User login
ITI protects against bleeding in hemophilia A with factor VIII inhibitors
Immune tolerance induction, or ITI, in hemophilia A patients with inhibitor development against factor VIII (FVIII) appears to provide some protection against bleeding, as bleeding during ITI in patients from the PedNet registry was dependent on inhibitor titer and ITI regimen, according to Kathelijn Fischer, MD.
Of 218 registry patients who were born during 1990-2009 and who had clinically relevant inhibitors and available data on joint bleeding, 157 had bleeding for at least 3 months. They were followed for a median of 26 months starting at age 16 months, and most had high titer inhibitors (52% had titers of 5-199 BU, and 32% had titers greater than 200 BU).
The bleeding rates in 12 patients without ITI who were on prophylaxis were similar to those in 89 such patients without prophylaxis (0.3 and 0.4 bleeds/month, respectively); no significant difference was seen between the groups based on inhibitor titer, Dr. Fischer of University Medical Center Utrecht, The Netherlands reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Similarly, the bleeding rate during ITI among those on prophylaxis did not differ significantly from the rate in those without prophylaxis (0.4 vs. 0.3/month, respectively), but the rate did increase significantly according to inhibitor titer: The rate increased from 0.05/month in the group with less than 5 BU, to 0.2/month in those with 5-199 BU, and to 0.5/month in the group with greater than 200 BU.
Further, while ITI dose did not affect bleeding, dosing frequency had a strong effect. The median rate with nondaily dosing in 36 patients vs. daily dosing in 63 patients was 0.4/month vs. 0.2/month, respectively, Dr. Fischer said.
She reported having no disclosures.
Immune tolerance induction, or ITI, in hemophilia A patients with inhibitor development against factor VIII (FVIII) appears to provide some protection against bleeding, as bleeding during ITI in patients from the PedNet registry was dependent on inhibitor titer and ITI regimen, according to Kathelijn Fischer, MD.
Of 218 registry patients who were born during 1990-2009 and who had clinically relevant inhibitors and available data on joint bleeding, 157 had bleeding for at least 3 months. They were followed for a median of 26 months starting at age 16 months, and most had high titer inhibitors (52% had titers of 5-199 BU, and 32% had titers greater than 200 BU).
The bleeding rates in 12 patients without ITI who were on prophylaxis were similar to those in 89 such patients without prophylaxis (0.3 and 0.4 bleeds/month, respectively); no significant difference was seen between the groups based on inhibitor titer, Dr. Fischer of University Medical Center Utrecht, The Netherlands reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Similarly, the bleeding rate during ITI among those on prophylaxis did not differ significantly from the rate in those without prophylaxis (0.4 vs. 0.3/month, respectively), but the rate did increase significantly according to inhibitor titer: The rate increased from 0.05/month in the group with less than 5 BU, to 0.2/month in those with 5-199 BU, and to 0.5/month in the group with greater than 200 BU.
Further, while ITI dose did not affect bleeding, dosing frequency had a strong effect. The median rate with nondaily dosing in 36 patients vs. daily dosing in 63 patients was 0.4/month vs. 0.2/month, respectively, Dr. Fischer said.
She reported having no disclosures.
Immune tolerance induction, or ITI, in hemophilia A patients with inhibitor development against factor VIII (FVIII) appears to provide some protection against bleeding, as bleeding during ITI in patients from the PedNet registry was dependent on inhibitor titer and ITI regimen, according to Kathelijn Fischer, MD.
Of 218 registry patients who were born during 1990-2009 and who had clinically relevant inhibitors and available data on joint bleeding, 157 had bleeding for at least 3 months. They were followed for a median of 26 months starting at age 16 months, and most had high titer inhibitors (52% had titers of 5-199 BU, and 32% had titers greater than 200 BU).
The bleeding rates in 12 patients without ITI who were on prophylaxis were similar to those in 89 such patients without prophylaxis (0.3 and 0.4 bleeds/month, respectively); no significant difference was seen between the groups based on inhibitor titer, Dr. Fischer of University Medical Center Utrecht, The Netherlands reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Similarly, the bleeding rate during ITI among those on prophylaxis did not differ significantly from the rate in those without prophylaxis (0.4 vs. 0.3/month, respectively), but the rate did increase significantly according to inhibitor titer: The rate increased from 0.05/month in the group with less than 5 BU, to 0.2/month in those with 5-199 BU, and to 0.5/month in the group with greater than 200 BU.
Further, while ITI dose did not affect bleeding, dosing frequency had a strong effect. The median rate with nondaily dosing in 36 patients vs. daily dosing in 63 patients was 0.4/month vs. 0.2/month, respectively, Dr. Fischer said.
She reported having no disclosures.
FROM EAHAD 2017
Key clinical point:
Major finding: Median bleeding rate with nondaily vs. daily ITI dosing was 0.4/month vs. 0.2/month, respectively.
Data source: An analysis of 218 patients from the PedNet registry.
Disclosures: Dr. Fischer reported having no disclosures.
Study: No link between vaccines, inhibitor development
The administration of pediatric vaccinations in close proximity to factor VIII (FVIII) exposure was not associated with inhibitor development in previously untreated patients with severe hemophilia A in the PedNet Registry.
Similarly, no association was seen between recurrent vaccinations and inhibitor development, Dr. van den Berg reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Inhibitor development in this patient population is a multifactorial event, but these findings show no association between vaccinations administered early in life and increased inhibitor risk, she concluded.
Dr. van den Berg received grant/research support from Bayer, Baxalta, Pfizer, CSI, and Grifols.
The administration of pediatric vaccinations in close proximity to factor VIII (FVIII) exposure was not associated with inhibitor development in previously untreated patients with severe hemophilia A in the PedNet Registry.
Similarly, no association was seen between recurrent vaccinations and inhibitor development, Dr. van den Berg reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Inhibitor development in this patient population is a multifactorial event, but these findings show no association between vaccinations administered early in life and increased inhibitor risk, she concluded.
Dr. van den Berg received grant/research support from Bayer, Baxalta, Pfizer, CSI, and Grifols.
The administration of pediatric vaccinations in close proximity to factor VIII (FVIII) exposure was not associated with inhibitor development in previously untreated patients with severe hemophilia A in the PedNet Registry.
Similarly, no association was seen between recurrent vaccinations and inhibitor development, Dr. van den Berg reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.
Inhibitor development in this patient population is a multifactorial event, but these findings show no association between vaccinations administered early in life and increased inhibitor risk, she concluded.
Dr. van den Berg received grant/research support from Bayer, Baxalta, Pfizer, CSI, and Grifols.
FROM EAHAD 2017
Key clinical point:
Major finding: The adjusted hazard ratio for any inhibitor development related to vaccinations in close proximity to FVIII was 0.65.
Data source: A review of data from 375 children in the PedNet Registry.
Disclosures: Dr. van den Berg received grant/research support from Bayer, Baxalta, Pfizer, CSI, and Grifols.
Biannual HCC ultrasound cost-effective, lifesaving in cirrhosis
Twice-yearly ultrasound screening for liver cancer increases survival an average of almost 5 months in cirrhosis patients and costs about $32,415 per life-year gained, according to new economic modeling.
“The overall gain in life expectancy might be considered modest,” but it’s “good by cancer screening standards.” The cost, meanwhile, is within the accepted threshold in the United States of $30,000-50,000 per life-year gained (LYG), said French investigators led by statistician Benjamin Cadier of the French National Institute of Health and Medical Research, Paris (Hepatology. 2017 Feb 8. doi:10.1002/hep.28961).
To estimate probabilities and costs for various scenarios, the team combined data from two large French cohorts – one of viral cirrhosis, another of HCC – with French and U.S. pricing data, among other information. French costs with biannual screening were far less, at $1,754 per LYG, because of a 4-10–fold difference in the price of surveillance and first-line curative treatment. The team estimated that 10-year overall survival was 67% with current monitoring practices, and 76% with biannual ultrasound.
The mean survival increase from 6.8 to 7.2 years was attributed to earlier detection, higher access to curative first-line treatment, and better treatment results. Radiofrequency ablation (RFA), as opposed to liver resection or transplant, provided the best value for the money. “Our results indicate that [guideline-directed] monitoring for patients with cirrhosis is cost-effective,” the team said.
“Later detection not only reduced the likelihood of curative treatment, but also increased the proportion of [liver transplants] among the curative treatments,” they said.
In the modeling, when biannual ultrasound surveillance detected a suspicious nodule, the recall policy included magnetic resonance imaging or computerized tomography, and liver biopsy, if needed, based on recent international guidelines, with subsequent treatment.
There was no outside funding for the work. The lead investigator had no conflicts. Other investigators were consultants for Bayer, General Electric, AbbVie, Janssen, Bristol-Meyer Squibb, Gilead, and other companies.
Twice-yearly ultrasound screening for liver cancer increases survival an average of almost 5 months in cirrhosis patients and costs about $32,415 per life-year gained, according to new economic modeling.
“The overall gain in life expectancy might be considered modest,” but it’s “good by cancer screening standards.” The cost, meanwhile, is within the accepted threshold in the United States of $30,000-50,000 per life-year gained (LYG), said French investigators led by statistician Benjamin Cadier of the French National Institute of Health and Medical Research, Paris (Hepatology. 2017 Feb 8. doi:10.1002/hep.28961).
To estimate probabilities and costs for various scenarios, the team combined data from two large French cohorts – one of viral cirrhosis, another of HCC – with French and U.S. pricing data, among other information. French costs with biannual screening were far less, at $1,754 per LYG, because of a 4-10–fold difference in the price of surveillance and first-line curative treatment. The team estimated that 10-year overall survival was 67% with current monitoring practices, and 76% with biannual ultrasound.
The mean survival increase from 6.8 to 7.2 years was attributed to earlier detection, higher access to curative first-line treatment, and better treatment results. Radiofrequency ablation (RFA), as opposed to liver resection or transplant, provided the best value for the money. “Our results indicate that [guideline-directed] monitoring for patients with cirrhosis is cost-effective,” the team said.
“Later detection not only reduced the likelihood of curative treatment, but also increased the proportion of [liver transplants] among the curative treatments,” they said.
In the modeling, when biannual ultrasound surveillance detected a suspicious nodule, the recall policy included magnetic resonance imaging or computerized tomography, and liver biopsy, if needed, based on recent international guidelines, with subsequent treatment.
There was no outside funding for the work. The lead investigator had no conflicts. Other investigators were consultants for Bayer, General Electric, AbbVie, Janssen, Bristol-Meyer Squibb, Gilead, and other companies.
Twice-yearly ultrasound screening for liver cancer increases survival an average of almost 5 months in cirrhosis patients and costs about $32,415 per life-year gained, according to new economic modeling.
“The overall gain in life expectancy might be considered modest,” but it’s “good by cancer screening standards.” The cost, meanwhile, is within the accepted threshold in the United States of $30,000-50,000 per life-year gained (LYG), said French investigators led by statistician Benjamin Cadier of the French National Institute of Health and Medical Research, Paris (Hepatology. 2017 Feb 8. doi:10.1002/hep.28961).
To estimate probabilities and costs for various scenarios, the team combined data from two large French cohorts – one of viral cirrhosis, another of HCC – with French and U.S. pricing data, among other information. French costs with biannual screening were far less, at $1,754 per LYG, because of a 4-10–fold difference in the price of surveillance and first-line curative treatment. The team estimated that 10-year overall survival was 67% with current monitoring practices, and 76% with biannual ultrasound.
The mean survival increase from 6.8 to 7.2 years was attributed to earlier detection, higher access to curative first-line treatment, and better treatment results. Radiofrequency ablation (RFA), as opposed to liver resection or transplant, provided the best value for the money. “Our results indicate that [guideline-directed] monitoring for patients with cirrhosis is cost-effective,” the team said.
“Later detection not only reduced the likelihood of curative treatment, but also increased the proportion of [liver transplants] among the curative treatments,” they said.
In the modeling, when biannual ultrasound surveillance detected a suspicious nodule, the recall policy included magnetic resonance imaging or computerized tomography, and liver biopsy, if needed, based on recent international guidelines, with subsequent treatment.
There was no outside funding for the work. The lead investigator had no conflicts. Other investigators were consultants for Bayer, General Electric, AbbVie, Janssen, Bristol-Meyer Squibb, Gilead, and other companies.
FROM HEPATOLOGY
Key clinical point:
Major finding: Twice-a-year ultrasound to catch liver cancer early increases survival an average of nearly 5 months in cirrhosis patients, and costs about $32,415 per life-year gained.
Data source: Economic modeling of two French cohorts.
Disclosures: There was no outside funding for the work. The lead investigator had no conflicts. Other investigators were consultants for Bayer, General Electric, AbbVie, Janssen, Bristol-Meyer Squibb, Gilead, and other companies.
Psoriatic arthritis raises diabetes risk
Psoriatic arthritis raises the risk of type 2 diabetes, and the risk correlates with higher disease activity, according to Canadian investigators.
They reviewed 1,065 patients free of diabetes when they entered treatment at the University of Toronto psoriatic arthritis (PsA) clinic during 1978-2014; 73 developed type 2 diabetes.
“This finding highlights the need to screen for DM [diabetes mellitis] in patients with PsA, especially in those with more active joint disease and elevated inflammatory markers. The control of inflammation may reduce the risk of developing DM,” said investigators led by Lihi Eder, MD, a research fellow at the University of Toronto (J Rheumatol. 2017 Feb 1; doi: 10.3899/jrheum.160861).
Psoriasis has been linked to diabetes before; the association with PsA, at least until now, has been less well supported.
Chronic inflammation could be part of the issue; it’s also been linked before to diabetes, independently of insulin resistance and obesity. More severe psoriasis, as indicated by higher Psoriasis Area and Severity Index scores, was associated with diabetes risk in the study, but fell out as an independent predictor after adjustment for obesity and other confounders.
Also, “part of the increased risk of cardiovascular in PsA may be attributed to the higher prevalence of DM, which was found in our study,” the investigators said.
Data about smoking, metabolic syndrome, and C-reactive protein weren’t routinely collected in the earlier years of the cohort, so could not be assessed. “It is possible that some of these variables could have modified the identified link between the extent of inflammation and DM risk,” they said.
Patients were 54 years old on average at baseline, and 56% were men. The mean duration of psoriasis at clinic presentation was 15.4 years, and of psoriatic arthritis 6.5 years. The mean duration of follow-up was 9.1 years.
Dr. Eder was supported by the Krembil Foundation and a Canadian Institutes of Health Research fellowship award.
Psoriatic arthritis raises the risk of type 2 diabetes, and the risk correlates with higher disease activity, according to Canadian investigators.
They reviewed 1,065 patients free of diabetes when they entered treatment at the University of Toronto psoriatic arthritis (PsA) clinic during 1978-2014; 73 developed type 2 diabetes.
“This finding highlights the need to screen for DM [diabetes mellitis] in patients with PsA, especially in those with more active joint disease and elevated inflammatory markers. The control of inflammation may reduce the risk of developing DM,” said investigators led by Lihi Eder, MD, a research fellow at the University of Toronto (J Rheumatol. 2017 Feb 1; doi: 10.3899/jrheum.160861).
Psoriasis has been linked to diabetes before; the association with PsA, at least until now, has been less well supported.
Chronic inflammation could be part of the issue; it’s also been linked before to diabetes, independently of insulin resistance and obesity. More severe psoriasis, as indicated by higher Psoriasis Area and Severity Index scores, was associated with diabetes risk in the study, but fell out as an independent predictor after adjustment for obesity and other confounders.
Also, “part of the increased risk of cardiovascular in PsA may be attributed to the higher prevalence of DM, which was found in our study,” the investigators said.
Data about smoking, metabolic syndrome, and C-reactive protein weren’t routinely collected in the earlier years of the cohort, so could not be assessed. “It is possible that some of these variables could have modified the identified link between the extent of inflammation and DM risk,” they said.
Patients were 54 years old on average at baseline, and 56% were men. The mean duration of psoriasis at clinic presentation was 15.4 years, and of psoriatic arthritis 6.5 years. The mean duration of follow-up was 9.1 years.
Dr. Eder was supported by the Krembil Foundation and a Canadian Institutes of Health Research fellowship award.
Psoriatic arthritis raises the risk of type 2 diabetes, and the risk correlates with higher disease activity, according to Canadian investigators.
They reviewed 1,065 patients free of diabetes when they entered treatment at the University of Toronto psoriatic arthritis (PsA) clinic during 1978-2014; 73 developed type 2 diabetes.
“This finding highlights the need to screen for DM [diabetes mellitis] in patients with PsA, especially in those with more active joint disease and elevated inflammatory markers. The control of inflammation may reduce the risk of developing DM,” said investigators led by Lihi Eder, MD, a research fellow at the University of Toronto (J Rheumatol. 2017 Feb 1; doi: 10.3899/jrheum.160861).
Psoriasis has been linked to diabetes before; the association with PsA, at least until now, has been less well supported.
Chronic inflammation could be part of the issue; it’s also been linked before to diabetes, independently of insulin resistance and obesity. More severe psoriasis, as indicated by higher Psoriasis Area and Severity Index scores, was associated with diabetes risk in the study, but fell out as an independent predictor after adjustment for obesity and other confounders.
Also, “part of the increased risk of cardiovascular in PsA may be attributed to the higher prevalence of DM, which was found in our study,” the investigators said.
Data about smoking, metabolic syndrome, and C-reactive protein weren’t routinely collected in the earlier years of the cohort, so could not be assessed. “It is possible that some of these variables could have modified the identified link between the extent of inflammation and DM risk,” they said.
Patients were 54 years old on average at baseline, and 56% were men. The mean duration of psoriasis at clinic presentation was 15.4 years, and of psoriatic arthritis 6.5 years. The mean duration of follow-up was 9.1 years.
Dr. Eder was supported by the Krembil Foundation and a Canadian Institutes of Health Research fellowship award.
FROM THE JOURNAL OF RHEUMATOLOGY
Key clinical point:
Major finding: Morning tender joint count (HR 1.53), morning erythrocyte sedimentation rate (HR 1.21), and body mass index (HR 1.09) significantly predicted diabetes.
Data source: A review of 1,065 patients free of diabetes when they entered treatment at the University of Toronto psoriatic arthritis (PsA) clinic during 1978-2014.
Disclosures: The lead investigator was supported by the Krembil Foundation and a Canadian Institutes of Health Research fellowship award.
New ACC guidance on periprocedural management of anticoagulation in A-fib falls short
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
In reviewing Dr. Estes’ comments on a consensus statement regarding anticoagulation bridging for patients with atrial fibrillation, the most important point is that there are minimal good data to support decision making; therefore, treatments need to be individualized to the patient. He provides a reasonable paradigm for his own decision making in these complex patients. Ultimately, until there is better evidence, the decision on whether to bridge or not to bridge patients’ anticoagulation will continue to be an individual choice based upon bleeding risk with the planned surgical procedure, potential for significant adverse outcomes if bleeding occurs, and the risk of stroke or other embolic phenomenon with cessation of anticoagulation.
Dr. Linda Harris is the division chief, vascular surgery, at the State University of New York at Buffalo and an associate editor of Vascular Specialist.
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
SNOWMASS, COLO. – The 2017 American College of Cardiology Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation is a dense, 28-page document filled with multicolored flow charts and six separate management algorithms. But this complex scheme is no substitute for practical clinical judgment and individualized decision making, N.A. Mark Estes, MD, said at the Annual Cardiovascular Conference at Snowmass.
The decision pathway attempts to guide physicians in making decisions about whether and how to interrupt anticoagulation or bridge with a parenteral agent such as low-molecular-weight heparin, and how to restart oral anticoagulation post-procedure (J Am Coll Cardiol. 2017 Jan 5; doi: 10.1016/j.jacc.2016.11.024).
The document defies concise summary. Dr. Estes chose instead to describe the approach he uses in clinical decision-making regarding anticoagulation in patients with atrial fibrillation undergoing invasive procedures. He relies upon three elements: stroke risk as assessed by CHA2DS2-VASc score; bleeding risk using the HAS-BLED score; and the inherent bleeding risk of the procedure itself.
“An important thing to remember is, any procedure done along the spinal cord or intracranially carries an extremely high risk of bleeding,” the cardiologist noted by way of example.
If a patient with atrial fibrillation has a CHA2DS2-VASc score of 2 or less, he doesn’t offer bridging regardless of the HAS-BLED score. If the stroke risk is high as defined by a CHA2DS2-VASc score of 7 or more, and the patient’s bleeding risk isn’t high, meaning the HAS-BLED score is less than 3, he seriously considers bridging, provided that the patient’s oral anticoagulant is warfarin.
“I don’t think at this point we should be bridging with the DOACs [the direct oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban]. All the available data on bridging with the DOACs indicates that it results in a high risk of bleeding with no reduction in risk of stroke,” Dr. Estes said.
The “vast majority” of patients with atrial fibrillation facing surgery have a CHA2DS2-VASc score of 3-7 and thus fall into a category where individualized consideration of the risks and benefits of bridging rules. The large, randomized, double-blind BRIDGE trial speaks to this population. In this study of atrial fibrillation patients on warfarin prior to their procedure, bridging with low-molecular-weight heparin resulted in an increased risk of major bleeding with no reduction in stroke risk compared with a temporary halt of warfarin with no bridging (N Engl J Med. 2015 Aug 27;373[9]:823-33).
“This is a no-brainer,” Dr. Estes said. “When you bridge, your patients bleed more, and you don’t reduce strokes.”
The real challenge is the type of patient who falls into what he called “the dilemma zone,” with a CHA2DS2-VASc score of 7 or more and a HAS-BLED score of 3 or higher, meaning they are at very high risk for both stroke and bleeding.
“I have a discussion with those patients. I usually do not bridge. I’m biased because of having done a lot more harm than good in bridging,” the cardiologist said.
Dr. Estes reported serving as a consultant to Boston Scientific, Medtronic, and St. Jude Medical.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
AHEAD studies establish bleed rate benchmarks
The findings from a large cohort study of patients with moderate and severe hemophilia A have supplied benchmarks that can be used in developing new treatments, Alessandro Gringeri, MD, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.*
More than 37% of 869 patients with moderate or severe hemophilia A who were on prophylaxis and who were enrolled in the noninterventional, prospective, long-term AHEAD international and German cohort studies experienced less than one bleed per year on average, and 50% had an annual bleed rate of less than two.
Furthermore, a median of 56% of those on prophylaxis had an annual joint bleed rate (AJBR) of less than one, and nearly 70% had an AJBR of less than two. Study subjects were enrolled from 22 countries at a mean age at screening of 23.4 years. Most (67%) had severe hemophilia A, and 79% were on prophylaxis, said Dr. Gringeri of Global Medical Affairs Hematology, Shire, Austria.
Among patients in the international arm and the German arm of the study, the median annual bleed rates, respectively, were 1.2 and 2.5 in year 1, 1.2 and 2.2 in year 2, and 1.9 in each arm in year 3. Median AJBRs were 0.9 in each arm in year 1, 0.9 and 0 in year 2, and 1.0 and 0.8 in year 3.
The data provide a valid benchmark for new products and therapeutic approaches, Dr. Gringeri concluded.
Dr. Gringeri is an employee of Shire.
CORRECTION 2/11/17: An earlier version of this article misstated the presenting author's name.
The findings from a large cohort study of patients with moderate and severe hemophilia A have supplied benchmarks that can be used in developing new treatments, Alessandro Gringeri, MD, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.*
More than 37% of 869 patients with moderate or severe hemophilia A who were on prophylaxis and who were enrolled in the noninterventional, prospective, long-term AHEAD international and German cohort studies experienced less than one bleed per year on average, and 50% had an annual bleed rate of less than two.
Furthermore, a median of 56% of those on prophylaxis had an annual joint bleed rate (AJBR) of less than one, and nearly 70% had an AJBR of less than two. Study subjects were enrolled from 22 countries at a mean age at screening of 23.4 years. Most (67%) had severe hemophilia A, and 79% were on prophylaxis, said Dr. Gringeri of Global Medical Affairs Hematology, Shire, Austria.
Among patients in the international arm and the German arm of the study, the median annual bleed rates, respectively, were 1.2 and 2.5 in year 1, 1.2 and 2.2 in year 2, and 1.9 in each arm in year 3. Median AJBRs were 0.9 in each arm in year 1, 0.9 and 0 in year 2, and 1.0 and 0.8 in year 3.
The data provide a valid benchmark for new products and therapeutic approaches, Dr. Gringeri concluded.
Dr. Gringeri is an employee of Shire.
CORRECTION 2/11/17: An earlier version of this article misstated the presenting author's name.
The findings from a large cohort study of patients with moderate and severe hemophilia A have supplied benchmarks that can be used in developing new treatments, Alessandro Gringeri, MD, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.*
More than 37% of 869 patients with moderate or severe hemophilia A who were on prophylaxis and who were enrolled in the noninterventional, prospective, long-term AHEAD international and German cohort studies experienced less than one bleed per year on average, and 50% had an annual bleed rate of less than two.
Furthermore, a median of 56% of those on prophylaxis had an annual joint bleed rate (AJBR) of less than one, and nearly 70% had an AJBR of less than two. Study subjects were enrolled from 22 countries at a mean age at screening of 23.4 years. Most (67%) had severe hemophilia A, and 79% were on prophylaxis, said Dr. Gringeri of Global Medical Affairs Hematology, Shire, Austria.
Among patients in the international arm and the German arm of the study, the median annual bleed rates, respectively, were 1.2 and 2.5 in year 1, 1.2 and 2.2 in year 2, and 1.9 in each arm in year 3. Median AJBRs were 0.9 in each arm in year 1, 0.9 and 0 in year 2, and 1.0 and 0.8 in year 3.
The data provide a valid benchmark for new products and therapeutic approaches, Dr. Gringeri concluded.
Dr. Gringeri is an employee of Shire.
CORRECTION 2/11/17: An earlier version of this article misstated the presenting author's name.
FROM EAHAD 2017
Key clinical point:
Major finding: 37% of hemophilia A patients on prophylaxis experienced less than one bleed per year on average.
Data source: The prospective long-term AHEAD cohort studies, including 869 patients.
Disclosures: Dr. Gringeri is an employee of Shire.
Consider plumes from laser hair removal a biohazard
The plume of burning hair occurring during laser hair removal should be considered a biohazard, reported Gary S. Chuang, MD, of Harvard Medical School, Boston and his coauthors.
Use of smoke evacuators, good ventilation, and respiratory protection are warranted, especially for health care workers exposed to the plume for extended periods, they said.
While the laser was treating the hair, the particle counters recorded a eightfold increase in ultrafine-particle concentrations, compared with ambient room baseline; this occurred even with a smoke evacuator within 5 cm of the procedure site. When a smoke evacuator was turned off for 30 seconds, the increase was 26-fold, Dr. Chuang and his associates reported.
Read more at JAMA Dermatology (2016;152[12]:1320-6).
The plume of burning hair occurring during laser hair removal should be considered a biohazard, reported Gary S. Chuang, MD, of Harvard Medical School, Boston and his coauthors.
Use of smoke evacuators, good ventilation, and respiratory protection are warranted, especially for health care workers exposed to the plume for extended periods, they said.
While the laser was treating the hair, the particle counters recorded a eightfold increase in ultrafine-particle concentrations, compared with ambient room baseline; this occurred even with a smoke evacuator within 5 cm of the procedure site. When a smoke evacuator was turned off for 30 seconds, the increase was 26-fold, Dr. Chuang and his associates reported.
Read more at JAMA Dermatology (2016;152[12]:1320-6).
The plume of burning hair occurring during laser hair removal should be considered a biohazard, reported Gary S. Chuang, MD, of Harvard Medical School, Boston and his coauthors.
Use of smoke evacuators, good ventilation, and respiratory protection are warranted, especially for health care workers exposed to the plume for extended periods, they said.
While the laser was treating the hair, the particle counters recorded a eightfold increase in ultrafine-particle concentrations, compared with ambient room baseline; this occurred even with a smoke evacuator within 5 cm of the procedure site. When a smoke evacuator was turned off for 30 seconds, the increase was 26-fold, Dr. Chuang and his associates reported.
Read more at JAMA Dermatology (2016;152[12]:1320-6).
FROM JAMA DERMATOLOGY
Picosecond alexandrite laser with lens modification effective for wrinkles
reported Robert A. Weiss, MD, of the MD Laser and Vein Institute, Baltimore, and his associates.
In a prospective, blinded study of perioral and periocular wrinkles in 40 healthy women (average age 58 years) who were nonsmokers, a 6-mm spot size diffractive lens array delivered a fluence of 0.71 J/cm2 at each focal point using 10-Hz pulse repetition at a pulse duration of 750 picoseconds. During each treatment, four passes of the 755-nm alexandrite laser (Picosure) for a total of 5,000 pulses were delivered. At 6 months follow-up, the mean Fitzpatrick wrinkle score had improved to 3.47 from the baseline average of 5.48 (P less than .05), with an overall average change in score of 1.97. Adverse events were mild, and all resolved, most within 24 hours (Lasers Surg Med. 2017 Jan;49[1]:40-44).
At 1 and 6 months, physician satisfaction ratings were 97.4% and 89.5% (extremely satisfied or satisfied), respectively. At 1 month, 42.1% of the patients were extremely satisfied, and 47.4% were satisfied. At 6 months, 42.1% were extremely likely to recommend the treatment, and 44.7% were likely to recommend the treatment.
The picosecond 755-nm alexandrite laser has been reported to be effective for tattoo removal, compared with the nanosecond domain lasers, they noted.
Dr. Weiss and a coauthor are consultants, researchers, and speakers for Cynosure, manufacturer of PicoSure. The other authors had no financial disclosures.
reported Robert A. Weiss, MD, of the MD Laser and Vein Institute, Baltimore, and his associates.
In a prospective, blinded study of perioral and periocular wrinkles in 40 healthy women (average age 58 years) who were nonsmokers, a 6-mm spot size diffractive lens array delivered a fluence of 0.71 J/cm2 at each focal point using 10-Hz pulse repetition at a pulse duration of 750 picoseconds. During each treatment, four passes of the 755-nm alexandrite laser (Picosure) for a total of 5,000 pulses were delivered. At 6 months follow-up, the mean Fitzpatrick wrinkle score had improved to 3.47 from the baseline average of 5.48 (P less than .05), with an overall average change in score of 1.97. Adverse events were mild, and all resolved, most within 24 hours (Lasers Surg Med. 2017 Jan;49[1]:40-44).
At 1 and 6 months, physician satisfaction ratings were 97.4% and 89.5% (extremely satisfied or satisfied), respectively. At 1 month, 42.1% of the patients were extremely satisfied, and 47.4% were satisfied. At 6 months, 42.1% were extremely likely to recommend the treatment, and 44.7% were likely to recommend the treatment.
The picosecond 755-nm alexandrite laser has been reported to be effective for tattoo removal, compared with the nanosecond domain lasers, they noted.
Dr. Weiss and a coauthor are consultants, researchers, and speakers for Cynosure, manufacturer of PicoSure. The other authors had no financial disclosures.
reported Robert A. Weiss, MD, of the MD Laser and Vein Institute, Baltimore, and his associates.
In a prospective, blinded study of perioral and periocular wrinkles in 40 healthy women (average age 58 years) who were nonsmokers, a 6-mm spot size diffractive lens array delivered a fluence of 0.71 J/cm2 at each focal point using 10-Hz pulse repetition at a pulse duration of 750 picoseconds. During each treatment, four passes of the 755-nm alexandrite laser (Picosure) for a total of 5,000 pulses were delivered. At 6 months follow-up, the mean Fitzpatrick wrinkle score had improved to 3.47 from the baseline average of 5.48 (P less than .05), with an overall average change in score of 1.97. Adverse events were mild, and all resolved, most within 24 hours (Lasers Surg Med. 2017 Jan;49[1]:40-44).
At 1 and 6 months, physician satisfaction ratings were 97.4% and 89.5% (extremely satisfied or satisfied), respectively. At 1 month, 42.1% of the patients were extremely satisfied, and 47.4% were satisfied. At 6 months, 42.1% were extremely likely to recommend the treatment, and 44.7% were likely to recommend the treatment.
The picosecond 755-nm alexandrite laser has been reported to be effective for tattoo removal, compared with the nanosecond domain lasers, they noted.
Dr. Weiss and a coauthor are consultants, researchers, and speakers for Cynosure, manufacturer of PicoSure. The other authors had no financial disclosures.
FROM LASERS IN SURGERY AND MEDICINE
Five quick ways HHS Secretary Tom Price could change the course of health policy
After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.
As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.
But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.
“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.
Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.
Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.
Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”
Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:
Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.
As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)
Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.
Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.
For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.
Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.
Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.
“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.
Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”
Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.
The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.
This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.
As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.
But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.
“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.
Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.
Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.
Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”
Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:
Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.
As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)
Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.
Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.
For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.
Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.
Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.
“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.
Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”
Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.
The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.
This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-47 vote.
As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.
But there is much more now within Price’s purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.
“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.
Price, a Georgia physician who opposes the Affordable Care Act, abortion, and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.
Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price’s nomination was announced.
Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: “I don’t know if I want to brainstorm bad ideas for him to do.”
Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:
Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in two separate Supreme Court rulings, one about private firms’ rights to make religious objections, and one about nonprofit religious hospitals and schools.
As secretary, Price would have two main options. He could expand the “accommodation” that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)
Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through postsurgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay, or cancel that project, since he “has been a critic in the past,” said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.
Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women’s health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.
For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary’s leadership.
Price could also throw the weight of the department into a probe into Planned Parenthood’s ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.
Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. “The core authority is statutory,” said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.
“The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner,” Myers said.
Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations, or other procedures that violated a “religious belief or moral conviction.”
Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don’t want to provide birth control to unmarried women, or HIV treatment to homosexuals.
The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump’s website before he was inaugurated and the page was taken down. “The Administration will act to protect individual conscience in health care,” it said. Many expect the rules to be reinstated in their original form.
This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Why like attracts like in malaria
Photo courtesy of CDC
Past research has shown that malaria-carrying mosquitoes prefer to feed on humans who are already infected with malaria.
Now, researchers believe they have discovered why.
The
team identified a naturally occurring compound, known as HMBPP, that is derived from the malaria parasite Plasmodium falciparum and
triggers the release of mosquito-attracting chemicals, making a human
host more enticing to the insects.
“The malaria parasite produces a molecule, HMBPP, which stimulates the human red blood cells to release more carbon dioxide and volatile compounds with an irresistible smell to malaria mosquitoes,” explained study author Ingrid Faye, of Stockholm University in Sweden.
She and her colleagues described this discovery in Science.
To determine if HMBPP could influence mosquitoes’ blood-meal-seeking and feeding behaviors, the researchers devised a “dual choice attraction” test for Anopheles gambiae mosquitoes.
Specifically, the team evaluated the mosquitoes’ preference to land on and feed off of an artificial membrane containing HMBPP-supplemented red blood cells (hmbRBCs) or normal red blood cells (RBCs).
More than 95% of the mosquitoes tested chose hmbRBCs over RBCs, and the mosquitoes consumed hmbRBCs more intensively and for longer periods of time than they did RBCs.
The researchers also found that blood spiked with HMBPP activated the expression of Plasmodium-specific genes involved in protecting the mosquitoes’ vital functions while also improving receptivity to infection and amplifying the likelihood of parasite transmission.
“This seems to be a well-functioning system, developed over millions of years, which means that the malaria parasite can survive and spread to more people without killing the host,” Faye said.
She and her colleagues believe the discovery of HMBPP as a driver of mosquito attraction exposes a weakness in Plasmodium that could be exploited to better pinpoint disease-carrying Anopheles gambiae mosquitoes and possibly prevent the spread of malaria. 
Photo courtesy of CDC
Past research has shown that malaria-carrying mosquitoes prefer to feed on humans who are already infected with malaria.
Now, researchers believe they have discovered why.
The
team identified a naturally occurring compound, known as HMBPP, that is derived from the malaria parasite Plasmodium falciparum and
triggers the release of mosquito-attracting chemicals, making a human
host more enticing to the insects.
“The malaria parasite produces a molecule, HMBPP, which stimulates the human red blood cells to release more carbon dioxide and volatile compounds with an irresistible smell to malaria mosquitoes,” explained study author Ingrid Faye, of Stockholm University in Sweden.
She and her colleagues described this discovery in Science.
To determine if HMBPP could influence mosquitoes’ blood-meal-seeking and feeding behaviors, the researchers devised a “dual choice attraction” test for Anopheles gambiae mosquitoes.
Specifically, the team evaluated the mosquitoes’ preference to land on and feed off of an artificial membrane containing HMBPP-supplemented red blood cells (hmbRBCs) or normal red blood cells (RBCs).
More than 95% of the mosquitoes tested chose hmbRBCs over RBCs, and the mosquitoes consumed hmbRBCs more intensively and for longer periods of time than they did RBCs.
The researchers also found that blood spiked with HMBPP activated the expression of Plasmodium-specific genes involved in protecting the mosquitoes’ vital functions while also improving receptivity to infection and amplifying the likelihood of parasite transmission.
“This seems to be a well-functioning system, developed over millions of years, which means that the malaria parasite can survive and spread to more people without killing the host,” Faye said.
She and her colleagues believe the discovery of HMBPP as a driver of mosquito attraction exposes a weakness in Plasmodium that could be exploited to better pinpoint disease-carrying Anopheles gambiae mosquitoes and possibly prevent the spread of malaria.
Photo courtesy of CDC
Past research has shown that malaria-carrying mosquitoes prefer to feed on humans who are already infected with malaria.
Now, researchers believe they have discovered why.
The
team identified a naturally occurring compound, known as HMBPP, that is derived from the malaria parasite Plasmodium falciparum and
triggers the release of mosquito-attracting chemicals, making a human
host more enticing to the insects.
“The malaria parasite produces a molecule, HMBPP, which stimulates the human red blood cells to release more carbon dioxide and volatile compounds with an irresistible smell to malaria mosquitoes,” explained study author Ingrid Faye, of Stockholm University in Sweden.
She and her colleagues described this discovery in Science.
To determine if HMBPP could influence mosquitoes’ blood-meal-seeking and feeding behaviors, the researchers devised a “dual choice attraction” test for Anopheles gambiae mosquitoes.
Specifically, the team evaluated the mosquitoes’ preference to land on and feed off of an artificial membrane containing HMBPP-supplemented red blood cells (hmbRBCs) or normal red blood cells (RBCs).
More than 95% of the mosquitoes tested chose hmbRBCs over RBCs, and the mosquitoes consumed hmbRBCs more intensively and for longer periods of time than they did RBCs.
The researchers also found that blood spiked with HMBPP activated the expression of Plasmodium-specific genes involved in protecting the mosquitoes’ vital functions while also improving receptivity to infection and amplifying the likelihood of parasite transmission.
“This seems to be a well-functioning system, developed over millions of years, which means that the malaria parasite can survive and spread to more people without killing the host,” Faye said.
She and her colleagues believe the discovery of HMBPP as a driver of mosquito attraction exposes a weakness in Plasmodium that could be exploited to better pinpoint disease-carrying Anopheles gambiae mosquitoes and possibly prevent the spread of malaria.