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Hand deformity happens early in children with dystrophic epidermolysis bullosa
London – A predictable course of hand contracture was seen in a U.K. study of children with recessive dystrophic epidermolysis bullosa (RDEB), with all children experiencing moderate or severe hand deformity by the age of 12 years.
This stark finding, reported at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), highlighted the importance of intervening early with surgical methods that aim to prevent the pseudosyndactyly, or “mitten” hand deformity, which is an unfortunate characteristic of the genetic skin condition.
The investigative team, from the plastic and reconstructive surgery department at Great Ormond Street Hospital for Children NHS Trust, London, presented data from a retrospective case review of 24 children who attended their specialist pediatric EB center between 2010 and 2019. Of these, seven children had surgery to release hand contractures.
A total of 250 hand assessments were made via the novel Assessment of the Component Hand Contractures in Epidermolysis Bullosa (ACE). The assessment provides a hand deformity grade (HDG) – none, mild, moderate, and severe –based on the typical contractures that are seen in RDEB, such as between the fingers (web space contractures), finger flexion contractures, and thumb adduction contractures.
Using the ACE tool, “we found four significant time points regarding hand contracture development,” Catherine Miller, one of the team’s occupational therapists, said during a poster presentation. At birth, none of the children had any signs of hand deformity, but by 2 years of age half had mild hand contracture. By age 6, all children had some form of hand deformity, Ms. Miller said, and by age 12 all had moderate to severe hand deformity, “so adding to the data that hand deformities really are inevitable.”
Other findings were that the thumb and finger web spaces were the first to contract, Ms. Miller said. “So they tend to develop earlier and progress relatively slowly.” By contrast the finger flexion contractures occurred later on, “but progress more relatively rapidly,” she observed.
“Our data are limited as not every child is included at every age, and out tool has not yet been validated,” Ms. Miller and team acknowledged in the poster. “We assume that hand contractures do not improve, and therefore have included operated hands (mean age 6 years) at their last preoperative HDG in order to represent older children and more advanced hand deformities.”
In an interview, Ms. Miller noted that families have a lot going on when their newborn is diagnosed with RDEB, so introducing the idea that there will be substantial hand deformities in the future “is a difficult conversation. We have to take that gently.”
There are nonsurgical approaches to keeping the hands open, such as “encouraging them to open their hands in play, daily stretches; we can make splints with a silicon substance and other thermoplastic materials,” Ms. Miller said.
Hand surgery is a ‘blunt tool’
“The primary problem, of course, is the dermal fibrosis that we see that creates scarring and secondary problems,” said Gill Smith, a plastic surgery consultant who works with Ms. Miller at the hospital.
“In an ideal world, you would bandage up [the children] so that they could never injure their hands, but then they couldn’t use them, they couldn’t grow properly, and they could not develop,” Ms. Smith said in an oral presentation about hand surgery in children with RDEB. “You do not want them to get to the secondary stage, because the secondary stage is a real problem – you get all these impairments of hand function – pseudosyndactyly, finger contraction, and first web contracture, and ending up in a ‘mitten’ hand.”
Surgery is a very “crude” and “blunt tool,” Ms. Smith emphasized. Prevention is key, and perhaps in the future gene therapy, mesenchymal stem cells, and the like will mean that there is less need for hand surgery, she intimated. Until then, there are some things that can be done surgically – such as wrapping the hands, using gloves to protect the skin, stretching out the web spaces of the palm, and using splints. “All of these things we are trying to improve all the time, and come up with new ideas.”
The question is when to intervene? Ms. Smith said that in any other type of hand surgery, particularly in children where growth and function might be affected, the aim would be to “go in early.” In children with RDEB, however, the timing is not so clear: “Should we be going in early, before secondary joint changes, before we get secondary tendon shortening?” Perhaps this would result in less complex surgery, she suggested, but “it is a really huge deal for families and for children. For the moment we are still only really doing it when there [are] quite significant functional difficulties.”
When it comes to the type of surgery done to release the hands, “everyone has variants on the release technique,” but none are known to be better than any other, Ms. Smith said. Surgical release deals with consequences of dermal fibrosis but also creates more fibrosis, she cautioned.
Effects of hand surgery do not last long
How long the surgery’s effect will last is “what everyone wants to know, and I don’t think anyone has found a really good answer. It is variable, but unfortunately it’s a lot shorter than we’d like,” said Ms. Smith.
Indeed, data in another poster presentation by Ms. Smith and colleagues showed that the situation can be ‘back to square one’ within just a couple of years. Of the seven patients who had surgery at a mean 7 years of age (range 6-10 years), “most had returned to their original total score by 2 years post surgery,” the team wrote. All children “were initially happy with both appearance and function after surgery” they added; however, “happiness gradually decreased with time as they lost function and their scores increased with recurrence of contracture.”
The team noted that “sometimes after surgery a different component of the hand contracture worsened but function was preserved.”
While the ACE tool used by the team has not yet been validated, they believe it to be “a systematic tool with a structured method of administration.” As such it can help with informed decision making, they believe, and it could be used with functional measures to see how hand contractures might be impacting hand function and quality of life.
The ACE tool can be downloaded for free from the GOSH website.
SOURCE: Jessop N et al. EB 2020. Posters 42 and 43; Smith G et al. Poster 63.
London – A predictable course of hand contracture was seen in a U.K. study of children with recessive dystrophic epidermolysis bullosa (RDEB), with all children experiencing moderate or severe hand deformity by the age of 12 years.
This stark finding, reported at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), highlighted the importance of intervening early with surgical methods that aim to prevent the pseudosyndactyly, or “mitten” hand deformity, which is an unfortunate characteristic of the genetic skin condition.
The investigative team, from the plastic and reconstructive surgery department at Great Ormond Street Hospital for Children NHS Trust, London, presented data from a retrospective case review of 24 children who attended their specialist pediatric EB center between 2010 and 2019. Of these, seven children had surgery to release hand contractures.
A total of 250 hand assessments were made via the novel Assessment of the Component Hand Contractures in Epidermolysis Bullosa (ACE). The assessment provides a hand deformity grade (HDG) – none, mild, moderate, and severe –based on the typical contractures that are seen in RDEB, such as between the fingers (web space contractures), finger flexion contractures, and thumb adduction contractures.
Using the ACE tool, “we found four significant time points regarding hand contracture development,” Catherine Miller, one of the team’s occupational therapists, said during a poster presentation. At birth, none of the children had any signs of hand deformity, but by 2 years of age half had mild hand contracture. By age 6, all children had some form of hand deformity, Ms. Miller said, and by age 12 all had moderate to severe hand deformity, “so adding to the data that hand deformities really are inevitable.”
Other findings were that the thumb and finger web spaces were the first to contract, Ms. Miller said. “So they tend to develop earlier and progress relatively slowly.” By contrast the finger flexion contractures occurred later on, “but progress more relatively rapidly,” she observed.
“Our data are limited as not every child is included at every age, and out tool has not yet been validated,” Ms. Miller and team acknowledged in the poster. “We assume that hand contractures do not improve, and therefore have included operated hands (mean age 6 years) at their last preoperative HDG in order to represent older children and more advanced hand deformities.”
In an interview, Ms. Miller noted that families have a lot going on when their newborn is diagnosed with RDEB, so introducing the idea that there will be substantial hand deformities in the future “is a difficult conversation. We have to take that gently.”
There are nonsurgical approaches to keeping the hands open, such as “encouraging them to open their hands in play, daily stretches; we can make splints with a silicon substance and other thermoplastic materials,” Ms. Miller said.
Hand surgery is a ‘blunt tool’
“The primary problem, of course, is the dermal fibrosis that we see that creates scarring and secondary problems,” said Gill Smith, a plastic surgery consultant who works with Ms. Miller at the hospital.
“In an ideal world, you would bandage up [the children] so that they could never injure their hands, but then they couldn’t use them, they couldn’t grow properly, and they could not develop,” Ms. Smith said in an oral presentation about hand surgery in children with RDEB. “You do not want them to get to the secondary stage, because the secondary stage is a real problem – you get all these impairments of hand function – pseudosyndactyly, finger contraction, and first web contracture, and ending up in a ‘mitten’ hand.”
Surgery is a very “crude” and “blunt tool,” Ms. Smith emphasized. Prevention is key, and perhaps in the future gene therapy, mesenchymal stem cells, and the like will mean that there is less need for hand surgery, she intimated. Until then, there are some things that can be done surgically – such as wrapping the hands, using gloves to protect the skin, stretching out the web spaces of the palm, and using splints. “All of these things we are trying to improve all the time, and come up with new ideas.”
The question is when to intervene? Ms. Smith said that in any other type of hand surgery, particularly in children where growth and function might be affected, the aim would be to “go in early.” In children with RDEB, however, the timing is not so clear: “Should we be going in early, before secondary joint changes, before we get secondary tendon shortening?” Perhaps this would result in less complex surgery, she suggested, but “it is a really huge deal for families and for children. For the moment we are still only really doing it when there [are] quite significant functional difficulties.”
When it comes to the type of surgery done to release the hands, “everyone has variants on the release technique,” but none are known to be better than any other, Ms. Smith said. Surgical release deals with consequences of dermal fibrosis but also creates more fibrosis, she cautioned.
Effects of hand surgery do not last long
How long the surgery’s effect will last is “what everyone wants to know, and I don’t think anyone has found a really good answer. It is variable, but unfortunately it’s a lot shorter than we’d like,” said Ms. Smith.
Indeed, data in another poster presentation by Ms. Smith and colleagues showed that the situation can be ‘back to square one’ within just a couple of years. Of the seven patients who had surgery at a mean 7 years of age (range 6-10 years), “most had returned to their original total score by 2 years post surgery,” the team wrote. All children “were initially happy with both appearance and function after surgery” they added; however, “happiness gradually decreased with time as they lost function and their scores increased with recurrence of contracture.”
The team noted that “sometimes after surgery a different component of the hand contracture worsened but function was preserved.”
While the ACE tool used by the team has not yet been validated, they believe it to be “a systematic tool with a structured method of administration.” As such it can help with informed decision making, they believe, and it could be used with functional measures to see how hand contractures might be impacting hand function and quality of life.
The ACE tool can be downloaded for free from the GOSH website.
SOURCE: Jessop N et al. EB 2020. Posters 42 and 43; Smith G et al. Poster 63.
London – A predictable course of hand contracture was seen in a U.K. study of children with recessive dystrophic epidermolysis bullosa (RDEB), with all children experiencing moderate or severe hand deformity by the age of 12 years.
This stark finding, reported at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA), highlighted the importance of intervening early with surgical methods that aim to prevent the pseudosyndactyly, or “mitten” hand deformity, which is an unfortunate characteristic of the genetic skin condition.
The investigative team, from the plastic and reconstructive surgery department at Great Ormond Street Hospital for Children NHS Trust, London, presented data from a retrospective case review of 24 children who attended their specialist pediatric EB center between 2010 and 2019. Of these, seven children had surgery to release hand contractures.
A total of 250 hand assessments were made via the novel Assessment of the Component Hand Contractures in Epidermolysis Bullosa (ACE). The assessment provides a hand deformity grade (HDG) – none, mild, moderate, and severe –based on the typical contractures that are seen in RDEB, such as between the fingers (web space contractures), finger flexion contractures, and thumb adduction contractures.
Using the ACE tool, “we found four significant time points regarding hand contracture development,” Catherine Miller, one of the team’s occupational therapists, said during a poster presentation. At birth, none of the children had any signs of hand deformity, but by 2 years of age half had mild hand contracture. By age 6, all children had some form of hand deformity, Ms. Miller said, and by age 12 all had moderate to severe hand deformity, “so adding to the data that hand deformities really are inevitable.”
Other findings were that the thumb and finger web spaces were the first to contract, Ms. Miller said. “So they tend to develop earlier and progress relatively slowly.” By contrast the finger flexion contractures occurred later on, “but progress more relatively rapidly,” she observed.
“Our data are limited as not every child is included at every age, and out tool has not yet been validated,” Ms. Miller and team acknowledged in the poster. “We assume that hand contractures do not improve, and therefore have included operated hands (mean age 6 years) at their last preoperative HDG in order to represent older children and more advanced hand deformities.”
In an interview, Ms. Miller noted that families have a lot going on when their newborn is diagnosed with RDEB, so introducing the idea that there will be substantial hand deformities in the future “is a difficult conversation. We have to take that gently.”
There are nonsurgical approaches to keeping the hands open, such as “encouraging them to open their hands in play, daily stretches; we can make splints with a silicon substance and other thermoplastic materials,” Ms. Miller said.
Hand surgery is a ‘blunt tool’
“The primary problem, of course, is the dermal fibrosis that we see that creates scarring and secondary problems,” said Gill Smith, a plastic surgery consultant who works with Ms. Miller at the hospital.
“In an ideal world, you would bandage up [the children] so that they could never injure their hands, but then they couldn’t use them, they couldn’t grow properly, and they could not develop,” Ms. Smith said in an oral presentation about hand surgery in children with RDEB. “You do not want them to get to the secondary stage, because the secondary stage is a real problem – you get all these impairments of hand function – pseudosyndactyly, finger contraction, and first web contracture, and ending up in a ‘mitten’ hand.”
Surgery is a very “crude” and “blunt tool,” Ms. Smith emphasized. Prevention is key, and perhaps in the future gene therapy, mesenchymal stem cells, and the like will mean that there is less need for hand surgery, she intimated. Until then, there are some things that can be done surgically – such as wrapping the hands, using gloves to protect the skin, stretching out the web spaces of the palm, and using splints. “All of these things we are trying to improve all the time, and come up with new ideas.”
The question is when to intervene? Ms. Smith said that in any other type of hand surgery, particularly in children where growth and function might be affected, the aim would be to “go in early.” In children with RDEB, however, the timing is not so clear: “Should we be going in early, before secondary joint changes, before we get secondary tendon shortening?” Perhaps this would result in less complex surgery, she suggested, but “it is a really huge deal for families and for children. For the moment we are still only really doing it when there [are] quite significant functional difficulties.”
When it comes to the type of surgery done to release the hands, “everyone has variants on the release technique,” but none are known to be better than any other, Ms. Smith said. Surgical release deals with consequences of dermal fibrosis but also creates more fibrosis, she cautioned.
Effects of hand surgery do not last long
How long the surgery’s effect will last is “what everyone wants to know, and I don’t think anyone has found a really good answer. It is variable, but unfortunately it’s a lot shorter than we’d like,” said Ms. Smith.
Indeed, data in another poster presentation by Ms. Smith and colleagues showed that the situation can be ‘back to square one’ within just a couple of years. Of the seven patients who had surgery at a mean 7 years of age (range 6-10 years), “most had returned to their original total score by 2 years post surgery,” the team wrote. All children “were initially happy with both appearance and function after surgery” they added; however, “happiness gradually decreased with time as they lost function and their scores increased with recurrence of contracture.”
The team noted that “sometimes after surgery a different component of the hand contracture worsened but function was preserved.”
While the ACE tool used by the team has not yet been validated, they believe it to be “a systematic tool with a structured method of administration.” As such it can help with informed decision making, they believe, and it could be used with functional measures to see how hand contractures might be impacting hand function and quality of life.
The ACE tool can be downloaded for free from the GOSH website.
SOURCE: Jessop N et al. EB 2020. Posters 42 and 43; Smith G et al. Poster 63.
REPORTING FROM EB 2020
Opioid use disorder up in sepsis hospitalizations
ORLANDO –
The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.
Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.
Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.
“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.
This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.
“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”
The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.
“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.
The retrospective study by Dr. Alrawashdeh and coinvestigators focused on electronic health record data for adults admitted to 373 hospitals in the United States between 2009 and 2015, including 375,479 who had sepsis.
Over time, there was a significant increase in the prevalence of OUD among those hospitalized for sepsis, from less than 2.0% in 2009 to more than 3% in 2015, representing a significant 77.3% increase. In general, the prevalence of sepsis was significantly higher among hospitalized patients with OUD compared with patients without the disorder, at 7.2% and 5.6%, respectively.
The sepsis patients with OUD tended to be younger, healthier, and more likely to be white compared with patients without OUD, according to the report. Moreover, the sepsis patients with OUD more often had endocarditis and gram-positive and fungal bloodstream infections. They also required more mechanical ventilation and had more ICU admissions, with longer stays in both the ICU and hospital.
The OUD patients accounted for 2.1% of sepsis-associated deaths overall, but 3.3% of those deaths in healthy patients, and 7.1% of deaths among younger patients, according to the report.
Those findings provide some clues that could help guide clinical practice, according to Dr. Martin. For example, the data show a nearly fivefold increased risk of endocarditis with OUD (3.9% versus 0.7%), which may inform screening practices.
“While we don’t necessarily screen every sepsis patient for endocarditis, if it’s an opioid use disorder patient – particularly one with a bloodstream infection – then that’s almost certainly something you should be doing,” Dr. Martin said.
The data suggest gram-positive bacterial and fungal infections will more likely be encountered among these patients, which could guide empiric treatment, he said.
Providers specializing in OUD should have a heightened awareness of the potential for infection and sepsis among those patients, and perhaps be more attuned to fever and other signs of infection that might warrant a referral or additional care, Dr. Martin added.
Dr. Alrawashdeh reported no disclosures related to the study.
SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.
ORLANDO –
The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.
Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.
Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.
“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.
This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.
“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”
The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.
“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.
The retrospective study by Dr. Alrawashdeh and coinvestigators focused on electronic health record data for adults admitted to 373 hospitals in the United States between 2009 and 2015, including 375,479 who had sepsis.
Over time, there was a significant increase in the prevalence of OUD among those hospitalized for sepsis, from less than 2.0% in 2009 to more than 3% in 2015, representing a significant 77.3% increase. In general, the prevalence of sepsis was significantly higher among hospitalized patients with OUD compared with patients without the disorder, at 7.2% and 5.6%, respectively.
The sepsis patients with OUD tended to be younger, healthier, and more likely to be white compared with patients without OUD, according to the report. Moreover, the sepsis patients with OUD more often had endocarditis and gram-positive and fungal bloodstream infections. They also required more mechanical ventilation and had more ICU admissions, with longer stays in both the ICU and hospital.
The OUD patients accounted for 2.1% of sepsis-associated deaths overall, but 3.3% of those deaths in healthy patients, and 7.1% of deaths among younger patients, according to the report.
Those findings provide some clues that could help guide clinical practice, according to Dr. Martin. For example, the data show a nearly fivefold increased risk of endocarditis with OUD (3.9% versus 0.7%), which may inform screening practices.
“While we don’t necessarily screen every sepsis patient for endocarditis, if it’s an opioid use disorder patient – particularly one with a bloodstream infection – then that’s almost certainly something you should be doing,” Dr. Martin said.
The data suggest gram-positive bacterial and fungal infections will more likely be encountered among these patients, which could guide empiric treatment, he said.
Providers specializing in OUD should have a heightened awareness of the potential for infection and sepsis among those patients, and perhaps be more attuned to fever and other signs of infection that might warrant a referral or additional care, Dr. Martin added.
Dr. Alrawashdeh reported no disclosures related to the study.
SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.
ORLANDO –
The prevalence of opioid use disorder (OUD) has significantly increased over the past 15 years, the analysis further shows.
Results of the study, presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine, further suggested that OUD disproportionately contributes to sepsis deaths in younger, healthier patients.
Together, these findings underscore the importance of ongoing efforts to address the opioid epidemic in the United States, according to researcher Mohammad Alrawashdeh, PhD, MSN, a postdoctoral research fellow with Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston.
“In addition to ongoing efforts to combat the opioid crisis, future public health interventions should focus on increasing awareness, recognition, and aggressive treatment of sepsis in this population,” Dr. Alrawashdeh said in an oral presentation of the study.
This study fills an important knowledge gap regarding the connection between OUD and sepsis, according to Greg S. Martin, MD, MS, FCCM, professor of medicine in pulmonary critical care at Emory University, Atlanta, and secretary for the Society of Critical Care Medicine.
“We’ve not really ever been able to piece together the relationship between opioid use disorders and sepsis,” Dr. Martin said in an interview. “It’s not that people wouldn’t suspect that there’s a connection – it’s more that we have simply not been able to get the kind of data that you can use, like they’ve done here, that really helps you to answer that question.”
The study suggests not only that OUD and sepsis are linked, Dr. Martin added, but that health care providers need to be prepared to potentially see further increases in the number of patients with OUD seen in the intensive care unit.
“Both of those are things that we certainly need to be aware of, both from the individual practitioner perspective and also the public health planning perspective,” he said.
The retrospective study by Dr. Alrawashdeh and coinvestigators focused on electronic health record data for adults admitted to 373 hospitals in the United States between 2009 and 2015, including 375,479 who had sepsis.
Over time, there was a significant increase in the prevalence of OUD among those hospitalized for sepsis, from less than 2.0% in 2009 to more than 3% in 2015, representing a significant 77.3% increase. In general, the prevalence of sepsis was significantly higher among hospitalized patients with OUD compared with patients without the disorder, at 7.2% and 5.6%, respectively.
The sepsis patients with OUD tended to be younger, healthier, and more likely to be white compared with patients without OUD, according to the report. Moreover, the sepsis patients with OUD more often had endocarditis and gram-positive and fungal bloodstream infections. They also required more mechanical ventilation and had more ICU admissions, with longer stays in both the ICU and hospital.
The OUD patients accounted for 2.1% of sepsis-associated deaths overall, but 3.3% of those deaths in healthy patients, and 7.1% of deaths among younger patients, according to the report.
Those findings provide some clues that could help guide clinical practice, according to Dr. Martin. For example, the data show a nearly fivefold increased risk of endocarditis with OUD (3.9% versus 0.7%), which may inform screening practices.
“While we don’t necessarily screen every sepsis patient for endocarditis, if it’s an opioid use disorder patient – particularly one with a bloodstream infection – then that’s almost certainly something you should be doing,” Dr. Martin said.
The data suggest gram-positive bacterial and fungal infections will more likely be encountered among these patients, which could guide empiric treatment, he said.
Providers specializing in OUD should have a heightened awareness of the potential for infection and sepsis among those patients, and perhaps be more attuned to fever and other signs of infection that might warrant a referral or additional care, Dr. Martin added.
Dr. Alrawashdeh reported no disclosures related to the study.
SOURCE: Alrawashdeh M et al. Crit Care Med. 2020 Jan;48(1):28. Abstract 56.
REPORTING FROM CCC49
Apalutamide benefit sustained in mCSPC regardless of next therapy
SAN FRANCISCO – , an exploratory analysis of the TITAN trial suggests.
Previous trial results for all 1,052 men randomized showed significant improvements in radiographic progression-free survival and overall survival from adding apalutamide versus placebo to androgen deprivation therapy (N Engl J Med. 2019;381:13-24), leading to recent Food and Drug Administration approval of the drug for metastatic castration-sensitive prostate cancer.
In the new analysis, investigators assessed progression-free survival 2 (PFS2), measured from time of randomization to investigator-determined disease progression or death, among the 277 men who went on to receive a subsequent life-prolonging therapy after progression on their trial therapy.
Results reported at the 2020 Genitourinary Cancers Symposium showed that the risk of PFS2 events was similarly reduced for patients who had initially received apalutamide vs. placebo regardless of whether their next therapy was a new hormonal therapy (32% reduction in risk) or a taxane (37% reduction in risk).
“The PFS2 benefit is an indicator of effective early intensification of treatment, is consistent with the overall survival benefit we have seen with this agent, and together shows totality of the treatment trajectory,” reported Neeraj Agarwal, MD, the study’s lead investigator. “These results may assist with counseling of patients with metastatic castration-sensitive prostate cancer who are contemplating various treatment options.”
The analysis was performed post hoc, and the subsequent therapy was left up to the treating clinicians, acknowledged Dr. Agarwal, professor of medicine and director of the genitourinary oncology program at the Huntsman Cancer Institute, University of Utah, Salt Lake City.
“A small number of events on subsequent therapy and the nonrandomized treatment decision preclude determination of best subsequent therapy based on these data,” he said. “We need further events and for data to mature more in order to pursue additional in-depth analysis.”
Some caveats
As only about a fifth of patients experienced PFS2 events, “these findings need to be interpreted with some caution,” said invited discussant Dana E. Rathkopf, MD, a genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York.
Another caveat is that the cohort analyzed comprised poor responders, who had experienced progression at a median of roughly 12 months whether on apalutamide or placebo, she noted. “If the patients were all on treatment for about 12 months, it does make me wonder why the apalutamide patients responded better than placebo patients to a second hormonal therapy, because you might think that, in the setting of poor response to upfront apalutamide, these patients may develop some type of intrinsic resistance that would suggest they would not respond to a second-line androgen receptor inhibitor relative to a taxane.”
Patients in TITAN were stratified on prior receipt of docetaxel before undergoing randomization. But simply by chance, among those receiving subsequent hormonal therapy, a larger share of those initially treated with apalutamide than of those initially treated with placebo had received the taxane (33% vs. 16%), which may have influenced outcomes, Dr. Rathkopf added.
“Further maturation of the data will tell us more,” she said. “But clearly, apalutamide in both the SPARTAN and TITAN trials improved PFS2 relative to placebo, and this begs the question of how we can better select treatment using predictive markers.”
Study details
Among the 277 men experiencing progression on their trial therapy and going on to receive a life-prolonging subsequent therapy, about 30% later received a new hormonal therapy – abiraterone or enzalutamide – and 35% subsequently received a taxane – docetaxel or cabazitaxel.
Overall, PFS2 was significantly better for men initially randomized to apalutamide, compared with counterparts initially randomized to placebo (hazard ratio for events, 0.66; P = .0026), Dr. Agarwal reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In stratified analyses, PFS2 was also significantly better with initial apalutamide vs. placebo whether patients went on to receive a new hormonal therapy (hazard ratio for events, 0.684; P = .0326) or taxane chemotherapy (hazard ratio for events, 0.634; P = .0062). Median values were not reached.
The trial was funded by Janssen Research & Development. Dr. Agarwal and Dr. Rathkopf each disclosed relationships with numerous pharmaceutical companies, including Janssen.
SOURCE: Agarwal N et al. GUCS 2020. Abstract 82.
SAN FRANCISCO – , an exploratory analysis of the TITAN trial suggests.
Previous trial results for all 1,052 men randomized showed significant improvements in radiographic progression-free survival and overall survival from adding apalutamide versus placebo to androgen deprivation therapy (N Engl J Med. 2019;381:13-24), leading to recent Food and Drug Administration approval of the drug for metastatic castration-sensitive prostate cancer.
In the new analysis, investigators assessed progression-free survival 2 (PFS2), measured from time of randomization to investigator-determined disease progression or death, among the 277 men who went on to receive a subsequent life-prolonging therapy after progression on their trial therapy.
Results reported at the 2020 Genitourinary Cancers Symposium showed that the risk of PFS2 events was similarly reduced for patients who had initially received apalutamide vs. placebo regardless of whether their next therapy was a new hormonal therapy (32% reduction in risk) or a taxane (37% reduction in risk).
“The PFS2 benefit is an indicator of effective early intensification of treatment, is consistent with the overall survival benefit we have seen with this agent, and together shows totality of the treatment trajectory,” reported Neeraj Agarwal, MD, the study’s lead investigator. “These results may assist with counseling of patients with metastatic castration-sensitive prostate cancer who are contemplating various treatment options.”
The analysis was performed post hoc, and the subsequent therapy was left up to the treating clinicians, acknowledged Dr. Agarwal, professor of medicine and director of the genitourinary oncology program at the Huntsman Cancer Institute, University of Utah, Salt Lake City.
“A small number of events on subsequent therapy and the nonrandomized treatment decision preclude determination of best subsequent therapy based on these data,” he said. “We need further events and for data to mature more in order to pursue additional in-depth analysis.”
Some caveats
As only about a fifth of patients experienced PFS2 events, “these findings need to be interpreted with some caution,” said invited discussant Dana E. Rathkopf, MD, a genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York.
Another caveat is that the cohort analyzed comprised poor responders, who had experienced progression at a median of roughly 12 months whether on apalutamide or placebo, she noted. “If the patients were all on treatment for about 12 months, it does make me wonder why the apalutamide patients responded better than placebo patients to a second hormonal therapy, because you might think that, in the setting of poor response to upfront apalutamide, these patients may develop some type of intrinsic resistance that would suggest they would not respond to a second-line androgen receptor inhibitor relative to a taxane.”
Patients in TITAN were stratified on prior receipt of docetaxel before undergoing randomization. But simply by chance, among those receiving subsequent hormonal therapy, a larger share of those initially treated with apalutamide than of those initially treated with placebo had received the taxane (33% vs. 16%), which may have influenced outcomes, Dr. Rathkopf added.
“Further maturation of the data will tell us more,” she said. “But clearly, apalutamide in both the SPARTAN and TITAN trials improved PFS2 relative to placebo, and this begs the question of how we can better select treatment using predictive markers.”
Study details
Among the 277 men experiencing progression on their trial therapy and going on to receive a life-prolonging subsequent therapy, about 30% later received a new hormonal therapy – abiraterone or enzalutamide – and 35% subsequently received a taxane – docetaxel or cabazitaxel.
Overall, PFS2 was significantly better for men initially randomized to apalutamide, compared with counterparts initially randomized to placebo (hazard ratio for events, 0.66; P = .0026), Dr. Agarwal reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In stratified analyses, PFS2 was also significantly better with initial apalutamide vs. placebo whether patients went on to receive a new hormonal therapy (hazard ratio for events, 0.684; P = .0326) or taxane chemotherapy (hazard ratio for events, 0.634; P = .0062). Median values were not reached.
The trial was funded by Janssen Research & Development. Dr. Agarwal and Dr. Rathkopf each disclosed relationships with numerous pharmaceutical companies, including Janssen.
SOURCE: Agarwal N et al. GUCS 2020. Abstract 82.
SAN FRANCISCO – , an exploratory analysis of the TITAN trial suggests.
Previous trial results for all 1,052 men randomized showed significant improvements in radiographic progression-free survival and overall survival from adding apalutamide versus placebo to androgen deprivation therapy (N Engl J Med. 2019;381:13-24), leading to recent Food and Drug Administration approval of the drug for metastatic castration-sensitive prostate cancer.
In the new analysis, investigators assessed progression-free survival 2 (PFS2), measured from time of randomization to investigator-determined disease progression or death, among the 277 men who went on to receive a subsequent life-prolonging therapy after progression on their trial therapy.
Results reported at the 2020 Genitourinary Cancers Symposium showed that the risk of PFS2 events was similarly reduced for patients who had initially received apalutamide vs. placebo regardless of whether their next therapy was a new hormonal therapy (32% reduction in risk) or a taxane (37% reduction in risk).
“The PFS2 benefit is an indicator of effective early intensification of treatment, is consistent with the overall survival benefit we have seen with this agent, and together shows totality of the treatment trajectory,” reported Neeraj Agarwal, MD, the study’s lead investigator. “These results may assist with counseling of patients with metastatic castration-sensitive prostate cancer who are contemplating various treatment options.”
The analysis was performed post hoc, and the subsequent therapy was left up to the treating clinicians, acknowledged Dr. Agarwal, professor of medicine and director of the genitourinary oncology program at the Huntsman Cancer Institute, University of Utah, Salt Lake City.
“A small number of events on subsequent therapy and the nonrandomized treatment decision preclude determination of best subsequent therapy based on these data,” he said. “We need further events and for data to mature more in order to pursue additional in-depth analysis.”
Some caveats
As only about a fifth of patients experienced PFS2 events, “these findings need to be interpreted with some caution,” said invited discussant Dana E. Rathkopf, MD, a genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York.
Another caveat is that the cohort analyzed comprised poor responders, who had experienced progression at a median of roughly 12 months whether on apalutamide or placebo, she noted. “If the patients were all on treatment for about 12 months, it does make me wonder why the apalutamide patients responded better than placebo patients to a second hormonal therapy, because you might think that, in the setting of poor response to upfront apalutamide, these patients may develop some type of intrinsic resistance that would suggest they would not respond to a second-line androgen receptor inhibitor relative to a taxane.”
Patients in TITAN were stratified on prior receipt of docetaxel before undergoing randomization. But simply by chance, among those receiving subsequent hormonal therapy, a larger share of those initially treated with apalutamide than of those initially treated with placebo had received the taxane (33% vs. 16%), which may have influenced outcomes, Dr. Rathkopf added.
“Further maturation of the data will tell us more,” she said. “But clearly, apalutamide in both the SPARTAN and TITAN trials improved PFS2 relative to placebo, and this begs the question of how we can better select treatment using predictive markers.”
Study details
Among the 277 men experiencing progression on their trial therapy and going on to receive a life-prolonging subsequent therapy, about 30% later received a new hormonal therapy – abiraterone or enzalutamide – and 35% subsequently received a taxane – docetaxel or cabazitaxel.
Overall, PFS2 was significantly better for men initially randomized to apalutamide, compared with counterparts initially randomized to placebo (hazard ratio for events, 0.66; P = .0026), Dr. Agarwal reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In stratified analyses, PFS2 was also significantly better with initial apalutamide vs. placebo whether patients went on to receive a new hormonal therapy (hazard ratio for events, 0.684; P = .0326) or taxane chemotherapy (hazard ratio for events, 0.634; P = .0062). Median values were not reached.
The trial was funded by Janssen Research & Development. Dr. Agarwal and Dr. Rathkopf each disclosed relationships with numerous pharmaceutical companies, including Janssen.
SOURCE: Agarwal N et al. GUCS 2020. Abstract 82.
REPORTING FROM GUCS 2020
Seminoma: Risk-adapted strategy could mean less toxic chemo
SAN FRANCISCO – with its toxicity. This was among key findings of the phase 2 SEMITEP trial reported at the 2020 Genitourinary Cancers Symposium.
Although four cycles of etoposide-cisplatin cure almost all cases of good-prognosis metastatic seminoma (Eur Urol. 2014;65:381-6), long-term cisplatin toxicity in this predominantly young population remains problematic, noted lead investigator Yohann Loriot, MD, PhD, a medical oncologist at Gustave Roussy Institute, Villejuif, France.
In SEMITEP, he and his colleagues tested a risk-adapted strategy among 98 patients with metastatic seminoma who met International Germ Cell Cancer Collaboration Group criteria for good prognosis and had not received any chemotherapy or radiotherapy.
Fully 68.4% had a negative FDG-PET result after two cycles of etoposide-cisplatin and were given only one cycle of carboplatin to complete treatment (based on that drug’s activity in low-volume disease), Dr. Loriot reported. The rest went on to receive an additional two cycles of etoposide-cisplatin, completing the standard regimen.
At 3 years, 9 in 10 patients were alive and free of progression in both the deescalated chemotherapy group and the standard chemotherapy group. The cumulative incidence of peripheral neuropathy, however, was about 10 times higher in the standard chemotherapy group.
“Deescalating chemotherapy based on an early FDG-PET is safe and feasible in metastatic seminoma,” Dr. Loriot said. “This strategy provides shorter treatment, reduces neuropathy, and eliminates need for bleomycin and its associated toxicity. SEMITEP supports the deescalating strategy in metastatic seminoma.”
Ready for prime time?
The SEMITEP trial achieved the main goal of reducing toxicity but had several noteworthy caveats, according to invited discussant Peter Albers, MD, professor and chairman of the department of urology, Heinrich-Heine University Düsseldorf, Germany.
First, in an “astonishing” feat, FDG-PET was performed and evaluable after just two cycles of chemotherapy, or 3 weeks, when typical practice is to wait until 8 or 10 weeks, he said.
“Second, I really don’t understand why carboplatin was given in an FDG-PET–negative seminoma,” Dr. Albers said. “There is, in my view, no reason to add another chemotherapy agent to this patient population if you really claim this to be a biomarker. Carboplatin is known to be inferior to cisplatin in metastatic seminoma.”
Third, enrolled patients predominantly had low-volume disease, with about two-thirds having clinical stage IIA or IIB. “So this study is not representative for all metastatic seminoma patients,” Dr. Albers cautioned. “But obviously, it gives a good signal, and those patients who had IIC disease in the deescalation arm have shown no recurrences so far.
“This trial is important and obviously accurately done, but to my mind, it’s not yet practice-changing. We need a clear comparison to standard treatment before we introduce FDG-PET as a biomarker in this indication,” he concluded, recommending that, for now, risk-stratified approaches should be limited to clinical trials.
Study details
Although 72% of patients in SEMITEP had a negative early FDG-PET result, four of them requested standard chemotherapy anyway and were analyzed in that group, Dr. Loriot noted at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
With a median follow-up of 33.9 months, the 36-month rate of progression-free survival was 89.9% in the deescalated chemotherapy group, essentially the same as the 90% in the standard chemotherapy group. There were no deaths during follow-up in either group.
During chemotherapy, the deescalation group had lower rates of grade 3 or 4 nausea and vomiting and ototoxicity, and a higher rate of grade 3 or 4 thrombocytopenia.
At 3 years, the cumulative incidence of any-grade peripheral neuropathy was less than 5% in the deescalated chemotherapy group, compared with about 50% in the standard chemotherapy group (P less than .001). There was also a trend toward a lower incidence of ototoxicity with deescalation.
The trial was funded by Institut National du Cancer (Programme Hospitalier de Recherche Clinique). Dr. Loriot disclosed no relevant conflicts of interest. Dr. Albers disclosed relationships with Sanofi, Roche, and Merck Sharp & Dohme Corp.
SOURCE: Loriot Y et al. GUCS 2020. Abstract 387.
SAN FRANCISCO – with its toxicity. This was among key findings of the phase 2 SEMITEP trial reported at the 2020 Genitourinary Cancers Symposium.
Although four cycles of etoposide-cisplatin cure almost all cases of good-prognosis metastatic seminoma (Eur Urol. 2014;65:381-6), long-term cisplatin toxicity in this predominantly young population remains problematic, noted lead investigator Yohann Loriot, MD, PhD, a medical oncologist at Gustave Roussy Institute, Villejuif, France.
In SEMITEP, he and his colleagues tested a risk-adapted strategy among 98 patients with metastatic seminoma who met International Germ Cell Cancer Collaboration Group criteria for good prognosis and had not received any chemotherapy or radiotherapy.
Fully 68.4% had a negative FDG-PET result after two cycles of etoposide-cisplatin and were given only one cycle of carboplatin to complete treatment (based on that drug’s activity in low-volume disease), Dr. Loriot reported. The rest went on to receive an additional two cycles of etoposide-cisplatin, completing the standard regimen.
At 3 years, 9 in 10 patients were alive and free of progression in both the deescalated chemotherapy group and the standard chemotherapy group. The cumulative incidence of peripheral neuropathy, however, was about 10 times higher in the standard chemotherapy group.
“Deescalating chemotherapy based on an early FDG-PET is safe and feasible in metastatic seminoma,” Dr. Loriot said. “This strategy provides shorter treatment, reduces neuropathy, and eliminates need for bleomycin and its associated toxicity. SEMITEP supports the deescalating strategy in metastatic seminoma.”
Ready for prime time?
The SEMITEP trial achieved the main goal of reducing toxicity but had several noteworthy caveats, according to invited discussant Peter Albers, MD, professor and chairman of the department of urology, Heinrich-Heine University Düsseldorf, Germany.
First, in an “astonishing” feat, FDG-PET was performed and evaluable after just two cycles of chemotherapy, or 3 weeks, when typical practice is to wait until 8 or 10 weeks, he said.
“Second, I really don’t understand why carboplatin was given in an FDG-PET–negative seminoma,” Dr. Albers said. “There is, in my view, no reason to add another chemotherapy agent to this patient population if you really claim this to be a biomarker. Carboplatin is known to be inferior to cisplatin in metastatic seminoma.”
Third, enrolled patients predominantly had low-volume disease, with about two-thirds having clinical stage IIA or IIB. “So this study is not representative for all metastatic seminoma patients,” Dr. Albers cautioned. “But obviously, it gives a good signal, and those patients who had IIC disease in the deescalation arm have shown no recurrences so far.
“This trial is important and obviously accurately done, but to my mind, it’s not yet practice-changing. We need a clear comparison to standard treatment before we introduce FDG-PET as a biomarker in this indication,” he concluded, recommending that, for now, risk-stratified approaches should be limited to clinical trials.
Study details
Although 72% of patients in SEMITEP had a negative early FDG-PET result, four of them requested standard chemotherapy anyway and were analyzed in that group, Dr. Loriot noted at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
With a median follow-up of 33.9 months, the 36-month rate of progression-free survival was 89.9% in the deescalated chemotherapy group, essentially the same as the 90% in the standard chemotherapy group. There were no deaths during follow-up in either group.
During chemotherapy, the deescalation group had lower rates of grade 3 or 4 nausea and vomiting and ototoxicity, and a higher rate of grade 3 or 4 thrombocytopenia.
At 3 years, the cumulative incidence of any-grade peripheral neuropathy was less than 5% in the deescalated chemotherapy group, compared with about 50% in the standard chemotherapy group (P less than .001). There was also a trend toward a lower incidence of ototoxicity with deescalation.
The trial was funded by Institut National du Cancer (Programme Hospitalier de Recherche Clinique). Dr. Loriot disclosed no relevant conflicts of interest. Dr. Albers disclosed relationships with Sanofi, Roche, and Merck Sharp & Dohme Corp.
SOURCE: Loriot Y et al. GUCS 2020. Abstract 387.
SAN FRANCISCO – with its toxicity. This was among key findings of the phase 2 SEMITEP trial reported at the 2020 Genitourinary Cancers Symposium.
Although four cycles of etoposide-cisplatin cure almost all cases of good-prognosis metastatic seminoma (Eur Urol. 2014;65:381-6), long-term cisplatin toxicity in this predominantly young population remains problematic, noted lead investigator Yohann Loriot, MD, PhD, a medical oncologist at Gustave Roussy Institute, Villejuif, France.
In SEMITEP, he and his colleagues tested a risk-adapted strategy among 98 patients with metastatic seminoma who met International Germ Cell Cancer Collaboration Group criteria for good prognosis and had not received any chemotherapy or radiotherapy.
Fully 68.4% had a negative FDG-PET result after two cycles of etoposide-cisplatin and were given only one cycle of carboplatin to complete treatment (based on that drug’s activity in low-volume disease), Dr. Loriot reported. The rest went on to receive an additional two cycles of etoposide-cisplatin, completing the standard regimen.
At 3 years, 9 in 10 patients were alive and free of progression in both the deescalated chemotherapy group and the standard chemotherapy group. The cumulative incidence of peripheral neuropathy, however, was about 10 times higher in the standard chemotherapy group.
“Deescalating chemotherapy based on an early FDG-PET is safe and feasible in metastatic seminoma,” Dr. Loriot said. “This strategy provides shorter treatment, reduces neuropathy, and eliminates need for bleomycin and its associated toxicity. SEMITEP supports the deescalating strategy in metastatic seminoma.”
Ready for prime time?
The SEMITEP trial achieved the main goal of reducing toxicity but had several noteworthy caveats, according to invited discussant Peter Albers, MD, professor and chairman of the department of urology, Heinrich-Heine University Düsseldorf, Germany.
First, in an “astonishing” feat, FDG-PET was performed and evaluable after just two cycles of chemotherapy, or 3 weeks, when typical practice is to wait until 8 or 10 weeks, he said.
“Second, I really don’t understand why carboplatin was given in an FDG-PET–negative seminoma,” Dr. Albers said. “There is, in my view, no reason to add another chemotherapy agent to this patient population if you really claim this to be a biomarker. Carboplatin is known to be inferior to cisplatin in metastatic seminoma.”
Third, enrolled patients predominantly had low-volume disease, with about two-thirds having clinical stage IIA or IIB. “So this study is not representative for all metastatic seminoma patients,” Dr. Albers cautioned. “But obviously, it gives a good signal, and those patients who had IIC disease in the deescalation arm have shown no recurrences so far.
“This trial is important and obviously accurately done, but to my mind, it’s not yet practice-changing. We need a clear comparison to standard treatment before we introduce FDG-PET as a biomarker in this indication,” he concluded, recommending that, for now, risk-stratified approaches should be limited to clinical trials.
Study details
Although 72% of patients in SEMITEP had a negative early FDG-PET result, four of them requested standard chemotherapy anyway and were analyzed in that group, Dr. Loriot noted at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
With a median follow-up of 33.9 months, the 36-month rate of progression-free survival was 89.9% in the deescalated chemotherapy group, essentially the same as the 90% in the standard chemotherapy group. There were no deaths during follow-up in either group.
During chemotherapy, the deescalation group had lower rates of grade 3 or 4 nausea and vomiting and ototoxicity, and a higher rate of grade 3 or 4 thrombocytopenia.
At 3 years, the cumulative incidence of any-grade peripheral neuropathy was less than 5% in the deescalated chemotherapy group, compared with about 50% in the standard chemotherapy group (P less than .001). There was also a trend toward a lower incidence of ototoxicity with deescalation.
The trial was funded by Institut National du Cancer (Programme Hospitalier de Recherche Clinique). Dr. Loriot disclosed no relevant conflicts of interest. Dr. Albers disclosed relationships with Sanofi, Roche, and Merck Sharp & Dohme Corp.
SOURCE: Loriot Y et al. GUCS 2020. Abstract 387.
REPORTING FROM GUCS 2020
FDA opens the door to biosimilar insulin
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
GI leaders receive AGA’s prestigious recognition prizes
AGA has announced the 2020 recipients of the annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA Recognition Prizes allow members to honor their colleagues and peers for outstanding contributions to the field of gastroenterology,” said Hashem B. El-Serag, MD, MPH, AGAF, president of the AGA Institute. “The 2020 AGA Recognition Prize winners are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”
The AGA Recognition Prizes will be presented during Digestive Disease Week® 2020, May 1-5, 2020, in Chicago, Illinois.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to Gail Hecht, MD, MS, AGAF, for her substantial contributions to the field of gastroenterology and AGA. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Hecht is internationally renowned for her pivotal contributions to the understanding of the important diarrheal pathogen, enteropathogenic E. coli. She is also a passionate advocate for the science and practice of gastroenterology, including serving as AGA Institute President. Dr. Hecht’s collegial and generous spirit, her past and continued leadership roles in AGA, her passion for and contributions to science and clinical medicine, and her dedication to both her patients and trainees have strengthened the specialty of gastroenterology, and also inspired and shaped the next generation of investigators and gastroenterologists. Dr. Hecht is currently assistant dean, medical student research and professor of medicine and microbiology/immunology at Loyola University Chicago Stritch School of Medicine, and a staff physician at Hines VA Medical Center, Chicago, Ill.
Distinguished Achievement Award in Basic Science
AGA recognizes R. Balfour Sartor, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly contributed to the understanding of the pathogenesis of inflammatory bowel diseases (IBD). Dr. Sartor’s seminal observations throughout his career helped launch the area of inquiry that led to the recognition that the microbiome is a key to metabolic disease, IBD, intestinal neoplasia and hepatic disorders. Dr. Sartor is the Margaret W. and Lorimer W. Midgett Distinguished Professor and a professor, departments of medicine, microbiology and immunology, University of North Carolina, Chapel Hill.
William Beaumont Prize
AGA honors two individuals with the William Beaumont Prize in Gastroenterology, which recognizes individuals who have made unique, outstanding contributions of major importance to the field of gastroenterology.
Dennis Ahnen, MD, AGAF, had made many contributions to the field of gastroenterology that have significantly advanced the care of patients through clinical and translational research into the pathobiology of colorectal cancer and its prevention. Dr. Ahnen, has provided exemplary service to AGA. He is director of genetics at Gastroenterology of the Rockies and Professor Emeritus of medicine at the University of Colorado Anschutz Medical Campus School of Medicine, Aurora.
Peter Kahrilas, MD, AGAF, has worked tirelessly and creatively to characterize the function and pathophysiology of the esophagus and has written the esophageal papers upon which a large portion of current research is based. Dr. Kahrilas has also dedicated many years of service to AGA and is currently the Gilbert H. Marquardt Professor of Medicine in the division of gastroenterology at the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Distinguished Educator Award
AGA honors Robert Fontana, MD, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels. Dr. Fontana’s greatest teaching impact has been the establishment of one of the most highly successful transplant hepatology fellowship training programs in the country. He has taught countless medical students, residents and fellows, as well as faculty members via his clear, concise, and well-organized lectures and presentations. Dr. Fontana is a professor of medicine, medical director of liver transplantation, and director of transplant hepatology fellowship ACGME-accredited training program at the University of Michigan, Ann Arbor.
Distinguished Clinician Awards
The AGA Distinguished Clinician Awards recognize members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award in Private Practice to Kimberly Persley, MD, AGAF. Dr. Persley made a huge impact on patient care in her community as the first IBD-specialty trained private practice gastroenterologist in the Dallas-Fort Worth, Texas, region. She was sought out by gastroenterologists and patients throughout the region for her thorough, kind and holistic care. Dr. Persley is a partner at Texas Digestive Disease Consultants and assistant clinical professor of medicine at the University of Texas Southwestern Medical School, Dallas, Texas.
AGA is honored to present the Distinguished Clinician Award in Clinical Academic Practice, to Gary Lichtenstein, MD, AGAF. Dr. Lichtenstein is a renowned physician, educator, and investigator whose local, regional, and national prominence is remarkable. Patients and physicians throughout the country seek his consultation and advice in IBD. Dr. Lichtenstein is a professor of medicine and director of the IBD Center at the University of Pennsylvania, Philadelphia.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Juanita Merchant, MD, PhD. This award recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Merchant is an exceptional mentor, providing guidance to multiple learners to jump start, enhance and guide their careers as scientists in gastroenterology. Many of her trainees are faculty in institutions around the world who have also stimulated young learners to pursue careers in science. Dr. Merchant is professor and chief of gastroenterology and hepatology at the University of Arizona, Tucson.
Research Service Award
AGA honors Peter Perrin, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterological science and research. As a program director at the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, Dr. Perrin has had a huge impact on NIH-funded digestive diseases research. At NIDDK, he has the largest portfolio of grants that have high impact in digestive diseases, in topics including immunology, microbiology, infectious diseases and IBD, barrier and transport functions, and AIDS/HIV.
Outstanding Service Award
AGA honors the Funderburg family with the Outstanding Service Award, which was created in 1972 to honor an individual(s) who has contributed significantly to society’s health and welfare. The family, which includes Rob and Cathy, Alex and Patty, and Hugh and Gail, has significantly contributed to the AGA Research Foundation through their personal philanthropy. Their parents established the AGA – R. Robert and Sally Funderburg Research Award in Gastric Cancer in 1992. In total, the family has given $3 million and with their most recent gift, they have permanently endowed their research award in gastric cancer.
The family encourages collaboration and communication between and among the Funderburg recipients and as a result, AGA established the annual Funderburg Symposium at DDW. This symposium allows leaders in the gastric cancer field, many of whom are past Funderburg recipients, to come together and learn about the latest advances and findings in gastric cancer research.
Young Investigator Awards
The AGA Young Investigator Awards recognize two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Jennifer Lai, MD, MBA, with the Young Investigator Award in Clinical Science. Dr. Lai has pioneered a research program in frailty in hepatology that is changing the way that gastroenterologists and hepatologists manage patients with liver disease. She has carved out a niche at the junction of aging and hepatology research that is particularly timely given the influx of older patients with cirrhosis being seen in clinical practice, as well as the rapid rise in cirrhotic patients with multiple co-morbidities and frailty seeking liver transplantation. Dr. Lai is an associate professor of medicine in residence and director of the Advancing Research in Clinical Hepatology Group in the division of gastroenterology and hepatology, at the University of California, San Francisco.
AGA honors Nobuhiko Kamada, PhD, with the Young Investigator Award in Basic Science. Dr. Kamada is known for his innovation combining fields examining the microbiota and the immune system in IBD, specifically, the interplay between diet, commensal and pathogenic microbes, and the immune system. He has published stellar findings that have been highly cited within short periods of time due to their innovation. Dr. Kamada is an assistant professor in the division of gastroenterology at the University of Michigan Medical School, Ann Arbor.
AGA has announced the 2020 recipients of the annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA Recognition Prizes allow members to honor their colleagues and peers for outstanding contributions to the field of gastroenterology,” said Hashem B. El-Serag, MD, MPH, AGAF, president of the AGA Institute. “The 2020 AGA Recognition Prize winners are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”
The AGA Recognition Prizes will be presented during Digestive Disease Week® 2020, May 1-5, 2020, in Chicago, Illinois.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to Gail Hecht, MD, MS, AGAF, for her substantial contributions to the field of gastroenterology and AGA. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Hecht is internationally renowned for her pivotal contributions to the understanding of the important diarrheal pathogen, enteropathogenic E. coli. She is also a passionate advocate for the science and practice of gastroenterology, including serving as AGA Institute President. Dr. Hecht’s collegial and generous spirit, her past and continued leadership roles in AGA, her passion for and contributions to science and clinical medicine, and her dedication to both her patients and trainees have strengthened the specialty of gastroenterology, and also inspired and shaped the next generation of investigators and gastroenterologists. Dr. Hecht is currently assistant dean, medical student research and professor of medicine and microbiology/immunology at Loyola University Chicago Stritch School of Medicine, and a staff physician at Hines VA Medical Center, Chicago, Ill.
Distinguished Achievement Award in Basic Science
AGA recognizes R. Balfour Sartor, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly contributed to the understanding of the pathogenesis of inflammatory bowel diseases (IBD). Dr. Sartor’s seminal observations throughout his career helped launch the area of inquiry that led to the recognition that the microbiome is a key to metabolic disease, IBD, intestinal neoplasia and hepatic disorders. Dr. Sartor is the Margaret W. and Lorimer W. Midgett Distinguished Professor and a professor, departments of medicine, microbiology and immunology, University of North Carolina, Chapel Hill.
William Beaumont Prize
AGA honors two individuals with the William Beaumont Prize in Gastroenterology, which recognizes individuals who have made unique, outstanding contributions of major importance to the field of gastroenterology.
Dennis Ahnen, MD, AGAF, had made many contributions to the field of gastroenterology that have significantly advanced the care of patients through clinical and translational research into the pathobiology of colorectal cancer and its prevention. Dr. Ahnen, has provided exemplary service to AGA. He is director of genetics at Gastroenterology of the Rockies and Professor Emeritus of medicine at the University of Colorado Anschutz Medical Campus School of Medicine, Aurora.
Peter Kahrilas, MD, AGAF, has worked tirelessly and creatively to characterize the function and pathophysiology of the esophagus and has written the esophageal papers upon which a large portion of current research is based. Dr. Kahrilas has also dedicated many years of service to AGA and is currently the Gilbert H. Marquardt Professor of Medicine in the division of gastroenterology at the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Distinguished Educator Award
AGA honors Robert Fontana, MD, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels. Dr. Fontana’s greatest teaching impact has been the establishment of one of the most highly successful transplant hepatology fellowship training programs in the country. He has taught countless medical students, residents and fellows, as well as faculty members via his clear, concise, and well-organized lectures and presentations. Dr. Fontana is a professor of medicine, medical director of liver transplantation, and director of transplant hepatology fellowship ACGME-accredited training program at the University of Michigan, Ann Arbor.
Distinguished Clinician Awards
The AGA Distinguished Clinician Awards recognize members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award in Private Practice to Kimberly Persley, MD, AGAF. Dr. Persley made a huge impact on patient care in her community as the first IBD-specialty trained private practice gastroenterologist in the Dallas-Fort Worth, Texas, region. She was sought out by gastroenterologists and patients throughout the region for her thorough, kind and holistic care. Dr. Persley is a partner at Texas Digestive Disease Consultants and assistant clinical professor of medicine at the University of Texas Southwestern Medical School, Dallas, Texas.
AGA is honored to present the Distinguished Clinician Award in Clinical Academic Practice, to Gary Lichtenstein, MD, AGAF. Dr. Lichtenstein is a renowned physician, educator, and investigator whose local, regional, and national prominence is remarkable. Patients and physicians throughout the country seek his consultation and advice in IBD. Dr. Lichtenstein is a professor of medicine and director of the IBD Center at the University of Pennsylvania, Philadelphia.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Juanita Merchant, MD, PhD. This award recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Merchant is an exceptional mentor, providing guidance to multiple learners to jump start, enhance and guide their careers as scientists in gastroenterology. Many of her trainees are faculty in institutions around the world who have also stimulated young learners to pursue careers in science. Dr. Merchant is professor and chief of gastroenterology and hepatology at the University of Arizona, Tucson.
Research Service Award
AGA honors Peter Perrin, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterological science and research. As a program director at the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, Dr. Perrin has had a huge impact on NIH-funded digestive diseases research. At NIDDK, he has the largest portfolio of grants that have high impact in digestive diseases, in topics including immunology, microbiology, infectious diseases and IBD, barrier and transport functions, and AIDS/HIV.
Outstanding Service Award
AGA honors the Funderburg family with the Outstanding Service Award, which was created in 1972 to honor an individual(s) who has contributed significantly to society’s health and welfare. The family, which includes Rob and Cathy, Alex and Patty, and Hugh and Gail, has significantly contributed to the AGA Research Foundation through their personal philanthropy. Their parents established the AGA – R. Robert and Sally Funderburg Research Award in Gastric Cancer in 1992. In total, the family has given $3 million and with their most recent gift, they have permanently endowed their research award in gastric cancer.
The family encourages collaboration and communication between and among the Funderburg recipients and as a result, AGA established the annual Funderburg Symposium at DDW. This symposium allows leaders in the gastric cancer field, many of whom are past Funderburg recipients, to come together and learn about the latest advances and findings in gastric cancer research.
Young Investigator Awards
The AGA Young Investigator Awards recognize two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Jennifer Lai, MD, MBA, with the Young Investigator Award in Clinical Science. Dr. Lai has pioneered a research program in frailty in hepatology that is changing the way that gastroenterologists and hepatologists manage patients with liver disease. She has carved out a niche at the junction of aging and hepatology research that is particularly timely given the influx of older patients with cirrhosis being seen in clinical practice, as well as the rapid rise in cirrhotic patients with multiple co-morbidities and frailty seeking liver transplantation. Dr. Lai is an associate professor of medicine in residence and director of the Advancing Research in Clinical Hepatology Group in the division of gastroenterology and hepatology, at the University of California, San Francisco.
AGA honors Nobuhiko Kamada, PhD, with the Young Investigator Award in Basic Science. Dr. Kamada is known for his innovation combining fields examining the microbiota and the immune system in IBD, specifically, the interplay between diet, commensal and pathogenic microbes, and the immune system. He has published stellar findings that have been highly cited within short periods of time due to their innovation. Dr. Kamada is an assistant professor in the division of gastroenterology at the University of Michigan Medical School, Ann Arbor.
AGA has announced the 2020 recipients of the annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA Recognition Prizes allow members to honor their colleagues and peers for outstanding contributions to the field of gastroenterology,” said Hashem B. El-Serag, MD, MPH, AGAF, president of the AGA Institute. “The 2020 AGA Recognition Prize winners are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”
The AGA Recognition Prizes will be presented during Digestive Disease Week® 2020, May 1-5, 2020, in Chicago, Illinois.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to Gail Hecht, MD, MS, AGAF, for her substantial contributions to the field of gastroenterology and AGA. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Hecht is internationally renowned for her pivotal contributions to the understanding of the important diarrheal pathogen, enteropathogenic E. coli. She is also a passionate advocate for the science and practice of gastroenterology, including serving as AGA Institute President. Dr. Hecht’s collegial and generous spirit, her past and continued leadership roles in AGA, her passion for and contributions to science and clinical medicine, and her dedication to both her patients and trainees have strengthened the specialty of gastroenterology, and also inspired and shaped the next generation of investigators and gastroenterologists. Dr. Hecht is currently assistant dean, medical student research and professor of medicine and microbiology/immunology at Loyola University Chicago Stritch School of Medicine, and a staff physician at Hines VA Medical Center, Chicago, Ill.
Distinguished Achievement Award in Basic Science
AGA recognizes R. Balfour Sartor, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly contributed to the understanding of the pathogenesis of inflammatory bowel diseases (IBD). Dr. Sartor’s seminal observations throughout his career helped launch the area of inquiry that led to the recognition that the microbiome is a key to metabolic disease, IBD, intestinal neoplasia and hepatic disorders. Dr. Sartor is the Margaret W. and Lorimer W. Midgett Distinguished Professor and a professor, departments of medicine, microbiology and immunology, University of North Carolina, Chapel Hill.
William Beaumont Prize
AGA honors two individuals with the William Beaumont Prize in Gastroenterology, which recognizes individuals who have made unique, outstanding contributions of major importance to the field of gastroenterology.
Dennis Ahnen, MD, AGAF, had made many contributions to the field of gastroenterology that have significantly advanced the care of patients through clinical and translational research into the pathobiology of colorectal cancer and its prevention. Dr. Ahnen, has provided exemplary service to AGA. He is director of genetics at Gastroenterology of the Rockies and Professor Emeritus of medicine at the University of Colorado Anschutz Medical Campus School of Medicine, Aurora.
Peter Kahrilas, MD, AGAF, has worked tirelessly and creatively to characterize the function and pathophysiology of the esophagus and has written the esophageal papers upon which a large portion of current research is based. Dr. Kahrilas has also dedicated many years of service to AGA and is currently the Gilbert H. Marquardt Professor of Medicine in the division of gastroenterology at the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Distinguished Educator Award
AGA honors Robert Fontana, MD, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels. Dr. Fontana’s greatest teaching impact has been the establishment of one of the most highly successful transplant hepatology fellowship training programs in the country. He has taught countless medical students, residents and fellows, as well as faculty members via his clear, concise, and well-organized lectures and presentations. Dr. Fontana is a professor of medicine, medical director of liver transplantation, and director of transplant hepatology fellowship ACGME-accredited training program at the University of Michigan, Ann Arbor.
Distinguished Clinician Awards
The AGA Distinguished Clinician Awards recognize members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award in Private Practice to Kimberly Persley, MD, AGAF. Dr. Persley made a huge impact on patient care in her community as the first IBD-specialty trained private practice gastroenterologist in the Dallas-Fort Worth, Texas, region. She was sought out by gastroenterologists and patients throughout the region for her thorough, kind and holistic care. Dr. Persley is a partner at Texas Digestive Disease Consultants and assistant clinical professor of medicine at the University of Texas Southwestern Medical School, Dallas, Texas.
AGA is honored to present the Distinguished Clinician Award in Clinical Academic Practice, to Gary Lichtenstein, MD, AGAF. Dr. Lichtenstein is a renowned physician, educator, and investigator whose local, regional, and national prominence is remarkable. Patients and physicians throughout the country seek his consultation and advice in IBD. Dr. Lichtenstein is a professor of medicine and director of the IBD Center at the University of Pennsylvania, Philadelphia.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Juanita Merchant, MD, PhD. This award recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Merchant is an exceptional mentor, providing guidance to multiple learners to jump start, enhance and guide their careers as scientists in gastroenterology. Many of her trainees are faculty in institutions around the world who have also stimulated young learners to pursue careers in science. Dr. Merchant is professor and chief of gastroenterology and hepatology at the University of Arizona, Tucson.
Research Service Award
AGA honors Peter Perrin, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterological science and research. As a program director at the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Bethesda, MD, Dr. Perrin has had a huge impact on NIH-funded digestive diseases research. At NIDDK, he has the largest portfolio of grants that have high impact in digestive diseases, in topics including immunology, microbiology, infectious diseases and IBD, barrier and transport functions, and AIDS/HIV.
Outstanding Service Award
AGA honors the Funderburg family with the Outstanding Service Award, which was created in 1972 to honor an individual(s) who has contributed significantly to society’s health and welfare. The family, which includes Rob and Cathy, Alex and Patty, and Hugh and Gail, has significantly contributed to the AGA Research Foundation through their personal philanthropy. Their parents established the AGA – R. Robert and Sally Funderburg Research Award in Gastric Cancer in 1992. In total, the family has given $3 million and with their most recent gift, they have permanently endowed their research award in gastric cancer.
The family encourages collaboration and communication between and among the Funderburg recipients and as a result, AGA established the annual Funderburg Symposium at DDW. This symposium allows leaders in the gastric cancer field, many of whom are past Funderburg recipients, to come together and learn about the latest advances and findings in gastric cancer research.
Young Investigator Awards
The AGA Young Investigator Awards recognize two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Jennifer Lai, MD, MBA, with the Young Investigator Award in Clinical Science. Dr. Lai has pioneered a research program in frailty in hepatology that is changing the way that gastroenterologists and hepatologists manage patients with liver disease. She has carved out a niche at the junction of aging and hepatology research that is particularly timely given the influx of older patients with cirrhosis being seen in clinical practice, as well as the rapid rise in cirrhotic patients with multiple co-morbidities and frailty seeking liver transplantation. Dr. Lai is an associate professor of medicine in residence and director of the Advancing Research in Clinical Hepatology Group in the division of gastroenterology and hepatology, at the University of California, San Francisco.
AGA honors Nobuhiko Kamada, PhD, with the Young Investigator Award in Basic Science. Dr. Kamada is known for his innovation combining fields examining the microbiota and the immune system in IBD, specifically, the interplay between diet, commensal and pathogenic microbes, and the immune system. He has published stellar findings that have been highly cited within short periods of time due to their innovation. Dr. Kamada is an assistant professor in the division of gastroenterology at the University of Michigan Medical School, Ann Arbor.
AGA honors today’s luminaries in GI
Celebrate with the AGA Research Foundation. AGA members are pillars of the GI community, dedicated to helping us achieve our goal of a world free of digestive diseases.
To honor the lifelong contributions and achievements of some of our most esteemed members, we are pleased to present the AGA Research Foundation’s newest program, AGA Honors: Celebrating Difference Makers in Our Field.
Our honorees have been chosen for their pivotal role in shaping the future of gastroenterology and hepatology. Honorees span the gamut from mentors and researchers to administrators and clinicians and educators across a myriad of disciplines:
John I. Allen, MD, MBA, AGAF
Rodger A. Liddle, MD
C. Richard Boland, MD, AGAF
David A. Lieberman, MD, AGAF
Martin Brotman, MD, AGAF
Pankaj J. Pasricha, MD
Michael Camilleri, MD, AGAF
Chung Owyang, MD, AGAF
Eugene B. Chang, MD, AGAF
Jean-Pierre Raufman, MD
Sheila Crowe, MD, AGAF
Don C. Rockey, MD, AGAF
Francis M. Giardiello, MD, AGAF
Anil K. Rustgi, MD, AGAF
Fred S. Gorelick, MD
Robert S. Sandler, MD, MPH, AGAF
Gail A. Hecht, MD, AGAF
Michael L. Weinstein, MD
Wayne I. Lencer, MD, AGAF
C. Mel Wilcox, MD
We invite you to learn more about our honorees and to celebrate their contributions to the field by making a donation to the AGA Research Foundation by visiting our website at http://foundation.gastro.org/aga-honors-celebrating/.
Celebrate with the AGA Research Foundation. AGA members are pillars of the GI community, dedicated to helping us achieve our goal of a world free of digestive diseases.
To honor the lifelong contributions and achievements of some of our most esteemed members, we are pleased to present the AGA Research Foundation’s newest program, AGA Honors: Celebrating Difference Makers in Our Field.
Our honorees have been chosen for their pivotal role in shaping the future of gastroenterology and hepatology. Honorees span the gamut from mentors and researchers to administrators and clinicians and educators across a myriad of disciplines:
John I. Allen, MD, MBA, AGAF
Rodger A. Liddle, MD
C. Richard Boland, MD, AGAF
David A. Lieberman, MD, AGAF
Martin Brotman, MD, AGAF
Pankaj J. Pasricha, MD
Michael Camilleri, MD, AGAF
Chung Owyang, MD, AGAF
Eugene B. Chang, MD, AGAF
Jean-Pierre Raufman, MD
Sheila Crowe, MD, AGAF
Don C. Rockey, MD, AGAF
Francis M. Giardiello, MD, AGAF
Anil K. Rustgi, MD, AGAF
Fred S. Gorelick, MD
Robert S. Sandler, MD, MPH, AGAF
Gail A. Hecht, MD, AGAF
Michael L. Weinstein, MD
Wayne I. Lencer, MD, AGAF
C. Mel Wilcox, MD
We invite you to learn more about our honorees and to celebrate their contributions to the field by making a donation to the AGA Research Foundation by visiting our website at http://foundation.gastro.org/aga-honors-celebrating/.
Celebrate with the AGA Research Foundation. AGA members are pillars of the GI community, dedicated to helping us achieve our goal of a world free of digestive diseases.
To honor the lifelong contributions and achievements of some of our most esteemed members, we are pleased to present the AGA Research Foundation’s newest program, AGA Honors: Celebrating Difference Makers in Our Field.
Our honorees have been chosen for their pivotal role in shaping the future of gastroenterology and hepatology. Honorees span the gamut from mentors and researchers to administrators and clinicians and educators across a myriad of disciplines:
John I. Allen, MD, MBA, AGAF
Rodger A. Liddle, MD
C. Richard Boland, MD, AGAF
David A. Lieberman, MD, AGAF
Martin Brotman, MD, AGAF
Pankaj J. Pasricha, MD
Michael Camilleri, MD, AGAF
Chung Owyang, MD, AGAF
Eugene B. Chang, MD, AGAF
Jean-Pierre Raufman, MD
Sheila Crowe, MD, AGAF
Don C. Rockey, MD, AGAF
Francis M. Giardiello, MD, AGAF
Anil K. Rustgi, MD, AGAF
Fred S. Gorelick, MD
Robert S. Sandler, MD, MPH, AGAF
Gail A. Hecht, MD, AGAF
Michael L. Weinstein, MD
Wayne I. Lencer, MD, AGAF
C. Mel Wilcox, MD
We invite you to learn more about our honorees and to celebrate their contributions to the field by making a donation to the AGA Research Foundation by visiting our website at http://foundation.gastro.org/aga-honors-celebrating/.
Now open: registration for DDW® 2020 and the AGA Postgraduate Course
Digestive Disease Week® (DDW) is taking place May 2-5, 2020, at McCormick Place in Chicago, Ill. Featuring clinical care updates – presented nowhere else during DDW – the AGA Postgraduate Course will be held in conjunction with DDW on May 2 and 3. You can register for both together. Visit DDW.org and AGA University, agau.gastro.org, to learn more about each.
Improve patient care
The AGA Postgraduate Course is a comprehensive 1.5-day program highlighting ground-breaking advances in the delivery of high-quality, patient-centered GI care. Attendees will participate in dynamic case-based sessions, learning lunches and panel discussions, and will walk away with best practices for treating a variety of disease states and digestive disorders.
The brightest ideas and breakthroughs in digestive disease
DDW continues to improve and consolidate its reputation as the meeting that brings the brightest ideas and breakthroughs in digestive disease. Prepare to be blown away in the Windy City by all that DDW has to offer:
More than 400 scientific sessions, organized by educational tracks and presented in a wide range of session formats. New sessions include an AGA Clinical Plenary, Topic-Focused Workshops on hypnosis techniques and nutrition, and expanded programming in the DDW Trainee and Early Career Lounge.
Opportunities to connect with over 14,000 attendees from around the world, including top GI experts. New Continuing Conversation blocks, immediately following select invited-speaker sessions, allow you time to network with presenters and fellow attendees.
An Exhibit Hall spotlighting new innovations and technologies that you can implement in your practice.
Digestive Disease Week® (DDW) is taking place May 2-5, 2020, at McCormick Place in Chicago, Ill. Featuring clinical care updates – presented nowhere else during DDW – the AGA Postgraduate Course will be held in conjunction with DDW on May 2 and 3. You can register for both together. Visit DDW.org and AGA University, agau.gastro.org, to learn more about each.
Improve patient care
The AGA Postgraduate Course is a comprehensive 1.5-day program highlighting ground-breaking advances in the delivery of high-quality, patient-centered GI care. Attendees will participate in dynamic case-based sessions, learning lunches and panel discussions, and will walk away with best practices for treating a variety of disease states and digestive disorders.
The brightest ideas and breakthroughs in digestive disease
DDW continues to improve and consolidate its reputation as the meeting that brings the brightest ideas and breakthroughs in digestive disease. Prepare to be blown away in the Windy City by all that DDW has to offer:
More than 400 scientific sessions, organized by educational tracks and presented in a wide range of session formats. New sessions include an AGA Clinical Plenary, Topic-Focused Workshops on hypnosis techniques and nutrition, and expanded programming in the DDW Trainee and Early Career Lounge.
Opportunities to connect with over 14,000 attendees from around the world, including top GI experts. New Continuing Conversation blocks, immediately following select invited-speaker sessions, allow you time to network with presenters and fellow attendees.
An Exhibit Hall spotlighting new innovations and technologies that you can implement in your practice.
Digestive Disease Week® (DDW) is taking place May 2-5, 2020, at McCormick Place in Chicago, Ill. Featuring clinical care updates – presented nowhere else during DDW – the AGA Postgraduate Course will be held in conjunction with DDW on May 2 and 3. You can register for both together. Visit DDW.org and AGA University, agau.gastro.org, to learn more about each.
Improve patient care
The AGA Postgraduate Course is a comprehensive 1.5-day program highlighting ground-breaking advances in the delivery of high-quality, patient-centered GI care. Attendees will participate in dynamic case-based sessions, learning lunches and panel discussions, and will walk away with best practices for treating a variety of disease states and digestive disorders.
The brightest ideas and breakthroughs in digestive disease
DDW continues to improve and consolidate its reputation as the meeting that brings the brightest ideas and breakthroughs in digestive disease. Prepare to be blown away in the Windy City by all that DDW has to offer:
More than 400 scientific sessions, organized by educational tracks and presented in a wide range of session formats. New sessions include an AGA Clinical Plenary, Topic-Focused Workshops on hypnosis techniques and nutrition, and expanded programming in the DDW Trainee and Early Career Lounge.
Opportunities to connect with over 14,000 attendees from around the world, including top GI experts. New Continuing Conversation blocks, immediately following select invited-speaker sessions, allow you time to network with presenters and fellow attendees.
An Exhibit Hall spotlighting new innovations and technologies that you can implement in your practice.
Diversify GI: Mayra Sanchez
We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.
Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.
“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”
Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.
“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”
An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.
While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.
“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
Let’s get personal
What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”
... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”
What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”
What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”
If I weren’t in gastroenterology, I would be ... “a writer.”
In my free time I like to ... “travel with my family to experience new cultures.”
We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.
Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.
“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”
Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.
“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”
An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.
While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.
“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
Let’s get personal
What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”
... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”
What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”
What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”
If I weren’t in gastroenterology, I would be ... “a writer.”
In my free time I like to ... “travel with my family to experience new cultures.”
We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.
Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.
“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”
Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.
“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”
An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.
While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.
“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
Let’s get personal
What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”
... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”
What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”
What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”
If I weren’t in gastroenterology, I would be ... “a writer.”
In my free time I like to ... “travel with my family to experience new cultures.”
AGA congressional champion Phil Roe announces retirement
Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.
Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
GI wins with Roe
Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.
Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.
Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.
Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.
Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
GI wins with Roe
Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.
Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.
Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.
Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.
Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
GI wins with Roe
Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.
Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.
Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.