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Getting a good night’s sleep
For most things, the harder you work at it, the more successful you’ll be. Except when it comes to sleep. Nothing frightens sleep away faster than an all-out effort to find it. And yet, it should be the easiest of all health habits to cultivate. Sleep should be a hardwired, physiologic, default condition (sort of like eating and sex, all are which are evolutionary imperatives). And yet, lack of sleep is a common and grave problem even in our safe and comfortable modern environment.
Lack of sleep depletes your willpower, making it less likely you’ll actually go to the gym or be able to resist that bear claw pastry calling you back to the break room. Poor sleep impairs your ability to lose and keep off weight. It can lead to mistakes of inattention – a problem if you’re flying a plane or screening for melanoma.
As a recovering insomniac, I’ve scouted out the territory for you and have taken a few notes as a Baedeker on your journey to better sleep. Tracking sleep is easy; most any fitness tracker or smart watch outfitted with the right app will do the work for you. I’ve used my Apple Watch and Pillow for years. (I’ve no conflict of interest). I’ve found that the quality score it provides each night is interesting, but not all that important. Using pad and paper you could just as easily quantify your sleep: How many hours were you in bed, asleep, and how did you feel the next day.
Here is something important I learned about myself: I don’t need 8 hours. You might not either. Most articles say that we adults need 7-8 hours of sleep. I wasted a lot of effort trying to keep it above the 7-hour mark. Then I realized that even on nights when I got 6-7, I felt fine the next day! Don’t assume you need 8 hours. It could be 6 or it could be 9. It might in fact change depending on how you slept recently, what is happening in your life, or which season it is. If you feel alert and well rested, then you’ve likely found all the sleep you need.
Let’s assume you aren’t well rested. Now what? Like most of good health, a behavioral approach is needed to get you on the right path. You’ve likely heard that bright, particularly blue, light is harmful to falling asleep. Good news! Most devices will let you filter blue light out if you must continue that “Better Call Saul” binge. Better options: Leave your tablet in the living room and plug in your phone on the opposite side of the room (with a short cord). Invest instead in a book light and actual books. There is something about the patina of paper that can encourage sleep to come find you.
Keep the room comfortably cool. What’s important here is the temperature drop. That is, going from warm to cool. This is why a warm shower or bath before getting into bed can help you. Your temperature will drop, a signal for sleep.
So now you’re asleep. But wait, you say you’re awake again and it’s 3:00 a.m.? This is sleep maintenance insomnia. You lie there, patiently waiting, like anticipating your waiter’s return when you’re eating in Rome – ah, you could be there all night. Nothing you do seems to bring sleep back around. The best advice is to try to retrain yourself that when you are up, you’re up, and when in bed, you’re asleep. You can try getting up, moving to a different room. Try meditation or reading. Wait until you feel the urge to sleep sneak back on you, then head back to bed. Although sometimes difficult, you might consider riding it out. If you can’t fall back, then get on with your day (although I don’t recommend sending emails at 3:45 a.m., it freaks people out, I’ve learned). The following night, you will likely be sleep deprived and might find you can fall asleep easier and for longer.
Be forgiving. Unlike your diet or exercise, sleep isn’t as much in your control. You can work a little harder in spin, or double your effort to keep to your plant/keto diet. But for sleep, you must just be patient. It will come. When it is good and ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
For most things, the harder you work at it, the more successful you’ll be. Except when it comes to sleep. Nothing frightens sleep away faster than an all-out effort to find it. And yet, it should be the easiest of all health habits to cultivate. Sleep should be a hardwired, physiologic, default condition (sort of like eating and sex, all are which are evolutionary imperatives). And yet, lack of sleep is a common and grave problem even in our safe and comfortable modern environment.
Lack of sleep depletes your willpower, making it less likely you’ll actually go to the gym or be able to resist that bear claw pastry calling you back to the break room. Poor sleep impairs your ability to lose and keep off weight. It can lead to mistakes of inattention – a problem if you’re flying a plane or screening for melanoma.
As a recovering insomniac, I’ve scouted out the territory for you and have taken a few notes as a Baedeker on your journey to better sleep. Tracking sleep is easy; most any fitness tracker or smart watch outfitted with the right app will do the work for you. I’ve used my Apple Watch and Pillow for years. (I’ve no conflict of interest). I’ve found that the quality score it provides each night is interesting, but not all that important. Using pad and paper you could just as easily quantify your sleep: How many hours were you in bed, asleep, and how did you feel the next day.
Here is something important I learned about myself: I don’t need 8 hours. You might not either. Most articles say that we adults need 7-8 hours of sleep. I wasted a lot of effort trying to keep it above the 7-hour mark. Then I realized that even on nights when I got 6-7, I felt fine the next day! Don’t assume you need 8 hours. It could be 6 or it could be 9. It might in fact change depending on how you slept recently, what is happening in your life, or which season it is. If you feel alert and well rested, then you’ve likely found all the sleep you need.
Let’s assume you aren’t well rested. Now what? Like most of good health, a behavioral approach is needed to get you on the right path. You’ve likely heard that bright, particularly blue, light is harmful to falling asleep. Good news! Most devices will let you filter blue light out if you must continue that “Better Call Saul” binge. Better options: Leave your tablet in the living room and plug in your phone on the opposite side of the room (with a short cord). Invest instead in a book light and actual books. There is something about the patina of paper that can encourage sleep to come find you.
Keep the room comfortably cool. What’s important here is the temperature drop. That is, going from warm to cool. This is why a warm shower or bath before getting into bed can help you. Your temperature will drop, a signal for sleep.
So now you’re asleep. But wait, you say you’re awake again and it’s 3:00 a.m.? This is sleep maintenance insomnia. You lie there, patiently waiting, like anticipating your waiter’s return when you’re eating in Rome – ah, you could be there all night. Nothing you do seems to bring sleep back around. The best advice is to try to retrain yourself that when you are up, you’re up, and when in bed, you’re asleep. You can try getting up, moving to a different room. Try meditation or reading. Wait until you feel the urge to sleep sneak back on you, then head back to bed. Although sometimes difficult, you might consider riding it out. If you can’t fall back, then get on with your day (although I don’t recommend sending emails at 3:45 a.m., it freaks people out, I’ve learned). The following night, you will likely be sleep deprived and might find you can fall asleep easier and for longer.
Be forgiving. Unlike your diet or exercise, sleep isn’t as much in your control. You can work a little harder in spin, or double your effort to keep to your plant/keto diet. But for sleep, you must just be patient. It will come. When it is good and ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
For most things, the harder you work at it, the more successful you’ll be. Except when it comes to sleep. Nothing frightens sleep away faster than an all-out effort to find it. And yet, it should be the easiest of all health habits to cultivate. Sleep should be a hardwired, physiologic, default condition (sort of like eating and sex, all are which are evolutionary imperatives). And yet, lack of sleep is a common and grave problem even in our safe and comfortable modern environment.
Lack of sleep depletes your willpower, making it less likely you’ll actually go to the gym or be able to resist that bear claw pastry calling you back to the break room. Poor sleep impairs your ability to lose and keep off weight. It can lead to mistakes of inattention – a problem if you’re flying a plane or screening for melanoma.
As a recovering insomniac, I’ve scouted out the territory for you and have taken a few notes as a Baedeker on your journey to better sleep. Tracking sleep is easy; most any fitness tracker or smart watch outfitted with the right app will do the work for you. I’ve used my Apple Watch and Pillow for years. (I’ve no conflict of interest). I’ve found that the quality score it provides each night is interesting, but not all that important. Using pad and paper you could just as easily quantify your sleep: How many hours were you in bed, asleep, and how did you feel the next day.
Here is something important I learned about myself: I don’t need 8 hours. You might not either. Most articles say that we adults need 7-8 hours of sleep. I wasted a lot of effort trying to keep it above the 7-hour mark. Then I realized that even on nights when I got 6-7, I felt fine the next day! Don’t assume you need 8 hours. It could be 6 or it could be 9. It might in fact change depending on how you slept recently, what is happening in your life, or which season it is. If you feel alert and well rested, then you’ve likely found all the sleep you need.
Let’s assume you aren’t well rested. Now what? Like most of good health, a behavioral approach is needed to get you on the right path. You’ve likely heard that bright, particularly blue, light is harmful to falling asleep. Good news! Most devices will let you filter blue light out if you must continue that “Better Call Saul” binge. Better options: Leave your tablet in the living room and plug in your phone on the opposite side of the room (with a short cord). Invest instead in a book light and actual books. There is something about the patina of paper that can encourage sleep to come find you.
Keep the room comfortably cool. What’s important here is the temperature drop. That is, going from warm to cool. This is why a warm shower or bath before getting into bed can help you. Your temperature will drop, a signal for sleep.
So now you’re asleep. But wait, you say you’re awake again and it’s 3:00 a.m.? This is sleep maintenance insomnia. You lie there, patiently waiting, like anticipating your waiter’s return when you’re eating in Rome – ah, you could be there all night. Nothing you do seems to bring sleep back around. The best advice is to try to retrain yourself that when you are up, you’re up, and when in bed, you’re asleep. You can try getting up, moving to a different room. Try meditation or reading. Wait until you feel the urge to sleep sneak back on you, then head back to bed. Although sometimes difficult, you might consider riding it out. If you can’t fall back, then get on with your day (although I don’t recommend sending emails at 3:45 a.m., it freaks people out, I’ve learned). The following night, you will likely be sleep deprived and might find you can fall asleep easier and for longer.
Be forgiving. Unlike your diet or exercise, sleep isn’t as much in your control. You can work a little harder in spin, or double your effort to keep to your plant/keto diet. But for sleep, you must just be patient. It will come. When it is good and ready.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Inhibitor risk nears zero after 75 days in previously untreated hemophilia A
PRAGUE—For previously untreated patients (PUPs) with severe hemophilia A, the risk of developing factor VIII (FVIII) alloantibodies (inhibitors) becomes negligible after 75 exposure days, according to a recent study involving more than 1,000 infants.
This finding answers a long-standing and important question in the management of hemophilia A, reported lead author H. Marijke van den Berg, MD, PhD, of University Medical Centre in Utrecht, The Netherlands.
Inhibitor development is the biggest safety concern facing infants with severe hemophilia A because it affects 25%-35% of the patient population, but no previous studies have adequately described the associated risk profile, she noted.
“Most studies until now collected data until about 50 [exposure days] and not that far beyond,” Dr. van den Berg said at the annual congress of the European Association for Haemophilia and Allied Disorders. “So we were interested to see the serum plateau in our large cohort.”
Such a plateau would represent the time point at which risk of inhibitor development approaches zero.
Dr. van den Berg and her colleagues followed 1,038 PUPs with severe hemophilia A from first exposure to FVIII onward. Data were from drawn from the PedNet Registry. From the initial group, 943 patients (91%) were followed until 50 exposure days, and 899 (87%) were followed until 75 exposure days.
Inhibitor development was defined by a minimum of two positive inhibitor titers. In addition to determining the point in time of inhibitor development, the investigators performed a survival analysis for inhibitor incidence and reported median ages at first exposure and at exposure day 75.
The results showed that 298 out of 300 instances of inhibitor development occurred within 75 exposure days, and no inhibitors developed between exposure day 75 and 150. The final two instances occurred at exposure day 249 and 262, both with a low titer.
Median age at first exposure was 1.1 years, compared with 2.3 years at exposure day 75.
These findings suggest that risk of inhibitors is “near zero” after 75 days and that risk is approaching zero just 1 year after first exposure to FVIII, she said.
The results from this study could affect the design of future clinical trials for PUPs.
“Our recommendation will be to continue frequent [inhibitor] testing until 75 exposure days,” Dr. van den Berg said.
The time frame involved is very short, so close monitoring should be feasible for investigators, she noted.
Dr. van den Berg said that additional data, including Kaplan-Meier curves, would “hopefully” be published in a journal soon.
Dr. van den Berg reported having no relevant financial disclosures.
SOURCE: van den Berg HM et al. EAHAD 2019, Abstract OR05.
PRAGUE—For previously untreated patients (PUPs) with severe hemophilia A, the risk of developing factor VIII (FVIII) alloantibodies (inhibitors) becomes negligible after 75 exposure days, according to a recent study involving more than 1,000 infants.
This finding answers a long-standing and important question in the management of hemophilia A, reported lead author H. Marijke van den Berg, MD, PhD, of University Medical Centre in Utrecht, The Netherlands.
Inhibitor development is the biggest safety concern facing infants with severe hemophilia A because it affects 25%-35% of the patient population, but no previous studies have adequately described the associated risk profile, she noted.
“Most studies until now collected data until about 50 [exposure days] and not that far beyond,” Dr. van den Berg said at the annual congress of the European Association for Haemophilia and Allied Disorders. “So we were interested to see the serum plateau in our large cohort.”
Such a plateau would represent the time point at which risk of inhibitor development approaches zero.
Dr. van den Berg and her colleagues followed 1,038 PUPs with severe hemophilia A from first exposure to FVIII onward. Data were from drawn from the PedNet Registry. From the initial group, 943 patients (91%) were followed until 50 exposure days, and 899 (87%) were followed until 75 exposure days.
Inhibitor development was defined by a minimum of two positive inhibitor titers. In addition to determining the point in time of inhibitor development, the investigators performed a survival analysis for inhibitor incidence and reported median ages at first exposure and at exposure day 75.
The results showed that 298 out of 300 instances of inhibitor development occurred within 75 exposure days, and no inhibitors developed between exposure day 75 and 150. The final two instances occurred at exposure day 249 and 262, both with a low titer.
Median age at first exposure was 1.1 years, compared with 2.3 years at exposure day 75.
These findings suggest that risk of inhibitors is “near zero” after 75 days and that risk is approaching zero just 1 year after first exposure to FVIII, she said.
The results from this study could affect the design of future clinical trials for PUPs.
“Our recommendation will be to continue frequent [inhibitor] testing until 75 exposure days,” Dr. van den Berg said.
The time frame involved is very short, so close monitoring should be feasible for investigators, she noted.
Dr. van den Berg said that additional data, including Kaplan-Meier curves, would “hopefully” be published in a journal soon.
Dr. van den Berg reported having no relevant financial disclosures.
SOURCE: van den Berg HM et al. EAHAD 2019, Abstract OR05.
PRAGUE—For previously untreated patients (PUPs) with severe hemophilia A, the risk of developing factor VIII (FVIII) alloantibodies (inhibitors) becomes negligible after 75 exposure days, according to a recent study involving more than 1,000 infants.
This finding answers a long-standing and important question in the management of hemophilia A, reported lead author H. Marijke van den Berg, MD, PhD, of University Medical Centre in Utrecht, The Netherlands.
Inhibitor development is the biggest safety concern facing infants with severe hemophilia A because it affects 25%-35% of the patient population, but no previous studies have adequately described the associated risk profile, she noted.
“Most studies until now collected data until about 50 [exposure days] and not that far beyond,” Dr. van den Berg said at the annual congress of the European Association for Haemophilia and Allied Disorders. “So we were interested to see the serum plateau in our large cohort.”
Such a plateau would represent the time point at which risk of inhibitor development approaches zero.
Dr. van den Berg and her colleagues followed 1,038 PUPs with severe hemophilia A from first exposure to FVIII onward. Data were from drawn from the PedNet Registry. From the initial group, 943 patients (91%) were followed until 50 exposure days, and 899 (87%) were followed until 75 exposure days.
Inhibitor development was defined by a minimum of two positive inhibitor titers. In addition to determining the point in time of inhibitor development, the investigators performed a survival analysis for inhibitor incidence and reported median ages at first exposure and at exposure day 75.
The results showed that 298 out of 300 instances of inhibitor development occurred within 75 exposure days, and no inhibitors developed between exposure day 75 and 150. The final two instances occurred at exposure day 249 and 262, both with a low titer.
Median age at first exposure was 1.1 years, compared with 2.3 years at exposure day 75.
These findings suggest that risk of inhibitors is “near zero” after 75 days and that risk is approaching zero just 1 year after first exposure to FVIII, she said.
The results from this study could affect the design of future clinical trials for PUPs.
“Our recommendation will be to continue frequent [inhibitor] testing until 75 exposure days,” Dr. van den Berg said.
The time frame involved is very short, so close monitoring should be feasible for investigators, she noted.
Dr. van den Berg said that additional data, including Kaplan-Meier curves, would “hopefully” be published in a journal soon.
Dr. van den Berg reported having no relevant financial disclosures.
SOURCE: van den Berg HM et al. EAHAD 2019, Abstract OR05.
REPORTING FROM EAHAD 2019
Key clinical point: Major finding: Less than 1% of infants with severe hemophilia A developed inhibitors after 75 exposure days.
Study details: An observational study involving 1,038 previously untreated patients with severe hemophilia A, of which 899 (87%) were followed until 75 exposure days.
Disclosures: Dr. van den Berg reported having no relevant financial disclosures.
Source: van den Berg HM et al. EAHAD 2019, Abstract OR05.
Hemophilia intracranial hemorrhage rates declining
PRAGUE – Despite improvements over the past 60 years, intracranial hemorrhage (ICH) remains a significant complication in hemophilia, occurring most frequently among patients with severe forms of the disease, according to a large-scale meta-analysis involving 56 studies and nearly 80,000 patients.
The consequences of a single incident of ICH can be irreparable and life-changing, so clinician knowledge of incidence rates and risk factors is essential, said lead author Anne-Fleur Zwagemaker, a PhD candidate from Amsterdam University Medical Center.
“Intracranial hemorrhage is one of the most severe and fearful complications in hemophilia,” Ms. Zwagemaker said in a presentation at the annual congress of the European Association for Haemophilia and Allied Disorders. “Our aim was to give more precise estimates of ICH numbers and risk factors in hemophilia.”
The review is notable for its scale and quality. After eliminating studies with fewer than 50 patients or other insufficiencies, the investigators were left with 56 studies conducted between 1960 and 2018, involving 79,818 patients with hemophilia. With a mean observation period of 12 years, the data encompassed almost 1 million person-years of data.
Across all studies, 1,508 ICH events were reported. Incidence and mortality rates were 400 and 80 per 100,000 person-years, respectively.
To optimize accuracy, the investigators further restricted studies to those with a sample size of at least 365 patients, leading to a pooled incidence rate of 3.8%. Studies with relevant data showed that about half of the cases of ICH (48%) were spontaneous. Regarding most common bleed locations, about two-thirds were either subdural (30%) or intracerebral (32%).
Pooled incidence rates of ICH have decreased steadily over time, from 7%-8% during the 1960-1979 time period, to 5%-6% from 1980-1999, and most recently to about 3%.
Mortality rates during the same time periods decreased in a similar fashion, from 300, to 100, to 75 deaths per 100,000 person-years.
Additional analysis revealed an expected relationship between disease severity and likelihood of ICH. Mild cases of hemophilia had an ICH incidence rate of 0.9%, moderate cases had a rate of 1.3%, and severe cases topped the scale at 4.5%, entailing an incidence rate ratio of 2.7 between severe and nonsevere patients.
“I think our data show that in hemophilia, ICH is still a very important and frequent complication,” Ms. Zwagemaker said. “Luckily, we also see a decline in numbers, but I think it’s still very important that we identify those at risk in hemophilia and that we acknowledge it’s still a very important problem.”
Dr. Zwagemaker reported having no relevant financial disclosures.
SOURCE: Zwagemaker AF et al. EAHAD 2019, Abstract OR08.
PRAGUE – Despite improvements over the past 60 years, intracranial hemorrhage (ICH) remains a significant complication in hemophilia, occurring most frequently among patients with severe forms of the disease, according to a large-scale meta-analysis involving 56 studies and nearly 80,000 patients.
The consequences of a single incident of ICH can be irreparable and life-changing, so clinician knowledge of incidence rates and risk factors is essential, said lead author Anne-Fleur Zwagemaker, a PhD candidate from Amsterdam University Medical Center.
“Intracranial hemorrhage is one of the most severe and fearful complications in hemophilia,” Ms. Zwagemaker said in a presentation at the annual congress of the European Association for Haemophilia and Allied Disorders. “Our aim was to give more precise estimates of ICH numbers and risk factors in hemophilia.”
The review is notable for its scale and quality. After eliminating studies with fewer than 50 patients or other insufficiencies, the investigators were left with 56 studies conducted between 1960 and 2018, involving 79,818 patients with hemophilia. With a mean observation period of 12 years, the data encompassed almost 1 million person-years of data.
Across all studies, 1,508 ICH events were reported. Incidence and mortality rates were 400 and 80 per 100,000 person-years, respectively.
To optimize accuracy, the investigators further restricted studies to those with a sample size of at least 365 patients, leading to a pooled incidence rate of 3.8%. Studies with relevant data showed that about half of the cases of ICH (48%) were spontaneous. Regarding most common bleed locations, about two-thirds were either subdural (30%) or intracerebral (32%).
Pooled incidence rates of ICH have decreased steadily over time, from 7%-8% during the 1960-1979 time period, to 5%-6% from 1980-1999, and most recently to about 3%.
Mortality rates during the same time periods decreased in a similar fashion, from 300, to 100, to 75 deaths per 100,000 person-years.
Additional analysis revealed an expected relationship between disease severity and likelihood of ICH. Mild cases of hemophilia had an ICH incidence rate of 0.9%, moderate cases had a rate of 1.3%, and severe cases topped the scale at 4.5%, entailing an incidence rate ratio of 2.7 between severe and nonsevere patients.
“I think our data show that in hemophilia, ICH is still a very important and frequent complication,” Ms. Zwagemaker said. “Luckily, we also see a decline in numbers, but I think it’s still very important that we identify those at risk in hemophilia and that we acknowledge it’s still a very important problem.”
Dr. Zwagemaker reported having no relevant financial disclosures.
SOURCE: Zwagemaker AF et al. EAHAD 2019, Abstract OR08.
PRAGUE – Despite improvements over the past 60 years, intracranial hemorrhage (ICH) remains a significant complication in hemophilia, occurring most frequently among patients with severe forms of the disease, according to a large-scale meta-analysis involving 56 studies and nearly 80,000 patients.
The consequences of a single incident of ICH can be irreparable and life-changing, so clinician knowledge of incidence rates and risk factors is essential, said lead author Anne-Fleur Zwagemaker, a PhD candidate from Amsterdam University Medical Center.
“Intracranial hemorrhage is one of the most severe and fearful complications in hemophilia,” Ms. Zwagemaker said in a presentation at the annual congress of the European Association for Haemophilia and Allied Disorders. “Our aim was to give more precise estimates of ICH numbers and risk factors in hemophilia.”
The review is notable for its scale and quality. After eliminating studies with fewer than 50 patients or other insufficiencies, the investigators were left with 56 studies conducted between 1960 and 2018, involving 79,818 patients with hemophilia. With a mean observation period of 12 years, the data encompassed almost 1 million person-years of data.
Across all studies, 1,508 ICH events were reported. Incidence and mortality rates were 400 and 80 per 100,000 person-years, respectively.
To optimize accuracy, the investigators further restricted studies to those with a sample size of at least 365 patients, leading to a pooled incidence rate of 3.8%. Studies with relevant data showed that about half of the cases of ICH (48%) were spontaneous. Regarding most common bleed locations, about two-thirds were either subdural (30%) or intracerebral (32%).
Pooled incidence rates of ICH have decreased steadily over time, from 7%-8% during the 1960-1979 time period, to 5%-6% from 1980-1999, and most recently to about 3%.
Mortality rates during the same time periods decreased in a similar fashion, from 300, to 100, to 75 deaths per 100,000 person-years.
Additional analysis revealed an expected relationship between disease severity and likelihood of ICH. Mild cases of hemophilia had an ICH incidence rate of 0.9%, moderate cases had a rate of 1.3%, and severe cases topped the scale at 4.5%, entailing an incidence rate ratio of 2.7 between severe and nonsevere patients.
“I think our data show that in hemophilia, ICH is still a very important and frequent complication,” Ms. Zwagemaker said. “Luckily, we also see a decline in numbers, but I think it’s still very important that we identify those at risk in hemophilia and that we acknowledge it’s still a very important problem.”
Dr. Zwagemaker reported having no relevant financial disclosures.
SOURCE: Zwagemaker AF et al. EAHAD 2019, Abstract OR08.
REPORTING FROM EAHAD 2019
Key clinical point:
Major finding: The incidence rate of ICH was approximately 7%-8% from 1960 to 1979, compared with approximately 3% from 2000 to 2018.
Study details: A review of 56 studies conducted between 1960 and 2018, involving 79,818 patients with hemophilia.
Disclosures: Dr. Zwagemaker reported having no relevant financial disclosures.
Source: Zwagemaker AF et al. EAHAD 2019, Abstract OR08.
Survey: Health care costs, access unlikely to improve in 2019
but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.
Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.
A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.
but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.
Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.
A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.
but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.
Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.
A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.
Survey: Reproductive counseling is often MIA in IBD
LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.
Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”
Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”
Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”
In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).
Just over a third – 35% – of the patients said they’d been counseled about reproductive health by a physician. This finding reflects findings in previous research, said Dr. Rao, who spoke in an interview.
Just 15% of those who’d undergone IBD surgery reported getting guidance about the effects of surgery on fertility.
More than a third (35%) of women and 15% of men said they’d considered not having children because of their IBD. In fact, “most potential dads and moms have the chance to do very well,” Dr. Streett said.
Without reproductive counseling, she added, parents won’t know about the risks of passing on IBD. According to Dr. Rao, there’s an estimated less than 5% chance that IBD will be passed on to children if one parent has the condition; the risk is much higher if both parents have it.
Going forward, “there’s a really urgent need for proactive counseling on the part of gastroenterologists and health care teams to give people of childbearing age the right information so they can be informed to make the best decisions,” Dr. Streett said.
The study was funded by a philanthropic grant. The study authors report no relevant disclosures.
With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org.
SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.
LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.
Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”
Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”
Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”
In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).
Just over a third – 35% – of the patients said they’d been counseled about reproductive health by a physician. This finding reflects findings in previous research, said Dr. Rao, who spoke in an interview.
Just 15% of those who’d undergone IBD surgery reported getting guidance about the effects of surgery on fertility.
More than a third (35%) of women and 15% of men said they’d considered not having children because of their IBD. In fact, “most potential dads and moms have the chance to do very well,” Dr. Streett said.
Without reproductive counseling, she added, parents won’t know about the risks of passing on IBD. According to Dr. Rao, there’s an estimated less than 5% chance that IBD will be passed on to children if one parent has the condition; the risk is much higher if both parents have it.
Going forward, “there’s a really urgent need for proactive counseling on the part of gastroenterologists and health care teams to give people of childbearing age the right information so they can be informed to make the best decisions,” Dr. Streett said.
The study was funded by a philanthropic grant. The study authors report no relevant disclosures.
With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org.
SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.
LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.
Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”
Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”
Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”
In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).
Just over a third – 35% – of the patients said they’d been counseled about reproductive health by a physician. This finding reflects findings in previous research, said Dr. Rao, who spoke in an interview.
Just 15% of those who’d undergone IBD surgery reported getting guidance about the effects of surgery on fertility.
More than a third (35%) of women and 15% of men said they’d considered not having children because of their IBD. In fact, “most potential dads and moms have the chance to do very well,” Dr. Streett said.
Without reproductive counseling, she added, parents won’t know about the risks of passing on IBD. According to Dr. Rao, there’s an estimated less than 5% chance that IBD will be passed on to children if one parent has the condition; the risk is much higher if both parents have it.
Going forward, “there’s a really urgent need for proactive counseling on the part of gastroenterologists and health care teams to give people of childbearing age the right information so they can be informed to make the best decisions,” Dr. Streett said.
The study was funded by a philanthropic grant. The study authors report no relevant disclosures.
With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org.
SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: Patients with inflammatory bowel disease aren’t getting proper guidance regarding fertility, pregnancy, and genetic risks.
Major finding: Among surveyed patients, 65% said they’d never received reproductive counseling from a physician.
Study details: Single-center survey of 100 patients (median age = 30, 54% female).
Disclosures: The study was funded by a philanthropic grant. The study authors report no relevant disclosures.
Source: Rao A et al. Crohn’s & Colitis Congress 2019, Abstract P009.
Donate to the SVS Gala
Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org.
Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org.
Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org.
Updated Patient Fliers Available Now
The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.
The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.
The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.
Tranexamic acid shows improvements in heavy menstrual bleeding
new research suggests.
Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.
The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).
The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.
While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).
The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.
Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.
“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.
The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.
SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.
new research suggests.
Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.
The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).
The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.
While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).
The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.
Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.
“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.
The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.
SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.
new research suggests.
Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.
The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).
The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.
While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).
The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.
Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.
“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.
The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.
SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.
FROM THE JOURNAL OF PEDIATRIC & ADOLESCENT GYNECOLOGY
Key clinical point: Tranexamic acid appears to improve quality of life for adolescents with heavy menstrual bleeding.
Major finding: Patients treated with tranexamic acid reported significant improvements in mean menstrual impact questionnaire scores.
Study details: Open-label efficacy study in 25 adolescent girls with heavy menstrual bleeding.
Disclosures: The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.
Source: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.
HHS to target step therapy, Stark Law in 2019
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”
REPORTING FROM AMA NATIONAL ADVOCACY CONFERENCE
Probiotic, prebiotic, and postbiotic skin care
A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.
The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm2 that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.
What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.
Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.
Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.
In 2007, the National Institutes of Health initiated the Human Microbiome Project, and in 2016, the White House announced the creation of a new National Microbiome Initiative (NMI). Through this research, the identification and importance of our gut bacteria has led to a vast increase in development and near obsession with probiotic supplements, foods, and drinks (examples include Kombucha tea, kimchi, miso, and Kefir). Although oral consumption of prebiotics and probiotics may prove to be helpful, the skin does have its own unique flora and will benefit from targeted skin care. In the meantime, fostering the skins’s microflora is as important or more important than the replacement of it. My recommendations include using “microflora friendly” products that are lather-free, cream- or oil-based cleansers with acidic pH’s, and moisturizing heavily and consistently. I recommend staying away from antibacterial wipes, antibacterial soaps, and sanitizers.
Fostering this bacterial rich environment will help maintain your skin integrity. Squeaky clean skin is damaged skin.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.
References
Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.
Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.
Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.
Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.
Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.
Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.
Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.
Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.
Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.
A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.
The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm2 that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.
What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.
Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.
Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.
In 2007, the National Institutes of Health initiated the Human Microbiome Project, and in 2016, the White House announced the creation of a new National Microbiome Initiative (NMI). Through this research, the identification and importance of our gut bacteria has led to a vast increase in development and near obsession with probiotic supplements, foods, and drinks (examples include Kombucha tea, kimchi, miso, and Kefir). Although oral consumption of prebiotics and probiotics may prove to be helpful, the skin does have its own unique flora and will benefit from targeted skin care. In the meantime, fostering the skins’s microflora is as important or more important than the replacement of it. My recommendations include using “microflora friendly” products that are lather-free, cream- or oil-based cleansers with acidic pH’s, and moisturizing heavily and consistently. I recommend staying away from antibacterial wipes, antibacterial soaps, and sanitizers.
Fostering this bacterial rich environment will help maintain your skin integrity. Squeaky clean skin is damaged skin.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.
References
Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.
Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.
Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.
Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.
Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.
Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.
Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.
Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.
Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.
A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.
The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm2 that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.
What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.
Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.
Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.
In 2007, the National Institutes of Health initiated the Human Microbiome Project, and in 2016, the White House announced the creation of a new National Microbiome Initiative (NMI). Through this research, the identification and importance of our gut bacteria has led to a vast increase in development and near obsession with probiotic supplements, foods, and drinks (examples include Kombucha tea, kimchi, miso, and Kefir). Although oral consumption of prebiotics and probiotics may prove to be helpful, the skin does have its own unique flora and will benefit from targeted skin care. In the meantime, fostering the skins’s microflora is as important or more important than the replacement of it. My recommendations include using “microflora friendly” products that are lather-free, cream- or oil-based cleansers with acidic pH’s, and moisturizing heavily and consistently. I recommend staying away from antibacterial wipes, antibacterial soaps, and sanitizers.
Fostering this bacterial rich environment will help maintain your skin integrity. Squeaky clean skin is damaged skin.
Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.
References
Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.
Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.
Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.
Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.
Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.
Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.
Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.
Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.
Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.