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Common cold could protect against COVID-19, study says
, according to a small study published Jan. 10 in Nature Communications.
Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.
The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.
“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.
People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.
“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”
For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.
The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.
The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.
The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.
“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.
But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.
A version of this article first appeared on WebMD.com
, according to a small study published Jan. 10 in Nature Communications.
Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.
The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.
“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.
People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.
“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”
For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.
The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.
The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.
The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.
“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.
But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.
A version of this article first appeared on WebMD.com
, according to a small study published Jan. 10 in Nature Communications.
Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.
The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.
“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.
People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.
“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”
For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.
The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.
The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.
The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.
“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.
But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.
A version of this article first appeared on WebMD.com
Ranking seven COVID-19 antigen tests by ease of use: Report
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Physicians react: Should docs lose their licenses for spreading false COVID information?
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
Single-use duodenoscope is cost effective in ERCP
, according to a new analysis.
The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.
Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.
“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.
Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.
In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.
The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.
The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.
A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).
In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.
The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.
“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.
The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.
Consider for a moment: The single-use duodenoscope (SUD) represents a revolutionary approach to duodenoscope infection control. Who, even 10 years ago, would have imagined that a disposable duodenoscope would even be technically achievable, much less economically feasible? Notwithstanding, determining how to incorporate such a revolutionary new technology and its associated capital and recurring costs can be every bit as complex and challenging as conceiving and developing the SUD. The authors provide insights into answering these questions through Markov modeling, comparing cost-effectiveness of SUDs to traditional duodenoscopes (TD) using available data on TD and SUD performance, and extrapolating from nonendoscopic infection management data.
This analysis is helpful because it demonstrates that, despite SUD cost approaching $3,000, Centers for Medicare & Medicaid Services inpatient and outpatient cost-defrayment payments may result in SUDs being cost-effective within limits and assumptions the study incorporates. This information is also timely, because these CMS subsidies are guaranteed only through mid-2022 for Medicare inpatients and 2023 for Medicare outpatients.
Though useful and timely, this study does make assumptions that narrow its applicability to real-world endoscopic retrograde cholangiopancreatography (ERCP). Clinically, it considers only patients with uncomplicated common bile duct stones. While choledocholithiasis is the indication for ERCP in the majority of patients, over 40% of ERCPs in the United States are performed for other, often more complex applications. While most procedures in the referenced studies were performed by high-volume ERCP experts, a substantial proportion of ERCPs are performed by lower-volume ERCP proceduralists, who actually perform a substantial proportion of straight-forward ERCPs addressing uncomplicated choledocholithiasis.
This study focuses on cost implications on CMS Transitional Pass-through (TPT) and New Technology Add-On Payment (NTAP) subsidies available only for Medicare inpatients and outpatients, respectively. These reimbursements are set to expire in 2022 (inpatients) and 2023 (outpatients). What will happen after that? Also, the amount of TPT and NTAP cost defrayments are institution-dependent, because cost-to-charge ratio (CCR), an important factor in calculating these subsidies, varies substantially between institutions and regions. Looking to the future, how will the cost of SUDs be incorporated into the hospital business model when TPT and NTAP are over?
SUDs are a technological marvel and a remarkable advance in endoscopic infection control. But innovations in medical technology are expectedly accompanied by new operational challenges: How to incorporate them into day-to-day practice and develop a business model that avails valuable new resources to patients. Such operational challenges require as much heavy lifting as the technological innovation needed to produce innovative devices like SUDs. The authors’ vision and effort in ideating and executing this study give us a head-start on this path by helping us to imagine what is possible.
John A. Martin, MD, is associate professor and consultant at the Mayo Clinic, Rochester, Minn. He is a former member of the editorial board for GI & Hepatology News, but has no relevant conflicts to disclose.
Consider for a moment: The single-use duodenoscope (SUD) represents a revolutionary approach to duodenoscope infection control. Who, even 10 years ago, would have imagined that a disposable duodenoscope would even be technically achievable, much less economically feasible? Notwithstanding, determining how to incorporate such a revolutionary new technology and its associated capital and recurring costs can be every bit as complex and challenging as conceiving and developing the SUD. The authors provide insights into answering these questions through Markov modeling, comparing cost-effectiveness of SUDs to traditional duodenoscopes (TD) using available data on TD and SUD performance, and extrapolating from nonendoscopic infection management data.
This analysis is helpful because it demonstrates that, despite SUD cost approaching $3,000, Centers for Medicare & Medicaid Services inpatient and outpatient cost-defrayment payments may result in SUDs being cost-effective within limits and assumptions the study incorporates. This information is also timely, because these CMS subsidies are guaranteed only through mid-2022 for Medicare inpatients and 2023 for Medicare outpatients.
Though useful and timely, this study does make assumptions that narrow its applicability to real-world endoscopic retrograde cholangiopancreatography (ERCP). Clinically, it considers only patients with uncomplicated common bile duct stones. While choledocholithiasis is the indication for ERCP in the majority of patients, over 40% of ERCPs in the United States are performed for other, often more complex applications. While most procedures in the referenced studies were performed by high-volume ERCP experts, a substantial proportion of ERCPs are performed by lower-volume ERCP proceduralists, who actually perform a substantial proportion of straight-forward ERCPs addressing uncomplicated choledocholithiasis.
This study focuses on cost implications on CMS Transitional Pass-through (TPT) and New Technology Add-On Payment (NTAP) subsidies available only for Medicare inpatients and outpatients, respectively. These reimbursements are set to expire in 2022 (inpatients) and 2023 (outpatients). What will happen after that? Also, the amount of TPT and NTAP cost defrayments are institution-dependent, because cost-to-charge ratio (CCR), an important factor in calculating these subsidies, varies substantially between institutions and regions. Looking to the future, how will the cost of SUDs be incorporated into the hospital business model when TPT and NTAP are over?
SUDs are a technological marvel and a remarkable advance in endoscopic infection control. But innovations in medical technology are expectedly accompanied by new operational challenges: How to incorporate them into day-to-day practice and develop a business model that avails valuable new resources to patients. Such operational challenges require as much heavy lifting as the technological innovation needed to produce innovative devices like SUDs. The authors’ vision and effort in ideating and executing this study give us a head-start on this path by helping us to imagine what is possible.
John A. Martin, MD, is associate professor and consultant at the Mayo Clinic, Rochester, Minn. He is a former member of the editorial board for GI & Hepatology News, but has no relevant conflicts to disclose.
Consider for a moment: The single-use duodenoscope (SUD) represents a revolutionary approach to duodenoscope infection control. Who, even 10 years ago, would have imagined that a disposable duodenoscope would even be technically achievable, much less economically feasible? Notwithstanding, determining how to incorporate such a revolutionary new technology and its associated capital and recurring costs can be every bit as complex and challenging as conceiving and developing the SUD. The authors provide insights into answering these questions through Markov modeling, comparing cost-effectiveness of SUDs to traditional duodenoscopes (TD) using available data on TD and SUD performance, and extrapolating from nonendoscopic infection management data.
This analysis is helpful because it demonstrates that, despite SUD cost approaching $3,000, Centers for Medicare & Medicaid Services inpatient and outpatient cost-defrayment payments may result in SUDs being cost-effective within limits and assumptions the study incorporates. This information is also timely, because these CMS subsidies are guaranteed only through mid-2022 for Medicare inpatients and 2023 for Medicare outpatients.
Though useful and timely, this study does make assumptions that narrow its applicability to real-world endoscopic retrograde cholangiopancreatography (ERCP). Clinically, it considers only patients with uncomplicated common bile duct stones. While choledocholithiasis is the indication for ERCP in the majority of patients, over 40% of ERCPs in the United States are performed for other, often more complex applications. While most procedures in the referenced studies were performed by high-volume ERCP experts, a substantial proportion of ERCPs are performed by lower-volume ERCP proceduralists, who actually perform a substantial proportion of straight-forward ERCPs addressing uncomplicated choledocholithiasis.
This study focuses on cost implications on CMS Transitional Pass-through (TPT) and New Technology Add-On Payment (NTAP) subsidies available only for Medicare inpatients and outpatients, respectively. These reimbursements are set to expire in 2022 (inpatients) and 2023 (outpatients). What will happen after that? Also, the amount of TPT and NTAP cost defrayments are institution-dependent, because cost-to-charge ratio (CCR), an important factor in calculating these subsidies, varies substantially between institutions and regions. Looking to the future, how will the cost of SUDs be incorporated into the hospital business model when TPT and NTAP are over?
SUDs are a technological marvel and a remarkable advance in endoscopic infection control. But innovations in medical technology are expectedly accompanied by new operational challenges: How to incorporate them into day-to-day practice and develop a business model that avails valuable new resources to patients. Such operational challenges require as much heavy lifting as the technological innovation needed to produce innovative devices like SUDs. The authors’ vision and effort in ideating and executing this study give us a head-start on this path by helping us to imagine what is possible.
John A. Martin, MD, is associate professor and consultant at the Mayo Clinic, Rochester, Minn. He is a former member of the editorial board for GI & Hepatology News, but has no relevant conflicts to disclose.
, according to a new analysis.
The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.
Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.
“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.
Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.
In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.
The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.
The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.
A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).
In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.
The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.
“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.
The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.
, according to a new analysis.
The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.
Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.
“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.
Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.
In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.
The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.
The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.
A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).
In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.
The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.
“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.
The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.
FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY
Atopic Dermatitis: Phenotypes
Medicare intends to limit payment for controversial Alzheimer’s drug
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
, federal officials announced Jan. 11.
On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
‘Unusual but appropriate’ step
The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.
On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”
The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.
“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
Biogen disappointed
Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.
“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.
In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.
“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.
Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
Others weigh in
BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.
However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.
In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.
“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.
A version of this article first appeared on Medscape.com.
‘Highly encouraging’ MRD results for zanubrutinib add-on in CLL
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
FROM THE LANCET HEMATOLOGY
Sorting out sleep complaints in children with AD can be complex
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
FROM RAD 2021
Physician as trusted counselor
Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.
A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.
The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.
Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.
What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.
How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.
A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.
Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.
Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.
A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.
The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.
Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.
What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.
How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.
A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.
Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.
Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.
A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.
The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.
Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.
What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.
How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.
A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.
Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.
Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
The death of expertise
Unless your social circle is packed with medical professionals, I suspect you are the go-to gal/guy when there is a question about the pandemic. Seated around the fire pit trying to stay warm and socially distanced, inevitably the discussion will turn to COVID. Someone will report something they have read about vaccine side effects or the appropriate timing of isolation or quarantine and then turn to me assuming that I have inside information and ask: “But Will you know all about that. Tell us what have you heard.”
By now, well into our second year of the pandemic, my friends and neighbors should have come to expect my usual answer. “I don’t really know any more about this than you have read on the Internet or seen on television.” I am flattered that folks keep asking for my observations. I guess old habits die slowly. Although I usually introduce myself as an ex-pediatrician, the “doctor” descriptor still seems to command some respect, whether it is deserved or not.
It is not just my waning ability to speak authoritatively about the pandemic that has put expertise at death’s door. Although my formal medical education is more than a half-century old, like most physicians I have tried to stay abreast of what’s happening in health care. Keeping up to date with the new developments in pathophysiology and pharmacology does take some work, but the pandemic has shone a spotlight on how quickly these changes can occur.
With the pandemic, a sense of urgency has thrust onto the world stage opinions that in the past might have been quietly held theories based on preliminary studies. However, even the most careful scientists who might otherwise have been content to patiently wait for peer review are sharing their findings prematurely with international news sources and on social media. Not surprisingly, this rush to share has generated confusion and concern and in many cases resulted in retractions or corrections. Even more importantly, it has made us all skeptical about who these “experts” are, making often disproven pronouncements.
While my friends still persist in politely asking my opinion based on the same reports we are all reading on the Internet, I sense the nation as a whole has become wary of claimed expertise. I haven’t done a Google search but I wouldn’t be surprised if “expert” gets far fewer hits than the term “so-called expert.”
Even before we were engulfed by the pandemic, there has been an unfortunate phenomenon in which health care providers and other scientists are parlaying their degrees to promote products with little if any proven efficacy. Of course, this country has a long history of snake oil salesmen making their rounds. However, the electronic media and the Internet have increased the power to persuade so that we are awash in so-called experts. Many good scientists, in an attempt to be helpful, have succumbed to the sin of impatience. And there are a few who had never earned the moniker “expert.”
I hope that expertise returns to the landscape when the pandemic abates. But, I fear it may be a while.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Unless your social circle is packed with medical professionals, I suspect you are the go-to gal/guy when there is a question about the pandemic. Seated around the fire pit trying to stay warm and socially distanced, inevitably the discussion will turn to COVID. Someone will report something they have read about vaccine side effects or the appropriate timing of isolation or quarantine and then turn to me assuming that I have inside information and ask: “But Will you know all about that. Tell us what have you heard.”
By now, well into our second year of the pandemic, my friends and neighbors should have come to expect my usual answer. “I don’t really know any more about this than you have read on the Internet or seen on television.” I am flattered that folks keep asking for my observations. I guess old habits die slowly. Although I usually introduce myself as an ex-pediatrician, the “doctor” descriptor still seems to command some respect, whether it is deserved or not.
It is not just my waning ability to speak authoritatively about the pandemic that has put expertise at death’s door. Although my formal medical education is more than a half-century old, like most physicians I have tried to stay abreast of what’s happening in health care. Keeping up to date with the new developments in pathophysiology and pharmacology does take some work, but the pandemic has shone a spotlight on how quickly these changes can occur.
With the pandemic, a sense of urgency has thrust onto the world stage opinions that in the past might have been quietly held theories based on preliminary studies. However, even the most careful scientists who might otherwise have been content to patiently wait for peer review are sharing their findings prematurely with international news sources and on social media. Not surprisingly, this rush to share has generated confusion and concern and in many cases resulted in retractions or corrections. Even more importantly, it has made us all skeptical about who these “experts” are, making often disproven pronouncements.
While my friends still persist in politely asking my opinion based on the same reports we are all reading on the Internet, I sense the nation as a whole has become wary of claimed expertise. I haven’t done a Google search but I wouldn’t be surprised if “expert” gets far fewer hits than the term “so-called expert.”
Even before we were engulfed by the pandemic, there has been an unfortunate phenomenon in which health care providers and other scientists are parlaying their degrees to promote products with little if any proven efficacy. Of course, this country has a long history of snake oil salesmen making their rounds. However, the electronic media and the Internet have increased the power to persuade so that we are awash in so-called experts. Many good scientists, in an attempt to be helpful, have succumbed to the sin of impatience. And there are a few who had never earned the moniker “expert.”
I hope that expertise returns to the landscape when the pandemic abates. But, I fear it may be a while.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Unless your social circle is packed with medical professionals, I suspect you are the go-to gal/guy when there is a question about the pandemic. Seated around the fire pit trying to stay warm and socially distanced, inevitably the discussion will turn to COVID. Someone will report something they have read about vaccine side effects or the appropriate timing of isolation or quarantine and then turn to me assuming that I have inside information and ask: “But Will you know all about that. Tell us what have you heard.”
By now, well into our second year of the pandemic, my friends and neighbors should have come to expect my usual answer. “I don’t really know any more about this than you have read on the Internet or seen on television.” I am flattered that folks keep asking for my observations. I guess old habits die slowly. Although I usually introduce myself as an ex-pediatrician, the “doctor” descriptor still seems to command some respect, whether it is deserved or not.
It is not just my waning ability to speak authoritatively about the pandemic that has put expertise at death’s door. Although my formal medical education is more than a half-century old, like most physicians I have tried to stay abreast of what’s happening in health care. Keeping up to date with the new developments in pathophysiology and pharmacology does take some work, but the pandemic has shone a spotlight on how quickly these changes can occur.
With the pandemic, a sense of urgency has thrust onto the world stage opinions that in the past might have been quietly held theories based on preliminary studies. However, even the most careful scientists who might otherwise have been content to patiently wait for peer review are sharing their findings prematurely with international news sources and on social media. Not surprisingly, this rush to share has generated confusion and concern and in many cases resulted in retractions or corrections. Even more importantly, it has made us all skeptical about who these “experts” are, making often disproven pronouncements.
While my friends still persist in politely asking my opinion based on the same reports we are all reading on the Internet, I sense the nation as a whole has become wary of claimed expertise. I haven’t done a Google search but I wouldn’t be surprised if “expert” gets far fewer hits than the term “so-called expert.”
Even before we were engulfed by the pandemic, there has been an unfortunate phenomenon in which health care providers and other scientists are parlaying their degrees to promote products with little if any proven efficacy. Of course, this country has a long history of snake oil salesmen making their rounds. However, the electronic media and the Internet have increased the power to persuade so that we are awash in so-called experts. Many good scientists, in an attempt to be helpful, have succumbed to the sin of impatience. And there are a few who had never earned the moniker “expert.”
I hope that expertise returns to the landscape when the pandemic abates. But, I fear it may be a while.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].