User login
News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
Pediatric vaccines & infectious diseases, 2022
Introduction
ICYMI articles featuring 9 important developments of the past year – and COVID is still here
By Christopher J. Harrison, MD
Table of contents
Antibiotics use and vaccine antibody levels
Commentary
Emerging tick-borne pathogen has spread to state of Georgia
Commentary
WHO, UNICEF warn about increased risk of measles outbreaks
Commentary
Babies die as congenital syphilis continues a decade-long surge across the U.S.
Commentary
Meningococcal vaccine shows moderate protective effect against gonorrhea
Commentary
Adolescents are undertested for STIs
Commentary
TB treatment can be shortened for most children: Study
Commentary
Nirsevimab protects healthy infants from RSV
Commentary
Norovirus vaccine candidates employ different approaches
Commentary
Introduction
ICYMI articles featuring 9 important developments of the past year – and COVID is still here
By Christopher J. Harrison, MD
Table of contents
Antibiotics use and vaccine antibody levels
Commentary
Emerging tick-borne pathogen has spread to state of Georgia
Commentary
WHO, UNICEF warn about increased risk of measles outbreaks
Commentary
Babies die as congenital syphilis continues a decade-long surge across the U.S.
Commentary
Meningococcal vaccine shows moderate protective effect against gonorrhea
Commentary
Adolescents are undertested for STIs
Commentary
TB treatment can be shortened for most children: Study
Commentary
Nirsevimab protects healthy infants from RSV
Commentary
Norovirus vaccine candidates employ different approaches
Commentary
Introduction
ICYMI articles featuring 9 important developments of the past year – and COVID is still here
By Christopher J. Harrison, MD
Table of contents
Antibiotics use and vaccine antibody levels
Commentary
Emerging tick-borne pathogen has spread to state of Georgia
Commentary
WHO, UNICEF warn about increased risk of measles outbreaks
Commentary
Babies die as congenital syphilis continues a decade-long surge across the U.S.
Commentary
Meningococcal vaccine shows moderate protective effect against gonorrhea
Commentary
Adolescents are undertested for STIs
Commentary
TB treatment can be shortened for most children: Study
Commentary
Nirsevimab protects healthy infants from RSV
Commentary
Norovirus vaccine candidates employ different approaches
Commentary
ICYMI articles featuring 9 important developments of the past year – and COVID is still here
We can’t affect most of the world’s big problems, but we can continue to do what pediatric providers have always done well – share the best science-based knowledge with families and be strong vaccine advocates.
You can read about some new aspects of science-based 2021-2022 data in this digital issue. For example, there are newer international data on the longer-acting and more effective anti-RSV monoclonal antibody nirsevimab, which may soon replace palivizumab. Closer to home, check out the article on lower antibody concentrations in infants related to the number and class of antibiotics that they had received. Measles outbreaks in areas of the world with the lowest measles vaccine uptake will likely produce more imported measles in the United States. If you have never heard of Lone-star virus, an article tells us it occurs mostly in Southern and Atlantic coastal regions; no specific treatment exists, but it is now in the differential diagnosis for endemic tick-borne febrile infections.
A bit of good news is the World Health Organization recommending a shorter course of treatment for pediatric tuberculosis. Pediatric TB has a long history of poor treatment adherence, so shorter, simpler regimens are certainly welcome. And finally, prospects for a norovirus vaccine are looking brighter with new approaches generating mucosal antibodies – a key in protection against gastrointestinal infections.
Again, no articles in this digital supplement feature SARS-CoV-2 this year, but a summer surge continues because of third-generation Omicron viruses BA.4/BA.5. The surge exists because the SARS-CoV-2 vaccine is being underutilized; plus BA.4/BA.5 is the most contagious variant yet.
A major reason deaths are not surging is COVID-19 vaccines. Having multiple vaccines authorized within 9 months of SARS-CoV-2 hitting U.S. shores is amazing despite the hiccups and politicization that accompanied implementation. Each vaccine more than met the original goal: greater than or equal to 50% effectiveness with an acceptable adverse effect profile. In the United States, two mRMA-vaccines (Moderna and Pfizer) are now authorized for use down to 6 months of age; Novavax’s more traditional protein-based vaccine was more recently given an emergency use authorization for those 18 years and older. Ongoing trials indicate that Omicron-based mRNA vaccines are highly immunogenic and safe even if blended with the original strain vaccine. Fall boosters will have an Omicron component. We need to immunize and boost enough folks so that SARS-CoV-2 variants arise infrequently, allowing high-risk persons to be able to go out in public without masks.
Dr. Harrison is professor, University of Missouri–Kansas City School of Medicine, department of medicine, infectious diseases section. He has no conflicts of interest.
We can’t affect most of the world’s big problems, but we can continue to do what pediatric providers have always done well – share the best science-based knowledge with families and be strong vaccine advocates.
You can read about some new aspects of science-based 2021-2022 data in this digital issue. For example, there are newer international data on the longer-acting and more effective anti-RSV monoclonal antibody nirsevimab, which may soon replace palivizumab. Closer to home, check out the article on lower antibody concentrations in infants related to the number and class of antibiotics that they had received. Measles outbreaks in areas of the world with the lowest measles vaccine uptake will likely produce more imported measles in the United States. If you have never heard of Lone-star virus, an article tells us it occurs mostly in Southern and Atlantic coastal regions; no specific treatment exists, but it is now in the differential diagnosis for endemic tick-borne febrile infections.
A bit of good news is the World Health Organization recommending a shorter course of treatment for pediatric tuberculosis. Pediatric TB has a long history of poor treatment adherence, so shorter, simpler regimens are certainly welcome. And finally, prospects for a norovirus vaccine are looking brighter with new approaches generating mucosal antibodies – a key in protection against gastrointestinal infections.
Again, no articles in this digital supplement feature SARS-CoV-2 this year, but a summer surge continues because of third-generation Omicron viruses BA.4/BA.5. The surge exists because the SARS-CoV-2 vaccine is being underutilized; plus BA.4/BA.5 is the most contagious variant yet.
A major reason deaths are not surging is COVID-19 vaccines. Having multiple vaccines authorized within 9 months of SARS-CoV-2 hitting U.S. shores is amazing despite the hiccups and politicization that accompanied implementation. Each vaccine more than met the original goal: greater than or equal to 50% effectiveness with an acceptable adverse effect profile. In the United States, two mRMA-vaccines (Moderna and Pfizer) are now authorized for use down to 6 months of age; Novavax’s more traditional protein-based vaccine was more recently given an emergency use authorization for those 18 years and older. Ongoing trials indicate that Omicron-based mRNA vaccines are highly immunogenic and safe even if blended with the original strain vaccine. Fall boosters will have an Omicron component. We need to immunize and boost enough folks so that SARS-CoV-2 variants arise infrequently, allowing high-risk persons to be able to go out in public without masks.
Dr. Harrison is professor, University of Missouri–Kansas City School of Medicine, department of medicine, infectious diseases section. He has no conflicts of interest.
We can’t affect most of the world’s big problems, but we can continue to do what pediatric providers have always done well – share the best science-based knowledge with families and be strong vaccine advocates.
You can read about some new aspects of science-based 2021-2022 data in this digital issue. For example, there are newer international data on the longer-acting and more effective anti-RSV monoclonal antibody nirsevimab, which may soon replace palivizumab. Closer to home, check out the article on lower antibody concentrations in infants related to the number and class of antibiotics that they had received. Measles outbreaks in areas of the world with the lowest measles vaccine uptake will likely produce more imported measles in the United States. If you have never heard of Lone-star virus, an article tells us it occurs mostly in Southern and Atlantic coastal regions; no specific treatment exists, but it is now in the differential diagnosis for endemic tick-borne febrile infections.
A bit of good news is the World Health Organization recommending a shorter course of treatment for pediatric tuberculosis. Pediatric TB has a long history of poor treatment adherence, so shorter, simpler regimens are certainly welcome. And finally, prospects for a norovirus vaccine are looking brighter with new approaches generating mucosal antibodies – a key in protection against gastrointestinal infections.
Again, no articles in this digital supplement feature SARS-CoV-2 this year, but a summer surge continues because of third-generation Omicron viruses BA.4/BA.5. The surge exists because the SARS-CoV-2 vaccine is being underutilized; plus BA.4/BA.5 is the most contagious variant yet.
A major reason deaths are not surging is COVID-19 vaccines. Having multiple vaccines authorized within 9 months of SARS-CoV-2 hitting U.S. shores is amazing despite the hiccups and politicization that accompanied implementation. Each vaccine more than met the original goal: greater than or equal to 50% effectiveness with an acceptable adverse effect profile. In the United States, two mRMA-vaccines (Moderna and Pfizer) are now authorized for use down to 6 months of age; Novavax’s more traditional protein-based vaccine was more recently given an emergency use authorization for those 18 years and older. Ongoing trials indicate that Omicron-based mRNA vaccines are highly immunogenic and safe even if blended with the original strain vaccine. Fall boosters will have an Omicron component. We need to immunize and boost enough folks so that SARS-CoV-2 variants arise infrequently, allowing high-risk persons to be able to go out in public without masks.
Dr. Harrison is professor, University of Missouri–Kansas City School of Medicine, department of medicine, infectious diseases section. He has no conflicts of interest.
The potential problem(s) with a once-a-year COVID vaccine
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Comments from the White House this week suggesting a once-a-year COVID-19 shot for most Americans, “just like your annual flu shot,” were met with backlash from many who say COVID and influenza come from different viruses and need different schedules.
Remarks, from “capitulation” to too few data, hit the airwaves and social media.
Some, however, agree with the White House vision and say that asking people to get one shot in the fall instead of periodic pushes for boosters will raise public confidence and buy-in and reduce consumer confusion.
Health leaders, including Bob Wachter, MD, chair of the department of medicine at the University of California, San Francisco, say they like the framing of the concept – that people who are not high-risk should plan each year for a COVID shot and a flu shot.
& we need strategy to bump uptake,” Dr. Wachter tweeted this week.
But the numbers of Americans seeking boosters remain low. Only one-third of all eligible people 50 years and older have gotten a second COVID booster, according to the Centers for Disease Control and Prevention. About half of those who got the original two shots got a first booster.
Meanwhile, the United States is still averaging about 70,000 new COVID cases and more than 300 deaths every day.
The suggested change in approach comes as Pfizer/BioNTech and Moderna roll out their new boosters that target Omicron subvariants BA.4 and BA.5 after the CDC recommended their use and the U.S. Food and Drug Administration approved emergency use authorization.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant,” President Joe Biden said in a statement promoting the yearly approach.
Some say annual shot premature
Other experts say it’s too soon to tell whether an annual approach will work.
“We have no data to support that current vaccines, including the new BA.5 booster, will provide durable protection beyond 4-6 months. It would be good to aspire to this objective, and much longer duration or protection, but that will likely require next generation and nasal vaccines,” said Eric Topol, MD, Medscape’s editor-in-chief and founder and director of the Scripps Research Translational Institute.
A report in Nature Reviews Immunology states, “Mucosal vaccines offer the potential to trigger robust protective immune responses at the predominant sites of pathogen infection” and potentially “can prevent an infection from becoming established in the first place, rather than only curtailing infection and protecting against the development of disease symptoms.”
Dr. Topol tweeted after the White House statements, “[An annual vaccine] has the ring of Covid capitulation.”
William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., told this news organization that he cautions against interpreting the White House comments as official policy.
“This is the difficulty of having public health announcements come out of Washington,” he said. “They ought to come out of the CDC.”
He says there is a reasonable analogy between COVID and influenza, but warns, “don’t push the analogy.”
They are both serious respiratory viruses that can cause much illness and death in essentially the same populations, he notes. These are the older, frail people, people who have underlying illnesses or are immunocompromised.
Both viruses also mutate. But there the paths diverge.
“We’ve gotten into a pattern of annually updating the influenza vaccine because it is such a singularly seasonal virus,” Dr. Schaffner said. “Basically it disappears during the summer. We’ve had plenty of COVID during the summers.”
For COVID, he said, “We will need a periodic booster. Could this be annually? That would certainly make it easier.” But it’s too soon to tell, he said.
Dr. Schaffner noted that several manufacturers are working on a combined flu/COVID vaccine.
Just a ‘first step’ toward annual shot
The currently updated COVID vaccine may be the first step toward an annual vaccine, but it’s only the first step, Dr. Schaffner said. “We haven’t committed to further steps yet because we’re watching this virus.”
Syra Madad, DHSc, MSc, an infectious disease epidemiologist at Harvard University’s Belfer Center for Science and International Affairs, Cambridge, Mass., and the New York City hospital system, told this news organization that arguments on both sides make sense.
Having a single message once a year can help eliminate the considerable confusion involving people on individual timelines with different levels of immunity and separate campaigns for COVID and flu shots coming at different times of the year.
“Communication around vaccines is very muddled and that shows in our overall vaccination rates, particularly booster rates,” she says. “The overall strategy is hopeful and makes sense if we’re going to progress that way based on data.”
However, she said that the data are just not there yet to show it’s time for an annual vaccine. First, scientists will need to see how long protection lasts with the Omicron-specific vaccine and how well and how long it protects against severe disease and death as well as infection.
COVID is less predictable than influenza and the influenza vaccine has been around for decades, Dr. Madad noted. With influenza, the patterns are more easily anticipated with their “ladder-like pattern,” she said. “COVID-19 is not like that.”
What is hopeful, she said, “is that we’ve been in the Omicron dynasty since November of 2021. I’m hopeful that we’ll stick with that particular variant.”
Dr. Topol, Dr. Schaffner, and Dr. Madad declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Flashy, blingy doc sabotages his own malpractice trial in rural farm town
During a medical malpractice trial in New Jersey, jurors waited nearly 4 hours for the physician defendant to show up. When he did arrive, the body-building surgeon was sporting two thick gold chains and a diamond pinky ring, and had the top buttons of his shirt open enough to reveal his chest hair.
“This trial was in a very rural, farming community,” recalls medical liability defense attorney Catherine Flynn, of Flynn Watts LLC, based in Parsippany, N.J. “Many of the jurors were wearing flannel shirts and jeans. The doctor’s wife walked in wearing a five-carat diamond ring and other jewelry.”
Ms. Flynn took the couple aside and asked them to remove the jewelry. She explained that the opulent accessories could damage the jury’s view of the physician. The surgeon and his wife, however, refused to remove their jewelry, she said. They didn’t think it was a big deal.
The case against the surgeon involved intraoperative damage to a patient when the physician inadvertently removed a portion of nerve in the area of the procedure. After repair of the nerve, the patient had a positive result. However, the patient alleged the surgeon’s negligence resulted in permanent damage despite the successful repair.
Jurors ultimately found the physician negligent in the case and awarded the plaintiff $1.2 million. Ms. Flynn believes that physician’s flamboyant attire and arrogant nature tainted the jury’s decision.
“In certain counties in New Jersey, his attire would not have been a problem,” she said. “In this rural, farming county, it was a huge problem. You have to know your audience. There are a lot of other things that come into play in a medical malpractice case, but when it comes to damages in a case, you don’t want to be sending the message that supports what somebody’s bias may already be telling them about a doctor.”
The surgeon appealed the verdict, and the case ultimately settled for a lesser amount, according to Ms. Flynn.
An over-the-top wardrobe is just one way that physicians can negatively influence jurors during legal trials. From subtle facial expressions to sudden outbursts to downright rudeness, attorneys have witnessed countless examples of physicians sabotaging their own trials.
“The minute you enter the courthouse, jurors or potential jurors are sizing you up,” says health law attorney Michael Clark, of Womble Bond Dickinson (US) LLP, based in Houston. “The same phenomenon occurs in a deposition. Awareness of how you are being assessed at all times, and the image that is needed, is important since a negative impression by jurors can have a detrimental effect on a physician’s case.”
Juror: We didn’t like the doctor’s shoes
In another case, attorneys warned a physician defendant against dressing in his signature wardrobe during his trial. Against their advice, the doctor showed up daily to his trial in bright pastel, monochromatic suits with matching Gucci-brand shoes, said medical liability defense attorney Meredith C. Lander, of Kaufman Borgeest & Ryan LLP, based in Connecticut. On the witness stand, the doctor was long-winded and wasn’t “terribly likable,” Ms. Lander said.
However, the evidence weighed in the physician’s favor, and there was strong testimony by defense experts. The physician won the case, Ms. Lander said, but after the verdict, the jury foreperson approached the trial attorney and made some disparaging remarks about the defendant.
“The foreperson said the jury didn’t like the doctor or his ‘Gucci suits and shoes,’ but they believed the experts,” Ms. Lander said.
Disruptive behavior can also harm jurors’ perception of physicians, Ms. Flynn adds. During one instance, a surgeon insisted on sitting next to Ms. Flynn, although she generally requests clients sit in the first row so that jurors are not so focused on their reactions during testimony. The surgeon loudly peppered Ms. Flynn with questions as witnesses testified, prompting a reprimand from the judge.
“The judge admonished the doctor several times and said, ‘Doctor, you’re raising your voice. You’ll get a chance to speak with your attorney during the break,’ ” Ms. Flynn recalled. “The doctor refused to stop talking, and the judge told him in front of the jury to go sit in the back of the courtroom. His reaction was, ‘Why do I have to move?! I need to sit here!’ ”
The surgeon eventually moved to the back of the courtroom and a sheriff’s deputy stood next to him. Testimony continued until a note in the form of a paper airplane landed on the table in front of Ms. Flynn. She carefully crumpled the note and tossed it in the wastebasket. Luckily, this drew a laugh from jurors, she said.
But things got worse when the surgeon testified. Rather than answer the questions, he interrupted and started telling jurors his own version of events.
“The judge finally said, ‘Doctor, if you don’t listen to your attorney and answer her questions, I’m going to make you get off the stand,’ ” Ms. Flynn said. “That was the most unbelievable, egregious self-sabotage trial moment I’ve ever experienced.”
Fortunately, the physician’s legal case was strong, and the experts who testified drove the defense’s side home, Ms. Flynn said. The surgeon won the case.
Attorney: Watch what you say in the elevator
Other, more subtle behaviors – while often unintentional – can also be damaging.
Physicians often let their guard down while outside the courtroom and can unknowingly wind up next to a juror in an elevator or standing in a hallway, said Laura Postilion, a partner at Quintairos, Prieto, Wood & Boyer, P.A., based in Chicago.
“For instance, a doctor is in an elevator and feels that some witness on the stand was lying,” Ms. Postilion said. “They might be very upset about it and start ranting about a witness lying, not realizing there is a juror is in the elevator with you.”
Physicians should also be cautious when speaking on the phone to their family or friends during a trial break.
“At the Daley Center in downtown Chicago, there are these long corridors and long line of windows; a lot of people will stand there during breaks. A doctor may be talking to his or her spouse and saying, ‘Yeah, this juror is sleeping!’ Jurors are [often] looking for drama. They’re looking for somebody letting their guard down. Hearing a doctor speak badly about them would certainly give them a reason to dislike the physician.”
Ms. Postilion warns against talking about jurors in or outside of the courtroom. This includes parking structures, she said.
Physicians can take additional steps to save themselves from negative judgment from jurors, attorneys say. Even before the trial starts, Ms. Postilion advises clients to make their social media accounts private. Some curious jurors may look up a physician’s social media accounts to learn more about their personal life, political leanings, or social beliefs, which could prejudice them against the doctor, she said.
Once on the stand, the words and tone used are key. The last thing a physician defendant wants is to come across as arrogant or condescending to jurors, said medical liability defense attorney Michael Moroney, of Flynn Watts LLC.
“For instance, a defendant might say, ‘Well, let me make this simple for you,’ as if they’re talking to a bunch of schoolchildren,” he said. “You don’t know who’s on the jury. That type of language can be offensive.”
Ms. Lander counsels her clients to refrain from using the common phrase, “honestly,” before answering questions on the stand.
“Everything you’re saying on the stand is presumed to be honest,” she said. “When you start an answer with, ‘Honestly…’ out of habit, it really does undercut everything that follows and everything else that’s already been said. It suggests that you were not being honest in your other answers.”
Attitude, body language speak volumes
Keep in mind that plaintiffs’ attorneys will try their best to rattle physicians on the stand and get them to appear unlikeable, says Mr. Clark, the Houston-based health law attorney. Physicians who lose their cool and begin arguing with attorneys play into their strategy.
“Plaintiffs’ attorneys have been trained in ways to get under their skin,” he said. “Righteous indignation and annoyance are best left for a rare occasion. Think about how you feel in a social setting when people are bickering in front of you. It’s uncomfortable at best. That’s how a jury feels too.”
Body language is also important, Mr. Clark notes. Physicians should avoid crossed arms, leaning back and rocking, or putting a hand on their mouth while testifying, he said. Many attorneys have practice sessions with their clients and record the interaction so that doctors can watch it and see how they look.
“Know your strengths and weaknesses,” he said. “Get help from your lawyer and perhaps consultants about how to improve these skills. Practice and preparation are important.”
Ms. Postilion goes over courtroom clothing with physician clients before trial. Anything “too flashy, too high-end, or too dumpy” should be avoided, she said. Getting accustomed to the courtroom and practicing in an empty courtroom are good ways to ensure that a physician’s voice is loud enough and projecting far enough in the courtroom, she adds.
“The doctor should try to be the best version of him- or herself to jurors,” she said. “A jury can pick up someone who’s trying to be something they’re not. A good attorney can help the doctor find the best version of themselves and capitalize on it. What is it that you want the jury to know about your care of the patient? Take that overall feeling and make sure it’s clearly expressed to the jury.”
A version of this article first appeared on Medscape.com.
During a medical malpractice trial in New Jersey, jurors waited nearly 4 hours for the physician defendant to show up. When he did arrive, the body-building surgeon was sporting two thick gold chains and a diamond pinky ring, and had the top buttons of his shirt open enough to reveal his chest hair.
“This trial was in a very rural, farming community,” recalls medical liability defense attorney Catherine Flynn, of Flynn Watts LLC, based in Parsippany, N.J. “Many of the jurors were wearing flannel shirts and jeans. The doctor’s wife walked in wearing a five-carat diamond ring and other jewelry.”
Ms. Flynn took the couple aside and asked them to remove the jewelry. She explained that the opulent accessories could damage the jury’s view of the physician. The surgeon and his wife, however, refused to remove their jewelry, she said. They didn’t think it was a big deal.
The case against the surgeon involved intraoperative damage to a patient when the physician inadvertently removed a portion of nerve in the area of the procedure. After repair of the nerve, the patient had a positive result. However, the patient alleged the surgeon’s negligence resulted in permanent damage despite the successful repair.
Jurors ultimately found the physician negligent in the case and awarded the plaintiff $1.2 million. Ms. Flynn believes that physician’s flamboyant attire and arrogant nature tainted the jury’s decision.
“In certain counties in New Jersey, his attire would not have been a problem,” she said. “In this rural, farming county, it was a huge problem. You have to know your audience. There are a lot of other things that come into play in a medical malpractice case, but when it comes to damages in a case, you don’t want to be sending the message that supports what somebody’s bias may already be telling them about a doctor.”
The surgeon appealed the verdict, and the case ultimately settled for a lesser amount, according to Ms. Flynn.
An over-the-top wardrobe is just one way that physicians can negatively influence jurors during legal trials. From subtle facial expressions to sudden outbursts to downright rudeness, attorneys have witnessed countless examples of physicians sabotaging their own trials.
“The minute you enter the courthouse, jurors or potential jurors are sizing you up,” says health law attorney Michael Clark, of Womble Bond Dickinson (US) LLP, based in Houston. “The same phenomenon occurs in a deposition. Awareness of how you are being assessed at all times, and the image that is needed, is important since a negative impression by jurors can have a detrimental effect on a physician’s case.”
Juror: We didn’t like the doctor’s shoes
In another case, attorneys warned a physician defendant against dressing in his signature wardrobe during his trial. Against their advice, the doctor showed up daily to his trial in bright pastel, monochromatic suits with matching Gucci-brand shoes, said medical liability defense attorney Meredith C. Lander, of Kaufman Borgeest & Ryan LLP, based in Connecticut. On the witness stand, the doctor was long-winded and wasn’t “terribly likable,” Ms. Lander said.
However, the evidence weighed in the physician’s favor, and there was strong testimony by defense experts. The physician won the case, Ms. Lander said, but after the verdict, the jury foreperson approached the trial attorney and made some disparaging remarks about the defendant.
“The foreperson said the jury didn’t like the doctor or his ‘Gucci suits and shoes,’ but they believed the experts,” Ms. Lander said.
Disruptive behavior can also harm jurors’ perception of physicians, Ms. Flynn adds. During one instance, a surgeon insisted on sitting next to Ms. Flynn, although she generally requests clients sit in the first row so that jurors are not so focused on their reactions during testimony. The surgeon loudly peppered Ms. Flynn with questions as witnesses testified, prompting a reprimand from the judge.
“The judge admonished the doctor several times and said, ‘Doctor, you’re raising your voice. You’ll get a chance to speak with your attorney during the break,’ ” Ms. Flynn recalled. “The doctor refused to stop talking, and the judge told him in front of the jury to go sit in the back of the courtroom. His reaction was, ‘Why do I have to move?! I need to sit here!’ ”
The surgeon eventually moved to the back of the courtroom and a sheriff’s deputy stood next to him. Testimony continued until a note in the form of a paper airplane landed on the table in front of Ms. Flynn. She carefully crumpled the note and tossed it in the wastebasket. Luckily, this drew a laugh from jurors, she said.
But things got worse when the surgeon testified. Rather than answer the questions, he interrupted and started telling jurors his own version of events.
“The judge finally said, ‘Doctor, if you don’t listen to your attorney and answer her questions, I’m going to make you get off the stand,’ ” Ms. Flynn said. “That was the most unbelievable, egregious self-sabotage trial moment I’ve ever experienced.”
Fortunately, the physician’s legal case was strong, and the experts who testified drove the defense’s side home, Ms. Flynn said. The surgeon won the case.
Attorney: Watch what you say in the elevator
Other, more subtle behaviors – while often unintentional – can also be damaging.
Physicians often let their guard down while outside the courtroom and can unknowingly wind up next to a juror in an elevator or standing in a hallway, said Laura Postilion, a partner at Quintairos, Prieto, Wood & Boyer, P.A., based in Chicago.
“For instance, a doctor is in an elevator and feels that some witness on the stand was lying,” Ms. Postilion said. “They might be very upset about it and start ranting about a witness lying, not realizing there is a juror is in the elevator with you.”
Physicians should also be cautious when speaking on the phone to their family or friends during a trial break.
“At the Daley Center in downtown Chicago, there are these long corridors and long line of windows; a lot of people will stand there during breaks. A doctor may be talking to his or her spouse and saying, ‘Yeah, this juror is sleeping!’ Jurors are [often] looking for drama. They’re looking for somebody letting their guard down. Hearing a doctor speak badly about them would certainly give them a reason to dislike the physician.”
Ms. Postilion warns against talking about jurors in or outside of the courtroom. This includes parking structures, she said.
Physicians can take additional steps to save themselves from negative judgment from jurors, attorneys say. Even before the trial starts, Ms. Postilion advises clients to make their social media accounts private. Some curious jurors may look up a physician’s social media accounts to learn more about their personal life, political leanings, or social beliefs, which could prejudice them against the doctor, she said.
Once on the stand, the words and tone used are key. The last thing a physician defendant wants is to come across as arrogant or condescending to jurors, said medical liability defense attorney Michael Moroney, of Flynn Watts LLC.
“For instance, a defendant might say, ‘Well, let me make this simple for you,’ as if they’re talking to a bunch of schoolchildren,” he said. “You don’t know who’s on the jury. That type of language can be offensive.”
Ms. Lander counsels her clients to refrain from using the common phrase, “honestly,” before answering questions on the stand.
“Everything you’re saying on the stand is presumed to be honest,” she said. “When you start an answer with, ‘Honestly…’ out of habit, it really does undercut everything that follows and everything else that’s already been said. It suggests that you were not being honest in your other answers.”
Attitude, body language speak volumes
Keep in mind that plaintiffs’ attorneys will try their best to rattle physicians on the stand and get them to appear unlikeable, says Mr. Clark, the Houston-based health law attorney. Physicians who lose their cool and begin arguing with attorneys play into their strategy.
“Plaintiffs’ attorneys have been trained in ways to get under their skin,” he said. “Righteous indignation and annoyance are best left for a rare occasion. Think about how you feel in a social setting when people are bickering in front of you. It’s uncomfortable at best. That’s how a jury feels too.”
Body language is also important, Mr. Clark notes. Physicians should avoid crossed arms, leaning back and rocking, or putting a hand on their mouth while testifying, he said. Many attorneys have practice sessions with their clients and record the interaction so that doctors can watch it and see how they look.
“Know your strengths and weaknesses,” he said. “Get help from your lawyer and perhaps consultants about how to improve these skills. Practice and preparation are important.”
Ms. Postilion goes over courtroom clothing with physician clients before trial. Anything “too flashy, too high-end, or too dumpy” should be avoided, she said. Getting accustomed to the courtroom and practicing in an empty courtroom are good ways to ensure that a physician’s voice is loud enough and projecting far enough in the courtroom, she adds.
“The doctor should try to be the best version of him- or herself to jurors,” she said. “A jury can pick up someone who’s trying to be something they’re not. A good attorney can help the doctor find the best version of themselves and capitalize on it. What is it that you want the jury to know about your care of the patient? Take that overall feeling and make sure it’s clearly expressed to the jury.”
A version of this article first appeared on Medscape.com.
During a medical malpractice trial in New Jersey, jurors waited nearly 4 hours for the physician defendant to show up. When he did arrive, the body-building surgeon was sporting two thick gold chains and a diamond pinky ring, and had the top buttons of his shirt open enough to reveal his chest hair.
“This trial was in a very rural, farming community,” recalls medical liability defense attorney Catherine Flynn, of Flynn Watts LLC, based in Parsippany, N.J. “Many of the jurors were wearing flannel shirts and jeans. The doctor’s wife walked in wearing a five-carat diamond ring and other jewelry.”
Ms. Flynn took the couple aside and asked them to remove the jewelry. She explained that the opulent accessories could damage the jury’s view of the physician. The surgeon and his wife, however, refused to remove their jewelry, she said. They didn’t think it was a big deal.
The case against the surgeon involved intraoperative damage to a patient when the physician inadvertently removed a portion of nerve in the area of the procedure. After repair of the nerve, the patient had a positive result. However, the patient alleged the surgeon’s negligence resulted in permanent damage despite the successful repair.
Jurors ultimately found the physician negligent in the case and awarded the plaintiff $1.2 million. Ms. Flynn believes that physician’s flamboyant attire and arrogant nature tainted the jury’s decision.
“In certain counties in New Jersey, his attire would not have been a problem,” she said. “In this rural, farming county, it was a huge problem. You have to know your audience. There are a lot of other things that come into play in a medical malpractice case, but when it comes to damages in a case, you don’t want to be sending the message that supports what somebody’s bias may already be telling them about a doctor.”
The surgeon appealed the verdict, and the case ultimately settled for a lesser amount, according to Ms. Flynn.
An over-the-top wardrobe is just one way that physicians can negatively influence jurors during legal trials. From subtle facial expressions to sudden outbursts to downright rudeness, attorneys have witnessed countless examples of physicians sabotaging their own trials.
“The minute you enter the courthouse, jurors or potential jurors are sizing you up,” says health law attorney Michael Clark, of Womble Bond Dickinson (US) LLP, based in Houston. “The same phenomenon occurs in a deposition. Awareness of how you are being assessed at all times, and the image that is needed, is important since a negative impression by jurors can have a detrimental effect on a physician’s case.”
Juror: We didn’t like the doctor’s shoes
In another case, attorneys warned a physician defendant against dressing in his signature wardrobe during his trial. Against their advice, the doctor showed up daily to his trial in bright pastel, monochromatic suits with matching Gucci-brand shoes, said medical liability defense attorney Meredith C. Lander, of Kaufman Borgeest & Ryan LLP, based in Connecticut. On the witness stand, the doctor was long-winded and wasn’t “terribly likable,” Ms. Lander said.
However, the evidence weighed in the physician’s favor, and there was strong testimony by defense experts. The physician won the case, Ms. Lander said, but after the verdict, the jury foreperson approached the trial attorney and made some disparaging remarks about the defendant.
“The foreperson said the jury didn’t like the doctor or his ‘Gucci suits and shoes,’ but they believed the experts,” Ms. Lander said.
Disruptive behavior can also harm jurors’ perception of physicians, Ms. Flynn adds. During one instance, a surgeon insisted on sitting next to Ms. Flynn, although she generally requests clients sit in the first row so that jurors are not so focused on their reactions during testimony. The surgeon loudly peppered Ms. Flynn with questions as witnesses testified, prompting a reprimand from the judge.
“The judge admonished the doctor several times and said, ‘Doctor, you’re raising your voice. You’ll get a chance to speak with your attorney during the break,’ ” Ms. Flynn recalled. “The doctor refused to stop talking, and the judge told him in front of the jury to go sit in the back of the courtroom. His reaction was, ‘Why do I have to move?! I need to sit here!’ ”
The surgeon eventually moved to the back of the courtroom and a sheriff’s deputy stood next to him. Testimony continued until a note in the form of a paper airplane landed on the table in front of Ms. Flynn. She carefully crumpled the note and tossed it in the wastebasket. Luckily, this drew a laugh from jurors, she said.
But things got worse when the surgeon testified. Rather than answer the questions, he interrupted and started telling jurors his own version of events.
“The judge finally said, ‘Doctor, if you don’t listen to your attorney and answer her questions, I’m going to make you get off the stand,’ ” Ms. Flynn said. “That was the most unbelievable, egregious self-sabotage trial moment I’ve ever experienced.”
Fortunately, the physician’s legal case was strong, and the experts who testified drove the defense’s side home, Ms. Flynn said. The surgeon won the case.
Attorney: Watch what you say in the elevator
Other, more subtle behaviors – while often unintentional – can also be damaging.
Physicians often let their guard down while outside the courtroom and can unknowingly wind up next to a juror in an elevator or standing in a hallway, said Laura Postilion, a partner at Quintairos, Prieto, Wood & Boyer, P.A., based in Chicago.
“For instance, a doctor is in an elevator and feels that some witness on the stand was lying,” Ms. Postilion said. “They might be very upset about it and start ranting about a witness lying, not realizing there is a juror is in the elevator with you.”
Physicians should also be cautious when speaking on the phone to their family or friends during a trial break.
“At the Daley Center in downtown Chicago, there are these long corridors and long line of windows; a lot of people will stand there during breaks. A doctor may be talking to his or her spouse and saying, ‘Yeah, this juror is sleeping!’ Jurors are [often] looking for drama. They’re looking for somebody letting their guard down. Hearing a doctor speak badly about them would certainly give them a reason to dislike the physician.”
Ms. Postilion warns against talking about jurors in or outside of the courtroom. This includes parking structures, she said.
Physicians can take additional steps to save themselves from negative judgment from jurors, attorneys say. Even before the trial starts, Ms. Postilion advises clients to make their social media accounts private. Some curious jurors may look up a physician’s social media accounts to learn more about their personal life, political leanings, or social beliefs, which could prejudice them against the doctor, she said.
Once on the stand, the words and tone used are key. The last thing a physician defendant wants is to come across as arrogant or condescending to jurors, said medical liability defense attorney Michael Moroney, of Flynn Watts LLC.
“For instance, a defendant might say, ‘Well, let me make this simple for you,’ as if they’re talking to a bunch of schoolchildren,” he said. “You don’t know who’s on the jury. That type of language can be offensive.”
Ms. Lander counsels her clients to refrain from using the common phrase, “honestly,” before answering questions on the stand.
“Everything you’re saying on the stand is presumed to be honest,” she said. “When you start an answer with, ‘Honestly…’ out of habit, it really does undercut everything that follows and everything else that’s already been said. It suggests that you were not being honest in your other answers.”
Attitude, body language speak volumes
Keep in mind that plaintiffs’ attorneys will try their best to rattle physicians on the stand and get them to appear unlikeable, says Mr. Clark, the Houston-based health law attorney. Physicians who lose their cool and begin arguing with attorneys play into their strategy.
“Plaintiffs’ attorneys have been trained in ways to get under their skin,” he said. “Righteous indignation and annoyance are best left for a rare occasion. Think about how you feel in a social setting when people are bickering in front of you. It’s uncomfortable at best. That’s how a jury feels too.”
Body language is also important, Mr. Clark notes. Physicians should avoid crossed arms, leaning back and rocking, or putting a hand on their mouth while testifying, he said. Many attorneys have practice sessions with their clients and record the interaction so that doctors can watch it and see how they look.
“Know your strengths and weaknesses,” he said. “Get help from your lawyer and perhaps consultants about how to improve these skills. Practice and preparation are important.”
Ms. Postilion goes over courtroom clothing with physician clients before trial. Anything “too flashy, too high-end, or too dumpy” should be avoided, she said. Getting accustomed to the courtroom and practicing in an empty courtroom are good ways to ensure that a physician’s voice is loud enough and projecting far enough in the courtroom, she adds.
“The doctor should try to be the best version of him- or herself to jurors,” she said. “A jury can pick up someone who’s trying to be something they’re not. A good attorney can help the doctor find the best version of themselves and capitalize on it. What is it that you want the jury to know about your care of the patient? Take that overall feeling and make sure it’s clearly expressed to the jury.”
A version of this article first appeared on Medscape.com.
Why some infectious disease docs are ‘encouraged’ by new bivalent COVID vaccines
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
A panel of infectious disease experts shared their take recently on the importance of the newly approved bivalent COVID-19 vaccines, why authorization without human data is not for them a cause for alarm, and what they are most optimistic about at this stage of the pandemic.
“I’m very encouraged by this new development,” Kathryn M. Edwards, MD, said during a media briefing sponsored by the Infectious Diseases Society of America (IDSA).
, she said. “It does seem that if you have a circulating strain BA.4 and BA.5, hitting it with the appropriate vaccine targeted for that is most immunogenic, certainly. We will hopefully see that in terms of effectiveness.”
Changing the vaccines at this point is appropriate, Walter A. Orenstein, MD, said. “One of our challenges is that this virus mutates. Our immune response is focused on an area of the virus that can change and be evaded,” said Dr. Orenstein, professor and associate director of the Emory Vaccine Center at Emory University, Atlanta.
“This is different than measles or polio,” he said. “But for influenza and now with SARS-CoV-2 ... we have to update our vaccines, because the virus changes.”
Man versus mouse
Dr. Edwards addressed the controversy over a lack of human data specific to these next-generation Pfizer/BioNTech and Moderna vaccines. “I do not want people to be unhappy or worried that the bivalent vaccine will act in a different way than the ones that we have been administering for the past 2 years.”
The Food and Drug Administration emergency use authorization may have relied primarily on animal studies, she said, but mice given a vaccine specific to BA.4 and BA.5 “have a much more robust immune response,” compared with those given a BA.1 vaccine.
Also, “over and over and over again we have seen with these SARS-CoV-2 vaccines that the mouse responses mirror the human responses,” said Dr. Edwards, scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University, Nashville, Tenn., and an IDSA fellow.
“Human data will be coming very soon to look at the immunogenicity,” she said.
A ‘glass half full’ perspective
When asked what they are most optimistic about at this point in the COVID-19 pandemic, Dr. Orenstein said, “I’m really positive in the sense that the vaccines we have are already very effective against severe disease, death, and hospitalization. I feel really good about that. And we have great tools.
“The bottom line for me is, I want to get it myself,” he said regarding the bivalent vaccine.
“There are a lot of things to be happy with,” Dr. Edwards said. “I’m kind of a glass-half-full kind of person.”
Dr. Edwards is confident that the surveillance systems now in place can accurately detect major changes in the virus, including new variants. She is also optimistic about the mRNA technology that allows rapid updates to COVID-19 vaccines.
Furthermore, “I’m happy that we’re beginning to open up – that we can go do different things that we have done in the past and feel much more comfortable,” she said.
More motivational messaging needed
Now is also a good time to renew efforts to get people vaccinated.
“We invested a lot into developing these vaccines, but I think we also need to invest in what I call ‘implementation science research,’ ” Dr. Orenstein said, the goal being to convince people to get vaccinated.
He pointed out that it’s vaccinations, not vaccines, that saves lives. “Vaccine doses that remain in the vial are 0% effective.
“When I was director of the United States’ immunization program at the CDC,” Dr. Orenstein said, “my director of communications used to say that you need the right message delivered by the right messenger through the right communications channel.”
Dr. Edwards agreed that listening to people’s concerns and respecting their questions are important. “We also need to make sure that we use the proper messenger, just as Walt said. Maybe the proper messenger isn’t an old gray-haired lady,” she said, referring to herself, “but it’s someone that lives in your community or is your primary care doctor who has taken care of you or your children for many years.”
Research on how to better motivate people to get vaccinated is warranted, Dr. Edwards said, as well as on “how to make sure that this is really a medical issue and not a political issue. That’s been a really big problem.”
A version of this article first appeared on Medscape.com.
Parent training pays off for children with autism
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
“Referrals for parent training should now be considered the expected standard for medical practice,” said a member of the research team, Timothy B. Smith, PhD, a professor of psychology at Brigham Young University, Provo, Utah.
Programs that show parents how to teach functional skills and address maladaptive behaviors, also known as parent-mediated or parent-implemented interventions, offer an alternative to one-on-one professional services, which are in short supply, according to the paper, which was published in the Journal of Autism and Developmental Disorders.
Methods and results
The meta-analysis included 54 papers based on randomized clinical trials involving 2,895 children, which compared the effects of various parent interventions with professional treatment, treatment as usual, or being on a wait-list to receive an intervention.
Overall the research team reported “moderately strong” average benefits from the parent-mediated interventions (Hedges’ g, 0.553), indicating a medium effect size. Parent interventions had the greatest effect on outcomes involving positive behavior and social skills (0.603), followed by language and communication (0.545), maladaptive behavior (0.519), and life skills (0.239).
Similar benefits were observed regardless of a child’s age or sex or which parent or parents implemented an intervention. The effects also appeared to be consistent regardless of intervention characteristics, such as the number of training sessions parents received, although the researchers noted that many studies did not provide data on such details.
Paul Carbone, MD, a professor of pediatrics at the University of Utah, Salt Lake City, who was not involved in the review, said it demonstrates that such parental engagement is “vitally important” and pediatricians “should not hesitate to refer interested families.”
Dr. Carbone, who is the medical director of an assessment program for children with suspected developmental disabilities, said many training programs for parents have adopted telehealth, adding to their convenience. To make appropriate referrals, primary care clinicians should become acquainted with local programs and learn which outcomes they target, he said.
Dr. Smith noted that primary care physicians are “better trained now than ever” to identify autism spectrum disorder and therefore are among the first to identify those conditions and help parents understand “that their actions at home absolutely make a difference in the child’s development.”
Overcoming limitations, future research needs
The research team attempted to overcome limitations with previous reviews by using comprehensive search terms and other methods to identify relevant studies, including some that had not been published. They included only studies that reflect common practice of training multiple parents simultaneously, they wrote.
Dr. Smith noted that long-term outcomes data and further study to compare effects on children with mild, moderate, and severe autism are needed.
Although logic would suggest greater benefits for children with severe disease, there are no data to demonstrate that, he said.
The authors of the study and Dr. Carbone reported no relevant competing interests.
FROM JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS
Candy, desserts: A ‘gateway’ to unhealthy eating among teens
Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.
“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.
“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.
Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.
Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
Blame the pandemic?
Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.
For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).
More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.
During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.
Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.
During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.
The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.
Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
Not all UPFs are bad
“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.
“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.
Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”
“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.
Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.
“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.
The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.
A version of this article first appeared on Medscape.com.
Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.
“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.
“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.
Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.
Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
Blame the pandemic?
Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.
For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).
More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.
During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.
Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.
During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.
The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.
Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
Not all UPFs are bad
“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.
“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.
Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”
“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.
Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.
“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.
The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.
A version of this article first appeared on Medscape.com.
Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.
“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.
“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.
Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.
Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
Blame the pandemic?
Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.
For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).
More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.
During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.
Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.
During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.
The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.
Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
Not all UPFs are bad
“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.
“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.
Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”
“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.
Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.
“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.
The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION 2022
Fish in pregnancy not dangerous after all, says new study
A new study has called into question the decades-long official guidance advising pregnant women to limit consumption of certain fish because of their potentially high mercury content. That advice was based particularly on one 1997 study suggesting a correlation between fetal exposure to methylmercury and cognitive dysfunction at age 7.
The U.K’s National Health Service currently advises not only pregnant women but also all those who are potentially fertile (those “who are planning a pregnancy or may have a child one day”) to limit oily fish consumption to no more than two portions per week. During pregnancy and while trying to get pregnant, women are advised to avoid shark, swordfish, and marlin altogether.
Suspicions arose from study involving consumption of pilot whale
However, researchers from the University of Bristol (England) now suggest that assumptions generated by the original 1997 study – of a cohort of women in the Faroe Islands – were unwarranted. “It was clearly stated that the methylmercury levels were associated with consumption of pilot whale (a sea mammal, not a fish),” they said.
The pilot whale is a species known to concentrate cadmium and mercury, and indeed in 1989 Faroe Islanders themselves had been advised to limit consumption of both whale meat and blubber, and to abstain completely from liver and kidneys.
Yet, as the authors pointed out, following the 1997 study, “the subsequent assumptions were that seafood in general was responsible for increased mercury levels in the mother.”
New study shows ‘no evidence of harm’
Their new research, published in NeuroToxicology, has now shown that “there is no evidence of harm from these fish,” they said. They recommend that advice for pregnant women should now be revised.
The study drew together analyses on over 4,131 pregnant mothers from the Avon Longitudinal Study of Parents and Children (ALSPAC), also known as the ‘Children of the 90s’ study, with similar detailed studies conducted in the Seychelles. The two populations differ considerably in their frequency of fish consumption: fish is a major component of the diet in the Seychelles, but eaten less frequently in the Avon study area, centered on Bristol.
The team looked for studies using the data from these two contrasting cohorts where mercury levels had been measured during pregnancy and the children followed up at frequent intervals during their childhood. Longitudinal studies in the Seychelles “have not demonstrated harmful cognitive effects in children with increasing maternal mercury levels”, they reported.
The same proved true in the United Kingdom, a more-developed country where fish is eaten less frequently, they found. They summarized the results from various papers that used ALSPAC data and found no adverse associations between total mercury levels measured in maternal whole blood and umbilical cord tissue with children’s cognitive development, in terms of either IQ or scholastic abilities.
In addition, extensive dietary questionnaires during pregnancy had allowed estimates of total fish intake to be calculated, as well as variations in the amount of each type of seafood consumed. “Although seafood is a source of dietary mercury, it appeared to explain a relatively small proportion (9%) of the variation in total blood mercury in our U.K. study population,” they said – actually less than the variance attributable to socio-demographic characteristics of the mother (10.4%).
Positive benefits of eating fish irrespective of type
What mattered was not which types of fish were eaten but whether the woman ate fish or not, which emerged as the most important factor. The mother’s prenatal mercury level was positively associated with her child’s IQ if she had eaten fish in pregnancy, but not if she had not.
“Significantly beneficial associations with prenatal mercury levels were shown for total and performance IQ, mathematical/scientific reasoning, and birth weight, in fish-consuming versus non–fish-consuming mothers,” the authors said. “These beneficial findings are similar to those observed in the Seychelles, where fish consumption is high and prenatal mercury levels are 10 times higher than U.S. levels.”
Caroline Taylor, PhD, senior research fellow and coauthor of the study, said: “We found that the mother’s mercury level during pregnancy is likely to have no adverse effect on the development of the child provided that the mother eats fish. If she did not eat fish, then there was some evidence that her mercury level could have a harmful effect on the child.”
The team said that this was because the essential nutrients in the fish could be protective against the mercury content of the fish. “This could be because of the benefits from the mix of essential nutrients that fish provides, including long-chain fatty acids, iodine, vitamin D and selenium,” said Dr. Taylor.
Women stopped eating any fish ‘to be on the safe side’
The authors called for a change in official guidance. “Health advice to pregnant women concerning consumption of mercury-containing foods has resulted in anxiety, with subsequent avoidance of fish consumption during pregnancy.” Seafood contains many nutrients crucial for children’s growth and development, but “there is the possibility that some women will stop eating any fish ‘to be on the safe side.’ ”
The authors said: “Although advice to pregnant women was generally that fish was good, the accompanying caveat was to avoid fish with high levels of mercury. Psychologically, the latter was the message that women remembered, and the general reaction has been for women to reduce their intake of all seafood.”
Coauthor Jean Golding, emeritus professor of pediatric and perinatal epidemiology at the University of Bristol, said: “It is important that advisories from health professionals revise their advice warning against eating certain species of fish. There is no evidence of harm from these fish, but there is evidence from different countries that such advice can cause confusion in pregnant women. The guidance for pregnancy should highlight ‘Eat at least two portions of fish a week, one of which should be oily’ – and omit all warnings that certain fish should not be eaten.”
The study was funded via core support for ALSPAC by the UK Medical Research Council and the UK Wellcome Trust.
A version of this article first appeared on Medscape UK.
A new study has called into question the decades-long official guidance advising pregnant women to limit consumption of certain fish because of their potentially high mercury content. That advice was based particularly on one 1997 study suggesting a correlation between fetal exposure to methylmercury and cognitive dysfunction at age 7.
The U.K’s National Health Service currently advises not only pregnant women but also all those who are potentially fertile (those “who are planning a pregnancy or may have a child one day”) to limit oily fish consumption to no more than two portions per week. During pregnancy and while trying to get pregnant, women are advised to avoid shark, swordfish, and marlin altogether.
Suspicions arose from study involving consumption of pilot whale
However, researchers from the University of Bristol (England) now suggest that assumptions generated by the original 1997 study – of a cohort of women in the Faroe Islands – were unwarranted. “It was clearly stated that the methylmercury levels were associated with consumption of pilot whale (a sea mammal, not a fish),” they said.
The pilot whale is a species known to concentrate cadmium and mercury, and indeed in 1989 Faroe Islanders themselves had been advised to limit consumption of both whale meat and blubber, and to abstain completely from liver and kidneys.
Yet, as the authors pointed out, following the 1997 study, “the subsequent assumptions were that seafood in general was responsible for increased mercury levels in the mother.”
New study shows ‘no evidence of harm’
Their new research, published in NeuroToxicology, has now shown that “there is no evidence of harm from these fish,” they said. They recommend that advice for pregnant women should now be revised.
The study drew together analyses on over 4,131 pregnant mothers from the Avon Longitudinal Study of Parents and Children (ALSPAC), also known as the ‘Children of the 90s’ study, with similar detailed studies conducted in the Seychelles. The two populations differ considerably in their frequency of fish consumption: fish is a major component of the diet in the Seychelles, but eaten less frequently in the Avon study area, centered on Bristol.
The team looked for studies using the data from these two contrasting cohorts where mercury levels had been measured during pregnancy and the children followed up at frequent intervals during their childhood. Longitudinal studies in the Seychelles “have not demonstrated harmful cognitive effects in children with increasing maternal mercury levels”, they reported.
The same proved true in the United Kingdom, a more-developed country where fish is eaten less frequently, they found. They summarized the results from various papers that used ALSPAC data and found no adverse associations between total mercury levels measured in maternal whole blood and umbilical cord tissue with children’s cognitive development, in terms of either IQ or scholastic abilities.
In addition, extensive dietary questionnaires during pregnancy had allowed estimates of total fish intake to be calculated, as well as variations in the amount of each type of seafood consumed. “Although seafood is a source of dietary mercury, it appeared to explain a relatively small proportion (9%) of the variation in total blood mercury in our U.K. study population,” they said – actually less than the variance attributable to socio-demographic characteristics of the mother (10.4%).
Positive benefits of eating fish irrespective of type
What mattered was not which types of fish were eaten but whether the woman ate fish or not, which emerged as the most important factor. The mother’s prenatal mercury level was positively associated with her child’s IQ if she had eaten fish in pregnancy, but not if she had not.
“Significantly beneficial associations with prenatal mercury levels were shown for total and performance IQ, mathematical/scientific reasoning, and birth weight, in fish-consuming versus non–fish-consuming mothers,” the authors said. “These beneficial findings are similar to those observed in the Seychelles, where fish consumption is high and prenatal mercury levels are 10 times higher than U.S. levels.”
Caroline Taylor, PhD, senior research fellow and coauthor of the study, said: “We found that the mother’s mercury level during pregnancy is likely to have no adverse effect on the development of the child provided that the mother eats fish. If she did not eat fish, then there was some evidence that her mercury level could have a harmful effect on the child.”
The team said that this was because the essential nutrients in the fish could be protective against the mercury content of the fish. “This could be because of the benefits from the mix of essential nutrients that fish provides, including long-chain fatty acids, iodine, vitamin D and selenium,” said Dr. Taylor.
Women stopped eating any fish ‘to be on the safe side’
The authors called for a change in official guidance. “Health advice to pregnant women concerning consumption of mercury-containing foods has resulted in anxiety, with subsequent avoidance of fish consumption during pregnancy.” Seafood contains many nutrients crucial for children’s growth and development, but “there is the possibility that some women will stop eating any fish ‘to be on the safe side.’ ”
The authors said: “Although advice to pregnant women was generally that fish was good, the accompanying caveat was to avoid fish with high levels of mercury. Psychologically, the latter was the message that women remembered, and the general reaction has been for women to reduce their intake of all seafood.”
Coauthor Jean Golding, emeritus professor of pediatric and perinatal epidemiology at the University of Bristol, said: “It is important that advisories from health professionals revise their advice warning against eating certain species of fish. There is no evidence of harm from these fish, but there is evidence from different countries that such advice can cause confusion in pregnant women. The guidance for pregnancy should highlight ‘Eat at least two portions of fish a week, one of which should be oily’ – and omit all warnings that certain fish should not be eaten.”
The study was funded via core support for ALSPAC by the UK Medical Research Council and the UK Wellcome Trust.
A version of this article first appeared on Medscape UK.
A new study has called into question the decades-long official guidance advising pregnant women to limit consumption of certain fish because of their potentially high mercury content. That advice was based particularly on one 1997 study suggesting a correlation between fetal exposure to methylmercury and cognitive dysfunction at age 7.
The U.K’s National Health Service currently advises not only pregnant women but also all those who are potentially fertile (those “who are planning a pregnancy or may have a child one day”) to limit oily fish consumption to no more than two portions per week. During pregnancy and while trying to get pregnant, women are advised to avoid shark, swordfish, and marlin altogether.
Suspicions arose from study involving consumption of pilot whale
However, researchers from the University of Bristol (England) now suggest that assumptions generated by the original 1997 study – of a cohort of women in the Faroe Islands – were unwarranted. “It was clearly stated that the methylmercury levels were associated with consumption of pilot whale (a sea mammal, not a fish),” they said.
The pilot whale is a species known to concentrate cadmium and mercury, and indeed in 1989 Faroe Islanders themselves had been advised to limit consumption of both whale meat and blubber, and to abstain completely from liver and kidneys.
Yet, as the authors pointed out, following the 1997 study, “the subsequent assumptions were that seafood in general was responsible for increased mercury levels in the mother.”
New study shows ‘no evidence of harm’
Their new research, published in NeuroToxicology, has now shown that “there is no evidence of harm from these fish,” they said. They recommend that advice for pregnant women should now be revised.
The study drew together analyses on over 4,131 pregnant mothers from the Avon Longitudinal Study of Parents and Children (ALSPAC), also known as the ‘Children of the 90s’ study, with similar detailed studies conducted in the Seychelles. The two populations differ considerably in their frequency of fish consumption: fish is a major component of the diet in the Seychelles, but eaten less frequently in the Avon study area, centered on Bristol.
The team looked for studies using the data from these two contrasting cohorts where mercury levels had been measured during pregnancy and the children followed up at frequent intervals during their childhood. Longitudinal studies in the Seychelles “have not demonstrated harmful cognitive effects in children with increasing maternal mercury levels”, they reported.
The same proved true in the United Kingdom, a more-developed country where fish is eaten less frequently, they found. They summarized the results from various papers that used ALSPAC data and found no adverse associations between total mercury levels measured in maternal whole blood and umbilical cord tissue with children’s cognitive development, in terms of either IQ or scholastic abilities.
In addition, extensive dietary questionnaires during pregnancy had allowed estimates of total fish intake to be calculated, as well as variations in the amount of each type of seafood consumed. “Although seafood is a source of dietary mercury, it appeared to explain a relatively small proportion (9%) of the variation in total blood mercury in our U.K. study population,” they said – actually less than the variance attributable to socio-demographic characteristics of the mother (10.4%).
Positive benefits of eating fish irrespective of type
What mattered was not which types of fish were eaten but whether the woman ate fish or not, which emerged as the most important factor. The mother’s prenatal mercury level was positively associated with her child’s IQ if she had eaten fish in pregnancy, but not if she had not.
“Significantly beneficial associations with prenatal mercury levels were shown for total and performance IQ, mathematical/scientific reasoning, and birth weight, in fish-consuming versus non–fish-consuming mothers,” the authors said. “These beneficial findings are similar to those observed in the Seychelles, where fish consumption is high and prenatal mercury levels are 10 times higher than U.S. levels.”
Caroline Taylor, PhD, senior research fellow and coauthor of the study, said: “We found that the mother’s mercury level during pregnancy is likely to have no adverse effect on the development of the child provided that the mother eats fish. If she did not eat fish, then there was some evidence that her mercury level could have a harmful effect on the child.”
The team said that this was because the essential nutrients in the fish could be protective against the mercury content of the fish. “This could be because of the benefits from the mix of essential nutrients that fish provides, including long-chain fatty acids, iodine, vitamin D and selenium,” said Dr. Taylor.
Women stopped eating any fish ‘to be on the safe side’
The authors called for a change in official guidance. “Health advice to pregnant women concerning consumption of mercury-containing foods has resulted in anxiety, with subsequent avoidance of fish consumption during pregnancy.” Seafood contains many nutrients crucial for children’s growth and development, but “there is the possibility that some women will stop eating any fish ‘to be on the safe side.’ ”
The authors said: “Although advice to pregnant women was generally that fish was good, the accompanying caveat was to avoid fish with high levels of mercury. Psychologically, the latter was the message that women remembered, and the general reaction has been for women to reduce their intake of all seafood.”
Coauthor Jean Golding, emeritus professor of pediatric and perinatal epidemiology at the University of Bristol, said: “It is important that advisories from health professionals revise their advice warning against eating certain species of fish. There is no evidence of harm from these fish, but there is evidence from different countries that such advice can cause confusion in pregnant women. The guidance for pregnancy should highlight ‘Eat at least two portions of fish a week, one of which should be oily’ – and omit all warnings that certain fish should not be eaten.”
The study was funded via core support for ALSPAC by the UK Medical Research Council and the UK Wellcome Trust.
A version of this article first appeared on Medscape UK.
FROM NEUROTOXICOLOGY
Isotretinoin prescribers need better education on emergency contraception
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
FROM PEDIATRIC DERMATOLOGY
AI and reality – diagnosing otitis media is a real challenge
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
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 pdnews@mdedge.com.
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
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 pdnews@mdedge.com.
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
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 pdnews@mdedge.com.