ACS Surgery News

TUCSON, ARIZ. – Following pelvic floor surgery, patients regard failure to achieve functional goals as severe adverse events, according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.

Alexander Raths/Fotolia

“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.

The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.

The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.

Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”

Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.

Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.

At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”

Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.

The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.

SOURCE: McGuire B et al. SGS 2019, Abstract 01.

TUCSON, ARIZ. – Following pelvic floor surgery, patients regard failure to achieve functional goals as severe adverse events, according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.

Alexander Raths/Fotolia

“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.

The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.

The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.

Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”

Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.

Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.

At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”

Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.

The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.

SOURCE: McGuire B et al. SGS 2019, Abstract 01.

TUCSON, ARIZ. – Following pelvic floor surgery, patients regard failure to achieve functional goals as severe adverse events, according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.

Alexander Raths/Fotolia

“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.

The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.

The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.

Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”

Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.

Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.

At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”

Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.

The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.

SOURCE: McGuire B et al. SGS 2019, Abstract 01.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.

WASHINGTON –Anticipating two pivotal trials scheduled for presentation at the 2019 annual meeting of the American College of Cardiology (ACC), an investigator-led study of transaortic valve replacement (TAVR) for aortic stenosis presented as a latebreaker at 2019 CRT meeting produced excellent results.

Ted Bosworth/MDedge News

Not least impressive, “our mortality rates are the lowest ever reported in any TAVR study at one year,” said Ronald Waksman, MD, Associate Director, Division of Cardiology, Medstar Heart Institute, Washington, DC.

In a population of patients with a median age of 71.1 years, all-cause mortality was just 3% at one year while the rate of deaths due to cardiovascular causes was only 1%, according to results of the 200-patient Low Risk TAVR study (LRT 1.0, NCT02628899) that Dr. Waksman presented.

In addition, there were low rates at one year for stroke (2.1%, none of which was deemed disability), myocardial infarction (1%), new onset atrial fibrillation (6.2%), and pacemaker placement (7.3%). The rate of rehospitalization for any cause was 20.4% but only 3.1% were considered related to TAVR. Rehospitalization for any cardiovascular cause at one year occurred in 6.8%.

Although leaflet thickening was observed at one year with imaging in 14%, this has not had any identifiable clinical consequences so far, and hemodynamics have remained stable, according to Dr. Waksman, who presented the interim 30-day outcomes at the 2018 CRT meeting.

These findings are raising expectations for two phase 3 TAVR trials in low-risk patients that are being presented as latebreakers at the 2019 ACC annual meeting. Both are large randomized trials comparing TAVR to surgical aortic valve replacement (SAVR) in low risk patients. Each trial is testing a single type of value and is funded by the valve manufacturers.

In the PARTNER-3 trial, patients randomized to TAVR received the Sapien 3 valve (Edwards Lifesciences). In the other latebreaking trial, patients randomized to TAVR received an Evolut valve (Medtronic Cardiovascular). Both are comparing TAVR to SAVR with a composite primary outcome that includes mortality and stroke measured at 30 days and one year.

In contrast to these trials, LRT 1.0 was conducted with no funding from a third party, according to Dr. Waksman. The eleven centers participated in the study at their own cost. Also, the choice of TAVR device was left to the discretion of the interventional cardiologist. Finally, most of the participating centers, although experienced in TAVR, did not have a high-volume case load. In general, with the exception of Dr. Waksman’s center, most performed 100 to 150 TAVRs per year.

“We were struck by the excellence of the performance of these sites,” said Dr. Waksman, noting that a comparison of outcomes at his center relative to the lower volume centers showed no significant differences in outcome.

This real-world experience raises the bar for the pivotal phase 3 trials, which, if positive, are expected to lead the FDA to grant an indication for TAVR in low-risk patients, according to Dr. Waksman. He announced that an LRT 2.0 trial, which will again include centers performing TAVRs at moderate volumes, is now enrolling.

SOURCE: 2019 Cardiovascular Research Technologies (CRT) Meeting.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

Hemodynamic complications of arteriovenous (AV) access are uncommon but can be potentially life threatening. Fistulas and grafts can cause a decrease in systemic vascular resistance and secondary increase in cardiac output in patients who may already have myocardial dysfunction secondary to their end-stage renal disease.¹ This increased cardiac output is usually insignificant but in rare cases can result in clinically significant cardiac failure. Patients with high-output fistulas with volume flow greater than 2 L/min may be at increased risk of heart failure but volume flow less than 2 L/min does not preclude this complication.²

In patients with AV access–related heart failure, optimal medical management and reduction of fistula flow or ligation of the dialysis access should be considered. If continued hemodialysis is necessary, loss of a functioning dialysis access is problematic and difficult management decisions must be made. Following successful renal transplantation, ligation of vascular access in the presence of symptomatic heart failure may represent a straightforward decision. Nonetheless, there is no clear consensus of how to manage patent fistulas or grafts in patients following renal transplantation in the absence of significant cardiac symptoms with particular concern to the important issues of transplant survival and long-term cardiac prognosis. Yaffe and Greenstein³ recommend preservation of almost all fistulas after transplantation in the absence of significant complications such as venous hypertension, pseudoaneurysm, significant high-output cardiac failure or hand ischemia. They recommend taking into account the 10-year adjusted renal transplantation graft survival rates and the relative paucity of donors, recognizing the possibility that the patient may have to return to dialysis at some point in the future. They also reference the lack of information regarding the beneficial impact of fistula ligation on cardiac morphology and function as a rationale for access preservation.

A recent presentation at the American Heart Association Scientific Sessions by Michael B. Stokes, MD,⁴ from the department of cardiology at Royal Adelaide Hospital in Australia, suggests that cardiovascular disease is responsible for 40% of deaths among kidney transplant recipients and that left ventricular (LV) mass is strongly associated with cardiovascular mortality.

He states that, although there is no guideline consensus on the management of an AV fistula following successful renal transplantation, the fistula continues to contribute adversely to cardiac remodeling and function. The lack of previous randomized controlled trials in this area led Dr. Stokes and his colleagues to randomly assign 64 patients at least 1 year following successful kidney transplantation with stable renal function and a functioning AV fistula to either fistula ligation or no intervention. All patients underwent cardiac MRI at baseline and 6 months.

The primary endpoint of decrease in LV mass at 6 months was significant in the ligation group but not in the control group. The ligation group also had significant decrease in LV end diastolic volume, LV end systolic volume, and multiple other parameters. In addition, NT-proBNP levels and left atrial volume were significantly reduced in the ligation group when compared with the control group. Complications in the ligation group included six patients with thrombosis of their fistula vein and two infections, all of which resolved with outpatient anti-inflammatory or antimicrobial therapy.

Dr. Stokes believes that control patients in his study face “persisting and substantial deleterious cardiac remodeling” and that “further investigation would clarify the impact of AV fistula ligation on clinical outcomes following kidney transplantation.”

I believe this is important information and represents the first randomized controlled data regarding the long-term adverse cardiac effects of a patent fistula after renal transplantation. Unfortunately, information regarding baseline fistula volume flow is not provided in this abstract. As discussed earlier, patients with high-flow fistulas may be at increased risk of heart failure and hemodynamic data can be critical in establishing an algorithm for managing these challenging patients.

Ligation of a functioning and asymptomatic access in a patient with a successful renal transplant should be recommended only after informed discussion with the patient weighing the ongoing potential negative effects on cardiac function of continued access patency versus the potential need for future hemodialysis. Dr. Stokes presents interesting data that must be considered in this controversy. I believe that, in the absence of a universally applicable algorithm, the clinical decision to recommend AV fistula ligation after successful kidney transplantation should be individualized and based on ongoing assessment of cardiac and renal function and fistula complications and hemodynamics.

References

1. Eur Heart J 2017;38:1913-23.

2. Nephrol Dial Transplant 2008;23:282-7.

3. J Vasc Access 2012;13:405-8.

4. Stokes MB, et al. LBS.05 – Late Breaking Clinical Trial: Hot News in HF. Presented at American Heart Association Scientific Sessions. 2018 Nov 10-12. Chicago.
 

Larry A. Scher, MD, is a vascular surgeon at the Montefiore Greene Medical Arts Pavilion, New York, and an associate medical editor for Vascular Specialist.

The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.

pandpstock001/Thinktock

The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”

“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”

The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.

“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”

The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.

Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”

Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”

gtwachtman@mdedge.com

The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.

pandpstock001/Thinktock

The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”

“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”

The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.

“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”

The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.

Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”

Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”

gtwachtman@mdedge.com

The Office of the National Coordinator of Health Information Technology is looking to adopt standardized application programming interfaces (APIs) in an effort to boost interoperability of health data.

pandpstock001/Thinktock

The Department of Health & Human Services office posted a proposed rule Feb. 11, 2019, that would, according to an agency press release, “help allow individuals to securely and easily access structured and unstructured EHI [electronic health information] formats using smartphones and other mobile devices.”

“We think our rule is going to help reduce burden and improve care,” Michael Lipinski, director of the Regulatory Affairs Division in the ONC Office of Policy, said in an interview. “It is going to do that through technology. With the APIs, you should be able to get to your information easier and have it readily available. Whether that is from another health care provider or using other health care products through the API to improve care, you will have that ability between the certified API and the information blocking policies to use third party developers and their products.”

The proposed rule also included a requirement that EHRs certified by ONC be able to easily export information contained within the EHR and make the format used to extract and export the data contained within the EHR publicly available.

“Another third party developer can build to that and offer competing services to pull that information out,” Mr. Lipinski said. “That would obviously help if you were choosing to switch [EHRs] if you didn’t like the features you were getting from your EHR. ... That functionality should help if you want to do that.”

The standardizing of APIs to help the delivery of data will go hand in hand with information blocking aspects of the proposed rule, which defines the few exceptions where an activity would not be considered information blocking, such as when engaging in practices will prevent patient harm; engaging in consistent, nondiscriminatory practices to protect patient privacy; and implementing practices to promote the security of health information.

Mr. Lipinski said these changes will help prevent providers from hiding behind HIPAA rules as the excuse to not share patient information, which will help with care coordination. “From a provider’s perspective, this should help them get more access to information, more access in a structured way and then easily get and share that information.”

Ultimately, Mr. Lipinski said, the goal is “to increase competition and lower cost while still improving the quality of care for patients.”

gtwachtman@mdedge.com

LONDON – Female investigators are less likely to secure research funding than male investigators, not because their proposed project is of lesser scientific merit, but simply because they are women, according to research published in The Lancet.

Sara Freeman/MDedge News

Women had a 30% lower chance of success in getting funding for a project than did their male counterparts when the caliber of the principal investigator was considered as an explicit part of the grant application process, with an 8.8% probability of getting funded versus 12.7%, respectively. If the application was considered solely on a project basis, however, the gender bias was less (12.1% vs. 12.9%).

The overall success of grant applications was 15.8% in the analysis, which considered almost 24,000 grant applications from more than 7,000 principal investigators submitted to the Canadian Institutes of Health Research (CIHR) between 2011 and 2016.

“I see our study as basically one good thwack in a long game of whack-a-mole,” lead study author Holly O. Witteman, PhD, said during an event to launch a special edition of The Lancet focusing on advancing women in science, medicine, and global health.

Dr. Witteman’s research is one of three original articles included in the thematic issue that brings together female authors and commentators to look at gender equity and what needs to be done to address imbalances. The issue is the result of a call for papers that led to more than 300 submissions from more than 40 countries and, according to an editorial from The Lancet, highlights that gender equity in medicine “is not only a matter of justice and rights, it is crucial for producing the best research and providing the best care to patients.”

That there are discrepancies in research funding awarded to female and male investigators has been known for years, Dr. Witteman, associate professor of family and emergency medicine at Laval University, Quebec City, said at the London press conference. To learn how and why, a “quasiexperimental” approach was used to find out what factors might be influencing the gender gap.

“Women are scored lower for competence compared to men with the same publication record,” she said. It’s not that they publish less or do easier research, or that the quality is lower, they are just viewed less favorably overall throughout their careers. Even when you control for confounding factors, “they still don’t advance as quickly,” she said.

“It had been documented for a while that, overall, women tend to get less grant funding and there hasn’t been any evidence to show either way if maybe women’s grant applications weren’t as good,” Dr. Witteman explained.

In 2014, the CIHR changed the way it funded research projects, creating a “natural experiment.” Two new grant application programs were put in place which largely differed by whether or not an explicit review of the principal investigator and their ability to conduct the research was included.

Adjusting for age and type of research, Dr. Witteman and her coauthors found that there was little difference in the success of women in securing research funding when their grant applications were judged solely on a scientific basis; however, when the focus was placed on the principal investigator, women were disadvantaged.

Dr. Witteman said that “this provides robust evidence in support of the idea that women write equally good grant applications but aren’t evaluated as being equally good scientists.”

So how to redress the balance? Dr. Witteman suggested that one way was for funders to collect robust evidence on the success of grant applications and be transparent who is getting funded and how much funding is being awarded. Institutions should invest in and support young investigators, distributing power and flattening traditionally male-led hierarchies. Salaries should be aligned and research support evened out, she said.

SOURCE: Witteman HO et al. Lancet. 2019. doi: 10.1016/S0140-6736(18)32611-4

LONDON – Female investigators are less likely to secure research funding than male investigators, not because their proposed project is of lesser scientific merit, but simply because they are women, according to research published in The Lancet.

Sara Freeman/MDedge News

Women had a 30% lower chance of success in getting funding for a project than did their male counterparts when the caliber of the principal investigator was considered as an explicit part of the grant application process, with an 8.8% probability of getting funded versus 12.7%, respectively. If the application was considered solely on a project basis, however, the gender bias was less (12.1% vs. 12.9%).

The overall success of grant applications was 15.8% in the analysis, which considered almost 24,000 grant applications from more than 7,000 principal investigators submitted to the Canadian Institutes of Health Research (CIHR) between 2011 and 2016.

“I see our study as basically one good thwack in a long game of whack-a-mole,” lead study author Holly O. Witteman, PhD, said during an event to launch a special edition of The Lancet focusing on advancing women in science, medicine, and global health.

Dr. Witteman’s research is one of three original articles included in the thematic issue that brings together female authors and commentators to look at gender equity and what needs to be done to address imbalances. The issue is the result of a call for papers that led to more than 300 submissions from more than 40 countries and, according to an editorial from The Lancet, highlights that gender equity in medicine “is not only a matter of justice and rights, it is crucial for producing the best research and providing the best care to patients.”

That there are discrepancies in research funding awarded to female and male investigators has been known for years, Dr. Witteman, associate professor of family and emergency medicine at Laval University, Quebec City, said at the London press conference. To learn how and why, a “quasiexperimental” approach was used to find out what factors might be influencing the gender gap.

“Women are scored lower for competence compared to men with the same publication record,” she said. It’s not that they publish less or do easier research, or that the quality is lower, they are just viewed less favorably overall throughout their careers. Even when you control for confounding factors, “they still don’t advance as quickly,” she said.

“It had been documented for a while that, overall, women tend to get less grant funding and there hasn’t been any evidence to show either way if maybe women’s grant applications weren’t as good,” Dr. Witteman explained.

In 2014, the CIHR changed the way it funded research projects, creating a “natural experiment.” Two new grant application programs were put in place which largely differed by whether or not an explicit review of the principal investigator and their ability to conduct the research was included.

Adjusting for age and type of research, Dr. Witteman and her coauthors found that there was little difference in the success of women in securing research funding when their grant applications were judged solely on a scientific basis; however, when the focus was placed on the principal investigator, women were disadvantaged.

Dr. Witteman said that “this provides robust evidence in support of the idea that women write equally good grant applications but aren’t evaluated as being equally good scientists.”

So how to redress the balance? Dr. Witteman suggested that one way was for funders to collect robust evidence on the success of grant applications and be transparent who is getting funded and how much funding is being awarded. Institutions should invest in and support young investigators, distributing power and flattening traditionally male-led hierarchies. Salaries should be aligned and research support evened out, she said.

SOURCE: Witteman HO et al. Lancet. 2019. doi: 10.1016/S0140-6736(18)32611-4

LONDON – Female investigators are less likely to secure research funding than male investigators, not because their proposed project is of lesser scientific merit, but simply because they are women, according to research published in The Lancet.

Sara Freeman/MDedge News

Women had a 30% lower chance of success in getting funding for a project than did their male counterparts when the caliber of the principal investigator was considered as an explicit part of the grant application process, with an 8.8% probability of getting funded versus 12.7%, respectively. If the application was considered solely on a project basis, however, the gender bias was less (12.1% vs. 12.9%).

The overall success of grant applications was 15.8% in the analysis, which considered almost 24,000 grant applications from more than 7,000 principal investigators submitted to the Canadian Institutes of Health Research (CIHR) between 2011 and 2016.

“I see our study as basically one good thwack in a long game of whack-a-mole,” lead study author Holly O. Witteman, PhD, said during an event to launch a special edition of The Lancet focusing on advancing women in science, medicine, and global health.

Dr. Witteman’s research is one of three original articles included in the thematic issue that brings together female authors and commentators to look at gender equity and what needs to be done to address imbalances. The issue is the result of a call for papers that led to more than 300 submissions from more than 40 countries and, according to an editorial from The Lancet, highlights that gender equity in medicine “is not only a matter of justice and rights, it is crucial for producing the best research and providing the best care to patients.”

That there are discrepancies in research funding awarded to female and male investigators has been known for years, Dr. Witteman, associate professor of family and emergency medicine at Laval University, Quebec City, said at the London press conference. To learn how and why, a “quasiexperimental” approach was used to find out what factors might be influencing the gender gap.

“Women are scored lower for competence compared to men with the same publication record,” she said. It’s not that they publish less or do easier research, or that the quality is lower, they are just viewed less favorably overall throughout their careers. Even when you control for confounding factors, “they still don’t advance as quickly,” she said.

“It had been documented for a while that, overall, women tend to get less grant funding and there hasn’t been any evidence to show either way if maybe women’s grant applications weren’t as good,” Dr. Witteman explained.

In 2014, the CIHR changed the way it funded research projects, creating a “natural experiment.” Two new grant application programs were put in place which largely differed by whether or not an explicit review of the principal investigator and their ability to conduct the research was included.

Adjusting for age and type of research, Dr. Witteman and her coauthors found that there was little difference in the success of women in securing research funding when their grant applications were judged solely on a scientific basis; however, when the focus was placed on the principal investigator, women were disadvantaged.

Dr. Witteman said that “this provides robust evidence in support of the idea that women write equally good grant applications but aren’t evaluated as being equally good scientists.”

So how to redress the balance? Dr. Witteman suggested that one way was for funders to collect robust evidence on the success of grant applications and be transparent who is getting funded and how much funding is being awarded. Institutions should invest in and support young investigators, distributing power and flattening traditionally male-led hierarchies. Salaries should be aligned and research support evened out, she said.

SOURCE: Witteman HO et al. Lancet. 2019. doi: 10.1016/S0140-6736(18)32611-4

CORONADO, CALIF. – Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

dbrunk@mdedge.com

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

CORONADO, CALIF. – Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

dbrunk@mdedge.com

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

CORONADO, CALIF. – Head and neck mucinous adenocarcinoma is commonly diagnosed at a low tumor stage with no nodal involvement but with the potential for distant metastases.

The findings come from the largest study of its kind to date, which was presented by Neel R. Sangal at the Triological Society’s Combined Sections Meeting.

“Mucinous carcinoma was previously classified as colloid carcinoma, which leads to increased confusion in the nomenclature,” said Mr. Sangal, a 4th-year student at New Jersey Medical School, Newark.

“This changed in the 1980s, which led to difficulty in characterizing the disease over time. This histology is well studied in the GI system, in the lungs, and in the breast, but the head and neck presentation is extremely rare, and it lacks comprehensive study.

“It commonly presents as a slow-growing, painless, nonulcerated nodule. From case reports, it’s typically low-grade and indolent, but it commonly recurs, and it does have metastatic potential,” he said. “Histologically, it’s characterized by nets of aggressive epithelial cells that are accompanied by significant extracellular mucin.”

In an effort to understand the demographic, clinicopathologic, treatment, and survival characteristics of mucinous adenocarcinoma, the researchers evaluated cases from the Surveillance, Epidemiology, and End Results Program (SEER) database between 1973 and 2014. They selected patients based on their International Classification of Diseases morphological code specific for mucinous adenocarcinoma and ICD primary site code consistent for cancers of the head and neck.

In all, 583 cases met criteria, “which highlights how rare this disease is,” Mr. Sangal said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

The mean age at diagnosis was 64.8 years; 55.2% of cases were male, 64.5% were white, 15.4% were black, 8.7% were Hispanic, 6.7% were Asian, and the remaining 5% were from other ethnicities. The four most frequent primary sites were the eyelid (29.8%), followed by skin of the face (22.6%), skin of the scalp and neck (12.2%), and the parotid gland (8.7%). Most of the lesions lacked nodal involvement and metastasis (94.1% and 96.2%, respectively). Histology presented mainly at lower stages. Specifically, 68% had T0-1 disease, 21.5% had T2-3 disease, and 10.5% had T4 disease.

When the researchers stratified treatment frequency by various clinical pathologic characteristics, they found large differences in the type of treatment received by the primary site. “Those on the salivary gland tended to receive radiation at a much higher percentage than those of the skin, which mostly received surgery alone,” Mr. Sangal said. “We also found a linear correlation between T stage and increased use of radiation alongside surgery. Similarly, those with nodal involvement and distant metastasis had increased rates of radiation with surgery.”

Disease-specific survival and overall survival rates were 92.2% and 80.5%, respectively. Advanced age at diagnosis was a significant predictor of survival. In addition, Hispanics had the highest rates of survival, while the white and black patients had similar survival curves. “Tumors of the parotid gland had significantly worse survival outcomes than those of the skin,” Mr. Sangal added. “We also found a linear correlation between T stage and survival. Similarly, those with nodal involvement and distant metastasis also had decreased survival.”

He acknowledged certain limitations of the study, including the potential for inconsistent coding in the SEER database.

Samer T. Elsamna was lead author on the study. None of the researchers reported having financial disclosures.

dbrunk@mdedge.com

SOURCE: Elsamna ST et al. Triological CSM 2019, Abstracts.

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

dbrunk@mdedge.com

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

dbrunk@mdedge.com

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

dbrunk@mdedge.com

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.

Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.

As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.

In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.

The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.

Since 2011, research has offered new perspective on the use of mesh in specific POP situations.

“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”

She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).

In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).

In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”

She focused much of her presentation on sacral colpopexy. According to Dr. Ridgeway, sacral colpopexy appears to result in lower rates of mesh complications, compared with transvaginal POP surgery with mesh.

“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”

She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.

In the interview, she offered these tips about the procedure:

• “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
• “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
• “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
• “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”

Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.

Global Academy and this news organization are owned by the same company.

LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.

Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.

As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.

In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.

The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.

Since 2011, research has offered new perspective on the use of mesh in specific POP situations.

“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”

She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).

In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).

In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”

She focused much of her presentation on sacral colpopexy. According to Dr. Ridgeway, sacral colpopexy appears to result in lower rates of mesh complications, compared with transvaginal POP surgery with mesh.

“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”

She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.

In the interview, she offered these tips about the procedure:

• “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
• “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
• “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
• “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”

Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.

Global Academy and this news organization are owned by the same company.

LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.

Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.

As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.

In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.

The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.

Since 2011, research has offered new perspective on the use of mesh in specific POP situations.

“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”

She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).

In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).

In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”

She focused much of her presentation on sacral colpopexy. According to Dr. Ridgeway, sacral colpopexy appears to result in lower rates of mesh complications, compared with transvaginal POP surgery with mesh.

“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”

She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.

In the interview, she offered these tips about the procedure:

• “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
• “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
• “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
• “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”

Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.

Global Academy and this news organization are owned by the same company.

HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.

Courtesy whitehouse.gov

Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”

Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.

Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.

The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.

Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.

A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.

President Trump called for similar efforts to address pediatric cancer.

“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”

President Trump also asked Congress to legislate a prohibition of late-term abortion.

“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”

He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.

“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.

He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.

“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.

“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”

gtwachtman@mdedge.com

SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.

HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.

Courtesy whitehouse.gov

Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”

Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.

Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.

The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.

Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.

A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.

President Trump called for similar efforts to address pediatric cancer.

“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”

President Trump also asked Congress to legislate a prohibition of late-term abortion.

“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”

He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.

“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.

He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.

“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.

“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”

gtwachtman@mdedge.com

SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.

HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.

Courtesy whitehouse.gov

Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”

Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.

Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.

The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.

Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.

A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.

President Trump called for similar efforts to address pediatric cancer.

“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”

President Trump also asked Congress to legislate a prohibition of late-term abortion.

“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”

He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.

“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.

He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.

“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.

“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”

gtwachtman@mdedge.com

SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.