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‘Children are not little adults’ and need special protection during heat waves
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
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.
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
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.
After more than a week of record-breaking temperatures across much of the country, public health experts are cautioning that children are more susceptible to heat illness than adults are – even more so when they’re on the athletic field, living without air conditioning, or waiting in a parked car.
Cases of heat-related illness are rising with average air temperatures, and experts say almost half of those getting sick are children. The reason is twofold: Children’s bodies have more trouble regulating temperature than do those of adults, and they rely on adults to help protect them from overheating.
Parents, coaches, and other caretakers, who can experience the same heat very differently from the way children do, may struggle to identify a dangerous situation or catch the early symptoms of heat-related illness in children.
“Children are not little adults,” said Dr. Aaron Bernstein, a pediatric hospitalist at Boston Children’s Hospital.
Jan Null, a meteorologist in California, recalled being surprised at the effect of heat in a car. It was 86 degrees on a July afternoon more than 2 decades ago when an infant in San Jose was forgotten in a parked car and died of heatstroke.
Mr. Null said a reporter asked him after the death, “How hot could it have gotten in that car?”
Mr. Null’s research with two emergency doctors at Stanford University eventually produced a startling answer. Within an hour, the temperature in that car could have exceeded 120 degrees Fahrenheit. Their work revealed that a quick errand can be dangerous for a child left behind in the car – even for less than 15 minutes, even with the windows cracked, and even on a mild day.
As record heat becomes more frequent, posing serious risks even to healthy adults, the number of cases of heat-related illnesses has gone up, including among children. Those most at risk are young children in parked vehicles and adolescents returning to school and participating in sports during the hottest days of the year.
More than 9,000 high school athletes are treated for heat-related illnesses every year.
Heat-related illnesses occur when exposure to high temperatures and humidity, which can be intensified by physical exertion, overwhelms the body’s ability to cool itself. Cases range from mild, like benign heat rashes in infants, to more serious, when the body’s core temperature increases. That can lead to life-threatening instances of heatstroke, diagnosed once the body temperature rises above 104 degrees, potentially causing organ failure.
Prevention is key. Experts emphasize that drinking plenty of water, avoiding the outdoors during the hot midday and afternoon hours, and taking it slow when adjusting to exercise are the most effective ways to avoid getting sick.
Children’s bodies take longer to increase sweat production and otherwise acclimatize in a warm environment than adults’ do, research shows. Young children are more susceptible to dehydration because a larger percentage of their body weight is water.
Infants and younger children have more trouble regulating their body temperature, in part because they often don’t recognize when they should drink more water or remove clothing to cool down. A 1995 study showed that young children who spent 30 minutes in a 95-degree room saw their core temperatures rise significantly higher and faster than their mothers’ – even though they sweat more than adults do relative to their size.
Pediatricians advise caretakers to monitor how much water children consume and encourage them to drink before they ask for it. Thirst indicates the body is already dehydrated.
They should dress children in light-colored, lightweight clothes; limit outdoor time during the hottest hours; and look for ways to cool down, such as by visiting an air-conditioned place like a library, taking a cool bath, or going for a swim.
To address the risks to student athletes, the National Athletic Trainers’ Association recommends that high school athletes acclimatize by gradually building their activity over the course of 2 weeks when returning to their sport for a new season – including by slowly stepping up the amount of any protective equipment they wear.
“You’re gradually increasing that intensity over a week to 2 weeks so your body can get used to the heat,” said Kathy Dieringer, president of NATA.
Warning signs and solutions
Experts note a flushed face, fatigue, muscle cramps, headache, dizziness, vomiting, and a lot of sweating are among the symptoms of heat exhaustion, which can develop into heatstroke if untreated. A doctor should be notified if symptoms worsen, such as if the child seems disoriented or cannot drink.
Taking immediate steps to cool a child experiencing heat exhaustion or heatstroke is critical. The child should be taken to a shaded or cool area; be given cool fluids with salt, like sports drinks; and have any sweaty or heavy garments removed.
For adolescents, being submerged in an ice bath is the most effective way to cool the body, while younger children can be wrapped in cold, wet towels or misted with lukewarm water and placed in front of a fan.
Although children’s deaths in parked cars have been well documented, the tragic incidents continue to occur. According to federal statistics, 23 children died of vehicular heatstroke in 2021. Mr. Null, who collects his own data, said 13 children have died so far this year.
Caretakers should never leave children alone in a parked car, Mr. Null said. Take steps to prevent young children from entering the car themselves and becoming trapped, including locking the car while it’s parked at home.
More than half of cases of vehicular pediatric heatstroke occur because a caretaker accidentally left a child behind, he said. While in-car technology reminding adults to check their back seats has become more common, only a fraction of vehicles have it, requiring parents to come up with their own methods, like leaving a stuffed animal in the front seat.
The good news, Mr. Null said, is that simple behavioral changes can protect youngsters. “This is preventable in 100% of the cases,” he said.
A lopsided risk
People living in low-income areas fare worse when temperatures climb. Access to air conditioning, which includes the ability to afford the electricity bill, is a serious health concern.
A study of heat in urban areas released last year showed that low-income neighborhoods and communities of color experience much higher temperatures than those of wealthier, White residents. In more impoverished areas during the summer, temperatures can be as much as 7 degrees Fahrenheit warmer.
The study’s authors said their findings in the United States reflect that “the legacy of redlining looms large,” referring to a federal housing policy that refused to insure mortgages in or near predominantly Black neighborhoods.
“These areas have less tree canopy, more streets, and higher building densities, meaning that in addition to their other racist outcomes, redlining policies directly codified into law existing disparity in urban land use and reinforced urban design choices that magnify urban heating into the present,” they concluded.
Dr. Bernstein, who leads Harvard’s Center for Climate, Health, and the Global Environment, coauthored a commentary in JAMA arguing that advancing health equity is critical to action on climate change.
The center works with front-line health clinics to help their predominantly low-income patients respond to the health impacts of climate change. Federally backed clinics alone provide care to about 30 million Americans, including many children, he said.
Dr. Bernstein also recently led a nationwide study that found that from May through September, days with higher temperatures are associated with more visits to children’s hospital emergency rooms. Many visits were more directly linked to heat, although the study also pointed to how high temperatures can exacerbate existing health conditions such as neurological disorders.
“Children are more vulnerable to climate change through how these climate shocks reshape the world in which they grow up,” Dr. Bernstein said.
Helping people better understand the health risks of extreme heat and how to protect themselves and their families are among the public health system’s major challenges, experts said.
The National Weather Service’s heat alert system is mainly based on the heat index, a measure of how hot it feels when relative humidity is factored in with air temperature.
But the alerts are not related to effects on health, said Kathy Baughman McLeod, director of the Adrienne Arsht-Rockefeller Foundation Resilience Center. By the time temperatures rise to the level that a weather alert is issued, many vulnerable people – like children, pregnant women, and the elderly – may already be experiencing heat exhaustion or heatstroke.
The center developed a new heat alert system, which is being tested in Seville, Spain, historically one of the hottest cities in Europe.
The system marries metrics such as air temperature and humidity with public health data to categorize heat waves and, when they are serious enough, give them names – making it easier for people to understand heat as an environmental threat that requires prevention measures.
The categories are determined through a metric known as excess deaths, which compares how many people died on a day with the forecast temperature versus an average day. That may help health officials understand how severe a heat wave is expected to be and make informed recommendations to the public based on risk factors such as age or medical history.
The health-based alert system would also allow officials to target caretakers of children and seniors through school systems, preschools, and senior centers, Ms. Baughman McLeod said.
Giving people better ways to conceptualize heat is critical, she said.
“It’s not dramatic. It doesn’t rip the roof off of your house,” Ms. Baughman McLeod said. “It’s silent and invisible.”
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.
Health care stayed front and center at Democratic debate
This time, it wasn’t just about Medicare-for-all.
Voters got a better look at Democrats’ health care priorities on Tuesday, as
While the debate began on the topic of impeaching President Trump, Sen. Bernie Sanders of Vermont soon steered the discussion back to kitchen-table issues.
“I think what would be a disaster, if the American people believe that all we were doing is taking on Trump,” he said. “We’re forgetting that 87 million Americans are uninsured or underinsured.”
That was only the beginning of a series of health care conversations that lasted through much of the three-hour debate.
With Sen. Elizabeth Warren of Massachusetts polling in second place before the night began, she was pressed to offer more details about what Medicare-for-all would look like under her leadership – in particular, whether she would raise taxes to pay for it.
“I have made clear what my principles are here,” she said. “That is, costs will go up for the wealthy and for big corporations, and for hardworking, middle-class families, costs will go down.”
But Mayor Pete Buttigieg of South Bend, Ind., pushed back, pointing out that, unlike Sen. Sanders – who has said taxes would increase to pay for his universal health care plan – she had not actually said whether she would raise taxes.
“Your signature is to have a plan for everything, except this,” Mr. Buttigieg said. “No plan has been laid out to explain how a multitrillion-dollar hole in this plan that Sen. Warren is putting forward is supposed to get filled in.”
Sen. Amy Klobuchar of Minnesota challenged the practicality of focusing on such a sweeping overhaul as Medicare-for-all. She pushed her support for a public option and noted the importance of issues that get less attention, like long-term care.
“The difference between a plan and a pipe dream is something that you can actually get done,” Sen. Klobuchar said.
But Sen. Warren stood her ground. When she was studying bankruptcy as a professor at Harvard Law School, she said, she noticed that two out of three families that went bankrupt after a medical problem had health insurance. The problem is cost, she said: “That is why hardworking people go broke.”
The candidates also staked their claim on two issues that are critically important to Democratic voters: strengthening gun control measures and guaranteeing access to reproductive health care.
Former Vice President Joe Biden trumpeted his role in securing the now-lapsed assault weapons ban in 1994. Among others, Sen. Kamala Harris of California called for a “comprehensive” background check requirement and a ban on the importation of assault weapons.
And one by one, the candidates vowed to codify abortion access, especially in light of recent conservative attacks in a number of states on the premise of the Supreme Court’s Roe v. Wade decision.
“It’s not an exaggeration to say women will die because these Republican legislatures in these various states who are out of touch with America are telling women what to do with their bodies,” Sen. Harris said, a reference to crackdowns on abortion access in many Republican-controlled states.
After pointing out earlier in the evening that two Planned Parenthood clinics in Ohio recently closed because of a Trump administration policy change, Sen. Cory Booker of New Jersey said he would create an office of reproductive freedom and reproductive rights in his White House.
“It’s an assault on the most fundamental ideal that human beings should control their own body,” Sen. Booker said.
And addressing the opioid crisis, blamed for lowering life expectancy in the United States, many of the candidates called outright for jailing the executives of opioid manufacturers, whom Sen. Harris called “nothing more than some high-level dope dealers.”
“The people who should pay for the treatment are the very people that got people hooked and killed them in the first place,” she said.
The evening was also Sen. Sanders’ first appearance on the debate stage since he had a heart attack and underwent heart surgery just weeks ago. Asked about his health, he seemed impatient: “I’m healthy. I’m feeling great,” Sen. Sanders said as he brought the conversation back to policy.
The debate took place in Westerville, Ohio, a traditionally conservative suburb of Columbus that had turned blue in recent years – a nod to Democrats’ hopes of winning with the support of suburban voters in 2020.
And with those 12 Democrats standing elbow-to-elbow, the debate hosted by CNN and the New York Times had an unusual distinction: the most candidates to ever appear onstage at a presidential debate.
The fifth Democratic debate is scheduled for Nov. 20. The Democratic National Committee plans to hold 12 primary debates in total.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
This time, it wasn’t just about Medicare-for-all.
Voters got a better look at Democrats’ health care priorities on Tuesday, as
While the debate began on the topic of impeaching President Trump, Sen. Bernie Sanders of Vermont soon steered the discussion back to kitchen-table issues.
“I think what would be a disaster, if the American people believe that all we were doing is taking on Trump,” he said. “We’re forgetting that 87 million Americans are uninsured or underinsured.”
That was only the beginning of a series of health care conversations that lasted through much of the three-hour debate.
With Sen. Elizabeth Warren of Massachusetts polling in second place before the night began, she was pressed to offer more details about what Medicare-for-all would look like under her leadership – in particular, whether she would raise taxes to pay for it.
“I have made clear what my principles are here,” she said. “That is, costs will go up for the wealthy and for big corporations, and for hardworking, middle-class families, costs will go down.”
But Mayor Pete Buttigieg of South Bend, Ind., pushed back, pointing out that, unlike Sen. Sanders – who has said taxes would increase to pay for his universal health care plan – she had not actually said whether she would raise taxes.
“Your signature is to have a plan for everything, except this,” Mr. Buttigieg said. “No plan has been laid out to explain how a multitrillion-dollar hole in this plan that Sen. Warren is putting forward is supposed to get filled in.”
Sen. Amy Klobuchar of Minnesota challenged the practicality of focusing on such a sweeping overhaul as Medicare-for-all. She pushed her support for a public option and noted the importance of issues that get less attention, like long-term care.
“The difference between a plan and a pipe dream is something that you can actually get done,” Sen. Klobuchar said.
But Sen. Warren stood her ground. When she was studying bankruptcy as a professor at Harvard Law School, she said, she noticed that two out of three families that went bankrupt after a medical problem had health insurance. The problem is cost, she said: “That is why hardworking people go broke.”
The candidates also staked their claim on two issues that are critically important to Democratic voters: strengthening gun control measures and guaranteeing access to reproductive health care.
Former Vice President Joe Biden trumpeted his role in securing the now-lapsed assault weapons ban in 1994. Among others, Sen. Kamala Harris of California called for a “comprehensive” background check requirement and a ban on the importation of assault weapons.
And one by one, the candidates vowed to codify abortion access, especially in light of recent conservative attacks in a number of states on the premise of the Supreme Court’s Roe v. Wade decision.
“It’s not an exaggeration to say women will die because these Republican legislatures in these various states who are out of touch with America are telling women what to do with their bodies,” Sen. Harris said, a reference to crackdowns on abortion access in many Republican-controlled states.
After pointing out earlier in the evening that two Planned Parenthood clinics in Ohio recently closed because of a Trump administration policy change, Sen. Cory Booker of New Jersey said he would create an office of reproductive freedom and reproductive rights in his White House.
“It’s an assault on the most fundamental ideal that human beings should control their own body,” Sen. Booker said.
And addressing the opioid crisis, blamed for lowering life expectancy in the United States, many of the candidates called outright for jailing the executives of opioid manufacturers, whom Sen. Harris called “nothing more than some high-level dope dealers.”
“The people who should pay for the treatment are the very people that got people hooked and killed them in the first place,” she said.
The evening was also Sen. Sanders’ first appearance on the debate stage since he had a heart attack and underwent heart surgery just weeks ago. Asked about his health, he seemed impatient: “I’m healthy. I’m feeling great,” Sen. Sanders said as he brought the conversation back to policy.
The debate took place in Westerville, Ohio, a traditionally conservative suburb of Columbus that had turned blue in recent years – a nod to Democrats’ hopes of winning with the support of suburban voters in 2020.
And with those 12 Democrats standing elbow-to-elbow, the debate hosted by CNN and the New York Times had an unusual distinction: the most candidates to ever appear onstage at a presidential debate.
The fifth Democratic debate is scheduled for Nov. 20. The Democratic National Committee plans to hold 12 primary debates in total.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
This time, it wasn’t just about Medicare-for-all.
Voters got a better look at Democrats’ health care priorities on Tuesday, as
While the debate began on the topic of impeaching President Trump, Sen. Bernie Sanders of Vermont soon steered the discussion back to kitchen-table issues.
“I think what would be a disaster, if the American people believe that all we were doing is taking on Trump,” he said. “We’re forgetting that 87 million Americans are uninsured or underinsured.”
That was only the beginning of a series of health care conversations that lasted through much of the three-hour debate.
With Sen. Elizabeth Warren of Massachusetts polling in second place before the night began, she was pressed to offer more details about what Medicare-for-all would look like under her leadership – in particular, whether she would raise taxes to pay for it.
“I have made clear what my principles are here,” she said. “That is, costs will go up for the wealthy and for big corporations, and for hardworking, middle-class families, costs will go down.”
But Mayor Pete Buttigieg of South Bend, Ind., pushed back, pointing out that, unlike Sen. Sanders – who has said taxes would increase to pay for his universal health care plan – she had not actually said whether she would raise taxes.
“Your signature is to have a plan for everything, except this,” Mr. Buttigieg said. “No plan has been laid out to explain how a multitrillion-dollar hole in this plan that Sen. Warren is putting forward is supposed to get filled in.”
Sen. Amy Klobuchar of Minnesota challenged the practicality of focusing on such a sweeping overhaul as Medicare-for-all. She pushed her support for a public option and noted the importance of issues that get less attention, like long-term care.
“The difference between a plan and a pipe dream is something that you can actually get done,” Sen. Klobuchar said.
But Sen. Warren stood her ground. When she was studying bankruptcy as a professor at Harvard Law School, she said, she noticed that two out of three families that went bankrupt after a medical problem had health insurance. The problem is cost, she said: “That is why hardworking people go broke.”
The candidates also staked their claim on two issues that are critically important to Democratic voters: strengthening gun control measures and guaranteeing access to reproductive health care.
Former Vice President Joe Biden trumpeted his role in securing the now-lapsed assault weapons ban in 1994. Among others, Sen. Kamala Harris of California called for a “comprehensive” background check requirement and a ban on the importation of assault weapons.
And one by one, the candidates vowed to codify abortion access, especially in light of recent conservative attacks in a number of states on the premise of the Supreme Court’s Roe v. Wade decision.
“It’s not an exaggeration to say women will die because these Republican legislatures in these various states who are out of touch with America are telling women what to do with their bodies,” Sen. Harris said, a reference to crackdowns on abortion access in many Republican-controlled states.
After pointing out earlier in the evening that two Planned Parenthood clinics in Ohio recently closed because of a Trump administration policy change, Sen. Cory Booker of New Jersey said he would create an office of reproductive freedom and reproductive rights in his White House.
“It’s an assault on the most fundamental ideal that human beings should control their own body,” Sen. Booker said.
And addressing the opioid crisis, blamed for lowering life expectancy in the United States, many of the candidates called outright for jailing the executives of opioid manufacturers, whom Sen. Harris called “nothing more than some high-level dope dealers.”
“The people who should pay for the treatment are the very people that got people hooked and killed them in the first place,” she said.
The evening was also Sen. Sanders’ first appearance on the debate stage since he had a heart attack and underwent heart surgery just weeks ago. Asked about his health, he seemed impatient: “I’m healthy. I’m feeling great,” Sen. Sanders said as he brought the conversation back to policy.
The debate took place in Westerville, Ohio, a traditionally conservative suburb of Columbus that had turned blue in recent years – a nod to Democrats’ hopes of winning with the support of suburban voters in 2020.
And with those 12 Democrats standing elbow-to-elbow, the debate hosted by CNN and the New York Times had an unusual distinction: the most candidates to ever appear onstage at a presidential debate.
The fifth Democratic debate is scheduled for Nov. 20. The Democratic National Committee plans to hold 12 primary debates in total.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
FDA overlooked red flags in esketamine testing
For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment – prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”
That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug – announced in press releases, celebrated on the evening news, and embraced by major health care providers like the Department of Veterans Affairs.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA with at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, which raised red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly green-light drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents, and interviews with participants, KHN found.
Jess Fiedorowicz, MD, director of the Mood Disorders Center at the University of Iowa, Iowa City, and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Dr. Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows – step by step – how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a 2-day study during which 30 patients were given esketamine intravenously.
“Breakthrough therapy” status puts drugs on a fast track to approval, with more frequent input from the FDA.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like “How many drugs must fail before a patient’s depression is considered intractable or ‘treatment resistant’?” and “How many successful clinical trials are necessary for FDA approval?”
Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Dr. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Matthew Rudorfer, MD, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said, “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”
But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, PharmD, system director of medication safety for Fairview Health Services based in Minneapolis.
A Nasal Spray Offers A Path To A Patent
Spravato is available only under supervision at a certified facility where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality, and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and posttraumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and is (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said, “I am offering real-world proof of efficacy, and that is I am both alive and here today.”
The drug did not work “for the majority of people who took it,” Dr. Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”
Concerns About Testing Precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out during the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid acting.”
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “each convincing on its own.” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms, compared with the placebo treatment, on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than 2 years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Erick Turner, MD, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression – even though those who had suicidal ideation with some intent to act in the previous 6 months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Alan Schatzberg, MD, a Stanford (Calif.) University researcher who has studied ketamine, suggested there might be a link caused by “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors (Am J Psych. 2019. doi: 10.1176/appi.ajp.2019.19040423).
Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Ms. Witczak said in an interview. She voted against the drug.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment – prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”
That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug – announced in press releases, celebrated on the evening news, and embraced by major health care providers like the Department of Veterans Affairs.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA with at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, which raised red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly green-light drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents, and interviews with participants, KHN found.
Jess Fiedorowicz, MD, director of the Mood Disorders Center at the University of Iowa, Iowa City, and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Dr. Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows – step by step – how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a 2-day study during which 30 patients were given esketamine intravenously.
“Breakthrough therapy” status puts drugs on a fast track to approval, with more frequent input from the FDA.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like “How many drugs must fail before a patient’s depression is considered intractable or ‘treatment resistant’?” and “How many successful clinical trials are necessary for FDA approval?”
Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Dr. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Matthew Rudorfer, MD, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said, “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”
But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, PharmD, system director of medication safety for Fairview Health Services based in Minneapolis.
A Nasal Spray Offers A Path To A Patent
Spravato is available only under supervision at a certified facility where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality, and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and posttraumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and is (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said, “I am offering real-world proof of efficacy, and that is I am both alive and here today.”
The drug did not work “for the majority of people who took it,” Dr. Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”
Concerns About Testing Precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out during the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid acting.”
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “each convincing on its own.” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms, compared with the placebo treatment, on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than 2 years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Erick Turner, MD, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression – even though those who had suicidal ideation with some intent to act in the previous 6 months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Alan Schatzberg, MD, a Stanford (Calif.) University researcher who has studied ketamine, suggested there might be a link caused by “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors (Am J Psych. 2019. doi: 10.1176/appi.ajp.2019.19040423).
Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Ms. Witczak said in an interview. She voted against the drug.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment – prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”
That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug – announced in press releases, celebrated on the evening news, and embraced by major health care providers like the Department of Veterans Affairs.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA with at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, which raised red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly green-light drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents, and interviews with participants, KHN found.
Jess Fiedorowicz, MD, director of the Mood Disorders Center at the University of Iowa, Iowa City, and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Dr. Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows – step by step – how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a 2-day study during which 30 patients were given esketamine intravenously.
“Breakthrough therapy” status puts drugs on a fast track to approval, with more frequent input from the FDA.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like “How many drugs must fail before a patient’s depression is considered intractable or ‘treatment resistant’?” and “How many successful clinical trials are necessary for FDA approval?”
Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Dr. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Matthew Rudorfer, MD, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said, “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”
But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, PharmD, system director of medication safety for Fairview Health Services based in Minneapolis.
A Nasal Spray Offers A Path To A Patent
Spravato is available only under supervision at a certified facility where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality, and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and posttraumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and is (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said, “I am offering real-world proof of efficacy, and that is I am both alive and here today.”
The drug did not work “for the majority of people who took it,” Dr. Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”
Concerns About Testing Precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out during the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid acting.”
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “each convincing on its own.” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms, compared with the placebo treatment, on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than 2 years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Erick Turner, MD, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression – even though those who had suicidal ideation with some intent to act in the previous 6 months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Alan Schatzberg, MD, a Stanford (Calif.) University researcher who has studied ketamine, suggested there might be a link caused by “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors (Am J Psych. 2019. doi: 10.1176/appi.ajp.2019.19040423).
Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Ms. Witczak said in an interview. She voted against the drug.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Trump zeroes in on surprise medical bills in White House chat with patients, experts
President Trump on Jan. 23 instructed administration officials to investigate how to prevent surprise medical bills, broadening his focus on drug prices to include other issues of price transparency in health care.
several attendees said.
“The pricing is hurting patients, and we’ve stopped a lot of it, but we’re going to stop all of it,” Mr. Trump said during a roundtable discussion when reporters were briefly allowed into the otherwise closed-door meeting.
David Silverstein, the founder of a Colorado-based nonprofit called Broken Healthcare who attended, said Mr. Trump struck an aggressive tone, calling for a solution with “the biggest teeth you can find.”
“Reading the tea leaves, I think there’s big change coming,” Mr. Silverstein said.
Surprise billing, or the practice of charging patients for care that is more expensive than anticipated or not covered by their insurance, has received a flood of attention in the past year, particularly as Kaiser Health News and other news organizations have undertaken investigations into patients’ most outrageous medical bills.
Attendees said each of 10 invited guests – among them patients as well as doctors with their own stories of unexpected bills – was given an opportunity to talk, though Mr. Trump did not stay to hear all of their stories during the roughly hour-long gathering.
The group included Paul Davis, a retired doctor from Findlay, Ohio, whose family’s experience with a $17,850 bill for a simple urine test was detailed in a KHN-NPR “Bill of the Month” feature last year.
Mr. Davis’ daughter, Elizabeth Moreno, was a college student in Texas when she had spinal surgery to remedy debilitating back pain. After the surgery, she was asked to provide a urine sample and later received a bill from an out-of-network lab in Houston that tested it. Experts said such tests rarely cost more than $200, not nearly what the lab charged Ms. Moreno and her insurance company. But fearing damage to his daughter’s credit, Mr. Davis paid the lab $5,000 and filed a complaint with the Texas attorney general’s office, alleging “price gouging of staggering proportions.”
Mr. Davis said White House officials made it clear that price transparency is a “high priority” for Trump, and while they did not see eye to eye on every subject, he said he was struck by their sincerity.
“These people seemed earnest in wanting to do something constructive to fix this,” Mr. Davis said.
Dr. Martin Makary, a surgeon and health policy expert at Johns Hopkins University who has written about transparency in health care and attended the meeting, said it was a good opportunity for the White House to hear firsthand about a serious and widespread issue.
“This is how most of America lives, and [Americans are] getting hammered,” he said.
Mr. Trump has often railed against high prescription drug prices but has said less about other problems with the nation’s health care system. In October, shortly before the midterm elections, he unveiled a proposal to tie the price Medicare pays for some drugs to the prices paid for the same drugs overseas, for example.
Mr. Trump, Mr. Azar, and Mr. Acosta said efforts to control costs in health care were yielding positive results, discussing in particular the expansion of association health plans and the new requirement that hospitals post their list prices online. The president also took credit for the recent increase in generic drug approvals, which he said would help lower drug prices.
Discussing the partial government shutdown, Mr. Trump said Americans “want to see what we’re doing, like today we lowered prescription drug prices, first time in 50 years,” according to a White House pool report.
Mr. Trump appeared to be referring to a recent claim by the White House Council of Economic Advisers that prescription drug prices fell last year.
However, as STAT pointed out in a recent fact check, the report from which that claim was gleaned said “growth in relative drug prices has slowed since January 2017,” not that there was an overall decrease in prices.
Annual increases in overall drug spending have leveled off as pharmaceutical companies have released fewer blockbuster drugs; patents have expired on brand-name drugs; and the waning effect of a spike driven by the release of astronomically expensive drugs to treat hepatitis C. Drugmakers are also wary of increasing their prices in the midst of growing political pressure.
Since Democrats seized control of the House of Representatives this month, party leaders have rushed to announce investigations and schedule hearings dealing with health care, focusing in particular on drug costs and protections for those with preexisting conditions.
Recently, the House Oversight Committee announced a “sweeping” investigation into drug prices, pointing to an AARP report saying the vast majority of brand-name drugs had more than doubled in price between 2005 and 2017.
KHN correspondents Shefali Luthra and Jay Hancock contributed to this report. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
President Trump on Jan. 23 instructed administration officials to investigate how to prevent surprise medical bills, broadening his focus on drug prices to include other issues of price transparency in health care.
several attendees said.
“The pricing is hurting patients, and we’ve stopped a lot of it, but we’re going to stop all of it,” Mr. Trump said during a roundtable discussion when reporters were briefly allowed into the otherwise closed-door meeting.
David Silverstein, the founder of a Colorado-based nonprofit called Broken Healthcare who attended, said Mr. Trump struck an aggressive tone, calling for a solution with “the biggest teeth you can find.”
“Reading the tea leaves, I think there’s big change coming,” Mr. Silverstein said.
Surprise billing, or the practice of charging patients for care that is more expensive than anticipated or not covered by their insurance, has received a flood of attention in the past year, particularly as Kaiser Health News and other news organizations have undertaken investigations into patients’ most outrageous medical bills.
Attendees said each of 10 invited guests – among them patients as well as doctors with their own stories of unexpected bills – was given an opportunity to talk, though Mr. Trump did not stay to hear all of their stories during the roughly hour-long gathering.
The group included Paul Davis, a retired doctor from Findlay, Ohio, whose family’s experience with a $17,850 bill for a simple urine test was detailed in a KHN-NPR “Bill of the Month” feature last year.
Mr. Davis’ daughter, Elizabeth Moreno, was a college student in Texas when she had spinal surgery to remedy debilitating back pain. After the surgery, she was asked to provide a urine sample and later received a bill from an out-of-network lab in Houston that tested it. Experts said such tests rarely cost more than $200, not nearly what the lab charged Ms. Moreno and her insurance company. But fearing damage to his daughter’s credit, Mr. Davis paid the lab $5,000 and filed a complaint with the Texas attorney general’s office, alleging “price gouging of staggering proportions.”
Mr. Davis said White House officials made it clear that price transparency is a “high priority” for Trump, and while they did not see eye to eye on every subject, he said he was struck by their sincerity.
“These people seemed earnest in wanting to do something constructive to fix this,” Mr. Davis said.
Dr. Martin Makary, a surgeon and health policy expert at Johns Hopkins University who has written about transparency in health care and attended the meeting, said it was a good opportunity for the White House to hear firsthand about a serious and widespread issue.
“This is how most of America lives, and [Americans are] getting hammered,” he said.
Mr. Trump has often railed against high prescription drug prices but has said less about other problems with the nation’s health care system. In October, shortly before the midterm elections, he unveiled a proposal to tie the price Medicare pays for some drugs to the prices paid for the same drugs overseas, for example.
Mr. Trump, Mr. Azar, and Mr. Acosta said efforts to control costs in health care were yielding positive results, discussing in particular the expansion of association health plans and the new requirement that hospitals post their list prices online. The president also took credit for the recent increase in generic drug approvals, which he said would help lower drug prices.
Discussing the partial government shutdown, Mr. Trump said Americans “want to see what we’re doing, like today we lowered prescription drug prices, first time in 50 years,” according to a White House pool report.
Mr. Trump appeared to be referring to a recent claim by the White House Council of Economic Advisers that prescription drug prices fell last year.
However, as STAT pointed out in a recent fact check, the report from which that claim was gleaned said “growth in relative drug prices has slowed since January 2017,” not that there was an overall decrease in prices.
Annual increases in overall drug spending have leveled off as pharmaceutical companies have released fewer blockbuster drugs; patents have expired on brand-name drugs; and the waning effect of a spike driven by the release of astronomically expensive drugs to treat hepatitis C. Drugmakers are also wary of increasing their prices in the midst of growing political pressure.
Since Democrats seized control of the House of Representatives this month, party leaders have rushed to announce investigations and schedule hearings dealing with health care, focusing in particular on drug costs and protections for those with preexisting conditions.
Recently, the House Oversight Committee announced a “sweeping” investigation into drug prices, pointing to an AARP report saying the vast majority of brand-name drugs had more than doubled in price between 2005 and 2017.
KHN correspondents Shefali Luthra and Jay Hancock contributed to this report. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
President Trump on Jan. 23 instructed administration officials to investigate how to prevent surprise medical bills, broadening his focus on drug prices to include other issues of price transparency in health care.
several attendees said.
“The pricing is hurting patients, and we’ve stopped a lot of it, but we’re going to stop all of it,” Mr. Trump said during a roundtable discussion when reporters were briefly allowed into the otherwise closed-door meeting.
David Silverstein, the founder of a Colorado-based nonprofit called Broken Healthcare who attended, said Mr. Trump struck an aggressive tone, calling for a solution with “the biggest teeth you can find.”
“Reading the tea leaves, I think there’s big change coming,” Mr. Silverstein said.
Surprise billing, or the practice of charging patients for care that is more expensive than anticipated or not covered by their insurance, has received a flood of attention in the past year, particularly as Kaiser Health News and other news organizations have undertaken investigations into patients’ most outrageous medical bills.
Attendees said each of 10 invited guests – among them patients as well as doctors with their own stories of unexpected bills – was given an opportunity to talk, though Mr. Trump did not stay to hear all of their stories during the roughly hour-long gathering.
The group included Paul Davis, a retired doctor from Findlay, Ohio, whose family’s experience with a $17,850 bill for a simple urine test was detailed in a KHN-NPR “Bill of the Month” feature last year.
Mr. Davis’ daughter, Elizabeth Moreno, was a college student in Texas when she had spinal surgery to remedy debilitating back pain. After the surgery, she was asked to provide a urine sample and later received a bill from an out-of-network lab in Houston that tested it. Experts said such tests rarely cost more than $200, not nearly what the lab charged Ms. Moreno and her insurance company. But fearing damage to his daughter’s credit, Mr. Davis paid the lab $5,000 and filed a complaint with the Texas attorney general’s office, alleging “price gouging of staggering proportions.”
Mr. Davis said White House officials made it clear that price transparency is a “high priority” for Trump, and while they did not see eye to eye on every subject, he said he was struck by their sincerity.
“These people seemed earnest in wanting to do something constructive to fix this,” Mr. Davis said.
Dr. Martin Makary, a surgeon and health policy expert at Johns Hopkins University who has written about transparency in health care and attended the meeting, said it was a good opportunity for the White House to hear firsthand about a serious and widespread issue.
“This is how most of America lives, and [Americans are] getting hammered,” he said.
Mr. Trump has often railed against high prescription drug prices but has said less about other problems with the nation’s health care system. In October, shortly before the midterm elections, he unveiled a proposal to tie the price Medicare pays for some drugs to the prices paid for the same drugs overseas, for example.
Mr. Trump, Mr. Azar, and Mr. Acosta said efforts to control costs in health care were yielding positive results, discussing in particular the expansion of association health plans and the new requirement that hospitals post their list prices online. The president also took credit for the recent increase in generic drug approvals, which he said would help lower drug prices.
Discussing the partial government shutdown, Mr. Trump said Americans “want to see what we’re doing, like today we lowered prescription drug prices, first time in 50 years,” according to a White House pool report.
Mr. Trump appeared to be referring to a recent claim by the White House Council of Economic Advisers that prescription drug prices fell last year.
However, as STAT pointed out in a recent fact check, the report from which that claim was gleaned said “growth in relative drug prices has slowed since January 2017,” not that there was an overall decrease in prices.
Annual increases in overall drug spending have leveled off as pharmaceutical companies have released fewer blockbuster drugs; patents have expired on brand-name drugs; and the waning effect of a spike driven by the release of astronomically expensive drugs to treat hepatitis C. Drugmakers are also wary of increasing their prices in the midst of growing political pressure.
Since Democrats seized control of the House of Representatives this month, party leaders have rushed to announce investigations and schedule hearings dealing with health care, focusing in particular on drug costs and protections for those with preexisting conditions.
Recently, the House Oversight Committee announced a “sweeping” investigation into drug prices, pointing to an AARP report saying the vast majority of brand-name drugs had more than doubled in price between 2005 and 2017.
KHN correspondents Shefali Luthra and Jay Hancock contributed to this report. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Democrats taking key leadership jobs have pocketed millions from Pharma
Three of the lawmakers who will lead the House next year as Congress focuses on skyrocketing drug costs are among the biggest recipients of campaign contributions from the pharmaceutical industry, a new KHN analysis shows.
On Nov. 28, House Democrats selected Rep. Steny Hoyer of Maryland to serve as the next majority leader and Rep. James Clyburn of South Carolina as majority whip, making them the No. 2 and No. 3 most powerful Democrats as their party regains control of the House in January.
Both lawmakers have received more than $1 million from pharmaceutical company political action committees (PACs) in the past decade. Just four members of Congress hold that distinction, including Rep. Kevin McCarthy of California, whom Republicans chose as the next House minority leader earlier this month.
Adding Rep. Nancy Pelosi, the California Democrat expected to be the next speaker, the three-person House Democratic leadership team has collected more than $2.3 million total in campaign contributions from drugmakers since the 2007-2008 election cycle, according to KHN’s database.
High drug prices surfaced as a major campaign issue in 2018. With almost half of Americans saying they were worried about prescription drug costs last summer, many Democrats told voters they’d tackle the issue in the next Congress. But the large amount of money going to key Democrats, and Republicans, raises questions about whether Congress will take on the pharmaceutical industry.
In the past decade, members of Congress from both parties have received about $81 million from 68 pharma PACs run by employees of companies that make drugs and industry trade groups.
Brendan Fischer, who directs federal reform programs at the nonpartisan Campaign Legal Center, said drugmakers, like other wealthy industries, “shower money” on congressional leaders who are mulling legislation that could affect the pharmaceutical industry.
“Both Democrats and Republicans have discussed taking action on prescription drug prices, and drug companies likely expect that big contributions will help them maintain access to, and influence over, powerful lawmakers,” he said.
Mr. McCarthy, who has close ties to President Donald Trump, has received more than $1.08 million from drugmaker PACs since 2007. According to the latest data, which runs through September, he received about $250,000 this election cycle.
The fourth lawmaker to top $1 million is Sen. Richard Burr, a North Carolina Republican who serves on both the Senate Committee on Health, Education, Labor and Pensions and the Senate Committee on Finance. North Carolina is also home to a number of research universities and drugmakers’ headquarters.
While campaign contributions may seem tantalizing as a metric for influence, industries are not necessarily buying votes with their cash. More likely, they are buying access – a sizable donation from a drugmaker’s PAC may increase the chances its lobbyists get a meeting with an influential lawmaker, for example.
Mr. Clyburn, who like Mr. Hoyer has served as a top Democratic leader since 2007, has received more from drugmaker PACs over the past decade than any other member of Congress – more than $1.09 million. During the 2018 election cycle, he received at least $170,000, despite trouncing his Republican opponent in his safely Democratic district.
A party leader and the highest-ranking African-American in Congress, Mr. Clyburn has had ties to the pharmaceutical industry over the years. In 2013, he was a featured speaker at a conference hosted by PhRMA, the industry’s leading trade group. The conference was held at the James E. Clyburn Research Center at the Medical University of South Carolina, a hub for biopharmaceutical research.
This fall, Mr. Hoyer topped the million-dollar mark in drugmaker PAC contributions over the past decade, collecting more than $1.02 million since 2007 and more than $128,000 this election cycle.
“Mr. Hoyer’s positions on legislation are based on what is in the best interest of his constituents and the American people, and he has made it clear the new Congress will tackle rising health care and prescription drug costs,” said Mariel Saez, a Hoyer spokeswoman.
The offices of Mr. Clyburn, Mr. McCarthy, and Ms. Pelosi did not respond to requests for comment.
Ms. Pelosi, in contrast to her deputies, has received nearly $193,000 total from drugmaker PACs the past decade. In the month before the midterm elections, she intensified her calls for action to control drug prices, saying on Election Day that she believed Democrats could find “common ground” with Trump on addressing the problem.
Senior committee members also tend to draw huge sums from the industries they oversee. Rep. Frank Pallone of New Jersey, the Democrat who is expected to chair the House Committee on Energy and Commerce, received nearly $169,000 this election cycle from drugmaker PACs, according to KHN’s database. Since 2007, he has collected more than $840,000.
Similarly, Rep. Greg Walden, the Oregon Republican who is finishing his term as chair of the committee, received $302,300, the most of any member this election cycle in contributions from drugmaker PACs.
By contrast, Rep. Elijah Cummings – the Maryland Democrat who is expected to head the House Committee on Oversight and Government Reform – has attracted minimal drugmaker cash, receiving just $18,500 since the 2007-2008 election cycle. He has made it clear that he intends to target pharmaceutical companies next year as he investigates climbing drug costs.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Three of the lawmakers who will lead the House next year as Congress focuses on skyrocketing drug costs are among the biggest recipients of campaign contributions from the pharmaceutical industry, a new KHN analysis shows.
On Nov. 28, House Democrats selected Rep. Steny Hoyer of Maryland to serve as the next majority leader and Rep. James Clyburn of South Carolina as majority whip, making them the No. 2 and No. 3 most powerful Democrats as their party regains control of the House in January.
Both lawmakers have received more than $1 million from pharmaceutical company political action committees (PACs) in the past decade. Just four members of Congress hold that distinction, including Rep. Kevin McCarthy of California, whom Republicans chose as the next House minority leader earlier this month.
Adding Rep. Nancy Pelosi, the California Democrat expected to be the next speaker, the three-person House Democratic leadership team has collected more than $2.3 million total in campaign contributions from drugmakers since the 2007-2008 election cycle, according to KHN’s database.
High drug prices surfaced as a major campaign issue in 2018. With almost half of Americans saying they were worried about prescription drug costs last summer, many Democrats told voters they’d tackle the issue in the next Congress. But the large amount of money going to key Democrats, and Republicans, raises questions about whether Congress will take on the pharmaceutical industry.
In the past decade, members of Congress from both parties have received about $81 million from 68 pharma PACs run by employees of companies that make drugs and industry trade groups.
Brendan Fischer, who directs federal reform programs at the nonpartisan Campaign Legal Center, said drugmakers, like other wealthy industries, “shower money” on congressional leaders who are mulling legislation that could affect the pharmaceutical industry.
“Both Democrats and Republicans have discussed taking action on prescription drug prices, and drug companies likely expect that big contributions will help them maintain access to, and influence over, powerful lawmakers,” he said.
Mr. McCarthy, who has close ties to President Donald Trump, has received more than $1.08 million from drugmaker PACs since 2007. According to the latest data, which runs through September, he received about $250,000 this election cycle.
The fourth lawmaker to top $1 million is Sen. Richard Burr, a North Carolina Republican who serves on both the Senate Committee on Health, Education, Labor and Pensions and the Senate Committee on Finance. North Carolina is also home to a number of research universities and drugmakers’ headquarters.
While campaign contributions may seem tantalizing as a metric for influence, industries are not necessarily buying votes with their cash. More likely, they are buying access – a sizable donation from a drugmaker’s PAC may increase the chances its lobbyists get a meeting with an influential lawmaker, for example.
Mr. Clyburn, who like Mr. Hoyer has served as a top Democratic leader since 2007, has received more from drugmaker PACs over the past decade than any other member of Congress – more than $1.09 million. During the 2018 election cycle, he received at least $170,000, despite trouncing his Republican opponent in his safely Democratic district.
A party leader and the highest-ranking African-American in Congress, Mr. Clyburn has had ties to the pharmaceutical industry over the years. In 2013, he was a featured speaker at a conference hosted by PhRMA, the industry’s leading trade group. The conference was held at the James E. Clyburn Research Center at the Medical University of South Carolina, a hub for biopharmaceutical research.
This fall, Mr. Hoyer topped the million-dollar mark in drugmaker PAC contributions over the past decade, collecting more than $1.02 million since 2007 and more than $128,000 this election cycle.
“Mr. Hoyer’s positions on legislation are based on what is in the best interest of his constituents and the American people, and he has made it clear the new Congress will tackle rising health care and prescription drug costs,” said Mariel Saez, a Hoyer spokeswoman.
The offices of Mr. Clyburn, Mr. McCarthy, and Ms. Pelosi did not respond to requests for comment.
Ms. Pelosi, in contrast to her deputies, has received nearly $193,000 total from drugmaker PACs the past decade. In the month before the midterm elections, she intensified her calls for action to control drug prices, saying on Election Day that she believed Democrats could find “common ground” with Trump on addressing the problem.
Senior committee members also tend to draw huge sums from the industries they oversee. Rep. Frank Pallone of New Jersey, the Democrat who is expected to chair the House Committee on Energy and Commerce, received nearly $169,000 this election cycle from drugmaker PACs, according to KHN’s database. Since 2007, he has collected more than $840,000.
Similarly, Rep. Greg Walden, the Oregon Republican who is finishing his term as chair of the committee, received $302,300, the most of any member this election cycle in contributions from drugmaker PACs.
By contrast, Rep. Elijah Cummings – the Maryland Democrat who is expected to head the House Committee on Oversight and Government Reform – has attracted minimal drugmaker cash, receiving just $18,500 since the 2007-2008 election cycle. He has made it clear that he intends to target pharmaceutical companies next year as he investigates climbing drug costs.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Three of the lawmakers who will lead the House next year as Congress focuses on skyrocketing drug costs are among the biggest recipients of campaign contributions from the pharmaceutical industry, a new KHN analysis shows.
On Nov. 28, House Democrats selected Rep. Steny Hoyer of Maryland to serve as the next majority leader and Rep. James Clyburn of South Carolina as majority whip, making them the No. 2 and No. 3 most powerful Democrats as their party regains control of the House in January.
Both lawmakers have received more than $1 million from pharmaceutical company political action committees (PACs) in the past decade. Just four members of Congress hold that distinction, including Rep. Kevin McCarthy of California, whom Republicans chose as the next House minority leader earlier this month.
Adding Rep. Nancy Pelosi, the California Democrat expected to be the next speaker, the three-person House Democratic leadership team has collected more than $2.3 million total in campaign contributions from drugmakers since the 2007-2008 election cycle, according to KHN’s database.
High drug prices surfaced as a major campaign issue in 2018. With almost half of Americans saying they were worried about prescription drug costs last summer, many Democrats told voters they’d tackle the issue in the next Congress. But the large amount of money going to key Democrats, and Republicans, raises questions about whether Congress will take on the pharmaceutical industry.
In the past decade, members of Congress from both parties have received about $81 million from 68 pharma PACs run by employees of companies that make drugs and industry trade groups.
Brendan Fischer, who directs federal reform programs at the nonpartisan Campaign Legal Center, said drugmakers, like other wealthy industries, “shower money” on congressional leaders who are mulling legislation that could affect the pharmaceutical industry.
“Both Democrats and Republicans have discussed taking action on prescription drug prices, and drug companies likely expect that big contributions will help them maintain access to, and influence over, powerful lawmakers,” he said.
Mr. McCarthy, who has close ties to President Donald Trump, has received more than $1.08 million from drugmaker PACs since 2007. According to the latest data, which runs through September, he received about $250,000 this election cycle.
The fourth lawmaker to top $1 million is Sen. Richard Burr, a North Carolina Republican who serves on both the Senate Committee on Health, Education, Labor and Pensions and the Senate Committee on Finance. North Carolina is also home to a number of research universities and drugmakers’ headquarters.
While campaign contributions may seem tantalizing as a metric for influence, industries are not necessarily buying votes with their cash. More likely, they are buying access – a sizable donation from a drugmaker’s PAC may increase the chances its lobbyists get a meeting with an influential lawmaker, for example.
Mr. Clyburn, who like Mr. Hoyer has served as a top Democratic leader since 2007, has received more from drugmaker PACs over the past decade than any other member of Congress – more than $1.09 million. During the 2018 election cycle, he received at least $170,000, despite trouncing his Republican opponent in his safely Democratic district.
A party leader and the highest-ranking African-American in Congress, Mr. Clyburn has had ties to the pharmaceutical industry over the years. In 2013, he was a featured speaker at a conference hosted by PhRMA, the industry’s leading trade group. The conference was held at the James E. Clyburn Research Center at the Medical University of South Carolina, a hub for biopharmaceutical research.
This fall, Mr. Hoyer topped the million-dollar mark in drugmaker PAC contributions over the past decade, collecting more than $1.02 million since 2007 and more than $128,000 this election cycle.
“Mr. Hoyer’s positions on legislation are based on what is in the best interest of his constituents and the American people, and he has made it clear the new Congress will tackle rising health care and prescription drug costs,” said Mariel Saez, a Hoyer spokeswoman.
The offices of Mr. Clyburn, Mr. McCarthy, and Ms. Pelosi did not respond to requests for comment.
Ms. Pelosi, in contrast to her deputies, has received nearly $193,000 total from drugmaker PACs the past decade. In the month before the midterm elections, she intensified her calls for action to control drug prices, saying on Election Day that she believed Democrats could find “common ground” with Trump on addressing the problem.
Senior committee members also tend to draw huge sums from the industries they oversee. Rep. Frank Pallone of New Jersey, the Democrat who is expected to chair the House Committee on Energy and Commerce, received nearly $169,000 this election cycle from drugmaker PACs, according to KHN’s database. Since 2007, he has collected more than $840,000.
Similarly, Rep. Greg Walden, the Oregon Republican who is finishing his term as chair of the committee, received $302,300, the most of any member this election cycle in contributions from drugmaker PACs.
By contrast, Rep. Elijah Cummings – the Maryland Democrat who is expected to head the House Committee on Oversight and Government Reform – has attracted minimal drugmaker cash, receiving just $18,500 since the 2007-2008 election cycle. He has made it clear that he intends to target pharmaceutical companies next year as he investigates climbing drug costs.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
McCain’s complicated health care legacy: He hated the ACA. He also saved it
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.