient, you first have to look at their insurance to see how much care you can actually give them.
Maen Hussein, MD, is physician director of finance at Florida Cancer Specialists and Research Institute, Fort Myers. He is a board member of the Florida Cancer Specialists Foundation and sits on the board of directors for the Florida Society of Clinical Oncology.
A version of this article first appeared on Medscape.com.
WHO calls for pause on booster doses
The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.
WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.
“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”
So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.
“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.
But not everyone agrees.
Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.
“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”
Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.
Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”
He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.
“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.
“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.
“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.
A version of this article first appeared on WebMD.com.
The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.
WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.
“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”
So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.
“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.
But not everyone agrees.
Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.
“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”
Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.
Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”
He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.
“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.
“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.
“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.
A version of this article first appeared on WebMD.com.
The World Health Organization is calling on wealthy nations to wait to give their citizens booster doses of COVID-19 vaccines until at least the end of September to give more people in other countries a chance to get a first dose of these lifesaving shots.
WHO Director-General Tedros Ghebreyesus, PhD, said that more than 80% of the 4 billion vaccine doses given around the world had been distributed to high-income countries, though they represent less than half the world’s population.
“I understand the concern of all governments to protect their people from the Delta variant,” Dr. Ghebreyesus said. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected.”
So far, high-income countries have given about 100 vaccine doses for every 100 people, while low-income countries have given just 1.5 doses for every 100 people.
“Which means, in some of the most vulnerable countries in the world with the weakest health systems, health care workers are working without protection. … the older populations remain at high risk,” said Bruce Aylward, MD, the WHO’s senior adviser on organizational change.
But not everyone agrees.
Leana Wen, MD, a visiting professor at the Milken Institute School of Public Health at George Washington University, Washington, said there are doses already in the United States that won’t last long enough to be sent elsewhere.
“Yes, we need to get vaccines to the world (which also includes helping with distribution, not just supply), but there are doses expiring here in the U.S.,” she said on Twitter. “Why not allow those immunosuppressed to receive them?”
Israel became the first country to start giving some residents booster shots on Sunday, offering extra doses to seniors who are more than 5 months past their last vaccinations. On Monday, Germany announced it would also give booster doses to vulnerable patients, such as nursing home residents, beginning in September.
Dr. Aylward said the moratorium was all about “trying to put a hold on those policies until and unless we get the rest of the world caught up.”
He said it’s clear from the emergence of variant after variant that if we don’t stop the transmission of the virus around the world, the pandemic will continue to put pressure on the vaccines, making them less and less effective.
“We cannot get out of it unless the whole world gets out of it together,” Dr. Aylward said.
“We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries,” Dr. Ghebreyesus said, asking leaders of high-income countries to wait on distributing booster doses until at least 10% of the world’s population is vaccinated.
“To make that happen, we need everyone’s cooperation, especially the handful of countries and companies that control the global supply of vaccines,” he said.
A version of this article first appeared on WebMD.com.
Will the Delta variant peak and then burn out?
When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.
Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.
Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.
Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.
Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.
The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.
So the question of the summer has become: “When will Delta burn out here?”
Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:
- Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
- Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
- September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
- Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
- Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”
The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
What a difference vaccination may make
An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)
But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.
Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.
Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.
“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.
It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?
That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
Roles of public policy, individual behavior
Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.
“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.
The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.
The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”
Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.
Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.
“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
Once the Delta variant subsides, what’s next?
It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.
There’s also Delta-plus, just found in two people in South Korea.
Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
On the horizon: Variant-proof vaccines
What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.
Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.
The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.
A version of this article first appeared on WebMD.com.
When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.
Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.
Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.
Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.
Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.
The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.
So the question of the summer has become: “When will Delta burn out here?”
Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:
- Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
- Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
- September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
- Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
- Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”
The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
What a difference vaccination may make
An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)
But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.
Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.
Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.
“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.
It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?
That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
Roles of public policy, individual behavior
Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.
“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.
The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.
The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”
Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.
Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.
“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
Once the Delta variant subsides, what’s next?
It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.
There’s also Delta-plus, just found in two people in South Korea.
Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
On the horizon: Variant-proof vaccines
What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.
Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.
The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.
A version of this article first appeared on WebMD.com.
When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.
Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.
Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.
Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.
Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.
The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.
So the question of the summer has become: “When will Delta burn out here?”
Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:
- Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
- Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
- September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
- Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
- Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”
The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
What a difference vaccination may make
An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)
But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.
Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.
Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.
“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.
It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?
That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
Roles of public policy, individual behavior
Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.
“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.
The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.
The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”
Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.
Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.
“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
Once the Delta variant subsides, what’s next?
It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.
There’s also Delta-plus, just found in two people in South Korea.
Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
On the horizon: Variant-proof vaccines
What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.
Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.
The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.
A version of this article first appeared on WebMD.com.
Analysis: Don’t want a vaccine? Be prepared to pay more for insurance
America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.
The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.
And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.
So, how about an economic argument? Get a COVID shot to protect your wallet.
Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”
Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.
In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.
More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.
For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.
A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.
But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.
The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.
The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.
Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.
That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.
Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.
KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.
But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.
The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.
And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.
So, how about an economic argument? Get a COVID shot to protect your wallet.
Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”
Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.
In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.
More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.
For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.
A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.
But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.
The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.
The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.
Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.
That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.
Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.
KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.
But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
America’s COVID-19 vaccination rate is around 60% for ages 12 and up. That’s not enough to reach so-called herd immunity, and in states like Missouri – where a number of counties have vaccination rates under 25% – hospitals are overwhelmed by serious outbreaks of the more contagious delta variant.
The vaccine resisters offer all kinds of reasons for refusing the free shots and for ignoring efforts to nudge them to get inoculated. Campaigns urging Americans to get vaccinated for their health, for their grandparents, for their neighbors, or to get free doughnuts or a free joint haven’t done the trick. States have even held lotteries with a chance to win millions or a college scholarship.
And yet there are still huge numbers of unvaccinated people. Federal, state, and municipal governments as well as private businesses continue to largely avoid mandates for their employees out of fears they will provoke a backlash.
So, how about an economic argument? Get a COVID shot to protect your wallet.
Getting hospitalized with COVID in the United States typically generates huge bills. Those submitted by COVID patients to the NPR-Kaiser Health News “Bill of the Month” project include a $17,000 bill for a brief hospital stay in Marietta, Ga., (reduced to about $4,000 for an uninsured patient under a “charity care” policy); a $104,000 bill for a 14-day hospitalization in Miami for an uninsured man; and a bill for possibly hundreds of thousands for a 2-week hospital stay – some of it on a ventilator – for a foreign tourist in Hawaii whose travel health insurance contained a “pandemic exclusion.”
Even though insurance companies negotiate lower prices and cover much of the cost of care, an over-$1,000 out-of-pocket bill for a deductible – plus more for copays and possibly some out-of-network care – should be a pretty scary incentive.
In 2020, before COVID vaccines, most major private insurers waived patient payments – from coinsurance to deductibles – for COVID treatment. But many, if not most, have allowed that policy to lapse. Aetna, for example, ended that policy Feb. 28; UnitedHealthcare began rolling back its waivers late last year and ended them by the end of March.
More than 97% of hospitalized patients last month were unvaccinated. Though the vaccines will not necessarily prevent you from catching the coronavirus, they are highly effective at assuring you will have a milder case and are kept out of the hospital.
For this reason, there’s logic behind insurers’ waiver rollback: Why should patients be kept financially unharmed from what is now a preventable hospitalization, thanks to a vaccine that the government paid for and made available free of charge? It is now in many drugstores, it’s popping up at highway rest stops and bus stops, and it can be delivered and administered at home in parts of the country.
A harsher society might impose tough penalties on people who refuse vaccinations and contract the virus. Recently, the National Football League decreed that teams will forfeit a game canceled because of a COVID outbreak among unvaccinated players – and neither team’s players will be paid.
But insurers could try to do more, like penalizing the unvaccinated. And there is precedent. Already, some policies won’t cover treatment necessitated by what insurance companies deem risky behavior, such as scuba diving and rock climbing.
The Affordable Care Act allows insurers to charge smokers up to 50% more than what nonsmokers pay for some health plans. Four-fifths of states follow that protocol, though most employer-based plans do not do so. In 49 states, people caught driving without auto insurance face fines, confiscation of their car, loss of their license, and even jail. And reckless drivers pay more for insurance.
The logic behind the policies is that the offenders’ behavior can hurt others and costs society a lot of money. If a person decides not to get vaccinated and contracts a bad case of COVID, they are not only exposing others in their workplace or neighborhoods; the tens or hundreds of thousands spent on their care could mean higher premiums for others as well in their insurance plans next year. What’s more, outbreaks in low-vaccination regions could help breed more vaccine-resistant variants that affect everyone.
Yes, we often cover people whose habits may have contributed to their illness – insurance regularly pays for drug and alcohol rehab and cancer treatment for smokers.
That’s one reason, perhaps, that insurers too have so far favored carrots, not sticks, to get people vaccinated. Some private insurers are offering people who get vaccinated a credit toward their medical premiums, or gift cards and sweepstakes prizes, according to America’s Health Insurance Plans, an industry organization.
Tough love might be easier if the Food and Drug Administration gives vaccines full approval, rather than the current emergency use authorization. Even so, taxpayer-financed plans like Medicaid and Medicare must treat everyone the same and would encounter a lengthy process to secure federal waivers to experiment with incentives, according to Larry Levitt, executive vice president of Kaiser Family Foundation. These programs cannot charge different rates to different patients in a state.
KFF polling shows such incentives are of limited value, anyway. Many holdouts say they will be vaccinated only if required to do so by their employers.
But what if the financial cost of not getting vaccinated were just too high? If patients thought about the price they might need to pay for their own care, maybe they would reconsider remaining unprotected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.