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Will interchangeable insulin be more affordable in the U.S.?
When the Food and Drug Administration approved Semglee, the first interchangeable biosimilar insulin, the agency pitched it as having the potential to be less costly than insulins currently on the market, but lack of transparency in pharmaceutical pricing has left analysts and advocates guessing whether it will indeed be a source of relief.
Semglee (Mylan Pharmaceuticals), first approved as a biosimilar in June 2020, costs about $100 a vial.
But receiving the “interchangeable designation” in July 2021, the first for any insulin, now allows Semglee to be substituted for the branded Lantus (insulin glargine, Sanofi) at the pharmacy without the need for a separate prescription, the same way as generic medicines.
A spokesperson for Viatris – Mylan’s parent company told this news organization that the interchangeable, with its new labeling, will be “introduced before the end of the year,” but it would not give any more details.
“Additional information, including pricing information, for interchangeable biosimilar Semglee will be provided at the time of product launch,” said the spokesperson.
Even at $100 a vial, it is not cheap
Ian Devaney, a spokesman for the advocacy group T1 International, said the organization is optimistic, given that “another player has been able to enter into a space that has for so long been dominated by Eli Lilly, Novo Nordisk, and Sanofi.” Increased competition “will help drive down the overall costs of insulin,” Mr. Devaney said in an interview. But, he added, for many people, especially in low-income countries, Semglee’s launch will have little to no impact on price.
Even at $100 a vial in the United States, “this is not an insignificant amount of money and presents a very difficult financial challenge for those dependent on insulin to survive,” he said.
A current Semglee user agreed, sharing her story with this news organization via T1 International. “My son uses three to five vials of long-acting insulin per month, and I use one to three vials per month,” said the woman, who prefers to remain anonymous. “If we were to lose Medicaid, we would still be paying up to $800 out of pocket monthly to survive, and that’s not even counting fast-acting insulin or other supplies. While $100 a vial may be cheaper, these costs are still outrageous.”
The woman also noted that, while new competitors are welcome, they also have been disruptive. After her doctor switched her to Semglee, she was notified that it was on back order. “It took a week to get it filled, and when it finally came in, it was in short supply,” she said, noting that she and her son received one Semglee pen each, “well short of the three and five each we were expecting.”
U.S. pricing is all ‘smoke and mirrors’
Sara W. Koblitz, a food and drug law attorney with Hyman Phelps in Washington, D.C., noted in a blog post that interchangeable Semglee will likely be awarded a year of marketing exclusivity, which will block other interchangeable competitors from entering the market during that time.
With no competition, “Mylan can price Semglee only slightly less than Lantus and still take market share, only marginally reducing costs to consumers,” she wrote.
Jing Luo, MD, MPH, an assistant professor of medicine at the University of Pittsburgh, who has studied insulin access and costs, said that having just one interchangeable on the market might not be enough to drive insulin costs down.
And, he told this news organization, “there’s even a possibility that Semglee prices will go up, but hopefully that will not be the case.”
Manufacturers like Mylan can also offer confidential discounts and rebates to pharmacy benefit managers (PBMs), health plans, and health plan sponsors (usually large companies that are self-insured) that make it difficult to assess the true cost, said David Steinberg, PharmD, director of pharmacy insights at Scripta Insights. The Wellesley, Mass.–based company advises self-insured employers on how to optimize pharmacy benefits.
When it comes to pricing, “it’s a lot of smoke and mirrors,” Dr. Steinberg said in an interview.
Dr. Steinberg also noted that some PBMs might choose to continue contracts with Sanofi that offer rebates for Lantus, leaving Semglee in a less-preferred position on a formulary, which could increase how much the patient pays at the pharmacy counter.
Medicare and Medicaid, however, can put Semglee in the top-tier preferred formulary position. Most Medicaid plans cover Semglee, but it appears that Medicare has not added coverage yet.
Does current pricing predict the future?
The currently marketed Semglee has an average wholesale price (AWP) that is one third of Lantus’, and about half of what is published for Basaglar (insulin glargine, Eli Lilly), a “follow-on biologic” approved in 2015 that is similar to Lantus, Dr. Steinberg said.
The AWP is often cited by analysts when talking about costs. The AWP of the current Semglee 10-mL vial is $118.38; the Lantus 10-mL vial is $340.27, said Steinberg.
Five prefilled Semglee pens (each 3 mL) are $177.58; for Lantus, the AWP for five 3-mL pens is $510.37.
Dr. Luo said he has seen a box of Semglee pens retail between $177 and $195, compared with about $500 retail for the Lantus pens.
Currently, people with commercial insurance can get Semglee for $0-75 a month, for up to a year, using the company’s savings program.
Steinberg said it’s possible that Mylan could increase the list price for the interchangeable Semglee, but that move could backfire. “I think their goal initially is to get market share,” he said.
After Basaglar came on the market – in late 2016 – the price of Lantus came down significantly over the next few years, according to a 2019 study by Dr. Luo’s colleagues at the University of Pittsburgh.
But Basaglar has not hung on to market share, according to Scott Strumello, a person with autoimmune type 1 diabetes who tweets and blogs about insulin and other issues.
In early August, Mr. Strumello tweeted some Lilly data that showed U.S. sales of Basaglar declined 42% in the first two quarters of 2021, compared with the same period in 2020.
Dr. Steinberg noted that the decline may have to do with rebates being given to PBMs by competitors Sanofi and Novo Nordisk. Sanofi “is very aggressive when it comes to pricing with their PBM partners,” he said.
While Mr. Devaney said people with diabetes are hopeful that Semglee can break the big three manufacturers’ monopoly, he added: “We don’t see Semglee as something that is solving the root cause of the insulin price crisis, which is high list prices and pharmaceutical industry greed.”
A version of this article first appeared on Medscape.com.
When the Food and Drug Administration approved Semglee, the first interchangeable biosimilar insulin, the agency pitched it as having the potential to be less costly than insulins currently on the market, but lack of transparency in pharmaceutical pricing has left analysts and advocates guessing whether it will indeed be a source of relief.
Semglee (Mylan Pharmaceuticals), first approved as a biosimilar in June 2020, costs about $100 a vial.
But receiving the “interchangeable designation” in July 2021, the first for any insulin, now allows Semglee to be substituted for the branded Lantus (insulin glargine, Sanofi) at the pharmacy without the need for a separate prescription, the same way as generic medicines.
A spokesperson for Viatris – Mylan’s parent company told this news organization that the interchangeable, with its new labeling, will be “introduced before the end of the year,” but it would not give any more details.
“Additional information, including pricing information, for interchangeable biosimilar Semglee will be provided at the time of product launch,” said the spokesperson.
Even at $100 a vial, it is not cheap
Ian Devaney, a spokesman for the advocacy group T1 International, said the organization is optimistic, given that “another player has been able to enter into a space that has for so long been dominated by Eli Lilly, Novo Nordisk, and Sanofi.” Increased competition “will help drive down the overall costs of insulin,” Mr. Devaney said in an interview. But, he added, for many people, especially in low-income countries, Semglee’s launch will have little to no impact on price.
Even at $100 a vial in the United States, “this is not an insignificant amount of money and presents a very difficult financial challenge for those dependent on insulin to survive,” he said.
A current Semglee user agreed, sharing her story with this news organization via T1 International. “My son uses three to five vials of long-acting insulin per month, and I use one to three vials per month,” said the woman, who prefers to remain anonymous. “If we were to lose Medicaid, we would still be paying up to $800 out of pocket monthly to survive, and that’s not even counting fast-acting insulin or other supplies. While $100 a vial may be cheaper, these costs are still outrageous.”
The woman also noted that, while new competitors are welcome, they also have been disruptive. After her doctor switched her to Semglee, she was notified that it was on back order. “It took a week to get it filled, and when it finally came in, it was in short supply,” she said, noting that she and her son received one Semglee pen each, “well short of the three and five each we were expecting.”
U.S. pricing is all ‘smoke and mirrors’
Sara W. Koblitz, a food and drug law attorney with Hyman Phelps in Washington, D.C., noted in a blog post that interchangeable Semglee will likely be awarded a year of marketing exclusivity, which will block other interchangeable competitors from entering the market during that time.
With no competition, “Mylan can price Semglee only slightly less than Lantus and still take market share, only marginally reducing costs to consumers,” she wrote.
Jing Luo, MD, MPH, an assistant professor of medicine at the University of Pittsburgh, who has studied insulin access and costs, said that having just one interchangeable on the market might not be enough to drive insulin costs down.
And, he told this news organization, “there’s even a possibility that Semglee prices will go up, but hopefully that will not be the case.”
Manufacturers like Mylan can also offer confidential discounts and rebates to pharmacy benefit managers (PBMs), health plans, and health plan sponsors (usually large companies that are self-insured) that make it difficult to assess the true cost, said David Steinberg, PharmD, director of pharmacy insights at Scripta Insights. The Wellesley, Mass.–based company advises self-insured employers on how to optimize pharmacy benefits.
When it comes to pricing, “it’s a lot of smoke and mirrors,” Dr. Steinberg said in an interview.
Dr. Steinberg also noted that some PBMs might choose to continue contracts with Sanofi that offer rebates for Lantus, leaving Semglee in a less-preferred position on a formulary, which could increase how much the patient pays at the pharmacy counter.
Medicare and Medicaid, however, can put Semglee in the top-tier preferred formulary position. Most Medicaid plans cover Semglee, but it appears that Medicare has not added coverage yet.
Does current pricing predict the future?
The currently marketed Semglee has an average wholesale price (AWP) that is one third of Lantus’, and about half of what is published for Basaglar (insulin glargine, Eli Lilly), a “follow-on biologic” approved in 2015 that is similar to Lantus, Dr. Steinberg said.
The AWP is often cited by analysts when talking about costs. The AWP of the current Semglee 10-mL vial is $118.38; the Lantus 10-mL vial is $340.27, said Steinberg.
Five prefilled Semglee pens (each 3 mL) are $177.58; for Lantus, the AWP for five 3-mL pens is $510.37.
Dr. Luo said he has seen a box of Semglee pens retail between $177 and $195, compared with about $500 retail for the Lantus pens.
Currently, people with commercial insurance can get Semglee for $0-75 a month, for up to a year, using the company’s savings program.
Steinberg said it’s possible that Mylan could increase the list price for the interchangeable Semglee, but that move could backfire. “I think their goal initially is to get market share,” he said.
After Basaglar came on the market – in late 2016 – the price of Lantus came down significantly over the next few years, according to a 2019 study by Dr. Luo’s colleagues at the University of Pittsburgh.
But Basaglar has not hung on to market share, according to Scott Strumello, a person with autoimmune type 1 diabetes who tweets and blogs about insulin and other issues.
In early August, Mr. Strumello tweeted some Lilly data that showed U.S. sales of Basaglar declined 42% in the first two quarters of 2021, compared with the same period in 2020.
Dr. Steinberg noted that the decline may have to do with rebates being given to PBMs by competitors Sanofi and Novo Nordisk. Sanofi “is very aggressive when it comes to pricing with their PBM partners,” he said.
While Mr. Devaney said people with diabetes are hopeful that Semglee can break the big three manufacturers’ monopoly, he added: “We don’t see Semglee as something that is solving the root cause of the insulin price crisis, which is high list prices and pharmaceutical industry greed.”
A version of this article first appeared on Medscape.com.
When the Food and Drug Administration approved Semglee, the first interchangeable biosimilar insulin, the agency pitched it as having the potential to be less costly than insulins currently on the market, but lack of transparency in pharmaceutical pricing has left analysts and advocates guessing whether it will indeed be a source of relief.
Semglee (Mylan Pharmaceuticals), first approved as a biosimilar in June 2020, costs about $100 a vial.
But receiving the “interchangeable designation” in July 2021, the first for any insulin, now allows Semglee to be substituted for the branded Lantus (insulin glargine, Sanofi) at the pharmacy without the need for a separate prescription, the same way as generic medicines.
A spokesperson for Viatris – Mylan’s parent company told this news organization that the interchangeable, with its new labeling, will be “introduced before the end of the year,” but it would not give any more details.
“Additional information, including pricing information, for interchangeable biosimilar Semglee will be provided at the time of product launch,” said the spokesperson.
Even at $100 a vial, it is not cheap
Ian Devaney, a spokesman for the advocacy group T1 International, said the organization is optimistic, given that “another player has been able to enter into a space that has for so long been dominated by Eli Lilly, Novo Nordisk, and Sanofi.” Increased competition “will help drive down the overall costs of insulin,” Mr. Devaney said in an interview. But, he added, for many people, especially in low-income countries, Semglee’s launch will have little to no impact on price.
Even at $100 a vial in the United States, “this is not an insignificant amount of money and presents a very difficult financial challenge for those dependent on insulin to survive,” he said.
A current Semglee user agreed, sharing her story with this news organization via T1 International. “My son uses three to five vials of long-acting insulin per month, and I use one to three vials per month,” said the woman, who prefers to remain anonymous. “If we were to lose Medicaid, we would still be paying up to $800 out of pocket monthly to survive, and that’s not even counting fast-acting insulin or other supplies. While $100 a vial may be cheaper, these costs are still outrageous.”
The woman also noted that, while new competitors are welcome, they also have been disruptive. After her doctor switched her to Semglee, she was notified that it was on back order. “It took a week to get it filled, and when it finally came in, it was in short supply,” she said, noting that she and her son received one Semglee pen each, “well short of the three and five each we were expecting.”
U.S. pricing is all ‘smoke and mirrors’
Sara W. Koblitz, a food and drug law attorney with Hyman Phelps in Washington, D.C., noted in a blog post that interchangeable Semglee will likely be awarded a year of marketing exclusivity, which will block other interchangeable competitors from entering the market during that time.
With no competition, “Mylan can price Semglee only slightly less than Lantus and still take market share, only marginally reducing costs to consumers,” she wrote.
Jing Luo, MD, MPH, an assistant professor of medicine at the University of Pittsburgh, who has studied insulin access and costs, said that having just one interchangeable on the market might not be enough to drive insulin costs down.
And, he told this news organization, “there’s even a possibility that Semglee prices will go up, but hopefully that will not be the case.”
Manufacturers like Mylan can also offer confidential discounts and rebates to pharmacy benefit managers (PBMs), health plans, and health plan sponsors (usually large companies that are self-insured) that make it difficult to assess the true cost, said David Steinberg, PharmD, director of pharmacy insights at Scripta Insights. The Wellesley, Mass.–based company advises self-insured employers on how to optimize pharmacy benefits.
When it comes to pricing, “it’s a lot of smoke and mirrors,” Dr. Steinberg said in an interview.
Dr. Steinberg also noted that some PBMs might choose to continue contracts with Sanofi that offer rebates for Lantus, leaving Semglee in a less-preferred position on a formulary, which could increase how much the patient pays at the pharmacy counter.
Medicare and Medicaid, however, can put Semglee in the top-tier preferred formulary position. Most Medicaid plans cover Semglee, but it appears that Medicare has not added coverage yet.
Does current pricing predict the future?
The currently marketed Semglee has an average wholesale price (AWP) that is one third of Lantus’, and about half of what is published for Basaglar (insulin glargine, Eli Lilly), a “follow-on biologic” approved in 2015 that is similar to Lantus, Dr. Steinberg said.
The AWP is often cited by analysts when talking about costs. The AWP of the current Semglee 10-mL vial is $118.38; the Lantus 10-mL vial is $340.27, said Steinberg.
Five prefilled Semglee pens (each 3 mL) are $177.58; for Lantus, the AWP for five 3-mL pens is $510.37.
Dr. Luo said he has seen a box of Semglee pens retail between $177 and $195, compared with about $500 retail for the Lantus pens.
Currently, people with commercial insurance can get Semglee for $0-75 a month, for up to a year, using the company’s savings program.
Steinberg said it’s possible that Mylan could increase the list price for the interchangeable Semglee, but that move could backfire. “I think their goal initially is to get market share,” he said.
After Basaglar came on the market – in late 2016 – the price of Lantus came down significantly over the next few years, according to a 2019 study by Dr. Luo’s colleagues at the University of Pittsburgh.
But Basaglar has not hung on to market share, according to Scott Strumello, a person with autoimmune type 1 diabetes who tweets and blogs about insulin and other issues.
In early August, Mr. Strumello tweeted some Lilly data that showed U.S. sales of Basaglar declined 42% in the first two quarters of 2021, compared with the same period in 2020.
Dr. Steinberg noted that the decline may have to do with rebates being given to PBMs by competitors Sanofi and Novo Nordisk. Sanofi “is very aggressive when it comes to pricing with their PBM partners,” he said.
While Mr. Devaney said people with diabetes are hopeful that Semglee can break the big three manufacturers’ monopoly, he added: “We don’t see Semglee as something that is solving the root cause of the insulin price crisis, which is high list prices and pharmaceutical industry greed.”
A version of this article first appeared on Medscape.com.
Working without a net
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
My first hospital consult was also on my first day of practice, in July, 1998.
I was in a small room, subleased from an oncology group. My schedule, as first day schedules are, was sparse.
Around noon one of the oncology docs asked me to come to his exam room, so I went across the hall. There he had a lady in her late 50s, with known metastatic cancer. He’d brought her in for a few days of worsening headaches and diplopia, and my 10-second neurological exam showed dysconjugate gaze and dysarthria. He said he was admitting her to the hospital, and asked if I’d consult on her.
I hung out in the hospital’s MRI control room later that day, waiting for her images to come up. I was nervous, maybe even a little scared. In spite of having survived medical school, residency, and fellowship, I was worried I’d screwed up the case, somehow. If the MRI was normal, I’d look like an idiot. My career would be over, on day one. No one would ever consult me again.
Of course, the MRI showed a brainstem metastasis (in addition to other places), and my initial differential was correct. Good for me, terrible for the patient. I ordered Decadron, called the oncologist, spoke to the patient and her family, and went home. I followed her for maybe a another few days, mainly because I didn’t know what the protocol was for signing off.
Self-doubt is common in all fields, especially when starting out, but probably strongest in medicine. A lot depends on us getting the right answer – quickly – in cases like that one. In my case this was compounded by its being my first day of practice. There was no attending I could call for help. I was working without a net.
But the years of training paid off, I got the case right, and moved on. Twenty-three years later it seems silly that I was so worried. Nowadays I order the MRI, move to the next patient, and try not to think about it until the results come back or a nurse calls with a status change. If my initial impression is wrong, I move down the differential list.
But
It’s what makes us better doctors.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I did peer review: I saw turf wars, ego, and unfairness
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
After making an insulting comment to a surgery scheduler, a surgeon become the subject of a peer review investigation.
The surgeon had been called in on a Saturday morning for surgery, but when he arrived at the hospital, staff informed him that the operating room had been incorrectly booked and asked him to come back that afternoon. When the surgeon returned, the room still wasn’t ready, recounted David Beran, DO, a peer reviewer and medical director for the emergency department at University Medical Center New Orleans, in Louisiana. After more waiting and staff uncertainty about which operating room was going to open, the surgeon became frustrated and said to the scheduler: “Any idiot could figure this out!”
During his peer review, the surgeon acknowledged that he shouldn’t have made the rude remark to the scheduler, Dr. Beran said. His exasperation stemmed from an ongoing problem – operating rooms at the hospital were being inefficiently managed.
“The surgeon acknowledged that even though there was a systems issue at the root, that’s not justification to speak to people unprofessionally,” Dr. Beran said. “So, there was education for the surgeon, but the surgeon was also able to explain the frustration that led to that point.”
System problems are commonly encountered by peer reviewers, said Dr. Beran.
“There’s a huge gap between administration and clinical professionals when it comes to peer review,” he said. “So many times, bad situations, whether they’re clinical or behavioral, often boil down to systems issues or some inadequacy, whether it’s an EMR [electronic medical record] problem, an inefficacy, or how complicated a process is for an end user. But having a peer review situation that then leads to a system-level change that prevents that problem from happening again is really unlikely. There’s a huge disconnect between those two.”
Peer review is generally a process that goes on behind closed doors. Although structures may differ, peer review is generally described as the process by which physicians assess the quality of their peers’ work to ensure that standards of care are being met. The process is often used to evaluate issues regarding clinical care as well as behavioral complaints against physicians.
Doctors who undergo peer review frequently share their experiences, but reviewers themselves rarely speak out. For this story,
“Peer review processes are in place to build stronger institutions and stronger practices, and they’re supposed to be helpful,” Dr. Beran said. “But because of how opaque they are, it immediately puts physicians on the defensive, and it doesn’t always succeed in what it’s trying to do. I think that’s one of the biggest challenges.”
Biased reviewers taint evaluations
A peer reviewer on and off throughout her career, Indiana family physician Lana Patch, MD, said she always strived to be fair when evaluating fellow physicians. But not every reviewer she encountered operated the same way, she said. Some were biased.
In one case, Dr. Patch peer reviewed a general surgeon who had performed a hysterectomy on a 16-year-old girl. The surgeon believed the teenager likely had an acute appendicitis, but it turned out she had a uterine pathology, Dr. Patch said. The surgeon saved the girl’s life, but the case came under review because of the patient’s age and the fact that her uterus was removed. A local obstetrician-gynecologist weighed in on the case.
“The local ob.gyn. saw it as a turf battle,” recalled Dr. Patch, who is now retired after 30 years of practice in eastern Indiana. “The doctor had nothing but bad to say about the surgeon. He was a competitor.”
Because it was a small hospital, the committee sometimes had trouble finding a specialist who was qualified to give an opinion and who wasn’t in competition with the physician in question, said Dr. Patch. Eventually they found an outside pediatric gynecologist who reviewed the case and concluded that the surgeon had followed the standard of care.
Personal agendas in can come from different directions, said Robert Marder, MD, the author of several books on peer review. Dr. Marder is a consultant who assists with peer review redesign. He has worked with hundreds of medical staff leaders and is a former vice president at the Greeley Company, a consulting firm in Danvers, Mass., that performs peer review redesign. Dr. Marder is president of Robert J. Marder Consulting.
“It goes both ways,” Dr. Marder said. “I’ve seen where somebody with a personal view decides to bring things to the peer review committee specifically because they want the peer review committee to have an adverse view of this person and get them off the medical staff. And I’ve seen hospitals that are uncomfortable with a certain person for whatever reason and want the peer review committee to address it, as opposed to addressing it from a human resource standpoint.”
Dr. Patch recalled a case in which reviewers and hospital leaders were at odds over the credentialing of a physician. Fifteen years earlier, while driving in California, the psychiatrist had been pulled over and was found with an ounce of marijuana, she said.
“We wanted to privilege him,” Dr. Patch said. “As staff physicians, we felt that was 15 years ago, people change over time. Doctors are human beings, too. He seemed to have good credentials and good training. The hospital said, ‘Oh no, we can’t have somebody like this.’ “
The psychiatrist was placed on probation and had to undergo a review every 90 days for about 3 years. Eventually, he was privileged, Dr. Patch said.
Bias among reviewers, including unintentional bias, is also a challenge, Dr. Marder noted. Some initial reviewers score a physician too harshly, he said, whereas others underscore.
“Underscoring is more insidious and more difficult to deal with,” Dr. Marder said. “Underscoring is where the reviewer is too nice. They tend to dismiss things from their colleagues rather than recognize them as an opportunity to help them improve. With underscoring, a lot of committees, if the initial reviewer says the care was appropriate, they don’t even look at the case. They just take that one person’s word for it.”
Reviewers: Looks can be deceiving
When first examining the documented details of a case, it can be easy for peer reviewers to make a quick judgment about what happened, Dr. Beran said.
“You get these complaints, and you read through it, and you think, ‘Oh man, this person really messed up,’ “ he said. “Then you hear the doctor’s side of it, and you realize, ‘No, there’s a much bigger picture at play.’ You realize both sides have valid perspectives on it.”
In one case, for example, Dr. Beran recalled a complaint against a physician who made a snarky remark to a nurse. The doctor had asked the nurse for a piece of equipment, and the nurse said she was busy preparing the room for a patient. The doctor made a comment along the lines of, “Well, would you like me to do that for you and also intubate the patient while you do some charting?!”
At first glance, it appeared that the physician lashed out inappropriately at the nurse. But when reviewers heard from the doctor, they learned that the nurses knew that a trauma patient was coming by ambulance and that he would likely require a ventilator, Dr. Beran said. As the minutes ticked by, however, the nurses were seen in the break room chatting. Nothing had been prepared in the room, including any airway supply.
“The patient had a prolonged course and a very difficult intubation and could have very easily wound up with a much worse outcome for something the nurses had been warned about prior to the patient’s arrival,” he said. “I can see anybody getting upset in that situation if I warned them 5 or 10 minutes beforehand, ‘Get this stuff ready,’ and then nothing was done.”
There was no direct penalty for the physician.
Just as some complaints can be misleading, the clinical record in some peer review cases can also lead reviewers astray.
Physicians frequently include too much irrelevant information in the record, which can cloud a peer review, said Hans Duvefelt, MD, a family physician at Pines Health Services, in Van Buren, Maine. Dr. Duvefelt is a former medical director at Bucksport Regional Health Center, in Ellsworth, Maine. Both facilities are federally qualified health centers where continuous, random peer reviews are required.
In one case, Dr. Duvefelt was peer reviewing a physician’s office note regarding an elderly patient with a low-grade fever. The final diagnosis was urinary tract infection. Dr. Duvefelt said he had trouble following the doctor’s line of thinking because of a plethora of unnecessary data in the 10-page document. The office note included past medical history, prior lab and imaging test results, and an extensive narrative section that included a mixture of active medical problems and ongoing relationships with specialists, he said.
After reading through the printout three times, Dr. Duvefelt said he finally found mention of increased urinary dribbling and details about an enlarged prostate. He also spotted a same-day urinalysis among nearly a dozen other previous lab tests that had no connection to body temperature. Dr. Duvefelt gave the physician a passing grade but also left a scathing note about all the irrelevant information.
“It’s very common,” Dr. Duvefelt said. “It’s a disaster. Other doctors can’t follow your thinking. A reviewer has a hard time determining whether the doctor acted reasonably.”
Slackers make bad reviewers
Although dedicated reviewers work hard to get to the bottom of cases, it’s not uncommon for some committee members to hardly work at all, according to experts.
Dr. Marder said he’s seen many instances in which reviewers were assigned a review but did not complete it for months. Most committees have set time frames in which reviewers must complete their review.
“That delays that review, and by that time, the review is older and it’s harder to remember things,” he said. “It’s not fair to the physician. If there was a problem the physician could fix and you don’t tell him for 3 or 4 months what it is, he may do the same thing again. The case might come before the committee again and it looks like he’s repeated something, but you never gave him the opportunity to improve.”
Other reviewers fail to attend meetings regularly. Peer review committee members are generally volunteers, and meetings are usually held in the early mornings or late evenings.
“There are reasons for not attending occasionally, but some people put on a committee just don’t take it seriously,” Dr. Marder said. “They don’t fulfill their responsibilities as well as they should. If you accept the job, do the job.”
For physicians considering becoming a peer reviewer, Dr. Beran offers these tips: Be transparent, help physicians understand next steps, and make yourself as available as allowed to answer questions.
Know your committee’s policies and procedures, and follow them, added Dr. Marder. It’s also a good idea to work with your hospital’s quality staff, he said.
Reviewers should keep in mind that they may not always be the one assessing someone else, Dr. Beran said.
“Realize very easily you could be on the other side of that table for things that are outside your control,” he said. “How would you want to be treated?”
A version of this article first appeared on Medscape.com.
Six shifts driving the future of medicine, strategist says
Contact lenses that detect glucose in tears. Capsules embedded in clothes that can be used to counteract the risk of sensitive skin conditions.
These are just
At the annual meeting of the Society for Pediatric Dermatology, Zayna Khayat, PhD, said that the future of medicine is driven by six shifts pulling society from a past oriented around the health care system – the buildings, clinicians, and payers – to a patient-oriented perspective. “That doesn’t just happen on its own,” said Dr. Khayat, a future strategist at Toronto-based SE Health. “There are big forces that are pulling us to the future whether we want it to or not. One is that patients have woken up. They have grown to have power in many other complex decisions in their life, and they’re expecting no less from our health care system.”
During her presentation, she discussed the six shifts:
1. The timing of service placement. The traditional model of medicine is “an intermittent and interventional science that waits for the symptoms and goes in and either fixes or manages them,” she said. “So, it’s not really health care; it’s sick care. That’s been fine in the industrial era when we needed to get medicine to stop catastrophic events. Not only is it shifting to be proactive and preventative but it’s shifting to a new science of medicine called predictive medicine.”
As for proactive and preventative care, she continued, each patient’s choice of behaviors related to diet, exercise, and stress “mingles with DNA to produce health, yet we spend about 90% of our resources on sick care. Now, health systems are moving their resources to things like education, housing, transportation, food security, equity, and racial divides. ... This is trickling down to how we train health care professionals. We know that patients live very little of their time in formal care settings, so all of their health is created – or destroyed – well outside of the clinical setting. We train our health professionals mostly in a clinical setting. Health systems are now starting to reimagine how training happens so we can train people to understand the fully loaded context of their patients’ lives.”
2. A shift in precision. For all its advances and science breakthroughs, medicine “is still quite crude,” said Dr. Khayat, who is also an adjunct professor in the Rotman School of Management at the University of Toronto. “It’s very analog, based on a one-size-fits-all approach. In the business world, we call this a segment of one: the idea that in some clinical trial, a result was produced that was based on the average of everybody, and therefore we just give everybody what worked for the average. ... We don’t need to have that trade-off anymore, because it won’t be a trade-off of higher cost to tailor down to an N of 1. It will be highly personalized, intelligent medicine, very precise.”
3. A shift from institution-centered to person-centered care. “The artifacts that health care was built on are very analog and are going to get decentralized out of buildings, dephysicalized, disintermediated,” she predicted. “We’ll have a seamless digital physical experience, expanded channels through which patients can access their services. Pick a channel that makes sense for the patient and don’t let care follow the place but rather let care follow the person.”
4. A shift in care duration, from episodic and intermittent care to more continuous care. “With very little input you should know what’s going on at any point in time instead of time-sharing access to diagnostics and to clinicians,” Dr. Khayat said. Wrist-worn devices that gather personal omics “are now really democratized, with every aspect of a diagnostic clinic available within or connected to a smartphone. This allows for data to be gathered and shared with clinicians, including tools under the skin that can get some of the biochemical data in real time instead of poking and prodding and waiting for a diagnostic lab.” These devices, she said, will become easier to use, cheaper, and will work faster, and provide much better data “at almost zero cost.”
Technologies being developed include tattoos that can read biomarkers, innovations in clothing that can detect biochemical reactions in the skin, underwear that can read vital signs, and contact lenses that can measure glucose levels. “The skin will become a major noninvasive way to obtain information,” she said.
5. A shift in power from providers to patients. “It’s estimated that about 80% of health care decisions could be self-managed by people in their communities,” Dr. Khayat said.
6. A shift from volume-based to value-based care. “Because we’ve been obsessed with the system, we’ve paid for stuff like visits, pills, MRI scans, et cetera,” she said. “We don’t need to do that anymore. Health systems don’t want to keep paying for stuff if they don’t see the results. Because of all the other shifts, we can pay for results. Some call this value-based care. I call it fee-for-health.”
She noted that the future of medicine is underpinned by innovations in AI/predictalytics, voice recognition, virtual reality, blockchain, IoT sensors, 3D printing, omics, robotics, autonomous transport, neurotechnology, nanobiology, and cellular therapy. “They’re moving at a very fast pace because they don’t need the kind of cost, capital, and expertise that the previous tools did,” she said. “This is the promise that technology can bring.”
Dr. Khayat disclosed that she has been a workshop participant for Roche Canada.
Contact lenses that detect glucose in tears. Capsules embedded in clothes that can be used to counteract the risk of sensitive skin conditions.
These are just
At the annual meeting of the Society for Pediatric Dermatology, Zayna Khayat, PhD, said that the future of medicine is driven by six shifts pulling society from a past oriented around the health care system – the buildings, clinicians, and payers – to a patient-oriented perspective. “That doesn’t just happen on its own,” said Dr. Khayat, a future strategist at Toronto-based SE Health. “There are big forces that are pulling us to the future whether we want it to or not. One is that patients have woken up. They have grown to have power in many other complex decisions in their life, and they’re expecting no less from our health care system.”
During her presentation, she discussed the six shifts:
1. The timing of service placement. The traditional model of medicine is “an intermittent and interventional science that waits for the symptoms and goes in and either fixes or manages them,” she said. “So, it’s not really health care; it’s sick care. That’s been fine in the industrial era when we needed to get medicine to stop catastrophic events. Not only is it shifting to be proactive and preventative but it’s shifting to a new science of medicine called predictive medicine.”
As for proactive and preventative care, she continued, each patient’s choice of behaviors related to diet, exercise, and stress “mingles with DNA to produce health, yet we spend about 90% of our resources on sick care. Now, health systems are moving their resources to things like education, housing, transportation, food security, equity, and racial divides. ... This is trickling down to how we train health care professionals. We know that patients live very little of their time in formal care settings, so all of their health is created – or destroyed – well outside of the clinical setting. We train our health professionals mostly in a clinical setting. Health systems are now starting to reimagine how training happens so we can train people to understand the fully loaded context of their patients’ lives.”
2. A shift in precision. For all its advances and science breakthroughs, medicine “is still quite crude,” said Dr. Khayat, who is also an adjunct professor in the Rotman School of Management at the University of Toronto. “It’s very analog, based on a one-size-fits-all approach. In the business world, we call this a segment of one: the idea that in some clinical trial, a result was produced that was based on the average of everybody, and therefore we just give everybody what worked for the average. ... We don’t need to have that trade-off anymore, because it won’t be a trade-off of higher cost to tailor down to an N of 1. It will be highly personalized, intelligent medicine, very precise.”
3. A shift from institution-centered to person-centered care. “The artifacts that health care was built on are very analog and are going to get decentralized out of buildings, dephysicalized, disintermediated,” she predicted. “We’ll have a seamless digital physical experience, expanded channels through which patients can access their services. Pick a channel that makes sense for the patient and don’t let care follow the place but rather let care follow the person.”
4. A shift in care duration, from episodic and intermittent care to more continuous care. “With very little input you should know what’s going on at any point in time instead of time-sharing access to diagnostics and to clinicians,” Dr. Khayat said. Wrist-worn devices that gather personal omics “are now really democratized, with every aspect of a diagnostic clinic available within or connected to a smartphone. This allows for data to be gathered and shared with clinicians, including tools under the skin that can get some of the biochemical data in real time instead of poking and prodding and waiting for a diagnostic lab.” These devices, she said, will become easier to use, cheaper, and will work faster, and provide much better data “at almost zero cost.”
Technologies being developed include tattoos that can read biomarkers, innovations in clothing that can detect biochemical reactions in the skin, underwear that can read vital signs, and contact lenses that can measure glucose levels. “The skin will become a major noninvasive way to obtain information,” she said.
5. A shift in power from providers to patients. “It’s estimated that about 80% of health care decisions could be self-managed by people in their communities,” Dr. Khayat said.
6. A shift from volume-based to value-based care. “Because we’ve been obsessed with the system, we’ve paid for stuff like visits, pills, MRI scans, et cetera,” she said. “We don’t need to do that anymore. Health systems don’t want to keep paying for stuff if they don’t see the results. Because of all the other shifts, we can pay for results. Some call this value-based care. I call it fee-for-health.”
She noted that the future of medicine is underpinned by innovations in AI/predictalytics, voice recognition, virtual reality, blockchain, IoT sensors, 3D printing, omics, robotics, autonomous transport, neurotechnology, nanobiology, and cellular therapy. “They’re moving at a very fast pace because they don’t need the kind of cost, capital, and expertise that the previous tools did,” she said. “This is the promise that technology can bring.”
Dr. Khayat disclosed that she has been a workshop participant for Roche Canada.
Contact lenses that detect glucose in tears. Capsules embedded in clothes that can be used to counteract the risk of sensitive skin conditions.
These are just
At the annual meeting of the Society for Pediatric Dermatology, Zayna Khayat, PhD, said that the future of medicine is driven by six shifts pulling society from a past oriented around the health care system – the buildings, clinicians, and payers – to a patient-oriented perspective. “That doesn’t just happen on its own,” said Dr. Khayat, a future strategist at Toronto-based SE Health. “There are big forces that are pulling us to the future whether we want it to or not. One is that patients have woken up. They have grown to have power in many other complex decisions in their life, and they’re expecting no less from our health care system.”
During her presentation, she discussed the six shifts:
1. The timing of service placement. The traditional model of medicine is “an intermittent and interventional science that waits for the symptoms and goes in and either fixes or manages them,” she said. “So, it’s not really health care; it’s sick care. That’s been fine in the industrial era when we needed to get medicine to stop catastrophic events. Not only is it shifting to be proactive and preventative but it’s shifting to a new science of medicine called predictive medicine.”
As for proactive and preventative care, she continued, each patient’s choice of behaviors related to diet, exercise, and stress “mingles with DNA to produce health, yet we spend about 90% of our resources on sick care. Now, health systems are moving their resources to things like education, housing, transportation, food security, equity, and racial divides. ... This is trickling down to how we train health care professionals. We know that patients live very little of their time in formal care settings, so all of their health is created – or destroyed – well outside of the clinical setting. We train our health professionals mostly in a clinical setting. Health systems are now starting to reimagine how training happens so we can train people to understand the fully loaded context of their patients’ lives.”
2. A shift in precision. For all its advances and science breakthroughs, medicine “is still quite crude,” said Dr. Khayat, who is also an adjunct professor in the Rotman School of Management at the University of Toronto. “It’s very analog, based on a one-size-fits-all approach. In the business world, we call this a segment of one: the idea that in some clinical trial, a result was produced that was based on the average of everybody, and therefore we just give everybody what worked for the average. ... We don’t need to have that trade-off anymore, because it won’t be a trade-off of higher cost to tailor down to an N of 1. It will be highly personalized, intelligent medicine, very precise.”
3. A shift from institution-centered to person-centered care. “The artifacts that health care was built on are very analog and are going to get decentralized out of buildings, dephysicalized, disintermediated,” she predicted. “We’ll have a seamless digital physical experience, expanded channels through which patients can access their services. Pick a channel that makes sense for the patient and don’t let care follow the place but rather let care follow the person.”
4. A shift in care duration, from episodic and intermittent care to more continuous care. “With very little input you should know what’s going on at any point in time instead of time-sharing access to diagnostics and to clinicians,” Dr. Khayat said. Wrist-worn devices that gather personal omics “are now really democratized, with every aspect of a diagnostic clinic available within or connected to a smartphone. This allows for data to be gathered and shared with clinicians, including tools under the skin that can get some of the biochemical data in real time instead of poking and prodding and waiting for a diagnostic lab.” These devices, she said, will become easier to use, cheaper, and will work faster, and provide much better data “at almost zero cost.”
Technologies being developed include tattoos that can read biomarkers, innovations in clothing that can detect biochemical reactions in the skin, underwear that can read vital signs, and contact lenses that can measure glucose levels. “The skin will become a major noninvasive way to obtain information,” she said.
5. A shift in power from providers to patients. “It’s estimated that about 80% of health care decisions could be self-managed by people in their communities,” Dr. Khayat said.
6. A shift from volume-based to value-based care. “Because we’ve been obsessed with the system, we’ve paid for stuff like visits, pills, MRI scans, et cetera,” she said. “We don’t need to do that anymore. Health systems don’t want to keep paying for stuff if they don’t see the results. Because of all the other shifts, we can pay for results. Some call this value-based care. I call it fee-for-health.”
She noted that the future of medicine is underpinned by innovations in AI/predictalytics, voice recognition, virtual reality, blockchain, IoT sensors, 3D printing, omics, robotics, autonomous transport, neurotechnology, nanobiology, and cellular therapy. “They’re moving at a very fast pace because they don’t need the kind of cost, capital, and expertise that the previous tools did,” she said. “This is the promise that technology can bring.”
Dr. Khayat disclosed that she has been a workshop participant for Roche Canada.
FROM SPD 2021
United Healthcare settles claims it violated mental health parity
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
The nation’s largest health care insurer has agreed to pay $16 million in restitution and penalties to consumers, the federal government, and the state of New York to settle complaints that it illegally limited outpatient psychotherapy.
The settlement resolves a joint U.S. Department of Labor and New York Attorney General investigation and lawsuit that found that United Healthcare and United Behavioral Health (UBH) had, since at least 2013, violated the federal Mental Health Parity and Addiction Equity Act of 2008.
United Healthcare and UBH are fighting similar claims in Wit v United Behavioral Health, which is currently on appeal at the U.S. Court of Appeals for the Ninth Circuit. If that complaint is decided against UBH, the insurer might have to reprocess more than 67,000 claims.
The joint New York–federal investigation determined that United Healthcare reduced reimbursement rates for out-of-network mental health services and denied payment for many services using its Algorithms for Effective Reporting and Treatment (ALERT) utilization review program.
All outpatient psychotherapy was subjected to review; by comparison, only a handful of medical and surgical services were. That violated parity laws, the New York Attorney General’s office said in a statement.
“United’s denial of these vital services was both unlawful and dangerous,” New York Attorney General Letitia James said in the statement.
“Protecting access to mental health and substance disorder treatment is a priority for the Department of Labor and something I believe in strongly as a person in long-term recovery,” U.S. Secretary of Labor Marty Walsh said in another statement.
Mr. Walsh added that the settlement “provides compensation for many people who were denied full benefits and equitable treatment.”
‘Investigations change behavior’
Commenting for this news organization, Joe Parks, MD, medical director of the National Council for Mental Wellbeing, applauded the settlement.
“These kinds of investigations change behavior, and people get better coverage,” Dr. Parks said.
He also applauded New York, saying that it “has been one of the more assertive states in expecting companies to comply with parity requirements. They should be emulated by other states.”
Dr. Parks noted that a 2019 U.S. Government Accountability Office report showed that only 20 states routinely conducted parity compliance reviews.
A spokesperson for the American Psychiatric Association said it was notable that the Department of Labor focused on three issues that it had not publicly investigated before.
These were payment parity, the use of algorithms in mental health to identify practitioners and patients who use more health care than expected of the “average” person, and requiring disclosure of how the insurer set rates, guidelines, and medical necessity standards.
The American Psychological Association’s chief of psychological practice, Jared L. Skillings, PhD, said the group was gratified that the Department of Labor and New York took complaints seriously and that it “is encouraged that United Behavioral Health and United Healthcare have agreed to change their unfair procedures regarding reimbursement and denial of psychological care.”
The association “will monitor implementation of the settlement with high hopes for fair treatment for patients with mental health needs,” Dr. Skillings said in an interview.
Across-the-board cuts for therapy
The investigation found that United Healthcare reduced the allowable reimbursement amount for all nonphysicians across the board for psychotherapy – by 25% for PhD-level psychologists and by 35% for all MA-level therapists.
The company’s ALERT system used arbitrary thresholds to trigger utilization review, which “often led to denials of coverage when providers could not justify continued treatment after 20 sessions,” said the New York attorney general.
Beneficiaries had to figure out how to pay for continuing services or abruptly end necessary treatment.
United Healthcare agreed to stop reducing reimbursement and to not employ a similar policy in New York for at least 2 years. It will stop using ALERT and stop issuing denials for psychotherapy through at least 2023.
In addition, “We are committed to ensuring all our members have access to care and to reimbursing providers consistent with the terms of the member’s health plan and state and federal rules,” United Healthcare said.
Dr. Parks noted that United Healthcare had stopped using ALERT long before the settlement and was instead employing Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) and American Society of Addiction Medicine criteria, which he called “a good step forward.”
‘Meaningful’ payout
United Healthcare will pay $14.3 million in restitution to consumers, including $9 million to 20,000 New Yorkers who received denials of or reductions in reimbursement. The company will also pay more than $2 million in penalties, with $1.3 million going to New York.
The insurer has annual revenues of some $250 billion.
“It’s not a large amount of money in United’s overall business operation,” said Dr. Parks.
However, “It certainly could be a meaningful amount of money for the individuals that didn’t get coverage that paid out of pocket,” he added.
A version of this article first appeared on Medscape.com.
Politics or protection? What’s behind the push for boosters?
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.
On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.
So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
White House supports boosters
In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.
“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.
“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.
“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.
Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.
Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
‘FDA in a very difficult position’
After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.
Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.
“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.
“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”
He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.
“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”
Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.
“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
Boosters already being given
But after the White House announced that boosters were on the way, many people are not waiting.
Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.
“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.
She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.
Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.
“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
Consequences of a third shot
But giving or getting a third dose before approval by the FDA may have legal consequences.
In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.
“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”
The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.
They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.
In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.
“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.
A version of this article first appeared on Medscape.com.
Exercising to lose weight is not for every ‘body’
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Exercising to lose weight is not for every ‘body’
This first item comes from the “You’ve got to be kidding” section of LOTME’s supersecret topics-of-interest file.
Investigators at the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences and the University of Roehampton noticed that some people who enrolled in exercise programs to lose weight did just the opposite: they gained weight.
Being scientists, they decided to look at the effects of energy expenditure and how those effects varied among individuals. The likely culprit in this case, they determined, is something called compensatory mechanisms. One such mechanism involves eating more food because exercise stimulates appetite, and another might reduce energy expenditure on other components like resting metabolism so that the exercise is, in effect, less costly.
A look at the numbers shows how compensatory mechanisms worked in the study population of 1,750 adults. Among individuals with the highest BMI, 51% of the calories burned during activity translated into calories burned at the end of the day. For those with normal BMI, however, 72% of calories burned during activity were reflected in total expenditure.
“People living with obesity cut back their resting metabolism when they are more active. The result is that for every calorie they spend on exercise they save about half a calorie on resting,” the investigators explained.
In other words, some bodies will, unconsciously, work against the conscious effort of exercising to lose weight. Thank you very much, compensatory mechanisms, for the boundarylessness exhibited in exceeding your job description.
When it comes to the mix, walnuts go nuts
When it comes to mixed nuts, walnuts get no love. But we may be able to give you a reason to not pick them out: Your arteries.
Participants in a recent study who ate about a half-cup of walnuts every day for 2 years saw a drop in their low-density lipoprotein (LDL) cholesterol. The number and quality of LDL particles in healthy older adults also improved. How? Good ol’ omega-3 fatty acids.
Omega-3 is found in many foods linked to lower risks of heart disease, lower cholesterol levels, and lower blood sugar levels, but the one thing that makes the walnut a front runner for Miss Super Food 2021 is their ability to improve the quality of LDL particles.
“LDL particles come in various sizes [and] research has shown that small, dense LDL particles are more often associated with atherosclerosis, the plaque or fatty deposits that build up in the arteries,” Emilio Ros, MD, PhD, of the Hospital Clínic of Barcelona and the study’s senior investigator, said in a written statement.
The 708 participants, aged 63-79 years and mostly women, were divided into two groups: One received the walnut diet and the other did not. After 2 years, the walnut group had lower LDL levels by an average of 4.3 mg/dL. Total cholesterol was reduced by an average of 8.5 mg/dL. Also, their total LDL particle count was 4.3% lower and small LDL particles were down by 6.1%.
So instead of picking the walnuts out of the mix, try to find it in your heart to appreciate them. Your body already does.
Begun, the clone war has
Well, not quite yet, Master Yoda, but perhaps one day soon, if a study from Japan into the uncanny valley of the usage of cloned humanlike faces in robotics and artificial intelligence, published in PLOS One, is to be believed.
The study consisted of a number of six smaller experiments in which participants judged a series of images based on subjective eeriness, emotional valence, and realism. The images included people with the same cloned face; people with different faces; dogs; identical twins, triplets, quadruplets, etc.; and cloned animated characters. In the sixth experiment, the photos were the same as in the second (six cloned faces, six different faces, and a single face) but participants also answered the Disgust Scale–Revised to accurately analyze disgust sensitivity.
The results of all these experiments were quite clear: People found the cloned faces far creepier than the varied or single face, an effect the researchers called clone devaluation. Notably, this effect only applied to realistic human faces; most people didn’t find the cloned dogs or cloned animated characters creepy. However, those who did were more likely to find the human clones eerie on the Disgust Scale.
The authors noted that future robotics technology needs to be carefully considered to avoid the uncanny valley and this clone devaluation effect, which is a very good point. The last thing we need is a few million robots with identical faces getting angry at us and pulling a Terminator/Order 66 combo. We’re already in a viral apocalypse; we don’t need a robot one on top of that.
Congratulations to our new favorite reader
The winner of last week’s inaugural Pandemic Pandemonium comes to us from Tiffanie Roe. By getting her entry in first, just ahead of the flood of responses we received – and by flood we mean a very slow and very quickly repaired drip – Ms. Roe puts the gold medal for COVID-related insanity around the necks of Australian magpies, who may start attacking people wearing face masks during “swooping season” because the birds don’t recognize them.
Office-based pediatricians unprepared for emergencies
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
Emergency preparedness in U.S. pediatric offices is variable and less than ideal, especially in smaller independent practices, a 15-month multicenter study has found.
Researchers led by Kamal Abulebda, MD, associate professor of clinical pediatrics in the division of pediatric critical care medicine at Indiana University and Riley Hospital for Children in Indianapolis, report that adherence to the 2007 policy statement of the American Academy of Pediatrics on emergency preparedness in pediatric primary care offices was suboptimal across 42 offices in 9 states. They suggest that academic and community partnerships use in-situ simulation exercises to address preparedness gaps and implement standard procedures for contacting emergency medical services.
The group’s findings were published online in Pediatrics. “These data can be used to guide the development of interventions to improve emergency preparedness and care delivery in pediatric offices, Dr. Abulebda and coauthors wrote, noting that theirs is the first multicenter study to directly measure preparedness and quality of care in pediatric offices.
According to the authors, the incidence of a child’s requiring emergent stabilization in an individual office ranges from weekly to monthly, with seizures and respiratory distress being the most common events.
The study was conducted from 2018 to 2020 by 48 national teams participating in in-situ simulated sessions in the ambulatory setting. Office teams, recruited from practices by members of regional academic medical centers, included two patients – a child with respiratory distress and a child with a seizure. Almost 40% were from Indiana.
The scenarios and checklists for the mock exercises were created by content experts in pediatric emergency medicine and critical care using evidence-based guidelines and best practices.
Previous research has relied on self-reported surveys rather than direct measurement to assess adherence to the AAP guidelines, the authors say. In-person surveys assessed adherence to AAP recommendations for emergency preparedness. In-person surveys were, however, used to gauge adherence to AAP recommendations for emergency preparedness.
Findings
The overall mean emergency preparedness score was 74.7% (standard deviation [SD] 12.9), with an unweighted percentage of adherence to checklists calculated for each case. By emergency type, the median asthma case performance score was 63.6% (interquartile range [IQR] 43.2-81.2), and the median seizure case score was 69.2% (IQR 46.2-80.8).
On the measure of essential equipment and supplies, the mean subscore (relating to availability of such items as oxygen sources, suction devices, and epinephrine, for example) was 82.2% (SD 15.1).
As for recommended policies and protocols (e.g., regular assessment of the office, maintenance of emergency equipment and medications) the mean subscore fell to 57.1% (SD 25.6).
In multivariable analyses, offices with a standardized procedure for contacting EMS had a higher rate of activating that service during the simulations.
Independent practices and smaller total staff size were associated with lower preparedness compared with larger groups: beta = –11.89, 95% confidence interval [CI], 19.33-4.45).
Higher annual patient volume and larger total staff size were slightly associated with higher scores (beta = .001, 95% CI, .00-001, P = .017; and beta = .51, 95% CI, .19-.83, P = .002, respectively).
Affiliation with an academic medical center and the presence of learners were not associated with higher scores. And in multivariable regression, a higher annual patient volume lost its significant association with greater preparedness.
So why the lag in preparedness despite the long-standing AAP recommendations? “It’s most likely due to the rare occurrence of these emergencies in the office setting, in addition to most offices’ dependence on EMS when they encounter pediatric emergencies in their setting,” Dr. Abulebda said in an interview. “A 2018 study published by Yuknis and associates demonstrated that the average time from EMS notification to arrival on scene was just 6 minutes.”
In other study findings, 82% of offices did not have an infant bag valve mask and would therefore need to wait for EMS to administer lifesaving ventilation. “This highlights the need to have this equipment available and maintain the skills necessary to care for patients in respiratory distress, the most common emergency encountered in the office setting,” Dr. Abulebda and associates wrote.
A cardiac arrest board is another example of a potentially lifesaving piece of equipment that was not available in the majority of offices, likely because of the rarity of this event in the office setting, but lack of this item may result in poor cardiopulmonary resuscitation quality before the arrival of EMS.
In an accompanying editorial, Jesse Hackell, MD, a pediatrician at Boston Children’s Health Physicians and New York Medical College in Pomona, N.Y., noted that data from 2 decades ago suggested that many pediatric offices saw multiple children requiring emergency intervention each week. More recent figures, however, indicate the situation has evolved, with fewer than 1% of current pediatric EMS transports originating from the office setting.
Dr. Hackell agrees that implementation of AAP recommendations has been far from universal and cites the cost of equipment and supplies as well as a lack of access to training and evaluation as significant barriers to implementation. “In addition, the infrequent occurrence of these emergencies makes maintenance of resuscitation skills even more difficult without frequent practice,” he wrote.
Further complicating the issue, preparedness needs vary with practice location, the response time of local EMS, and proximity to an emergency department. “Pediatric offices in more rural areas, which are farther from these services, will require more equipment and more skills to provide optimal emergency care to children living in these underresourced areas,” he wrote.
He called for equitable distribution of preparedness training, equipment, and staffing, with guidance designed to meet patient needs and ensure optimal outcomes. “In discussion of recommendations, one should consider the likely conditions requiring this response, availability of resources beyond the pediatric office, and ongoing training and support needed to maintain provider skills at the level needed for a successful response to any pediatric emergency,” Dr. Hackell wrote.
This study was supported by grants from Indiana University Health Values and the RBaby Foundation. One study coauthor is a board observer of a medical device company. No other authors disclosed financial relationships relevant to this work. Dr. Hackell has disclosed having no competing interests.
FROM PEDIATRICS
Good news is no news
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve become kind of a hermit. At least, as much as someone who drives a car, goes to the store, and sees patients 5 days a week can be.
It seemed like the news was always dominated by another senseless mass shooting, an increasingly dysfunctional government, an environmental crisis going to hell (with us along for the ride), and endlessly escalating inflammatory political pundits (who always seem to get far more coverage than they deserve. Personally, I don’t think they deserve any, regardless of which side they’re on).
As things got worse, I became more obsessed with reading about them. I’d read the news on my iPad before bed, and when I first woke up, and several times a day at work.
It was driving me nuts. Perhaps it’s my personality to worry too much about these things. I was losing sleep and wasting valuable time at home and work.
I came to a decision. It was time to stop.
I deleted all my news apps and bookmarks. I’d go to lengths to avoid all news. If in a restaurant where a TV was on, I’d sit with my back to it. I stopped going to the doctor’s lounge (with its TVs constantly on a news network). When I had to wait to pick up my car at the shop, I sat outside and played games on my phone rather than use the waiting room with its blaring TV.
This doesn’t mean I’m completely unplugged. I still read interesting stories about science or history. I check the weather forecast. Family members occasionally send me amusing articles that I look at. I read online medical articles. I use the Internet to look things up. But I make a conscious effort not to look at headlines or other stuff on the periphery.
I’m not stupid or naive enough to believe that the insanity and acrimony won’t continue happening. But the bottom line is that obviously I can’t control or change it.
So I try not to let it upset me any more. If the only way to do that is to completely not read it and not know, I’m fine with that. After almost 50 years of reading news (I started when I was about 7, with my parent’s subscription to Newsweek), I’ve completely stopped.
Instead of reading the day’s events I now mindlessly play Toon Blast or read history books on my iPad before bed. Perhaps a waste of time, but no more so than getting upset, losing sleep, getting ulcers, and going gray over things I can’t control.
I have more time in the morning and my work day, since I’m not spending it scanning headlines.
Now my world is restricted to my family, friends, dogs, and job. Things I enjoy and have control over. Those around me have been told that I wish to discuss nothing about current events, and they respect that.
Now I sleep better, worry less (at least about those things), and have more time to focus on my immediate world. And that’s fine with me. It may be the way of the ostrich, but at this point in my life, that’s what I prefer.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Report urges complete residency overhaul
from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.
The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.
The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.
The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:
- Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
- Inattention to assuring congruence between applicant goals and program missions
- Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
- Increasing financial costs to students
- Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates
Seeking a common framework for competence
Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.
To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.
While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”
Among the committee’s three dozen recommendations are the following:
- The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
- Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
- The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
- An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”
Less than half of applicants get in-depth reviews
The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.
Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.
Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.
The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
Osteopathic students’ dilemma
To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.
Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.
The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.
This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.
For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.
Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.
Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.
A version of this article first appeared on Medscape.com.
from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.
The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.
The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.
The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:
- Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
- Inattention to assuring congruence between applicant goals and program missions
- Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
- Increasing financial costs to students
- Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates
Seeking a common framework for competence
Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.
To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.
While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”
Among the committee’s three dozen recommendations are the following:
- The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
- Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
- The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
- An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”
Less than half of applicants get in-depth reviews
The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.
Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.
Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.
The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
Osteopathic students’ dilemma
To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.
Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.
The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.
This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.
For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.
Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.
Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.
A version of this article first appeared on Medscape.com.
from the Graduate Medical Education Review Committee (UGRC) of the Coalition for Physician Accountability.
The 275-page report presents preliminary findings that were released in April 2021 and a long list of stakeholder comments. According to the report, the coalition will meet soon to discuss the final recommendations and consider next steps toward implementation.
The UGRC includes representatives of national medical organizations, medical schools, and residency programs. Among the organizations that participated in the report’s creation are the American Medical Association, the National Board of Medical Examiners, the American Osteopathic Association, the National Board of Osteopathic Medical Examiners, the Educational Commission for Foreign Medical Graduates, and the Association of American Medical Colleges.
The report identifies a list of challenges that affect the transition of medical students into residency programs and beyond. They include:
- Too much focus on finding and filling residency positions instead of “assuring learner competence and readiness for residency training”
- Inattention to assuring congruence between applicant goals and program missions
- Overreliance on licensure exam scores rather than “valid, trustworthy measures of students’ competence and clinical abilities”
- Increasing financial costs to students
- Individual and systemic biases in the UME-GME transition, as well as inequities related to international medical graduates
Seeking a common framework for competence
Overall, the report calls for increased standardization of how students are evaluated in medical school and how residency programs evaluate students. Less reliance should be placed on the numerical scores of the U.S. Medical Licensing Examination (USMLE), the report says, and more attention should be paid to the direct observation of student performance in clinical situations. In addition, the various organizations involved in the UME-GME transition process are asked to work better together.
To develop better methods of evaluating medical students and residents, UME and GME educators should jointly define and implement a common framework and set of competencies to apply to learners across the UME-GME transition, the report suggests.
While emphasizing the need for a broader student assessment framework, the report says, USMLE scores should also continue to be used in judging residency applicants. “Assessment information should be shared in residency applications and a postmatch learner handover. Licensing examinations should be used for their intended purpose to ensure requisite competence.”
Among the committee’s three dozen recommendations are the following:
- The Centers for Medicare & Medicaid Services should change the GME funding structure so that the initial residency period is calculated starting with the second year of postgraduate training. This change would allow residents to reconsider their career choices. Currently, if a resident decides to switch to another program or specialty after beginning training, the hospital may not receive full GME funding, so may be less likely to approve the change.
- Residency programs should improve recruitment practices to increase specialty-specific diversity of residents. Medical educators should also receive additional training regarding antiracism, avoiding bias, and ensuring equity.
- The self-reported demographic information of applicants to residency programs should be measured and shared with stakeholders, including the programs and medical schools, to promote equity. “A residency program that finds bias in its selection process could go back in real time to find qualified applicants who may have been missed, potentially improving outcomes,” the report notes.
- An interactive database of GME program and specialty track information should be created and made available to all applicants, medical schools, and residency programs at no cost to applicants. “Applicants and their advisors should be able to sort the information according to demographic and educational features that may significantly impact the likelihood of matching at a program.”
Less than half of applicants get in-depth reviews
The 2020 National Resident Matching Program Program Director Survey found that only 49% of applications received in-depth review. In light of this, the report suggests that the application system be updated to use modern information technology, including discrete fields for key data to expedite application reviews.
Many applications have been discarded because of various filters used to block consideration of certain applications. The report suggests that new filters be designed to ensure that each detects meaningful differences among applicants and promotes review based on mission alignment and likelihood of success in a program. Filters should be improved to decrease the likelihood of random exclusions of qualified applicants.
Specialty-specific, just-in-time training for all incoming first-year residents is also suggested to support the transition from the role of student to a physician ready to assume increased responsibility for patient care. In addition, the report urges adequate time be allowed between medical school graduation and residency to enable new residents to relocate and find homes.
The report also calls for a standardized process in the United States for initial licensing of doctors at entrance to residency in order to streamline the process of credentialing for both residency training and continuing practice.
Osteopathic students’ dilemma
To promote equitable treatment of applicants regardless of licensure examination requirements, comparable exams with different scales (COMLEX-USA and USMLE) should be reported within the electronic application system in a single field, the report said.
Osteopathic students, who make up 25% of U.S. medical students, must take the COMLEX-USA exam, but residency programs may filter them out if they don’t also take the USMLE exam. Thus, many osteopathic students take both exams, incurring extra time, cost, and stress.
The UGRC recommends creating a combined field in the electronic residency application service that normalizes the scores between the two exams. Residency programs could then filter applications based only on the single normalized score.
This approach makes sense from the viewpoint that it would reduce the pressure on osteopathic students to take the USMLE, Bryan Carmody, MD, an outspoken critic of various current training policies, said in an interview. But it could also have serious disadvantages.
For one thing, only osteopathic students can take the COMLEX-USA exam, he noted. If they don’t like their score, they can then take the USMLE test to get a higher score – an option that allopathic students don’t have. It’s not clear that they’d be prevented from doing this under the UGRC recommendation.
Second, he said, osteopathic students, on average, don’t do as well as allopathic students on the UMSLE exam. If they only take the COMLEX-USA test, they’re competing against other students who don’t do as well on tests as allopathic students do. If their scores were normalized with those of the USMLE test takers, they’d gain an unfair advantage against students who can only take the USMLE, including international medical graduates.
Although Dr. Carmody admitted that osteopathic students face a harder challenge than allopathic students in matching to residency programs, he said that the UGRC approach to the licensing exams might actually penalize them further. As a result of the scores of the two exams being averaged, residency program directors might discount the scores of all osteopathic students.
A version of this article first appeared on Medscape.com.