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TikTok challenge hits Taco Bell right in its ‘Stuft Nacho’
Losing weight for TikTok: Taco Bell edition
There are many reasons why a person would want to lose weight. Too numerous to list. Losing weight to improve your health, however, doesn’t bring in a few hundred thousand TikTok subscribers. Losing weight to convince Taco Bell to bring back an obscure menu item, on the other hand ...
Chris Sandberg, a 37-year-old man from San Francisco, has struggled with his weight for years, losing and gaining hundreds of pounds in an endless cycle of feast and famine. In an unrelated development, at the start of the pandemic he also started making videos on TikTok. As the pandemic wore on, he realized that his excess weight put him at increased risk for severe COVID, as well as other chronic diseases, and he resolved to lose weight. He decided to turn his weight-loss journey into a TikTok challenge but, as we said, losing weight for its own sake isn’t enough for the almighty algorithm. He needed a different goal, preferably something offbeat and a little silly.
Back in 2013, Taco Bell introduced the Grilled Stuft Nacho, “a flour tortilla, shaped like a nacho, stuffed with beef, cheesy jalapeño sauce, sour cream and crunchy red strips,” according to its website. Mr. Sandberg discovered the item in 2015 and instantly fell in love, purchasing one every day for a week. After that first week, however, he discovered, to his horror, that the Grilled Stuft Nacho had been discontinued.
That loss haunted him for years, until inspiration struck in 2021. He pledged to work out every day on TikTok until Taco Bell brought back the Grilled Stuft Nacho. A bit incongruous, exercising for notoriously unhealthy fast food, but that’s kind of the point. He began the challenge on Jan. 4, 2021, and has continued it every day since, nearly 500 days. Over that time, he’s lost 87 pounds (from 275 at the start to under 190) and currently has 450,000 TikTok subscribers.
A year into the challenge, a local Taco Bell made Mr. Sandberg his beloved Grilled Stuft Nacho, but since the challenge was to exercise until Taco Bell brings the item back to all its restaurants, not just for him, the great journey continues. And we admire him for it. In fact, he’s inspired us: We will write a LOTME every week until it receives a Pulitzer Prize. This is important journalism we do here. Don’t deny it!
Episode XIX: COVID strikes back
So what’s next for COVID? Is Disney going to turn it into a series? Can it support a spin-off? Did James Cameron really buy the movie rights? Can it compete against the NFL in the all-important 18-34 demographic? When are Star Wars characters going to get involved?
COVID’s motivations and negotiations are pretty much a mystery to us, but we can answer that last question. They already are involved. Well, one of them anyway.
The Chinese government has been enforcing a COVID lockdown in Shanghai for over a month now, but authorities had started letting people out of their homes for short periods of time. A recent push to bring down transmission, however, has made residents increasingly frustrated and argumentative, according to Reuters.
A now-unavailable video, which Reuters could not verify, surfaced on Chinese social media showing police in hazmat suits arguing with people who were being told that they were going to be quarantined because a neighbor had tested positive.
That’s when the Force kicks in, and this next bit comes directly from the Reuters report: “This is so that we can thoroughly remove any positive cases,” one of the officers is heard saying. “Stop asking me why, there is no why.”
There is no why? Does that remind you of someone? Someone short and green, with an odd syntax? That’s right. Clearly, Yoda it is. Yoda is alive and working for the Chinese government in Shanghai. You read it here first.
Your coffee may be guilty of sexual discrimination
How do you take your coffee? Espresso, drip, instant, or brewed from a regular old coffee machine? Well, a recent study published in Open Heart suggests that gender and brewing method can alter your coffee’s effect on cholesterol levels.
Besides caffeine, coffee beans have naturally occurring chemicals such as diterpenes, cafestol, and kahweol that raise cholesterol levels in the blood. And then there are the various brewing methods, which are going to release different amounts of chemicals from the beans. According to Consumer Reports, an ounce of espresso has 63 mg of caffeine and an ounce of regular coffee has 12-16 mg. That’s a bit deceiving, though, since no one ever drinks an ounce of regular coffee, so figure 96-128 mg of caffeine for an 8-ounce cup. That’s enough to make anyone’s heart race.
Data from 21,083 participants in the seventh survey of the Tromsø Study who were aged 40 and older showed that women drank a mean of 3.8 cups per day while men drank 4.9 cups. Drinking six or more cups of plunger-brewed coffee was associated with increased cholesterol in both genders, but drinking three to five cups of espresso was significantly associated with high cholesterol in men only. Having six or more cups of filtered coffee daily raised cholesterol in women, but instant coffee increased cholesterol levels in both genders, regardless of how many cups they drank.
People all over the planet drink coffee, some of us like our lives depend on it. Since “coffee is the most frequently consumed central stimulant worldwide,” the investigators said, “even small health effects can have considerable health consequences.”
We’ll drink to that.
Have you ever dreamed of having a clone?
When will science grace us with the ability to clone ourselves? It sounds like a dream come true. Our clones can do the stuff that we don’t want to do, like sit in on that 3-hour meeting or do our grocery shopping – really just all the boring stuff we don’t want to do.
In 1996, when a sheep named Dolly became the first mammal cloned successfully, people thought it was the start of an amazing cloning era, but, alas, we haven’t made it to cloning humans yet, as LiveScience discovered when it took a look at the subject.
The idea of cloning was quite exciting for science, as people looked forward to eradicating genetic diseases and birth defects. Research done in 1999, however, countered those hopes by suggesting that cloning might increase birth defects.
So why do you think we haven’t advanced to truly cloning humans? Ethics? Time and effort? Technological barriers? “Human cloning is a particularly dramatic action, and was one of the topics that helped launch American bioethics,” Hank Greely, professor of law and genetics at Stanford (Calif.) University, told LiveScience.
What if the clones turned evil and were bent on destroying the world?
We might imagine a clone of ourselves being completely identical to us in our thoughts, actions, and physical looks. However, that’s not necessarily true; a clone would be its own person even if it looks exactly like you.
So what do the professionals think? Is it worth giving human cloning a shot? Are there benefits? Mr. Greely said that “there are none that we should be willing to consider.”
The dream of having a clone to help your son with his math homework may have gone down the drain, but maybe it’s best not to open doors that could lead to drastic changes in our world.
Losing weight for TikTok: Taco Bell edition
There are many reasons why a person would want to lose weight. Too numerous to list. Losing weight to improve your health, however, doesn’t bring in a few hundred thousand TikTok subscribers. Losing weight to convince Taco Bell to bring back an obscure menu item, on the other hand ...
Chris Sandberg, a 37-year-old man from San Francisco, has struggled with his weight for years, losing and gaining hundreds of pounds in an endless cycle of feast and famine. In an unrelated development, at the start of the pandemic he also started making videos on TikTok. As the pandemic wore on, he realized that his excess weight put him at increased risk for severe COVID, as well as other chronic diseases, and he resolved to lose weight. He decided to turn his weight-loss journey into a TikTok challenge but, as we said, losing weight for its own sake isn’t enough for the almighty algorithm. He needed a different goal, preferably something offbeat and a little silly.
Back in 2013, Taco Bell introduced the Grilled Stuft Nacho, “a flour tortilla, shaped like a nacho, stuffed with beef, cheesy jalapeño sauce, sour cream and crunchy red strips,” according to its website. Mr. Sandberg discovered the item in 2015 and instantly fell in love, purchasing one every day for a week. After that first week, however, he discovered, to his horror, that the Grilled Stuft Nacho had been discontinued.
That loss haunted him for years, until inspiration struck in 2021. He pledged to work out every day on TikTok until Taco Bell brought back the Grilled Stuft Nacho. A bit incongruous, exercising for notoriously unhealthy fast food, but that’s kind of the point. He began the challenge on Jan. 4, 2021, and has continued it every day since, nearly 500 days. Over that time, he’s lost 87 pounds (from 275 at the start to under 190) and currently has 450,000 TikTok subscribers.
A year into the challenge, a local Taco Bell made Mr. Sandberg his beloved Grilled Stuft Nacho, but since the challenge was to exercise until Taco Bell brings the item back to all its restaurants, not just for him, the great journey continues. And we admire him for it. In fact, he’s inspired us: We will write a LOTME every week until it receives a Pulitzer Prize. This is important journalism we do here. Don’t deny it!
Episode XIX: COVID strikes back
So what’s next for COVID? Is Disney going to turn it into a series? Can it support a spin-off? Did James Cameron really buy the movie rights? Can it compete against the NFL in the all-important 18-34 demographic? When are Star Wars characters going to get involved?
COVID’s motivations and negotiations are pretty much a mystery to us, but we can answer that last question. They already are involved. Well, one of them anyway.
The Chinese government has been enforcing a COVID lockdown in Shanghai for over a month now, but authorities had started letting people out of their homes for short periods of time. A recent push to bring down transmission, however, has made residents increasingly frustrated and argumentative, according to Reuters.
A now-unavailable video, which Reuters could not verify, surfaced on Chinese social media showing police in hazmat suits arguing with people who were being told that they were going to be quarantined because a neighbor had tested positive.
That’s when the Force kicks in, and this next bit comes directly from the Reuters report: “This is so that we can thoroughly remove any positive cases,” one of the officers is heard saying. “Stop asking me why, there is no why.”
There is no why? Does that remind you of someone? Someone short and green, with an odd syntax? That’s right. Clearly, Yoda it is. Yoda is alive and working for the Chinese government in Shanghai. You read it here first.
Your coffee may be guilty of sexual discrimination
How do you take your coffee? Espresso, drip, instant, or brewed from a regular old coffee machine? Well, a recent study published in Open Heart suggests that gender and brewing method can alter your coffee’s effect on cholesterol levels.
Besides caffeine, coffee beans have naturally occurring chemicals such as diterpenes, cafestol, and kahweol that raise cholesterol levels in the blood. And then there are the various brewing methods, which are going to release different amounts of chemicals from the beans. According to Consumer Reports, an ounce of espresso has 63 mg of caffeine and an ounce of regular coffee has 12-16 mg. That’s a bit deceiving, though, since no one ever drinks an ounce of regular coffee, so figure 96-128 mg of caffeine for an 8-ounce cup. That’s enough to make anyone’s heart race.
Data from 21,083 participants in the seventh survey of the Tromsø Study who were aged 40 and older showed that women drank a mean of 3.8 cups per day while men drank 4.9 cups. Drinking six or more cups of plunger-brewed coffee was associated with increased cholesterol in both genders, but drinking three to five cups of espresso was significantly associated with high cholesterol in men only. Having six or more cups of filtered coffee daily raised cholesterol in women, but instant coffee increased cholesterol levels in both genders, regardless of how many cups they drank.
People all over the planet drink coffee, some of us like our lives depend on it. Since “coffee is the most frequently consumed central stimulant worldwide,” the investigators said, “even small health effects can have considerable health consequences.”
We’ll drink to that.
Have you ever dreamed of having a clone?
When will science grace us with the ability to clone ourselves? It sounds like a dream come true. Our clones can do the stuff that we don’t want to do, like sit in on that 3-hour meeting or do our grocery shopping – really just all the boring stuff we don’t want to do.
In 1996, when a sheep named Dolly became the first mammal cloned successfully, people thought it was the start of an amazing cloning era, but, alas, we haven’t made it to cloning humans yet, as LiveScience discovered when it took a look at the subject.
The idea of cloning was quite exciting for science, as people looked forward to eradicating genetic diseases and birth defects. Research done in 1999, however, countered those hopes by suggesting that cloning might increase birth defects.
So why do you think we haven’t advanced to truly cloning humans? Ethics? Time and effort? Technological barriers? “Human cloning is a particularly dramatic action, and was one of the topics that helped launch American bioethics,” Hank Greely, professor of law and genetics at Stanford (Calif.) University, told LiveScience.
What if the clones turned evil and were bent on destroying the world?
We might imagine a clone of ourselves being completely identical to us in our thoughts, actions, and physical looks. However, that’s not necessarily true; a clone would be its own person even if it looks exactly like you.
So what do the professionals think? Is it worth giving human cloning a shot? Are there benefits? Mr. Greely said that “there are none that we should be willing to consider.”
The dream of having a clone to help your son with his math homework may have gone down the drain, but maybe it’s best not to open doors that could lead to drastic changes in our world.
Losing weight for TikTok: Taco Bell edition
There are many reasons why a person would want to lose weight. Too numerous to list. Losing weight to improve your health, however, doesn’t bring in a few hundred thousand TikTok subscribers. Losing weight to convince Taco Bell to bring back an obscure menu item, on the other hand ...
Chris Sandberg, a 37-year-old man from San Francisco, has struggled with his weight for years, losing and gaining hundreds of pounds in an endless cycle of feast and famine. In an unrelated development, at the start of the pandemic he also started making videos on TikTok. As the pandemic wore on, he realized that his excess weight put him at increased risk for severe COVID, as well as other chronic diseases, and he resolved to lose weight. He decided to turn his weight-loss journey into a TikTok challenge but, as we said, losing weight for its own sake isn’t enough for the almighty algorithm. He needed a different goal, preferably something offbeat and a little silly.
Back in 2013, Taco Bell introduced the Grilled Stuft Nacho, “a flour tortilla, shaped like a nacho, stuffed with beef, cheesy jalapeño sauce, sour cream and crunchy red strips,” according to its website. Mr. Sandberg discovered the item in 2015 and instantly fell in love, purchasing one every day for a week. After that first week, however, he discovered, to his horror, that the Grilled Stuft Nacho had been discontinued.
That loss haunted him for years, until inspiration struck in 2021. He pledged to work out every day on TikTok until Taco Bell brought back the Grilled Stuft Nacho. A bit incongruous, exercising for notoriously unhealthy fast food, but that’s kind of the point. He began the challenge on Jan. 4, 2021, and has continued it every day since, nearly 500 days. Over that time, he’s lost 87 pounds (from 275 at the start to under 190) and currently has 450,000 TikTok subscribers.
A year into the challenge, a local Taco Bell made Mr. Sandberg his beloved Grilled Stuft Nacho, but since the challenge was to exercise until Taco Bell brings the item back to all its restaurants, not just for him, the great journey continues. And we admire him for it. In fact, he’s inspired us: We will write a LOTME every week until it receives a Pulitzer Prize. This is important journalism we do here. Don’t deny it!
Episode XIX: COVID strikes back
So what’s next for COVID? Is Disney going to turn it into a series? Can it support a spin-off? Did James Cameron really buy the movie rights? Can it compete against the NFL in the all-important 18-34 demographic? When are Star Wars characters going to get involved?
COVID’s motivations and negotiations are pretty much a mystery to us, but we can answer that last question. They already are involved. Well, one of them anyway.
The Chinese government has been enforcing a COVID lockdown in Shanghai for over a month now, but authorities had started letting people out of their homes for short periods of time. A recent push to bring down transmission, however, has made residents increasingly frustrated and argumentative, according to Reuters.
A now-unavailable video, which Reuters could not verify, surfaced on Chinese social media showing police in hazmat suits arguing with people who were being told that they were going to be quarantined because a neighbor had tested positive.
That’s when the Force kicks in, and this next bit comes directly from the Reuters report: “This is so that we can thoroughly remove any positive cases,” one of the officers is heard saying. “Stop asking me why, there is no why.”
There is no why? Does that remind you of someone? Someone short and green, with an odd syntax? That’s right. Clearly, Yoda it is. Yoda is alive and working for the Chinese government in Shanghai. You read it here first.
Your coffee may be guilty of sexual discrimination
How do you take your coffee? Espresso, drip, instant, or brewed from a regular old coffee machine? Well, a recent study published in Open Heart suggests that gender and brewing method can alter your coffee’s effect on cholesterol levels.
Besides caffeine, coffee beans have naturally occurring chemicals such as diterpenes, cafestol, and kahweol that raise cholesterol levels in the blood. And then there are the various brewing methods, which are going to release different amounts of chemicals from the beans. According to Consumer Reports, an ounce of espresso has 63 mg of caffeine and an ounce of regular coffee has 12-16 mg. That’s a bit deceiving, though, since no one ever drinks an ounce of regular coffee, so figure 96-128 mg of caffeine for an 8-ounce cup. That’s enough to make anyone’s heart race.
Data from 21,083 participants in the seventh survey of the Tromsø Study who were aged 40 and older showed that women drank a mean of 3.8 cups per day while men drank 4.9 cups. Drinking six or more cups of plunger-brewed coffee was associated with increased cholesterol in both genders, but drinking three to five cups of espresso was significantly associated with high cholesterol in men only. Having six or more cups of filtered coffee daily raised cholesterol in women, but instant coffee increased cholesterol levels in both genders, regardless of how many cups they drank.
People all over the planet drink coffee, some of us like our lives depend on it. Since “coffee is the most frequently consumed central stimulant worldwide,” the investigators said, “even small health effects can have considerable health consequences.”
We’ll drink to that.
Have you ever dreamed of having a clone?
When will science grace us with the ability to clone ourselves? It sounds like a dream come true. Our clones can do the stuff that we don’t want to do, like sit in on that 3-hour meeting or do our grocery shopping – really just all the boring stuff we don’t want to do.
In 1996, when a sheep named Dolly became the first mammal cloned successfully, people thought it was the start of an amazing cloning era, but, alas, we haven’t made it to cloning humans yet, as LiveScience discovered when it took a look at the subject.
The idea of cloning was quite exciting for science, as people looked forward to eradicating genetic diseases and birth defects. Research done in 1999, however, countered those hopes by suggesting that cloning might increase birth defects.
So why do you think we haven’t advanced to truly cloning humans? Ethics? Time and effort? Technological barriers? “Human cloning is a particularly dramatic action, and was one of the topics that helped launch American bioethics,” Hank Greely, professor of law and genetics at Stanford (Calif.) University, told LiveScience.
What if the clones turned evil and were bent on destroying the world?
We might imagine a clone of ourselves being completely identical to us in our thoughts, actions, and physical looks. However, that’s not necessarily true; a clone would be its own person even if it looks exactly like you.
So what do the professionals think? Is it worth giving human cloning a shot? Are there benefits? Mr. Greely said that “there are none that we should be willing to consider.”
The dream of having a clone to help your son with his math homework may have gone down the drain, but maybe it’s best not to open doors that could lead to drastic changes in our world.
Ex–hospital porter a neglected giant of cancer research
We have a half-forgotten Indian immigrant to thank – a hospital night porter turned biochemist –for revolutionizing treatment of leukemia, the once deadly childhood scourge that is still the most common pediatric cancer.
Dr. Yellapragada SubbaRow has been called the “father of chemotherapy” for developing methotrexate, a powerful, inexpensive therapy for leukemia and other diseases, and he is celebrated for additional scientific achievements. Yet Dr. SubbaRow’s life was marked more by struggle than glory.
Born poor in southeastern India, he nearly succumbed to a tropical disease that killed two older brothers, and he didn’t focus on schoolwork until his father died. Later, prejudice dogged his years as an immigrant to the United States, and a blood clot took his life at the age of 53.
Scientifically, however, Dr. SubbaRow (pronounced sue-buh-rao) triumphed, despite mammoth challenges and a lack of recognition that persists to this day. National Cancer Research Month is a fitting time to look back on his extraordinary life and work and pay tribute to his accomplishments.
‘Yella,’ folic acid, and a paradigm shift
No one appreciates Dr. SubbaRow more than a cadre of Indian-born physicians who have kept his legacy alive in journal articles, presentations, and a Pulitzer Prize-winning book. Among them is author and oncologist Siddhartha Mukherjee, MD, who chronicled Dr. SubbaRow’s achievements in his New York Times No. 1 bestseller, “The Emperor of All Maladies: A Biography of Cancer.”
As Dr. Mukherjee wrote, Dr. SubbaRow was a “pioneer in many ways, a physician turned cellular physiologist, a chemist who had accidentally wandered into biology.” (Per Indian tradition, SubbaRow is the doctor’s first name, and Yellapragada is his surname, but medical literature uses SubbaRow as his cognomen, with some variations in spelling. Dr. Mukherjee wrote that his friends called him “Yella.”)
Dr. SubbaRow came to the United States in 1923, after enduring a difficult childhood and young adulthood. He’d survived bouts of religious fervor, childhood rebellion (including a bid to run away from home and become a banana trader), and a failed arranged marriage. His wife bore him a child who died in infancy. He left it all behind.
In Boston, medical officials rejected his degree. Broke, he worked for a time as a night porter at Brigham and Women’s Hospital in Boston, changing sheets and cleaning urinals. To a poor but proud high-caste Indian Brahmin, the culture shock of carrying out these tasks must have been especially jarring.
Dr. SubbaRow went on to earn a diploma from Harvard Medical School, also in Boston, and became a junior faculty member. As a foreigner, Dr. Mukherjee wrote, Dr. SubbaRow was a “reclusive, nocturnal, heavily accented vegetarian,” so different from his colleagues that advancement seemed impossible. Despite his pioneering biochemistry work, Harvard later declined to offer Dr. SubbaRow a tenured faculty position.
By the early 1940s, he took a job at an upstate New York pharmaceutical company called Lederle Labs (later purchased by Pfizer). At Lederle, Dr. SubbaRow strove to synthesize the vitamin known as folic acid. He ended up creating a kind of antivitamin, a lookalike that acted like folic acid but only succeeded in gumming up the works in receptors. But what good would it do to stop the body from absorbing folic acid? Plenty, it turned out.
Discoveries pile up, but credit and fame prove elusive
Dr. SubbaRow was no stranger to producing landmark biological work. He’d previously codiscovered phosphocreatine and ATP, which are crucial to muscular contractions. However, “in 1935, he had to disown the extent of his role in the discovery of the color test related to phosphorus, instead giving the credit to his co-author, who was being considered for promotion to a full professorship at Harvard,” wrote author Gerald Posner in his 2020 book, “Pharma: Greed, Lies and the Poisoning of America.”
Houston-area oncologist Kirtan Nautiyal, MD, who paid tribute to Dr. SubbaRow in a 2018 article, contended that “with his Indian instinct for self-effacement, he had irreparably sabotaged his own career.”
Dr. SubbaRow and his team also developed “the first effective treatment of filariasis, which causes elephantiasis of the lower limbs and genitals in millions of people, mainly in tropical countries,” Dr. Nautiyal wrote. “Later in the decade, his antibiotic program generated polymyxin, the first effective treatment against the class of bacteria called Gram negatives, and aureomycin, the first “broad-spectrum’ antibiotic.” (Aureomycin is also the first tetracycline antibiotic.)
Dr. SubbaRow’s discovery of a folic acid antagonist would again go largely unheralded. But first came the realization that folic acid made childhood leukemia worse, not better, and the prospect that this process could potentially be reversed.
Rise of methotrexate and fall of leukemia
In Boston, Sidney Farber, MD, a Boston pathologist, was desperate to help Robert Sandler, a 2-year-old leukemia patient. Dr. Farber contacted his ex-colleague Dr. SubbaRow to request a supply of aminopterin, an early version of methotrexate that Dr. SubbaRow and his team had developed. Dr. Farber injected Robert with the substance and within 3 days, the toddler’s white blood count started falling – fast. He stopped bleeding, resumed eating, and once again seemed almost identical to his twin brother, as Dr. Mukherjee wrote in his book.
Leukemia had never gone into remission before. Unfortunately, the treatment only worked temporarily. Robert, like other children treated with the drug, relapsed and died within months. But Dr. Farber “saw a door open” – a chemical, a kind of chemotherapy, that could turn back cancer. In the case of folic acid antagonists, they do so by stopping cancer cells from replicating.
Methotrexate, a related agent synthesized by Dr. SubbaRow, would become a mainstay of leukemia treatment and begin to produce long-term remission from acute lymphoblastic leukemia in 1970, when combination chemotherapy was developed.
Other cancers fell to methotrexate treatment. “Previous assumptions that cancer was nearly always fatal were revised, and the field of medical oncology (treatment of cancer with chemotherapy), which had not previously existed, was formally established in 1971,” according to the National Cancer Institute’s history of methotrexate. This account does not mention Dr. SubbaRow.
Death takes the doctor, but his legacy remains
In biographies, as well as his own words, Dr. SubbaRow comes across as a prickly, hard-driving workaholic who had little interest in intimate human connections. “It is not good to ask in every letter when I will be back,” he wrote to his wife back in India, before cutting off ties completely in the early 1930s. “I will come as early as possible. ... I do not want to write anything more.”
It seems, as his biographer S.P.K. Gupta noted, that “he was quite determined that the time allotted to him on Earth should be completely devoted to finding cures for ailments that plagued mankind.”
Still, Dr. SubbaRow’s research team was devoted to him, and he had plenty of reasons to be bitter, such as the prejudice and isolation he encountered in the United States and earlier, in British-run India. According to Mr. Posner’s book, even as a young medical student, Dr. SubbaRow heeded the call of Indian independence activist Mohandas Gandhi. He “refused the British surgical gown given him at school and instead donned a traditional and simple cotton Khadi. That act of defiance cost SubbaRow the college degree that was necessary for him to get into the State Medical College.”
During the last year of his life, Dr. SubbaRow faced yet another humiliation: In his landmark 1948 study about aminopterin as a treatment for leukemia, his colleague Dr. Farber failed to credit him, an “astonishing omission” as Yaddanapudi Ravindranath, MBBS, a pediatric hematologist/oncologist at Wayne State University, Detroit, put it. “From everything I know, Dr. Farber spent the rest of his career apologizing and trying to make amends for it,” Dr. Ravindranath said in an interview.
A career cut short, and a lasting legacy
In 1948, at the age of 53, Dr. SubbaRow suddenly died. “Many think Dr. SubbaRow would have won [the] Nobel Prize had he lived a few years longer,” said Dr. Ravindranath.
Like Dr. SubbaRow, Dr. Ravindranath was born in Andhra Pradesh state, near the city of Chennai formerly known as Madras. “Being a compatriot, in a way I continue his legacy, and I am obviously proud of him,” said Dr. Ravindranath, who has conducted his own landmark research regarding methotrexate and leukemia.
Nearly 75 years after Dr. SubbaRow’s death, Indian-born physicians like Dr. Ravindranath continue to honor him in print, trying to ensure that he’s not forgotten. Methotrexate remains a crucial treatment for leukemia, along with a long list of other ailments, including psoriasis.
Recognition for “Yella” may have come late and infrequently, but a Lederle Laboratories research library named after him offered Dr. SubbaRow a kind of immortality. A plaque there memorialized him in stone as a scientist, teacher, philosopher, and humanitarian, featuring the quote: “Science simply prolongs life. Religion deepens it.”
By all accounts, Dr. SubbaRow was a man of science and faith who had faith in science.
We have a half-forgotten Indian immigrant to thank – a hospital night porter turned biochemist –for revolutionizing treatment of leukemia, the once deadly childhood scourge that is still the most common pediatric cancer.
Dr. Yellapragada SubbaRow has been called the “father of chemotherapy” for developing methotrexate, a powerful, inexpensive therapy for leukemia and other diseases, and he is celebrated for additional scientific achievements. Yet Dr. SubbaRow’s life was marked more by struggle than glory.
Born poor in southeastern India, he nearly succumbed to a tropical disease that killed two older brothers, and he didn’t focus on schoolwork until his father died. Later, prejudice dogged his years as an immigrant to the United States, and a blood clot took his life at the age of 53.
Scientifically, however, Dr. SubbaRow (pronounced sue-buh-rao) triumphed, despite mammoth challenges and a lack of recognition that persists to this day. National Cancer Research Month is a fitting time to look back on his extraordinary life and work and pay tribute to his accomplishments.
‘Yella,’ folic acid, and a paradigm shift
No one appreciates Dr. SubbaRow more than a cadre of Indian-born physicians who have kept his legacy alive in journal articles, presentations, and a Pulitzer Prize-winning book. Among them is author and oncologist Siddhartha Mukherjee, MD, who chronicled Dr. SubbaRow’s achievements in his New York Times No. 1 bestseller, “The Emperor of All Maladies: A Biography of Cancer.”
As Dr. Mukherjee wrote, Dr. SubbaRow was a “pioneer in many ways, a physician turned cellular physiologist, a chemist who had accidentally wandered into biology.” (Per Indian tradition, SubbaRow is the doctor’s first name, and Yellapragada is his surname, but medical literature uses SubbaRow as his cognomen, with some variations in spelling. Dr. Mukherjee wrote that his friends called him “Yella.”)
Dr. SubbaRow came to the United States in 1923, after enduring a difficult childhood and young adulthood. He’d survived bouts of religious fervor, childhood rebellion (including a bid to run away from home and become a banana trader), and a failed arranged marriage. His wife bore him a child who died in infancy. He left it all behind.
In Boston, medical officials rejected his degree. Broke, he worked for a time as a night porter at Brigham and Women’s Hospital in Boston, changing sheets and cleaning urinals. To a poor but proud high-caste Indian Brahmin, the culture shock of carrying out these tasks must have been especially jarring.
Dr. SubbaRow went on to earn a diploma from Harvard Medical School, also in Boston, and became a junior faculty member. As a foreigner, Dr. Mukherjee wrote, Dr. SubbaRow was a “reclusive, nocturnal, heavily accented vegetarian,” so different from his colleagues that advancement seemed impossible. Despite his pioneering biochemistry work, Harvard later declined to offer Dr. SubbaRow a tenured faculty position.
By the early 1940s, he took a job at an upstate New York pharmaceutical company called Lederle Labs (later purchased by Pfizer). At Lederle, Dr. SubbaRow strove to synthesize the vitamin known as folic acid. He ended up creating a kind of antivitamin, a lookalike that acted like folic acid but only succeeded in gumming up the works in receptors. But what good would it do to stop the body from absorbing folic acid? Plenty, it turned out.
Discoveries pile up, but credit and fame prove elusive
Dr. SubbaRow was no stranger to producing landmark biological work. He’d previously codiscovered phosphocreatine and ATP, which are crucial to muscular contractions. However, “in 1935, he had to disown the extent of his role in the discovery of the color test related to phosphorus, instead giving the credit to his co-author, who was being considered for promotion to a full professorship at Harvard,” wrote author Gerald Posner in his 2020 book, “Pharma: Greed, Lies and the Poisoning of America.”
Houston-area oncologist Kirtan Nautiyal, MD, who paid tribute to Dr. SubbaRow in a 2018 article, contended that “with his Indian instinct for self-effacement, he had irreparably sabotaged his own career.”
Dr. SubbaRow and his team also developed “the first effective treatment of filariasis, which causes elephantiasis of the lower limbs and genitals in millions of people, mainly in tropical countries,” Dr. Nautiyal wrote. “Later in the decade, his antibiotic program generated polymyxin, the first effective treatment against the class of bacteria called Gram negatives, and aureomycin, the first “broad-spectrum’ antibiotic.” (Aureomycin is also the first tetracycline antibiotic.)
Dr. SubbaRow’s discovery of a folic acid antagonist would again go largely unheralded. But first came the realization that folic acid made childhood leukemia worse, not better, and the prospect that this process could potentially be reversed.
Rise of methotrexate and fall of leukemia
In Boston, Sidney Farber, MD, a Boston pathologist, was desperate to help Robert Sandler, a 2-year-old leukemia patient. Dr. Farber contacted his ex-colleague Dr. SubbaRow to request a supply of aminopterin, an early version of methotrexate that Dr. SubbaRow and his team had developed. Dr. Farber injected Robert with the substance and within 3 days, the toddler’s white blood count started falling – fast. He stopped bleeding, resumed eating, and once again seemed almost identical to his twin brother, as Dr. Mukherjee wrote in his book.
Leukemia had never gone into remission before. Unfortunately, the treatment only worked temporarily. Robert, like other children treated with the drug, relapsed and died within months. But Dr. Farber “saw a door open” – a chemical, a kind of chemotherapy, that could turn back cancer. In the case of folic acid antagonists, they do so by stopping cancer cells from replicating.
Methotrexate, a related agent synthesized by Dr. SubbaRow, would become a mainstay of leukemia treatment and begin to produce long-term remission from acute lymphoblastic leukemia in 1970, when combination chemotherapy was developed.
Other cancers fell to methotrexate treatment. “Previous assumptions that cancer was nearly always fatal were revised, and the field of medical oncology (treatment of cancer with chemotherapy), which had not previously existed, was formally established in 1971,” according to the National Cancer Institute’s history of methotrexate. This account does not mention Dr. SubbaRow.
Death takes the doctor, but his legacy remains
In biographies, as well as his own words, Dr. SubbaRow comes across as a prickly, hard-driving workaholic who had little interest in intimate human connections. “It is not good to ask in every letter when I will be back,” he wrote to his wife back in India, before cutting off ties completely in the early 1930s. “I will come as early as possible. ... I do not want to write anything more.”
It seems, as his biographer S.P.K. Gupta noted, that “he was quite determined that the time allotted to him on Earth should be completely devoted to finding cures for ailments that plagued mankind.”
Still, Dr. SubbaRow’s research team was devoted to him, and he had plenty of reasons to be bitter, such as the prejudice and isolation he encountered in the United States and earlier, in British-run India. According to Mr. Posner’s book, even as a young medical student, Dr. SubbaRow heeded the call of Indian independence activist Mohandas Gandhi. He “refused the British surgical gown given him at school and instead donned a traditional and simple cotton Khadi. That act of defiance cost SubbaRow the college degree that was necessary for him to get into the State Medical College.”
During the last year of his life, Dr. SubbaRow faced yet another humiliation: In his landmark 1948 study about aminopterin as a treatment for leukemia, his colleague Dr. Farber failed to credit him, an “astonishing omission” as Yaddanapudi Ravindranath, MBBS, a pediatric hematologist/oncologist at Wayne State University, Detroit, put it. “From everything I know, Dr. Farber spent the rest of his career apologizing and trying to make amends for it,” Dr. Ravindranath said in an interview.
A career cut short, and a lasting legacy
In 1948, at the age of 53, Dr. SubbaRow suddenly died. “Many think Dr. SubbaRow would have won [the] Nobel Prize had he lived a few years longer,” said Dr. Ravindranath.
Like Dr. SubbaRow, Dr. Ravindranath was born in Andhra Pradesh state, near the city of Chennai formerly known as Madras. “Being a compatriot, in a way I continue his legacy, and I am obviously proud of him,” said Dr. Ravindranath, who has conducted his own landmark research regarding methotrexate and leukemia.
Nearly 75 years after Dr. SubbaRow’s death, Indian-born physicians like Dr. Ravindranath continue to honor him in print, trying to ensure that he’s not forgotten. Methotrexate remains a crucial treatment for leukemia, along with a long list of other ailments, including psoriasis.
Recognition for “Yella” may have come late and infrequently, but a Lederle Laboratories research library named after him offered Dr. SubbaRow a kind of immortality. A plaque there memorialized him in stone as a scientist, teacher, philosopher, and humanitarian, featuring the quote: “Science simply prolongs life. Religion deepens it.”
By all accounts, Dr. SubbaRow was a man of science and faith who had faith in science.
We have a half-forgotten Indian immigrant to thank – a hospital night porter turned biochemist –for revolutionizing treatment of leukemia, the once deadly childhood scourge that is still the most common pediatric cancer.
Dr. Yellapragada SubbaRow has been called the “father of chemotherapy” for developing methotrexate, a powerful, inexpensive therapy for leukemia and other diseases, and he is celebrated for additional scientific achievements. Yet Dr. SubbaRow’s life was marked more by struggle than glory.
Born poor in southeastern India, he nearly succumbed to a tropical disease that killed two older brothers, and he didn’t focus on schoolwork until his father died. Later, prejudice dogged his years as an immigrant to the United States, and a blood clot took his life at the age of 53.
Scientifically, however, Dr. SubbaRow (pronounced sue-buh-rao) triumphed, despite mammoth challenges and a lack of recognition that persists to this day. National Cancer Research Month is a fitting time to look back on his extraordinary life and work and pay tribute to his accomplishments.
‘Yella,’ folic acid, and a paradigm shift
No one appreciates Dr. SubbaRow more than a cadre of Indian-born physicians who have kept his legacy alive in journal articles, presentations, and a Pulitzer Prize-winning book. Among them is author and oncologist Siddhartha Mukherjee, MD, who chronicled Dr. SubbaRow’s achievements in his New York Times No. 1 bestseller, “The Emperor of All Maladies: A Biography of Cancer.”
As Dr. Mukherjee wrote, Dr. SubbaRow was a “pioneer in many ways, a physician turned cellular physiologist, a chemist who had accidentally wandered into biology.” (Per Indian tradition, SubbaRow is the doctor’s first name, and Yellapragada is his surname, but medical literature uses SubbaRow as his cognomen, with some variations in spelling. Dr. Mukherjee wrote that his friends called him “Yella.”)
Dr. SubbaRow came to the United States in 1923, after enduring a difficult childhood and young adulthood. He’d survived bouts of religious fervor, childhood rebellion (including a bid to run away from home and become a banana trader), and a failed arranged marriage. His wife bore him a child who died in infancy. He left it all behind.
In Boston, medical officials rejected his degree. Broke, he worked for a time as a night porter at Brigham and Women’s Hospital in Boston, changing sheets and cleaning urinals. To a poor but proud high-caste Indian Brahmin, the culture shock of carrying out these tasks must have been especially jarring.
Dr. SubbaRow went on to earn a diploma from Harvard Medical School, also in Boston, and became a junior faculty member. As a foreigner, Dr. Mukherjee wrote, Dr. SubbaRow was a “reclusive, nocturnal, heavily accented vegetarian,” so different from his colleagues that advancement seemed impossible. Despite his pioneering biochemistry work, Harvard later declined to offer Dr. SubbaRow a tenured faculty position.
By the early 1940s, he took a job at an upstate New York pharmaceutical company called Lederle Labs (later purchased by Pfizer). At Lederle, Dr. SubbaRow strove to synthesize the vitamin known as folic acid. He ended up creating a kind of antivitamin, a lookalike that acted like folic acid but only succeeded in gumming up the works in receptors. But what good would it do to stop the body from absorbing folic acid? Plenty, it turned out.
Discoveries pile up, but credit and fame prove elusive
Dr. SubbaRow was no stranger to producing landmark biological work. He’d previously codiscovered phosphocreatine and ATP, which are crucial to muscular contractions. However, “in 1935, he had to disown the extent of his role in the discovery of the color test related to phosphorus, instead giving the credit to his co-author, who was being considered for promotion to a full professorship at Harvard,” wrote author Gerald Posner in his 2020 book, “Pharma: Greed, Lies and the Poisoning of America.”
Houston-area oncologist Kirtan Nautiyal, MD, who paid tribute to Dr. SubbaRow in a 2018 article, contended that “with his Indian instinct for self-effacement, he had irreparably sabotaged his own career.”
Dr. SubbaRow and his team also developed “the first effective treatment of filariasis, which causes elephantiasis of the lower limbs and genitals in millions of people, mainly in tropical countries,” Dr. Nautiyal wrote. “Later in the decade, his antibiotic program generated polymyxin, the first effective treatment against the class of bacteria called Gram negatives, and aureomycin, the first “broad-spectrum’ antibiotic.” (Aureomycin is also the first tetracycline antibiotic.)
Dr. SubbaRow’s discovery of a folic acid antagonist would again go largely unheralded. But first came the realization that folic acid made childhood leukemia worse, not better, and the prospect that this process could potentially be reversed.
Rise of methotrexate and fall of leukemia
In Boston, Sidney Farber, MD, a Boston pathologist, was desperate to help Robert Sandler, a 2-year-old leukemia patient. Dr. Farber contacted his ex-colleague Dr. SubbaRow to request a supply of aminopterin, an early version of methotrexate that Dr. SubbaRow and his team had developed. Dr. Farber injected Robert with the substance and within 3 days, the toddler’s white blood count started falling – fast. He stopped bleeding, resumed eating, and once again seemed almost identical to his twin brother, as Dr. Mukherjee wrote in his book.
Leukemia had never gone into remission before. Unfortunately, the treatment only worked temporarily. Robert, like other children treated with the drug, relapsed and died within months. But Dr. Farber “saw a door open” – a chemical, a kind of chemotherapy, that could turn back cancer. In the case of folic acid antagonists, they do so by stopping cancer cells from replicating.
Methotrexate, a related agent synthesized by Dr. SubbaRow, would become a mainstay of leukemia treatment and begin to produce long-term remission from acute lymphoblastic leukemia in 1970, when combination chemotherapy was developed.
Other cancers fell to methotrexate treatment. “Previous assumptions that cancer was nearly always fatal were revised, and the field of medical oncology (treatment of cancer with chemotherapy), which had not previously existed, was formally established in 1971,” according to the National Cancer Institute’s history of methotrexate. This account does not mention Dr. SubbaRow.
Death takes the doctor, but his legacy remains
In biographies, as well as his own words, Dr. SubbaRow comes across as a prickly, hard-driving workaholic who had little interest in intimate human connections. “It is not good to ask in every letter when I will be back,” he wrote to his wife back in India, before cutting off ties completely in the early 1930s. “I will come as early as possible. ... I do not want to write anything more.”
It seems, as his biographer S.P.K. Gupta noted, that “he was quite determined that the time allotted to him on Earth should be completely devoted to finding cures for ailments that plagued mankind.”
Still, Dr. SubbaRow’s research team was devoted to him, and he had plenty of reasons to be bitter, such as the prejudice and isolation he encountered in the United States and earlier, in British-run India. According to Mr. Posner’s book, even as a young medical student, Dr. SubbaRow heeded the call of Indian independence activist Mohandas Gandhi. He “refused the British surgical gown given him at school and instead donned a traditional and simple cotton Khadi. That act of defiance cost SubbaRow the college degree that was necessary for him to get into the State Medical College.”
During the last year of his life, Dr. SubbaRow faced yet another humiliation: In his landmark 1948 study about aminopterin as a treatment for leukemia, his colleague Dr. Farber failed to credit him, an “astonishing omission” as Yaddanapudi Ravindranath, MBBS, a pediatric hematologist/oncologist at Wayne State University, Detroit, put it. “From everything I know, Dr. Farber spent the rest of his career apologizing and trying to make amends for it,” Dr. Ravindranath said in an interview.
A career cut short, and a lasting legacy
In 1948, at the age of 53, Dr. SubbaRow suddenly died. “Many think Dr. SubbaRow would have won [the] Nobel Prize had he lived a few years longer,” said Dr. Ravindranath.
Like Dr. SubbaRow, Dr. Ravindranath was born in Andhra Pradesh state, near the city of Chennai formerly known as Madras. “Being a compatriot, in a way I continue his legacy, and I am obviously proud of him,” said Dr. Ravindranath, who has conducted his own landmark research regarding methotrexate and leukemia.
Nearly 75 years after Dr. SubbaRow’s death, Indian-born physicians like Dr. Ravindranath continue to honor him in print, trying to ensure that he’s not forgotten. Methotrexate remains a crucial treatment for leukemia, along with a long list of other ailments, including psoriasis.
Recognition for “Yella” may have come late and infrequently, but a Lederle Laboratories research library named after him offered Dr. SubbaRow a kind of immortality. A plaque there memorialized him in stone as a scientist, teacher, philosopher, and humanitarian, featuring the quote: “Science simply prolongs life. Religion deepens it.”
By all accounts, Dr. SubbaRow was a man of science and faith who had faith in science.
Medical education programs tell how climate change affects health
Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.
“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”
Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.
Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.
“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”
Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.
According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
The Philadelphia Regional Center for Children’s Environmental Health
One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.
Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.
The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
Future generation of doctors fuel growth in climate change education
Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.
Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.
The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.
“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.
At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.
Of course, not all climate initiatives in medicine are new. A select few have existed for decades.
But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.
C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.
“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”
Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.
They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.
Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.
The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.
“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”
A version of this article first appeared on Medscape.com.
Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.
“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”
Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.
Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.
“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”
Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.
According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
The Philadelphia Regional Center for Children’s Environmental Health
One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.
Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.
The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
Future generation of doctors fuel growth in climate change education
Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.
Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.
The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.
“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.
At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.
Of course, not all climate initiatives in medicine are new. A select few have existed for decades.
But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.
C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.
“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”
Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.
They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.
Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.
The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.
“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”
A version of this article first appeared on Medscape.com.
Ms. Manivannan, copresident of Emory Medical Students for Climate Action, was in the first class of Emory’s medical students to experience the birth of a refined curriculum – lobbied for and partially created by students themselves. The new course of study addresses the myriad ways climate affects health: from air pollution and its effects on the lungs and cardiovascular system to heat-related kidney disease.
“We have known that climate has affected health for decades,” Ms. Manivannan said in a recent interview. “The narrative used to be that icebergs were melting and in 2050 polar bears would be extinct. The piece that’s different now is people are linking climate to increases in asthma and various diseases. We have a way to directly communicate that it’s not a far-off thing. It’s happening to your friends and family right now.”
Hospitals, medical schools, and public health programs are stepping up to educate the next generation of doctors as well as veteran medical workers on one of the most widespread, insidious health threats of our time – climate change – and specific ways it could affect their patients.
Although climate change may seem to many Americans like a distant threat, Marilyn Howarth, MD, a pediatrician in Philadelphia, is trying to make sure physicians are better prepared to treat a growing number of health problems associated with global warming.
“There isn’t a lot of education for pediatricians and internists on environmental health issues. It has not been a standard part of education in medical school or residency training,” Dr. Howarth, deputy director of the new Philadelphia Regional Center for Children’s Environmental Health, said. “With increasing attention on our climate, we really recognize there’s a real gap in physician knowledge, both in pediatric and adult care.”
Scientists have found that climate change can alter just about every system within the human body. Studies show that more extreme weather events, such as heat waves, thunderstorms, and floods, can worsen asthma and produce more pollen and mold, triggering debilitating respiratory problems.
According to the American Lung Association, ultrafine particles of air pollution can be inhaled and then travel throughout the bloodstream, wreaking havoc on organs and increasing risk of heart attack and stroke. Various types of air pollution also cause changes to the climate by trapping heat in the atmosphere, which leads to problems such as rising sea levels and extreme weather. Plus, in a new study published in Nature, scientists warn that warming climates are forcing animals to migrate to different areas, raising the risk that new infectious diseases will hop from animals – such as bats – to humans, a process called “zoonotic spillover” that many researchers believe is responsible for the COVID-19 pandemic.
The Philadelphia Regional Center for Children’s Environmental Health
One of the latest initiatives aimed at disseminating information about children’s health to health care providers is the Philadelphia Regional Center for Children’s Environmental Health, part of Children’s Hospital of Philadelphia and Penn Medicine. CHOP and Penn Medicine are jointly funding this center’s work, which will include educating health care providers on how to better screen for climate-caused health risks and treat related conditions, such as lead poisoning and asthma.
Outreach will focus on providers who treat patients with illnesses that researchers have linked to climate change, Dr. Howarth said. The center will offer clinicians access to seminars and webinars, along with online resources to help doctors treat environmental illnesses. For example, doctors at CHOP’s Poison Control Center are developing a toolkit for physicians to treat patients with elevated levels of lead in the blood. Scientists have linked extreme weather events related to climate change to flooding that pushes metals away from river banks where they were previously contained, allowing them to more easily contaminate homes, soils, and yards.
The initiative builds on CHOP’s Community Asthma Prevention Program (CAPP), which was launched in 1997 by Tyra Bryant-Stephens, MD, its current medical director. CAPP deploys community health workers into homes armed with supplies and tips for managing asthma. The new center will use similar tactics to provide education and resources to patients. The goal is to reach as many at-risk local children as possible.
Future generation of doctors fuel growth in climate change education
Lisa Doggett, MD, cofounder and president of the board of directors of Texas Physicians for Social Responsibility, announced in March that the University of Texas at Austin, Baylor College of Medicine, Houston, and the University of Texas Southwestern in Dallas have all decided to begin offering a course on environmental threats. Emory’s new curriculum has become more comprehensive every year since its start – thanks in part to the input of students like Ms. Manivannan. Faculty members tasked her with approving the new additions to the curriculum on how climate affects health, which in 2019 had consisted of a few slides about issues such as extreme heat exposure and air pollution and their effects on childbirth outcomes.
Material on climate change has now been woven into 13 courses. It is discussed at length in relation to pulmonology, cardiology, and gastropulmonology, for example, said Rebecca Philipsborn, MD, MPA, FAAP, faculty lead for the environmental and health curriculum at Emory.
The curriculum has only been incorporated into Emory’s program for the past 2 years. Dr. Philipsborn said the school plans to expand it to the clinical years to help trainees learn to treat conditions such as pediatric asthma.
“In the past few years, there has been so much momentum, and part of that is a testament to already seeing effects of climate change and how they affect delivery of health care,” she said.
At least one medical journal has recently ramped up its efforts to educate physicians on the links between health issues and climate change. Editors of Family Practice, from Oxford University Press, have announced that they plan to publish a special Climate Crisis and Primary Health Care issue in September.
Of course, not all climate initiatives in medicine are new. A select few have existed for decades.
But only now are physicians widely seeing the links between health and environment, according to Aaron Bernstein, MD, MPH, interim director of the Center for Climate, Health, and the Global Environment (C-CHANGE) at Harvard School of Public Health, Boston.
C-CHANGE, founded in 1996, was the first center in the world to focus on the health effects of environmental change.
“It’s taken 20 years, but what we’re seeing, I think, is the fruits of education,” Dr. Bernstein said. “There’s clearly a wave building here, and I think it really started with education and people younger than the people in charge calling them into account.”
Like the Philadelphia center, Harvard’s program conducts research on climate and health and educates people from high schoolers to health care veterans. Dr. Bernstein helps lead Climate MD, a program that aims to prepare health care workers for climate crises. The Climate MD team has published several articles in peer-reviewed journals on how to better treat patients struggling with environmental health problems. For example, an article on mapping patients in hurricane zones helped shed light on how systems can identify climate-vulnerable patients using public data.
They also developed a tool to help pediatricians provide “climate-informed primary care” – guidance on how to assess whether children are at risk of any harmful environmental exposures, a feature that is not part of standard pediatric visits.
Like the other programs, Climate MD uses community outreach to treat as many local patients as possible. Staff work with providers at more than 100 health clinics, particularly in areas where climate change disproportionately affects residents.
The next major step is to bring some of this into clinical practice, Dr. Bernstein said. In February 2020, C-CHANGE held its first symposium to address that issue.
“The key is to understand climate issues from a provider’s perspective,” he said. “Then those issues can really be brought to the bedside.”
A version of this article first appeared on Medscape.com.
CDC predicts a rise in COVID-19 hospitalizations and deaths in coming weeks
, according to a national forecast used by the Centers for Disease Control and Prevention.
The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.
The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.
In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.
Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.
The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.
On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.
Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.
The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.
A version of this article first appeared on WebMD.com.
, according to a national forecast used by the Centers for Disease Control and Prevention.
The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.
The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.
In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.
Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.
The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.
On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.
Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.
The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.
A version of this article first appeared on WebMD.com.
, according to a national forecast used by the Centers for Disease Control and Prevention.
The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.
The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.
In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.
Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.
The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.
On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.
Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.
The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.
A version of this article first appeared on WebMD.com.
‘Bane of my existence:’ The burden of Medicare Advantage denials
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
‘Agony of choice’ for clinicians treating leukemia
“Targeted therapies have outnumbered chemoimmunotherapy-based treatment approaches, demonstrating superior efficacy and tolerability profiles across nearly all CLL patient subgroups in the frontline and relapsed disease treatment setting,” author Jan-Paul Bohn, MD, PhD, of the department of internal medicine V, hematology and oncology, at Medical University of Innsbruck (Austria), reported in the review published in Memo, the Magazine of European Medical Oncology.
The options leave clinicians “spoilt for choice when selecting optimal therapy,” he said.
The three major drug classes to emerge – inhibitors of Bruton tyrosine kinase (BTK), antiapoptotic protein B-cell lymphoma 2 (BCL2) and phosphoinositide 3’-kinase (PI3K) – all appear similar in efficacy and tolerability.
Particularly in high-risk patients, the drugs have been so effective that the less desirable previous standard of “chemoimmunotherapy has widely faded into the background in the Western hemisphere,” Dr. Bohn wrote.
However, with caveats of the newer drugs including acquired resistances and potential toxicities, challenges have shifted to determining how to best juggle and/or combine the agents.
Frontline therapy
In terms of frontline options for CLL therapy, the BTK inhibitors, along with the BCL2 inhibitor venetoclax have been key in negating the need for chemotherapy, with some of the latest data showing superiority of venetoclax in combination with obinutuzumab (GVe) over chemotherapy even in the higher-risk subset of patients with mutated IGHV status and without TP53 disruption.
Hence, “chemoimmunotherapy may now even be questioned in the remaining subset of CLL patients with mutated IGHV status and without TP53 disruption,” Dr. Bohn reported.
That being said, the criteria for treatment choices in the frontline setting among the newer drug classes can often come down to the key issues of patients’ comorbidities and treatment preferences.
For example, in terms of patients who have higher risk because of tumor lysis syndrome (TLS), or issues including declining renal function, continuous BTK inhibitor treatment may be the preferred choice over the combination of venetoclax plus obinutuzumab (GVe), Dr. Bohn noted.
Conversely, for patients with cardiac comorbidities or a higher risk of bleeding, the GVe combination may be preferred over ibrutinib, with recent findings showing ibrutinib to be associated with as much as an 18-times higher risk of sudden unexplained death or cardiac death in young and fit patients who had preexisting arterial hypertension and/or a history of cardiac disorders requiring therapy.
For those with cardiac comorbidities, the more selective second-generation BTK inhibitor acalabrutinib is a potentially favorable alternative, as the drug is “at least similarly effective and more favorable in terms of tolerability, compared with ibrutinib, particularly as far as cardiac and bleeding side effects are considered,” Dr. Bohn said.
And in higher-risk cases involving TP53 dysfunction, a BTK inhibitor may be superior to GVe for frontline treatment, Dr. Bohn noted, with data showing progression-free survival in patients with and without deletion 17p to be significantly reduced with GVe versus the BTK inhibitor ibrutinib.
Relapsed and refractory disease
With similarly high efficacy observed with the new drug classes among relapsed and/or refractory patients, chemoimmunotherapy has likewise “become obsolete in nearly all patients naive to novel agents at relapse who typically present with genetically high-risk disease,” Dr. Bohn noted.
He wrote that most of the recommendations for frontline therapy hold true in the relapsed and refractory patients, with comorbidities and personal preferences again key drivers of treatment choices.
While data is currently limited regarding benefits of venetoclax-based regimens over BTK inhibitors in relapsed/refractory patients, there is “growing evidence suggesting similar clinical outcomes achievable with these agents in either order,” Dr. Bohn wrote.
Further recommendations regarding relapsed or refractory patients include:
- Among patients who do experience disease progression while on continuous treatment with BTK inhibitors, venetoclax-based regimes seem most effective. However, with relapse after venetoclax-based regimes, some growing evidence supports retreatment with the drug “depending on depth and duration of response achieved after first venetoclax exposure,” Dr. Bohn noted.
- For patients with deletion 17p, venetoclax shows promising efficacy during relapse when given as monotherapy until disease progression or occurrence of unacceptable toxicity.
- And for patients with TP53 abnormalities, the considerations are the same as for frontline therapy, with venetoclax showing promising efficacy when given in monotherapy until disease progression or occurrence of unacceptable toxicity.
Of note, PI3K inhibitors are generally not used in CLL patients naive to BTK and BCL2 inhibitors because of the higher risk of immune-mediated toxicities and infectious complications associated with the currently approved PI3K inhibitors idelalisib and duvelisib, he reported.
Nevertheless, “PI3K inhibitors remain a valuable therapeutic addition in patients refractory or intolerant to BTK inhibitors and venetoclax-based regimens,” Dr. Bohn said.
Newer agents, fixed duration
Commenting on the review, hematologist Seema A. Bhat, MD, an assistant professor with the Ohio State University Comprehensive Cancer Center, Columbus, said that the advances with targeted therapies in CLL are paying off with improved survival.
“With these recent advances in the treatment of CLL, especially the availability of targeted therapies, there has been an improvement in survival of patients with CLL, as the CLL-related death rate steadily reduced by approximately 3% per year between 2006 and 2015,” she said in an interview.
She added that even-newer agents in development, including the reversibly binding BTK inhibitor–like pirtobrutinib and nemtabrutinib, when approved, will further add to the treatment choices for patients.
Meanwhile, a key area of focus is the combination of BTK inhibitors and BCL2 inhibitors, specifically for a fixed duration of time to obtain a deeper response and hence possibility a time-limited therapy, she noted. “We are also excited about the possibility of having more fixed-duration treatments available for our patients, which will make their treatment journey less troublesome, both physically as well as financially.”
Dr. Bohn reported receiving personal fees from AbbVie, AstraZeneca and Janssen for advisory board participation. Dr. Bhat has served on advisory board for AstraZeneca and received honorarium from them.
“Targeted therapies have outnumbered chemoimmunotherapy-based treatment approaches, demonstrating superior efficacy and tolerability profiles across nearly all CLL patient subgroups in the frontline and relapsed disease treatment setting,” author Jan-Paul Bohn, MD, PhD, of the department of internal medicine V, hematology and oncology, at Medical University of Innsbruck (Austria), reported in the review published in Memo, the Magazine of European Medical Oncology.
The options leave clinicians “spoilt for choice when selecting optimal therapy,” he said.
The three major drug classes to emerge – inhibitors of Bruton tyrosine kinase (BTK), antiapoptotic protein B-cell lymphoma 2 (BCL2) and phosphoinositide 3’-kinase (PI3K) – all appear similar in efficacy and tolerability.
Particularly in high-risk patients, the drugs have been so effective that the less desirable previous standard of “chemoimmunotherapy has widely faded into the background in the Western hemisphere,” Dr. Bohn wrote.
However, with caveats of the newer drugs including acquired resistances and potential toxicities, challenges have shifted to determining how to best juggle and/or combine the agents.
Frontline therapy
In terms of frontline options for CLL therapy, the BTK inhibitors, along with the BCL2 inhibitor venetoclax have been key in negating the need for chemotherapy, with some of the latest data showing superiority of venetoclax in combination with obinutuzumab (GVe) over chemotherapy even in the higher-risk subset of patients with mutated IGHV status and without TP53 disruption.
Hence, “chemoimmunotherapy may now even be questioned in the remaining subset of CLL patients with mutated IGHV status and without TP53 disruption,” Dr. Bohn reported.
That being said, the criteria for treatment choices in the frontline setting among the newer drug classes can often come down to the key issues of patients’ comorbidities and treatment preferences.
For example, in terms of patients who have higher risk because of tumor lysis syndrome (TLS), or issues including declining renal function, continuous BTK inhibitor treatment may be the preferred choice over the combination of venetoclax plus obinutuzumab (GVe), Dr. Bohn noted.
Conversely, for patients with cardiac comorbidities or a higher risk of bleeding, the GVe combination may be preferred over ibrutinib, with recent findings showing ibrutinib to be associated with as much as an 18-times higher risk of sudden unexplained death or cardiac death in young and fit patients who had preexisting arterial hypertension and/or a history of cardiac disorders requiring therapy.
For those with cardiac comorbidities, the more selective second-generation BTK inhibitor acalabrutinib is a potentially favorable alternative, as the drug is “at least similarly effective and more favorable in terms of tolerability, compared with ibrutinib, particularly as far as cardiac and bleeding side effects are considered,” Dr. Bohn said.
And in higher-risk cases involving TP53 dysfunction, a BTK inhibitor may be superior to GVe for frontline treatment, Dr. Bohn noted, with data showing progression-free survival in patients with and without deletion 17p to be significantly reduced with GVe versus the BTK inhibitor ibrutinib.
Relapsed and refractory disease
With similarly high efficacy observed with the new drug classes among relapsed and/or refractory patients, chemoimmunotherapy has likewise “become obsolete in nearly all patients naive to novel agents at relapse who typically present with genetically high-risk disease,” Dr. Bohn noted.
He wrote that most of the recommendations for frontline therapy hold true in the relapsed and refractory patients, with comorbidities and personal preferences again key drivers of treatment choices.
While data is currently limited regarding benefits of venetoclax-based regimens over BTK inhibitors in relapsed/refractory patients, there is “growing evidence suggesting similar clinical outcomes achievable with these agents in either order,” Dr. Bohn wrote.
Further recommendations regarding relapsed or refractory patients include:
- Among patients who do experience disease progression while on continuous treatment with BTK inhibitors, venetoclax-based regimes seem most effective. However, with relapse after venetoclax-based regimes, some growing evidence supports retreatment with the drug “depending on depth and duration of response achieved after first venetoclax exposure,” Dr. Bohn noted.
- For patients with deletion 17p, venetoclax shows promising efficacy during relapse when given as monotherapy until disease progression or occurrence of unacceptable toxicity.
- And for patients with TP53 abnormalities, the considerations are the same as for frontline therapy, with venetoclax showing promising efficacy when given in monotherapy until disease progression or occurrence of unacceptable toxicity.
Of note, PI3K inhibitors are generally not used in CLL patients naive to BTK and BCL2 inhibitors because of the higher risk of immune-mediated toxicities and infectious complications associated with the currently approved PI3K inhibitors idelalisib and duvelisib, he reported.
Nevertheless, “PI3K inhibitors remain a valuable therapeutic addition in patients refractory or intolerant to BTK inhibitors and venetoclax-based regimens,” Dr. Bohn said.
Newer agents, fixed duration
Commenting on the review, hematologist Seema A. Bhat, MD, an assistant professor with the Ohio State University Comprehensive Cancer Center, Columbus, said that the advances with targeted therapies in CLL are paying off with improved survival.
“With these recent advances in the treatment of CLL, especially the availability of targeted therapies, there has been an improvement in survival of patients with CLL, as the CLL-related death rate steadily reduced by approximately 3% per year between 2006 and 2015,” she said in an interview.
She added that even-newer agents in development, including the reversibly binding BTK inhibitor–like pirtobrutinib and nemtabrutinib, when approved, will further add to the treatment choices for patients.
Meanwhile, a key area of focus is the combination of BTK inhibitors and BCL2 inhibitors, specifically for a fixed duration of time to obtain a deeper response and hence possibility a time-limited therapy, she noted. “We are also excited about the possibility of having more fixed-duration treatments available for our patients, which will make their treatment journey less troublesome, both physically as well as financially.”
Dr. Bohn reported receiving personal fees from AbbVie, AstraZeneca and Janssen for advisory board participation. Dr. Bhat has served on advisory board for AstraZeneca and received honorarium from them.
“Targeted therapies have outnumbered chemoimmunotherapy-based treatment approaches, demonstrating superior efficacy and tolerability profiles across nearly all CLL patient subgroups in the frontline and relapsed disease treatment setting,” author Jan-Paul Bohn, MD, PhD, of the department of internal medicine V, hematology and oncology, at Medical University of Innsbruck (Austria), reported in the review published in Memo, the Magazine of European Medical Oncology.
The options leave clinicians “spoilt for choice when selecting optimal therapy,” he said.
The three major drug classes to emerge – inhibitors of Bruton tyrosine kinase (BTK), antiapoptotic protein B-cell lymphoma 2 (BCL2) and phosphoinositide 3’-kinase (PI3K) – all appear similar in efficacy and tolerability.
Particularly in high-risk patients, the drugs have been so effective that the less desirable previous standard of “chemoimmunotherapy has widely faded into the background in the Western hemisphere,” Dr. Bohn wrote.
However, with caveats of the newer drugs including acquired resistances and potential toxicities, challenges have shifted to determining how to best juggle and/or combine the agents.
Frontline therapy
In terms of frontline options for CLL therapy, the BTK inhibitors, along with the BCL2 inhibitor venetoclax have been key in negating the need for chemotherapy, with some of the latest data showing superiority of venetoclax in combination with obinutuzumab (GVe) over chemotherapy even in the higher-risk subset of patients with mutated IGHV status and without TP53 disruption.
Hence, “chemoimmunotherapy may now even be questioned in the remaining subset of CLL patients with mutated IGHV status and without TP53 disruption,” Dr. Bohn reported.
That being said, the criteria for treatment choices in the frontline setting among the newer drug classes can often come down to the key issues of patients’ comorbidities and treatment preferences.
For example, in terms of patients who have higher risk because of tumor lysis syndrome (TLS), or issues including declining renal function, continuous BTK inhibitor treatment may be the preferred choice over the combination of venetoclax plus obinutuzumab (GVe), Dr. Bohn noted.
Conversely, for patients with cardiac comorbidities or a higher risk of bleeding, the GVe combination may be preferred over ibrutinib, with recent findings showing ibrutinib to be associated with as much as an 18-times higher risk of sudden unexplained death or cardiac death in young and fit patients who had preexisting arterial hypertension and/or a history of cardiac disorders requiring therapy.
For those with cardiac comorbidities, the more selective second-generation BTK inhibitor acalabrutinib is a potentially favorable alternative, as the drug is “at least similarly effective and more favorable in terms of tolerability, compared with ibrutinib, particularly as far as cardiac and bleeding side effects are considered,” Dr. Bohn said.
And in higher-risk cases involving TP53 dysfunction, a BTK inhibitor may be superior to GVe for frontline treatment, Dr. Bohn noted, with data showing progression-free survival in patients with and without deletion 17p to be significantly reduced with GVe versus the BTK inhibitor ibrutinib.
Relapsed and refractory disease
With similarly high efficacy observed with the new drug classes among relapsed and/or refractory patients, chemoimmunotherapy has likewise “become obsolete in nearly all patients naive to novel agents at relapse who typically present with genetically high-risk disease,” Dr. Bohn noted.
He wrote that most of the recommendations for frontline therapy hold true in the relapsed and refractory patients, with comorbidities and personal preferences again key drivers of treatment choices.
While data is currently limited regarding benefits of venetoclax-based regimens over BTK inhibitors in relapsed/refractory patients, there is “growing evidence suggesting similar clinical outcomes achievable with these agents in either order,” Dr. Bohn wrote.
Further recommendations regarding relapsed or refractory patients include:
- Among patients who do experience disease progression while on continuous treatment with BTK inhibitors, venetoclax-based regimes seem most effective. However, with relapse after venetoclax-based regimes, some growing evidence supports retreatment with the drug “depending on depth and duration of response achieved after first venetoclax exposure,” Dr. Bohn noted.
- For patients with deletion 17p, venetoclax shows promising efficacy during relapse when given as monotherapy until disease progression or occurrence of unacceptable toxicity.
- And for patients with TP53 abnormalities, the considerations are the same as for frontline therapy, with venetoclax showing promising efficacy when given in monotherapy until disease progression or occurrence of unacceptable toxicity.
Of note, PI3K inhibitors are generally not used in CLL patients naive to BTK and BCL2 inhibitors because of the higher risk of immune-mediated toxicities and infectious complications associated with the currently approved PI3K inhibitors idelalisib and duvelisib, he reported.
Nevertheless, “PI3K inhibitors remain a valuable therapeutic addition in patients refractory or intolerant to BTK inhibitors and venetoclax-based regimens,” Dr. Bohn said.
Newer agents, fixed duration
Commenting on the review, hematologist Seema A. Bhat, MD, an assistant professor with the Ohio State University Comprehensive Cancer Center, Columbus, said that the advances with targeted therapies in CLL are paying off with improved survival.
“With these recent advances in the treatment of CLL, especially the availability of targeted therapies, there has been an improvement in survival of patients with CLL, as the CLL-related death rate steadily reduced by approximately 3% per year between 2006 and 2015,” she said in an interview.
She added that even-newer agents in development, including the reversibly binding BTK inhibitor–like pirtobrutinib and nemtabrutinib, when approved, will further add to the treatment choices for patients.
Meanwhile, a key area of focus is the combination of BTK inhibitors and BCL2 inhibitors, specifically for a fixed duration of time to obtain a deeper response and hence possibility a time-limited therapy, she noted. “We are also excited about the possibility of having more fixed-duration treatments available for our patients, which will make their treatment journey less troublesome, both physically as well as financially.”
Dr. Bohn reported receiving personal fees from AbbVie, AstraZeneca and Janssen for advisory board participation. Dr. Bhat has served on advisory board for AstraZeneca and received honorarium from them.
FROM MEMO – MAGAZINE OF EUROPEAN MEDICAL ONCOLOGY
Innocent doc sued after 'secret' medical expert says claim has merit
When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.
A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery.
“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”
Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.
Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.
Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.
Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.
“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”
The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)
“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”
Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.
“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
Attorneys: Hidden experts increase costs, waste time
In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.
Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.
In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.
The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.
A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.
“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”
In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.
The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.
“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”
Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.
“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
Why are anonymous experts allowed?
Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.
“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”
This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.
“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”
Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.
“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.”
The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.
“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”
In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.
“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
Hidden experts may insulate plaintiffs’ attorneys from liability
Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.
The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.
“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”
In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.
In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant.
In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.
“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”
Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.
“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?”
A version of this article first appeared on Medscape.com.
When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.
A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery.
“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”
Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.
Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.
Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.
Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.
“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”
The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)
“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”
Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.
“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
Attorneys: Hidden experts increase costs, waste time
In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.
Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.
In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.
The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.
A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.
“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”
In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.
The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.
“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”
Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.
“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
Why are anonymous experts allowed?
Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.
“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”
This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.
“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”
Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.
“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.”
The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.
“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”
In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.
“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
Hidden experts may insulate plaintiffs’ attorneys from liability
Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.
The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.
“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”
In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.
In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant.
In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.
“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”
Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.
“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?”
A version of this article first appeared on Medscape.com.
When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.
A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery.
“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”
Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.
Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.
Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.
Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.
“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”
The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)
“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”
Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.
“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
Attorneys: Hidden experts increase costs, waste time
In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.
Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.
In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.
The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.
A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.
“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”
In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.
The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.
“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”
Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.
“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
Why are anonymous experts allowed?
Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.
“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”
This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.
“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”
Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.
“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.”
The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.
“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”
In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.
“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
Hidden experts may insulate plaintiffs’ attorneys from liability
Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.
The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.
“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”
In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.
In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant.
In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.
“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”
Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.
“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?”
A version of this article first appeared on Medscape.com.
‘Together, we can demand improvements’: Stanford Health Care’s residents vote to join union
More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.
“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.
“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.
“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.
Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”
“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.
The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
Concerns date back to initial COVID-19 vaccine rollout
The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.
Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.
Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.
The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
Part of a growing trend
Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”
The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.
In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”
Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.
Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.
A version of this article first appeared on Medscape.com.
More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.
“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.
“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.
“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.
Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”
“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.
The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
Concerns date back to initial COVID-19 vaccine rollout
The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.
Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.
Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.
The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
Part of a growing trend
Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”
The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.
In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”
Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.
Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.
A version of this article first appeared on Medscape.com.
More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.
“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.
“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.
“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.
Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”
“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.
The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
Concerns date back to initial COVID-19 vaccine rollout
The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.
Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.
Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.
The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
Part of a growing trend
Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”
The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.
In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”
Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.
Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.
A version of this article first appeared on Medscape.com.
FDA limits use of J&J COVID vaccine over blood clot risk
In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.
The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.
The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.
“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.
Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.
The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.
But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.
The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.
A version of this article first appeared on WebMD.com.
In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.
The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.
The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.
“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.
Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.
The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.
But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.
The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.
A version of this article first appeared on WebMD.com.
In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.
The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.
The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.
“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”
The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.
Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.
The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.
But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.
The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.
A version of this article first appeared on WebMD.com.
Telehealth continues to loom large, say experts
This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.
“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.
Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.
A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
Virtual care is in ‘early-adopter phase’
But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.
Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.
“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.
Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.
The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.
“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”
Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.
The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.
“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”
Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.
“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”
But health care at academic medical centers, she said, needs to adjust to the times.
“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”
Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.
This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.
“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.
Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.
A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
Virtual care is in ‘early-adopter phase’
But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.
Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.
“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.
Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.
The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.
“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”
Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.
The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.
“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”
Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.
“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”
But health care at academic medical centers, she said, needs to adjust to the times.
“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”
Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.
This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.
“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.
Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.
A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
Virtual care is in ‘early-adopter phase’
But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.
Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.
“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.
Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.
The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.
“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”
Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.
The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.
“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”
Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.
“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”
But health care at academic medical centers, she said, needs to adjust to the times.
“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”
Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.
AT INTERNAL MEDICINE 2022